Federal Register final rules — 1996-04-22

issue-1996-04-22Federal Register final rules — 1996-04-22Regulation

Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.

FR Doc. 96-9913 Interim Final Determination That State Has Corrected the Deficiency; Ohio
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17576-17577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9913]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[OH97-1; FRL-5462-2]

Interim Final Determination That State Has Corrected the 
Deficiency; Ohio

AGENCY: U.S. Environmental Protection Agency (USEPA).

ACTION: Interim final determination.

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SUMMARY: In the proposed rules section of this Federal Register, USEPA 
has proposed conditional approval of the State of Ohio's New Source 
Review (NSR) program rules. Based on the proposed conditional approval, 
USEPA is making an interim final determination by this action that Ohio 
has corrected the deficiency for which a sanctions clock began on 
October 21, 1994. This action will defer application of the offset 
sanction and defer the application of the highway sanction. Although 
this action is effective upon publication, USEPA will take comment and 
will publish a final rule taking into consideration any comments 
received on this interim final rule.

DATES: This action will be effective April 22, 1996. Comments must be 
received by May 22, 1996.

ADDRESSES: Comments should be sent to: J. Elmer Bortzer, Chief, 
Regulation Development Section, Air Programs Branch (AR-18J), U.S. 
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, 
Chicago, IL 60604. The State submittal and USEPA's analysis for that 
submittal, which are the basis for this action, are available for 
public review at the above address.

FOR FURTHER INFORMATION CONTACT: Genevieve Nearmyer, Permits and Grants 
Section, Air Programs Branch, U.S. Environmental Protection Agency, 
Region 5, 77 West Jackson Boulevard, Chicago, IL 60604. (312) 353-4761.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 20, 1993 the State submitted an NSR plan revision request 
which USEPA disapproved in full on September 24, 1994 (59 FR 48392). 
The USEPA's disapproval action started an

[[Page 17577]]

18-month clock for the application of one sanction (followed by a 
second sanction 6 months later) under section 179 of the Clean Air Act 
(CAA) and a 24-month clock for promulgation of a Federal implementation 
plan under section 110(c)(1) of the CAA. The State subsequently 
submitted a revised program on April 12, 1996. In the proposed rules 
section of this Federal Register, USEPA has proposed conditional 
approval of the State of Ohio's submittal of its NSR requested State 
Implementation Plan revision.

II. USEPA Action

    Based on the proposed conditional approval set forth in the 
proposed rules section of this Federal Register, USEPA believes that it 
is more likely than not that the State has corrected the original 
disapproval deficiency that started the sanction clock and, therefore, 
is taking this interim final action finding that the State has 
corrected the disapproval deficiency, effective on publication. This 
action does not stop the sanction clock that started for this area on 
October 21, 1994. However, this action will defer the application of 
the offsets sanction and will defer the application of the highway 
sanction. See 59 FR 39832 (Aug. 4, 1994) codified at 40 CFR 52.31. If 
USEPA takes final action conditionally approving the State's submittal, 
such action will continue any deferral of the offset and highway 
sanctions. When the State meets its commitment and USEPA takes final 
action fully approving the State's submittal meeting those commitments, 
such action will permanently stop the sanctions clock and will 
permanently lift any applied, stayed or deferred sanctions.
    At this time, USEPA is also providing the public with an 
opportunity to comment on this final action. If, based on the comments 
on this action and the comments on USEPA's proposed conditional 
approval of the State's submittal, USEPA determines that the State's 
submittal is not approvable and this final action was inappropriate, 
USEPA will take further action to disapprove the State's submittal and 
to find that the State has not corrected the original disapproval 
deficiency. Such action will retrigger the sanctions consequences as 
described in the sanctions rule. See 59 FR 39832.

III. Administrative Requirements

    Because USEPA has preliminarily determined that the State has an 
approvable plan, relief from sanctions should be provided as quickly as 
possible. Therefore, USEPA is invoking the good cause exception under 
the Administrative Procedure Act (APA) in not providing an opportunity 
for comment before this action takes effect.1 See 5 U.S.C. 
553(b)(B). The USEPA believes that notice-and-comment rulemaking before 
the effective date of this action is impracticable and contrary to the 
public interest. The USEPA has reviewed the State's submittal and, 
through its proposed action, is indicating that it is more likely than 
not that the State has corrected the deficiency that started the 
sanctions clock. Therefore, it is not in the public interest to 
initially apply sanctions or to keep applied sanctions in place when 
the State has most likely done all that it can to correct the 
deficiency that triggered the sanctions clock. Moreover, it would be 
impracticable to go through notice-and-comment rulemaking on a finding 
that the State has corrected the deficiency prior to the rulemaking 
approving the State's submittal. Therefore, USEPA believes that it is 
necessary to use the interim final rulemaking process to temporarily 
stay or defer sanctions while USEPA completes its rulemaking process on 
the approvability of the State's submittal. In addition, USEPA is 
invoking the good cause exception to the 30-day notice requirement of 
the APA because the purpose of this notice is to relieve a restriction. 
See 5 U.S.C. 553(d)(1).
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    \1\ As previously noted, however, by this action USEPA is 
providing the public with a chance to comment on USEPA's 
determination after the effective date and USEPA will consider any 
comments received in determining whether to reverse such action.
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    The Office of Management and Budget has exempted this action from 
review under Executive Order 12866.
    Under the Regulatory Flexibility Act, 5 U.S.C. Section 600 et seq., 
USEPA must prepare a regulatory flexibility analysis assessing the 
impact of any proposed or final rule on small entities. 5 U.S.C. 
sections 603 and 604. Alternatively, USEPA may certify that the rule 
will not have a significant economic impact on a substantial number of 
small entities. Small entities include small businesses, small not-for-
profit enterprises, and government entities with jurisdiction over 
populations of less than 50,000.
    This action temporarily relieves sources of an additional burden 
potentially placed on them by the sanctions provisions of the CAA. 
Therefore, I certify that it does not have an impact on any small 
entities.
    Under sections 202, 203 and 205 of the Unfunded Mandates Reform Act 
of 1995 (Unfunded Mandates Act), signed into law on March 22, 1995, 
USEPA must undertake various actions in association with proposed or 
final rules that include a Federal mandate that may result in estimated 
costs of $100 million or more to the private sector, or to a State, 
local and/or tribal government(s) in the aggregate. The USEPA must also 
develop a plan with regard to small governments that would be 
significantly or uniquely affected by the rule.
    Because this direct final rule is estimated to result in the 
expenditure by State, local and tribal governments or the private 
sector of less than $100 million in any one year, USEPA has not 
prepared a budgetary impact statement or specifically addressed the 
selection of the least costly, most cost effective, or least burdensome 
alternative because small governments will not be significantly or 
uniquely affected by this rule, USEPA is not required to develop a plan 
for small governments. Further, this final rule only defers the 
imposition of sanctions; it imposes no new requirements.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Hydrocarbons, 
Incorporation by reference, Intergovernmental regulations, Reporting 
and recordkeeping requirements, Ozone, and Volatile organic compounds.

    Authority: 42 U.S.C. 7401-7671q.

    Dated: April 15, 1996.
David A. Ullrich,
Acting Regional Administrator.
[FR Doc. 96-9913 Filed 4-19-96; 8:45 am]
BILLING CODE 6560-50-P

Complete official Federal Register PDF

FR Doc. 96-9833 Imported Fire Ant Quarantined Areas
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17550-17551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9833]

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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. 95-063-2]

Imported Fire Ant Quarantined Areas

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are adopting as a final rule, with one change, an interim 
rule that amended the imported fire ant regulations by designating all 
or portions of the following as quarantined areas: The entire State of 
Mississippi; Mecklenburg County in North Carolina; Bradley, Hamilton, 
McMinn, and Wayne Counties in Tennessee; and Brooks, Cameron, Delta, 
Dimmit, Duval, Jack, Kenedy, Kinney, Lamar, Mason, McCulloch, Montague, 
San Saba, Webb, Young, and Zavala Counties in Texas. As amended by this 
document, the rule expands the quarantined areas and imposes certain 
restrictions on the interstate movement of quarantined articles from 
those areas. This action is necessary to prevent the artificial spread 
of the imported fire ant to noninfested areas of the United States.

EFFECTIVE DATE: April 22, 1996.

FOR FURTHER INFORMATION CONTACT: Mr. Michael B. Stefan, Operations 
Officer, Domestic and Emergency Operations, PPQ, APHIS, 4700 River Road 
Unit 134, Riverdale, MD 20737-1236, (301) 734-7338; or e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION:

Background

    The imported fire ant regulations (contained in 7 CFR 301.81 
through 301.81-10, and referred to below as the regulations) quarantine 
infested States or infested areas within States and impose restrictions 
on the interstate movement of certain regulated articles for the 
purpose of preventing the artificial spread of the imported fire ant.
    Imported fire ants, Solenopsis invicta Buren and Solenopsis 
richteri Forel, are aggressive, stinging insects that, in large 
numbers, can seriously injure or even kill livestock, pets, and humans. 
The imported fire ant feeds on crops and builds large, hard mounds that 
damage farm and field machinery. The imported fire ant is not native to 
the United States. The regulations prevent the imported fire ant from 
spreading throughout its ecological range within this country.
    The regulations in Sec. 301.81-3 provide that the Administrator of 
the Animal and Plant Health Inspection Service (APHIS) will list as a 
quarantined area each State, or each portion of a State, that is 
infested with imported fire ants. The Administrator will designate less 
than an entire State only under the following conditions: (1) The State 
has adopted and is enforcing restrictions on the intrastate movement of 
the regulated articles listed in Sec. 301.81-2 that are equivalent to 
the interstate movement restrictions imposed by the regulations; and 
(2) designating less than the entire State will prevent the spread of 
the imported fire ant. The Administrator may include uninfested acreage 
within a quarantined area due to its proximity to an infestation or its 
inseparability from the infested locality for quarantine purposes.
    In an interim rule effective and published in the Federal Register 
on October 11, 1995 (60 FR 52831-52833, Docket No. 95-063-1), we 
amended the imported fire ant regulations by designating all or 
portions of the following as quarantined areas: The entire State of 
Mississippi; Mecklenburg County in North Carolina; Bradley, Hamilton, 
McMinn, and Wayne Counties in Tennessee; and Brooks, Cameron, Delta, 
Dimmit, Duval, Jack, Kenedy, Kinney, Lamar, Mason, McCulloch, Montague, 
San Saba, Webb, Young, and Zavala Counties in Texas. This action 
expanded the quarantined areas and imposed certain restrictions on the 
interstate movement of quarantined articles from those areas. This 
action was necessary because recent surveys conducted by APHIS and 
State and county agencies revealed that the imported fire ant had 
spread to these areas.
    We solicited comments concerning the interim rule for 60 days 
ending December 11, 1995. We received 1 comment by that date. The 
comment was from a State Department of Agriculture.
    The commenter stated that our description of the new quarantined 
area in Wayne County, Tennessee, was not clear and could be misread to 
describe a smaller portion of the county than what the commenter 
believed we intended. We agree with the commenter and are, therefore, 
amending the interim rule by revising the description of the 
quarantined area in Wayne County, Tennessee, to make it clear that it 
includes that portion of the county south of Highway 64 and that 
portion of the county west of Longitude 87 deg. 55'.
    Therefore, based on the rationale set forth in the interim rule and 
in this document, we are adopting the provisions of the interim rule as 
a final rule, with the changes discussed in this document.
    This final rule also affirms the information contained in the 
interim rule concerning Executive Order 12866 and the Regulatory 
Flexibility Act, Executive Orders 12372 and 12778, the National 
Environmental Policy Act, and the Paperwork Reduction Act.
    Further, for this action, the Office of Management and Budget has 
waived the review process required by Executive Order 12866.

Effective Date

    Pursuant to the administrative procedure provisions in 5 U.S.C. 
553, we find good cause for making this rule effective less than 30 
days after publication in the Federal Register. The interim rule 
adopted as final by this rule was effective on October 11, 1995. This 
rule revises the description of the quarantined area in the interim 
rule. Immediate action is necessary in order to prevent the artificial 
spread of imported fire ant to noninfested areas of the United States. 
Therefore, the Administrator of the Animal and Plant Health Inspection 
Service has determined that this rule should be effective upon 
publication in the Federal Register.

List of Subjects in 7 CFR Part 301

    Agricultural commodities, Plant diseases and pests, Quarantine, 
Reporting and recordkeeping requirements, Transportation.

    Accordingly, 7 CFR part 301 is amended as follows:

PART 301--DOMESTIC QUARANTINE NOTICES

    1. The authority citation for part 301 continues to read as 
follows:

    Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, and 
164-167; 7 CFR 2.22, 2.80, and 371.2(c).

[[Page 17551]]

    2. In Sec. 301.81-3, paragraph (e), the list of quarantined areas 
is amended by revising the entry for Wayne County, Tennessee, to read 
as follows:

Sec. 301.81-3  Quarantined areas.

* * * * *
    (e) * * *
* * * * *
TENNESSEE
* * * * *
    Wayne County. That portion of the county lying south of U.S. 
Highway 64 and also that portion of the county lying west of Longitude 
87 deg. 55'.
* * * * *
    Done in Washington, DC, this 15th day of April 1996.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-9833 Filed 4-19-96; 8:45 am]
BILLING CODE 3410-34-P

Complete official Federal Register PDF

FR Doc. 96-9828 Winter Pears Grown in Oregon, Washington, and California; Order Amending the Order
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17552-17555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9828]

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[[Page 17553]]

DEPARTMENT OF AGRICULTURE
7 CFR Part 927
[Docket No. AO-99-A-6; FV-92-065]

Winter Pears Grown in Oregon, Washington, and California; Order 
Amending the Order

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the marketing agreement and order for 
winter pears grown in Oregon, Washington, and California. The 
amendments were recommended by the Winter Pear Control Committee 
(WPCC), the agency responsible for local administration of the 
marketing order, and were favored by winter pear producers in a 
referendum held from November 1 through November 30, 1995. The 
amendments will: Redefine ``ship or handle'' to include shipments of 
winter pears within the production area; update the definition of 
``export market'' to recognize that there are now 50 states in the 
United States; authorize the WPCC to accept voluntary contributions and 
how such funds may be used; and revise the authority for exempting 
certain shipments from regulation. These amendments are designed to 
improve the administration, operation and function of the winter pear 
marketing agreement and order program.

EFFECTIVE DATE: May 22, 1996.

FOR FURTHER INFORMATION CONTACT: Britthany E. Beadle, Marketing 
Specialist, Marketing Order Administration Branch, Fruit and Vegetable 
Division, AMS, USDA, PO Box 96456, Room 2522-S, Washington, DC 20090-
6456, telephone (202) 720-5127; or Teresa L. Hutchinson, Marketing 
Specialist, Northwest Marketing Field Office, Marketing Order 
Administration Branch, Fruit and Vegetable Division, AMS, USDA, 1220 SW 
Third Avenue, room 369, Portland, Oregon 97204-2807, telephone: (503) 
326-2724.

SUPPLEMENTARY INFORMATION: Prior documents in this proceeding: Notice 
of Hearing issued on November 16, 1992, and published in the November 
20, 1992, issue of the Federal Register (57 FR 54728). Recommended 
Decision and Opportunity to File Written Exceptions issued on March 15, 
1995, and published in the Federal Register on March 21, 1995, (60 FR 
14914). Secretary's Decision and Referendum Order issued on June 22, 
1995, and published in the Federal Register on June 29, 1995, (60 FR 
3376).
    This administrative action is governed by the provisions of section 
556 and 557 of Title 5 of the United States Code and therefore, is 
excluded from the requirements of Executive Order 12866.
    This rule has been reviewed under Executive Order 12778, Civil 
Justice Reform. This rule is not intended to have retroactive effect. 
This rule will not preempt any State or local laws, regulations, or 
policies, unless they present an irreconcilable conflict with this 
rule.
    The Agricultural Marketing Agreement Act of 1937 (Act), as amended 
(7 U.S.C. 601 et seq.) provides that administrative proceedings must be 
exhausted before parties may file suit in court. Under section 
608c(15)(A) of the Act, any handler subject to an order may file with 
the Secretary a petition stating that the order, any provision of the 
order, or any obligation imposed in connection with the order is not in 
accordance with law and request a modification of the order or to be 
exempted therefrom. A handler is afforded the opportunity for a hearing 
on the petition. After the hearing the Secretary would rule on the 
petition. The Act provides that the district court of the United States 
in any district in which the handler is an inhabitant, or has his or 
her principal place of business, has jurisdiction in equity to review 
the Secretary's ruling on the petition, provided a bill in equity is 
filed not later than 20 days after date of the entry of the ruling.

Preliminary Statement

    This final rule was formulated on the record of a public hearing 
held in Portland, Oregon, on December 2, 1992, to consider the proposed 
amendment of Marketing Agreement and Order No. 927, regulating the 
handling of winter pears grown in Oregon, Washington, and California, 
hereinafter referred to collectively as the ``order.'' The hearing was 
held pursuant to the provisions of the Act and the applicable rules of 
practice and procedure governing proceedings to formulate marketing 
agreements and marketing orders (7 CFR Part 900). The Notice of Hearing 
contained several amendment proposals submitted by the WPCC established 
under the order to assist in local administration of the marketing 
order.
    This final rule: (1) Redefines ``ship or handle'' to include 
shipments of winter pears within the production area; (2) updates the 
definition of ``export market'' to recognize that there are now 50 
states in the United States; (3) authorizes the WPCC to accept 
voluntary contributions and specifies how such funds may be used; and 
(4) revises the authority for exempting certain shipments from 
regulation.
    Upon the basis of evidence introduced at the hearing and the record 
thereof, the Administrator of the Agricultural Marketing Service (AMS) 
on March 21, 1995, filed with the Hearing Clerk, Department of 
Agriculture, a Recommended Decision and Opportunity to File Written 
Exceptions thereto by April 20, 1995. None were filed.
    A Secretary's Decision and Referendum Order was issued on June 22, 
1995, directing that a referendum be conducted during the period 
November 1 through November 30, 1995, among winter pear producers to 
determine whether they favored the proposed amendments to the order. In 
that referendum, producers voted in favor of all four of the amendment 
proposals listed on the referendum ballot. All of the proposed 
amendments were favored by more then the requisite two-thirds of the 
producers voting in the referendum by number and volume.
    The amended marketing agreement was subsequently mailed to all 
winter pear handlers throughout the production area for their approval. 
The marketing agreement was signed by handlers of more than 50 percent 
of the volume of winter pears handled by all handlers during the 
representative period of July 1, 1994, through June 30, 1995.

Small Business Considerations

    In accordance with the provisions of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), the Administrator of the AMS has 
determined that this action will not have a significant economic impact 
on a substantial number of small entities. Small agricultural producers 
have been defined by the Small Business Administration (SBA) (13 CFR 
121.601) as those having annual receipts of less than $500,000. Small 
agricultural service firms, which include handlers under this order, 
are defined as those with annual receipts of less than $5 million.
    The purpose of the RFA is to fit regulatory actions to the scale of 
business subject to such actions in order that small businesses will 
not be unduly or disproportionately burdened. Marketing orders and 
rules issued thereunder are unique in that they are brought about 
through group action of essentially small entities acting on their own 
behalf. Thus, both the RFA and the Act have small entity orientation 
and compatibility. Interested persons were invited to present evidence 
at the hearing on the probable impact that the

[[Page 17554]]

proposed amendments to the order would have on small businesses.
    During the 1995-96 crop year, approximately 90 handlers were 
regulated under Marketing Order No. 927. In addition, there are about 
1,980 growers of winter pears in the regulated area. The Act provides 
for the application of uniform rules on regulated handlers. Since 
handlers covered under the winter pear marketing order are 
predominantly small businesses, the order itself is tailored to the 
size and nature of these small businesses. Marketing orders, and 
amendments thereto, are unique in that they are normally brought about 
through group action of essentially small entities for their own 
benefit. Thus, both the RFA and the Act are compatible with respect to 
small entities.
    All of the order amendments are designed to enhance the 
administration and functioning of the marketing agreement and order to 
the benefit of the industry. The benefits are expected to outweigh any 
costs associated with the amendments. Accordingly, it is determined 
that the amendments to the order will not have a significant economic 
impact on growers or handlers.
    In accordance with the Paperwork Reduction Act (44 U.S.C. Chapter 
35), the reporting and recordkeeping requirements that may result from 
the amendments will be submitted to the Office of Management and Budget 
(OMB) for approval.

List of Subjects in 7 CFR Part 929

    Marketing agreements, Pears, Reporting and recordkeeping 
requirements.

Order Amending the Order for Winter Pears Grown in Oregon, Washington, 
and California

Findings and Determinations

    The findings and determinations hereinafter set forth are 
supplementary and in addition to the findings and determinations 
previously made in connection with the issuance of the order; and all 
of said previous findings and determinations are hereby ratified and 
affirmed, except insofar as such findings and determinations may be in 
conflict with the findings and determinations set forth herein.
    (a) Findings and Determinations Upon the Basis of the Hearing 
Record. Pursuant to the provisions of the Agricultural Marketing 
Agreement Act of 1937, as amended (7 U.S.C. 601 et seq.), and the 
applicable rules of practice and procedure effective thereunder (7 CFR 
part 900), a public hearing was held upon the proposed amendments to 
Marketing Agreement and Order No. 927 (7 CFR part 927), covering winter 
pears grown in Oregon, Washington, and California.
    Upon the basis of the evidence introduced at such hearing and the 
record thereof, it is found that:
    (1) The marketing agreement and order, as amended, and as hereby 
further amended, and all of the terms and conditions thereof, will tend 
to effectuate the declared policy of the Act;
    (2) The marketing agreement and order, as amended, and as hereby 
further amended, regulates the handling of winter pears grown in the 
production area in the same manner as, and is applicable only to 
persons in the respective classes of commercial and industrial activity 
specified in the marketing agreement and order upon which hearings have 
been held;
    (3) The marketing agreement and order, as amended, and as hereby 
further amended, is limited in application to the smallest regional 
production area which is practicable, consistent with carrying out the 
declared policy of the Act, and the issuance of several orders 
applicable to subdivisions of the production area would not effectively 
carry out the declared policy of the Act;
    (4) The marketing agreement and order, as amended, and as hereby 
further amended, prescribes, insofar as practicable, such different 
terms applicable to different parts of the production area as are 
necessary to give due recognition to the differences in the production 
and marketing of winter pears grown in production area; and
    (5) All handling of winter pears grown in the production area is in 
the current of interstate or foreign commerce or directly burdens, 
obstructs, or affects such commerce.
    (b) Determinations. It is hereby determined that:
    (1) Handlers (excluding cooperative associations of growers who are 
not engaged in processing, distribution, or shipping of winter pears 
covered by the said order, as hereby amended) who during the period of 
July 1, 1994, through June 30, 1995, handled 50 percent or more of the 
volume of such winter pears covered by the said order, as amended and 
hereby further amended have signed a marketing agreement; and
    (2) The issuance of this amendatory order, amending the aforesaid 
order, is favored or approved by at least two-thirds of the producers 
who participated in a referendum and represented at least two-thirds of 
the volume of such commodity in the referendum, all such producers 
during the period June 1, 1994, through June 30, 1995 (which has been 
deemed to be a representative period), having been engaged within the 
production area in the production of winter pears for fresh market.

Order Relative to Handling

    It is therefore ordered, That on and after the effective date 
hereof, all handling of winter pears grown in Oregon, Washington, and 
California shall be in conformity to, and in compliance with, the terms 
and conditions of the said order as hereby amended as follows:
    The provisions of the proposed marketing agreement and order 
amending the order contained in the Secretary's Decision issued on June 
22, 1995, and published in the Federal Register on June 29, 1995, shall 
be and are the terms and provisions of this order amending the order 
and are set forth in full herein.

PART 927--WINTER PEARS GROWN IN OREGON, WASHINGTON, AND CALIFORNIA

    1. The authority citation for 7 CFR part 927 continues to read as 
follows:

    Authority: 7 U.S.C. 601-674.

    2. Section 927.8 is revised to read as follows:

Sec. 927.8   Ship or handle.

    Ship or handle means to sell, deliver, consign or transport pears, 
within the production area or between the production area and any point 
outside thereof: Provided, That the term ``handle'' shall not include 
the transportation of winter pear shipments within the production area 
from the orchard where grown to a packing facility located within the 
production area for preparation for market.
    3. Section 927.10 is revised to read as follows:

Sec. 927.10   Production area.

    Production area means and includes the States of Oregon, 
Washington, and California.
    4. Section 927.12 is revised to read as follows:

Sec. 927.12   Export market.

    Export market means any destination which is not within the 50 
states, or the District of Columbia, of the United States.
    5. In Sec. 927.41, paragraph (a) is revised to read as follows:

Sec. 927.41   Assessments.

    (a) Assessments will be levied only upon handlers who first handle 
pears.

[[Page 17555]]

Each handler shall pay assessments on all pears handled by such handler 
as the pro rata share of the expenses which the Secretary finds are 
reasonable and likely to be incurred by the Control Committee during a 
fiscal period. The payment of assessments for the maintenance and 
functioning of the Control Committee may be required under this part 
throughout the period such assessments are payable irrespective of 
whether particular provisions thereof are suspended or become 
inoperative.
* * * * *
    6. Section 927.45 is added to read as follows:

Sec. 927.45   Contributions.

    The Control Committee may accept voluntary contributions but these 
shall only be used to pay expenses incurred pursuant to section 927.47. 
Furthermore, such contributions shall be free from any encumbrances by 
the donor and the Control Committee shall retain complete control of 
their use.
    7. Section 927.47 is revised to read as follows:

Sec. 927.47   Research and development.

    The Control Committee, with the approval of the Secretary, may 
establish or provide for the establishment of production research, or 
marketing research and development projects designed to assist, 
improve, or promote the marketing, distribution, and consumption of 
pears. Such projects may provide for any form of marketing promotion, 
including paid advertising. The expense of such projects shall be paid 
from funds collected pursuant to Secs. 927.41 and 927.45. Expenditures 
for a particular variety of pears shall approximate the amount of 
assessments and voluntary contributions collected for that variety of 
pears.
    8. In Sec. 927.52, paragraph (b)(1) is revised to read as follows:

Sec. 927.52   Prerequisites to Control Committee recommendations.

* * * * *
    (b) * * *
    (1) The basis of one vote for each 25,000 boxes (except 2,500 boxes 
for Forelle and Seckel varieties) of the average quantity of such 
variety produced in the particular district and shipped therefrom 
during the immediately preceding three fiscal periods; or
* * * * *
    9. In Sec. 927.65, paragraph (b) is revised to read as follows:

Sec. 927.65   Exemption from regulation.

* * * * *
    (b) The Control Committee may prescribe rules and regulations, to 
become effective upon the approval of the Secretary, whereby quantities 
of pears or types of pear shipments may be exempted from any or all 
provisions of this subpart.
* * * * *
    Dated: April 16, 1996.
Michael V. Dunn,
Assistant Secretary, Marketing and Regulatory Programs.
[FR Doc. 96-9828 Filed 4-19-96; 8:45 am]
BILLING CODE 3410-02-P

Complete official Federal Register PDF

FR Doc. 96-9827 Expenses and Assessment Rate for Marketing Order Covering Olives Grown in California
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17555-17556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9827]

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE
7 CFR Part 932

[Docket No. FV96-932-1FIR]

Expenses and Assessment Rate for Marketing Order Covering Olives 
Grown in California

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Agriculture (Department) is adopting without 
change, the provisions of an interim final rule, that authorized 
expenses and established an assessment rate for the California Olive 
Committee (Committee) under Marketing Order No. 932 for the 1996 fiscal 
year. The Committee is responsible for local administration of the 
marketing order which regulates the handling of the California Olives. 
Authorization of this budget enables the Committee to incur expenses 
that are reasonable and necessary to administer the program. Funds to 
administer this program are derived from assessments on handlers.

EFFECTIVE DATE: Effective beginning January 1, 1996, through December 
31, 1996.

FOR FURTHER INFORMATION CONTACT: Terry Vawter, California Marketing 
Field Office, Fruit and Vegetable Division, AMS, USDA, 2202 Monterey 
Street, suite 102B, Fresno, California 93721, telephone 209-487-5901; 
or Tershirra T. Yeager, Marketing Order Administration Branch, F&V, 
AMS, USDA, PO Box 96456, room 2523-S, Washington, DC 20090-6456; 
telephone 202-720-5127.

SUPPLEMENTARY INFORMATION: This final rule is issued under Marketing 
Agreement No. 148 and Marketing Order No. 932 (7 CFR part 932), as 
amended, regulating the handling of olives grown in California, 
hereinafter referred to as the ``order.'' The order is effective under 
the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 
601-674), hereinafter referred to as the ``Act.''
    The Department of Agriculture is issuing this rule in conformance 
with Executive Order 12866.
    This final rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. Under the marketing order provisions now in 
effect, olives grown in California are subject to assessments. It is 
intended that the assessment rate as issued herein will be applicable 
to all assessable olives during the 1996 fiscal year, beginning January 
1, 1996, through December 31, 1996. This final rule will not preempt 
any State or local laws, regulations, or policies, unless they present 
an irreconcilable conflict with this rule.
    The Act provides that administrative proceedings must be exhausted 
before parties may file suit in court. Under section 608c(15)(A) of the 
Act, any handler subject to an order may file with the Secretary a 
petition stating that the order, any provision of the order, or any 
obligation imposed in connection with the order is not in accordance 
with law and request a modification of the order or to be exempted 
therefrom. A handler is afforded the opportunity for a hearing on the 
petition. After the hearing the Secretary would rule on the petition. 
The Act provides that the district court of the United States in any 
district in which the handler is an inhabitant, or has his or her 
principal place of business, has jurisdiction in equity to review the 
Secretary's ruling on the petition, provided a bill in equity is filed 
not later than 20 days after date of the entry of the ruling.
    Pursuant to requirements set forth in the Regulatory Flexibility 
Act (RFA), the Administrator of the Agricultural Marketing Service 
(AMS) has considered the economic impact of this rule on small 
entities.
    The purpose of the RFA is to fit regulatory actions to the scale of 
business subject to such actions in order that small businesses will 
not be unduly or disproportionately burdened. Marketing orders issued 
pursuant to the Act, and rules issued thereunder, are unique in that 
they are brought about through group action of essentially small 
entities acting on their own behalf. Thus, both statutes have small 
entity orientation and compatibility.
    There are 5 handlers of olives grown in California who are subject 
to regulation under the order and approximately 1,350 producers of 
olives in the regulated area. Small agricultural producers have been 
defined by the Small Business Administration (13 CFR 121.601) as those 
having annual receipts of less than $500,000, and small agricultural 
service firms are defined as those whose annual receipts are less

[[Page 17556]]

than $5,000,000. None of the olive handlers may be classified as small 
entities, while the majority of olive producers may be classified as 
small entities.
    The order, administered by the Department, requires that the 
assessment rate for a particular fiscal year apply to all assessable 
olives handled during the appropriate crop year, which for this season 
is August 1, 1995, through July 31, 1996. The budget of expenses for 
the 1996 fiscal year was prepared by the Committee and submitted to the 
Department for approval. The Committee consists of handlers and 
producers. They are familiar with the Committee's needs and with the 
costs for goods, services, and personnel in their local area and are 
thus in a position to formulate an appropriate budget. The budget was 
formulated and discussed in public meetings. Thus, all directly 
affected persons have an opportunity to participate and provide input.
    The assessment rate recommended by the Committee was derived by 
dividing anticipated expenses by actual receipts of olives by handlers 
during the crop year. Because that rate is applied to actual receipts, 
it must be established at a rate which will produce sufficient income 
to pay the Committee's expected expenses.
    The recommended budget and rate of assessment is usually acted upon 
by the Committee after the crop year begins and before the fiscal year 
starts, and expenses are incurred on a continuous basis. Therefore, the 
budget and assessment rate approval must be expedited so that the 
Committee will have funds to pay its expenses.
    The Committee met on December 14, 1995, and recommended 1996 
marketing order expenditures of $2,600,785 for its budget. This is 
$280,865 less in expenses than the previous year. The major budget 
categories for the 1996 fiscal year include administration ($388,350), 
research ($213,000), and market development ($1,999,435).
    The Committee also recommended an assessment rate of $28.26 per ton 
covering olives from the appropriate crop year. This is $1.78 less than 
last year's assessment rate of $30.04. The assessment rate, when 
applied to actual handler receipts of 62,182 tons from the 1995 olive 
crop year, would yield $1,757,726 in assessment income. This along with 
approximately $829,000 from the Committee's authorized reserves will be 
adequate to cover estimated expenses. Reserve funds forwarded from the 
1995 fiscal year are estimated at $210,000 which is within the maximum 
permitted by the order of one fiscal year's expenses.
    An interim final rule was issued on February 12, 1996, and 
published in the Federal Register (61 FR 6306; February 20, 1996). That 
rule provided a 30-day comment period which ended March 21, 1996. No 
comments were received.
    While this action will impose some additional costs on handlers, 
the costs are in the form of uniform assessments on all handlers. Some 
of the additional costs may be passed on to producers. However, these 
costs will be offset by the benefits derived from the operation of the 
marketing order. Therefore, the Administrator of the AMS has determined 
that this action will not have a significant economic impact on a 
substantial number of small entities.
    After consideration of all relevant material presented, including 
the Committee's recommendation, and other available information, it is 
found that this final rule, as hereinafter set forth, will tend to 
effectuate the declared policy of the Act.
    It is further found that good cause exists for not postponing the 
effective date of this rule until 30 days after publication in the 
Federal Register because: (1) The Committee needs to have sufficient 
funds to pay its expenses which are incurred on a continuous basis; (2) 
the 1996 fiscal year began on January 1, 1996, and the marketing order 
requires that the rate of assessment for the fiscal year apply to all 
assessable olives handled during the fiscal year; (3) handlers are 
aware of this rule which was recommended by the Committee at a public 
meeting; and (4) an interim final rule was published in the Federal 
Register providing a 30-day comment period, and no comments were 
received.

