issue-1994-01-10•Federal Register final rules — 1994-01-10
Federal Register final rules — 1994-01-10
issue-1994-01-10Federal Register final rules — 1994-01-10Regulation
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. 94-511 Private Land Mobile Licenses; Reclassification
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1285-1288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-511]
[[Page Unknown]]
[Federal Register: January 10, 1994]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Parts 22, 25, 80, 87, 90, 95 and 99
[GN Docket No. 93-252; FCC 94-2]
Private Land Mobile Licenses; Reclassification
In the matter of implementation of sections 3(n) and 332 of the
Communications Act; Regulatory Treatment of Mobile Services.
AGENCY: Federal Communications Commission.
ACTION: Procedures for waiver petitions.
-----------------------------------------------------------------------
SUMMARY: As a result of recent legislation, certain private land mobile
radio licensees will be reclassified as commercial mobile radio service
licensees and will be subject to foreign ownership restrictions within
the Communications Act of 1934, as amended. The Commission has now
established a procedure by which such licensees may file a waiver
petition with the Commission to request retention of existing foreign
ownership that would otherwise not be permitted. Such waiver petitions
must be received at the Commission by February 10, 1994.
DATES: This document is effective January 10, 1994. Petitions for
waiver must be filed with the Commission by February 10, 1994.
ADDRESS: Federal Communications Commission, 1919 M St. NW., Washington,
DC 20554.
FOR FURTHER INFORMATION CONTACT:
The Private Radio Bureau, Licensing Division, Consumer Assistance
Branch, (717) 337-1212 (for information regarding the filing of waiver
petitions). For information regarding this First Report and Order,
contact Carmen Cintron at (202) 632-6450 (Common Carrier Bureau, Mobile
Services Division) or Eric Malinen at (202) 632-6497 (Private Radio
Bureau, Land Mobile and Microwave Division).
SUPPLEMENTARY INFORMATION:
First Report and Order
Adopted: January 4, 1994; Released: January 5, 1994.
By the Commission:
I. Introduction
1. On September 23, 1993, we adopted a Notice of Proposed Rule
Making (Notice)\1\ in which we proposed, inter alia, to establish a
procedure by which private land mobile radio licensees that will be
reclassified as commercial mobile radio service (CMRS) providers
pursuant to this rule making proceeding could file a waiver petition to
retain existing foreign ownership. We now establish the filing
procedure for these waiver petitions and remind all potentially
affected licensees of the February 10, 1994, filing deadline. We also
emphasize that filing such a petition will not prejudice the licensee's
right at a later date to assert that it should not be classified as a
CMRS provider.
---------------------------------------------------------------------------
\1\GN Docket No. 93-252, 8 FCC Rcd 7988, 8002-03 76-78
(1993), 58 FR 53169 (October 14, 1993).
---------------------------------------------------------------------------
II. Background
2. The Omnibus Budget Reconciliation Act of 1993 (Budget Act)\2\
amended sections 3(n) and 332 of the Communications Act of 1934, as
amended, 47 U.S.C. 153(n), 332 (Communications Act), to create a
comprehensive regulatory framework for all mobile radio services.
``[A]ny provider of a private land mobile service that will be treated
as a common carrier as a result of the enactment of the Omnibus Budget
Reconciliation Act of 1993'' is subject to the foreign ownership
restrictions imposed on common carriers by section 310(b) of the
Communications Act, 47 U.S.C. 310(b).\3\ Nevertheless, the statute
allows affected licensees to petition the Commission for waiver of the
application of section 310(b) to any foreign ownership that lawfully
existed as of May 24, 1993. The statute requires that these petitions
for waiver be filed with the Commission by February 10, 1994 (within 6
months of enactment of the Budget Act). The Commission may grant such
waivers to eligible petitioners only upon the following conditions:
\2\Pub. L. No. 103-66, Title VI, Sec. 6002(b), 107 Stat. 312,
392, 395 (1993); see H.R. Conf. Rep. No. 213, 103d Cong., 1st Sess.
492, 494-95 (1993), reprinted in 1993 U.S. Code Cong. & Admin. News
1179, 1183-84.
\3\See 47 U.S.C. 332(c)(6); see also Budget Act, Section
6002(c)(2)(B) (effective dates). For the text of Section 310(b), see
paragraph 3, infra.
---------------------------------------------------------------------------
(A) The extent of foreign ownership interest shall not be
increased above the extent which existed on May 24, 1993.
(B) Such waiver shall not permit the subsequent transfer of
ownership to any other person in violation of section 310(b).
47 U.S.C. 332(c)(6)(A), (B).\4\
---------------------------------------------------------------------------
\4\In regard to condition (B), the legislative history of the
amended statute states: ``In effect, this condition ``grandfathers''
only the particular person who holds the foreign ownership on May
24, 1993; the ``grandfathering'' does not transfer to any future
foreign owners.'' H.R. Conf. Rep. No. 213, 103d Cong., 1st Sess. 495
(1993), reprinted in 1993 U.S. Code Cong. & Admin. News 1184.
---------------------------------------------------------------------------
3. Section 310(b) states in relevant part:
No * * * common carrier * * * license shall be granted to or
held by--
(1) any alien or the representative of any alien;
(2) any corporation organized under the laws of any foreign
government;
(3) any corporation of which any officer or director is an alien
or of which more than one-fifth of the capital stock is owned of
record or voted by aliens or their representatives or by a foreign
government or representative thereof or by any corporation organized
under the laws of a foreign country;
(4) any corporation directly or indirectly controlled by any
other corporation of which any officer or more than one-fourth of
the directors are aliens, or of which more than one-fourth of the
capital stock is owned of record or voted by aliens, their
representatives, or by a foreign government or representative
thereof, or by any corporation organized under the laws of a foreign
country, if the Commission finds that the public interest will be
served by the refusal or revocation of such license.
For the purposes of section 310(b), certain partnership interests,
as well as certain other interests held by non-corporate entities and
associations, may be considered ownership interests.\5\
---------------------------------------------------------------------------
\5\See e.g., Wilner & Scheiner, 103 FCC 2d 511 (1985),
reconsideration granted in part, 1 FCC Rcd 12 (1986); see also
Moving Phones Partnership, L.P. v. FCC, 998 F.2d 1051, 1055-57 (D.C.
Cir. 1993). Section 310(b) was amended in 1974 to eliminate the
restriction on alien ownership of private radio licensees. Pub. L.
93-505, 88 Stat 1576; H.R. Report No. 93-1423, 93rd Cong., 2d Sess.,
reprinted in 1974 U.S. Code Cong. & Admin. News 6305, 6307. However,
the ban on licensing radio facilities to foreign governments or
representatives, established in section 310(a), still applies to all
licensees.
---------------------------------------------------------------------------
4. The Notice proposed to establish a petition procedure to allow
licensees to ``grandfather'' their foreign ownership. Under this
procedure, petitioners would be required to (1) identify all foreign
persons or entities holding an interest in the licensee and the
percentage of ownership interest for each; and (2) certify that the
identity and level of foreign ownership are unchanged since May 24,
1993, and that no change will occur in the future (other than
divestiture of a foreign ownership interest to a domestic person or
entity) without prior notice to the Commission.\6\
---------------------------------------------------------------------------
\6\Notice, 8 FCC Rcd at 8002-03 77.
---------------------------------------------------------------------------
5. The Notice indicated that we intend to place the burden on
licensees to file petitions, regardless of whether we have made a final
determination as to whether the licensee is subject to reclassification
as a CMRS provider. Furthermore, the Notice stated that while the
filing of a petition would not prejudice a licensee's future arguments
as to whether it should be reclassified, licensees who failed to file a
timely petition would be subject to immediate enforcement of our
foreign ownership restrictions.\7\
---------------------------------------------------------------------------
\7\Id. at 8003 78.
---------------------------------------------------------------------------
III. Comments
6. A single commenter responded to this issue. Roamer One, Inc.,
argues that the Notice misread the Budget Act's amendment to the
Communications Act to the extent that it imposes ``immediate'' foreign
ownership restrictions on all private radio licensees.\8\ It maintains
that while the Notice refers to private land mobile service providers
that ``may'' be treated as common carriers, the statute refers to
existing private land mobile service providers that ``will'' be treated
as common carriers as a result of the enactment of the Budget Act.\9\
It contends that, prior to the completion of this rule making
proceeding, the Commission may not impose alien ownership restrictions
on private radio licensees who are unlikely to be classified as CMRS
providers.\10\
---------------------------------------------------------------------------
\8\Comments of Roamer One, Inc., at 15-16 (Nov. 8, 1993); see
also id. at iii-iv.
\9\Id. at 15.
\10\Id.
---------------------------------------------------------------------------
IV. Discussion
A. Who Should File a Waiver Petition
7. Initially, we agree with Roamer One that Section 332(c)(6) does
not impose foreign ownership restrictions on all private radio
licensees. As noted above, the foreign ownership restrictions apply
only to those current private land mobile service providers that ``will
be'' classified as CMRS providers ``as a result of enactment of the
[Budget Act].'' As we discussed in the Notice, a private land mobile
radio licensee could potentially be reclassified as a CMRS licensee if
it meets two criteria: Its service: (1) Is ``provided for profit,'' and
(2) makes ``interconnected service'' available ``to the public'' or
``to such classes of eligible users as to be effectively available to a
substantial portion of the public.'' In addition, it is possible that a
service might not fully satisfy the two criteria, but nonetheless be
classified as CMRS if the Commission were to find that the service is
the ``functional equivalent'' of CMRS.\11\ If a licensee determines
that there is a possibility that it will be reclassified as a CMRS
provider, it must also determine whether its foreign ownership as of
May 24, 1993, would be prohibited under section 310(b).\12\
---------------------------------------------------------------------------
\11\See Notice, 8 FCC Rcd at 7990-96 10-40.
\12\See paragraph 3, supra.
---------------------------------------------------------------------------
8. Final rules governing regulatory classification of mobile
services may not be available on or before the February 10, 1994,
filing deadline. We recognize that this presents private land mobile
licensees with the potentially difficult decision of whether they
should file petitions for waiver. Therefore, in instances where there
is any chance at all that the licensee might later be classified as a
CMRS provider, we strongly encourage the licensee to err on the side of
filing and thereby preserve all of its rights under the new statutory
provisions. Similarly, if a licensee is uncertain of whether it would
be affected by section 310(b) restrictions absent a waiver, we strongly
recommend that the licensee file a petition.
B. Contents of Waiver Petition
9. As noted above, section 332(c)(6) permits the Commission to
grant waiver petitions only where two conditions are met. First, the
waiver can only cover ``the [licensee's] extent of foreign ownership
interest [that has] not * * * increased above the extent which existed
on May 24, 1993.'' Consistent with the legislative history quoted
previously (see note 4, supra), we interpret this language to refer to
the precise identities of persons or entities and not merely to
preexisting levels of foreign ownership interests. Petitioners must
therefore identify in their petitions all foreign interests in the
licensee as of May 24, 1993, that would, absent a waiver, be subject to
the section 310(b) restrictions and for which a waiver is sought. For
instance, except as noted below, petitioners should specifically
identify all foreign persons or entities holding an ownership interest
in the licensee and the percentage of ownership interest of each and
identify all foreign partners,\13\ officers, and directors, regardless
of whether they have any ownership interest. While we will not require
publicly traded corporations\14\ to identify each foreign stockholder
in instances where this requirement would be especially onerous,\15\ we
note that it is the responsibility of all petitioners to ensure that
all foreign ownership listed in the petition, including that held by
individual stockholders, did exist as of May 24, 1993, and to retain
documentation substantiating that ownership.
---------------------------------------------------------------------------
\13\Petitioners must list all foreign partners regardless of
whether they are general or limited partners, except that
petitioners need not list a limited partner (1) whose level of
ownership interest in the licensee does not exceed the level allowed
by section 310(b), and (2) who is ``insulated'' from the management
and control of the partnership. See, e.g., Wilner and Scheiner,
supra, 103 FCC 2d at 517 n. 31, 520 n. 43; Attribution of Ownership
Interests, Memorandum Opinion and Order in MM Docket No. 83-46, 58
RR 2d 604, 619-20 48-50 (1985).
\14\For a definition of such corporations, see First Report and
Order and Memorandum Opinion and Order on Reconsideration in CC
Docket Nos. 90-6, 85-388, 6 FCC Rcd 6185, 6213 63 (1991).
\15\See, e.g., Advanced Mobile Phone Inc., 54 RR 2d 354, 362 29
(Com. Car. Bur. 1983) (applicant demonstrated sufficient compliance
with the requirements of FCC Form 401 by indicating the percentage
of its common stock held or voted by aliens, and by listing the
identities of its ten largest stockholders and stating that none of
them was an alien, and would not be required to circulate a
questionnaire to all of its stockholders). The burden will be on any
entity claiming such an onerous burden to explain why identifying
individual shareholders would be extraordinarily burdensome.
---------------------------------------------------------------------------
10. The second condition is that the waiver cannot permit any
``subsequent transfer of ownership to any other person in violation of
section 310(b).'' We interpret ``subsequent'' here to mean subsequent
to May 24, 1993. Petitioners must therefore certify in their petitions
that the identity and percentages of each listed component of foreign
ownership are unchanged since May 24, 1993, and that each listed
foreign officer, director or partner continues to hold the same
position. The waiver can recognize only the particular person or entity
that held the ownership interest on May 24, 1993; it cannot recognize
any subsequent transfers to other foreign owners or foreign officers or
directors.\16\ If, following the grant of a waiver in light of the
above condition, a licensee wishes to transfer ``grandfathered''
foreign ownership interests, the waiver will remain valid (for the
remaining ``grandfathered'' interests) only if the transfer is made to
a domestic person or entity.\17\ The same is true for ``grandfathered''
partners, officers, and directors.
---------------------------------------------------------------------------
\16\See note 4, supra. Thus, transfers to aliens that occurred
after May 24 are not covered by the grandfathering provisions of the
Budget Act even if they occurred before the Budget Act was enacted
on August 10, 1993. Where such a transfer is found to create an
ownership interest in violation of section 310(b), the licensee will
be required to comply with section 310(b) with respect to that
interest, regardless of whether alien ownership in the licensee that
existed prior to May 24 is grandfathered.
\17\Licensees seeking to transfer their ownership or control
would also be required to comply with section 310(d) of the
Communications Act, 47 U.S.C. 310(d), and with applicable Commission
rules.
---------------------------------------------------------------------------
C. Effective Date of Section 310(b) Restrictions
11. Roamer One appears to object to our statement in the Notice
that ``all reclassifiable private licensees are immediately subject to
the foreign ownership restrictions on common carriers by section
310(b).''\18\ As noted above, Roamer One contends that, prior to the
completion of this rule making proceeding, the Commission should not
impose alien ownership restrictions on private radio licensees who are
unlikely to be classified as CMRS providers. We agree that the
restrictions in section 310(b) would only apply to licensees that are
actually reclassified pursuant to the statute and its implementation in
this rule making. Section 310(b) does not and will not apply to private
land mobile radio licensees who will not be reclassified as CMRS
providers. On the other hand, the statute does require immediate
enforcement of section 310(b) for private land mobile providers that
are reclassified as CMRS. Section 6002(c)(2)(B) of the Budget Act
states:
\18\Notice, 8 FCC Rcd at 8002 76 (emphasis added).
---------------------------------------------------------------------------
[A]ny private land mobile service provided by any person before
[the Budget Act's] date of enactment, and any paging service
utilizing frequencies allocated as of January 1, 1993, for private
land mobile services, shall, except for purposes of section
332(c)(6) of [the Communications Act], be treated as a private
mobile service until 3 years after such date of enactment.
Budget Act, section 6002(c)(2)(B) (emphasis added). Although other
common carrier regulation may not apply to some licensees for 3 years,
unless a licensee timely files and is granted a waiver pursuant to
section 332(c)(6), section 310(b) will apply immediately upon the
effective date of our rules reclassifying the licensee's service as
CMRS. Accordingly, as stated above, licensees that may be reclassified
should file a timely waiver request to grandfather any foreign
ownership or other interest that existed as of May 24, 1993, and that
might be affected by the application of section 310(b).
V. Petitioning Procedure
12. In light of the above, we adopt the following petitioning
procedure. First, petitions should be in an informal, letter format,
and must contain the caption ``COMMERCIAL MOBILE RADIO SERVICE FOREIGN
OWNERSHIP WAIVER PETITION.'' Petitions must clearly specify the
licensee's name, radio service, call sign(s), station address(es) or
geographical location(s), and contact person with telephone number.
Petitions must specifically request a waiver of section 310(b),
identify the particular subsection(s) of section 310(b) for which the
waiver is requested, and state that the waiver is sought under section
332(c)(6). The original copy of the waiver petition must be signed by
the licensee,\19\ and this signature will be taken to certify that all
statements made in the petition are true, complete, correct, and made
in good faith.
---------------------------------------------------------------------------
\19\See Section 1.913 of the Commission's Rules, 47 CFR 1.913.
---------------------------------------------------------------------------
13. In addition, as proposed in the Notice, petitions must:
(1) identify by name,\20\ as of May 24, 1993, all foreign
persons or other entities holding ownership interests in the
licensee, directly or indirectly, that would, absent a waiver, not
be permitted to hold such interests under section 310(b), and for
which a waiver is sought; likewise, petitions must identify
similarly situated foreign partners, officers, or directors of the
licensee, regardless of whether they have any ownership interest in
the licensee;
---------------------------------------------------------------------------
\20\As noted previously, publicly traded corporations are not
required to identify all individual stockholders when to do so would
constitute an especially onerous burden. See notes 14-15, supra, and
accompanying text.
---------------------------------------------------------------------------
(2) as applicable, as of May 24, 1993, identify the following
for each person or other entity (including officers, directors and
partners) identified in (1) above: residence, citizenship, office or
directorship held, number of shares or nature of partnership
interests, number of votes, and percentage of votes; also, if the
entity is other than an individual, petitions must also identify the
name, address, and citizenship of the natural person authorized to
vote the stock; and
(3) Answer the following:
(a) Have the ownership and other interests listed pursuant to
(1) and (2) above remained the same since May 24, 1993?
(b) Have the officers, directors or partners continued to retain
their positions since May 24, 1993?
If the answer to (a) or (b) is ``No,'' please explain.
14. Petitioners must also certify that, in the case of an
individual petitioner, he or she is not subject to a denial of federal
benefits, that includes FCC benefits, pursuant to section 5301 of the
Anti-Drug Abuse Act of 1988, 21 U.S.C. section 862, or, in the case of
a non-individual petitioner, (e.g., corporation, partnership, or other
unincorporated association), no party to the application is subject to
a denial of federal benefits, that includes FCC benefits, pursuant to
that section. For the definition of a ``party'' for these purposes, see
47 CFR 1.2002(b).
15. The Commission has no authority to extend the Congressionally
mandated deadline date, so it is imperative that waiver petitions be
filed on time. To be timely received, petitions must, by February 10,
1994, be either (1) hand-delivered to the offices of the FCC in
Gettysburg, Pennsylvania, at the address below, or (2) received through
the U.S. Mail or other mail delivery service at the address below.
Federal Communications Commission, Attn: CMRS Foreign Ownership Waiver
Petition, 1270 Fairfield Road, Gettysburg, Pennsylvania 17325--7245.
Licensees should file one original and two copies. These petitions
do not require a filing fee.
VI. Final Regulatory Flexibility Analysis
16. Pursuant to the Regulatory Flexibility Act of 1980, 5 U.S.C.
604, the Commission's final analysis is as follows:
A. Need for, and Purpose of, This Action
As a result of recent legislation, certain private land mobile
radio licensees will be reclassified as commercial mobile radio service
licensees and will be subject to foreign ownership restrictions within
the Communications Act of 1934, as amended. This present First Report
and Order describes the procedure by which such licensees may file a
waiver petition with the Commission to request retention of existing
foreign ownership that would otherwise not be permitted.
B. Summary of the Issues Raised by the Public Comments in Response to
the Initial Regulatory Flexibility Analysis
In regard to the foreign ownership issue addressed by this First
Report and Order, no comments were submitted in response to our Initial
Regulatory Flexibility Analysis.
C. Significant Alternatives Considered
No significant alternatives were considered.
VII. Ordering Clauses
17. Accordingly, It is Ordered That, pursuant to the authority of
sections 4(i), 303(r), and 332(c)(6) of the Communications Act of 1934,
as amended, 47 U.S.C. 154(i), 303(r), and 332(c)(6), this First Report
and Order is adopted, effective upon publication in the Federal
Register.\21\
---------------------------------------------------------------------------
\21\In light of the statutory deadline for filing petitions, we
find that there is good cause to make this action effective
immediately upon publication in the Federal Register.
---------------------------------------------------------------------------
18. For further information on filing a waiver petition, contact
the Private Radio Bureau, Licensing Division, Consumer Assistance
Branch, (717) 337-1212. For further information regarding this First
Report and Order, contact Carmen Cintron at (202) 632-6450 (Common
Carrier Bureau, Mobile Services Division) or Eric Malinen at (202) 632-
6497 (Private Radio Bureau, Land Mobile and Microwave Division).
Federal Communications Commission.
William F. Caton,
Acting Secretary.
[FR Doc. 94-511 Filed 1-7-94; 8:45 am]
BILLING CODE 6712-01-M
Complete official Federal Register PDF
FR Doc. 94-494 South Dakota; Final Authorization of State Hazardous Waste Management Program
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1275-1277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-494]
[[Page Unknown]]
[Federal Register: January 10, 1994]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 271
[FRL-4823-6]
South Dakota; Final Authorization of State Hazardous Waste
Management Program
AGENCY: Environmental Protection Agency.
Action: Immediate final rule.
-----------------------------------------------------------------------
SUMMARY: The State of South Dakota has applied for final authorization
of revisions to its hazardous waste program under the Resource
Conservation and Recovery Act (RCRA). The Environmental Protection
Agency (EPA) has reviewed South Dakota's application and has made a
decision, subject to public review and comment, that South Dakota's
hazardous waste program revision satisfies all of the requirements
necessary to qualify for final authorization. Thus, EPA intends to
approve South Dakota's hazardous waste program revisions. South
Dakota's application for program revision is available for public
review and comment.
DATES: Final authorization for South Dakota shall be effective March
11, 1994, unless EPA publishes a prior Federal Register action
withdrawing this immediate final rule. All comments on South Dakota's
program revision application must be received by the close of business
February 9, 1994.
ADDRESSES: Copies of South Dakota's program revision application are
available during regular business hours at the following addresses for
inspection and copying: Division of Environmental Regulation,
Department of Water and Natural Resources, Office of Waste Management,
319 S. Coteau, Pierre, South Dakota 57501, phone: 605/773-3153 and U.S.
EPA Region VIII Library, 999 18th Street, suite 144, Denver, CO 80204-
2466, Phone 303/293-1444. Written comments should be sent to: Marcella
DeVargas (HWM-WM), U.S. Environmental Protection Agency, 999 18th
Street, suite 500, Denver, Colorado 80202-2466, Phone 303/293-1670.
FOR FURTHER INFORMATION CONTACT: Marcella DeVargas, Waste Management
Branch, U.S. EPA, 999 18th Street, suite 500, Denver, CO 80202-2466,
Phone: 303/293-1670.
SUPPLEMENTARY INFORMATION
A. Background
States with final authorization under section 3006(b) of the
Resource Conservation and Recovery Act (``RCRA'' or the ``the Act''),
42 U.S.C. 6929(b), have a continuing obligation to maintain a hazardous
waste program that is equivalent to, consistent with, and no less
stringent than the Federal hazardous waste program.
Revisions to State hazardous waste programs are necessary when
Federal or State statutory or regulatory authority is modified or when
certain other changes occur. Most commonly, State program revisions are
necessitated by changes to EPA's regulations in 40 CFR parts 124, 260
through 268 and 270.
B. South Dakota
South Dakota initially received final authorization in November
1984. Revisions to the program were approved on June 17, 1991, June 29,
1992, and September 8, 1993.
EPA has reviewed South Dakota's application, and has made an
immediate final decision that South Dakota's hazardous waste program
revision satisfies all of the requirements necessary to qualify for
final authorization. Consequently, EPA intends to grant final
authorization for the additional program modifications to South Dakota.
The public may submit written comments on EPA's immediate final
decision up until February 9, 1994. Copies of South Dakota's
application for program revision are available for inspection and
copying at the locations indicated in the ADDRESSES section of this
notice.
Approval of South Dakota's program revision shall become effective
in 60 days unless an adverse comment pertaining to the State's revision
discussed in this notice is received by the end of the comment period.
If an adverse comment is received EPA will publish either: (1) A
withdrawal of the immediate final decision or (2) a notice containing a
response to comments which either affirms that the immediate final
decision takes effect or reverses the decision.
A draft application was submitted on April 30, 1993. The State of
South Dakota addressed all of EPA's concerns prior to submittal of the
final application. Thus, the South Dakota program is granted immediate
final authorization for the provisions in the following Table.