List of Subjects in 7 CFR Part 932

    Marketing agreements, Olives, Reporting and recordkeeping 
requirements.

    For the reasons set forth in the preamble, 7 CFR parts 932 are 
amended as follows:

PART 932--OLIVES GROWN IN CALIFORNIA

    Accordingly, the interim final rule amending 7 CFR part 932 which 
was published at 61 FR 6306 on February 20, 1996, is adopted as a final 
rule without change.

    Dated: April 16, 1996.
Eric M. Forman,
Deputy Director, Fruit and Vegetable Division.
[FR Doc. 96-9827 Filed 4-19-96; 8:45 am]
BILLING CODE 3410-02-P

Complete official Federal Register PDF

FR Doc. 96-9826 Milk in the Central Arizona Marketing Area; Suspension of Certain Provisions of the Order
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17561-17562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9826]

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE
7 CFR Part 1131

[DA-96-03]

Milk in the Central Arizona Marketing Area; Suspension of Certain 
Provisions of the Order

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Suspension of rule.

-----------------------------------------------------------------------

SUMMARY: This document continues to suspend certain provisions of the 
Central Arizona Federal milk marketing order during April 1, 1996, 
through March 31, 1997. The continued suspension eliminates the 
requirement that a cooperative association ship at least 50 percent of 
its receipts to other handler pool plants to maintain pool status of a 
manufacturing plant operated by the cooperative. United Dairymen of 
Arizona, a cooperative association that represents nearly all of the 
producers who supply milk to the market, requested the suspension. The 
suspension is necessary to prevent uneconomical and inefficient 
movements of milk.

EFFECTIVE DATE: April 1, 1996, through March 31, 1997.

FOR FURTHER INFORMATION CONTACT: Clifford M. Carman, Marketing 
Specialist, USDA/AMS/Dairy Division, Order Formulation Branch, Room 
2971, South Building, PO Box 96456, Washington, DC 20090-6456, (202) 
720-9368.

SUPPLEMENTARY INFORMATION: Prior document in this proceeding:
    Notice of Proposed Suspension: Issued March 7, 1996; published 
March 13, 1996 (61 FR 10288).
    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires the 
Agency to examine the impact of a proposed rule on small entities. 
Pursuant to 5 U.S.C. 605(b), the Administrator of the Agricultural 
Marketing Service has certified that this rule will not have a 
significant economic impact on a substantial number of small entities. 
This rule lessens the regulatory impact of the order on certain milk 
handlers and tends to ensure that dairy farmers will continue to have 
their milk priced under the order and thereby receive the benefits that 
accrue from such pricing.
    The Department is issuing this final rule in conformance with 
Executive Order 12866.
    This final rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. This rule is not intended to have a retroactive 
effect. This rule will not preempt any state or local laws, 
regulations, or policies, unless they present an irreconcilable 
conflict with this rule.
    The Agricultural Marketing Agreement Act of 1937, as amended (7 
U.S.C. 601-674), provides that administrative proceedings must be 
exhausted before parties may file suit in court. Under section 
608c(15)(A) of the Act, any handler subject to an order may file with 
the Secretary a petition stating that the order, any provisions of the 
order, or any obligation imposed in connection with the order is not in 
accordance with the law and requesting a modification of an order or to 
be exempted from the order. A handler is afforded the opportunity for a 
hearing on the petition. After a hearing, the Secretary would rule on 
the petition. The Act provides that the district court of the United 
States in any district in which the handler is an inhabitant, or has 
its principal place of business, has jurisdiction in equity to review 
the Secretary's ruling on the petition, provided a bill in equity is 
filed not later than 20 days after the date of the entry of the ruling.
    This order of suspension is issued pursuant to the provisions of 
the Agricultural Marketing Agreement Act and of the order regulating 
the handling of milk in the Central Arizona marketing area.
    Notice of proposed rulemaking was published in the Federal Register 
on March 13, 1995 (61 FR 10288) concerning a proposed suspension of 
certain provisions of the order. Interested persons were afforded 
opportunity to file written data, views and arguments thereon. No 
comments were received.
    After consideration of all relevant material, including the 
proposal in the notice and other available information, it is hereby 
found and determined that for the months of April 1, 1996, through 
March 31, 1997, the following provisions of the order do not tend to 
effectuate the declared policy of the Act:
    In Sec. 1131.7(c), the words ``50 percent or more of'', 
``(including the skim milk and butterfat in fluid milk products 
transferred from its own plant pursuant to this paragraph that is not 
in excess of the skim milk and butterfat contained in member producer 
milk actually received at such plant)'' and ``or the previous 12-month 
period ending with the current month.''

Statement of Consideration

    This rule continues to suspend certain provisions of the Central 
Arizona order for the months of April 1996 through March 1997. The 
suspension removes the requirement that a cooperative association that 
operates a manufacturing plant in the marketing area must ship at least 
50 percent of its milk supply during the current month or the previous 
12-month period ending with the current month to other handlers' pool 
plants to maintain the pool status of its manufacturing plant.
    The order permits a cooperative association's manufacturing plant, 
located in the marketing area, to be a pool plant if at least 50 
percent of the producer milk of members of the cooperative association 
is physically received at pool plants of other handlers during the 
current month or the previous 12-month period ending with the current 
month.
    Continuation of the current suspension of this shipping requirement 
was requested by United Dairymen of Arizona (UDA), a cooperative 
association that represents nearly all of the dairy farmers who supply 
the Central Arizona market. UDA states that the continued pool status 
of their manufacturing plant is threatened if the suspension is not 
continued. UDA contends that the same marketing conditions that 
warranted the suspension last year still exist. UDA maintains that 
members who increased their milk production to meet the projected 
demands of fluid handlers for distribution into Mexico continue to 
suffer the adverse impact of the collapse of the Mexican peso.
    During the past year, there has been an increase in producer milk 
while handler requirements for bulk milk deliveries has decreased. This 
decrease is primarily a result of reduced Class I sales by Central 
Arizona handlers in Mexico because of the continued devaluation of the 
Mexican peso. Pool status of UDA's manufacturing plant will not be 
maintained absent continuation of the suspension. Thus, costly and 
inefficient movements of milk would have to be made to maintain pool 
status of producers who have historically supplied the market and to 
prevent disorderly marketing in the Central Arizona marketing area.
    UDA again requested that the suspension be granted for an 
indefinite period beginning in April 1996. After reviewing the 
marketing conditions of the Central Arizona marketing area and their 
relationship with the uncertain value of the Mexican peso, this

[[Page 17562]]

suspension will be for a one-year period.
    Accordingly, it is appropriate to suspend the aforesaid provisions 
beginning April 1, 1996, through March 31, 1997.
    It is hereby found and determined that thirty days' notice of the 
effective date hereof is impractical, unnecessary and contrary to the 
public interest in that:
    (a) The suspension is necessary to reflect current marketing 
conditions and to assure orderly marketing conditions in the marketing 
area, in that such rule is necessary to permit the continued pooling of 
the milk of dairy farmers who have historically supplied the market 
without the need for making costly and inefficient movements of milk;
    (b) This suspension does not require of persons affected 
substantial or extensive preparation prior to the effective date; and
    (c) Notice of proposed rulemaking was given interested parties and 
they were afforded opportunity to file written data, views or arguments 
concerning this suspension. No comments were received.
    Therefore, good cause exists for making this order effective less 
than 30 days from the date of publication in the Federal Register.

List of Subjects in 7 CFR Part 1131

    Milk marketing orders.

    For the reasons set forth in the preamble, the following provisions 
in title 7, part 1131, are amended as follows:

PART 1131--MILK IN THE CENTRAL ARIZONA MARKETING AREA

    1. The authority citation for 7 CFR Part 1131 continues to read as 
follows:

    Authority: 7 U.S.C. 601-674.

Sec. 1131.7   [Temporarily Suspended in Part]

    2. In Sec. 1131.7(c), the words ``50 percent or more of'', 
``(including the skim milk and butterfat in fluid milk products 
transferred from its own plant pursuant to this paragraph that is not 
in excess of the skim milk and butterfat contained in member producer 
milk actually received at such plant)'' and ``or the previous 12-month 
period ending with the current month.'' are suspended for the months of 
April 1, 1996, through March 31, 1997.

    Dated: April 16, 1996.
Michael V. Dunn,
Assistant Secretary, Marketing and Regulatory Programs.
[FR Doc. 96-9826 Filed 4-19-96; 8:45 am]
BILLING CODE 3410-02-P

Complete official Federal Register PDF

FR Doc. 96-9825 Limes and Avocados Grown in Florida; Suspension of Certain Volume Regulations and Reporting Requirements
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17551-17552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9825]

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service

7 CFR Parts 911 and 915

[Docket No. FV95-911-2IFR]

Limes and Avocados Grown in Florida; Suspension of Certain Volume 
Regulations and Reporting Requirements

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Interim final rule with request for comments; suspension.

-----------------------------------------------------------------------

SUMMARY: This rule suspends indefinitely certain volume regulation 
provisions of the marketing order covering limes grown in Florida. This 
rule indefinitely suspends the pack-out reporting requirements for the 
marketing orders covering limes and avocados grown in Florida. The 
marketing orders regulate the handling of limes and avocados grown in 
Florida and are administered by the Florida Lime Administrative 
Committee and the Avocado Administrative Committee, respectively. These 
provisions are not needed due to reduced Florida lime and avocado 
production. This rule will also reduce handler reporting burdens for 
both marketing orders.

DATES: Effective April 1, 1996. Comments which are received prior to 
May 22, 1996, will be considered prior to issuance of any final action.

ADDRESSES: Interested persons are invited to submit written comments 
concerning this action to: Docket Clerk, Fruit and Vegetable Division, 
AMS, USDA, P.O. Box 96456, room 2523-S, Washington, DC 20090-6456. 
Three copies of all written material shall be submitted, and they will 
be made available for public inspection at the office of the Docket 
Clerk during regular business hours. All comments should reference the 
docket number, date, and page number of this issue of the Federal 
Register.

FOR FURTHER INFORMATION CONTACT: Britthany E. Beadle and Caroline C. 
Thorpe, Marketing Order Administration Branch, Fruit and Vegetable 
Division, AMS, USDA, P.O. Box 96456, room 2522-S, Washington, DC 20090-
6456; telephone: 202-720-5127; or Aleck J. Jonas, Southeast Marketing 
Field Office, USDA/AMS, P.O. Box 2276, Winter Haven, Florida 33883; 
telephone: 813-299-4770.

SUPPLEMENTARY INFORMATION: This action is issued under the provisions 
of section 8c(16)(A) of the Agricultural Marketing Agreement Act of 
1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the 
Act; and of Marketing Agreements and Marketing Orders No. 911 (7 CFR 
part 911) and No. 915 (7 CFR part 915) regulating the handling of limes 
grown in Florida and avocados grown in South Florida, respectively. 
These agreements and orders are effective under the Agricultural 
Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), 
hereinafter referred to as the Act.
    The Department of Agriculture (Department) is issuing this action 
in conformance with Executive Order 12866.
    This action has been reviewed under Executive Order 12778, Civil 
Justice Reform. It is intended that this action will be applicable for 
the entire 1996 fiscal year which began April 1, 1996, and will 
continue until amended, suspended, or terminated. This action will not 
preempt any State or local laws, regulations, or policies, unless they 
present an irreconcilable conflict with this action.
    The Act provides that administrative proceedings must be exhausted 
before parties may file suit in court. Under section 8c(15)(A) of the 
Act, any handler subject to an order may file with the Secretary a 
petition stating that the order, any provision of the order, or any 
obligation imposed in connection with the order is not in accordance 
with law and requesting a modification of the order or to be exempted 
therefrom. A handler is afforded the opportunity for a hearing on the 
petition. After the hearing, the Secretary would rule on the petition. 
The Act provides that the district court of the United States in any 
district in which the handler is an inhabitant, or has his or her 
principal place of business, has jurisdiction in equity to review the 
Secretary's ruling on the petition, provided a bill in equity is filed 
not later than 20 days after the date of the entry of the ruling.
    Pursuant to the requirements set forth in the Regulatory 
Flexibility Act (RFA), the Administrator of the Agricultural Marketing 
Service (AMS) has considered the economic impact of this action on 
small entities.
    The purpose of the RFA is to fit regulatory actions to the scale of 
business subject to such actions in order that small businesses will 
not be unduly or disproportionately burdened. Marketing orders issued 
pursuant to the Act, and rules issued thereunder, are unique in that 
they are brought about through group action of essentially small 
entities acting on their own behalf. Thus, both statutes have small 
entity orientation and compatibility.
    There are about 10 Florida lime handlers subject to regulation 
under the marketing order covering limes grown in Florida, and about 30 
lime producers in Florida. Also, there are approximately 35 handlers of 
avocados and approximately 95 producers in the regulated area. Small 
agricultural producers have been defined by the Small Business 
Administration (13 CFR 121.601) as those having annual receipts of less 
than $500,000, and small agricultural service firms are defined as 
those whose annual receipts are less than $5,000,000. A majority of 
these handlers and producers may be classified as small entities.
    The Florida Lime Administrative Committee (FLAC) met on December 
13, 1995, and unanimously recommended a two year suspension of their 
lime volume regulations and pack-out requirements. However, the 
Department is revising the FLAC recommendation by suspending both of 
these requirements indefinitely. The Department has determined that 
since volume regulations have not been implemented for at least the 
past five years and lime production has been reduced to low levels 
these regulations should be suspended indefinitely. The Department does 
not anticipate that such regulations will be needed in the near future.
    Also, the Avocado Administrative Committee (AAC) met on January 10, 
1996, and recommended indefinite suspension of their pack-out reporting 
requirements.
    The suspension of Secs. 911.53-59 and 911.111 of the lime marketing 
order volume regulations and pack-out reporting requirements was 
published in the Federal Register (59 FR 13429, March 22, 1994) and is 
currently in

[[Page 17552]]

effect through March 31, 1996. The suspension of Sec. 915.150 paragraph 
(d) of the avocado marketing order pack-out reporting requirements was 
published in the Federal Register (59 FR 30866, June 16, 1994) and is 
currently in effect through March 31, 1996. This rule suspends these 
regulations indefinitely.
    Sections 911.53-59 (7 CFR 911.53-59) of the lime marketing order 
cover volume regulations and were used by FLAC to collect and maintain 
information from handlers, so that it could recommend to the Department 
that lime volume regulations be issued, when and if needed. FLAC 
determined that volume regulations will not be needed in the near 
future, and thus such information will not be needed, because of 
reduced production due to hurricane damage in 1992.
    Concerning pack-out reporting requirements, both FLAC and AAC 
recommended suspension of their pack-out reporting requirements. 
Section 911.111 (7 CFR 911.111) and Sec. 915.150 (7 CFR 915.150) 
contain provisions requiring Florida handlers to file certain reports 
with either the FLAC or the AAC concerning their Florida lime and 
avocado shipments, respectively. This action continues the suspension 
of these provisions since information collected under these provisions 
is not needed because lime and avocado production is so low. These 
provisions would require handlers to furnish information on types and 
number of containers of limes and avocados they pack each day. 
Sufficient information from other sources is available to meet 
committee needs during future seasons. Information needed for committee 
operations, marketing policies, and compliance is available from 
inspection certificates collected on a daily basis by committee staff. 
These resources are used to collect such information. Low lime and 
avocado production has also resulted in a substantial reduction of the 
both committees' staff and reduction of assessment income. Thus, the 
continuation of the suspension will reduce administrative costs and 
work load.
    These continued suspensions are a result of damage to the lime and 
avocado groves caused by Hurricane Andrew in August 1992. For limes, 
Hurricane Andrew reduced production acreage from approximately 6,500 
acres to approximately 1,500 acres with many non-producing trees in the 
remaining acreage. Production in the 1991-92 season was 1,682,677 
bushels. In the 1992-93 season, production prior to the hurricane was 
1,146,000 bushels. After the hurricane, in the 1993-94 season, 
production fell to 228,455 bushels and in the 1994-95 season, it was 
283,977 bushels. This was well below the levels reached prior to the 
hurricane.
    For avocados, Hurricane Andrew reduced production acreage from 
approximately 9,000 acres to less than 6,000 acres with many non-
producing trees in the remaining acreage. Production in the 1991-92 
season was 1,110,105 bushels. In the 1992-93 season, production fell to 
283,000 bushels and in the 1993-94 season it was 174,712 bushels. 
Although the 1994-95 season recovered to 778,951 bushels, it is well 
below the levels reached prior to the hurricane.
    Therefore, this action reflects the committees' and the 
Department's appraisal of the need to suspend certain volume 
regulations and pack-out reporting requirements under the orders, as 
specified. This rule indefinitely suspends certain reporting 
requirements for Florida limes and avocados, and lessens the overall 
reporting and recordkeeping burden under the orders. The Department's 
view is that this suspension will have a beneficial impact on Florida 
lime and avocado producers and handlers, since it lessens the reporting 
burden on handlers and will reduce the committees' expenses incurred 
under the orders.
    Based on the above, the Administrator of the AMS has determined 
that this action will not have a significant economic impact on a 
substantial number of small entities.
    The information collection requirements have been previously 
approved by the Office of Management and Budget (OMB) under the 
provisions of 44 U.S.C. Chapter 35 and have been assigned OMB Numbers 
0581-0091 and 0581-0078 for limes and avocados respectively.
    This action indefinitely suspends the annual reporting burden 
currently estimated at 210.4 hours for all regulated Florida lime 
handlers to: (1) Apply for a prorate base and allotment; (2) report 
daily the percentages, by size category, of the limes packed by them; 
and (3) report daily the number of containers of limes sold and 
delivered by them within the State of Florida.
    This action also indefinitely suspends the annual reporting burden 
currently estimated at 130 hours for all regulated Florida avocado 
handlers who file such reports. Specifically, this would apply to 
handlers who file: (1) The Avocado Handler Daily Size Report Form; and 
(2) the Avocado Handlers Weekly Report Form.
    After consideration of all relevant matter presented, the 
information and recommendations submitted by the committees, and other 
information, it is found that the provisions detailed below, at this 
time, do not tend to effectuate the declared policy of the Act.
    It is also found and determined, upon good cause, that it is 
impracticable, unnecessary and contrary to the public interest to give 
preliminary notice prior to putting this action into effect, and that 
good cause exists for not postponing the effective date of this action 
until 30 days after publication in the Federal Register because: (1) 
This action relieves restrictions by suspending certain volume 
regulation and pack-out reporting requirements under the orders for 
fresh Florida limes and avocados; (2) Florida lime and avocado handlers 
are aware of this suspension which was recommended by the committees at 
public meetings, and they will need no additional time to comply; (3) 
Florida fresh lime shipments are currently in progress, and they are 
expected to continue throughout the year; (4) such requirements need to 
be suspended promptly for both limes and avocados, so they are of 
maximum benefit to handlers; and (5) this rule provides a 30-day 
comment period, and any comments received will be considered prior to 
any finalization of this interim final action.

List of Subjects

7 CFR part 911

    Limes, Marketing agreements, Reporting and recordkeeping 
requirements.

7 CFR part 915

    Avocados, Marketing agreements, Reporting and recordkeeping 
requirements.

    For the reasons set forth in the preamble, 7 CFR parts 911 and 915 
are amended as follows:
    1. The authority citation for both 7 CFR parts 911 and 915 
continues to read as follows:

    Authority: 7 U.S.C. 601-674.

PART 911--[SUSPENDED IN PART]

    2. In part 911, Secs. 911.53 through 911.59, and Sec. 911.111 are 
suspended, indefinitely.

PART 915--[SUSPENDED IN PART]

    3. In Sec. 915.150, paragraph (d) is suspended, indefinitely.

    Dated: April 16, 1996.
Michael V. Dunn,
Assistant Secretary, Marketing and Regulatory Programs.
[FR Doc. 96-9825 Filed 4-19-96; 8:45 am]
BILLING CODE 3410-02-P

Complete official Federal Register PDF

FR Doc. 96-9824 Hazelnuts Grown in Oregon and Washington; Order Further Amending Marketing Order
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17556-17561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9824]

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DEPARTMENT OF AGRICULTURE
7 CFR Part 982

[Docket No. AO-205-A7; FV94-982-1FR]

Hazelnuts Grown in Oregon and Washington; Order Further Amending 
Marketing Order

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule further amends the marketing agreement and 
order for hazelnuts grown in Oregon and Washington (order). The 
amendments change order provisions regarding: Volume control; 
nomination and membership of the Hazelnut Marketing Board (Board); 
fiscal operations; and the administration and operation of the program. 
These changes were favored by hazelnut producers in a mail referendum 
held from November 27 through December 15, 1995. The amendments will 
improve the administration, operation, and functioning of the marketing 
order program by bringing the program more in line with current 
industry operating practices.

EFFECTIVE DATE: April 22, 1996.

FOR FURTHER INFORMATION CONTACT: Teresa L. Hutchinson, Marketing 
Specialist, Northwest Marketing Field Office, Fruit and Vegetable 
Division, Agricultural Marketing Service, USDA, 1220 SW Third Avenue, 
room 369, Portland, OR 97204; telephone 503-326-2724, FAX 503-326-7440; 
or Tom Tichenor, Marketing Order Administration Branch, Fruit and 
Vegetable Division, AMS, USDA, room 2523-S, PO Box 96456, Washington, 
DC 20090-6456; telephone 202-720-6862; FAX 202-720-5698.

SUPPLEMENTARY INFORMATION: Prior documents in this proceeding: Notice 
of Hearing issued on February 24, 1994, and published in the Federal 
Register on February 28, 1994 (59 FR 9425). Recommended Decision and 
Opportunity to File Written Exceptions issued on May 24, 1995, and 
published in the Federal Register on June 7, 1995 (60 FR 30170). 
Secretary's Decision and Referendum Order issued October 23, 1995, and 
published in the Federal Register on October 31, 1995 (60 FR 55333).

Preliminary Statement

    This administrative action is governed by the provisions of 
sections 556 and 557 of title 5 of the United States Code, and is 
therefore excluded from the requirements of Executive Order 12866.
    This rule has been reviewed under Executive Order 12778, Civil 
Justice

[[Page 17557]]

Reform. This action is not intended to have retroactive effect. This 
rule will not preempt any State or local laws, regulations, or 
policies, unless they present an irreconcilable conflict with this 
action.
    The Act provides that administrative proceedings must be exhausted 
before parties may file suit in court. Under section 608c(15)(A) of the 
Act, any handler subject to an order may file with the Secretary a 
petition stating that the order, any provision of the order, or any 
obligation imposed in connection with the order is not in accordance 
with law and request a modification of the order or to be exempted 
therefrom. A handler is afforded the opportunity for a hearing on the 
petition. After the hearing, the Secretary would rule on the petition. 
The Act provides that the district court of the United States in any 
district in which the handler is an inhabitant, or has his or her 
principal place of business, has jurisdiction in equity to review the 
Secretary's ruling on the petition, provided a bill in equity is filed 
not later than 20 days after the date of the entry of the ruling.
    The final rule was formulated on the record of a public hearing 
held in Newberg, Oregon, on March 8, 1994, to consider the proposed 
amendment of the Marketing Agreement and Order No. 982, regulating the 
handling of hazelnuts grown in Oregon and Washington, hereinafter 
referred to collectively as the ``order.'' Notice of the hearing was 
published in the February 28, 1994, issue of the Federal Register (59 
FR 9425).
    The hearing was held pursuant to the provisions of the Agricultural 
Marketing Agreement Act of 1937, as amended (7 U.S.C. 601 et seq.), 
hereinafter referred to as the ``Act,'' and the applicable rules of 
practice and procedure governing proceedings to formulate marketing 
agreements and marketing orders (7 CFR part 900). The Notice of Hearing 
contained several amendment proposals submitted by the Hazelnut 
Marketing Board (Board), established under the order to assist in local 
administration of the program.
    The proposals pertained to: (1) Changing the name of the commodity 
covered under the order from ``filberts'' to ``hazelnuts''; (2) for the 
purposes of inshell volume regulation, allowing the Board, with USDA 
approval, to make changes in the domestic market distribution area and 
providing the Board with the flexibility to recommend appropriate 
hazelnut releases for use until new crop hazelnuts are available for 
marketing; (3) increasing Board members' terms of office to two years 
and limiting the number of consecutive terms a member may serve from 
six terms to three; (4) changing voting procedures for nominating 
members to the Board, including changes to criteria used for nominating 
handler members and for weighing handlers' votes when electing 
nominees; (5) removing the ``verbatim'' reporting requirement on Board 
marketing policy meetings, and allowing Board telephone votes to remain 
unconfirmed until the next public Board meeting; (6) allowing the 
Board, with USDA approval, to establish different identification 
standards for inspected and certified hazelnuts; (7) changing 
procedures for establishing bonding requirements for deferred 
restricted obligations and allowing the Board to use defaulted bond 
payments to purchase excess restricted credits from handlers; (8) 
clarifying that mail order sales outside the production area are not 
exempt from order requirements; and (9) allowing the Board to accept 
advance assessment payments, provide discounts for such payments, 
borrow money, and accept voluntary contributions.
    Upon the basis of evidence introduced at the hearing and the record 
thereof, the Acting Assistant Secretary, Marketing and Regulatory 
Programs, on October 23, 1995, filed with the Hearing Clerk, U.S. 
Department of Agriculture, a Secretary's Decision and Referendum Order, 
directing that a referendum be conducted during the period November 27 
through December 15, 1995, among producers of Oregon and Washington 
hazelnuts to determine whether they favored the proposed amendments to 
the order. In the referendum, all amendment proposals were favored by 
more than two-thirds of the producers voting in the referendum. 
Accordingly, all proposed amendments are included in this order further 
amending the order.
    The amended marketing agreement was subsequently mailed to all 
hazelnut handlers in the production area for their approval. The 
marketing agreement was signed by hazelnut handlers representing more 
than 50 percent of the volume of hazelnuts handled by all handlers 
during the representative period of July 1, 1994, to June 30, 1995.

Small Business Considerations

    In accordance with the provisions of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), the Administrator of the Agriculture 
Marketing Service has determined that this action will not have a 
significant economic impact on a substantial number of small entities. 
Small agricultural service firms, which include handlers regulated 
under this order, have been defined by the Small Business 
Administration (SBA) (13 CFR 121.601) as those having annual receipts 
of less than $5,000,000. Small agricultural producers are defined as 
those having annual receipts of less than $500,000.
    The purpose of the RFA is to fit regulatory actions to the scale of 
business subject to such actions in order that small businesses will 
not be unduly or disproportionately burdened. Marketing orders and 
rules issued thereunder are unique in that they are brought about 
through group action of essentially small entities acting on their own 
behalf. Thus, both the RFA and the Act have small entity orientation 
and compatibility. Interested persons were invited to present evidence 
at the hearing on the probable impact that the proposed amendments to 
the order would have on small businesses.
    There are approximately 25 handlers regulated under Marketing Order 
No. 982. In addition, there are approximately 1,000 producers of 
hazelnuts in the production area. The Act requires the application of 
uniform rules on regulated handlers. Since handlers covered under the 
hazelnut marketing order are predominantly small businesses, the order 
itself is tailored to the size and nature of these small businesses. 
Marketing orders and amendments thereto are unique in that they are 
normally brought about through group action of essentially small 
entities for their own benefit. Thus, both the RFA and the Act are 
compatible with respect to small entities.
    For discussion of the anticipated impact on small businesses, the 
amendments have been grouped into program categories. Amendments 
concerning the order's marketing and volume control programs will: 
Change the name of the commodity to ``hazelnuts'' (Sec. 982.4 and every 
other place it appears in part 982); establish the trade demand area as 
the continental United States and allow the Board to make changes in 
the inshell trade acquisition area, with approval of the Secretary 
(Sec. 982.16); provide the Board the flexibility to release up to 15 
percent of the average three year inshell trade acquisitions for 
desirable carryout (Sec. 982.40); correct the current language that 
determines handler credit for ungraded hazelnuts (Sec. 982.51); 
establish the bonding rate for deferred restricted obligations at the 
estimated value of restricted credits for the current marketing year 
and allow the Board to use defaulted bond payments to purchase excess 
restricted credits (Sec. 982.54); and clarify that mail order sales 
outside the production area are not exempt from order requirements 
(Sec. 982.57). These amendments are

[[Page 17558]]

designed to assist the Board in its domestic and export marketing 
efforts. The amendments allow the Board to make program and management 
decisions that are more consistent with changing market conditions and 
to better respond to changing marketing needs. Because the Board acts 
in the best interests of the industry, increased Board decision-making 
flexibility should benefit the industry and, thus, small businesses in 
the industry.
    Regarding nomination and Board membership, the amendments will: 
Change from one to two years the length of Board member and alternate 
member terms of office (Sec. 982.33); limit the number of consecutive 
terms members and alternate members may hold to three 2-year terms 
(Sec. 982.33); and make conforming changes and a correction in the 
qualifications for nominating members (Secs. 982.30 and 982.32). The 
amendments are designed to ease the burden of conducting nomination 
meetings every year and enhance the Board's efficiency. The amendments 
are administrative in nature and will not impose additional costs on 
small businesses.
    Other amendments to the order's administrative procedures and 
operations will: Allow Board telephone votes to remain unconfirmed in 
writing until the next public Board meeting (Sec. 982.37); remove the 
``verbatim'' reporting requirement on Board marketing policy meetings 
(Sec. 982.39); allow the Board to accept advance assessment payments 
and provide discounts for such payments (Sec. 982.61); and allow the 
Board to accept voluntary contributions (new Sec. 982.63). These 
amendments are intended to improve the operations of the Board, lessen 
the administrative burden on Board members and staff, and improve 
management of the order's financial resources. As such, the changes 
will have negligible, if any, economic impact on small entities.
    Finally, one amendment provides the Board with the authority to 
establish more up-to-date identification standards (Sec. 982.46), which 
will make order identification and certification provisions consistent 
with current industry practices and provide handlers more flexibility 
in meeting identification requirements.
    All of these changes are designed to enhance the administration and 
functioning of the order to the benefit of the industry. Accordingly, 
it is determined that the revisions of the order will not have a 
significant economic impact on handlers or producers.
    In compliance with Office of Management and Budget (OMB) 
regulations (5 CFR part 1320) which implement the Paperwork Reduction 
Act of 1980 (44 U.S.C. Chapter 35), any reporting and recordkeeping 
requirements that may result from these amendments will be submitted to 
OMB for approval.

List of Subjects in 7 CFR Part 982

    Filberts, Hazelnuts, Marketing Agreements, Nuts, Reporting and 
recordkeeping requirements.

Order Further Amending the Order Regulating the Handling of Hazelnuts 
Grown in Oregon and Washington

Findings and Determinations

    The findings and determinations hereinafter set forth are 
supplementary and in addition to the findings and determinations 
previously made in connection with the issuance of the order; and all 
of said previous findings and determinations are hereby ratified and 
affirmed, except insofar as such findings and determinations may be in 
conflict with the findings and determinations set forth herein.
    (a) Findings and Determinations Upon the Basis of the Hearing 
Record. Pursuant to the provisions of the Agricultural Marketing 
Agreement Act of 1937, as amended (7 U.S.C. 601 et seq.), and the 
applicable rules of practice and procedure effective thereunder (7 CFR 
part 900), a public hearing was held upon the amendments to Marketing 
Agreement and Order No. 982 (7 CFR part 982), regulating the handling 
of hazelnuts grown in Oregon and Washington.
    Upon the basis of the evidence introduced at such hearing and the 
record thereof, it is found that:
    (1) The marketing agreement and order, as amended, and hereby 
further amended, and all of the terms and conditions thereof, will tend 
to effectuate the declared policy of the Act;
    (2) The marketing agreement and order, as amended, as hereby 
further amended, regulates the handling of hazelnuts grown in the 
production area in the same manner as, and is applicable only to 
persons in the respective classes of commercial and industrial activity 
specified in the marketing agreement and order upon which a hearing has 
been held;
    (3) The marketing agreement and order, as amended, as hereby 
further amended, is limited in application to the smallest regional 
production area which is practicable, consistent with carrying out the 
declared policy of the Act, and the issuance of several orders 
applicable to subdivisions of the production area would not effectively 
carry out the declared policy of the Act; and
    (4) All handling of hazelnuts grown in the production area is in 
the current of interstate or foreign commerce or directly burdens, 
obstructs or affects such commerce.
    (b) Additional findings. It is necessary and in the public interest 
to make these order amendments effective upon publication.
    A later effective date would unnecessarily delay the implementation 
of the order amendments and the improvement in operation of the 
marketing order program. The Board, producers, and handlers need as 
much time as possible to make plans to implement the amended order and 
discuss any needed changes to the regulations and Board operating 
procedures. Also, the order amendments include a change in the term of 
office for Board members and alternates and a change in the voting 
procedures for nominations. The industry will soon begin conducting 
nominations for a term of office beginning July 1, 1996, and these new 
procedures need to be in effect before nominations begin.
    In view of the foregoing, it is hereby found and determined that 
good cause exists for making these order amendments effective upon 
publication, and that it would be contrary to the public interest to 
delay the effective date of these order amendments for 30 days after 
publication in the Federal Register (Sec. 553(d), Administrative 
Procedure Act; 5 U.S.C. 551-559).
    (c) Determinations. It is hereby determined that:
    (1) Handlers (excluding cooperative associations of producers who 
are not engaged in processing, distributing, or shipping hazelnuts 
covered by the said order, as amended, as hereby further amended) who, 
during the period July 1, 1994, through June 30, 1995, handled 50 
percent or more of the volume of such hazelnuts covered by the said 
order, as amended, as hereby further amended, have signed an amended 
marketing agreement; and
    (2) The issuance of this amendatory order, further amending the 
aforesaid order, is favored or approved by at least two-thirds of the 
producers who participated in a referendum on the question of its 
approval and who, during the period July 1, 1994, through June 30, 1995 
(which has been deemed to be a representative period), have been 
engaged within the Oregon and Washington production area in the 
production of such hazelnuts for fresh market.