Provisions
------------------------------------------------------------------------
Federal Register reference State authority
------------------------------------------------------------------------
1. Listing of Spent Pickle Liquor, 51 FR
19320, 5/28/86........................... 74:28:22:01
2. Liability Coverage-Corporate Guarantee,
51 FR 25350, 7/11/86..................... 74:28:25:01, 74:28:28:01
3. Standards for Hazardous Waste Storage
and Treatment Systems, 51 FR 25422, 7/14/
86, 51 FR 29430, 8/15/86................. 74:28:21:02, 74:28:22:01,
74:28:23:01, 74:28:25:01,
74:28:28:01, 74:28:26:01
4. Corrections to List of Commercial
Chemical Products and Appendix VIII
Constituents, 51 FR 28296, 8/6/86........ 74:28:22:01
5. Biennial Report Correction, 51 FR 8/8/
86....................................... 74:28:25:01, 74:28:28:01
6. Exports of Hazardous Waste, 51 FR
28664, 8/8/86............................ 74:28:22:01, 74:28:23:01,
74:28:24:01
7. Standards for Generators, 51 FR 35190,
10/1/86.................................. 74:28:23:01
8. Listing of EBDC, 51 FR 37725, 10/24/86. 74:28:22:01
9. Revised Manual SW-846; Amended
Incorporation by Reference, 52 FR 8072, 3/
16/87.................................... 74:28:21:02, 74:28:26:01
10. Closure/Post-closure Care for Interim
Status Surface Impoundments, 52 FR 8704,
3/19/87.................................. 74:28:28:01
11. Definition of Solid Waste; Technical
Corrections, 52 FR 21306, 6/5/87......... 74:28:22:01, 74:28:27:01
12. Amendments to Part B Information
Requirements for Disposal Facilities, 52
FR 23447, 6/22/87, amended 9/9/87........ 74:28:26:01
13. List (Phase I) of Hazardous
Constituents for Ground-Water Monitoring,
52 FR 25942, 9/9/87...................... 74:28:25:01, 74:28:26:01
14. Identification and Listing of
Hazardous Waste, 52 FR 26012, 7/10/87.... 74:28:22:01
15. Exception Reporting for Small Quantity
Generators of Hazardous Waste, 52 FR
35894, 9/23/87........................... 74:28:23:01
16. Liability Requirements for Hazardous
Waste Facilities; Corporate Guarantee, 52
FR 44314, 11/18/87....................... 74:28:25:01, 74:28:28:01
17. HSWA Codification Rule 2 52 FR 45788,
12/1/87.................................. 74:28:26:01, 74:28:25:01,
74:28:28:01
18. Hazardous Waste Miscellaneous Units,
52 FR 46946, 12/10/87.................... 74:28:21:02, 74:28:25:01
19. Technical Corrections: Identification
and Listing of Hazardous Waste, 53 FR
13382, 4/22/88........................... 74:28:22:01
20. Identification and Listing of
Hazardous Waste; Technical Correction, 53
FR 27162, 7/19/88........................ 74:28:22:01
21. Farmer Exemption; Technical
Corrections, 53 FR 27164, 7/19/88........ 74:28:23:01, 74:28:25:01,
74:28:28:01, 74:28:30:01
22. Identification and Listing of
Hazardous Waste; Treatability Studies
Sample Exemption, 53 FR 27290, 7/19/88... 74:28:21:02, 74:28:22:01
23. Hazardous Waste Management System;
Standards for Hazardous Waste Tanks, 53
FR 34079, 9/2/88......................... 74:28:21:02, 74:28:25:01,
74:28:28:01, 74:28:26:01
24. Identification and Listing of
Hazardous Waste; Designation of
Reportable Quantities, 53 FR 35412, 9/13/
88....................................... 74:28:22:01
25. Permit Modification for Hazardous
Waste Management Facilities 53 FR 37912,
9/28/88, amended 10/24/88................ 74:28:26:01, 74:28:25:01,
74:38:28:01
26. Statistical Methods for Evaluating
Ground-Water Monitoring DA, 53 FR 39720,
10/11/88................................. 74:28:25:01
27. Identification and Listing of
Hazardous Waste; Removal of Iron Dextran
from List of Hazardous Wastes, 53 FR
43878, 10/31/88.......................... 74:28:22:01
28. Identification and Listing of
Hazardous Waste; Removal of Strontium
Sulfide from List, 53 FR 43881, 10/31/88. 74:28:22:01
29. Standards for Generators of Hazardous
Waste, 53 FR 45089, 11/8/88.............. 74:28:23:01
30. Hazardous Waste Misc. Units Standards
Applicable to Owners and Operators, 54 FR
615, 1/9/89.............................. 74:28:26:01
31. Amendment to Requirements for
Hazardous Waste Incinerator Permits, 54
FR 4286, 1/30/89......................... 74:28:26:01
32. Mining Waste Exclusions 54 FR 36592, 9/
1/89..................................... 74:28:22:01
33. Testing and Monitoring Activities, 54
FR 40260, 9/29/89........................ 74:28:21:02, 74:28:22:01
34. Reportable Quantity Adjust. Methyl
Bromide Production Wastes, 54 FR 41402,
10/6/89.................................. 74:28:22:01
35. Reportable Quantity Adjust. 54 FR
50968, 12/11/89.......................... 74:28:22:01
36. Changes to Part 124 48 FR 14146, 4/1/
83, amended 6/30/83, 7/26/83, 9/26/83, 1/
4/89..................................... 74:28:26:01, SDCL 34A-11-12
SDCL 1-26-17, MOA
37. Mining Waste Exclusion II 55 FR 2322,
1/23/90.................................. 74:28:21:02, 74:28:22:01,
74:28:23:01
38. Modification of F019 Listing 55 FR
5340, 2/14/90............................ 74:28:22:01
39. Testing and Monitoring Activities;
Technical Correction 55 FR 8948, 3/9/90.. 74:28:21:02, 74:28:22:01
40. Listing of 1,1-dimethylhydrazine,
Production Wastes 55 FR 18496, 5/2/90.... 74:28:22:01
41. Criteria for Listing Toxic Wastes;
Tech. Amend. 55 FR 18726, 5/4/90......... 74:28:22:01
42. HSWA Codification Rule Double Liners,
Correction, 55 FR 19262, 5/9/90.......... 74:28:25:01
43. Organic Air Emission Standards, for
Process Vents and Equipment Leaks, 55 FR
25454, 6/21/90........................... 74:28:21:02, 74:28:22:01,
74:28:25:01, 74:28:28:01,
74:28:26:01
------------------------------------------------------------------------
C. Decision
I conclude that South Dakota's application for program revision
meets all of the statutory and regulatory requirements established by
RCRA. Accordingly, South Dakota is granted final authorization to
operate its hazardous waste program as revised.
South Dakota has not requested authorization to operate its
hazardous waste program, as revised, in ``Indian Country'' as defined
in 18 U.S.C. 1151. Accordingly, today's decision to grant South Dakota
final hazardous waste authorization, as revised, does not extend to
Indian Country. The Environmental Protection Agency retains all
hazardous waste authority under RCRA which applies to ``Indian
Country'' in South Dakota.
South Dakota now has responsibility for permitting treatment,
storage, and disposal facilities within its borders and carrying out
other aspects of the RCRA program, subject to the limitation of its
revised program application and previously approved authorities. South
Dakota also has primary enforcement responsibilities, although EPA
retains the right to conduct inspections under section 3007 of RCRA and
to issue orders under sections 3008, 3013, and 7003 of RCRA.
South Dakota has agreed to submit a draft application for RCRA
cluster 1 and land disposal restriction rules by December 31, 1993, a
draft application for RCRA cluster 2 by December 31, 1994. Final
applications will be submitted within 60 working days of receipt of
EPA's comments on the draft application. The State has agreed to submit
a final application for the TC rules within six months of EPA's
decision on the proposed rule (December 24, 1992) to suspend the
Toxicity Characteristics rule (Hazardous Waste Codes D018 through
D043).
Compliance With Executive Order 12866
The Office of Management and Budget has exempted this rule from the
requirements of section 6 of Executive order 12866.
Certification Under the Regulatory Flexibility Act
Pursuant to the provisions of 4 U.S.C. 605(b), I hereby certify
that this authorization will not have a significant economic impact on
a substantial number of small entities. This authorization effectively
suspends the applicability of certain Federal regulations in favor of
South Dakota's program, thereby eliminating duplicative requirements
for handlers of hazardous waste in the State. It does not impose any
new burdens on small entities. This rule, therefore, does not require a
regulatory flexibility analysis.
List of Subjects in 40 CFR Part 271
Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous materials transportation,
Hazardous waste Indian lands, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements, Water pollution control,
Water supply.
Authority: This notice is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as amended
42 U.S.C. 6912(a), 6926, 6974(b).
Dated: December 28, 1993.
Jack W. McGraw,
Acting Regional Administrator.
[FR Doc. 94-494 Filed 1-7-94; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 94-480 Medicare Program; Coverage of Epoetin (EPO) Used by Competent Home Dialysis Patients
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1278-1285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-480]
[[Page Unknown]]
[Federal Register: January 10, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 405, 410, 413, and 414
[BPD-737-F]
RIN 0938-AF54
Medicare Program; Coverage of Epoetin (EPO) Used by Competent
Home Dialysis Patients
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule adopts as final the interim final rule that
provided for Medicare coverage of EPO used by ESRD beneficiaries who
dialyze at home and are competent to use the drug without medical or
other supervision and established criteria for selection of patients
that can be considered ``competent'' and for monitoring of the patients
who are selected. It also makes minor changes in response to public
comments on the interim rule.
The interim rule was necessary to implement section 4201(d)(1) of
the Omnibus Budget Reconciliation Act of 1990 (OBRA '90). The purpose
of the amendments is to facilitate use of EPO at home, while ensuring
that such use of the drug is safe.
EFFECTIVE DATE: These rules are effective on February 9, 1994.
FOR FURTHER INFORMATION CONTACT: Jackie Sheridan, (410) 966-4635.
SUPPLEMENTARY INFORMATION:
I. Background
Chronic renal failure (CRF) is a progressive and usually
irreversible decline in kidney function that does not always require
regular dialysis. However, CRF patients who have end-stage renal
disease (ESRD) do require a regular course of dialysis or kidney
transplantation in order to sustain life.
Section 299I of the Social Security Amendments of 1972 (Pub. L. 92-
603) established the Medicare ESRD benefit by extending coverage to any
individual who requires either dialysis or transplantation and meets
the following requirements:
Is fully or currently insured or entitled to monthly
benefits under title II of the Social Security Act; or
Is the spouse or dependent child of the insured or
entitled individual.
The methods and amounts of payment for services to ESRD patients
have changed over the years and are currently set forth in
Secs. 410.50, 410.52, and 413.170-413.179 of the HCFA rules. Law and
program policy have moved over the years towards encouraging greater
use of self-dialysis and home dialysis.
On June 1, 1989, the Food and Drug Administration (FDA) approved
the generic drug epoetin which we commonly refer to as ``EPO''. EPO is
a sterile, colorless, preservative-free, liquid, biologically
engineered protein that stimulates the bone marrow to make new red
blood cells. EPO may be covered under the Medicare program when used to
treat anemia associated with chronic renal failure. Most chronic renal
failure patients are anemic because their kidneys are unable to produce
sufficient amounts of a substance called erythropoietin.
Patients with chronic renal failure include those who require renal
dialysis and are eligible for Medicare under the end-stage renal
disease (ESRD) provisions of the law. In accordance with the labeling
approved by the FDA, EPO may be administered either intravenously or
subcutaneously for the treatment of anemia associated with chronic
renal failure or anemia induced by the drug AZT used by patients with
the HIV virus. Individuals with chronic renal failure use the drug to
elevate or maintain the red blood cell level (as measured by the
hematocrit or hemoglobin level) and to decrease the need for blood
transfusions. Chronic renal patients considered for initiation of EPO
therapy should generally have a hematocrit of less than 30%.
In July, 1989, we issued instructions in the Provider Reimbursement
Manual--Part 1 (Chapter 27, Transmittal 11) authorizing Medicare
contractors to start paying for the drug EPO, as of June 1, 1989.
Coverage instructions were issued in November 1989 in the Intermediary
Manual--Part 3 (Transmittal 1449), Carriers Manual--Part 3 (Transmittal
1329), Hospital Manual (Transmittal 576) and the Renal Dialysis
Facility Manual (Transmittal 42). The effective date of the coverage
instructions was also June 1, 1989. The Medicare regulations were not
amended at that time.
Before enactment of Public Law 101-508 (OBRA '90), home use of EPO
was not covered. For patients who dialyzed at home to receive Medicare
payment for EPO, the drug had to be administered either in an ESRD
facility or as a service ``incident to'' a physician's professional
services.
II. Statutory Provisions
Section 4201(d)(1) of OBRA '90 amended section 1861(s)(2) of the
Act by adding a new subparagraph (Q) that--
Provides for coverage, effective July 1, 1991, of EPO that
is used by home dialysis patients who are competent to use the drug
without medical or other supervision and for coverage of items related
to administration of the drug; and
Requires the Secretary to establish by regulation methods
and standards for the safe and effective use of the drug at home.
Section 4201(c) of that same law provided for payment for EPO
furnished to ESRD patients by Medicare approved dialysis facilities to
be made at the rate of $11 per 1,000 units, rounded to the nearest 100
units, effective January 1, 1991. Section 13566 of the Omnibus Budget
Reconciliation Act of 1993 (OBRA '93, Pub. L. 103-66) sets the rate at
$10 per 1,000 units effective January 1, 1994.
Typically, EPO is administered at the end of the dialysis
treatment. Therefore, unless medical documentation shows that it is
necessary to administer EPO at a time other than during dialysis,
payment for patients who dialyze at a facility is made only to the
facility.
The change made by section 13555(b) of OBRA '93, which provides for
coverage of EPO self-administered by any dialysis patient (not limited
to those who dialyze at home) will be implemented by separate
regulations.
For home use of EPO supplied to a home dialysis patient competent
to administer the drug without medical supervision, HCFA pays only a
Medicare approved dialysis facility or a supplier of home dialysis
equipment and supplies, if the patient obtains the drug directly from
the supplier. In either case, payment for home use of EPO is made at
the rate described above.
If a home patient is competent to use EPO without supervision and
the drug has been prescribed, generally the patient's dialysis facility
would furnish it. If a physician administers EPO to the patient, it
should be the physician who receives the Monthly Capitation Payment
(MCP) for furnishing the beneficiary's renal-related services. If a
physician other than the MCP physician furnishes EPO, this physician
must look to the MCP physician for payment for EPO administration. In
this latter case, HCFA pays on a reasonable charge basis for the drug,
but makes no additional payment to the physician for administration.
HCFA will announce annually, for public comment, whether an update
in the EPO allowance is appropriate. By statute, any increase will not
exceed the percentage increase (if any) in the implicit price deflator
for the gross national product for the second quarter of the preceding
year over the implicit price deflator for the second quarter of the
second preceding year.
III. Provisions of the Interim Final Rule
In the interim final rule with comment period, published on
September 4, 1991, we made the changes discussed below:
A. Major changes.
We amended subpart U of part 405 of the HCFA rules, which sets
forth the conditions for coverage of services furnished to ESRD
beneficiaries, as follows:
1. Patient selection.
To ensure the safe and effective use of EPO by home dialysis
patients, we amended Sec. 405.2163 to require that the patient's
dialysis facility or the physician responsible for all dialysis-related
services make a comprehensive assessment of the patient and the
patient's needs at the time of selection for EPO therapy.