[[Page 17559]]

Order Relative to Handling

    It is therefore ordered, that on and after the effective date 
hereof, all handling of hazelnuts grown in Oregon and Washington, shall 
be in conformity to, and in compliance with, the terms and conditions 
of the said order as hereby further amended as follows:
    The provisions of the proposed marketing order amendments further 
amending the order contained in the Secretary's Decision issued on 
October 23, 1995, and published in the Federal Register on October 31, 
1995 (60 FR 55333), shall be and are the terms and provisions of this 
order further amending the order, and are set forth in full herein.

PART 982--HAZELNUTS GROWN IN OREGON AND WASHINGTON

    1. The authority citation for 7 CFR part 982 continues to read as 
follows:

    Authority: 7 U.S.C. 601-674.

    2. In part 982 the heading is revised and all references to 
``filbert'', ``filberts'', ``filbert/hazelnut'', ``filberts/hazelnuts'' 
are revised to read as ``hazelnut'', ``hazelnuts'', ``hazelnut'', and 
hazelnuts'', respectively.
    3. Section 982.4 is revised to read as follows:

Sec. 982.4   Hazelnuts.

    Hazelnuts means hazelnuts or filberts produced in the States of 
Oregon and Washington from trees of the genus Corylus.
    4. Section 982.16 is revised to read as follows:

Sec. 982.16   Inshell trade acquisitions.

    Inshell trade acquisitions means the quantity of inshell hazelnuts 
acquired by the trade from all handlers during a marketing year for 
distribution in the continental United States and such other 
distribution areas as may be recommended by the Board and established 
by the Secretary.
    5. Section 982.30 is amended by revising paragraphs (a), 
introductory text, (b)(1), (b)(2), and (b)(3) to read as follows:

Sec. 982.30   Establishment and membership.

    (a) There is hereby established a Hazelnut Marketing Board 
consisting of 10 members, each of whom shall have an alternate member, 
to administer the terms and provisions of this part. Each member and 
alternate shall meet the same eligibility qualifications. The 10 member 
positions shall be allocated as follows:
    (b) * * *
    (1) One member shall be nominated by the handler who handled the 
largest volume of hazelnuts during the two marketing years preceding 
the marketing year in which nominations are made;
    (2) One member shall be nominated by the handler who handled the 
second largest volume of hazelnuts during the two marketing years 
preceding the marketing year in which nominations are made;
    (3) One member shall be nominated by the handler who handled the 
third largest volume of hazelnuts during the two marketing years 
preceding the marketing year in which nominations are made;
* * * * *
    6. In Sec. 982.32, paragraphs (a), (b), (c) and (f) are revised to 
read as follows:

Sec. 982.32   Initial members and nomination of successor members.

    (a) Members and alternate members of the Board serving immediately 
prior to the effective date of this amended subpart shall continue to 
serve on the Board until their respective successors have been 
selected.
    (b) Nominations for successor handler members and alternate members 
specified in Sec. 982.30(b) (1) through (3) shall be made by the 
largest, second largest, and third largest handler determined according 
to the tonnage of certified merchantable hazelnuts and, when shelled 
hazelnut grade and size regulations are in effect, the inshell 
equivalent of certified shelled hazelnuts (computed to the nearest 
whole ton) recorded by the Board as handled by each such handler during 
the two marketing years preceding the marketing year in which 
nominations are made.
    (c) Nominations for successor handler member and alternate handler 
member positions specified in Sec. 982.30(b)(4) shall be made by the 
handlers in that category by mail ballot. All votes cast shall be 
weighted according to the tonnage of certified merchantable hazelnuts 
and, when shelled hazelnut grade and size regulations are in effect, 
the inshell equivalent of certified shelled hazelnuts (computed to the 
nearest whole ton) recorded by the Board as handled by each handler 
during the two marketing years preceding the marketing year in which 
nominations are made. If less than one ton is recorded for any such 
handler, the vote shall be weighted as one ton. Voting will be by 
position, and each eligible handler can vote for a member and an 
alternate member. The person receiving the highest number of weighted 
votes for each position shall be the nominee for that respective 
position.
* * * * *
    (f) Nominations received in the foregoing manner by the Board for 
all handler and grower member and alternate member positions shall be 
certified and sent to the Secretary at least 60 days prior to the 
beginning of each two-year term of office, together with all necessary 
data and other information deemed by the Board to be pertinent or 
requested by the Secretary. If nominations are not made within the time 
and manner specified in this subpart, the Secretary may, without regard 
to nominations, select the Board members and alternates on the basis of 
the representation provided for in this subpart.
* * * * *
    7. In Sec. 982.33, paragraph (b) is revised to read as follows:

Sec. 982.33  Selection and term of office.

* * * * *
    (b) Term of office. The term of office of Board members and their 
alternates shall be for two years beginning on July 1 and ending on 
June 30, but they shall serve until their respective successors are 
selected and have qualified: Provided, That beginning with the 1996-97 
marketing year, no member shall serve more than three consecutive two-
year terms as member and no alternate member shall serve more than 
three consecutive two-year terms as alternate unless specifically 
exempted by the Secretary. Nomination elections for all Board grower 
and handler member and alternate positions shall be held every two 
years.
* * * * *
    8. In Sec. 982.37, paragraph (b) is revised to read as follows:

Sec. 982.37  Procedure.

* * * * *
    (b) The Board may vote by mail, telephone, telegraph, or other 
means of communication: Provided, That any votes (except mail votes) so 
cast shall be confirmed at the next regularly scheduled meeting. When 
any proposition is submitted for voting by any such method, its 
adoption shall require 10 concurring votes.
* * * * *
    9. In Sec. 982.39, paragraph (i) is revised to read as follows:

Sec. 982.39  Duties.

* * * * *
    (i) To furnish to the Secretary a report of the proceedings of each 
meeting of the Board held for the purpose of making marketing policy 
recommendations.

[[Page 17560]]

Sec. 982.40  [Amended]

    10. In Sec. 982.40, paragraph (c)(2) introductory text is amended 
by removing the word ``shall'' in the third sentence and adding in its 
place the word ``may''.
    11. Section 982.46 is amended by revising paragraph (b) to read as 
follows:

Sec. 982.46  Inspection and certification.

* * * * *
    (b) All hazelnuts so inspected and certified shall be identified as 
prescribed by the Board. Such identification shall be affixed to the 
hazelnut containers by the handler under direction and supervision of 
the Board or the Federal-State Inspection Service, and shall not be 
removed or altered by any person except as directed by the Board.
* * * * *

Sec. 982.51  [Amended]

    12. In Sec. 982.51, paragraph (a) is amended by removing the word 
``percent'' at the end of the first sentence.
    13. Section 982.52 is amended by revising paragraph (b) to read as 
follows:

Sec. 982.52  Disposition of restricted hazelnuts.

* * * * *
    (b) Export. Sales of certified merchantable restricted hazelnuts 
for shipment to destinations outside the continental United States and 
such other distribution areas as may be recommended by the Board and 
established by the Secretary shall be made only by the Board. Any 
handler desiring to export any part or all of that handler's certified 
merchantable restricted hazelnuts shall deliver to the Board the 
certified merchantable restricted hazelnuts to be exported, but the 
Board shall be obligated to sell in export only such quantities for 
which it may be able to find satisfactory export outlets. Any hazelnuts 
so delivered for export which the Board is unable to export shall be 
returned to the handler delivering them. Sales for export shall be made 
by the Board only on execution of an agreement to prevent exportation 
into the area designated in Sec. 982.16. A handler may be permitted to 
act as an agent of the Board, upon such terms and conditions as the 
Board may specify, in negotiating export sales, and when so acting 
shall be entitled to receive a selling commission as authorized by the 
Board. The proceeds of all export sales, after deducting all expenses 
actually and necessarily incurred, shall be paid to the handler whose 
certified merchantable restricted hazelnuts are so sold by the Board.
* * * * *
    14. Section 982.54 is amended by revising paragraphs (b), (c), (d), 
(e) and (f) to read as follows:

Sec. 982.54  Deferment of restricted obligation.

* * * * *
    (b) Bonding requirement. Such bond or bonds shall, at all times 
during their effective period, be in such amounts that the aggregate 
thereof shall be no less than the total bonding value of the handler's 
deferred restricted obligation. The bonding value shall be the deferred 
restricted obligation poundage multiplied by the applicable bonding 
rate. The cost of such bond or bonds shall be borne by the handler 
filing same.
    (c) Bonding rate. Said bonding rate shall be an amount per pound as 
established by the Board. Such bonding rate shall be based on the 
estimated value of restricted credits for the current marketing year. 
Until bonding rates for a marketing year are fixed, the rates in effect 
for the preceding marketing year shall continue in effect. The Board 
should make any necessary adjustments once such new rates are fixed.
    (d) Restricted credit purchases. Any sums collected through default 
of a handler on the handler's bond shall be used by the Board to 
purchase restricted credits from handlers, who have such restricted 
credits in excess of their needs, and are willing to part with them. 
The Board shall at all times purchase the lowest priced restricted 
credits offered, and the purchases shall be made from the various 
handlers as nearly as practicable in proportion to the quantity of 
their respective offerings of the restricted credits to be purchased.
    (e) Unexpended sums. Any unexpended sums which have been collected 
by the Board through default of a handler on the handler's bond, 
remaining in the possession of the Board at the end of a marketing 
year, shall be used to reimburse the Board for its expenses, including 
administrative and other costs incurred in the collection of such sums, 
and in the purchase of restricted credits as provided in paragraph (d) 
of this section.
    (f) Transfer of restricted credit purchases. Restricted credits 
purchased as provided for in this section shall be turned over to those 
handlers who have defaulted on their bonds for liquidation of their 
restricted obligation. The quantity delivered to each handler shall be 
that quantity represented by sums collected through default.
* * * * *
    15. In Sec. 982.57, paragraph (b) is revised to read as follows:

Sec. 982.57  Exemptions.

* * * * *
    (b) Sales by growers direct to consumers. Any hazelnut grower may 
sell hazelnuts of such grower's own production free of the regulatory 
and assessment provisions of this part if such grower sells such 
hazelnuts in the area of production directly to end users at such 
grower's ranch or orchard or at roadside stands and farmers' markets. 
The Board, with the approval of the Secretary, may establish such 
rules, regulations, and safeguards and require such reports, 
certifications, and other conditions, as are necessary to ensure that 
such hazelnuts are disposed of only as authorized. Mail order sales are 
not exempt sales under this part.
    16. Section 982.58 is amended by revising the last sentence of 
paragraph (a) to read as follows:

Sec. 982.58  Research, promotion, and market development.

    (a) * * * The expenses of such projects shall be paid from funds 
collected pursuant to Sec. 982.61, Sec. 982.63, or credited pursuant to 
paragraph (b) of this section.
* * * * *
    17. Section 982.61 is amended by designating the current text as 
paragraph (a) and by adding a new paragraph (b) to read as follows:

Sec. 982.61  Assessments.

    (a) * * *
    (b) In order to provide funds for the administration of the 
provisions of this part during the first part of a fiscal period before 
sufficient operating income is available from assessments on the 
current year's shipments, the Board may accept the payment of 
assessments in advance, and may also borrow money for such purpose. 
Further, payment discounts may be authorized by the Board upon the 
approval of the Secretary to handlers making such advance assessment 
payments.
    18. A new Sec. 982.63 is added to read as follows:

Sec. 982.63  Contributions.

    The Board may accept voluntary contributions but these shall only 
be used to pay expenses incurred pursuant to Sec. 982.58. Furthermore, 
such contributions shall be free from any encumbrances by the donor and 
the Board shall retain complete control of their use.

[[Page 17561]]

    Dated: April 16, 1996.
Michael V. Dunn,
Assistant Secretary, Marketing and Regulatory Programs.
[FR Doc. 96-9824 Filed 4-19-96; 8:45 am]
BILLING CODE 3410-02-P

Complete official Federal Register PDF

FR Doc. 96-9823 Grading and Inspection, General Specifications for Approved Plants and Standards for Grades of Dairy Products; United States Standards for Grades of Nonfat Dry Milk (Spray Process)
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17547-17550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9823]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
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under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
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Federal Register / Vol. 61, No. 78 / Monday, April 22, 1996 / Rules 
and Regulations

[[Page 17547]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 58

[DA-93-03]

Grading and Inspection, General Specifications for Approved 
Plants and Standards for Grades of Dairy Products; United States 
Standards for Grades of Nonfat Dry Milk (Spray Process)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This document revises the United States Standards for Grades 
of Nonfat Dry Milk (Spray Process). The revision reduces existing 
bacterial standard plate count maximums and incorporates a coliform 
requirement to reflect the ability of the U.S. dairy industry to 
produce high-quality nonfat dry milk. The reduction in the maximum 
standard plate count is made possible through improved raw milk quality 
and enhanced processing and sanitation techniques. The inclusion of a 
maximum coliform count adds to the assurance that post-pasteurization 
contamination has not occurred. This revision was developed in 
cooperation with the American Dairy Products Institute and other trade 
associations.

EFFECTIVE DATE: May 22, 1996.

FOR FURTHER INFORMATION CONTACT: Roland S. Golden, Dairy Products 
Marketing Specialist, Dairy Standardization Branch, USDA/AMS/Dairy 
Division, Room 2750-S, P.O. Box 96456, Washington, DC 20090-6456, (202) 
720-7473.

SUPPLEMENTARY INFORMATION: This final rule has been reviewed under 
Executive Order 12778, Civil Justice Reform. This action is not 
intended to have retroactive effect. This rule does not preempt any 
State or local laws, regulations, or policies, unless they present an 
irreconcilable conflict with this rule. There are no administrative 
procedures which must be exhausted prior to any judicial challenge to 
the provisions of this rule.
    The final rule also has been reviewed in accordance with the 
Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The Administrator, 
Agricultural Marketing Service, has determined that the final rule will 
not have a significant economic impact on a substantial number of small 
entities because use of the standards is voluntary and the revisions 
would not increase costs to those utilizing the standards.
    The Department is issuing this rule in conformance with Executive 
Order 12866.
    To provide quality grade standards that reflect the ability of the 
U.S. dairy industry to produce high-quality nonfat dry milk, USDA is 
changing the U.S. Standards for Grades of Nonfat Dry Milk (Spray 
Process) as follows:

1. Expand the U.S. Grade Standards To Include a Maximum Coliform Count 
in USDA-Graded Product

    Coliform bacteria, abundantly present in the environment, are 
destroyed by pasteurization. Post-pasteurization contamination has 
occurred when coliform bacteria are present in nonfat dry milk. The 
addition of a coliform requirement into the U.S. grade standard 
increases the assurance that USDA graded nonfat dry milk is produced 
and packaged in a sanitary manner.

2. Reduce the Standard Plate Count Requirements

    Enumeration of bacteria by the standard plate count method has been 
a criterium used in the determination of U.S. grade for many years. 
Improvements in the sanitary production of nonfat dry milk have 
resulted in a gradual reduction in the number of bacteria present in 
the product. The revision reduces the allowable bacteria from 50,000 to 
40,000 per gram for U.S. Extra Grade and from 100,000 to 75,000 per 
gram for U.S. Standard Grade. These changes accurately reflect the 
ability of the U.S. dairy industry to produce high-quality nonfat dry 
milk and enhances the image of U.S. products on the world market.

3. Update the Terminology and Format of the Standards

    The current U.S. Standards for Grades of Nonfat Dry Milk (Spray 
Process) were last revised in 1984. Since that time, changes in 
terminology and formatting of standards have taken place. The revision 
updates the standards to provide consistency among the various U.S. 
grade standards.
    USDA grade standards are voluntary standards that are developed 
pursuant to the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et 
seq.) to facilitate the marketing process. Manufacturers of dairy 
products are free to choose whether or not to use these grade 
standards. USDA grade standards for dairy products have been developed 
to identify the degree of quality in the various products. Quality in 
general refers to usefulness, desirability, and value of the product--
its marketability as a commodity. When nonfat dry milk is officially 
graded, the USDA regulations and standards governing the grading of 
manufactured or processed dairy products are used. These regulations 
also require a charge for the grading service provided by USDA. The 
Agency believes this revision accurately identifies quality 
characteristics in nonfat dry milk.
    Corollary changes have also been made for the General 
Specifications for Dairy Plants Approved for USDA Inspection and 
Grading Service, to conform the definition of nonfat dry milk set forth 
therein with the final revision of the United States Standards for 
Grades of Nonfat Dry Milk (Spray Process).

Public Comments

    On March 6, 1995, the Department published a proposed rule (60 FR 
12156) to revise the United States Standards for Grades of Nonfat Dry 
Milk (Spray Process). The public comment period closed May 5, 1995. One 
comment was received from a dairy trade association representing the 
dry milk industry. That comment supported the proposed changes to the 
standards.

List of Subjects in 7 CFR Part 58

    Dairy products, Food grades and standards, Food labeling, Reporting 
and record keeping requirements.

    For the reasons set forth in the preamble, 7 CFR part 58 is amended 
as follows:

[[Page 17548]]

PART 58--[AMENDED]

    1. The authority citation for 7 CFR part 58 continues to read as 
follows:

    Authority: 7 U.S.C. 1621-1627.

    2. In Subpart B, Sec. 58.205 (a) is revised to read as follows:

Sec. 58.205   Meaning of words.

* * * * *
    (a) Nonfat dry milk. The product obtained by the removal of only 
water from pasteurized skim milk. It contains not more than 5 percent 
by weight of moisture and not more than 1\1/2\ percent by weight of 
milkfat and it conforms to the applicable provisions of 21 CFR 131 
``Milk and Cream'' as issued by the Food and Drug Administration. 
Nonfat dry milk shall not contain nor be derived from dry buttermilk, 
dry whey, or products other than skim milk, and shall not contain any 
added preservative, neutralizing agent, or other chemical.
* * * * *
    3. Subpart L--United States Standards for Grades of Nonfat Dry Milk 
(Spray Process) is revised to read as follows:
Subpart L--United States Standards for Grades of Nonfat Dry Milk (Spray 
Process)\1\
---------------------------------------------------------------------------

    \1\ Compliance with these standards does not excuse failure to 
comply with the provisions of the Federal Food, Drug, and Cosmestic 
Act.
---------------------------------------------------------------------------

Definitions

Sec.
58.2525  Nonfat dry milk.

U.S. Grades

58.2526  Nomenclature of U.S. grades.
58.2527  Basis for determination of U.S. grade.
58.2528  Specifications for U.S. grades.
58.2529  U.S. grade not assignable.
58.2532  Test methods.

Explanation of Terms

58.2537  Explanation of terms.

Supplement to U.S. Standards for Grades of Nonfat Dry Milk (Spray 
Process): U.S. Heat Treatment Classification

58.2538  Basis for obtaining heat treatment classification.
58.2539  Nomenclature of U.S. Heat Treatment Classification.
58.2540  Basis for determination of U.S. Heat Treatment 
Classification.
58.2541  Test method; whey protein nitrogen.

Subpart L--United States Standards for Grades of Nonfat Dry Milk 
(Spray Process) 1
---------------------------------------------------------------------------

    \\ Compliance with these standards does not excuse failure to 
comply with the provisions of the Federal Food, Drug, and Cosmetic 
Act.
---------------------------------------------------------------------------

Definitions

Sec. 58.2525   Nonfat dry milk.

    (a) ``Nonfat dry milk'' is the product obtained by the removal of 
only water from pasteurized skim milk. It contains not more than 5 
percent by weight of moisture and not more than 1\1/2\ percent by 
weight of milkfat and it conforms to the applicable provisions of 21 
CFR part 131 ``Milk and Cream'' as issued by the Food and Drug 
Administration. Nonfat dry milk covered by these standards shall not 
contain nor be derived from dry buttermilk, dry whey, or products other 
than skim milk, and shall not contain any added preservative, 
neutralizing agent, or other chemical.

U.S. Grades

Sec. 58.2526   Nomenclature of U.S. grades.

    The nomenclature of U.S. grades is as follows:
    (a) U.S. Extra.
    (b) U.S. Standard.

Sec. 58.2527   Basis for determination of U.S. grade.

    (a) The U.S. grade of nonfat dry milk is determined on the basis of 
flavor, physical appearance, bacterial estimate on the basis of 
standard plate count, milkfat content, moisture content, scorched 
particle content, solubility index, and titratable acidity.
    (b) The final U.S. grade shall be established on the basis of the 
lowest rating of any one of the quality factors.

Sec. 58.2528   Specifications for U.S. grades.

    (a) U.S. Extra Grade. U.S. Extra Grade nonfat dry milk shall 
conform to the following requirements (See Tables I, II, and III of 
this section):
    (1) Flavor. Reconstituted nonfat dry milk shall possess a sweet, 
pleasing, and desirable flavor, but may possess the following flavors 
to a slight degree: Chalky, cooked, feed, or flat. See Table I of this 
section.
    (2) Physical appearance. Nonfat dry milk shall possess a uniform 
white to light cream natural color. It shall be free from lumps, except 
those that readily break up with slight pressure, and be practically 
free from visible dark particles.
    The reconstituted product shall be free from graininess. See Table 
II of this section.
    (3) Bacterial estimate. Not more than 40,000 per gram standard 
plate count. See Table III of this section.
    (4) Milkfat content. Not more than 1.25 percent. See Table III of 
this section.
    (5) Moisture content. Not more than 4.0 percent. See Table III of 
this section.
    (6) Scorched particle content. Not more than 15.0 mg. See Table III 
of this section.
    (7) Solubility index. Not more than 1.2 ml., except that product 
classified as U.S. High-heat may have not more than 2.0 ml. See Table 
III of this section.
    (8) Titratable acidity. Not more than 0.15 percent (lactic acid). 
See Table III of this section.
    (b) U.S. Standard Grade. U.S. Standard Grade nonfat dry milk shall 
conform to the following requirements (See Tables I, II, and III of 
this section):
    (1) Flavor. Reconstituted nonfat dry milk shall possess a fairly 
pleasing flavor, but may possess the following flavors to a slight 
degree: Bitter, oxidized, scorched, storage, or utensil; the following 
to a definite degree: Chalky, cooked, feed, or flat. See Table I of 
this section.
    (2) Physical appearance. Nonfat dry milk may possess a slight 
unnatural color. It shall be free from lumps, except those that break 
readily under moderate pressure, and be reasonably free from visible 
dark particles. The reconstituted product shall be reasonably free from 
graininess. See Table II of this section.
    (3) Bacterial estimate. Not more than 75,000 per gram standard 
plate count. See Table III of this section.
    (4) Milkfat content. Not more than 1.50 percent. See Table III of 
this section.
    (5) Moisture content. Not more than 5.0 percent. See Table III of 
this section.
    (6) Scorched particle content. Not more than 22.5 mg. See Table III 
of this section.
    (7) Solubility index. Not more than 2.0 ml., except that product 
classified as U.S. High-heat may have not more than 2.5 ml. See Table 
III of this section.
    (8) Titratable acidity. Not more than 0.17 percent (lactic acid). 
See Table III of this section.

    Table I.--Classification of Flavor With Corresponding U.S. Grade    
------------------------------------------------------------------------
                                                         U.S. standard  
      Flavor characteristics         U.S. extra grade        grade      
------------------------------------------------------------------------
Bitter............................  --                 S                
Chalky............................  S                  D                
Cooked............................  S                  D                
Feed..............................  S                  D                
Flat..............................  S                  D                
Oxidized..........................  --                 S                

[[Page 17549]]

                                                                        
Scorched..........................  --                 S                
Storage...........................  --                 S                
Utensil...........................  --                 S                
------------------------------------------------------------------------
- = Not permitted     S = Slight     D = Definite.                      

Table II.--Classification of Physical Appearance With Corresponding U.S.
                                  Grade                                 
------------------------------------------------------------------------
       Physical appearance                               U.S. standard  
         characteristics           U.S. extra grade          grade      
------------------------------------------------------------------------
Dry Product:                                                            
  Lumpy.........................  Slight............  Moderate.         
  Unnatural color...............  --                  Slight.           
  Visible dark particles........  Practically free..  Reasonably free.  
Reconstituted   Product:                                                
  Grainy........................  --                  Reasonably free.  
------------------------------------------------------------------------
- = Not permitted.                                                      

    TABLE III.--Classification According to Laboratory Analysis With    
                        Corresponding U.S. Grade                        
------------------------------------------------------------------------
                                                                 U.S.   
                Laboratory tests                  U.S. extra   standard 
                                                     grade       grade  
------------------------------------------------------------------------
Bacterial estimate; Standard plate count; per                           
 gram (max).....................................   40,000      75,000   
Milkfat content; percent (max)..................        1.25        1.50
Moisture content; percent (max).................        4.0         5.0 
Scorched particle content; mg (max).............       15.0        22.5 
Solubility index; ml (max)......................        1.2         2.0 
  U.S. High-heat (max)..........................        2.0         2.5 
Titratable acidity (lactic acid); percent (max).        0.15        0.17
------------------------------------------------------------------------

Sec. 58.2529   U.S. grade not assignable.

    Nonfat dry milk shall not be assigned a U.S. grade for one or more 
of the following reasons:
    (a) The nonfat dry milk fails to meet or exceed the requirements 
for U.S. Standard Grade.
    (b) The nonfat dry milk has a direct microscopic clump (DMC) count 
exceeding 100 million per gram.
    (c) The nonfat dry milk has a coliform count exceeding 10 per gram.
    (d) The nonfat dry milk is produced in a plant that is rated 
ineligible for USDA grading service or is not USDA- approved.

Sec. 58.2532   Test methods.

    All required tests shall be performed in accordance with DA 
Instruction No. 918-RL, ``Instruction for Resident Grading Quality 
Control Service Programs and Laboratory Analysis,'' Dairy Grading 
Branch, Dairy Division, Agricultural Marketing Service, U.S. Department 
of Agriculture, Washington, DC 20090-6456; the latest revision of 
``Official Methods of Analysis of the Association of Official 
Analytical Chemists''; or the latest edition of ``Standard Methods for 
the Examination of Dairy Products'', available from the American Public 
Health Association, 1015 Fifteenth Street, NW., Washington, DC 20005.

Explanation of Terms

Sec. 58.2537   Explanation of terms.

    (a) With respect to flavor:
    (1) Slight. Detected only upon critical examination.
    (2) Definite. Not intense but detectable.
    (3) Bitter. Distasteful, similar to the taste of quinine.
    (4) Chalky. A tactual type of flavor lacking in characteristic milk 
flavor.
    (5) Cooked. Similar to a custard flavor and imparts a smooth 
aftertaste.
    (6) Feed. Feed flavors (such as alfalfa, sweet clover, silage, or 
similar feed) in milk carried through into the nonfat dry milk.
    (7) Flat. Insipid, practically devoid of any characteristic 
reconstituted nonfat dry milk flavor.
    (8) Oxidized. A flavor resembling cardboard and sometimes referred 
to as ``cappy'' or ``tallowy''.
    (9) Scorched. A more intensified flavor than ``cooked'' and imparts 
a burnt aftertaste.
    (10) Storage. Lacking in freshness and imparting a ``stale'' 
aftertaste.
    (11) Utensil. A flavor that is suggestive of improper or inadequate 
washing and sanitation of milking machines, utensils, or manufacturing 
equipment.
    (b) With respect to physical appearance:
    (1) Practically free. Present only upon very critical examination.
    (2) Reasonably free. Present only upon critical examination.
    (3) Slight pressure. Only sufficient pressure to disintegrate the 
lumps readily.
    (4) Moderate pressure. Only sufficient pressure to disintegrate the 
lumps easily.
    (5) Grainy. Minute particles of undissolved powder appearing in a 
thin film on the surface of a glass or tumbler.
    (6) Lumpy. Loss of powdery consistency but not caked into hard 
chunks.
    (7) Natural color. A color that is white to light cream.
    (8) Unnatural color. A color that is more intense than light cream 
and is brownish, dull, or grey-like.
    (9) Visible dark particles. The presence of scorched or discolored 
specks.

Supplement to U.S. Standards for Grades of Nonfat Dry Milk (Spray 
Process): U.S. Heat Treatment Classification

Sec. 58.2538  Basis for obtaining heat treatment classification.

    Heat treatment classification is not a U.S. grade requirement 
except in cases when the higher solubility index specified for U.S. 
High-heat product is permitted. In all other instances, product 
submitted for USDA grading may be analyzed for heat treatment 
classification upon request and the results shown on the grading 
certificate. Heat treatment classification will be made available only 
upon a product graded by USDA.

Sec. 58.2339  Nomenclature of U.S. Heat Treatment Classification.

    The nomenclature of U.S. Heat Treatment Classification is as 
follows:
    (a) U.S. High-heat.
    (b) U.S. Medium-heat.
    (c) U.S. Low-heat.

Sec. 58.2540  Basis for determination of U.S. Heat Treatment 
Classification.

    The whey protein nitrogen test shall be used in determining the 
heat treatment classification as follows:
    (a) U.S. High-heat. The finished product shall not exceed 1.50 mg. 
undenatured whey protein nitrogen per gram of nonfat dry milk.
    (b) U.S. Medium-heat. The finished product shall exceed 1.50 mg. 
undenatured whey protein nitrogen per gram of nonfat dry milk and shall 
be less than 6.00 mg. undenatured whey protein nitrogen per gram of 
nonfat dry milk.
    (c) U.S. Low-heat. The finished product shall be not less than 6.00 
mg. undenatured whey protein nitrogen per gram of nonfat dry milk.

Sec. 58.2541  Test method; whey protein nitrogen.

    The whey protein nitrogen test shall be performed in accordance 
with DA

[[Page 17550]]

Instruction 918-RL, ``Instruction for Resident Grading Quality Control 
Service Programs and Laboratory Analysis,'' Dairy Grading Branch, Dairy 
Division, Agricultural Marketing Service, U.S. Department of 
Agriculture, Washington, DC, 20090-6456, or the latest edition of 
``Standard Methods for the Examination of Dairy Products'', available 
from the American Public Health Association, 1015 Fifteenth Street NW., 
Washington, DC 20005.

    Dated: April 16, 1996.
Lon Hatamiya,
Administrator.
[FR Doc. 96-9823 Filed 4-19-96; 8:45 am]
BILLING CODE 3410-02-P

Complete official Federal Register PDF

FR Doc. 96-9813 Implementation of the Domestic Chemical Diversion Control Act of 1993 (Pub. L. 103-200); Correction
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Page 17566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9813]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1313 and 1316

 [DEA No. 112C]

Implementation of the Domestic Chemical Diversion Control Act of 
1993 (Pub. L. 103-200); Correction

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Correction to final regulations.

-----------------------------------------------------------------------

SUMMARY: This document contains corrections to the final regulations 
which were published on Thursday, June 22, 1995 (60 FR 32447). The 
regulations related to the registration, recordkeeping and reporting 
requirements for manufacturers, distributors, importers and exporters 
of listed chemicals.

EFFECTIVE DATE: April 22, 1996.

FOR FURTHER INFORMATION CONTACT:
 G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of 
Diversion Control, Drug Enforcement Administration, Washington, D.C. 
20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: The final regulations that are the subject 
of these corrections implement the Domestic Chemical Diversion Control 
Act of 1993 (Pub. L. 103-200) (DCDCA). The regulations amend Title 21, 
Code of Federal Regulations, to add a new Part 1309 and revise certain 
sections in Parts 1310, 1313 and 1316. As published, the final 
regulations contain errors that could cause confusion in the regulated 
industry.
    Accordingly, the publication June 22, 1995 of the final regulations 
to implement the DCDCA, which were the subject of Federal Register 
Document 95-14978, is corrected as follows:

PART 1313--[CORRECTED]

    1. On page 32465, in the first column, the section heading which 
reads ``Sec. 1312.32  Requirement of authorization for international 
transactions.'' is corrected to read ``Sec. 1313.32  Requirement of 
authorization for international transactions.''

PART 1316--[CORRECTED]

    2. On page 32465, in the third column, amendment Number 1 
immediately following PART 1316--[AMENDED] is corrected to read as 
follows:
    1. The authority citation for Part 1316, Subpart A is amended to 
read as follows:

    Authority: 21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965.

    Dated: April 16, 1996.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 96-9813 Filed 4-19-96; 8:45 am]
BILLING CODE 4410-09-M

Complete official Federal Register PDF

FR Doc. 96-9788 Removal of Obsolete Regulations for Discontinuance of Bus Transportation in One State
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Page 17579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9788]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION
Surface Transportation Board

49 CFR Part 1169

[STB Ex Parte No. 544]

Removal of Obsolete Regulations for Discontinuance of Bus 
Transportation in One State

AGENCY: Surface Transportation Board.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Surface Transportation Board (the Board) is removing from 
the Code of Federal Regulations obsolete regulations concerning 
discontinuance of bus transportation in one state.