We emphasized that proper patient selection is necessary for a
safe, effective program of EPO therapy at home. It is necessary for the
dialysis facility or the physician responsible for all dialysis-related
services to assess--
Whether the patient will actually be able to administer
the drug or have available the necessary assistance from a care-giver;
and
Whether the patient complies with certain elements
necessary for successful EPO therapy.
Accordingly, we required that, in order to be selected for home use
of EPO, a patient must--
Be a home dialysis patient (either peritoneal or
hemodialysis method).
Have a hematocrit (or comparable hemoglobin) of less than
30 percent unless medical documentation justifies a patient's need for
EPO with a hematocrit higher than 30 percent. For example, a patient
with severe angina, severe pulmonary disease, or severe hypotension may
require EPO to prevent adverse symptoms even though the patient has a
higher hematocrit.
Be under the care of the physician who is responsible for
the dialysis-related services and who prescribes EPO, and under the
care of the renal dialysis facility that establishes the plan of care
for the services and monitors the progress of the home EPO therapy.
Be trained by the facility to inject EPO or have an
appropriate caregiver who is trained to inject EPO.
In addition, as part of the assessment, we required the following:
a. The patient's hematocrit (or hemoglobin), serum iron,
transferrin saturation, serum ferritin, and blood pressure must be
measured.
b. An appropriate protocol, developed by the patient's physician or
facility and including monitoring of blood pressure, must be given to
the patient for the safe and effective use of the drug.
c. The patient must be capable of performing self-administration of
EPO, be able to learn aseptic technique, and be able to read the drug
labeling, or must have a primary care-giver who can perform these
tasks.
d. The patient must be able to adhere to a disciplined medical
regimen.
2. Patient care plan.
To ensure adequate monitoring of home EPO therapy, we amended
Sec. 405.2137(b) to add a new paragraph (b)(7) which requires that the
patient plan for a home dialysis patient who uses EPO in the home
include the following:
Review of diet and fluid modifications to monitor iron
stores and hyperkalemia related to dietary indiscretion or elevated
blood pressure.
Reevaluation of the patient's dialysis prescription taking
into account the patient's increased appetite and red blood cell
volume.
A method of teaching the patient to identify the signs and
symptoms of hypotension and hypertension.
The decrease or discontinuance of EPO if hypertension is
uncontrolled.
A method of followup on blood work and a means to keep the
physician informed of the results.
3. Other concerns.
In order to minimize possible abuse of EPO, we revised
Sec. 405.2163(g)(4) to require that the physician or facility ensure
that ``on hand'' EPO is limited to a two-month supply.
We also requested the public's views and suggestions regarding this
policy, and any other issues, including whether it is necessary to
impose special storage requirements for safe-keeping of EPO,
considering that the drug contains no preservatives and that its
presence might entail possible risks to children in the household.
B. Other minor changes.
We also made minor changes to codify in the rules the coverage of
EPO in general and to reflect the expansion of that coverage to include
EPO used at home by home dialysis patients. (As explained in the
``Background'' section of the preamble to the interim rule, previous
coverage of EPO was implemented through general instructions issued by
HCFA, but not reflected in the rules.)
Section 410.10 We amended this section to show that EPO used at
home by home-dialysis patients is now covered as one of the services
included in ``Medical and other health services'', as defined in
section 1861(s) of the Social Security Act.
Section 410.29 We amended this section to show that EPO may be
covered as an exception to the general exclusion of drugs that may be
self-administered.
Section 410.50 We amended this section to show that medically
necessary drugs and biologicals are covered as part of institutional
dialysis services furnished in a dialysis facility. (EPO covered as a
dialysis facility service is paid as an add-on to the facility payment
rate.)
Section 410.52 We amended this section to show that EPO for use by
competent patients in the home is now included in the scope of ESRD
services furnished in the patient's home.
Section 413.170(a)(1) We amended this section to update the cross
references to the ESRD program coverage provisions in the regulations.
Section 413.170(c) We added a new paragraph (c)(6) to describe
reimbursement for EPO when it is furnished by a Medicare-approved
dialysis facility or a supplier of home dialysis equipment and
supplies.
Sections 414.300 and 414.335 We added a new paragraph (d) to
Sec. 414.300 and a new Sec. 414.335 to specify method of payment for
EPO that the beneficiary obtains directly from a supplier of home
dialysis equipment and supplies.
IV. Discussion of Comments
We received fifteen letters of comment from two nephrologists,
three renal dietitians, three nephrology nurses, two dialysis centers,
two professional associations, one home health agency, one medicare
carrier, and one law firm.
A. Patient Selection
Comment: Two commenters, both nephrologists, recommended that EPO
be given for patients with hematocrits greater than 30 percent, even up
to 35 percent. One of the commenters stated that a hematocrit of 30
percent is not normal and that in a male, for whom normal hematocrit
would be closer to 40 percent, a 30 percent reading means that the
individual is functioning at three-quarters of his or her ability to do
exercises as well as other things. That, combined with the chronic
uremic state, which all dialysis patients have, makes it much more
difficult for these patients to function in a useful manner. The
commenter believes hematocrits closer to 35 percent would make much
more sense for keeping these patients in a normal state and making them
generally much more functional. The other commenter stated that his
dialysis center is not required to justify continuation of EPO to
patients with hematocrits of up to 35 percent. Commenters asked whether
justification would be required each month or a single letter of
justification would suffice.
Response: The drug labeling for EPO recommends dosage to maintain a
patient's hematocrit in the range of 30-33 percent (target range) with
a maximum of 36 percent. It also states that the dose of EPO should be
reduced when the hematocrit reaches the target range of 30-33 percent
or increases by more than 4 points in any two-week period. Therapy with
EPO can result in an abnormal increase in red blood cells if the
hematocrit is not carefully monitored and the dose appropriately
adjusted.
We believe we are justified in requiring a hematocrit of less than
30 percent for initiation of EPO therapy at home. Thirty percent is the
low end of the target range. Medical review guidelines in the manuals
used by Medicare intermediaries and carriers provide for payment of
subsequent claims for EPO without documentation of medical necessity as
long as the hematocrit is below 36 percent. We have revised
Sec. 405.2163(g)(2) to clarify that the 30 percent hematocrit threshold
applies only to initiation of EPO therapy.
Comment: One commenter, operating a renal dialysis program in a
university hospital, pointed out that, due to the close working
relationship that exists between the renal physicians, dialysis staff
and outpatient department, a physician may order EPO for an ESRD
patient, note that order in the patient's chart, and verbally inform
the pharmacist of the order without providing a written prescription.
The commenter believes this procedure to be the norm. However, the
fiscal intermediary processing those claims will not pay for any claims
for which a written prescription is not provided. The commenter
believes this process to be burdensome, especially since the order is
documented in the patient's medical chart. The commenter also asked
whether there will be any policy affecting refillable prescriptions.
Response: We are sympathetic to the concerns expressed by the
commenter and remain sensitive to requirements that may appear to be
overly burdensome. However, we believe the intermediary is justified in
requiring a written prescription. While in the case the commenter
presented it might seem to create additional paperwork, a written
prescription protects the pharmacist as well as providing a basis for
payment by the intermediary. The intermediary or carrier has discretion
to determine whether to require documentation on refillable
prescriptions on the basis of reasonableness and necessity.
Comment: The same commenter suggested that we establish more
specific guidelines for ``regular monitoring'' of patients who self-
administer EPO, especially with regard to maximum hematocrit readings.
Two commenters recommended including guidelines similar to those in the
manufacturer's labeling. Two other commenters suggested that we include
a mechanism for monitoring patient compliance such as the completion of
a patient log.
Response: The drug labeling for EPO provides general therapeutic
guidelines with regard to the starting dose and maintenance dose, as
well as when the dose should be reduced or increased. We believe the
labeling provides adequate guidelines and that physicians should have
the flexibility to interpret those guidelines with regard to their
patients. Since drug regimens will vary depending on the individual
patient's prescribed plan of treatment, we do not wish to be overly
prescriptive with respect to specific monitoring protocols. We have,
however, revised language at Sec. 405.2163(g)(2)(iii) to require that
the physician follow the drug labeling instructions when monitoring the
EPO home therapy as well as in developing appropriate protocols. We
also agree that a patient log is a valid means to monitor compliance.
To encourage use of that mechanism or similar effective mechanisms, we
have added ``(such as a patient log)'' in Sec. 405.2137(b)(7).
Comment: One commenter asked what type of medical documentation
will be required to support payment for occasional use of EPO prior to
dialysis, required because of temporary patient weakness or a low
hematocrit reading.
Response: Medicare eligibility based on ESRD is not established
until the patient has been undergoing routine dialysis for three months
or has a kidney transplant. Thus it is unlikely that a patient
undergoing EPO therapy before dialysis would be a Medicare beneficiary.
However, if a beneficiary whose Medicare eligibility is based on age or
disability receives EPO for either of the types of anemia listed on the
drug labeling, the drug may be covered if furnished ``incident to a
physician's service''. Routine documentation requirements for this
treatment include appropriate diagnostic coding on the HCFA-1500 claim
form filed by the physician.
Comment: One commenter stated that the rule implies that home
dialysis patients have not been receiving EPO and that the need for EPO
must be evaluated for each patient. The commenter points out that many
patients have met the criteria for EPO, have been monitored monthly by
appropriate laboratory tests and frequent blood pressure checks, and
may already have been determined to have hematocrits within the target
range. The commenter recommended that we not require full evaluation of
patients who are already on EPO.
Response: We realize that a patient who is receiving EPO may have a
hematocrit within the target range of 30-33 percent. We also realize
that any patient considered for home use of EPO would be under the care
of a physician who furnishes all dialysis-related services. We assume
that, in determining whether the patient is an appropriate candidate
for home use, the physician would take into account any previous
evaluations and whether the patient is currently receiving EPO.
Nevertheless, we continue to believe that every patient must be
evaluated before being approved for home use of EPO. The physician may
base the evaluation in part on information previously obtained in the
course of monitoring dialysis, but must also evaluate other factors,
such as competence to inject the drug and capacity for proper storage
of the drug, that are not pertinent to receiving EPO in a facility or a
physician's office.
Comment: One commenter believes that home health agencies (HHAs)
should not have to adhere to the standard of ensuring that the two-
month supply limitation is met, especially in a patient's own
household. The commenter believes that such a standard could impose on
the HHA inappropriate and unwarranted liability, especially since EPO
is a drug that allegedly ``may be abused.'' The same commenter also
requested that the phrase, ``in the judgment of the home health
agency,'' be inserted after the word ``patient'' in Sec. 405.2163(g)(2)
to prevent reviewing agencies from alleging that the patient did not
have the abilities necessary to self-administer EPO.
Response: Under Sec. 405.2163 (g)(2) and (h)(3), the patient's
physician or dialysis facility (and not the supplier) is responsible
for ensuring that the patient is capable of self-administering the drug
and, through the drug prescriptions, that the amount ``on hand'' does
not exceed a 2-month supply. Accordingly, if an HHA qualifies to be a
supplier of home dialysis equipment and supplies, that HHA would not be
subject to the responsibilities that aroused the commenter's concern.
Ordinarily, HHAs would not be involved in monitoring self-
administration of EPO.
Comment: One professional association commented that the wording in
Sec. 405.2163(g)(2)(iii), that is, ``being able to adhere to a
disciplined medical regimen'', is a broad subjective statement that
lacks meaning without some measurement of nonadherence. It recommended
replacing the language with the words ``be able to meet the
requirements of an established home dialysis training program and
periodic reassessment by qualified training staff.''
Response: We agree that the cited current language lacks
specificity and have removed it. However, we did not add the suggested
language because, in this context, it is training in the self-
administration of EPO (rather than in self-dialysis as such) that is
pertinent, and that is already dealt with in paragraph (g)(3).
B. Patient Care Plan
Comment: Three commenters, all renal dietitians, questioned the
wording of the requirement to review a patient's diet and fluid
modifications to monitor adequate iron stores and hyperkalemia. All
commented that the amount of iron required during EPO therapy can
rarely be met with dietary iron, since such diets are typically iron
deficient. They noted that oral or even intravenous supplemental iron
is required and recommended that we revise the language to include the
following:
Review of diet and fluid intake for indiscretions as
reflected by hyperkalemia and elevated blood pressure secondary to
volume overload.
Review of medications for adequate provision of
supplemental iron.
Evaluation of hematocrit and measures of iron stores.
Response: We agree with these comments and have revised
Sec. 405.2137(b)(7) (i)-(iii) to include the suggested content.
C. Other Concerns
Comment: One commenter asked for clarification of the effective
date.
Response: The law (section 4201(c) of the Omnibus Budget
Reconciliation Act of 1990) that set the payment rate at $11 per 1,000
units was effective January 1, 1991. However, under section 4201(d) of
that Act, coverage of EPO self-administered at home by home dialysis
patients is effective July 1, 1991. Thus, Medicare payment is available
for services that are furnished on or after that date and that also
meet the requirements of the interim final rule published on September
4, 1991.
Comment: Two commenters felt that an initial 2-month EPO supply
might be too much since (1) patients who receive the drug from a renal
facility must be seen by their physician monthly and (2) a 2-month
supply might discourage patients from maintaining blood pressure and
hematocrit monitoring. The commenters were also concerned that the
supplier or renal facility may be requested to take back unused
portions of EPO, if the home dialysis patient received a kidney
transplant or died soon after receiving the supply. They suggested that
a smaller quantity would alleviate the beneficiary's coinsurance
responsibility.
Response: First, we note that the provision sets the 2-month
initial supply as a maximum limit, to be used when circumstances make a
2-month supply appropriate. We recognize that patients who obtain their
supplies directly must be monitored monthly, and we would expect a
physician to prescribe a lesser amount for some patients. In
Sec. 405.2163, we have added a paragraph (h) to highlight the
responsibilities of the physician and the dialysis facility. Paragraph
(h)(3) makes clear that the 2-month supply is a maximum.
Comment: One commenter stated that billing procedures instructing
an initial billing of up to a 2-month supply followed by subsequent
billings limited to a 1-month supply are inconsistent with our proposed
regulations which appear to intend that the beneficiary maintain a 2-
month supply at all times.
Response: The commenter has misinterpreted the intent of the
policy. The intent is not to require a ``minimum'' 2-month supply, but
rather to ensure that the patient has at least a 1-month supply. As
stated above, the physician may initially prescribe ``up to'' a 2-month
supply. When half of the initial 2-month supply is used, the next 1-
month supply may be ordered, and so on.
Comment: In response to our specific request for comments on
whether it is necessary to impose special storage requirements for
safe-keeping of EPO, two commenters stated that storage and home safety
issues need to be more specifically addressed and documented. They
recommended that we require, as part of the assessment, assurance that
the patient has the ability to store EPO under refrigeration, secure
from tampering and out of the reach of children.
Response: We agree with the commenters and have revised
Sec. 405.2163(g) to add the suggested language.
Comment: One commenter questioned whether HCFA will establish
regional intermediaries to process home EPO claims.
Response: EPO claims from home dialysis patients who obtain their
dialysis supplies directly from suppliers will be processed by four
regional carriers that were designated under a final rule published on
June 18, 1992 (at 57 FR 27290), and that also process claims for
durable medical equipment, prosthetics, orthotics and other items
covered under Medicare Part B.
However, claims for items furnished incident to a physician's
service as defined in 42 CFR 410.10(b) will continue to be processed
under the current carrier configuration, and regional intermediaries
will continue to process claims from facilities.
Comment: One commenter stated that at least one 8-hour day should
be allocated to train a patient in proper techniques of self-
administration. The commenter also asked whether a training fee can be
charged for this training time or whether any additional reimbursement
can be obtained since this added monitoring activity expands physician
activities under the monthly capitation plan.
Response: We agree that patients need to be properly trained in the
self-administration of EPO; however, we do not believe that we should
set a specific minimum time limit for training as suggested by the
commenter. We believe there should be sufficient flexibility to allow
for differences in individual patients' learning ability.
There is no separate payment for training or retraining in, and
monitoring of, home use of EPO. A patient should be trained to self-
administer EPO as part of the home dialysis training program that is
paid for at the home dialysis training composite rate in accordance
with Sec. 413.170 of the HCFA rules. With respect to monitoring self-
administration of EPO, we believe the additional physician's time and
effort are minimal and should be subsumed within the physician's
monthly capitation payment under Sec. 414.314 of those rules.
Comment: Two commenters asked whether reimbursement can be expected
for home supplies needed to self-administer EPO, e.g., syringe, needle,
alcohol wipes.
Response: Payment for the medical supplies needed for
administration of EPO, whether in the home or in a facility, is
included in the Medicare payment rate for EPO. Both before OBRA '90 and
since the implementation of those provisions, HCFA has always included
the cost of supplies as part of the Medicare payment for EPO. We see no
basis for different treatment of supplies for self-administration of
EPO in the home.
The payment rate for EPO is $11.00 per 1,000 units and, we believe,
is more than adequate to cover the minimal cost of supplies (less than
20 cents per administration). The manufacturer of EPO is protected from
competition for seven years by the Orphan Drug Act. The company reports
substantial profits and gives rebates to facilities depending upon
usage. It appears that facilities pay considerably less for EPO than
the Medicare rate, providing sufficient payment for supplies needed for
administration.
The source of this information is the Department's Office of the
Inspector General (OIG) study, ``Draft Report--Review of Epogen
Reimbursement'' (Audit No. A-01-92-00506). The OIG reviewed invoices
paid by dialysis facilities and financial reports filed by the
manufacturer and found that facilities generally pay nine to ten
percent less for EPO than the Medicare payment rate. In addition, the
manufacturer gave surveyed facilities end-of-year rebates ranging from
two percent to eight percent depending upon the volume of EPO used.
Comment: Two commenters expressed the hope that local physicians
will be able to continue to administer EPO incident to a physician's
service.
Response: This regulation is in no way intended to preclude
provision of EPO furnished incident to a physician's service.
Comment: One commenter was of the opinion that there is no
statutory authority for the provision in Sec. 413.170(c)(6)) requiring
suppliers to accept assignment of benefits for EPO.
Response: The statutory provisions for payment of benefits for EPO
are in section 1881(b)(1). Section 1881(b)(1)(B) of the Act provides
for payments ``to or in behalf of'' beneficiaries for home dialysis
supplies and equipment. However, with respect to payment for self-
administered EPO, section 1881(b)(1)(C) permits payment only to a
supplier of home dialysis supplies and equipment that is not a provider
of services, a renal dialysis facility, or a physician. There is no
authority in the law to pay this benefit to a beneficiary. Therefore,
the law implicitly requires payment to a supplier under assignment.
Furthermore, any other reading of the statute would have anomalous
results. For example, if the statute did not require suppliers to
accept assignment, the beneficiary would be protected for charges for
home dialysis supplies and equipment, but not for EPO furnished
directly by the supplier. Nothing in the legislative history suggests
the Congress intended such a result.
V. Specific Changes to the Interim Final Rule.
In response to the comments discussed above, we have made the
following changes in the text of the interim final rule published on
September 4, 1991.
1. Patient care plan.
We have revised Sec. 405.2137(b)(7) to establish separate
requirements for review of medication and evaluation of hematocrit for
iron stores and to suggest use of a patient log for keeping the
physician informed of the results of blood tests.
2. Patient selection.
We have revised Sec. 405.2163 to--
Require that the physician follow the drug labeling when
he or she establishes the protocol and monitors home use of EPO;
Include as an assessment requirement obtaining assurance
that EPO can be stored under refrigeration, secure from tampering and
out of reach of children in the patient's residence.
Add a paragraph (h) to highlight the responsibilities of
the physician and the dialysis facility and to make clear that the
``two-month'' supply of EPO is a maximum and that control of the amount
``on hand'' is maintained through the physician's prescriptions.
B. Technical amendments.
1. Throughout the text ``Erythropoietin'' is changed to
``Epoetin'', which is the generic name of the drug.
2. In Sec. 413.170(c)(6), the cross-reference is corrected.
VI. Regulatory Impact Statement
A. Executive Order 12866
Executive Order 12866 (E.O. 12866) requires us to prepare an
analysis for any document that meets one of the E.O. 12866 criteria for
a ``significant regulatory action''; that is, that may--
Have an annual effect on the economy of $100 million or
more or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
Create a serious inconsistency or otherwise interfere with
an action taken or planned by another agency;
Materially alter the budgetary impact of entitlements,
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or
Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
E.O. 12866.
In the proposed rule, we determined that a regulatory impact
analysis was not required for these rules because they would not have
an annual impact of $100 million or more or meet any of the other
threshold criteria. However, we indicated our intention to include in
the final rule a cost and benefit analysis that considers the social
benefits to Medicare beneficiaries who use EPO at home. We asked for
specific comments concerning benefits from home administration of EPO.
We listed, as examples of these benefits, savings in travel and
transportation costs previously required to obtain EPO or the ability
of the beneficiary to resume employment. We also requested public
comment on any benefits and costs that may be anticipated as a result
of this regulation.
No comments were received concerning the benefits of self-
administration of EPO or on any portion of the impact analysis. Thus,
we have prepared an analysis based on our review of data available to
us and of pertinent literature.
The following chart summarizes home dialysis beneficiary records
for the period February 28, 1991 through February 29, 1992. It reflects
the most current data on file and also encompasses the time immediately
before and after July 1, 1991, the effective data of coverage of home
administration of EPO. We identified, as ESRD beneficiaries who are
potentially eligible for home use of EPO, beneficiaries who have
completed the necessary home dialysis training or were home dialysis
patients during this period. The chart indicates the number of
beneficiaries on home dialysis and the number receiving EPO therapy as
of June 30, 1991. The same information is shown for the billing period
November 1, 1991 through January 31, 1992, the most current billing
information for home dialysis beneficiaries.
Home Dialysis Beneficiaries
[February 28, 1991-February 29, 1992]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Dialysis
Beneficiaries Self-Adm.* Fac/Phy.** Not Receiv'g EPO
--------------------------------------------------------------------------------------------------------------------------------------------------------
As of 6/30/91....................................... 38,515 12,733 25,782
Billing Period 11/1/91-1/31/92...................... 38,515 1,656 11,890 24,969
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Self-Adm. stands for self-administered.
**Fac/Phy. stands for facility or physician administered.
Our records indicate that as of June 30, 1991 there were 38,515
beneficiaries that dialyzed at home. Before coverage of home
administration of EPO, 12,733 of these beneficiaries received EPO in
the ESRD facility or in a physician's office. As a result of coverage
of home administration of EPO, 1,656 beneficiaries or 4.3 percent of
home dialysis beneficiaries self-administer EPO. We estimate that this
number will increase as more beneficiaries become qualified to self-
administer EPO and realize the benefits of home administration.
In attempting to perform a cost-benefit analysis, we reviewed three
published reports and one unpublished report. We also relied upon
billing information submitted by intermediaries. Average expenditure
for ESRD beneficiaries receiving EPO therapy approximate $6,900
exclusive of dialysis treatment. This amount includes the cost of the
drug and other services such as iron treatment and hypertension
therapy. The average annual cost for patients not using EPO
approximates $450, exclusive of dialysis treatments, and includes the
cost of other services such as blood transfusions and hepatitis
therapy. The annual expenditures for EPO users represent very gross
estimates. More definitive cost data and experience with the
administration of EPO is needed in order to permit analysis of actual
costs and EPO's relative effects.
As mentioned earlier in this preamble, use of EPO by chronic renal
failure patients reduces or eliminates the need for blood transfusions.
EPO also reduces the recipients' risk of transfusion-related illnesses.
The transmission of non-A, non-B hepatitis is of greatest concern (see
``Recombinant Human Erythropoietin: Factors to Consider in Cost-Benefit
Analysis'', American Journal of Kidney Diseases, Vol. XVII, No. 1,
January 1991). Although rare, the threat of acquired immunodeficiency
syndrome (AIDS) and hepatitis B should also be considered. For ESRD
patients receiving EPO, the risk of hepatitis infection related to
transfusions has been reduced from 13.8 to 4.5 percent because the
patient's need for blood transfusions has been reduced and in some
cases eliminated.
Reducing the need for transfusions also increases kidney transplant
success in chronic renal failure patients by reducing sensitization.
According to the above cited article, some individuals receiving
frequent transfusions may develop cytotoxic antibodies. Excessive
cytotoxity levels may result in increased waiting time for suitable
organs. Also, when high cytotoxity levels are present, graft survival
rates are reduced. When EPO is used, thus reducing or eliminating the
need for transfusions, patients are more likely to retain transplanted
organs successfully.
There are other potential benefits associated with the use of EPO.
Since EPO stimulates the production of red blood cells thereby reducing
or eliminating anemia, the need for hospitalization due to anemia or
anemia-related illnesses could be expected to decline.
Another very important though not quantifiable benefit of receiving
EPO is improved quality of life. An article appearing in The Journal of
the American Medical Association (JAMA) (The Quality of Life of
Hemodialysis Recipients Treated with Recombinant Human Erythropoietin,
Vol. 263, No. 6, February 9, 1990) reported on the results of a study
of over 300 hemodialysis patients in nine dialysis centers. The study
showed that hemodialysis patients receiving EPO are happier--their
energy levels are higher, physical functioning is improved, physical
activity levels are increased, etc. Similar results were also reported
in the American Journal of Kidney Diseases article mentioned earlier in
this impact statement. Although these studies did not specifically
study home dialysis patients, we believe that results would be equally
true for this group.
In reviewing the literature on EPO, we also found that most EPO
recipients require additional medications or therapies to counteract
possible adverse effects. Some of the possible side effects of EPO
therapy are iron depletion, hypertension, and arteriovenous graft
clotting.
Iron Depletion--EPO recipients may not get the full benefit of
increased hematocrits from EPO if they lack sufficient iron reserves.
EPO increases the body's production of red blood cells. This requires
sufficient iron reserves. Consequently, patients on EPO may become iron
deficient. Their iron reserves must be monitored and iron supplements
administered to ensure that the patient's iron reserves are not
depleted.
Hypertension--Use of EPO may elevate a patient's blood pressure, a
reaction that may be related to the rate of increase in hematocrit.
Therefore, an EPO patient's blood pressure must be carefully monitored.
Thirty percent of all EPO patients receive hypertension therapy.
Arteriovenous (AV) Graft Clotting--Fourteen percent of all EPO
patients experience clotting of AV graft as compared to 6 percent of
chronic renal patients not receiving EPO. The cause of the AV clotting
is believed due to increased hematocrit.