EFFECTIVE DATE: January 1, 1996.

FOR FURTHER INFORMATION CONTACT: Beryl Gordon, (202) 927-5610. [TDD for 
the hearing impaired: (202) 927-5721.]

SUPPLEMENTARY INFORMATION: Effective January 1, 1996, the ICC 
Termination Act of 1995, Pub. L. No. 104-88, 109 Stat. 803 (ICCTA) 
abolished the Interstate Commerce Commission (ICC) and established the 
Board within the Department of Transportation. Section 204 of the ICCTA 
provides that ``[t]he Board shall promptly rescind all regulations 
established by the [ICC] that are based on provisions of law repealed 
and not substantively reenacted by this Act.''
    Under the Bus Regulatory Reform Act of 1982 (the Bus Act), state 
regulation of bus exit was relaxed. As here pertinent, section 16 of 
the Bus Act (codified at 49 U.S.C. 10935) provided a mechanism for bus 
companies to seek ICC permission to discontinue service on intrastate 
routes that form part of interstate routes when they have been denied 
permission by state regulatory bodies to discontinue such 
service.1 In Preemption of State Regulations--Regular-Route Exit, 
133 M.C.C. 20 (1982), the ICC issued rules, found at 49 CFR 1169, to 
implement this statutory provision.
---------------------------------------------------------------------------

    \1\  Under 49 U.S.C. 10935, discontinuance means total cessation 
of service or reducing the level of service to less than one trip 
per weekday (excluding Saturdays and Sundays).
---------------------------------------------------------------------------

    Pursuant to the ICCTA, 49 U.S.C. 10935 has been repealed. Because 
the section 10935 statutory basis for the part 1169 regulations for 
discontinuance of bus transportation in one state has been repealed, we 
are removing the now obsolete part 1169 regulations.2
---------------------------------------------------------------------------

    \2\  We note that the repeal was not intended to reintroduce 
state regulation. Rather, under the preemption provisions of old 49 
U.S.C. 11501(e), which were amended and recodified at 49 U.S.C. 
14501(a), interstate or intrastate scheduling changes, including 
discontinuance and the reduction of the level of service on a 
carrier's interstate routes, are preempted from state regulation. 
The new law, we also note, leaves unchanged the ability of states to 
require notice, not to exceed 30 days, of schedule changes and 
discontinuances. As before, states may regulate intrastate commuter 
bus operations and strictly intrastate routes.
---------------------------------------------------------------------------

    Because this action merely reflects, and is required by, the 
enactment of the Act and will not have an adverse effect on the 
interests of any person, this action will be deemed to be effective as 
of January 1, 1996.
    This action will not significantly affect either the quality of the 
human environment or the conservation of energy resources.

List of Subjects in 49 CFR Part 1169

    Administrative practice and procedure, Buses, Motor Carriers.

    Decided: April 9, 1996.

    By the Board, Chairman Morgan, Vice Chairman Simmons, and 
Commissioner Owen.
Vernon A. Williams ,
Secretary.

PART 1169--[REMOVED]

    For the reasons set forth in the preamble and under the authority 
of 49 U.S.C. 721(a), title 49, chapter X of the Code of Federal 
Regulations is amended by removing part 1169.

[FR Doc. 96-9788 Filed 4-19-96; 8:45 am]
BILLING CODE 4915-00-P

Complete official Federal Register PDF

FR Doc. 96-9784 New Animal Drugs; Change of Sponsor
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Page 17566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9784]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the change of sponsor name for a new animal 
drug application (NADA) from MAC-PAGE, Inc., to ADM Animal Health & 
Nutrition Div.

EFFECTIVE DATE: April 22, 1996.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 6, 1994 
(59 FR 50828), FDA published a final rule amending the animal drug 
regulations to reflect the change of sponsors for all NADA's held by 
Central Soya, P. O. Box 1400, Fort Wayne, IN 46801-2508, including MAC-
PAGE, Inc., 1600 South Wilson Ave., Dunn, NC 28334, a wholly-owned 
subsidiary of Central Soya, transferred to Premiere Agri Technologies, 
Inc. The subsidiaries retained their names and drug labeler codes. In 
the Federal Register of September 11, 1995 (60 FR 40752), FDA published 
a final rule amending the animal drug regulations to reflect the change 
of sponsor name from Premiere Agri Technologies, Inc., and the names of 
all wholly-owned subsidiaries, to ADM Animal Health & Nutrition Div., 
P.O. Box 2508, Fort Wayne, IN 46801-2508. Both final rules, which 
reflected these changes, inadvertently did not include NADA 131-957 
(Tylosin). This document corrects that error. Accordingly, FDA is 
amending the regulations in 21 CFR 558.625 to reflect the change of 
sponsor.

List of Subject in 21 CFR Part 558

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.625  [Amended]

    2. Section 558.625 Tylosin is amended in paragraph (b)(79) by 
removing ``047427'' and adding in its place ``012286''.

    Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-9784 Filed 4-19-96; 8:45 am]
BILLING CODE 4160-01-F

Complete official Federal Register PDF

FR Doc. 96-9779 New Animal Drugs; Change of Sponsor Name and Address
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17565-17566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9779]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

New Animal Drugs; Change of Sponsor Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor name and address from 
Agribusiness Marketers, Inc., to Mallinckrodt Veterinary Operations, 
Inc.

EFFECTIVE DATE:  April 22, 1996.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Agribusiness Marketers, Inc., 2667 West 
Dual, Baton Rouge, LA 70815, has informed FDA of a change of sponsor 
name and address to Mallinckrodt Veterinary Operations, Inc., 421 East 
Hawley St., Mundelein, IL 60060.
    Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the change of sponsor name and 
address.

List of Subjects in 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is 
amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    -Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) by removing the entry for ``Agribusiness Marketers, Inc.,'' and 
by alphabetically adding a new entry for ``Mallinckrodt Veterinary 
Operations, Inc., 421 East Hawley St., Mundelein, IL

[[Page 17566]]

60060.....015563'' and in the table in paragraph (c)(2) in the entry 
for ``015563'' by removing the sponsor name ``Agribusiness Marketers, 
Inc.,'' and adding in its place ``Mallinckrodt Veterinary Operations, 
Inc., 421 East Hawley St., Mundelein, IL 60060.''

    Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-9779 Filed 4-19-96; 8:45 am]
BILLING CODE 4160-01-F

Complete official Federal Register PDF

FR Doc. 96-9749 Removal of 28 CFR Part 25Recommendations to the President on Civil Aeronautics Board Decisions
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17575-17576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9749]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

28 CFR Part 25

[AG Order No. 2002-95]
RIN 1105-AA41

Removal of 28 CFR Part 25--Recommendations to the President on 
Civil Aeronautics Board Decisions

AGENCY: Department of Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rule removes 28 CFR part 25--Recommendations to the 
President on Civil Aeronautics Board Decisions--from the Code of 
Federal Regulations. Part 25 is unnecessary, and its removal will help 
to streamline the Code of Federal Regulations.

DATES: This final rule is effective April 22, 1996.

FOR FURTHER INFORMATION CONTACT:
Howard Blumenthal, Assistant Chief, Legal Policy Section, Antitrust 
Division, Room 3121 Main Justice Building, 10th & Pennsylvania Avenue 
NW., Washington, DC 20530; telephone (202) 514-2513.

SUPPLEMENTARY INFORMATION: Title 28 CFR part 25 contains Department of 
Justice (``Department'') regulations setting forth procedures for 
receiving comments from private parties on possible recommendations by 
the Department to the President concerning decisions by the Secretary 
of Transportation (``Secretary'') submitted for Presidential approval 
pursuant to 49 U.S.C. 41307 and 41509. (At the time this regulation was 
promulgated, these duties were performed by the Civil Aeronautics Board 
(``CAB'') pursuant to 49 U.S.C. 1461, but the CAB's authority in this 
regard was subsequently transferred to the Secretary.) Under 49 U.S.C. 
41307 and 41509, the Secretary must submit for Presidential review 
decisions made by the Secretary to issue, deny, amend, revoke, etc., 
certificates to domestic or foreign air carriers to provide foreign air 
transportation, or to suspend, cancel, or reject tariffs for foreign 
air transportation. The President may disapprove decisions of the 
Secretary only for reasons based on foreign relations or national 
defense considerations. E.O. 12597, 52 FR 18335 (1987), provides that 
the Department, along with certain other Executive Branch agencies, may 
make recommendations to the President concerning such decisions by the 
Secretary for reasons relating to the national defense or foreign 
relations. Any other concerns that the Department may have with the 
Secretary's decisions, including those related to regulatory policy, 
are to be presented to the Department of Transportation (``DOT'') in 
accordance with the procedures of DOT.
    Under section 8 of E.O. 12597, ``[d]epartments and agencies * * * 
that regularly make recommendations in connection with the [above 
described] presidential review * * * shall * * * (a) establish public 
dockets for all written communications * * * between their officers and 
employees and private parties in connection with the preparation of 
such recommendations; and (b) prescribe such other procedures governing 
oral and written communications as they deem appropriate.'' (Emphasis 
added.) Essentially, 28 CFR part 25 provides that public comments 
concerning possible Department recommendations shall be in writing 
whenever possible, shall be submitted in duplicate, and shall, unless 
such communications are entitled to confidential treatment or are 
publicly available from DOT, be placed in a public docket established 
in the Legal Procedures Unit of the Antitrust Division.
    The Department has had no occasion to make recommendations to the 
President concerning the national defense or foreign relations 
implications of the issuance of certificates to provide foreign air 
transportation or the rejection of tariffs for foreign air 
transportation, nor has it received comments from private parties on 
any such possible recommendations, for at least the last seven years. 
Furthermore, the Department does not anticipate doing so on a regular 
basis in the future. Thus, 28 CFR part 25 is not required to be 
promulgated by E.O. 12597, and its inclusion in the Code of Federal 
Regulations is unnecessary. Private parties wishing to submit comments 
to the Department concerning possible recommendations by the Department 
under 49 U.S.C. 41307 and 41509 will be informed of the proper 
procedures to follow, and a public docket for comments will be created, 
on an ad hoc basis should such an occasion ever arise. Therefore, the 
Department is removing 28 CFR part 25.

Administrative Procedure Act, 5 U.S.C. 553

    Because this regulation imposes no new requirements or 
restrictions, the Department of Justice finds good cause for exempting 
it from the provisions of the Administrative Procedure Act (5 U.S.C. 
553) requiring notice of proposed rulemaking, the opportunity for 
public comment, and delay in effective date.

Regulatory Flexibility Act

    The Attorney General, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it 
certifies that this regulation will not have a significant economic 
impact on a substantial number of small entities.

Executive Order 12612

    This regulation will not have substantial direct effects on the 
states, on the relationship between the national government and the 
states, or on the distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with Executive 
Order 12612, it is determined that this rule does not have sufficient 
federalism implications to warrant the preparation of a Federalism 
Assessment.

Executive Order 12866

    This regulation has been drafted and reviewed in accordance with 
Executive Order 12866, section 1(b), Principles of Regulation. The 
Department of Justice has determined that this rule is not a 
``significant regulatory action'' under Executive Order 12866, section 
3(f), and accordingly this rule has not been reviewed by the Office of 
Management and Budget.

List of Subjects in 28 CFR Part 25

    Administrative practice and procedure, Air transportation, 
Antitrust.

    Accordingly, for the reasons set forth in the preamble and pursuant 
to 28 U.S.C. 509, 510, and 5 U.S.C. 301, in Title 28 of the Code of 
Federal Regulations, part 25 is removed.

[[Page 17576]]

    Dated: December 14, 1995.
Janet Reno,
Attorney General.
[FR Doc. 96-9749 Filed 4-19-96; 8:45 am]
BILLING CODE 4410-01-M

Complete official Federal Register PDF

FR Doc. 96-9735 Drug Labeling; Sodium Labeling for Over-the-Counter Drugs
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17798-17806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9735]

[[Page 17797]]

_______________________________________________________________________

Part IV

Department of Health and Human Services

_______________________________________________________________________

Food and Drug Administration

_______________________________________________________________________

21 CFR Parts 201 and 331

Sodium Labeling for Over-the-Counter Drugs and Labeling of Orally 
Ingested Over-the-Counter Drug Products Containing Calcium, Magnesium, 
and Potassium; Final and Proposed Rules

Federal Register / Vol. 61, No. 78 / Monday, April 22, 1995 / Rules 
and Regulations

[[Page 17798]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 331

[Docket No. 90N-0309]
RIN 0910-AA63

Drug Labeling; Sodium Labeling for Over-the-Counter Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule with opportunity for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the general 
labeling provisions for over-the-counter (OTC) drug products to require 
that the sodium content of all OTC drug products intended for oral 
ingestion be included in labeling when the product contains 5 
milligrams (mg) or more sodium per a single dose; require that all OTC 
drug products intended for oral ingestion containing more than 140 mg 
sodium in the labeled maximum daily dose bear a general warning that 
persons who are on a sodium-restricted diet should not take the product 
unless directed by a doctor; and provide for the voluntary use of 
certain terms (``sodium free,'' ``very low sodium,'' and ``low 
sodium'') relating to an OTC drug product's sodium content per labeled 
maximum daily dose. FDA is issuing this final rule in order to provide 
uniform sodium content labeling for all OTC drug products intended for 
oral ingestion (whether marketed under an OTC drug monograph, an 
approved application, or no application), and to provide for the 
voluntary use in OTC drug labeling of the same terms used to describe 
sodium content in food labeling.

DATES: This final rule is effective April 22, 1997; written comments by 
July 22, 1996.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-105), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2304.

SUPPLEMENTARY INFORMATION:

I. Background

    -In the Federal Register of April 25, 1991 (56 FR 19222), FDA 
proposed to amend the general labeling provisions for OTC drug products 
to: (1) Require that the sodium content of all orally administered OTC 
drug products be included in labeling when the product contains 5 mg or 
more sodium per a single recommended dose; (2) require that orally 
administered OTC drug products containing more than 140 mg sodium in 
the maximum recommended daily dose be labeled with a general warning 
that persons who are on a sodium-restricted diet should not take the 
product unless directed by a doctor; and (3) provide for the voluntary 
use of certain descriptive terms relating to the OTC drug product's 
sodium content. FDA issued the notice of proposed rulemaking in order 
to provide uniform sodium content labeling for all orally administered 
OTC drug products, and to provide for the voluntary use in OTC drug 
labeling of the same descriptive terms as those used to describe sodium 
content in food labeling. To promote uniformity, the agency also 
proposed to delete the existing sodium labeling requirements in the 
final monograph for OTC antacid drug products (21 CFR part 331).
    -Interested persons were invited to file written comments, 
objections, or requests for oral hearing on the proposed regulation 
before the Commissioner of Food and Drugs (the Commissioner) and to 
file comments on the agency's economic impact determination by June 24, 
1991. In the Federal Register of June 12, 1991 (56 FR 26946), FDA 
published a notice extending the comment period until July 24, 1991.
    -In response to the proposed rule, comments were received from five 
state governments, five manufacturers, two trade associations, one 
health professional association, one consumer organization, and FDA 
employees. No comments were received on the agency's economic impact 
determination.-
    -Based on comments received, the agency is seeking comments from 
interested individuals on whether this final rule should be amended to 
include sodium content labeling for OTC rectal laxative, vaginal, 
dentifrice, mouthwash, and mouth rinse drug products. (See section 
I.B., comment 6 of this document.) Comments should be sent to the 
Dockets Management Branch (address above) by July 22, 1996.

II. The Agency's Conclusions on the Comments

A. General Comments

    -1. Most comments generally supported the proposal to include 
sodium content in OTC drug product labeling. A number of the comments 
stated that this labeling would be especially helpful to those 
individuals who must restrict their sodium intake, specifically the 
elderly. Several comments were opposed to the warning statement (see 
section II.D., comment 12 of this document).
    -2. Several comments supported uniform sodium labeling for foods 
and OTC drug products. One comment favored use of the descriptive terms 
``sodium free,'' ``very low sodium,'' and ``low sodium'' for OTC drug 
products because food labeling has made these terms familiar to 
consumers on a low-sodium diet. However, the comment strongly opposed 
sodium warning labeling for OTC drug products, which it considered 
unnecessary and counterproductive (see also section II.D., comment 12 
of this document). Another comment noted that the proposed sodium 
warning requirement for those OTC drugs containing over 140 mg sodium 
per maximum recommended daily dose is consistent with the labeling of 
foods. The comment noted that consumers are familiar with food labeling 
where a serving containing 140 mg or less sodium is considered ``low 
sodium.''
    -Another comment acknowledged the value of the proposed terms, 
provided they are consistent with those used in food labeling. However, 
the comment contended that basing drug labeling on ``per maximum daily 
dosage'' is inconsistent with food labeling which is based on ``per 
serving.'' The comment indicated that ``per dose'' labeling for drugs 
would be more consistent with the food labeling. The comment also noted 
that sodium labeling for foods has no warning threshold, while the 
proposed sodium labeling for OTC drug products does have a warning 
threshold. Another comment stated that drugs are not produced, 
consumed, or regulated like foods and thus should not be treated like 
foods for warning purposes.
    -FDA does not consider sodium labeling for OTC drug products to be 
either unnecessary or counterproductive. The agency has determined that 
such labeling is important and, wherever possible, should be comparable 
to that used for foods because consumers are already familiar with that 
labeling. While consumption patterns for drugs are not the same as 
those for foods, a substantial portion of daily sodium intake can come 
from OTC drugs, especially those used frequently, such as antacids, 
internal analgesics, and laxatives. Thus, the agency concludes that 
consumers

[[Page 17799]]

should be informed about the sodium content of drugs as well as foods.
    -The agency believes that ``maximum daily dose'' is the most 
appropriate basis for sodium descriptor labeling of OTC drug products, 
even though this basis differs from that for food labeling. Consumers 
may use multiple doses per day of many OTC drug products, and OTC drug 
product labeling informs consumers how much of a drug can be safely 
consumed daily. On the other hand, in many cases only a single serving 
of many different foods containing sodium is likely to be consumed in 1 
day, although there is no upper limit on the number of servings that 
could be consumed. Thus, the consumption patterns vary for foods and 
for drugs. Because of food consumption patterns, nutritional labeling, 
including the descriptive terms used, is based on ``per serving,'' and 
the consumer must determine the total daily intake of each food. By 
contrast, OTC drugs have a safe consumption limit, and sodium labeling 
is more appropriately based on the labeled maximum daily dosage. The 
agency is using the term ``labeled maximum daily dosage'' in place of 
``maximum recommended daily dosage'' to indicate that this dosage 
appears in the product's labeling.
    -Although the use of descriptive terms for sodium in the labeling 
of foods is based on the sodium content ``per serving'' rather than on 
a ``maximum daily intake,'' physicians usually monitor a patient's 
total daily sodium intake, not how much is consumed at each meal. When 
physicians instruct people to maintain a low-sodium diet, the 
physicians and individuals determine what foods to avoid to keep the 
daily sodium intake at an acceptable level. If an antacid is needed, 
total daily sodium intake can be reduced by using a calcium antacid 
rather than a sodium antacid.
    -The agency acknowledges that the basis for the descriptive terms 
for sodium labeling of OTC drug products is not the same as for food 
labeling. Nonetheless, the agency considers the two to be consistent. 
In general, the amount of sodium derived from a given OTC drug in 1 day 
is limited to the amount contained in the labeled maximum daily dosage, 
while that derived from a given food is often the amount of sodium in a 
single daily serving. Therefore, in this final rule for OTC drug 
product labeling the agency is providing for the voluntary use of 
descriptive terms for sodium that are based on the labeled maximum 
daily dose. (See also section II.E., comment 15 of this document.)
    -3. One comment expressed concern that descriptive terms based on 
sodium content using rounded-off numbers could be different from 
descriptive terms based on sodium content using actual numbers. The 
comment stated that potential compliance problems could arise if an FDA 
inspector examined the label of an affected product, multiplied the 
rounded-off, approximated sodium content number by the maximum 
recommended daily dose, and arrived at a number that did not fall 
within the range that correlates to the descriptive term on the label. 
The comment contended that calculations for descriptive terms should be 
done using actual sodium content numbers. The comment suggested that if 
discrepancies between actual and rounded-off numbers occur, reasonable 
documentation showing the method of calculation using the actual sodium 
content numbers should be accepted as sufficient to resolve the matter.
    -Another comment supported the first comment's position on the 
rounding-off rules. The comment mentioned the sodium content labeling 
regulation for food in Sec. 101.9(g)(5) (21 CFR 101.9(g)(5)), which 
states: ``A food with a label declaration of calories, sugars, total 
fat, saturated fat, cholesterol, or sodium shall be deemed to be 
misbranded under section 403(a) of the act if the nutrient content of 
the composite is greater than 20 percent in excess of the value for 
that nutrient declared on the label.'' This regulation, referred to as 
the ``120 percent rule,'' provides an upper limit to the amount that 
sodium content may vary in food, above which a product would be deemed 
misbranded. The comment suggested that such a rule for the upper limit 
of variation for sodium labeling for OTC drugs, without an accompanying 
lower limit, would be reasonable because manufacturers will tend to 
declare as low a sodium content as is reasonable for the product. The 
comment contended that applying the ``120 percent rule'' to sodium 
labeling of OTC drugs would alleviate many of the compliance issues 
associated with providing a sodium content on the label that is 
different from the actual sodium content.
    -The agency has reconsidered the ``rounding-off'' provision and 
concludes that rounding-off could result in potential discrepancies 
between the actual and apparent sodium content, and may lead to 
consumer confusion. For instance, if the actual sodium content of a 
product is 8 mg per dosage unit and the product is to be taken four 
times daily, the labeled maximum daily dose is 32 mg. Because the 
sodium content is less than 35 mg (per labeled maximum daily dose), the 
term ``very low sodium'' could be used. However, if the actual dosage 
unit (8 mg) is rounded-off to 10 mg, the apparent labeled maximum daily 
dose for that product would be 40 mg and the descriptive term would be 
``low sodium.''
    -Food labeling regulations provide for rounding-off the sodium 
content to the nearest 5 or 10 mg sodium per serving. Because most food 
products contain naturally occurring sodium, at least in small amounts, 
some variation in sodium content is expected. On the other hand, most 
OTC drug products are manufactured and the amount of sodium in products 
can be strictly controlled. Thus, the sodium content of OTC drug 
products is expected to be less variable than that of foods. The agency 
concludes that the sodium content of OTC drug products can readily be 
disclosed in mg per dosage unit, without rounding-off. As a result, the 
agency considers the ``120 percent rule'' provided for in Sec. 101.9(g) 
of the food regulations unnecessary for OTC drug products. Therefore, 
the agency is revising proposed Sec. 201.64(b) in this final rule (21 
CFR 201.64(b)) to eliminate the 5 mg and 10 mg rounding-off provision. 
The final rule requires that the sodium content be rounded-off to the 
nearest whole number, whatever the content per dosage unit.

B. Comments on the Scope of Sodium Labeling

    -4. Three comments disagreed with the agency's ``across-the-board'' 
sodium warning requirement for OTC drugs, stating that this method 
ignores the OTC drug review's category-by-category mechanism for 
considering warnings. One comment added that if a warning statement is 
required, the agency should consider the product's pharmacologic class, 
its use patterns, and the currently required labeling of particular 
active ingredients. Another comment contended that sodium warnings 
should only be required where a need has been shown for a particular 
category of OTC drugs.
    -FDA disagrees with the comments, which provided no scientific 
basis for their concerns. Although the agency generally considers OTC 
drug labeling on a category-by-category basis, FDA has required certain 
``across-the-board'' labeling during the course of the OTC drug review, 
such as the pregnancy-nursing warning in Sec. 201.63 (21 CFR 201.63). 
Thus, an ``across the board'' approach is consistent with past agency 
regulatory actions. FDA has determined that a certain level (140 mg) of 
sodium

[[Page 17800]]

may present a potential safety problem, regardless of the source of the 
sodium. Therefore, the agency sees no reason to consider the warning on 
a category-by-category basis, which would result in a lack of 
uniformity in product labeling until the agency's evaluation of each 
drug category is completed. The agency's ``across-the-board'' approach 
to sodium labeling is not based on various drug categories; it is based 
on sodium being present in any OTC drug product.
    -5. Two comments agreed with the proposal to include both active 
and inactive ingredients when labeling/calculating total sodium content 
in an OTC drug product. One comment added that all recommended diluents 
should also be included in the sodium content labeling.
    -FDA appreciates the comments' concurrence. Including all sources 
of sodium in the total sodium content labeling enables consumers to 
determine the total amount of sodium consumed, regardless of the 
source. Diluents in OTC drug products are inactive ingredients and 
would be covered by this rulemaking. Under Sec. 201.64(b) of this final 
rule, the agency is requiring the sodium content labeling of OTC drug 
products to include both active and inactive ingredients, which would 
include any diluents used in these products.
    -6. Several comments contended that the scope of covered products 
should be limited to products intended for ingestion rather than orally 
administered products. The comments argued that ``orally administered'' 
OTC drug products include dentifrices and mouthwashes that are not 
ingested, but rather expectorated. The comments pointed out any 
absorption of sodium from these products is minuscule.
    -The agency agrees that certain OTC drug products, such as 
dentifrices and mouthwashes, although orally administered, need not be 
covered by this rulemaking. These products are not intended to be 
ingested by the user, and the agency does not have sufficient 
information on the absorption of sodium when these products are used to 
warrant a labeling requirement at this time. However, orally 
administered gum or lozenge forms of OTC drug products intended for 
either partial or complete ingestion are covered by this rule. 
Therefore, in this final rule the agency is changing the language in 
Sec. 201.64(a), (c), and (d) from ``orally administered OTC drug 
products'' to ``OTC drug products intended for oral ingestion,'' and is 
adding the following sentence to Sec. 201.64(a): ``OTC drug products 
intended for oral ingestion include gum and lozenge dosage forms, but 
do not include dentifrices, mouthwashes, or mouth rinses.''
    -The agency notes that some OTC laxative and vaginal drug products 
intended for rectal or vaginal administration can contain very high 
levels of sodium from both active and inactive ingredients. Significant 
amounts of some of these products may be absorbed. At this time, the 
agency does not have sufficient information on the absorption of sodium 
from these products to warrant a labeling requirement.
    -The agency is seeking comments from interested individuals on 
whether this final rule should be amended to include sodium content 
labeling for OTC rectal laxative, vaginal, dentifrice, mouthwash, and 
mouth rinse drug products. Comments should be sent to the Dockets 
Management Branch (address above) by July 22, 1996.
    -7. Two comments suggested requiring sodium content labeling for 
prescription drugs as well as OTC drug products. The comments stated 
that this information was important for the elderly and for patients 
receiving more than one drug product. One comment added that physicians 
treating patients on sodium restricted diets need to be aware of the 
amount of sodium in prescription products.
    -The agency agrees that sodium content labeling of prescription 
drugs would be beneficial. This information would be helpful to 
physicians, pharmacists, and consumers so they can make informed 
decisions. However, prescription drug labeling is outside the scope of 
this rulemaking for OTC drug products. Currently, the agency is 
actively considering the comments' recommendation for prescription drug 
labeling and is appraising whether the problem can best be dealt with 
via a regulation, guidance document, or another approach. At this time, 
the agency encourages sodium content labeling of prescription drugs on 
a voluntary basis.

C. Comments on Sodium Content Labeling

    -8. One comment recommended that any level of sodium in OTC drug 
products be listed on the label to enable consumers to make their own 
decision as to what is an insignificant amount of sodium in relation to 
their diet. Another comment suggested that the minimum level of sodium 
requiring labeling be increased from greater than 5 mg per maximum 
recommended dose to greater than 70 mg per maximum recommended daily 
dose. The comment mentioned that data generated by the Food and 
Nutrient Board indicate that 4,000 to 5,800 mg sodium are consumed per 
capita per day. Therefore, the sodium consumed in medications provides 
only a minimal amount and does not pose the same potential risk as 
food. The comment reasoned that 70 mg is only 5 percent of the Food and 
Nutrient Board's recommended daily intake of 1.4 grams (g) sodium for 
people on sodium restricted diets. The comment contended that this 
amount of sodium would not pose a risk to consumers on a low-sodium 
diet because 70 mg does not contribute a significant amount to their 
daily intake.
    -The agency has considered the comments' suggestions and has 
decided to use 5 mg of sodium per maximum recommended dose as the basis 
for including sodium content in the labeling of OTC drug products. As 
discussed in section II.E., comment 13 of this document, the agency 
considers a sodium level below 5 mg per dose to be physiologically 
insignificant. Thus, the agency is not requiring any labeling if the 
amount of sodium in the product is below 5 mg.
    -The agency considers a 5 mg maximum recommended dose standard a 
reasonable approach, based in part on experience with OTC antacid drug 
product labeling. Although the agency believes a 70 mg labeled maximum 
daily dose standard is not unreasonable, a 5 mg maximum labeled dose is 
consistent with the antacid monograph, which has been in effect since 
1974. As discussed in the proposed rule, the existing requirement for 
OTC antacid drug products in Sec. 331.30(f) (21 CFR 331.30(f)) provides 
that the labeling include sodium content per dosage unit if it contains 
5 mg or more. This labeling requirement for OTC antacids has been in 
effect for over 20 years, and consumers are familiar with that 
approach. The sodium labeling requirements in this final rule, based on 
sodium content per dose, are similar to those in the antacid monograph.
    -The 5 mg approach will also result in more informative labeling 
than the 70 mg approach, because more products will be labeled with 
sodium content. More than 14 doses per day of a product containing less 
than 5 mg sodium per dose would be required to exceed 70 mg sodium per 
labeled maximum daily dose. Almost all OTC drug products are not taken 
that often. Thus, more products will likely require sodium content 
labeling based on 5 mg per dose than would result using 70 mg per 
labeled maximum daily dose as the basis. (See also section I.E., 
comment 13. of this document)
    -9. Three comments endorsed the agency's proposal to express the 
sodium

[[Page 17801]]

content of an OTC drug product in mg per dosage unit. The first comment 
suggested that those monographs now stating sodium labeling in 
milliequivalents (mEq) could be amended to mg. The comment stated that 
sodium declaration is more useful when provided in terms of dosage 
units (such as a teaspoonful or a tablet) than in terms of the 
recommended dosage amount, because the recommended dosage amount can 
vary. The second comment considered the option of having the sodium 
content declaration based on the recommended daily dose, but rejected 
that option because studies have shown that consumers frequently take 
more than the recommended daily dosage for OTC drug products. The third 
comment stated that the sodium content declaration should include the 
total sodium in both mg and mEq per dosage unit, average daily intake, 
and maximum recommended daily intake, if applicable.
    -The agency appreciates the comments' endorsements of the 
requirement that sodium content be listed in mg per dosage unit. The 
agency does not believe that listing some or all of the options (e.g., 
in both mg and mEq per dosage unit, per average daily intake, and per 
maximum daily intake) would be useful, because these multiple numbers 
would tend to confuse consumers and would unnecessarily clutter the 
label. Further, the agency believes consumers are more familiar with 
the term ``mg'' as used in food labeling than the term ``mEq.'' 
Therefore, in this final rule the agency is using only mg per dosage 
unit for declaring the sodium content of OTC drug products.
    -As one comment noted, other OTC drug monographs address sodium 
labeling. These monographs will be amended to delete specific sodium 
labeling requirements so that the sodium labeling of all OTC drug 
products will appear in a single regulation. In the proposed rule for 
sodium labeling, the agency proposed to delete the existing 
requirements for OTC antacid drug products that appear in 
Sec. 331.30(c)(5) and (f) (56 FR 19224 to 19225). The agency is 
finalizing that in this final rule. The sodium labeling requirements 
proposed in Sec. 334.50(b)(5) and (b)(8) of the tentative final 
monograph for OTC laxative drug products (50 FR 2124 at 2153, January 
15, 1985) and proposed in Sec. 343.50(c)(1)(viii)(A) and 
(c)(1)(viii)(B) and Sec. 343.50(c)(2)(viii)(A) and (c)(2)(viii)(B) of 
the tentative final monograph for OTC internal analgesic, antipyretic, 
and antirheumatic drug products (53 FR 46204 at 46256 to 46257, 
November 16, 1988) will be deleted when the final monographs for those 
drug classes are issued in a future issue of the Federal Register.
    -10. One comment requested that the agency require sodium content 
information to be presented in a predetermined place on the OTC drug 
product label, such as the ingredients list. The comment gave an 
example of a product containing a level of sodium requiring a warning 
while, at the same time, its label prominently displayed ``75% less 
sodium than (a comparable product)'' under active ingredients. The 
actual sodium content was listed at the end of a long paragraph of 
warnings and would make the product off-limits to an individual on a 
sodium-restricted diet. The comment contended that such labeling could 
potentially mislead consumers.
    -FDA agrees that the sodium content of an OTC drug product should 
be expressed at a specific location on the product label. By 
designating a specific location, consumers can find the sodium content 
of the product more quickly and with less confusion because the 
information will appear in the same location in the labeling of all 
orally ingested OTC drug products. The agency believes the most logical 
place for the sodium content labeling is at the end of the ingredients 
section. Further, the sodium content should be listed on a separate 
line after the heading 'Sodium Content' so that it is easily recognized 
by the consumer. Accordingly, the agency is amending proposed 
Sec. 201.64(b) in this final rule to add a sentence that states: ``The 
sodium content per dosage unit shall be listed on a separate line after 
the heading 'Sodium Content' as the last statement in the ingredients 
section.''
    -11. One comment suggested that product labeling state a 
recommended safe range of sodium intake to provide consumers with a 
baseline for the control of sodium consumption.
    -The comment's request for labeling to advise consumers of a safe 
level of sodium is impractical because different medical and 
physiological problems require different levels of sodium restriction. 
Consumers should consult with physicians or other health professionals 
to determine the optimum levels of sodium consumption for their 
particular conditions. Thus, FDA is not requiring that the labeling 
state a recommended safe range of sodium intake at this time.