The foregoing benefits and adverse effects of using EPO are the
same for patients who receive the drug in a physician's office or ESRD
facility as for patients who self-administer the drug. Those
beneficiaries who received EPO in a physician's office or ESRD facility
and, as a result of this regulation, shift to self-administration will
realize further benefits, such as savings of time and in transportation
costs. In order to receive the full benefit of EPO therapy, most
patients receive it at least three times a week. Therefore, we estimate
that the savings in transportation costs will average approximately
$300 per beneficiary for calendar year 1992. Of course, this estimate
is only an average; the actual saving will vary depending on distance
traveled to and from the ESRD facility or physician's office by a
particular beneficiary.
Since EPO is a relatively new drug, definitive information on its
large scale effectiveness, direct costs, savings, etc., is not
available. Literature supports the view that ESRD beneficiaries
receiving EPO experience an improved quality of life, resulting in
higher energy levels and improved physical functioning. For those
beneficiaries who did receive EPO in a physician's office or ESRD
facility and meet the criteria for self-administration, the change to
self-administration will save time and eliminate travel expenses
associated with office and facility visits. We expect that over time
more home dialysis beneficiaries who did not receive EPO or received a
reduced dosage because they were unable to travel to the physician's
office or ESRD facility as often as needed will become candidates for
self-administration of EPO. We do not have data on which to base a
prediction of the number who will choose this form of administration.
Obviously, each beneficiary's physician will need to consider potential
adverse as well as beneficial effects.
B. Regulatory Flexibility Act
We generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 602
through 612) unless the Secretary certifies that a final rule will not
have a significant economic impact on a substantial number of small
entities. For purposes of the RFA, individuals are not considered to be
small entities.
Also, section 1102(b) of the Act requires the Secretary to prepare
a regulatory impact analysis if a final rule may have a significant
impact on the operations of a substantial number of small rural
hospitals. This analysis must conform to the provisions of section 604
of the RFA. For purposes of section 1102(b) of the Act, we define a
small rural hospital as a hospital that is located outside of a
Metropolitan Statistical Area and has fewer than 50 beds.
We are not preparing analyses for either the RFA or section 1102(b)
of the Act since we have determined, and the Secretary certifies, that
this rule will not have a significant economic impact on a substantial
number of small entities and will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Paperwork Reduction Act
Section 405.2137 of this rule contains information collection
requirements that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1980. When OMB
approves these provisions, we will publish a Federal Register notice to
that effect. If you comment on the information collection requirements,
please send a copy of those comments directly to: Office of Information
and Regulatory Affairs, Office of Management and Budget, room 3002, New
Executive Office Building, Washington, DC 20503, Attention: Allison
Herron Eydt, Desk Officer for HCFA.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney disease, Laboratories, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 410
Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Rural areas, X-rays.
42 CFR Part 413
Health facilities, Kidney diseases, Medicare, Puerto Rico,
Reporting and recordkeeping requirements.
42 CFR Part 414
End-stage renal (ESRD), Health professions, Laboratories, Medicare.
42 CFR CHAPTER IV HEALTH CARE FINANCING ADMINISTRATION, DEPARTMENT OF
HEALTH AND HUMAN SERVICES
The interim rule with comment period that was published on
September 4, 1991, at 56 FR 43706, to amend Parts 405, 410, 413, and
414 of this chapter is adopted as final with the changes set forth
below.
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart U--Conditions for Coverage of Suppliers of End-Stage Renal
Disease (ESRD) Services
1. The authority citation for subpart U continues to read as
follows:
Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, and 1881 of
the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh,
1395kk, and 1395rr), unless otherwise noted.
2. Section 405.2137 is amended to revise paragraph (b)(7), to read
as follows:
Sec. 405.2137 Condition: Patient long-term program and patient care
plan.
* * * * *
(b) Standard: Patient care plan. * * *
(7) For a home dialysis patient who uses EPO in the home, the plan
must provide for monitoring home use of EPO that includes the
following:
(i) Review of diet and fluid intake for indiscretions as indicated
by hyperkalemia and elevated blood pressure secondary to volume
overload.
(ii) Review of medications to ensure adequate provision of
supplemental iron.
(iii) Ongoing evaluations of hematocrit and iron stores.
(iv) A reevaluation of the dialysis prescription taking into
account the patient's increased appetite and red blood cell volume.
(v) A method for physician followup on blood tests and a mechanism
(such as a patient log) for keeping the physician informed of the
results.
(vi) Training of the patient to identify the signs and symptoms of
hypotension and hypertension.
(vii) The decrease or discontinuance of EPO if hypertension is
uncontrollable.
3. Section 405.2163 is amended to revise paragraph (g) and add a
new paragraph (h), to read as follows:
Sec. 405.2163 Condition: Minimal service requirements for a renal
dialysis facility or renal dialysis center.
* * * * *
(g) Use of EPO at home: Patient selection. The dialysis facility,
or the physician responsible for all dialysis-related services
furnished to the patient, must make a comprehensive assessment that
includes the following:
(1) Pre-selection monitoring. The patient's hematocrit (or
hemoglobin), serum iron, transferrin saturation, serum ferritin, and
blood pressure must be measured.
(2) Conditions the patient must meet. The assessment must find that
the patient meets the following conditions:
(i) Is a home dialysis patient.
(ii) Has a hematocrit (or comparable hemoglobin level) that is as
follows:
(A) For a patient who is initiating EPO treatment, no higher than
30 percent unless there is medical documentation showing the need for
EPO despite a hematocrit (or comparable hemoglobin level) higher than
30 percent. (Patients with severe angina, severe pulmonary distress, or
severe hypertension may require EPO to prevent adverse symptoms even if
they have higher hematocrit or hemoglobin levels.)
(B) For a patient who has been receiving EPO from the facility or
the physician, between 30 and 33 percent.
(iii) Is under the care of--
(A) A physician who is responsible for all dialysis-related
services and who prescribes the EPO and follows the drug labeling
instructions when monitoring the EPO home therapy; and
(B) A renal dialysis facility that establishes the plan of care and
monitors the progress of the home EPO therapy.
(3) Conditions the patient or the patient's caregiver must meet.
The assessment must find that the patient or a caregiver who assists
the patient in performing self-dialysis meets the following conditions:
(i) Is trained by the facility to inject EPO and is capable of
carrying out the procedure.
(ii) Is capable of reading and understanding the drug labeling.
(iii) Is trained in, and capable of observing, aseptic techniques.
(4) Care and storage of drug. The assessment must find that EPO can
be stored in the patient's residence under refrigeration and that the
patient is aware of the potential hazard of a child's having access to
the drug and syringes.
(h) Use of EPO at home: Responsibilities of the physician or the
dialysis facility. The patient's physician or dialysis facility must--
(1) Develop a protocol that follows the drug label instructions;
(2) Make the protocol available to the patient to ensure safe and
effective home use of EPO; and
(3) Through the amounts prescribed, ensure that the drug ``on
hand'' at any time does not exceed a 2-month supply.
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
1. The authority citation for part 410 continues to read as
follows:
Authority: Secs. 1102, 1832, 1833, 1835, 1861 (r), (s), and
(cc), 1871, and 1881 of the Social Security Act. (42 U.S.C. 1302,
1395k, 1395l, 1395n, 1395x (r), (s), and (cc), 1395hh, and 1395rr).
2. Nomenclature change.
In Secs. 410.10(k), 410.50(d), and 410.52(a)(4), ``erythropoietin''
is revised to read ``epoetin''.
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT
1. The authority citation for part 413 is revised to read as
follows:
Authority: Secs. 1102, 1122, 1814(b), 1815, 1833(a), 1861(v),
1871, 1881, 1883, and 1886 of the Social Security Act (42 U.S.C.
1302, 1320a-1, 1395f(b), 1395g, 1395l(a), 1395x(v), 1395hh, 1395rr,
1395tt, and 1395ww).
Sec. 413.170 [Amended]
2. In Sec. 413.170(c)(6), ``Erythropoietin'' is revised to read
``Epoetin'', and ``Sec. 413.170(c)(5)(iii)'' is revised to read
``paragraph (c)(6)(iii) of this section.''
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
1. The authority citation for part 414 continues to read as
follows:
Authority: Secs. 1102, 1833(a), 1871, and 1881 of the Social
Security Act (42 U.S.C. 1302, 1395l(a), 1395hh, and 1395rr).
Sec. 414.300 [Amended]
2. In Sec. 414.300(d), ``Erythropoietin'' is revised to read
``Epoetin''.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: September 23, 1993.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Approved: October 13, 1993.
Donna E. Shalala,
Secretary.
[FR Doc. 94-480 Filed 1-7-94; 8:45 am]
BILLING CODE 4120-01-P
Complete official Federal Register PDF
FR Doc. 94-448 Tobacco; Importer Assessments: Effective Date
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Page 1274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-448]
[[Page Unknown]]
[Federal Register: January 10, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Commodity Credit Corporation
7 CFR Part 1464
RIN 0560-AD53
Tobacco; Importer Assessments: Effective Date
AGENCY: Commodity Credit Corporation, USDA.
ACTION: Correction; interim rule; effective date.
-----------------------------------------------------------------------
SUMMARY: This document contains a correction to the interim rule
concerning tobacco importer assessments, which was published on
Thursday, December 23, 1993, at 58 FR 68017. The effective date was
inadvertently omitted from the interim rule. This document establishes
an effective date of January 1, 1994, for the interim rule.
EFFECTIVE DATE: The effective date for the interim rule published at 58
FR 68017 is January 1, 1994.
FOR FURTHER INFORMATION CONTACT: Gary W. Wheeler, Tobacco Marketing
Specialist, Tobacco and Peanuts Division, Agricultural Stabilization
and Conservation Service, United States Department of Agriculture, P.O.
Box 2415, Washington, DC 20013-0215, telephone 202-720-7562.
Signed in Washington, DC, on January 4, 1994.
Grant Buntrock,
Executive Vice President, Commodity Credit Corporation.
[FR Doc. 94-448 Filed 1-7-94; 8:45 am]
BILLING CODE 3410-05-P
Complete official Federal Register PDF
FR Doc. 94-447 Defense Federal Acquisition Regulation Supplement; North American Free Trade Agreement Implementation Act
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1288-1292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-447]
[[Page Unknown]]
[Federal Register: January 10, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
48 CFR Parts 225 and 252
Defense Federal Acquisition Regulation Supplement; North American
Free Trade Agreement Implementation Act
AGENCY: Department of Defense (DoD).
ACTION: Interim rule with request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Director of Defense Procurement is issuing an interim rule
amending the Defense Federal Acquisition Regulation Supplement (DFARS)
to integrate Buy American Act and Balance of Payments Program waivers
necessitated by the North American Free Trade Agreement Implementation
Act with similar existing Department of Defense waivers for countries
with memoranda of understanding or other international agreements.
DATES: Effective Date: January 1, 1994. This rule applies to
solicitations issued on or after January 1, 1994.
Comment Date: Comments on the interim DFARS rule should be
submitted in writing to the address shown below on or before February
9, 1994, to be considered in the formulation of a final rule. Please
cite DFARS Case 93-D310 in all correspondence related to this issue.
ADDRESSES: Interested parties should submit written comments to The
Defense Acquisition Regulations Council, ATTN: Mrs. Alyce Sullivan,
OUSD (A&T)DP(DAR), IMD 3D139, 3062 Defense Pentagon, Washington, DC
20301-3062. Telefax number (703) 697-9845.
FOR FURTHER INFORMATION CONTACT: Mrs. Alyce Sullivan, (703) 697-7266.
SUPPLEMENTARY INFORMATION:
A. Background
Chapter Ten of the North American Free Trade Agreement (NAFTA)
Implementation Act of 1993 requires the United States, Canada, and
Mexico to eliminate ``buy national'' restrictions on non-defense
related purchases by the federal governments. NAFTA is being
implemented in the Federal Acquisition Regulation but also requires
revision of the DFARS to integrate Buy American Act and Balance of
Payments Program waivers necessitated by NAFTA with similar existing
Department of Defense waivers for countries with memoranda of
understanding or other international agreements.
B. Regulatory Flexibility Act
The interim rule may have a significant economic impact on a
substantial number of small entities within the meaning of the
Regulatory Flexibility Act, 5 U.S.C. 601 et seq., because the rule
waives the Buy American Act for certain Mexican and Canadian products.
An Initial Regulatory Flexibility Analysis (IRFA) has been prepared and
will be provided to the Chief Counsel for Advocacy for the Small
Business Administration. Comments are invited. Comments from small
entities concerning the affected DFARS subpart will be considered in
accordance with 5 U.S.C. 610. Such comments must be submitted
separately and cite DFARS Case 93-610 in correspondence.
C. Paperwork Reduction Act
The Paperwork Reduction Act applies because the provisions at
252.225-7006, Buy American Act-Trade Agreements-Balance of Payments
Program Certificate, and 252.225-7035, Buy American Act-North American
Free Trade Agreement Implementation Act-Balance of Payments Program
Certificate, require offerors to list the line item number and country
of origin for any end product other than a domestic end product.
Accordingly, a request for clearance of a new information collection
requirement concerning the North American Free Trade Agreement Act is
being submitted to the Office of Management and Budget under 44 U.S.C.
3501, et seq.
D. Determination To Issue an Interim Rule
A determination has been made under the authority of the Secretary
of Defense to issue this rule as an interim rule. Urgent and compelling
reasons exist to promulgate this rule before affording the public an
opportunity to comment. This action is necessary because the North
American Free Trade Agreement Implementation Act, signed into law on
December 8, 1993, becomes effective on January 1, 1994. However,
pursuant to Public Law 98-577 and Federal Acquisition Regulation 1.501,
public comments received in response to this interim rule will be
considered in formulating the final rule.
List of Subjects in 48 CFR Parts 225 and 252
Government procurement.