D. Comments on Sodium Warning Labeling

    -12. Two comments contended that the agency's proposal to include a 
sodium warning in the labeling of OTC drug products when the maximum 
recommended daily dose contains more than 140 mg of sodium is 
inconsistent with the labeling of foods, which does not require 
warnings at any level. The comments questioned the choice of 140 mg per 
maximum recommended daily dose as the level that triggers the sodium 
warning. The comments argued that the warning may unnecessarily confuse 
or alarm consumers. The first comment contended that the choice of 140 
mg is completely arbitrary and questioned its scientific relevance. The 
comment stated that there is no evidence that consumers derive a 
significant percentage of sodium intake from OTC drug products.
    -The second comment stated that 140 mg of sodium is markedly lower 
than the level required to effect an increase in blood pressure. 
Asserting that OTC drugs are intended for short term use, the comment 
said intermittent use of such products will not affect the long-term 
benefit of a low-sodium diet because the resulting increase in blood 
pressure is rapidly reversed upon discontinuation of the product. The 
comment contended that the sodium warning, if required, should be based 
on ``per dose'' or ``per dosage unit,'' rather than ``maximum 
recommended daily dose,'' because a single dose more closely resembles 
a single serving, the unit used for food labeling. The comment also 
contended that the readability of the label will be compromised as the 
label becomes more cluttered, and that additional warnings of 
questionable value will only reduce the impact of other warnings on the 
label.
    -Noting that the sodium warning represents a familiar cautionary 
signal for consumers, a third comment stated that sodium-containing 
drugs could contribute a significant percentage of the daily sodium 
intake for some individuals. The comment mentioned that 1,000 mg of 
sodium per day is common for sodium restricted diets and that 140 mg of 
sodium represents 14 percent of the daily allowance for such diets. 
Several comments argued that sodium warnings should be considered on a 
case-by-case basis. (See section II.B., comment 4 of this document.)
    -FDA is establishing, where possible, uniformity in labeling 
between foods and OTC drug products. FDA recognizes that OTC drug 
products containing greater than 140 mg of sodium require a warning, 
while foods do not require a warning at any level of sodium. The 
labeling requirements for drugs need to be somewhat different from 
those for foods because of the differences in

[[Page 17802]]

consumption patterns. (See section II.A., comment 2 of this document.) 
The agency considers the labeling approach in this final rule 
appropriate, even though it is not the same as that for foods in all 
respects.
    -The choice of 140 mg as the level of sodium above which a warning 
should be required is not, as one comment contended, completely 
arbitrary. In a survey conducted by the agency and discussed in the 
final rule for declaration of sodium content and label claims for foods 
on the basis of sodium content (49 FR 15510 at 15519, April 18, 1984), 
it was found that over 50 percent of the foods surveyed contained less 
than 140 mg of sodium per serving. Thus, the agency determined that a 
substantial portion of the food supply is eligible to bear the ``low 
sodium'' descriptive term. By establishing 140 mg as an upper limit for 
the term ``low sodium'' for OTC drug products and requiring a warning 
for products containing sodium above that level, consumers can more 
easily monitor their total daily sodium intake. Requiring a warning for 
products below the 140 mg level could be confusing to consumers because 
some products containing the term ``low-sodium'' could, at the same 
time, contain the warning. FDA believes that a warning requirement for 
OTC drug products that contain more than 140 mg sodium would not 
unnecessarily confuse or alarm consumers, as two comments suggested. As 
another comment stated, the sodium warning represents a familiar 
cautionary signal for consumers. The agency concludes that the warning 
requirement will be welcomed by those who want to monitor their sodium 
intake.-
    -The agency considers a numeric value that can be readily converted 
from mg to mEq useful for dietary planning, because physicians and 
dietitians sometimes calculate sodium in mEq rather than mg when 
prescribing sodium restrictions (49 FR 15510 at 15519). One mEq of 
sodium is equivalent to 23 mg. Thus, the 140 mg sodium level is 
approximately 6 mEq, allowing for easy calculation. The comments did 
not provide any evidence that warnings based on some other level of 
sodium would be more informative or useful to consumers than the 140 mg 
level proposed by the agency.
    -The agency agrees with one comment's contention that an OTC drug 
containing 140 mg of sodium is well below the level needed to affect 
blood pressure. However, it is the total amount of sodium consumed from 
all sources, both foods and drugs, that must be considered. As one 
comment pointed out, 140 mg represents 14 percent of a common (1,000 
mg) sodium-restricted diet. The agency considers the level of sodium 
found in some OTC drug products, such as antacids, to be significant 
for people on low- sodium diets, especially if the drug product is 
taken in multiple daily doses as most antacids are. While many 
consumers do not derive significant amounts of sodium from OTC drug 
products, many others do. The agency concludes that it is important to 
provide information to those consumers who can be adversely affected by 
the sodium content of OTC drug products.
    -The agency disagrees with one comment's suggestion that the 
warning, if required, should be based on ``per dose,'' rather than on 
``maximum recommended daily dose.'' Drug products are often taken in 
multiple doses in 1 day, while many different foods are more likely to 
be consumed only once a day. Thus, by equating one serving of food to 
one dose of drug, the intake per day for a drug would be a multiple of 
the amount in one dose, while the intake per day for a food may be only 
the amount found in a single serving of food. Because low-sodium diets 
are based on the total amount of sodium consumed in 1 day, the agency 
believes it is appropriate to base the sodium warning threshold on the 
labeled maximum daily dose.
    -The agency shares the comment's concern about readability of the 
label and avoiding unnecessary clutter. However, the agency considers a 
warning for OTC drug products containing appreciable amounts of sodium 
important to alert those consumers who wish or need to minimize their 
sodium intake. Therefore, in this final rule the agency is providing 
for a mandatory warning for all OTC drug products intended for oral 
ingestion containing more than 140 mg sodium per labeled maximum daily 
dose.

E. Comments on Use of Descriptive Terms in Sodium Labeling

    - 13. One comment supported the intent of the sodium labeling 
proposal, but asserted that the term ``sodium free'' should be 
prohibited on drugs containing any sodium. The comment stated that 
labeling should be reliable and not mislead consumers as to the sodium 
content of OTC drug products. The comment contended that most consumers 
expect products labeled as ``sodium free'' to contain no sodium, but 
this would not be true if ``sodium free'' products were allowed to 
contain up to less than 5 mg of sodium. The comment mentioned health 
concerns about high blood pressure related to sodium, and argued that 
inaccurate labeling adversely impacts consumer purchasing decisions. 
The comment acknowledged that agency regulations for food allow 
products with less than 5 mg of sodium per serving to be labeled as 
``sodium free.'' The comment requested that the existing food 
regulations and the proposed OTC drug regulations be modified to 
prohibit the use of the term ``sodium free'' on food and drug products 
containing any sodium.
    -The agency has considered the comment's request and concludes that 
the term ``sodium free'' should only be used for products containing 
``0 mg'' sodium, as defined in this final rule. Thus, the level of 
sodium in OTC drug products for which the term ``sodium free'' proposed 
in Sec. 201.64(d) may be used is being changed from ``less than 5 
milligrams per maximum recommended daily dose'' to ``0 milligrams per 
labeled maximum daily dose'' in this final rule. The agency's basis for 
the term ``sodium free'' in the proposed rule for sodium labeling of 
OTC drug products (56 FR 19222 at 19223) was based on the sodium 
labeling regulation for foods in Sec. 101.61(b)(1)(i) (21 CFR 
101.61(b)(1)(i)), which provides for the voluntary use of ``sodium 
free'' in the labeling of foods containing less than 5 mg sodium per 
serving. Most foods naturally contain at least trace amounts of sodium 
and the amount of sodium in a given food can vary. The agency concluded 
that the 5 mg sodium level for food is, practically speaking, a 
nonsignificant amount of dietary sodium.
    -However, in contrast to foods in which sodium may occur naturally, 
the amount of sodium in OTC drug products can be controlled during the 
manufacturing process. With today's analytical methodology, sodium can 
be accurately measured in parts per million. Thus, the agency believes 
consumers expect labels of drug products to accurately and reliably 
convey the level of ingredients in the product. While there may be no 
need to inform consumers of minute amounts of sodium (e.g., this final 
rule requires sodium content labeling only for those products 
containing 5 or more mg sodium per recommended dose), there is also no 
reason to label a product as ``sodium free'' when, in fact, it contains 
more than ``0 mg'' of sodium, as defined in this final rule.
    -In Sec. 201.64(b) of this final rule, sodium content labeling is 
rounded-off to the nearest whole number as mg per dosage unit. Thus, a 
product containing less than 0.5 mg sodium per dosage unit could be 
labeled as ``0 mg'' sodium and

[[Page 17803]]

a product containing more than 0.5 mg and less than 1.5 mg sodium could 
be labeled as ``1 mg'' sodium. The agency believes that the term 
``sodium free'' should not be used in the labeling of OTC drug products 
except for those products that contain ``0 mg'' sodium per labeled 
maximum daily dose. Thus, a product containing 0.4 mg sodium per tablet 
or teaspoon (rounded-off to 0) with labeling to take one tablet or 
teaspoon daily may use the descriptive term ``sodium free'' in its 
labeling. However, when the recommended dose in an OTC drug monograph 
provides for more than one dosage unit per day, e.g., the directions 
advise to take one or two tablets (or teaspoons) or to take two tablets 
(or teaspoons), the same product containing 0.4 mg sodium (rounded-off 
to 0) per tablet or teaspoon could not use the term ``sodium free'' 
because the labeled maximum dose contains 0.8 mg (rounded-off to 1). 
The labeling set forth in this final rule also eliminates the 
possibility that products labeled ``sodium free'' will at the same time 
be labeled with a sodium content greater than ``0 mg,'' a potential 
basis for consumer confusion.
    -Similarly, the agency determined that the term ``alcohol free'' 
may not be used in the labeling of OTC drug products that contain any 
alcohol (see the Federal Register of March 13, 1995, 60 FR 13590). In 
Sec. 328.50(e) (21 CFR 328.50(e)) the agency requires: ``For a product 
to state in its labeling that it is 'alcohol free,' it must contain no 
alcohol (0 percent).''
    -Therefore, in this final rule, the agency is providing under 
Sec. 201.64(d) for the voluntary use of the term ``sodium free'' if the 
amount of sodium in the labeled maximum daily dose is ``0 mg.'' The 
agency recognizes that this position differs from that for nutrition 
labeling for foods, but believes that, for OTC drug product labeling, 
it is more appropriate. Any request to change the existing ``sodium 
free'' labeling for food products in Sec. 101.61(b)(1)(i) should be 
made in a citizen petition, in accord with Sec. 10.30 (21 CFR 10.30).
    -14. One comment recommended a relative print size limit on 
descriptive terms for sodium content to ensure that the primary 
emphasis of the OTC drug product label remains on the medical 
indication of the product. The comment stated that a consumer's 
foremost reason for purchasing an OTC drug product should be based on 
its medical indication, not on its sodium content.
    -FDA agrees with the comment that a relative print size limit on 
descriptive terms would be useful to help ensure that consumers are not 
distracted from the medical purpose of the product. The food 
regulations (21 CFR 103.13(f)) provide that a nutrient content claim 
shall be in a type size no larger than two times the statement of 
identity and shall not be unduly prominent in type style compared to 
the statement of identity. The agency believes that a related approach 
should also be used for OTC drug products.
    -The agency does not believe that the print size of the descriptive 
terms for sodium labeling for OTC drug products should be any larger 
than the print size of the statement of identity. Allowing larger print 
size (e.g., two times the size of that for the statement of identity, 
as for nutrient claims) could result in label clutter or misplaced 
emphasis. OTC drug products are generally marketed in smaller packages 
than foods and, thus, have less label space available than food 
products. Accordingly, the agency is adding in Sec. 201.64(h) of this 
final rule the following statement:
    The terms ``sodium free,'' ``very low sodium,'' and ``low sodium'' 
shall be in print size and style no larger than the product's statement 
of identity and shall not be unduly prominent in print size or style 
compared to the statement of identity.
    -15. One comment stated that descriptive terms in sodium labeling 
of OTC drug products will help improve consumer understanding of the 
message, and that the terms must be in simple language for lay persons 
to understand. Another comment contended that voluntary descriptive 
terms are unnecessary, often confusing, and potentially misleading. The 
comment suggested the proposed terms ``sodium free,'' ``very low 
sodium,'' and ``low sodium'' could translate into ``healthy'' and 
thereby become misleading. Further, the comment questioned using these 
descriptive terms in conjunction with the required warning, arguing 
that an inconsistent jump occurs from 140 mg (maximum daily dosage as 
``low sodium'') to 141 mg (maximum daily dosage requiring a warning). 
The comment concluded that these two diverse measurements would prime 
the consumer for confusion.
    -The agency believes the voluntary descriptive terms ``sodium 
free,'' ``very low sodium,'' and ``low sodium'' are simple for 
consumers to understand. The terms are not intended to convey the exact 
level of sodium in a product, only an approximation. The comment did 
not provide any evidence that consumers might misinterpret these terms 
as meaning ``healthy,'' specifically as they relate to OTC drug product 
labeling. The agency recognizes that the jump for the maximum daily 
dose from 140 mg, representing ``low sodium,'' to 141 mg, requiring a 
warning, is not ideal. However, many standards have a set criterion, 
above or below which some action is triggered. The agency concludes 
there is no evidence to believe that these preset levels will lead to 
consumer confusion. (See also section II.A., comment 2 of this 
document.)

F. Comments on the Sodium-Hypertension Relationship

    16. One comment considered it inappropriate for the agency to adopt 
regulations that address only sodium intake without reference to the 
anion (chloride). The comment urged that FDA regulations reflect the 
``emerging learning that the chloride ion is a necessary causative 
element in salt-induced hypertension.'' The comment referenced 16 
studies (Ref. 1) to show that both the sodium and chloride ions play 
roles in inducing hypertension in some persons, and that other sodium 
salts do not induce hypertension.
    -The comment stated that a report by the National Academy of 
Sciences/National Research Council (Ref. 2) on diet and health 
correlated dietary ``salt'' or ``sodium chloride,'' rather than 
``sodium,'' with hypertension. The comment added that recent medical 
surveys reflect the growing understanding that both the sodium and the 
chloride ions play roles in causing salt-sensitive hypertension. For 
example, the comment cited the Yearbook of Medicine (Ref. 3) as stating 
that ``it remains to be established that any commonly ingested sodium 
salt other than sodium chloride can increase blood pressure in patients 
with salt-sensitive essential hypertension.''
    -A second comment also contended that the effects of sodium on 
blood pressure are limited to sodium in the form of sodium chloride. 
The comment provided literature references (Ref. 4) suggesting that 
when the accompanying anion was other than chloride, sodium intake did 
not affect blood pressure. The comment mentioned that sodium in drug 
products is usually present as the benzoate, phosphate, or citrate 
salt, and contended that there is no clear evidence that the sodium 
content of the drug presents a hazard sufficient to deem the proposed 
warning appropriate.
    One comment, which approved of sodium content labeling but was 
opposed to the warning, mentioned a submission made in response to 
FDA's request for scientific data and information to determine if a 
scientific basis exists for health claims relating to sodium and 
hypertension (Ref. 5). In that submission, the comment concluded that 
there are no well-

[[Page 17804]]

documented scientific data supporting a clear relationship between 
dietary sodium and hypertension applicable to the general public. The 
comment claimed that recent scientific evidence shows that a reduced 
sodium diet does not reduce the risk of hypertension in healthy 
individuals, but that it may contribute to heart disease and additional 
health risks. The comment concluded that appropriate scientific 
evidence does not exist to support any general health claims based on a 
relationship between sodium and hypertension.
    -The comment subsequently provided current articles and reviews on 
the salt-blood pressure relationship (Ref. 6). The comment emphasized 
one article (Ref. 7) that addressed the question of whether and how 
sodium chloride intake influences blood pressure. The authors stated 
that past literature was interpreted as ``demonstrating a strong 
relationship between salt intake and blood pressure, a substantial 
benefit to all hypertensive persons of reduced salt intake, and a 
relatively low risk to society of promulgating this policy.'' Based on 
more recent studies, the authors suggested that only a portion (30 to 
40 percent) of adults are salt (sodium chloride) sensitive and that 
salt sensitivity is linked to other cations and anions in the diet 
(e.g., adequate potassium and calcium intake may protect against salt 
sensitivity). The comment contended that because of new and mounting 
evidence that low-sodium diets may present some risk to individuals who 
are not salt-sensitive hypertensives, FDA should not require the sodium 
warning. Although opposed to the warning, the comment agreed that some 
individuals need to monitor their sodium intake.
    -The agency agrees with the comments that the sodium ion is not the 
only influence on hypertension. The question of whether or not the 
chloride ion is necessary for sodium to increase blood pressure is an 
academic issue. Even if chloride or another ion in addition to sodium 
is necessary to elevate blood pressure, hypertension is not the sole 
reason for this rulemaking. There are other conditions for which 
physicians recommend low-sodium diets. For instance, sodium bicarbonate 
reportedly exacerbates congestive heart failure. While sodium chloride 
is the primary source of sodium in the general population, sodium 
bicarbonate and other sodium-containing ingredients can account for a 
considerable amount of sodium in OTC drug products. Sodium labeling is 
not aimed specifically at patients with hypertension, but is intended 
to benefit all people who need or wish to monitor their sodium intake 
for whatever reason. The comments made no mention of the effect of 
sodium on any aspects of health other than hypertension.
    -This rulemaking does not state a causal relationship between 
sodium and hypertension, but rather provides for sodium content 
labeling and recommends that individuals on a low-sodium diet consult a 
physician if daily doses of greater than 140 mg sodium are to be 
ingested. This final rule provides that the labeling of OTC drug 
products include the total sodium content (including both active and 
inactive ingredients). It is reasonable for consumers on low-sodium 
diets to consult with their physician before taking OTC drug products 
with a high sodium content. The physician can put the variables into 
perspective and decide whether specific OTC drug products should be 
used. Alternative products containing less or no sodium may be 
available.
    -The agency has previously considered the relationship of sodium 
and hypertension and agrees that this is a complex subject that 
deserves more study. The agency recognizes that there are differences 
of opinion on this subject. Nonetheless, in a final rule on food 
labeling (health claims and labeling statements; sodium and 
hypertension), the agency stated ``based on the totality of the 
scientific evidence, there is significant agreement among qualified 
experts that diets high in sodium are associated with high blood 
pressure'' (58 FR 2820 at 2822, January 6, 1993). The agency stated 
that some studies indicate that sodium chloride and other sodium salts 
have distinct effects on blood pressure (58 FR 2829). Sodium chloride 
is the major source of sodium in foods and most studies investigating 
the effect of sodium on hypertension have involved either increasing or 
decreasing sodium chloride intake. The agency acknowledged that if it 
is true that sodium chloride, and not sodium, is implicated in high 
blood pressure, products containing other sources of sodium may be 
incorrectly considered to promote high blood pressure. The agency 
allowed the optional term ``salt'' to be used in addition to ``sodium'' 
in health claims in food labeling. However, the agency noted there is 
not significant scientific agreement that only sodium chloride affects 
blood pressure (58 FR 2829). Therefore, the basis for health claims 
relating to hypertension in that final rule was sodium content, not 
sodium chloride content.
    -FDA recognizes that not all individuals need to or should reduce 
their sodium intake. Sodium consumed from OTC drug products alone may, 
for most individuals, be insignificant and may not cause a significant 
increase in blood pressure. However, OTC drug products are not a 
consumer's sole source of sodium. All sources of sodium must be taken 
into account when monitoring daily intake. Even though, as one comment 
suggested, some individuals may need counseling from physicians or 
dietitians in order to maintain a strict low-sodium diet, the agency 
considers the sodium warning for OTC drug products helpful even for 
those individuals. This rulemaking does not recommend specific levels 
of sodium intake for the general population or for individuals h 
specific conditions. However, for those who need or want to monitor 
their sodium intake, the agency concludes that sodium content and 
warning labeling for OTC drug products is useful.

 References

     (1) Comment No. C00017, Docket No. 90N-0309, Dockets Management 
Branch.
     (2) Committee on Diet and Health, National Academy of Sciences/
National Research Council (U.S.), Diet and Health: Implications for 
Reducing Chronic Disease Risk, National Academy Press, Washington, 
1989.
     (3) D. E. Rogers et al., editors, Yearbook of Medicine, 
Yearbook Medical Publishers, Inc., Chicago, pp 589-590, 1989.
    -(4) Comment No. C00014, Docket No. 90N-0309, Dockets Management 
Branch.
    -(5) Comment No. C00007, Docket No. 91N-0095, Dockets Management 
Branch.
    -(6) Comment No. SUP 1, Docket No. 90N-0309, Dockets Management 
Branch.
    -(7) Muntzel, M., and T. Drueke, ``A Comprehensive Review of the 
Salt and Blood Pressure Relationship,'' American Journal of 
Hypertension, 5:1S-42S, 1992.

III. Summary of Significant Changes from the Proposed Rule

    -1. In this final rule, the agency is revising Sec. 201.64(b) to 
eliminate the 5-mg rounding-off provision. The final rule requires that 
the sodium content be rounded-off to the nearest whole number, whatever 
the content, per dosage unit. (See section II.A., comment no. 3 of this 
document.)
    -2. The agency is changing the language in Sec. 201.64(a) and (c) 
through (f) from ``orally administered OTC drug products'' to ``OTC 
drug products intended for oral ingestion,'' and is adding the 
following sentence to Sec. 201.64(a): ``OTC drug products intended for 
oral ingestion include gum and lozenge dosage forms, but do not include 
dentifrices, mouthwashes, or mouth rinses.'' (See section II.B., 
comment no. 6 of this document.)
    -3. The agency is adding the following in Sec. 201.64(b): ``The 
sodium content per

[[Page 17805]]

dosage unit shall be listed on a separate line after the heading 
`Sodium Content' as the last statement in the ingredients section.'' 
(See section II.C., comment no. 10 of this document.)
    -4. Proposed Sec. 201.64(d) provided for the voluntary use of the 
term ``sodium free'' for products containing ``less than 5 milligrams'' 
of sodium in the maximum recommended daily dose. This final rule allows 
for the use of the term ``sodium free'' only for those products 
containing ``0 mg'' of sodium in the labeled maximum daily dose. The 
agency is revising the example in proposed Sec. 201.64(d) to clarify 
the basis for use of descriptive terms, taking into account the 
rounding-off provision for the sodium content in mg per dosage unit to 
the nearest whole number. (See section II.A., comment no. 3; section 
II.E., comment no. 13; and part III.1 of this document.)
    -5. The agency has added a provision in Sec. 201.64(h) of this 
final rule limiting the print size and style of the ``sodium free,'' 
``very low sodium,'' and ``low sodium'' terms to no larger than and not 
unduly prominent in comparison to the product's statement of identity. 
(See section II.E., comment no. 14 of this document.)

IV. The Agency's Final Conclusions on Sodium Labeling-

    FDA believes that the public interest in and the public health 
consequences of sodium intake have produced a need for more informative 
and consistent sodium content labeling information on drugs and foods. 
This is true for individuals with hypertension, heart failure, or other 
conditions who must monitor their sodium intake.
    -To establish uniform content declarations, warnings, and 
descriptive terms for sodium in foods and OTC drug products, the agency 
is implementing the following requirements for OTC drug products 
intended for oral ingestion: (1) The product must have a sodium content 
declaration if it contains five mg or more of sodium per single labeled 
dose (which may involve one or more dosage units, e.g., tablets, 
teaspoons). (2) The product must bear a sodium warning if it contains 
more than 140 mg (about 6 mEq) of sodium in the labeled maximum daily 
dose. This warning states: ``Do not use this product if you are on a 
sodium-restricted diet unless directed by a doctor.'' (3) Manufacturers 
may use the following descriptive terms for sodium content: ``Sodium-
free'' for products containing 0 mg sodium in the labeled maximum daily 
dose; ``very low sodium'' for products containing 35 mg or less; and 
``low sodium'' for products containing 140 mg or less. The requirement 
for a sodium content declaration is based on the number of mg of sodium 
in one dose, while the requirement for a warning statement and the use 
of the optional descriptive terms are based on the number of mg of 
sodium in the labeled maximum daily dose.
    -Because consumers and health professionals are accustomed to 
computing sodium intake in mg (49 FR 15510 at 15530), and to provide 
for uniformity in the declaration of sodium content labeling for foods 
and OTC drug products intended for oral ingestion, the term 
``milligrams'' or the abbreviation ``mg'' is used to designate the 
sodium content of OTC drug products. The total sodium content 
(including both active and inactive ingredients), in mg per dosage 
unit, should be rounded-off to the nearest whole number. If the single 
recommended dose (one or more dosage units) of the product contains 5 
mg or more of sodium, a declaration of sodium content expressed in mg 
per single dosage unit (e.g., tablet, teaspoon) is required to be 
listed on a separate line after the heading ``Sodium Content'' as the 
last statement in the ingredients section.
    -The new sodium labeling requirements apply to all OTC drugs 
intended for oral ingestion, whether marketed under an OTC drug 
monograph, an approved application, or no application. The existing 
requirements relating to sodium labeling in Sec. 331.30(c)(5) and (f) 
of the final monograph for OTC antacid drug products are being deleted. 
The proposed sodium labeling requirements being considered in other 
ongoing OTC drug rulemakings will be deleted when final monographs for 
those drug classes are issued in a future issue of the Federal 
Register.

V. Analysis of Impacts

    -An analysis of the costs and benefits of this regulation, 
conducted under Executive Order 12291 was discussed in the proposed 
rule (56 FR 19222 at 19225). No comments were received in response to 
the agency's request for specific comment on the economic impact of 
this rulemaking. Executive Order 12291 has been superseded by Executive 
Order 12866.
    -FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and, thus, is not subject to review under the Executive Order.
    -The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. With this final rule, one-time label modification 
costs associated with changing product labels will be incurred by some 
manufacturers. FDA estimates those costs to total less than $500,000 
for the entire industry. This projected cost is based on estimates of 
the number of products that will be affected by this final rule, the 
number of distinct label changes that will be required, and the cost of 
printing new labels.
    -OTC antacid drug products are the primary products having a 
significant number of orally administered active ingredients containing 
sodium. The monograph for those products has been in effect since 1974 
and these products currently bear sodium labeling. For these products, 
the labeling change will involve a slight change in wording, resulting 
only in a minor cost to have a labeling revision printed. In almost all 
cases, manufacturers can routinely revise labeling at the next printing 
so that minimal costs should be incurred. Manufacturers will have up to 
12 months after publication of this final rule in the Federal Register 
to revise their product labeling. FDA anticipates that most antacid 
drug products would undergo a label printing within a 12-month period. 
Because these OTC antacid drug products already bear sodium labeling 
warnings, the agency may extend the time period beyond 12 months, if 
necessary, upon request, for the revised wording to be implemented.
    -Other OTC drug products (i.e., laxatives and internal analgesics) 
having a few sodium-containing active ingredients affected by this 
final rule previously were not required to bear sodium labeling. These 
products will need to have new labels printed to incorporate the sodium 
labeling. These products must also have new labeling printed in the 
future when the final monographs for OTC laxative and internal 
analgesic drug products are published. This again involves one-time 
label modification costs. For products undergoing such labeling 
changes, the incremental costs attributable to this rule for sodium 
labeling will be

[[Page 17806]]

negligible. A limited number of OTC laxative and internal analgesic 
drug products contain sodium-containing active ingredients. Tentative 
final monographs with sodium labeling requirements for these products 
have been published, and no adverse comments concerning economic 
impacts have been received in response to the proposals. The agency is 
not aware of any significant number of other OTC drug products that 
will be affected due to the sodium content of inactive ingredients. Use 
of the descriptive terms for sodium set forth in this rulemaking is 
voluntary. Therefore, any implementation of these terms could be done 
by a manufacturer at any time that new labeling is ordered. The agency 
finds that the cost of adding one of these descriptive terms to the 
product's labeling will be negligible. Accordingly, the agency 
certifies that the final rule will not have a significant economic 
impact on a substantial number of small entities. Therefore, under the 
Regulatory Flexibility Act, no further analysis is required.

VI. Paperwork Reduction Act of 1995

    -FDA concludes that the labeling requirements in this document are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the 
warning statement and the sodium terms are a ``public disclosure of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)). The sodium content per dosage unit is product 
formulation information that manufacturers have on hand as part of 
their usual and customary business practice.

VII. Environmental Impact

    -The agency has determined under 21 CFR 25.24(c)(6) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects

21 CFR Part 201

    -Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 331

    -Labeling, Over-the-counter drugs.

    -Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, title 
21 of the Code of Federal Regulations is amended in parts 201 and 331 
as follows

:-PART 201--LABELING

    -1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    -Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508, 
510, 512, 530-542, 701, 704, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358, 
360, 360b, 360gg-360ss, 371, 374, 379e); secs. 215, 301, 351, 361 of 
the Public Health Service Act (42 U.S.C. 216, 241, 262, 264).

    -2. New Sec. 201.64 is added to subpart C to read as follows:

Sec. 201.64   Sodium labeling.

    -(a) The labeling of over-the-counter (OTC) drug products intended 
for oral ingestion shall contain the sodium content per dosage unit 
(e.g., tablet, teaspoonful) if the sodium content of a single 
recommended dose of the product (which may be one or more dosage units) 
is 5 milligrams or more. OTC drug products intended for oral ingestion 
include gum and lozenge dosage forms, but do not include dentifrices, 
mouthwashes, or mouth rinses.
    -(b) The sodium content shall be expressed in milligrams per dosage 
unit and shall include the total amount of sodium regardless of the 
source, i.e., from both active and inactive ingredients. The sodium 
content shall be rounded-off to the nearest whole number. The sodium 
content per dosage unit shall be listed on a separate line after the 
heading ``Sodium Content'' as the last statement in the ingredients 
section.
    -(c) The labeling of OTC drug products intended for oral ingestion 
shall contain the following warning under the heading ``Warning'' (or 
``Warnings'' if it appears with additional warning statements) if the 
amount of sodium present in the labeled maximum daily dose of the 
product is more than 140 milligrams: ``Do not use this product if you 
are on a sodium-restricted diet unless directed by a doctor.''
    -(d) The term ``sodium free'' may be used in the labeling of OTC 
drug products intended for oral ingestion if the amount of sodium in 
the labeled maximum daily dose is 0 milligram. For example, a product 
containing 0.4 (rounded-off to zero (0)) milligram sodium per tablet 
with directions to take one tablet daily may use the term ``sodium 
free'' in its labeling. However, when the recommended dose provides for 
taking more than one dosage unit per day, e.g., take one or two 
tablets, or take two tablets, the same product containing 0.4 milligram 
sodium per tablet shall not use the term ``sodium free'' because the 
labeled maximum daily dose contains 0.8 milligram sodium.
    -(e) The term ``very low sodium'' may be used in the labeling of 
OTC drug products intended for oral ingestion if the amount of sodium 
in the labeled maximum daily dose is 35 milligrams or less.
    -(f) The term ``low sodium'' may be used in the labeling of OTC 
drug products intended for oral ingestion if the amount of sodium in 
the labeled maximum daily dose is 140 milligrams or less.
    -(g) The term ``salt'' is not synonymous with the term sodium and 
shall not be used interchangeably or substituted for the term 
``sodium.''
    -(h) The terms ``sodium free,'' ``very low sodium,'' and ``low 
sodium'' shall be in print size and style no larger than the product's 
statement of identity and shall not be unduly prominent in print size 
or style compared to the statement of identity.
    -(i) Any product subject to this paragraph that is not labeled as 
required by this paragraph and that is initially introduced or 
initially delivered for introduction into interstate commerce after 
April 22, 1997, is misbranded under sections 201(n) and 502(a) and (f) 
of the Federal Food, Drug, and Cosmetic Act.

PART 331--ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE

    -3. The authority citation for 21 CFR part 331 continues to read as 
follows:

    -Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371).

Sec. 331.30   [Amended]

    -4. Section 331.30 Labeling of antacid products is amended by 
removing paragraph (c)(5) and redesignating paragraphs (c)(6) and 
(c)(7) as paragraphs (c)(5) and (c)(6), respectively, and by removing 
paragraph (f) and redesignating paragraph (g) as paragraph (f).

    Dated: March 30, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-9735 Filed 4-19-96; 8:45 am]
BILLING CODE 4160-01-F

Complete official Federal Register PDF

FR Doc. 96-9704 Medals of Honor
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17578-17579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9704]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION
49 CFR Part 79

[Docket No. OST-96-1258; Notice 96-8]
RIN 2105-AC41

Medals of Honor

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: DOT is clarifying its regulations regarding award of Medals of 
Honor for bravery in land transportation accidents/incidents. This 
action is taken on the Department's initiative in response to the 
President's Regulatory Reinvention Initiative.

EFFECTIVE DATE: May 22, 1996.

FOR FURTHER INFORMATION CONTACT: Robert I. Ross, Office of the General 
Counsel, C-10, Department of Transportation, Washington, DC 20590, 
telephone (202) 366-9156, FAX (202) 366-9170.

SUPPLEMENTARY INFORMATION: Acting through DOT, the President of the 
United States may award a bronze medal for bravery to any person who, 
by extreme daring, risks his/her life in trying to prevent, or to save 
the life of a person in, a grave accident in the United States that 
involves an interstate rail carrier or a motor vehicle being operated 
on public highways. See 49 U.S.C. 80504. The regulations implementing 
this authority were last amended in 1968. DOT is revising them in order 
to simplify language and otherwise make them easier to understand. 
Because these changes are editorial in nature and do not change the 
substantive requirements, the Department finds that notice and comment 
are unnecessary and contrary to the public interest.

Analysis of Regulatory Impacts

    This amendment is not a ``significant regulatory action'' within 
the meaning of Executive Order 12866. It is also not significant within 
the definition in DOT's Regulatory Policies and Procedures, 49 FR 11034 
(1979), in part because it does not involve any change in important 
Departmental policies. There will be no economic impact as a result of 
this change. Moreover, I certify that this rule will not have a 
significant economic impact on a substantial number of small entities.
    This rule does not significantly affect the environment, and 
therefore an environmental impact statement is not required under the 
National Environmental Policy Act of 1969. It has also been reviewed 
under Executive Order 12612, Federalism, and it has been determined 
that it does not have sufficient implications for federalism to warrant 
preparation of a Federalism Assessment.
    Finally, the rule does not contain any collection of information 
requirements, requiring review under the Paperwork Reduction Act of 
1980.

List of Subjects in 49 CFR Part 79

    Decorations, Medals, Awards.

    In accordance with the above, DOT revises 49 CFR Part 79, to read 
as follows:

PART 79--MEDALS OF HONOR

Sec.
79.1  Scope.
79.3  Application.
79.5  Investigation.
79.7  Award.
79.9  Design.

    Authority: 49 U.S.C. 80504.

Sec. 79.1   Scope.

    (a) This Part implements 49 U.S.C. 80504, which authorizes the 
President of the United States to award a bronze medal for bravery to 
any person who, by extreme daring, risks his/her life in trying to 
prevent, or to save the life of a person in, a grave accident/incident 
in the United States that involves an interstate rail carrier or a 
motor vehicle being operated on public highways.
    (b) The actions for which the medal may be awarded must reflect 
such unusual daring and bravery that a person would not normally be 
expected to perform them as a regular part of his/her regular work or 
vocation.

Sec. 79.3   Application.

    (a) Any person may apply for the award of the medal described in 
Sec. 79.1, but only on behalf of another person, by writing to the 
Secretary of Transportation, Attention: Medals of Honor, within two (2) 
years of the action that is the subject of the application.
    (b) Although no application form is required, the following 
information must be provided:
    (1) Name, address, and telephone number of the person submitting 
the application.
    (2) Name, address, and telephone number of the person on whose 
behalf the application is submitted.
    (3) Date, time, place, and weather conditions of the action that is 
the subject of the application.

[[Page 17579]]

    (4) Identification of rail or motor carrier involved, or of 
operator of motor vehicles involved.
    (5) Identification of any public or private authority that 
investigated the accident/incident involved.
    (6) Name, address, and telephone number of any witness to the 
action that is the subject of the application.
    (7) Detailed description of the action that is the subject of the 
application, including why the person submitting the application thinks 
that the action merits the extraordinary recognition embodied in the 
Medal of Honor.
    (c) An application and any documentary or other evidence supporting 
it must be supported by oath or affirmation, or by the signer's 
acknowledgment that a knowingly false statement is punishable as 
perjury.

Sec. 79.5   Investigation.

    The Department of Transportation may make any investigation of an 
application that it deems appropriate, including the taking of 
testimony under oath or affirmation.

Sec. 79.7   Award.

    If the Secretary of Transportation decides that it is warranted, 
the Secretary shall award the Medal on behalf of and in the name of the 
President of the United States.

Sec. 79.9   Design.

    The Department is authorized to adopt and revise the existing 
designs for the award, rosette, and ribbon provided for by statute.

    Issued in Washington, DC, on this 1st day of April, 1996.
Federico Pena,
Secretary of Transportation.
[FR Doc. 96-9704 Filed 4-19-96; 8:45 am]
BILLING CODE 4910-62-P

Complete official Federal Register PDF

FR Doc. 96-9703 National Security Information; Removal of Regulations
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17564-17565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9703]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION
Office of the Secretary

14 CFR Part 311

[Docket No. OST-96-1259; Notice 96-9]
RIN 2105-AC40

National Security Information; Removal of Regulations

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: DOT is removing regulations regarding National Security 
Information that it inherited from the Civil Aeronautics Board because 
they merely reference DOT's own rules on the same subject. This action 
is taken on the Department's initiative in response to the President's 
Regulatory Reinvention Initiative.

EFFECTIVE DATE: May 22, 1996.

FOR FURTHER INFORMATION CONTACT: Robert I. Ross, Office of the General 
Counsel, C-10, Department of Transportation, Washington, DC 20590, 
telephone (202) 366-9156, FAX (202) 366-9170.

SUPPLEMENTARY INFORMATION: In 1985, the Civil Aeronautics Board (CAB) 
ceased to exist and many of its functions and resources were 
transferred to DOT. Since both CAB and DOT had administrative 
regulations on many common subjects, as a service to persons accustomed 
to using the CAB regulations, those regulations were revised to 
reference the DOT regulations. Enough time has passed that the 
duplicative references can be removed. This document removes 14 CFR 
Part 311, CAB's regulatory part covering classification and 
declassification of national security information and materials, in 
favor of DOT's at 49 CFR Part 8, to which Part 311 has referred for 
many years. As part of the President's Regulatory Reinvention 
Initiative, we will be removing other duplicative or obsolete parts in 
separate rulemakings. Because these changes are editorial in nature and 
do not change the substantive requirements, the Department finds that 
notice and comment are unnecessary and contrary to the public interest.

Analysis of Regulatory Impacts

    This rule is not a ``significant regulatory action'' within the 
meaning of Executive Order 12866. It is also not significant within the 
definition in DOT's Regulatory Policies and Procedures, 49 FR 11034 
(1979), in part because it does not involve any change in important 
Departmental policies. There is no economic impact as a result of this 
change. Moreover, I certify that this rule will not have a significant 
economic impact on a substantial number of small entities.
    This rule does not significantly affect the environment, and 
therefore an environmental impact statement is not required under the 
National Environmental Policy Act of 1969. It has also been reviewed 
under Executive Order 12612, Federalism, and it has been determined 
that it does not have sufficient implications for federalism to warrant 
preparation of a Federalism Assessment.
    Finally, the rule does not contain any collection of information 
requirements, requiring review under the Paperwork Reduction Act of 
1980.

List of Subjects in 14 CFR Part 311

    Classified information.

[[Page 17565]]

PART 311--[REMOVED]

    In accordance with the above and under the authority of 49 U.S.C. 
40113, DOT removes 14 CFR Part 311.

    Issued in Washington, DC, on this 1st day of April, 1996.
Federico Pena,
Secretary.
[FR Doc. 96-9703 Filed 4-19-96; 8:45 am]
BILLING CODE 4910-62-P

Complete official Federal Register PDF

FR Doc. 96-9702 Release of Internal Staff Memoranda Relating to Public Meetings of the Civil Aeronautics Board
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Page 17565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9702]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION
14 CFR Part 399

[Docket No. OST-96-1260; Notice 96-10]
RIN 2105-AC42

Release of Internal Staff Memoranda Relating to Public Meetings 
of the Civil Aeronautics Board

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: DOT is removing provisions concerning release of internal 
staff memorandum after public meetings of the Civil Aeronautics Board 
(CAB). The CAB was sunset in 1985 and the provisions no longer have any 
relevancy. This action is taken on the Department's initiative in 
response to the President's Regulatory Reinvention Initiative.

EFFECTIVE DATE: Effective May 22, 1996.

FOR FURTHER INFORMATION CONTACT: Robert I. Ross, Office of the General 
Counsel, C-10, Department of Transportation, Washington, DC 20590, 
telephone (202) 366-9156, FAX (202) 366-9170.

SUPPLEMENTARY INFORMATION: In 1985, the Civil Aeronautics Board (CAB) 
ceased to exist and many of its functions and resources were 
transferred to DOT. Some of its regulations, although no longer 
relevant, have remained in the Code of Federal Regulations. 
Specifically, Sec. 399.102 of title 14, Code of Federal Regulations, 
has no relevancy to DOT The section specifically sets forth procedures 
peculiar to an agency that, like the CAB, was subject to the Government 
in the Sunshine Act, which does not apply to DOT. We are, therefore, 
removing the section because this procedure is not used at DOT. 
Analogous information may continue to be sought under the Freedom of 
Information Act. As part of the President's Regulatory Reinvention 
Initiative, we will be removing other duplicative or obsolete parts in 
separate rulemakings. Because these changes are editorial in nature and 
do not change the substantive requirements, the Department finds that 
notice and comment are unnecessary and contrary to the public interest.

Analysis of Regulatory Impacts

    This amendment is not a ``significant regulatory action'' within 
the meaning of Executive Order 12866. It is also not significant within 
the definition in DOT's Regulatory Policies and Procedures, 49 FR 11034 
(1979), in part because it does not involve any change in important 
Departmental policies. There is no economic impact as a result of this 
change. Moreover, I certify that this rule will not have a significant 
economic impact on a substantial number of small entities.
    This rule does not significantly affect the environment, and 
therefore an environmental impact statement is not required under the 
National Environmental Policy Act of 1969. It has also been reviewed 
under Executive Order 12612, Federalism, and it has been determined 
that it does not have sufficient implications for federalism to warrant 
preparation of a Federalism Assessment.
    Finally, the rule does not contain any collection of information 
requirements, requiring review under the Paperwork Reduction Act of 
1980.

List of Subjects in 14 CFR Part 399

    Administrative practice and procedure, Air carriers, Air rates and 
fares, Air taxis, Consumer protection, Small businesses.

    In accordance with the above, DOT amends 14 CFR Part 399 as 
follows:

PART 399--[AMENDED]

    1. The authority citation to Part 399 continues to read as follows:

    Authority: 49 U.S.C. 40101, 40102, 40105, 40109, 40113, 40114, 
40115, 41101, 41102, 41104, 41105, 41106, 41107, 41108, 41109, 
41110, 41301, 41302, 41303, 41304, 41305, 41306, 41307, 41309, 
41310, 41501, 41503, 41504, 41506, 41507, 41508, 41509, 41510, 
41511, 41701, 41702, 41705, 41706, 41707, 41708, 41709, 41711, 
41712, 41713, 41901, 41902, 41903, 41904, 41905, 41906, 41907, 
41908, 41909, 41910, 41911, 41912, 42111, 42112, 46101, 46102, 
46301, 46501.

Sec. 399.102   [Removed]

    2. Section 399.102 is removed.

    Issued in Washington, DC, on this 1st day of April, 1996.
Federico Pena,
Secretary of Transportation.
[FR Doc. 96-9702 Filed 4-19-96; 8:45 am]
BILLING CODE 4910-62-P

Complete official Federal Register PDF

FR Doc. 96-9701 Use of the Official Seal
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17577-17578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9701]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 3

[Docket No. OST-96-1264; Notice 96-11]
RIN 2105-AC39

Use of the Official Seal

AGENCY: Office of the Secretary, Department of Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: DOT is removing from the Code of Federal Regulations 
regulations governing what uses may be made of its Official Seal and 
which officials have the authority to affix it because the regulations 
duplicate internal directives that are available to the public. This 
action is taken on the Department's initiative in response to the 
President's Regulatory Reinvention Initiative.

EFFECTIVE DATE: May 22, 1996.

[[Page 17578]]

FOR FURTHER INFORMATION CONTACT: Robert I. Ross, Office of the General 
Counsel, C-10, Department of Transportation, Washington, DC 20590, 
telephone (202) 366-9156, FAX (202) 366-9170.

SUPPLEMENTARY INFORMATION: Since its establishment in 1967, DOT has had 
an Official Seal, which indicates official action of DOT and must be 
judicially noticed. These same provisions appear in DOT's internal 
directives, which are public documents. To eliminate duplication, the 
regulations regarding appropriate uses of the Seal and identification 
of which officials of DOT may affix it will be removed from the Code of 
Federal Regulations but continue to appear in the internal directives. 
Because these changes are editorial in nature and do not change the 
substantive requirements, the Department finds that notice and comment 
are unnecessary and contrary to the public interest.

Analysis of Regulatory Impacts

    This amendment is not a ``significant regulatory action'' within 
the meaning of Executive Order 12866. It is also not significant within 
the definition in DOT's Regulatory Policies and Procedures, 49 FR 11034 
(1979), in part because it does not involve any change in important 
Departmental policies. There is no economic impact as a result of this 
change. Moreover, I certify that this rule will not have a significant 
economic impact on a substantial number of small entities.
    This rule does not significantly affect the environment, and 
therefore an environmental impact statement is not required under the 
National Environmental Policy Act of 1969. It has also been reviewed 
under Executive Order 12612, Federalism, and it has been determined 
that it does not have sufficient implications for federalism to warrant 
preparation of a Federalism Assessment.
    Finally, the rule does not contain any collection of information 
requirements, requiring review under the Paperwork Reduction Act of 
1980.

List of Subjects in 49 CFR Part 3

    Seals and insignia.

    In accordance with the above, DOT amends 49 CFR Part 3 as follows:

PART 3--[AMENDED]

    1. The authority citation to Part 3 is revised to read as follows:

    Authority: 49 U.S.C. 102(e).

Secs. 3.3 and 3.5  [Removed]

    2. Sections 3.3 and 3.5 are removed.

    Issued in Washington, DC, on this 1st day of April, 1996.
Federico Pena,
Secretary of Transportation.
[FR Doc. 96-9701 Filed 4-19-96; 8:45 am]
BILLING CODE 4910-62-P

Complete official Federal Register PDF

FR Doc. 96-9653 Vessel Rebuilt Determinations
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17814-17816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9653]

[[Page 17813]]

_______________________________________________________________________

Part V

Department of Transportation

_______________________________________________________________________

Coast Guard

_______________________________________________________________________

46 CFR Part 67

Vessel Rebuilt Determinations; Final Rule

Federal Register / Vol. 61, No. 78 / Monday, April 22, 1996 / Rules 
and Regulations

[[Page 17814]]

DEPARTMENT OF TRANSPORTATION

Coast Guard

46 CFR Part 67

[CGD 94-040]
RIN 2115-AE85

Vessel Rebuilt Determinations

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is amending its regulation to clarify the 
standard for determining when work on a vessel performed outside of the 
U.S. constitutes a foreign rebuilding, which results in a loss of 
coastwise privileges. Clarifying this standard will help vessel owners 
and operators make better business decisions regarding work to be 
performed on their vessels. This rule adopts a notice of proposed 
rulemaking (NPRM) titled Vessel Rebuilt Determinations (CGD 94-040; 60 
FR 17290) published on April 5, 1995, as final with minor changes.

EFFECTIVE DATE: This final rule is effective on June 21, 1996.

ADDRESSES: Unless otherwise indicated, documents referred to in this 
preamble are available for inspection or copying at the office of the 
Executive Secretary, Marine Safety Council (G-LRA/3406) (CGD 94-025), 
U.S. Coast Guard Headquarters, 2100 Second Street SW., Washington, DC 
20593-0001, between 8 a.m. and 3 p.m., Monday through Friday, except 
Federal holidays. The telephone number is (202) 267-1477.

FOR FURTHER INFORMATION CONTACT: LTJG Michael Antonellis, National 
Maritime Center at (703) 235-8447.

SUPPLEMENTARY INFORMATION:

Regulatory History

    Two public meetings were held, both preceded by a notice in the 
Federal Register. The first meeting was on November 16, 1993 (58 FR 
51298), and the second on February 15, 1994 (59 FR 725). The stated 
purpose of the public meetings was to obtain public input concerning 
whether the Coast Guard should undertake rulemaking to develop clearer 
standards for vessel rebuilt determinations.
    On May 10, 1994, the Coast Guard published a policy statement in 
the Federal Register (CGD 93-063; 59 FR 24060) announcing that it was 
planning to undertake rulemaking regarding vessel rebuilt 
determinations.
    As indicated above, on April 5, 1995, the Coast Guard published the 
NPRM. In the NPRM, the Coast Guard proposed to clarify when a vessel is 
deemed to have been rebuilt outside the United States, thereby losing 
the privilege of engaging in the coastwise trade.

Background and Purpose

    When Congress enacted the Merchant Marine Act, 1920 (46 U.S.C. app. 
Sec. 883), popularly referred to as the ``Jones Act,'' it included a 
provision to provide for a protected trade. Section 27 of the Jones Act 
generally prohibited the transportation of merchandise in the coastwise 
trade except in vessels built in and documented under the laws of the 
United States and owned by citizens of the United States.
    In 1956, Congress amended Section 27 by enacting what is known as 
the ``Second Proviso.'' Under the proviso as enacted, a vessel of more 
than 500 gross tons entitled to engage in the coastwise trade which is 
later rebuilt outside the United States permanently loses the right to 
engage in the coastwise trade. Further, the proviso originally required 
the owner of a vessel of more than 500 gross tons documented in the 
United States which is rebuilt outside the United States to make a 
report of the circumstances of the rebuilding to the Secretary of 
Transportation.
    The Second Proviso was amended numerous times as discussed in the 
NPRM and now applies to all vessels engaged in coastwise trade, 
regardless of tonnage. It was implemented by the Coast Guard primarily 
by regulations at 46 CFR Sec. 67.177. The regulatory standard in 
Sec. 67.177 states that a vessel is rebuilt when ``any considerable 
part of its hull or superstructure is built upon or substantially 
altered.'' While the wording of the regulatory standard has remained 
stable over the years, the Coast Guard's administration of the standard 
has changed and is fully discussed in the NPRM.

Discussion of Comments and Changes

    The Coast Guard received three letters in response to the NPRM. Two 
letters specifically complimented the Coast Guard for its efforts in 
providing the industry with clearer standards relating to vessel 
rebuilt determinations. Generally, the three letters addressed the six 
matters discussed below.
    First: Two comments suggested that the Coast Guard provide a list 
of items, such as furnishings and fittings, that could be excluded from 
being considered as part of the hull and superstructure for purposes of 
making vessel rebuilt determinations. In the preamble to the NPRM, the 
Coast Guard identified a number of items which it has previously 
considered to be furnishings and fittings. This list, which is not 
exhaustive, may be used for guidance. The Coast Guard believes that 
providing a specific list would work to the detriment of vessel owners 
and limit the Coast Guard's flexibility to determine whether those 
items not included on the list should or should not be excluded.
    Second: One comment recommended that the numerical lower and upper 
parameters of 5 percent to 10 percent be adjusted to provide greater 
flexibility. Paragraph (b) of Sec. 67.177 of the NPRM establishes 
numerical parameters for rebuilt determinations for vessels, the hull 
and superstructure of which are constructed of steel or aluminum. The 
Coast Guard agrees that adjusting the minimum threshold to 7.5 percent 
is appropriate because that level reflects the Coast Guard's past 
determinations of the percentage of steelweight that does not 
constitute a rebuilding. However, the Coast Guard finds that raising 
the maximum threshold would not reflect past Coast Guard practices. 
Therefore, in order to adopt a standard that is consistent with past 
Coast Guard practices, the numerical lower and upper parameters in the 
final rule are set at 7.5 percent and 10 percent. The Coast Guard's 
National Maritime Center, after consultation with the Maritime 
Administration and the maritime industry, will reevaluate these minimum 
and maximum threshold levels in the future. Based on the history of 
vessel rebuild determinations, the Coast Guard may propose additional 
changes to these levels and perhaps other aspects of vessel rebuilt 
determinations. A shipowner may still apply for a preliminary rebuilt 
determination regardless of the level of work being done.
    Third: One comment favored the use of a ``surface area comparison'' 
as opposed to the ``comparability'' standard proposed for vessels built 
of materials other than steel or aluminum. The comparability approach 
provided in paragraph (c) of Sec. 67.177 of the NPRM requires that the 
applicant for a rebuilt determination calculate to the maximum extent 
practicable what the steelweight of the vessel as a whole would be if 
it were constructed of steel or aluminum. This standard has been tested 
over time and determined to work effectively.
    Fourth: One comment indicated a need for the Coast Guard to clarify 
that repairs in kind should be exempted from the standards applicable 
to vessel rebuilt determinations. The Coast Guard believes that vessels 
undergoing repairs overseas should continue to report these repairs and 
provide the necessary information to ensure that the Coast Guard can 
make an independent

[[Page 17815]]

determination that the vessel has not been rebuilt.
    Fifth: One comment requested that the term ``vessel steelweight'' 
be clarified. Vessel steelweight is the actual weight of the hull and 
superstructure without furnishings and outfit, machinery, and fluids. 
The term ``vessel steelweight'' is intended to mean the same as 
``discounted lightship weight.''
    Sixth: One comment expressed concern that if a vessel is determined 
to be rebuilt, it may also be considered a new vessel and, as a result, 
be subject to the provisions of the Oil Pollution Act of 1990 (OPA) 
(Pub. L. 101-380). A rebuilt determination will not result in a vessel 
being reclassified as a new vessel. If a vessel is subject to this 
regulation and is determined to be rebuilt outside of the U.S. pursuant 
to this rule, then that vessel will lose its coastwise privileges. 
Whether a vessel is subject to the applicability of OPA requirements is 
in no way determined by this rule. That a vessel loses its coastwise 
privileges because it has been determined to have been rebuilt outside 
of the U.S. does not mean necessarily that the vessel will be 
considered essentially a new vessel and subject to OPA requirements.
    After reviewing and considering these comments, the Coast Guard is 
adopting the NPRM as final with minor modifications. In effect, the 
term ``Commandant'' wherever it appeared in the NPRM was replaced with 
the term ``National Vessel Documentation Center'' (NVDC). The final 
rule raises the lower parameter of a rebuilt determination to from 5 
percent to 7.5 percent. The Coast Guard has undergone a significant 
reorganization and, as a result, established the NVDC in West Virginia 
to streamline the vessel documentation program. The public was informed 
of the establishment of NVDC in a Federal Register notice published on 
June 15, 1995 (60 FR 31602).

Regulatory Evaluation

    These regulations are not a significant regulatory action under 
section 3(f) of Executive Order 12866 and do not require an assessment 
of potential costs and benefits under section 6(a)(3) of that order. 
They have not been reviewed by the Office of Management and Budget 
under that order. However, they are considered significant under the 
regulatory policies and procedures of the Department of Transportation 
(DOT) (44 FR 11040; February 26, 1979) due to the interests expressed 
by a segment of the maritime industry and the Government of Canada.
    The Coast Guard expects the economic impact of these regulations to 
be so minimal that a full Regulatory Evaluation under paragraph 10e of 
the regulatory policies and procedures of DOT is unnecessary. These 
regulations merely clarify existing policies and practices followed in 
evaluating rebuilt determinations. As such, the changes are 
administrative in nature and provide better guidance to vessel owners 
planning for work to be performed on their vessels.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the 
Coast Guard must consider whether these regulations will have a 
significant economic impact on a substantial number of small entities. 
``Small entities'' may include: (1) small businesses and not-for-profit 
organizations that are independently owned and operated and are not 
dominant in their fields; and (2) governmental jurisdictions with 
populations of less than 50,000.
    The Coast Guard expects the economic impact of these regulations to 
be minimal because they clarify existing policy and practices. The 
changes to the existing regulations are administrative in nature and 
are designed to provide better guidance to vessel owners planning to 
perform work on their vessels. Because it expects the impact of this 
rule to be minimal, the Coast Guard certifies under 5 U.S.C. 605(b) 
that these regulations will not have a significant economic impact on a 
substantial number of small entities.

Collection of Information

    Under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the 
Office of Management and Budget (OMB) reviews each rule that contains a 
collection-of-information requirement to determine whether the 
practical value of the information is worth the burden imposed by its 
collection. Collection-of-information requirements include reporting, 
recordkeeping, notification, and other similar requirements.
    This regulation contains collection-of-information requirements in 
46 CFR 67.177. However, these collection-of-information requirements 
are the same as those contained in the existing regulations which have 
been previously approved by OMB and assigned Control No. 2115-0110. 
This regulation adds no new or additional collection-of-information 
requirements. The regulations will reduce paperwork submissions by 
providing sufficiently clear guidance that many of the applications for 
preliminary rebuilt determinations may become unnecessary.

Federalism

    This rulemaking has been analyzed in accordance with the principles 
and criteria contained in Executive Order 12612 and it has been 
determined that this rulemaking does not have sufficient federalism 
implications to warrant the preparation of a Federalism Assessment.

Environment

    The Coast Guard considered the environmental impact of this 
rulemaking and concluded that, under paragraph 2.B.2 of Commandant 
Instruction M16475.1B, this rule is categorically excluded from further 
environmental documentation. This rule is administrative in nature and 
will have no significant effect on the environment. A ``Categorical 
Exclusion Determination'' is available in the docket for inspection or 
copying where indicated under ADDRESSES.

List of Subjects in 46 CFR Part 67

    Fees, Incorporation by reference, Vessels.

    For the reasons set out in the preamble, the Coast Guard amends 46 
CFR part 67 as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 is revised to read as 
follows:

    Authority: 14 U.S.C. 664; 31 U.S.C. 9701; 42 U.S.C. 9118; 46 
U.S.C. 2103, 2107, 2110; 46 U.S.C. app. 841a, 876; 49 CFR 1.45, 
1.46.

Sec. 67.19  [Amended]

    2. In Sec. 67.19(d)(3), remove ``67.177(a)'' and add, in its place, 
``67.177''.

Sec. 67.21  [Amended]

    3. In Sec. 67.21(c), remove ``67.177(a)'' and add, in its place, 
``67.177''.
    4. Section 67.177 is revised to read as follows:

Sec. 67.177  Application for foreign rebuilding determination.

    A vessel is deemed rebuilt foreign when any considerable part of 
its hull or superstructure is built upon or substantially altered 
outside of the United States. In determining whether a vessel is 
rebuilt foreign, the following parameters apply:
    (a) Regardless of its material of construction, a vessel is deemed 
rebuilt when a major component of the hull or superstructure not built 
in the United States is added to the vessel.
    (b) For a vessel of which the hull and superstructure is 
constructed of steel or aluminum--
    (1) A vessel is deemed rebuilt when work performed on its hull or 
superstructure constitutes more than 10

[[Page 17816]]

percent of the vessel's steelweight, prior to the work, also known as 
discounted lightship weight.
    (2) A vessel may be considered rebuilt when work performed on its 
hull or superstructure constitutes more than 7.5 percent but not more 
than 10 percent of the vessel's steelweight prior to the work.
    (3) A vessel is not considered rebuilt when work performed on its 
hull or superstructure constitutes 7.5 percent or less of the vessel's 
steelweight prior to the work.
    (c) For a vessel of which the hull and superstructure is 
constructed of material other than steel or aluminum--
    (1) A vessel is deemed rebuilt when work performed on its hull or 
superstructure constitutes a quantum of work determined, to the maximum 
extent practicable, to be comparable to more than 10 percent of the 
vessel's steelweight prior to the work, calculated as if the vessel 
were wholly constructed of steel or aluminum.
    (2) A vessel may be considered rebuilt when work performed on its 
hull or superstructure constitutes a quantum of work determined, to the 
maximum extent practicable, to be comparable to more than 7.5 percent 
but not more than 10 percent of the vessel's steelweight prior to the 
work, calculated as if the vessel were wholly constructed of steel or 
aluminum.
    (3) A vessel is not considered rebuilt when work performed on its 
hull or superstructure constitutes a quantum of work determined, to the 
maximum extent practicable, to be comparable to 7.5 percent or less of 
the vessel's steelweight prior to the work, calculated as if the vessel 
were wholly constructed of steel or aluminum.
    (d) For a vessel of mixed construction, such as a vessel the hull 
of which is constructed of steel or aluminum and the superstructure of 
which is constructed of fibrous reinforced plastic, the steelweight of 
the work performed on the portion of the vessel constructed of a 
material other than steel or aluminum will be determined, to the 
maximum extent practicable, and aggregated with the work performed on 
the portion of the vessel constructed of steel or aluminum. The 
numerical parameters described in paragraph (b) of this section will 
then be applied to the aggregate of the work performed on the vessel 
compared to the vessel's steelweight prior to the work, calculated as 
if the vessel were wholly constructed of steel or aluminum, to 
determine whether the vessel has been rebuilt.
    (e) The owner of a vessel currently entitled to coastwise, Great 
Lakes, or fisheries endorsements which is altered outside the United 
States and the work performed is determined to constitute or be 
comparable to more than 7.5 percent of the vessel's steelweight prior 
to the work, or which has a major component of the hull or 
superstructure not built in the United States added, must file the 
following information with the National Vessel Documentation Center 
within 30 days following the earlier of completion of the work or 
redelivery of the vessel to the owner or owner's representative:
    (1) A written statement applying for a rebuilt determination, 
outlining in detail the work performed and naming the place(s) where 
the work was performed;
    (2) Calculations showing the actual or comparable steelweight of 
the work performed on the vessel, the actual or comparable steelweight 
of the vessel, and comparing the actual or comparable steelweight of 
the work performed to the actual or comparable steelweight of the 
vessel;
    (3) Accurate sketches or blueprints describing the work performed; 
and
    (4) Any further submissions requested by the National Vessel 
Documentation Center.
    (f) Regardless of the extent of actual work performed, the owner of 
a vessel currently entitled to coastwise, Great Lakes, or fisheries 
endorsements may, as an alternative to filing the items listed in 
paragraph (e) of this section, submit a written statement to the 
National Vessel Documentation Center declaring the vessel rebuilt 
outside the United States. The vessel will then be deemed to have been 
rebuilt outside the United States with loss of trading privileges.
    (g) A vessel owner may apply for a preliminary rebuilt 
determination by submitting:
    (1) A written statement applying for a preliminary rebuilt 
determination, outlining in detail the work planned and naming the 
place(s) where the work is to be performed;
    (2) Calculations showing the actual or comparable steelweight of 
work to be performed on the vessel, the actual or comparable 
steelweight of the vessel, and comparing the actual or comparable 
steelweight of the planned work to the actual or comparable steelweight 
of the vessel;
    (3) Accurate sketches or blueprints describing the planned work; 
and
    (4) Any further submissions requested by the National Vessel 
Documentation Center.

    Note: A statement submitted in accordance with paragraph (f) of 
this section does not constitute an application for a rebuilt 
determination and does not require payment of a fee.

    Dated: March 18, 1996.
A.E. Henn,
Vice Admiral, U.S. Coast Guard, Acting Commandant.
[FR Doc. 96-9653 Filed 4-19-96; 8:45 am]
BILLING CODE 4910-14-M

Complete official Federal Register PDF

FR Doc. 96-9570 Federal Sector Equal Employment Opportunity
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Page 17576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9570]

=======================================================================
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EQUAL EMPLOYMENT OPPORTUNITY COMMISSION

29 CFR Part 1614

Federal Sector Equal Employment Opportunity

AGENCY: Equal Employment Opportunity Commission.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule amends the Federal sector equal employment 
opportunity provisions concerning the time limit for a complainant to 
file an appeal with the Merit Systems Protection Board (Board) 
following an agency's final decision on a mixed case complaint. The 
rule is being amended because the Board lengthened the time limits for 
filing a timely appeal from a complaint raising issues of prohibited 
discrimination.

EFFECTIVE DATE: April 22, 1996.

FOR FURTHER INFORMATION CONTACT: Thomas J. Schlageter, Assistant Legal 
Counsel, or Daniel T. Riordan, Senior Attorney, Advice and External 
Litigation Division, Equal Employment Opportunity Commission, 1801 L 
Street NW., Washington, D.C. 20507; telephone (202) 663-4669 or (202) 
663-7026 (TDD). Copies of this final rule are also available in the 
following formats: Large print, braille, audio-tape and electronic file 
on computer disk. Requests for this notice in an alternative format 
should be made to the Publications Information Center at (800) 669-3362 
(Voice) or (800) 800-3302 (TDD).

SUPPLEMENTARY INFORMATION: This change in the EEOC's procedures came 
about as a result of the Board's revision of its procedures for 
accepting appeals following a final decision by an agency on a mixed 
case complaint. The Board enlarged the time limit for accepting such 
appeals in a final rule at 59 FR 31109, June 17, 1994, which amended 5 
CFR Sec. 1201.154(b)(1) of its regulations. The Board changed the time 
limit for filing initial appeals to bring the Board's procedures more 
in line with the legal and regulatory time limits for filing with the 
Federal Courts and EEOC, and also to make the Board's appellate 
processes more accessible to Federal employees. 59 FR 31109. EEOC is 
therefore amending its regulation to conform with the new time limit 
established by the Board.
    We are issuing a final rule rather than a notice of proposed 
rulemaking because we have determined, for good cause, that publication 
of a proposed rule and solicitation of comments is not necessary. The 
Board initially announced this change as a proposed rule at 59 FR 
18764, April 20, 1994, and asked for comments; a significant majority 
of the comments received favored or were not opposed to the change.