Claudia L. Naugle,
Executive Editor, Defense Acquisition Regulations Council.
Therefore, 48 CFR parts 225 and 252 are amended as follows:
1. The authority citation for 48 CFR parts 225 and 252 continues to
read as follows:
Authority: 41 U.S.C. 421 and FAR subpart 1.3.
PART 225--FOREIGN ACQUISITION
2. Section 225.000-70 is amended by revising paragraph (m) to read
as follows:
225.000-70 Definitions.
As used in this part--
* * * * *
(m) U.S. made end product is defined in the clause at 252.225-7007,
Trade Agreements.
3. Section 225.000-71 is amended by revising paragraphs (a)(2) and
(c)(1) to read as follows:
225.000-71 General guidelines.
* * * * *
(a) Statutory or policy restrictions.
* * * * *
(2) Where an exception to or waiver of a restriction would result
in award of a foreign end product, apply the policies and procedures of
the Buy American Act or the Balance of Payments Program, and, if
applicable, the trade agreements.
* * * * *
(c) Trade agreements. (1) Determine whether the product is covered
by the Trade Agreements Act or the North American Free Trade Agreement
Implementation Act (see subpart 225.4).
* * * * *
4. Section 225.105 (3) and (5)(ii)(A) are revised to read as
follows:
225.105 Evaluating offers.
* * * * *
(3) Treat offers of eligible products under acquisitions subject to
the Trade Agreements Act or NAFTA as if they were qualifying country
offers. (See Example 4 of Table 25-1, Evaluation.)
* * * * *
(5) * * *
(ii) * * *
(A) ``U.S. made end product'' under trade agreements;
* * * * *
5. Section 225.109(a) is revised to read as follows:
225.109 Solicitation provisions and contract clauses.
(a) Use the provision at 252.225-7000, Buy American Act--Balance of
Payments Program Certificate, instead of the provisions at FAR 52.225-
1, Buy American Certificate, and FAR 52.225-6, Balance of Payments
Program Certificate. Use the provision in any solicitation which
includes the clause at 252.225-7001, Buy American Act and Balance of
Payments Program, unless the solicitation includes either the clause at
252.225-7007, Trade Agreements Act, or the clause at 252.225-7036,
North American Free Trade Agreements Implementation Act.
* * * * *
6. Section 225.401 is revised to read as follows:
225.401 Definitions.
Eligible product means, instead of the definition at FAR 25.401, a
designated, NAFTA, or Caribbean Basin country end product in the
categories listed in 225.403.70.
7. Section 225.402 is amended by revising paragraphs (c) (i) and
(ii) to read as follows:
225.402 Policy.
* * * * *
(c)(i) Except as provided in paragraph (c)(ii) of this section, do
not purchase nondesignated country end products subject to the Trade
Agreements Act unless they are NAFTA, Caribbean Basin or qualifying
country end products (see 225.872-1).
(ii) National interest waivers under section 302(b)(2) of the Trade
Agreements Act are approved on a case-by-case basis. Except as
delegated in paragraphs (c)(ii) (A), (B), and (C) of this section, a
request for a national interest waiver shall include supporting
rationale and be submitted under department/agency procedures to the
Director of Defense Procurement.
* * * * *
8. Section 225.403-70 is amended by revising the introductory
paragraph and by removing Federal Supply Group (FSG) 52, and the
Category/Description of Measuring tools, to read as follows:
225.403-70 Products subject to trade agreement acts.
Foreign end products subject to the Trade Agreements Act and NAFTA
are those in the following Federal supply groups (FSG). If a product is
not in one of the listed groups, the Trade Agreements Act and NAFTA do
not apply. As noted in FAR 25.401, Caribbean Basin country end products
are limited to those end products which are eligible for duty-free
treatment under 19 U.S.C. 2703(b). The list of products has been
annotated to indicate those products which, due to this limitation, are
eligible for designated and NAFTA countries, but are not presently
eligible for Caribbean Basin countries.
* * * * *
225.407 [Amended]
9. Section 225.407 is redesignated as 225.408; paragraphs (a)(1)
and (a)(2)(A) of newly designated section 225.408 are amended by
removing the word ``Act'' wherever it appears after ``Trade
Agreements''; and new paragraphs (a) (3) and (4) are added, to read as
follows:
225.408 Solicitation provision and contract clause.
(a) * * *
(3) Use the provision at 252.225-7035, Buy American Act--North
American Free Trade Agreement Implementation Act--Balance of Payments
Program Certificate, instead of the provision at FAR 52.225-20, Buy
American Act--North American Free Trade Agreement Implementation Act--
Balance of Payments Program Certificate, in all solicitations that
include the clause at 252.225-7036, North American Free Trade Agreement
Implementation Act.
(4) (A) Use the clause at 252.225-7036, North American Free Trade
Agreement Implementation Act, instead of the clause at FAR 52.225-21,
Buy American Act--North American Free Trade Agreement Implementation
Act--Balance of Payments Program. The clause need not be used where
purchase from foreign sources is restricted (see 225.403(d)(1)(B)). The
clause may be used where the contracting officer anticipates a waiver
of the restriction.
(B) Use the clause in all solicitations and contracts for the items
listed at 225.403-70, when the estimated value is $50,000 or more and
the Trade Agreements Act does not apply. Include the clause in
solicitations for multiple line items if any line item is subject to
NAFTA.
(C) Application of the procedures in 225.402(a) and the acquisition
of noneligible and eligible products under the same solicitation may
result in the application of the North American Free Trade Agreement
Implementation Act to only some of the items solicited. In such case,
indicate in the schedule those items covered by the Act.
10. Section 225.602(3)(ii) is revised to read as follows:
Subpart 225.6--Customs and Duties
225.602 Policy.
* * * * *
(3) * * *
(ii) Eligible products (end products but not components) on defense
contracts subject to the Trade Agreements Act or NAFTA; and
* * * * *
11. Section 225.603 is amended to add new paragraph (1)(ii)(C), and
to revise paragraph (1)(iii)(C)(3) to read as follows:
225.603 Procedures.
* * * * *
(1) * * *
(ii) * * *
(C) 252.225-7037, Duty-Free Entry--NAFTA Country End Products and
Supplies; or
* * * * *
(iii) * * *
(C) * * *
(3) Such acquisition abroad is authorized by the terms of the
contract, the subcontract, or by the contracting officer. In any case,
follow the procedures required by the clauses in FAR 52.225-10, Duty-
Free Entry, and 252.225-7009, Duty-Free Entry--Qualifying Country End
Products and Supples, and 252.225-7037, Duty-Free Entry--NAFTA Country
End Products and Supplies, to the extent practicable.
* * * * *
12. Section 225.605-70 is amended by redesignating paragraph (c) as
paragraph (d), and adding new paragraph (c) to read as follows:
225.605-70 Additional solicitation provisions and contract clauses.
* * * * *
(c) Use the clause at 252.225-7037, Duty-Free Entry--NAFTA Country
End Products and Supplies, in all solicitations and contracts for
supplies and services when the clause at FAR 52.225-10, Duty-Free
Entry, is not used and NAFTA applies (see 225.403-70).
* * * * *
PART 252--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
13. Section 252.225-7001 is amended by revising the clause heading
and paragraph (c) to read as follows:
252.225-7001 Buy American Act and Balance of Payments Program.
As prescribed in 225.109(d), use the following clause:
Buy American Act and Balance of Payments Program (January 1994)
* * * * *
(c) The Contractor agrees that it will deliver only domestic end
products unless, in its offer, it specified delivery of other end
products in the Buy American Act and Balance of Payments Certificate
or the Buy American Act--Trade Agreements--Balance of Payments
Program Certificate. An offer certifying that a qualifying country
end product will be supplied requires the Contractor to deliver a
qualifying country end product or a domestic end product.
* * * * *
(End of clause)
14. Section 252.225-7006 is amended by revising the section
heading, the clause title, and paragraph (a); paragraph (b) is revised;
paragraph (c)(2)(v) is redesignated as paragraph (vi) and reprinted for
the convenience of the reader; and a new paragraph (c)(2)(v) is added,
to read as follows:
252.225-7006 Buy American Act--Trade Agreements--Balance of Payments
Program Certificate.
As prescribed in 225.408(a)(1), use the following provision:
Buy American Act--Trade Agreements--Balance of Payments Program
Certificate (Jan. 1994)
(a) Definitions.
Caribbean Basin country end product, designated country end
product, domestic end product, NAFTA country end product,
nondesignated country end product, qualifying country end product,
and U.S. made end product have the meanings given in the Trade
Agreements or Buy American Act and Balance of Payments Program
clauses of this solicitation.
(b) Evaluation.
Offers will be evaluated by giving preference to U.S. made end
products, qualifying country end products, designated country end
products, NAFTA country end products, and Caribbean Basin country
end products over other end products.
(c) Certifications. * * *
(v) The Offeror certifies that the following supplies qualify as
NAFTA country end products: (insert line item number) (insert
country of origin).
(vi) The Offeror certifies that the following supplies are other
nondesignated country end products. (insert line item number)
(insert country of origin). (End of provision)
15. Section 252.225-7007 is amended by revising the section heading
and clause title; to revise the introductory language; to redesignate
current paragraphs (a)(5), (6), and (7) as (a)(7), (8), and (9)
respectively and add new paragraphs (a)(5) and (6); to revise newly
designated paragraph (a)(9)(ii); and to revise paragraphs (b), (c), and
(d), to read as follows:
252.225-7007 Trade Agreements.
As prescribed in 225.408(a)(2), use the following clause:
Trade Agreements (Jan. 1994)
(a) * * *
(5) NAFTA country end product means an article that--
(i) Is wholly the growth, product, or manufacture of the NAFTA
country; or
(ii) Has, in the case of an article which consists in whole or
in part of materials from another country or instrumentality, been
substantially transformed in a NAFTA country into a new and
different article of commerce with a name, character, or use
distinct from that of the article or articles from which it was so
transformed. The term includes services (except transportation
services) incidental to its supply, provided that the value of those
incidental services does not exceed the value of the product itself.
It does not include service contracts as such.
(6) North American Free Trade Agreement (NAFTA) country means
Canada or Mexico.
* * * * *
(9) * * *
* * * * *
(ii) In the case of an article which consists in whole or in
part of materials from another country or instrumentality, has been
substantially transformed in the United States into a new and
distinct article of commerce with a name, character, or use distinct
from that of the article or articles from which it was so
transformed.
(b) This clause implements the Trade Agreements Act of 1979 (19
U.S.C. 2501 et seq.), the North American Free Trade Agreement
Implementation Act of 1993, and the Caribbean Basin Initiative by
providing a preference for U.S. made end products and designated
country end products over nondesignated country end products, except
nondesignated country end products which are qualifying country end
products, NAFTA country end products, or Caribbean Basin end
products.
(c) The Contractor agrees to deliver under this contract only
U.S. made end products unless, in its offer, it specified delivery
of qualifying country, NAFTA country, or nondesignated country end
products in the Buy American Act--Trade Agreements--Balance of
Payments Program Certificate provision.
(1) Offerors may not supply a nondesignated country end product
unless it is a qualifying country end product, NAFTA country end
product, or Caribbean Basin country end product, or a national
interest waiver has been granted under section 302 of the Trade
Agreements Act of 1979 (see FAR 25.402(c)).
(2) An offer certifying that a qualifying country end product, a
designated country end product, a NAFTA country end product, or a
Caribbean Basin country end product will be supplied, requires the
Contractor to supply a qualifying country end product, a designated
country end product, a NAFTA country end product, or a Caribbean
Basin country end product, whichever is certified, or, at the
Contractor's option, a U.S. made end product.
(d) The offered price of end products listed and certified under
paragraphs (c)(2)(i) and (vi) of the Buy American Act--Trade
Agreements--Balance of Payments Program Certificate provision of the
solicitation must include all applicable duty. The offered price of
qualifying country end products, designated country end products,
NAFTA country end products, and Caribbean Basin country end products
for line items subject to the Trade Agreements Act or the North
American Free Trade Agreement Implementation Act, should not include
customer fees or duty. (End of clause)
16. Section 252.225-7010 is amended by revising the introductory
text to read as follows:
252.225-7010 Duty Free Entry--Additional Provisions.
As prescribed in 225.605-70(d), use the following clause:
* * * * *
17. A new section 252.225-7035 is added to read as follows:
252.225-7035 Buy American Act--North American Free Trade Agreement
Implementation Act--Balance of Payments Program Certificate.
As prescribed in 225.408(a)(3), use the following provision:
Buy American Act--North American Free Trade Agreement Implementation
Act--Balance of Payments Program Certificate (Jan. 1994)
(a) Definitions.
Domestic end product, qualifying country end product, and U.S.
made end product have the meanings given in the North American Free
Trade Agreement Implementation Act or Buy American Act and Balance
of Payments Program clauses of this solicitation.
(b) Evaluation.
Offers will be evaluated by giving preference to U.S. made end
products, qualifying country end products, or NAFTA country end
products over other end products.
(c) Certifications.
(1) The Offeror certifies that--
(i) Each end product, except the end products listed in
paragraph (c)(2) of this provision, is a domestic end product (as
defined in the Buy American Act and Balance of Payments Program
clause of this solicitation); and
(ii) Components of unknown origin are considered to have been
mined, produced, or manufactured outside the United States or a
qualifying country.
(2) The Offeror must identify and certify all end products that
are not domestic end products.
(i) The Offeror certifies that the following supplies qualify as
``U.S. made end products'' but do not meet the definition of
``domestic end product'': (insert line item number).