Regulatory Procedures

Executive Order 12866

    The Commission has determined that this regulatory action is not 
``significant'' as defined by Executive Order 12866, and is therefore 
not subject to review by the Office of Management and Budget.

Regulatory Flexibility Act

    In addition, the Commission also certifies under 5 U.S.C. 605(b), 
enacted by the Regulatory Flexibility Act (Pub. L. 96-354), that this 
rule will not have a significant economic impact on a substantial 
number of small entities. For this reason, a regulatory flexibility 
analysis is not required.

Paperwork Reduction Act

    This regulation contains no information collection requirements 
which are subject to review and approval by the Office of Management 
and Budget under the Paperwork Reduction Act of 1980 (44 U.S.C. chapter 
35).

List of Subjects in 29 CFR Part 1614

    Administrative practice and procedure, Aged, Equal employment 
opportunity, Government employees, Individuals with disabilities, 
Religious discrimination, Sex discrimination.
Gilbert F. Casellas,
Chairman.

    Accordingly, for the reasons set forth in the preamble, the Equal 
Employment Opportunity Commission is amending 29 CFR Part 1614 as 
follows:

PART 1614--FEDERAL SECTOR EQUAL EMPLOYMENT OPPORTUNITY

    1. The authority citation for 29 CFR Part 1614 continues to read as 
follows:

    Authority: 29 U.S.C. 206(d), 633a, 791 and 794a; 42 U.S.C. 
2000e-16; E.O. 10577, 3 CFR, 1954-1958 Comp., p. 218; E.O. 11222, 3 
CFR, 1964-1965 Comp., p. 306; E.O. 11478, 3 CFR, 1969 Comp., p. 133; 
E.O. 12106, 3 CFR, 1978 Comp., p. 263; Reorg. Plan No. 1 of 1978, 3 
CFR, 1978 Comp., p. 321.

Sec. 1614.302  [Amended]

    2. Section 1614.302 is amended by removing the number ``20'' in 
paragraphs (d)(1)(ii) and (d)(3) and adding in their place the number 
``30.''

[FR Doc. 96-9570 Filed 4-19-96; 8:45 am]
BILLING CODE 6750-06-P

Complete official Federal Register PDF

FR Doc. 96-9559 Design Standards for Highways; Geometric Design of Highways and Streets
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17566-17572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9559]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Part 625

[FHWA Docket No. 95-12]
RIN 2125-AD38

Design Standards for Highways; Geometric Design of Highways and 
Streets

AGENCY: Federal Highway Administration (FHWA), DOT.

ACTION: Interim final rule; request for comments.

-----------------------------------------------------------------------

SUMMARY: The National Highway System (NHS) was established by the 
National Highway System Designation Act of 1995 (Pub. L. 104-59, 109 
Stat. 568). To reflect the establishment of the NHS, the FHWA is 
revising several areas of the text in its regulation governing design 
standards for highways; updating the listing of standards; relocating 
the guides and references; and adopting as its interim

[[Page 17567]]

policy for the design standards which apply to highway construction and 
reconstruction projects on the NHS, a 1994 revision of the American 
Association of State Highway and Transportation Officials' (AASHTO) 
publication, ``A Policy on Geometric Design of Highways and Streets'' 
(Policy). The primary reason for development of the new Policy was to 
convert the numerical values in AASHTO's 1990 Policy to the metric 
system (SI). With the recent enactment of the National Highway System 
Designation Act of 1995 (Pub. L. 104-59, 109 Stat. 568), conversion to 
the metric system by the States now must take place by September 30, 
2000. Almost all of the States are continuing their conversion to 
metric to meet the previously established deadline of September 30, 
1996. This regulation will assure the States and other FHWA partners 
that the metric conversions used to formulate their plans will be 
consistent with the values adopted by the FHWA.

DATES: This interim final rule is effective May 22, 1996. Comments must 
be received on or before June 21, 1996. The incorporation by reference 
of certain publications listed in the regulation is approved by the 
Director of the Federal Register as of November 7, 1995.

ADDRESSES: Submit written, signed comments to FHWA Docket No. 95-12, 
Federal Highway Administration, Office of the Chief Counsel, Room 4232, 
HCC-10, 400 Seventh Street, SW., Washington, DC 20590. All comments 
received will be available for examination at the above address between 
8:30 a.m. and 3:30 p.m., e.t., Monday through Friday, except Federal 
holidays. Those desiring notification of receipt of comments must 
include a self-addressed stamped postcard. The current design standards 
are on file at the Office of the Federal Register in Washington, DC, 
and are available for inspection and copying from the FHWA Washington 
Headquarters and all FHWA Division and Regional Offices as prescribed 
in 49 CFR Part 7, appendix D. Copies of the current AASHTO publications 
are also available for purchase from the American Association of State 
Highway and Transportation Officials, suite 249, 444 North Capitol 
Street, NW., Washington, DC 20001.

FOR FURTHER INFORMATION CONTACT: Mr. Seppo I. Sillan, Geometric and 
Roadside Design Branch, Federal-Aid and Design Division, Office of 
Engineering (202) 366-0312, or Mr. Wilbert Baccus, Office of Chief 
Counsel (202) 366-0780, Federal Highway Administration, 400 Seventh 
Street SW., Washington DC 20590. Office hours are from 7:45 a.m. to 
4:15 p.m., e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION: The text changes in 23 CFR part 625 reflect 
the establishment of the National Highway System (NHS) by the National 
Highway System Designation Act of 1995 (Pub. L. 104-59, 109 Stat. 568) 
(NHS Act) as the basic highway network in the United States. References 
to ``Federal-aid highway projects'' have accordingly been changed to 
``NHS projects.'' The standards, policies, and standard speci- 
fications that have been approved by the FHWA for application on all 
projects on the NHS are incorporated by reference in 23 CFR part 625.
    Section 625.3(d) of the rule provides that these Federal design 
standards apply to all projects on the NHS, regardless of funding 
source. Under prior law, Federal standards applied to most projects 
solely as a condition of receipt of Federal grant funds. The change, 
applying Federal standards even to NHS projects wholly funded by a 
State, is based on provisions in both the Intermodal Surface 
Transportation Efficiency Act of 1991 (Pub. L. 102-240, 105 Stat. 1914) 
(ISTEA) and the NHS Act, and is consistent with the purpose for which 
the NHS was established. In 23 U.S.C. 109(c), as amended by Sec. 304 of 
the NHS Act, the Secretary is required, in cooperation with the State 
highway departments, to approve design and construction standards on 
the NHS. These provisions mirror the language and assignment of 
responsibility appearing in 23 U.S.C. 109(b), which has long been 
interpreted to require the Secretary to establish design standards for 
the Interstate System without regard for funding source. In expanding 
the Secretary's authority to all roads on the NHS, Congress sought to 
accommodate interstate commerce by ensuring a uniform, safe, 
interconnected system of principal arterial routes.
    Federal-aid projects not on the NHS are to be designed, 
constructed, operated, and maintained in accordance with State laws, 
regulations, directives, safety standards, design standards, and 
construction standards. This change implements section 1016(d) of the 
ISTEA, which added a new subsection (p) to 23 U.S.C. 109 requiring non-
NHS projects to meet State standards.
    The AASHTO is an organization which represents the 52 State highway 
and transportation agencies (including the District of Columbia and 
Puerto Rico). Its members consist of the duly constituted heads and 
other chief officials of those agencies. The Secretary of the United 
States Department of Transportation (DOT) is an ex officio member, and 
DOT officials participate in various AASHTO activities as nonvoting 
representatives. Among other functions, the AASHTO develops and issues 
standards, specifications, policies, guides and related materials for 
use by the States for highway projects. Many of the standards, policies 
and standard specifications approved by the FHWA and incorporated in 23 
CFR 625 were developed and issued by the AASHTO. Revisions made to such 
documents by the AASHTO are independently reviewed and adopted by the 
FHWA before they are applied to NHS projects.
    Recently the AASHTO revised the publication ``A Policy on Geometric 
Design of Highways and Streets'' (Policy). The primary reason for 
development of the new document was to convert the numerical values in 
the 1990 Policy to the metric system (SI). The FHWA's Metric Conversion 
Policy, published in the Federal Register on June 11, 1992, provided 
that newly authorized Federal-aid construction contracts must be only 
in metric units by September 30, 1996. Although this date will have to 
be changed to September 30, 2000, to comply with the recently enacted 
NHS Act, almost all of the States are continuing their conversion to 
metric to meet the previously established deadline of September 30, 
1996. This rulemaking is intended to assure the States and other FHWA 
partners that the metric conversions used to formulate their plans will 
be consistent with the values adopted by the FHWA. Another reason for 
revising the Policy is to provide the latest design criteria. A more 
detailed discussion of the changes in the revised Policy is included 
later in this preamble.
    In 1992, the FHWA initiated a phased 5-year plan to convert its 
activities and business operations to the metric system of weights and 
measures, as required by the Metric Conversion Act of 1975, Pub. L. 
100-418, 102 Stat. 1107, 1451 (Metric Act). Section 3 of this Act set a 
deadline date of September 30, 1992, for each Federal Government agency 
to begin using International System of Units (SI) in procurements, 
grants, and other business-related activities, except to the extent 
that such use is impractical or would likely cause significant 
inefficiencies or loss of markets to United States firms.
    In order to comply with the Metric Act, the FHWA developed a list 
of deadlines for converting to the metric system, which was published 
on June

[[Page 17568]]

11, 1992, at 57 FR 24843. This notice established that all newly 
authorized Federal-aid contracts must use only metric units by 
September 30, 1996. Although this date will have to be changed to 
September 30, 2000, to comply with the recently enacted NHS Act, almost 
all of the States are continuing their conversion to metric to meet the 
previously established deadline of September 30, 1996. In order to 
comply with the above deadline, and because it often takes several 
years between the time when designs are initiated and when projects are 
authorized, States have already begun to design projects using the 
metric system. Accordingly, the AASHTO developed and published the new 
Policy which uses only metric values for geometric design. Through this 
rulemaking the FHWA is adopting metric conversion values established by 
the AASHTO in this new Policy.
    The new Policy has replaced the previous version of this Policy, 
which was published by the AASHTO in 1990 and adopted by the FHWA in a 
final rule published in the Federal Register on April 29, 1993 (58 FR 
25939). The new Policy will constitute FHWA's policy on the geometric 
design of projects on the NHS. The 1994 Policy also takes the place of 
the publication entitled ``Interim Selected Metric Values for Geometric 
Design,'' AASHTO 1993, which was adopted by FHWA in a final rule 
published in the Federal Register on December 10, 1993 (58 FR 64897).
    Although the standards contained in the Policy apply to the 
Interstate System, specific guidance applicable to highways on the 
Interstate System is included in another AASHTO publication, ``A Policy 
on Design Standards--Interstate System.'' The current edition of that 
publication will be converted to the metric system in the near future.
    Generally, the criteria in the functional chapters on local roads 
and streets and on collectors (Chapters V and VI of the Policy) are not 
applicable to projects on the NHS. However, if highway segments 
functionally classified as less than principal arterials are 
incorporated in the NHS by virtue of being Strategic Highway Network 
(STRAHNET) Connectors or Intermodal Connectors, the standards used may 
be those appropriate for the functional classification of the segment 
taking into account the type of traffic using the segment.

Summary of Changes

    The following revisions have been made to the list of standards, 
policies, and standard specifications in Sec. 625.4:
    1. ``A Policy on Geometric Design of Highways and Streets,'' AASHTO 
1990, has been updated to indicate the 1994 edition.
    2. ``Interim Selected Metric Values for Geometric Design,'' AASHTO 
1993, has been deleted because metric values are now included in ``A 
Policy on Geometric Design of Highways and Streets.''
    3. ``A Policy on U-Turn Median Openings on Freeways,'' AASHTO 1960, 
has been deleted. This document is no longer applicable and not 
available from AASHTO.
    4. ``A Policy on Access Between Adjacent Railroads and Interstate 
Highways,'' AASHTO 1960, has been deleted. This document is no longer 
applicable and not available from AASHTO.
    5. ``Water Supply and Sewage Treatment at Safety Rest Areas,'' 
FHWA, 23 CFR part 650, subpart E, has been deleted. The safe drinking 
water requirements of this regulation have been superseded by the 
national primary drinking water regulations promulgated by the U.S. 
Environmental Protection Agency (40 CFR part 141) and the States to 
comply with safe drinking water legislation.
    6. ``Standard Specifications for Highway Bridges,'' Thirteenth 
Edition, AASHTO 1983, has been updated to indicate the fifteenth 
edition published in 1992 and ``Interim Specifications--Bridges,'' 
AASHTO 1984 through 1988, has been updated to indicate the 1993 through 
1995 editions.
    7. ``AASHTO LRFD Bridge Design Specifications,'' AASHTO 1994, has 
been added. These improved load and resistance factor design 
specifications are an alternative to the long- standing ``Standard 
Specifications for Highway Bridges,'' AASHTO.
    8. ``Bridge Welding Code, ANSI/AASHTO/AWS D1.5-88,'' AASHTO has 
been updated to indicate the 1995 edition.
    9. ``Reinforcing Steel Welding Code'' has been updated to indicate 
the new name and current edition, ``Structural Welding Code--
Reinforcing Steel,'' 1992.
    10. ``Standard Specifications for Structural Supports for Highway 
Signs, Luminaires and Traffic Signals,'' AASHTO, has been updated to 
indicate the 1994 edition.
    Section 625.5, Guides and References, contains a listing of 
references which are informational or guidance in character. This 
section is being removed from 23 CFR part 625 and will appear instead 
in the ``Federal-Aid Policy Guide'' (FAPG). The FAPG is an organized, 
looseleaf, single source documentation of the FHWA's current policies, 
regulations and nonregulatory procedural guidance information related 
to the Federal-aid highway program. It is available for inspection and 
copying as prescribed in 49 CFR part 7, appendix D.
    The remaining discussion in this section describes the changes in 
the new edition of the Policy. There were a number of changes that were 
made throughout the Policy. These include the following:
    1. All dimensions were converted to the metric system.
    2. Slope is expressed in nondimensional ratios. The vertical 
component is shown first and then the horizontal.
    3. Superelevation is expressed in percent.
    4. The more descriptive terms ``traveled way,'' ``roadway,'' 
``lane,'' and ``highway'' have been substituted for the term 
``pavement'' where appropriate; however, where the term ``pavement'' 
refers to a type of surface it is retained.
    The following paragraphs provide a brief synopsis of the 
information that is included in each of the 10 chapters of the Policy 
and, as appropriate, any significant additions, revisions or deletions 
beyond those listed above made to the currently approved 1990 AASHTO 
Policy in the 1994 Policy.

Chapter I--Highway Functions

    In this chapter the concept of functional classification is 
presented and the various components considered in detail. This serves 
as an introduction to functional classification and an explanation of 
how the concept is employed in the publication. There are no 
significant changes made in this chapter other than identification of 
the NHS as a new administrative system.

Chapter II--Design Controls and Criteria

    Those characteristics of vehicles, pedestrians, and traffic that 
act as criteria for design of various highway and street functional 
classes are covered in this chapter. The coverage of capacity is 
revised to agree with the Transportation Research Board's revised 
chapters of the ``Highway Capacity Manual.'' (At the time this part of 
the new Policy was undergoing revision, in mid-1993, a number, but not 
all, of the chapters in the manual had been revised.)
    More emphasis is placed on accommodating elderly persons based on 
information that has been published and studies that have been 
conducted since the old Policy was published. More information on 
bicycle transportation and characteristics has

[[Page 17569]]

been included. The concept of ``access management,'' which refers to 
setting access standards for various types of highways and 
incorporating access standards into legislation, has been added to the 
section on ``Access Control.'' The terminology used in the Americans 
with Disabilities Act (ADA), Pub. L. 101-336, 104 Stat. 327, and its 
implementing regulations has been incorporated in the discussion on 
designing highways and facilities to meet the needs of persons with 
disabilities.

Chapter III--Elements of Design

    The basic elements of design, such as sight distance, horizontal 
alinement, superelevation, widths of turning roadways, vertical 
alinement, maximum grades and climbing lanes are covered in this 
chapter. Significant revisions to the chapter include the following:
    1. In order to eliminate confusion as to which values are used to 
calculate lengths of vertical and horizontal curves, only the 
calculated values of stopping and passing sight distance are shown. 
These unrounded values are used in calculating lengths of vertical 
curves and, then, the lengths of vertical curves are rounded, as was 
done in the old Policy.
    2. Degree of curve is eliminated; curve criteria is based only on 
radius.
    3. The term ``crown'' has been replaced by more appropriate 
terminology such as ``cross slope'' in most places.
    4. The information on distribution of superelevation and 
superelevation runoff for curves with radius greater than minimum for 
low-speed urban streets has been eliminated and a recommendation that 
as much superelevation and as long runoff lengths as possible be 
provided even on curves greater than minimum is included.
    5. The values for the minimum middle ordinate on the inside of 
horizontal curves needed to provide horizontal stopping sight distance 
are based on computed values rather than rounded values.
    6. The information on design and capacity of climbing lanes for 
two-lane and multilane highways has been revised based on the new, 
revised chapters of the ``Highway Capacity Manual.''
    7. The information on truck escape ramps has been updated based on 
the latest published information.
    8. The new Policy notes that personal computers can be used to 
assist designers in developing vertical and horizontal alinements.
    9. The section on ``Maintenance of Traffic Through Construction 
Areas'' has been revised to be consistent with the ``Manual on Uniform 
Traffic Control Devices.''
    10. The references on highway drainage have been revised to refer 
to the latest publications.

Chapter IV--Cross Section Elements

    The elements of a highway, such as pavement cross slope, traffic 
lanes, shoulders, medians, frontage roads, and roadsides are discussed 
in this chapter. Significant revisions to the chapter include the 
following:
    1. More information on design to accommodate bicyclists has been 
added.
    2. The information on design of and use of curbs has been revised.
    3. The section on design of pedestrian facilities has been modified 
somewhat to conform to the ADA implementing regulations.

Chapter V--Local Roads and Streets

    The design guidance applicable to those roads functionally 
classified as local rural roads and local urban streets is covered in 
this chapter. Significant revisions include the following:
    1. Traffic volume criteria in the tables for design speed, traveled 
way, shoulder width, and width and design loading for bridges is 
presented on the common basis of average daily traffic (ADT). This is 
based on recent research which concluded the existing practice of 
mixing ADT and design hour volume (DHV) was confusing.
    2. The values for minimum widths of traveled way and shoulder for 
local roads having various ranges of ADT have been modified based on 
National Cooperative Highway Research Program (NCHRP) Report 362, 
``Roadway Width for Low Traffic Volume Roads.'' In particular, a 5.4 m 
traveled way is now permitted for highways with ADT's of under 400. For 
rural local roads with ADT's of 400 to 1500 the lane and shoulder 
widths may be adjusted to a minimum roadway width of 9.0 m.

Chapter VI--Collector Roads and Streets

    The design guidance applicable to those roads functionally 
classified as rural collector roads and urban collector streets is 
covered in this chapter. Significant revisions to the chapter include 
the following:
    1. Traffic volume criteria in the tables for design speed, traveled 
way, shoulder width, and width and design loading for bridges is 
presented on the common basis of ADT. This is based on recent research 
which concluded the existing practice of mixing ADT and DHV was 
confusing.
    2. The values for minimum widths of traveled way and shoulder for 
rural collector roads having various ranges of ADT have been modified 
based on NCHRP Report 362, ``Roadway Width for Low Traffic Volume 
Roads.'' In particular, 2.7 m lane widths are now permitted for 
highways with ADT's of 250 or less and design speeds of 60 km/h or 
less.
    3. Traveled ways of a minimum width of 6.6 m are permitted to 
remain on reconstructed highways with any ADT provided the alinement is 
adequate and the safety records are satisfactory.
    4. More information on design to accommodate bicycles is included.

Chapter VII--Rural and Urban Arterials

    The basis for design of the principal and minor arterial road 
systems in rural and urban areas is presented in this chapter.
    The only significant change between the old and new Policy was to 
modify the table providing minimum widths of traveled way and shoulder 
based on information in NCHRP Report 362. Traffic volume criteria in 
the table is only in terms of ADT (either current or projected) and the 
width of traveled way for ADT's of 400 to 2000 and design speeds of 
under 100 km/h have been reduced slightly.

Chapter VIII--Freeways

    The various types of freeways, their design elements, controls, 
criteria and cross-sectional elements are covered in this chapter. The 
only significant change to this chapter was to eliminate specific 
right-of-way widths for the freeway cross sections. It is not 
considered necessary to specify a total right-of-way width since this 
is the sum of the individual cross-sectional elements.

Chapter IX--At-Grade Intersections

    The basic types of intersections and the elements involved in their 
designs, primarily those concerning the accommodation of turning 
movements, are described in this chapter. The following are the major 
changes in the chapter:
    1. Information on design to accommodate bicycles has been added.
    2. A discussion concerning the provision of free-flow right turns 
where speed change lanes are not provided and where pedestrians and 
bicyclists are a consideration has been added.
    3. Another Case dealing with stopped vehicles turning left from a 
major highway has been added to the discussion on intersection control.
    4. The section on sight distance at ramp terminals was eliminated 
because

[[Page 17570]]

sight distance at these locations is calculated in the same manner as 
at any other intersection.
    5. The section on railroad grade crossings was revised to add 
information on highway intersections adjacent to railroad grade 
crossings.

Chapter X--Grade Separations and Interchanges

    The basic types of interchanges and grade separations, along with 
the design of their features, are discussed in this chapter. The 
following are the significant changes in this chapter:
    1. Information on single point diamond interchanges was added.
    2. Information on the accommodation of pedestrians at interchanges 
was added.
    3. A discussion on ramp metering was added.
    4. Most of the information on models was eliminated because models 
and model types are illustrative only and not directly related to 
design criteria.

Review Procedure

    Based on an analysis of public comments received, and its own 
independent review, the FHWA will reexamine the acceptability of 
modifications adopted by this rule.

Rulemaking Analysis and Notices

    Section 553(b)(3)(B) of the Administrative Procedure Act provides 
that agencies may dispense with prior notice and opportunity for 
comment when the agency for good cause finds that such procedures are 
impracticable, unnecessary, or contrary to the public interest.
    The FHWA has determined that publication of a notice of proposed 
rulemaking would be contrary to the public interest. The FHWA's Metric 
Conversion Policy provides that newly authorized Federal Lands and 
Federal-aid construction contracts be formulated solely in metric units 
by September 30, 1996. Although this date will have to be changed to 
September 30, 2000, to comply with the recently enacted NHS Act, almost 
all of the States are continuing their conversion to metric to meet the 
previously established deadline of September 30, 1996. The Metric 
Conversion Policy was developed as required by Section 3 of the Metric 
Act, which mandates that all Federal Government agencies begin using 
the International System of Units in procurements, grants, and other 
business-related activities. Planning for Federal Lands and Federal-aid 
construction projects is already well underway, and States and other 
FHWA partners need to know now that the metric conversions used to 
formulate their plans will match the FHWA's conversions. Thus the FHWA 
believes that implementation of AASHTO's new Policy, which uses only 
metric values, should be accomplished as soon as possible. Adoption of 
the metric values in the new Policy now provides necessary certainty 
and continuity for States and other FHWA partners including highway 
construction contractors and consultants.
    The FHWA has also determined that prior notice and opportunity to 
comment are unnecessary. The text changes in 23 CFR part 625 only 
reflect the establishment of the National Highway System. The 
significant change is incorporation of the new Policy and the metric 
values contained therein. The FHWA has determined, however, that the 
metric values used in the new AASHTO Policy are essentially the same as 
the English measurements already adopted by the FHWA pursuant to notice 
and comment rulemaking. That rulemaking appeared in the Federal 
Register on April 29, 1993, wherein FHWA adopted AASHTO's old Policy. 
On December 10, 1993, FHWA adopted AASHTO's ``Interim Selected Metric 
Values for Geometric Design,'' which were meant to provide the States 
with metric values for the most critical elements of geometric design. 
Other changes to the old Policy that have been incorporated into the 
new Policy for the most part merely clarify the meaning of certain 
terminology, incorporate the latest geometric design information, or 
correct some minor errors in the old Policy.
    Accordingly, the FHWA anticipates that prior notice and opportunity 
for comment will most likely not result in the receipt of useful 
information. Nonetheless, public comment is solicited on this action. 
Comments received will be carefully considered in evaluating whether 
any change to this action is needed.

Executive Order 12866 (Regulatory Planning and Review) and DOT 
Regulatory Policies and Procedures

    The FHWA has determined that this action is not a significant 
regulatory action within the meaning of Executive Order 12866 or 
significant within the meaning of Department of Transportation 
Regulatory Policies and Procedures. The metric values selected in the 
new Policy are functionally equivalent to the English system 
measurements contained in the old Policy previously adopted by notice 
and comment rulemaking. Although the new Policy contains new material, 
the basic criteria remain essentially the same. In all practicality, 
the new Policy reflects the criteria, for the most part, which have 
been in use in designing Federal-aid highways. It is anticipated that 
the economic impact of the rulemaking will be minimal; therefore, a 
full regulatory evaluation is not required.

Regulatory Flexibility Act

    In compliance with the Regulatory Flexibility Act (Pub. L. 96-345, 
5 U.S.C. 601-612) the FHWA has evaluated the effects of this rule on 
small entities. Based on the evaluation, the FHWA hereby certifies that 
this action will not have a significant economic impact on a 
substantial number of small entities. As stated above, the FHWA made 
this determination based on the fact that metric values in the new 
Policy are functionally equivalent to the English system values they 
replace and the new material in the new Policy reflects criteria which 
for the most part is presently in use.

Executive Order 12612 (Federalism Assessment)

    This action has been analyzed in accordance with the principles and 
criteria contained in Executive Order 12612 and it has been determined 
that this action does not have sufficient federalism implications to 
warrant the preparation of a federalism assessment.

Executive Order 12372 (Intergovernmental Review)

    Catalog of Federal Domestic Assistance Program Number 20.205, 
Highway Planning and Construction. The regulations implementing 
Executive Order 12372 regarding intergovernmental consultation on 
Federal programs and activities apply to this program.

Paperwork Reduction Act

    This action does not contain a collection of information 
requirement for purposes of the Paperwork Reduction Act of 1980, 44 
U.S.C. 3501 et seq.

National Environmental Policy Act

    The agency has analyzed this action for the purpose of the National 
Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and has 
determined that this action would not have any effect on the quality of 
the environment.

Regulation Identification Number

    A regulation identification number (RIN) is assigned to each 
regulatory action listed in the Unified Agenda of Federal Regulations. 
The Regulatory Information Service Center publishes the Unified Agenda 
in April and

[[Page 17571]]

October of each year. The RIN contained in the heading of this document 
can be used to cross reference this action with the Unified Agenda.

List of Subjects in 23 CFR Part 625

    Design standards, Grant programs--transportation, Highways and 
roads, Incorporation by reference, Reporting and recordkeeping 
requirements.

    Issued on: April 8, 1996.
Rodney E. Slater,
Federal Highway Administrator.

    In consideration of the foregoing, the FHWA is amending Chapter I 
of title 23, Code of Federal Regulations as follows:
    1. Part 625 is revised to read as follows:

PART 625--DESIGN STANDARDS FOR HIGHWAYS

Sec.
625.1  Purpose.
625.2  Policy.
625.3  Application.
625.4  Standards, policies, and standard specifications.

    Authority: 23 U.S.C. 109, 315, and 402; sec. 1073 of Pub. L. 
102-240, 105 Stat. 1914, 2012; 49 CFR 1.48 (b) and (n).

Sec. 625.1  Purpose.

    To designate those standards, policies, and standard specifications 
that are acceptable to the Federal Highway Administration (FHWA) for 
application in the geometric and structural design of highways.

Sec. 625.2  Policy.

    (a) Plans and specifications for proposed National Highway System 
(NHS) projects shall provide for a facility that will--
    (1) Adequately serve the existing and planned future traffic of the 
highway in a manner that is conducive to safety, durability, and 
economy of maintenance; and
    (2) Be designed and constructed in accordance with criteria best 
suited to accomplish the objectives described in paragraph (a)(1) of 
this section and to conform to the particular needs of each locality.
    (b) Resurfacing, restoration, and rehabilitation (RRR) projects, 
other than those on the Interstate system and other freeways, shall be 
constructed in accordance with standards which preserve and extend the 
service life of highways and enhance highway safety. Resurfacing, 
restoration, and rehabilitation work includes placement of additional 
surface material and/or other work necessary to return an existing 
roadway, including shoulders, bridges, the roadside, and appurtenances 
to a condition of structural or functional adequacy.
    (c) An important goal of the FHWA is to provide the highest 
practical and feasible level of safety for people and property 
associated with the Nation's highway transportation systems and to 
reduce highway hazards and the resulting number and severity of 
accidents on all the Nation's highways.

Sec. 625.3  Application.

    (a) Applicable standards. (1) Design and construction standards for 
new construction, reconstruction, resurfacing (except for maintenance 
resurfacing), restoration, or rehabilitation of a highway on the NHS 
(other than a highway also on the Interstate System) shall be those 
approved by the Secretary in cooperation with the State highway 
departments. These standards may take into account, in addition to the 
criteria described in Sec. 625.2(a), the following:
    (i) The constructed and natural environment of the area;
    (ii) The environmental, scenic, aesthetic, historic, community, and 
preservation impacts of the activity; and
    (iii) Access for other modes of transportation.
    (2) Federal-aid projects not on the NHS are to be designed, 
constructed, operated, and maintained in accordance with State laws, 
regulations, directives, safety standards, design standards, and 
construction standards.
    (b) The standards, policies, and standard specifications contain 
specific criteria and controls for the design of NHS projects. 
Deviations from specific minimum values therein are to be handled in 
accordance with procedures in paragraph (f) of this section. If there 
is a conflict between criteria in the documents enumerated in 
Sec. 625.4 of this part, the latest listed standard, policy, or 
standard specification will govern.
    (c) Application of FHWA regulations, although cited in Sec. 625.4 
of this part as standards, policies, and standard specifications, shall 
be as set forth therein.
    (d) This regulation establishes Federal standards for work on the 
NHS regardless of funding source.
    (e) The Division Administrator shall determine the applicability of 
the roadway geometric design standards to traffic engineering, safety, 
and preventive maintenance projects which include very minor or no 
roadway work. Formal findings of applicability are expected only as 
needed to resolve controversies.
    (f) Exceptions. (1) Approval within the delegated authority 
provided by FHWA Order M1100.1 may be given on a project basis to 
designs which do not conform to the minimum criteria as set forth in 
the standards, policies, and standard specifications for:
    (i) Experimental features on projects; and
    (ii) Projects where conditions warrant that exceptions be made.
    (2) The determination to approve a project design that does not 
conform to the minimum criteria is to be made only after due 
consideration is given to all project conditions such as maximum 
service and safety benefits for the dollar invested, compatibility with 
adjacent sections of roadway and the probable time before 
reconstruction of the section due to increased traffic demands or 
changed conditions.

Sec. 625.4  Standards, policies, and standard specifications.

    The documents listed in this section are incorporated by reference 
with the approval of the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 and are on file at the Office of 
the Federal Register in Washington, DC. They are available as noted in 
paragraph (d) of this section. The other CFR references listed in this 
section are included for cross reference purposes only.
    (a) Roadway and appurtenances. (1) A Policy on Geometric Design of 
Highways and Streets, AASHTO 1994. (See Sec. 625.4(d)(1))
    (2) A Policy on Design Standards--Interstate System, AASHTO 1991. 
(See Sec. 625.4(d)(1))
    (3) The geometric design standards for resurfacing, restoration, 
and rehabilitation (RRR) projects on NHS highways other than freeways 
shall be the procedures and the design or design criteria established 
for individual projects, groups of projects, or all nonfreeway RRR 
projects in a State, and as approved by the FHWA. The other geometric 
design standards in this section do not apply to RRR projects on NHS 
highways other than freeways, except as adopted on an individual State 
basis. The RRR design standards shall reflect the consideration of the 
traffic, safety, economic, physical, community, and environmental needs 
of the projects.
    (4) Erosion and Sediment Control on Highway Construction Projects, 
refer to 23 CFR part 650, subpart B.
    (5) Location and Hydraulic Design of Encroachments on Flood Plains, 
refer to 23 CFR part 650, subpart A.
    (6) Procedures for Abatement of Highway Traffic Noise and 
Construction Noise, refer to 23 CFR part 772.
    (7) Accommodation of Utilities, refer to 23 CFR part 645, subpart 
B.
    (8) Pavement Design, refer to 23 CFR part 626.

[[Page 17572]]

    (b) Bridges and structures. (1) Standard Specifications for Highway 
Bridges, Fifteenth Edition, AASHTO 1992. (See Sec. 625.4(d)(1))
    (2) Interim Specifications--Bridges, AASHTO 1993. (See 
Sec. 625.4(d)(1))
    (3) Interim Specifications--Bridges, AASHTO 1994. (See 
Sec. 625.4(d)(1))
    (4) Interim Specifications--Bridges, AASHTO 1995. (See 
Sec. 625.4(d)(1))
    (5) AASHTO LRFD Bridge Design Specifications, First Edition, AASHTO 
1994 (U.S. Units). (See Sec. 625.4(d)(1))
    (6) AASHTO LRFD Bridge Design Specifications, First Edition, AASHTO 
1994 (SI Units). (See Sec. 625.4(d)(1))
    (7) Standard Specifications for Movable Highway Bridges, AASHTO 
1988. (See Sec. 625.4(d)(1))
    (8) Bridge Welding Code, ANSI/AASHTO/AWS D1.5-95, AASHTO. (See 
Sec. 625.4(d) (1) and (2))
    (9) Structural Welding Code--Reinforcing Steel, ANSI/AWS D1.4-92, 
1992. (See Sec. 625.4(d)(2))
    (10) Standard Specifications for Structural Supports for Highway 
Signs, Luminaires and Traffic Signals, AASHTO 1994. For use on NHS 
projects, the requirement for maximum change in velocity in Section 7, 
Breakaway Supports, may be 16 fps in lieu of the 15 fps contained in 
the AASHTO specifications. (See Sec. 625.4(d)(1))
    (11) Navigational Clearances for Bridges, refer to 23 CFR part 650, 
subpart H.
    (c) Materials. (1) General Materials Requirements, refer to 23 CFR 
part 635, subpart D.
    (2) Standard Specifications for Transportation Materials and 
Methods of Sampling and Testing, parts I and II, AASHTO 1995. (See 
Sec. 625.4(d)(1))
    (3) Sampling and Testing of Materials and Construction, refer to 23 
CFR part 637, subpart B.
    (d) Availability of documents incorporated by reference. The 
documents listed in Sec. 625.4 are incorporated by reference and are on 
file and available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW, suite 700, Washington, DC. 
These documents may also be reviewed at the Department of 
Transportation Library, 400 Seventh Street, SW, Washington, DC, in Room 
2200. These documents are also available for inspection and copying as 
provided in 49 CFR part 7, appendix D. Copies of these documents may be 
obtained from the following organizations:
    1. American Association of State Highway and Transportation 
Officials (AASHTO), Suite 249, 444 North Capitol Street, NW, 
Washington, DC 20001.
    2. American Welding Society (AWS), 2501 Northwest Seventh Street, 
Miami, FL 33125.

[FR Doc. 96-9559 Filed 4-19-96; 8:45 am]
BILLING CODE 4910-22-P

Complete official Federal Register PDF

FR Doc. 96-9456 Information Reporting and Backup Withholding
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17572-17575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9456]

=======================================================================
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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1, 31 and 602

[TD 8664]
RIN 1545-AL99

Information Reporting and Backup Withholding

Agency: Internal Revenue Service (IRS), Treasury.

ACTION: Final regulations.

-----------------------------------------------------------------------

SUMMARY: This document contains final regulations that provide rules 
regarding the reporting on Form 1042-S of certain bank deposit interest 
paid with respect to a United States bank account to an individual who 
is a nonresident alien of the United States and a resident of Canada. 
The IRS has determined that information concerning those deposits would 
be of significant use in furthering its compliance efforts, which 
include exchange of tax information with Canada.

EFFECTIVE DATE: January 1, 1997.

FOR FURTHER INFORMATION CONTACT: Teresa Burridge Hughes, (202) 622-3880 
(not a toll-free number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

    The collection of information contained in this final regulation 
has been reviewed and approved by the Office of Management and Budget 
in accordance with the requirements of the Paperwork Reduction Act (44 
U.S.C. 3507) under control number 1545-0096. Responses to this 
collection of information are mandatory.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless the collection of 
information displays a valid control number.
    The estimated annual burden per respondent/recordkeeper is 
approximately .10 hour, depending on individual circumstances.
    Comments concerning the accuracy of this burden estimate and 
suggestions for reducing this burden should be directed to the Internal 
Revenue Service, Attn: IRS Reports Clearance Officer, PC:FP, Washington 
DC 20224, and the Office of Management and Budget, Attn: Desk Officer 
for the Department of the Treasury, Office of Information and 
Regulatory Affairs, Washington, DC 20503.
    Books or records relating to this collection of information must be 
retained as long as their contents may become material in the 
administration of any internal revenue law. Generally, tax returns and 
tax return information are confidential, as required by 26 U.S.C. 6103.

Background

    This document contains final regulations to be added to the Income 
Tax Regulations (26 CFR part 1) under section 6049 of the Internal 
Revenue Code (Code). The final regulations provide rules regarding 
reporting on Form 1042-S of certain bank deposit interest paid with 
respect to a United States bank account to a nonresident alien 
individual who is a resident of Canada.
    Proposed regulations on this subject were set forth, at 
Secs. 1.6049-5(e)(2), 1.6049-6(e)(6), and 31.3406(a)-3(b)(1), in a 
notice of proposed rulemaking published in the Federal Register (53 FR 
5991) on February 29, 1988 [INTL-52-86 (1988-1 C.B. 892)]. The IRS 
received comments on the proposed regulations and held a public hearing 
on June 15, 1989. Having considered the comments and the statements 
made at the hearing, the IRS and the Treasury Department adopt the 
proposed regulations as modified by this Treasury decision.

Explanation of Provisions

A. Reporting of Payments to Canadians

    This Treasury decision requires reporting on a Form 1042-S of 
certain interest paid on deposits maintained at a bank's office within 
the United States when paid to a nonresident alien individual who is a 
resident of Canada. However, interest on certain bearer certificates of 
deposit targeted to foreign persons is excepted from the reporting 
requirement if the interest is paid outside the United States. This 
final regulation makes an exception to the current rule, based on 
Sec. 1.6049-5(b), that certain interest amounts paid to non-U.S. 
persons is not subject to reporting if a statement certifying non-U.S. 
status is furnished to the payor or middleman on a Form W-8 
(Certificate of Foreign Status), as described in Sec. 1.6049-
5(b)(2)(iv). However, although bank deposit interest paid to Canadians 
is made subject to reporting under this final regulation, backup 
withholding

[[Page 17573]]

under section 3406 is not required. Further, in response to suggestions 
from commentators that segregating interest amounts on the basis of 
residence would be burdensome, this final regulation allows payors 
voluntarily to report on a Form 1042-S payments to all foreign persons 
receiving bank deposit interest without segregating on the basis of 
residency.
    The payor determines whether a payee is a Canadian resident based 
on the address in the country of permanent residence required to be 
provided on the Form W-8. However, if the payor has actual knowledge 
that the payee is a U.S. person, Form 1099 reporting provisions apply.
    See proposed regulations published elsewhere in this issue of the 
Federal Register regarding proposed changes to the notice of proposed 
rulemaking published in the Federal Register on February 29, 1988.

B. Comments on Canadian Reporting Provisions

    Commentors stated that imposing information reporting with respect 
to deposits of nonresident aliens may undercut the competitiveness of 
U.S. banks. The IRS and Treasury considered these comments but, in 
light of our obligations under the United States-Canada income tax 
treaty and the reporting by Canadian banks of U.S. depositor interest 
to Canadian tax authorities, have decided to finalize these proposed 
regulations.
    In response to comments that the reporting requirement be delayed, 
or at least that a transition period be allowed, because of the time 
required to identify Canadian account holders and to modify processing 
systems for reporting purposes, the new reporting requirement will be 
phased in over a three-year period, starting with payments made on or 
after January 1, 1997. On or after that date, payors will identify 
Canadian account holders as Forms W-8 are received from new depositors 
or renewed by existing depositors. Upon identifying account holders as 
Canadians, payors must begin reporting bank deposit interest paid to 
those persons.
    Commentors also requested that the IRS develop and permit Form 
1042-S reporting on magnetic diskette, as is allowed for Form 1099 
filings; permit the Form 1042-S to be the transmittal document for the 
Form 1042-S filing; and allow financial institutions to file separate 
tapes or diskettes for each area of the bank, rather than bank-wide. 
These filing changes have previously been made by the IRS and require 
no further action.

Special Analyses

    It has been determined that this Treasury decision is not a 
significant regulatory action as defined in EO 12866. Therefore, a 
regulatory assessment is not required. It also has been determined that 
section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) 
and the Regulatory Flexibility Act (5 U.S.C. chapter 6) do not apply to 
these regulations, and, therefore, a Regulatory Flexibility Analysis is 
not required.

Drafting Information

    The principal author of these regulations is Teresa Burridge 
Hughes, Office of Associate Chief Counsel (International). However, 
other personnel from the IRS and Treasury Department participated in 
their development.

List of Subjects

26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

26 CFR Part 31

    Employment taxes, Income taxes, Penalties, Pensions, Railroad 
retirement, Reporting and recordkeeping requirements, Social security, 
Unemployment compensation.

26 CFR Part 602

    Reporting and recordkeeping requirements.

Adoption of Amendments to the Regulations

    Accordingly, 26 CFR parts 1, 31 and 602 are amended as follows:

PART 1--INCOME TAXES

    Paragraph 1. The authority for part 1 is amended by adding entries 
in numerical order to read as follows:

    Authority: 26 U.S.C. 7805 * * *

    Sections 1.6049-4 also issued under 26 U.S.C. 6049 (a), (b), 
(c), and (d).
    Section 1.6049-5 also issued under 26 U.S.C. 6049 (a), (b), (c), 
and (d). * * *

    Par. 2. Section 1.6049-4 is amended by:
    1. Removing the reference ``(b)(3)'' and adding ``(b)(3) and 
(b)(5)'' in its place in the first sentence of paragraphs (b)(1) and 
(b)(2) introductory text.
    2. Revising the first sentence of paragraphs (b)(3) and (b)(4).
    3. Adding paragraph (b)(5).
    4. Removing the authority citation at the end of the section.
    The revisions and addition read as follows:

Sec. 1.6049-4  Return of information as to interest paid and original 
issue discount includible in gross income after December 31, 1982.

* * * * *
    (b) * * *
    (3) * * * Except as provided in paragraph (b)(5) of this section, 
every person acting as a middleman (as defined in paragraph (f)(4) of 
this section) shall make an information return on Forms 1096 and 1099 
for the calendar year. * * *
    (4) * * * Except as provided in paragraph (b)(5) of this section, 
every person carrying on the banking business who makes payments of 
interest to another person (whether or not aggregating $10 or more) 
during a calendar year with respect to a certificate of deposit issued 
in bearer form shall make an information return on Forms 1096 and 1099. 
* * *
    (5) Interest payments to Canadian nonresident alien individuals--
(i) General rule. In the case of interest paid to a Canadian 
nonresident alien individual (as described in Sec. 1.6049-8(a)), the 
payor or middleman shall make an information return on Form 1042-S for 
the calendar year in which the interest is paid. The payor or middleman 
shall prepare and transmit Form 1042-S at the time and in the manner 
prescribed by section 1461 and the regulations under that section and 
by the form and its accompanying instructions. See Sec. 1.6049-6(e)(4) 
for furnishing a copy of the Form 1042-S to the payee. To determine 
whether an information return is required for original issue discount, 
see Secs. 1.6049-5(c) and 1.6049-8(a).
    (ii) Effective date. Paragraph (b)(5)(i) of this section shall be 
effective for payments made after December 31, 1996 with respect to a 
Form W-8 (Certificate of Foreign Status) furnished to the payor or 
middleman after that date.
* * * * *
    Par. 3. Section 1.6049-5 is amended by:
    1. Revising the introductory text of paragraph (b)(1).
    2. Revising the last sentence in paragraph (c).
    3. Removing authority citation at the end of the section.
    The revisions read as follows:

Sec. 1.6049-5  Interest and original issue discount subject to 
reporting after December 31, 1982.

* * * * *
    (b) * * * (1) * * * Subject to the provisions of Sec. 1.6049-8, the 
term interest does not include:
* * * * *

[[Page 17574]]

    (c) * * * Original issue discount on an obligation (including an 
obligation with a maturity of not more than 6 months from the date of 
original issue) held by a nonresident alien individual or foreign 
corporation is interest described in paragraph (b)(1)(vi) (A) or (B) of 
this section and, therefore is not interest subject to reporting under 
section 6049 unless it is described in Sec. 1.6049-8(a) (relating to 
bank deposit interest paid to a Canadian nonresident alien individual).
    Par. 4. Section 1.6049-6 is amended by:
    1. Redesignating paragraph (e)(4) as paragraph (e)(5).
    2. Adding new paragraph (e)(4).
    The addition reads as follows:

Sec. 1.6049-6  Statements to recipients of interest payments and 
holders of obligations for attributed original issue discount.

* * * * *
    (e) * * *
    (4) Special rule for amounts described in Sec. 1.6049-8(a) paid 
after December 31, 1996. In the case of amounts described in 
Sec. 1.6049-8(a) (relating to payments of interest to Canadian 
nonresident alien individuals) paid after December 31, 1996, any person 
who makes a Form 1042-S under section 6049(a) and Sec. 1.6049-4(b)(5) 
shall furnish a statement to the recipient. The statement shall include 
a copy of the Form 1042-S required to be prepared pursuant to 
Sec. 1.6049-4(b)(5) and a statement to the effect that the information 
on the Form is being furnished to the United States Internal Revenue 
Service and may be furnished to Canada.
* * * * *
    Par. 5. Section 1.6049-8 is added to read as follows:

Sec. 1.6049-8  Interest and original issue discount paid to residents 
of Canada.

    (a) Interest subject to reporting requirement. For purposes of 
Secs. 1.6049-4, 1.6049-6 and this section and except as provided in 
paragraph (b) of this section, the term interest means interest paid to 
a Canadian nonresident alien individual after December 31, 1996, where 
the interest is described in section 871(i)(2)(A) with respect to a 
deposit maintained at an office within the United States. For purposes 
of the regulations under section 6049, a Canadian nonresident alien 
individual is an individual who resides in Canada and is not a United 
States citizen. The payor or middleman may rely upon the permanent 
residence address (as defined in section 1441 and the regulations under 
that section) as stated on the Form W-8 (described in section 6049 and 
the regulations under that section) in order to determine whether the 
payment is made to a Canadian nonresident alien individual. Amounts 
described in this paragraph (a) are not subject to backup withholding 
under section 3406. See Sec. 31.3406(g)-1(d) of this chapter.
    (b) Interest excluded from reporting requirement. The term interest 
does not include an amount that is paid by the issuer or its agent 
outside the United States with respect to an obligation that is 
described in paragraph (b) (1) or (2) of this section.
    (1)(i) The obligation is not in registered form (within the meaning 
of section 163(f) and the regulations thereunder); is part of a larger 
single public offering of securities; and is described in section 
163(f)(2)(B).
    (ii) Unless it has actual knowledge to the contrary, a middleman 
may treat an obligation as if it is described in section 163(f)(2)(B) 
if the obligation or coupon therefrom, whichever is presented for 
payment, contains the statement described in section 
163(f)(2)(B)(ii)(II) and the regulations thereunder.
    (2)(i) The obligation has a face or principal amount of not less 
than $500,000, and satisfies the requirements described in paragraphs 
(b)(2)(i) (A), (B), and (C) of this section.
    (A) The obligation satisfies the requirements of sections 
163(f)(2)(B) (i) and (ii)(I) and the regulations thereunder (as if it 
were a registration-required obligation within the meaning of section 
163(f)(2)(A)) and is issued in accordance with the procedures of 
Sec. 1.163-5(c)(2)(i)(D)).
    (B) If the obligation is in registered form, it is registered in 
the name of an exempt recipient described in Sec. 1.6049-4(c)(1)(ii).
    (C) The obligation has on its face and on any detachable coupons 
the following statement (or a similar statement having the same 
effect): ``By accepting this obligation or coupon, the holder 
represents and warrants that it is not a United States person (other 
than an exempt recipient described in the regulations under section 
6049(b)(4) of the Internal Revenue Code and the regulations thereunder) 
and that it is not acting for or on behalf of a United States person 
(other than an exempt recipient described in the regulations under 
section 6049(b)(4) of the Internal Revenue Code and the regulations 
thereunder).''
    (ii) Unless the middleman has actual knowledge to the contrary, it 
may treat an obligation as satisfying the requirements of sections 
163(f)(2)(B) (i) and (ii)(I) and the regulations thereunder if the 
obligation or a coupon therefrom, whichever is presented for payment, 
contains the statement in paragraph (b)(2)(i)(C) of this section.

PART 31--EMPLOYMENT TAXES AND COLLECTION OF INCOME TAX AT SOURCE

    Par. 5a. The authority for part 31 continues to read in part as 
follows:

    Authority: 26 U.S.C. 7805 * * *

    Par. 6. Section 31.3406(g)-1 is amended by adding paragraph (d) to 
read as follows:

Sec. 31.3406(g)-1 Exception for payments to certain payees and certain 
other payments.

* * * * *
    (d) Reportable payments made to Canadian nonresident alien 
individuals. A payment of interest made to a Canadian nonresident alien 
individual under Sec. 1.6049-8(a) of this chapter is not subject to 
withholding under section 3406.

PART 602--OMB CONTROL NUMBERS UNDER THE PAPERWORK REDUCTION ACT

    Par. 7. The authority for part 602 continues to read as follows:

    Authority: 26 U.S.C. 7805.

    Par. 8. Section 602.101, paragraph (c) is amended by removing the 
entry ``Sec. 31.3406(a)-1-Sec. 31.3406(i)-1'' and adding entries to the 
table in numerical order to read as follows:

Sec. 602.101  OMB Control numbers.

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                             Current OMB
     CFR part or section where identified and described      control No.
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
1. 6049-6..................................................    1545-0096
                                                                        
                  *        *        *        *        *                 
31.3406(a)-1...............................................    1545-0112
31.3406(a)-2...............................................    1545-0112
31.3406(a)-3...............................................    1545-0112
31.3406(a)-4...............................................    1545-0112
31.3406(b)(2)-1............................................    1545-0112
31.3406(b)(2)-2............................................    1545-0112
31.3406(b)(2)-3............................................    1545-0112
31.3406(b)(2)-4............................................    1545-0112
31.3406(b)(2)-5............................................    1545-0112
31.3406(b)(3)-1............................................    1545-0112
31.3406(b)(3)-2............................................    1545-0112
31.3406(b)(3)-3............................................    1545-0112
31.3406(b)(3)-4............................................    1545-0112
31.3406(b)(4)-1............................................    1545-0112
31.3406(c)-1...............................................    1545-0112
31.3406(d)-1...............................................    1545-0112
31.3406(d)-2...............................................    1545-0112
31.3406(d)-3...............................................    1545-0112
31.3406(d)-4...............................................    1545-0112

[[Page 17575]]

                                                                        
31.3406(e)-1...............................................    1545-0112
31.3406(f)-1...............................................    1545-0112
31.3406(g)-1...............................................    1545-0096
                                                               1545-0112
31.3406(g)-2...............................................    1545-0112
31.3406(g)-3...............................................    1545-0112
31.3406(h)-1...............................................    1545-0112
31.3406(h)-2...............................................    1545-0112
31.3406(h)-3...............................................    1545-0112
31.3406(i)-1...............................................    1545-0112
                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

Margaret Milner Richardson,
Commissioner of Internal Revenue.

    Approved: March 27, 1996
Leslie Samuels,
Assistant Secretary of the Treasury.
[FR Doc 96-9456 Filed 4-15-96; 10:14 am]
BILLING CODE 4830-01-P

Complete official Federal Register PDF

FR Doc. 96-9357 Airworthiness Directives; Mooney Aircraft Corporation Model M20J Airplanes
[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Pages 17562-17564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9357]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 95-CE-102-AD; Amendment 39-9575; AD 95-26-16 R1]

Airworthiness Directives; Mooney Aircraft Corporation Model M20J 
Airplanes

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

-----------------------------------------------------------------------

SUMMARY: This document publishes in the Federal Register an amendment 
adopting Airworthiness Directive (AD) 95-26-16 R1, which was sent 
previously to all known U.S. owners and operators of certain Mooney 
Aircraft Corporation (Mooney) Model M20J airplanes. This AD requires 
repetitively inspecting the alternate air door assembly to ensure a 
cotter pin exists and is secure, and replacing the cotter pin if it 
does not exist or is not secure. It also provides the option of 
incorporating an alternate air door plate assembly of improved design 
as terminating action for the repetitive inspections. Priority letter 
AD 95-26-16 R1 was prompted by a fatal accident involving one of the 
affected airplanes where the alternate air door became lodged in the 
air intake of the fuel injector causing engine failure. The actions 
specified by this AD are intended to prevent the alternate air door 
from separating from the airplane and restricting air flow to the 
engine.

DATES: Effective May 16, 1996, to all persons except those to whom it 
was made immediately effective by priority letter AD 95-26-16 R1, 
issued January 5, 1996, which contained the requirements of this 
amendment.
    The incorporation by reference of certain publications listed in 
the regulations is approved by the Director of the Federal Register as 
of May 16, 1996.
    Comments for inclusion in the Rules Docket must be received on or 
before June 17, 1996.

ADDRESSES: Submit comments in triplicate to the Federal Aviation 
Administration (FAA), Central Region, Office of the Assistant Chief 
Counsel, Attention: Rules Docket 95-CE-102-AD, Room 1558, 601 E. 12th 
Street, Kansas City, Missouri 64106.
    Service information related to this AD may be obtained from the 
Mooney Aircraft Corporation, Box 72, Kerrville, Texas 78028; or may be 
examined at the Rules Docket at the address above, or at the Office of 
the Federal Register, 800 North Capitol Street NW., 7th Floor, suite 
700, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Alma Ramirez-Hodge, Aerospace 
Engineer, FAA, Fort Worth ACO, 2601 Meacham Boulevard, Fort Worth, 
Texas 76193-0150; telephone (817) 222-5147; facsimile (817) 222-5960.

SUPPLEMENTARY INFORMATION: On December 22, 1995, the FAA issued 
priority letter AD 95-26-16 to require repetitively inspecting the 
alternate air door assembly to ensure a cotter pin exists and is secure 
on certain Mooney Model M20J airplanes, and replacing the cotter pin 
with a part number MS 24665-132 if it does not exist or is not secure. 
A fatal accident involving a Mooney Model M20J airplane with reported 
engine failure in flight at 6,000 feet prompted the FAA to issue 
priority letter AD 95-26-16.
    After the reported engine failure, the pilot attempted to vector 
the airplane to the nearest airport and crashed into a wooded lot. 
Investigation of the accident revealed that the alternate air door bolt 
separated from its fastener, which allowed the alternate air door to 
lodge in the air intake of the fuel injector, resulting in restricted 
air flow to the engine.
    An FAA review of service history on Mooney Model M20J airplanes 
revealed four other incidents involving the alternate air door 
separating and becoming lodged in the intake of the fuel injector. 
These include two reports of rough engine operation while in flight 
with emergency landing, an aborted take-off because of engine power 
loss, and a service difficulty report found during a 100-hour time-in-
service (TIS) inspection.
    After the issuance of priority letter AD 95-26-16, Mooney developed 
an alternate air door plate assembly of improved design that, when 
incorporated on Mooney Model M20J airplanes, prevents the alternate air 
door assembly from separating from the airplane and restricting air 
flow to the engine. Mooney Service Bulletin (SB) M20-250B and SB M20-
253A, both dated December 1995, specify procedures for modifying the 
alternate air door assembly on Mooney Model M20J airplanes. This 
modification consists of incorporating the following parts of improved 
design:

--Plate assembly, part number (P/N) 600355-507;
--Four rivets, P/N MS20426AD3;
--A cotter pin, P/N MS24665-132;
--A self-locking castellated nut, P/N MS17825-4; and
--A washer, P/N AN960-416.

[[Page 17563]]

    After examining all information related to the subject accident and 
incidents, including the referenced service information, the FAA 
determined that (1) priority letter AD 95-26-16 should allow the option 
of incorporating an alternate air door plate assembly of improved 
design as terminating action for the repetitive inspections; and (2) AD 
action should be taken to prevent the alternate air door on certain 
Mooney Model M20J airplanes from separating and restricting air flow to 
the engine.
    Since an unsafe condition has been identified that is likely to 
exist or develop on other Mooney Model M20J airplanes of the same type 
design, the FAA revised priority letter AD 95-26-16 to provide the 
option of incorporating the above-referenced modification as 
terminating action for the requirement of repetitively inspecting the 
alternate air door assembly.
    Since it was found that immediate corrective action was required, 
notice and opportunity for prior public comment thereon were 
impracticable and contrary to the public interest, and good cause 
existed to make priority letter AD 95-26-16 R1 effective immediately by 
individual letters issued on January 5, 1996, to all known U.S. 
operators of certain Mooney Model M20J airplanes. These conditions 
still exist, and the AD is hereby published in the Federal Register as 
an amendment to section 39.13 of the Federal Aviation Regulations (14 
CFR 39.13) to make it effective as to all persons.

Comments Invited

    Although this action is in the form of a final rule that involves 
requirements affecting immediate flight safety and, thus, was not 
preceded by notice and opportunity to comment, comments are invited on 
this rule. Interested persons are invited to comment on this rule by 
submitting such written data, views, or arguments as they may desire. 
Communications should identify the Rules Docket number and be submitted 
in triplicate to the address specified above. All communications 
received on or before the closing date for comments will be considered, 
and this rule may be amended in light of the comments received. Factual 
information that supports the commenter's ideas and suggestions is 
extremely helpful in evaluating the effectiveness of the AD action and 
determining whether additional rulemaking action would be needed.
    Comments are specifically invited on the overall regulatory, 
economic, environmental, and energy aspects of the rule that might 
suggest a need to modify the rule. All comments submitted will be 
available, both before and after the closing date for comments, in the 
Rules Docket for examination by interested persons. A report that 
summarizes each FAA-public contact concerned with the substance of this 
AD will be filed in the Rules Docket.
    Commenters wishing the FAA to acknowledge receipt of their comments 
submitted in response to this notice must submit a self-addressed, 
stamped postcard on which the following statement is made: ``Comments 
to Docket No. 95-CE-102-AD.'' The postcard will be date stamped and 
returned to the commenter.
    The regulations adopted herein will not have substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Therefore, in 
accordance with Executive Order 12612, it is determined that this final 
rule does not have sufficient federalism implications to warrant the 
preparation of a Federalism Assessment.
    The FAA has determined that this regulation is an emergency 
regulation that must be issued immediately to correct an unsafe 
condition in aircraft, and is not a ``significant regulatory action'' 
under Executive Order 12866. It has been determined further that this 
action involves an emergency regulation under DOT Regulatory Policies 
and Procedures (44 FR 11034, February 26, 1979). If it is determined 
that this emergency regulation otherwise would be significant under DOT 
Regulatory Policies and Procedures, a final regulatory evaluation will 
be prepared and placed in the Rules Docket. A copy of it, if filed, may 
be obtained from the Rules Docket at the location provided under the 
caption ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by 
reference, Safety

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the 
Administrator, the Federal Aviation Administration amends part 39 of 
the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec. 39.13  [Amended]

    2. Section 39.13 is amended by adding a new airworthiness directive 
(AD) to read as follows:

95-26-16 R1 Mooney Aircraft Corporation: Amendment 39-9575; Docket 
No. 95-CE-102-AD. Revises priority letter AD 95-26-16, issued 
December 22, 1995.

    Applicability: Model M20J airplanes (serial numbers 24-0001 
through 24-3250 and 24-3252 through 24-3374), certificated in any 
category.

    Note 1: This AD applies to each airplane identified in the 
preceding applicability provision, regardless of whether it has been 
modified, altered, or repaired in the area subject to the 
requirements of this AD. For airplanes that have been modified, 
altered, or repaired so that the performance of the requirements of 
this AD is affected, the owner/operator must request approval for an 
alternative method of compliance in accordance with paragraph (e) of 
this AD. The request should include an assessment of the effect of 
the modification, alteration, or repair on the unsafe condition 
addressed by this AD; and, if the unsafe condition has not been 
eliminated, the request should include specific proposed actions to 
address it.

    Compliance: Required prior to further flight after the effective 
date of this AD, except to those operators receiving this action by 
priority letter issued January 5, 1996, which made these actions 
effective immediately upon receipt.
    To prevent the alternate air door from separating and 
restricting air flow to the engine, accomplish the following:

    Note 2: The paragraph structure of this AD is as follows:

Level 1: (a), (b), (c), etc.
Level 2: (1), (2), (3), etc.
Level 3: (i), (ii), (iii), etc.
Level 2 and Level 3 structures are designations of the Level 1 
paragraph they immediately follow.
    (a) Inspect the alternate air door assembly in accordance with 
the procedures contained in the Appendix to this AD to ensure that 
the cotter pin exists and is secure. If the cotter pin exists and is 
secure, reinspect the alternate air door assembly in accordance with 
the procedures contained in the Appendix to this AD at intervals not 
to exceed 10 hours time-in-service (TIS) until the modification 
specified in paragraph (b)(2) of this AD is accomplished.
    (b) If, during any of the inspections required by this AD, the 
cotter pin is found missing or is not secure, prior to further 
flight, accomplish one of the following:
    (1) Replace the cotter pin with a part number MS 24665-132 
cotter pin, and reinspect the alternate air door assembly at 
intervals not to exceed 10 hours TIS; or
    (2) Modify the alternate air door assembly. Accomplish these 
actions in accordance with the INSTRUCTIONS section of Mooney 
Service Bulletin (SB) M20-250B or SB M20-253A, both dated December 
1995, as applicable. This modification consists of incorporating the 
following parts of improved design:
    (i) plate assembly, part number (P/N) 600355-507;

[[Page 17564]]

    (ii) four rivets, P/N MS20426AD3;
    (iii) a cotter pin, P/N MS24665-132;
    (iv) a self-locking castellated nut, P/N MS17825-4; and
    (v) a washer, P/N AN960-416.

    Note 3: If the alternate air door assembly has been modified in 
accordance with Mooney SB M20-250A or SB M20-253, both dated May 10, 
1992, then the only parts required to be incorporated are the 
following:

--A cotter pin, P/N MS24665-132;
--A self-locking castellated nut, P/N MS17825-4; and
--A washer, P/N AN960-416.

    (c) Incorporating the modification specified in paragraph (b)(2) 
of this AD eliminates the requirement for the repetitive inspection 
requirement of this AD and may be incorporated at any time.
    (d) Special flight permits may be issued in accordance with 
sections 21.197 and 21.199 of the Federal Aviation Regulations (14 
CFR 21.197 and 21.199) to operate the airplane to a location where 
the requirements of this AD can be accomplished.
    (e) An alternative method of compliance or adjustment of the 
compliance time that provides an equivalent level of safety may be 
approved by the Manager, Airplane Certification Office (ACO), FAA, 
2601 Meacham Boulevard, Fort Worth, Texas 76193-0150. The request 
shall be forwarded through an appropriate FAA Maintenance Inspector, 
who may add comments and then send it to the Manager, Fort Worth 
ACO.

    Note 4: Information concerning the existence of approved 
alternative methods of compliance with this AD, if any, may be 
obtained from the Fort Worth ACO.

    (f) The modification required by this AD shall be done in 
accordance with Mooney Service Bulletin M20- 250B or Mooney Service 
Bulletin M20-253A, both dated December 1995, as applicable. This 
incorporation by reference was approved by the Director of the 
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 
51. Copies may be obtained from the Mooney Aircraft Corporation, Box 
72, Kerrville, Texas 78028. Copies may be inspected at the FAA, 
Central Region, Office of the Assistant Chief Counsel, Room 1558, 
601 E. 12th Street, Kansas City, Missouri, or at the Office of the 
Federal Register, 800 North Capitol Street, NW., 7th Floor, suite 
700, Washington, DC.
    (g) This AD (95-26-16 R1) revises priority letter AD 95-26-16.
    (h) This amendment (39-9575) becomes effective on May 16, 1996, 
to all persons except those persons to whom it was made immediately 
effective by priority letter AD 95-26-16 R1, issued January 5, 1996, 
which contained the requirements of this amendment.

Appendix to AD 95-26-16 R1

    I. INSPECTION PROCEDURES FOR AIRCRAFT PRIOR TO RETROFIT ACTION 
OF SERVICE BULLETINS M20-250, ORIGINAL ISSUE; M20-250, REVISION A; 
OR M20-253, ORIGINAL ISSUE.
    1. Remove top cowling from aircraft per M20J Service and 
Maintenance manual, reference Section 71-11-00.
    2. Remove the induction air filter from upper induction housing.
    3. Use mirror and flashlight to inspect cotter pin security 
through threaded portion of bolt of the alternate air door.
    4. Check security and condition of seal to alternate air door 
assembly, and replace the seal if cracked.
    5. If cotter pin is in place and secure, replace cowling per 
Section 71-11-00 of Service and Maintenance manual.
    6. If cotter pin is missing or not secure, replace with a part 
number MS 24665-132 cotter pin.

    II. INSPECTION PROCEDURES FOR AIRCRAFT AFTER RETROFIT ACTION OF 
SERVICE BULLETINS M20-250, REVISION A; OR M20-253, ORIGINAL ISSUE.
    1. Remove top cowling from aircraft per M20J Service and 
Maintenance manual, reference Section 71-11-00.
    2. Looking up from bottom of engine compartment, use mirror and 
flashlight to inspect cotter pin security through castellated nut 
and threaded portion of bolt of the alternate air door spring-loaded 
assembly.
    3. Check security and condition of seal to alternate air door 
assembly, and replace the seal if cracked.
    4. If cotter pin is in place and secure, replace cowling per 
Section 71-11-00 of Service and Maintenance manual.
    5. If cotter pin is missing or is not secure, replace with a 
part number MS 24665-132 cotter pin.
    Issued in Kansas City, Missouri, on April 10, 1996.
John R. Colomy,
Acting Manager, Small Airplane Directorate, Aircraft Certification 
Service.
[FR Doc. 96-9357 Filed 4-19-96; 8:45 am]
BILLING CODE 4910-13-P

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