(ii) The Offeror certifies that the following supplies are
qualifying country end products: (insert line item number) (insert
country of origin).
(iii) The Offeror certifies that the following supplies qualify
as NAFTA country end products: (insert line item number (insert
country of origin).
(iv) The Offeror certifies that the following supplies are other
non-NAFTA country end products: (insert line item number) (insert
country of origin). (End of provision)
18. A new section 252.225-7036 is added to read as follows:
252.225-7036 North American Free Trade Agreement Implementation Act.
As prescribed in 225.408(a)(4), use the following clause:
North American Free Trade Agreement Implementation Act (Jan. 1994)
(a) Definitions.
(1) Components, domestic end product, end product, nonqualifying
country, qualifying country, and qualifying country end product have
the meanings given in the Buy American Act and Balance of Payments
Program clause of this contract.
(2) North American Free Trade Agreement (NAFTA) country means
Canada or Mexico.
(3) NAFTA country end product means an article that--
(i) Is wholly the growth, product, or manufacture of a NAFTA
country; or
(ii) Has, in the case of an article which consists in whole or
in part of materials from another country or instrumentality, been
substantially transformed in a NAFTA country into a new and
different article of commerce with a name, character, or use
distinct from that of the article or articles from which it was so
transformed. The term includes services (except transportation
services) incidental to its supply, provided that the value of those
incidental services does not exceed the value of the product itself.
It does not include service contracts as such.
(4) Non-NAFTA country end product means any end product which is
not a U.S. made end product or a NAFTA country end product.
(5) United States means the United States, its designated
possessions, Puerto Rico, and any other place subject to its
jurisdiction, but does not include leased bases or trust
territories.
(6) U.S. made end product means an article which is--
(i) Wholly the growth, product or manufacture of the United
States, or
(ii) In the case of an article which consists in whole or in
part of materials from another country or instrumentality, has been
substantially transformed in the United States into a new and
distinct article of commerce with a name, character, or use distinct
from that of the article or articles from which it was so
transformed.
(b) This clause implements the North American Free Trade
Agreement Implementation Act of 1993 by providing a preference for
U.S. made end products and NAFTA country end products over non-NAFTA
country end products, except non-NAFTA country end products which
are qualifying country end products.
(c) The Contractor agrees to deliver under this contract only
U.S. made end products unless, in its offer, it specified delivery
of qualifying country, NAFTA country, or non-NAFTA country end
products in the Buy American Act--North American Free Trade
Agreement Implementation Act--Balance of Payments Program
Certificate provision. An offer certifying that a qualifying country
end product or a NAFTA country end product will be supplied requires
the Contractor to supply a qualifying country end product or a NAFTA
country end product, whichever is certified, or, at the Contractor's
option, a U.S. made end produce.
(d) The offered price of end products listed and certified under
paragraphs (c)(2)(i) and (iv) of the Buy American Act--North
American Free Trade Agreement Implementation Act-Balance of Payments
Program Certificate provision of the solicitation must include all
applicable duty. The offered price of qualifying country end
products or NAFTA country end products for line items subject to the
North American Free Trade Agreement Implementation Act, should not
include custom fees or duty. (End of clause)
19. A new section 252.225-7037 is added to read as follows:
252.225-7037 Duty-Free Entry--NAFTA Country End Products and Supplies.
As prescribed in 225.605-70(c), use the following clause:
Duty-Free Entry--NAFTA Country End Products and Supplies (Jan. 1994)
(a) Definitions.
NAFTA country and NAFTA country end products have the meaning
given in the North American Free Trade Agreement Implementation Act
clause of this contract.
(b) The requirements of this clause apply to this contract and
subcontracts, including purchase orders, that involve supplies to be
accorded duty-free entry whether--
(1) Placed directly with a foreign concern as a prime contract;
or
(2) As a subcontract or purchase order under a contract placed
with a domestic concern.
(c) Except as otherwise approved by the Contracting Officer, no
amount is or will be included in the contract price for duty for
NAFTA country end products.
(d) The Contractor warrants that--
(1) All NAFTA country supplies, for which duty-free entry is to
be claimed, are intended to be delivered to the Government; and
(2) The Contractor will pay duty to the extent that such
supplies, or any portion thereof (if not scrap or salvage) are
diverted to nongovernmental use, other than as a result of a
competitive sale made, directed, or authorized by the Contracting
Officer.
(e) The Government agrees to execute duty-free entry
certificates and to afford such assistance as appropriate to obtain
the duty-free entry of NAFTA country supplies for which the shipping
documents bear the notation specified in paragraph (f) of this
clause, except as the Contractor may otherwise agree.
(f) All shipping documents submitted to Customs, covering
foreign end products or supplies for which duty-free entry
certificates are to be issued under this clause, shall--
(1) Consign the shipments to the appropriate--
(i) Military department in care of the Contractor, including the
Contractor's delivery address; or
(ii) Military installation; and
(2) Include the following information--
(i) Prime contract number, and delivery order if applicable;
(ii) Number of the subcontract/purchase order for foreign
supplies if applicable;
(iii) Identification of carrier;
(iv) The notation: United States Government, Department of
Defense Duty-Free Entry to be claimed pursuant to Section XXII,
Chapter 98, Subchapter VIII, Item 9808.00.30 of the Harmonized
Tariff Schedule of the United States. Upon arrival of shipment at
the appropriate port of entry, District Director of Customs, please
release shipment under 19 CFR part 142, and notify Commander,
Defense Contract Management Area Operations (DCMAO) New York, ATTN:
Customs Division, International Logistics Office, 201 Varick Street,
New York, NY 10014, for execution of Customs Forms 7501, 7501A, or
7506 and any required duty-free entry certificates. (Note: This
notation shall be used only for direct shipments to a U.S. military
installation. In cases where the shipment will be consigned to other
than a military installation, e.g., a domestic contractor's plan,
the shipping document notation shall be altered to insert the name
and address of the contractor, agent or broker who will notify
Commander, DCMAO, NY, for execution of the duty-free certificate.)
(v) Gross weight in pounds (if freight is based on space
tonnage, state cubic feet in addition to gross shipping weight);
(vi) Estimated value in U.S. dollars; and
(vii) Activity Address Number of the contract administration
office actually administering the prime contract, e.g., for DCMAO
Dayton, DLA8DP.
(g) Prepartion of customs forms.
(1) Except for shipments consigned to a military installation,
the contractor shall prepare, or authorize an agent to prepare, any
customs forms required for the entry of foreign supplies in
connection with DoD contracts into the United States, its
possessions, or Puerto Rico, Submit the completed customs forms to
the District Director of Customs with a copy to DCMAO NY for
execution of any required duty-free entry certificates. Shipments
consigned directly to a military installation will be released in
accordance with 10.101 and 10.102 of the U.S. Customs regulations.
(2) For shipments containing both supplies which are to be
accorded duty-free entry and supplies which are not, the Contractor
shall identify on the customs forms those items that are eligible
for duty-free entry.
(h) The Contractor agrees--
(1) To prepare (if this contract is placed directly with a
foreign supplier), or to instruct the foreign supplier to prepare, a
sufficient number of copies of the bill of lading (or other shipping
document) so that at least two of the copies accompanying the
shipment will be available for use by the District Director of
Customs at the port of entry:
(2) To consign the shipment as specified in paragraph (f) of
this clause; and
(3) To mark the exterior of all packages as follows:
(i) ``United States Government, Department of Defense;'' and
(ii) The activity address number of the contract administration
office actually administering the prime contract.
(i) The Contractor agrees to notify the Contracting Officer
administering the prime contract in writing of any purchase under
the contract of NAFTA country supplies to be accorded duty-free
entry that are to be imported into the United States for delivery to
the Government or for incorporation in end items to be delivered to
the Government. The notice shall be furnished to the contract
administration office immediately upon award to the qualifying
country supplier. The notice shall contain--
(1) Prime contractor's name, address, and CAGE code;
(2) Prime contract number, and delivery order number if
applicable;
(3) Total dollar value of the prime contract or delivery order;
(4) Expiration date of the prime contract or delivery order;
(5) Foreign supplier's name and address;
(6) Number of the subcontract/purchase order for NAFTA supplies;
(7) Total dollar value of the subcontract for NAFTA supplies;
(8) Expiration date of the subcontract for NAFTA supplies;
(9) List of items purchased; and
(10) Certification by the purchaser of NAFTA supplies as
follows: I certify that all supplies for which duty-free entry is to
be claimed are intended to be delivered to the Government or
incorporated in the end items to be delivered under this contract,
and that duty shall be paid by the Contractor to the extent that
such supplies, or any portion (if not scrap or salvage) are diverted
to nongovernmental use other than as a result of a competitive sale
made, directed or authorized by the Contracting Officer; and
(11) The scheduled delivery date(s).
(j) This clause does not apply to purchases of NAFTA country
supplies in connection with this contract if--
(1) The NAFTA country supplies are identical in nature to
supplies purchased by the Contractor or any subcontractor in
connection with its commercial business; and
(2) It is not economical or feasible to account for such
supplies so as to ensure that the amount of the supplies for which
duty-free entry is claimed does not exceed the amount purchased in
connection with this contract.
(k) The Contractor agrees to insert the substance of this
clause, including this paragraph (k) in all subcontracts for
supplies. Each subcontract shall require the subcontractor to
identify this contract by including its contract number on any
shipping documents submitted to Customs covering supplies for which
duty-free entry is to be claimed pursuant to this clause. The
Contractor also agrees that the name and address of the Contracting
Officer administering the prime contract (name and address of the
contract administration office cognizant of the prime contract), and
its activity address number (Appendix G of the Defense FAR
Supplement), and the information required by paragraphs (i) (1),
(2), and (3) of this clause will be included in applicable
subcontracts. (End of clause)
[FR Doc. 94-447 Filed 1-7-94; 8:45 am]
BILLING CODE 3810-01-M
Complete official Federal Register PDF
FR Doc. 94-442 State-Administered Workplace Literacy Program; National Workplace Literacy Program
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1439-1445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-442]
[[Page Unknown]]
[Federal Register: January 10, 1994]
DEPARTMENT OF EDUCATION
34 CFR Parts 462 and 472
RIN 1830-AA11
State-Administered Workplace Literacy Program; National Workplace
Literacy Program
AGENCY: Department of Education.
ACTION: Final regulations.
-----------------------------------------------------------------------
SUMMARY: The Secretary amends existing regulations that govern the
State-Administered Workplace Literacy Program and the National
Workplace Literacy Program. These amendments are needed to increase
project accountability and to make technical changes. The regulations
provide rules for applying for and expending Federal funds under these
programs.
EFFECTIVE DATE: These regulations take effect either 45 days after
publication in the Federal Register or later if the Congress takes
certain adjournments. If you want to know the effective date of these
regulations, call or write the Department of Education contact persons.
A document announcing the effective date will be published in the
Federal Register.
FOR FURTHER INFORMATION CONTACT: Ms. Sarah E. Newcomb, Department of
Education, 400 Maryland Avenue SW., room 4417, Mary E. Switzer
Building, Washington, DC 20202-7320. Telephone: (202) 205-9872. Or Ms.
Jeanne Williams, Department of Education, 400 Maryland Avenue, SW.,
room 4518, Mary E. Switzer Building, Washington, DC 20202-7327.
Telephone: (202) 205-5977. Individuals who use a telecommunications
device for the deaf (TDD) may call the Federal Information Relay
Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern
time, Monday through Friday.
SUPPLEMENTARY INFORMATION:
Background
The State-Administered Workplace Literacy Program and the National
Workplace Literacy Program are important activities that assist in
achieving the National Education Goals. Specifically, the workplace
literacy programs address Goal 5, that every adult American will be
literate and will possess the knowledge and skills necessary to compete
in a global economy and exercise the rights and responsibilities of
citizenship. Moreover, the National Workplace Literacy Program supports
this goal by providing grants to exemplary partnerships between a
business, industry, or labor organization, or a private industry
council, and an education organization to support work-related literacy
education.
These regulations increase the accountability of workplace literacy
projects. The Department is implementing this strategy in order to
expand the demonstration and dissemination activities of projects,
thereby increasing the number of instructional approaches, materials,
and techniques for providing work-related literacy education that are
submitted to and approved by the Department's Program Effectiveness
Panel, and subsequently made available to practitioners.
On May 27, 1993, the Secretary published a notice of proposed
rulemaking (NPRM) for these programs in the Federal Register (58 FR
30916).
Analysis of Comments and Changes
In response to the Secretary's invitation in the NPRM, 33 parties
submitted comments on the proposed regulations. An analysis of the
comments and of the changes in the regulations since publication of the
NPRM follows.
Issues are grouped according to subject, with appropriate sections
of the regulations referenced in parentheses.
Technical and other minor changes--and suggested changes the
Secretary is not legally authorized to make under the applicable
statutory authority and comments on subjects outside the scope of these
regulations--are not addressed.
PART 462--STATE-ADMINISTERED WORKPLACE LITERACY PROGRAM
Partnership Agreement (Secs. 462.30(c) and 462.32(b))
Comments: Some commenters were concerned that requiring partners to
enter into a binding agreement would have a dampening effect on
businesses joining partnerships, and recommended a less restrictive
approach. Another commenter supported requiring a binding agreement.
Discussion: For five years the Secretary has required, under the
National Workplace Literacy Program, the types of binding agreements
that would become part of the State-Administered program. The
Secretary's experience is that these agreements are essential to
eliciting quality applications, promoting project success, and ensuring
accountable grant performance.
Changes: None.
PART 472--NATIONAL WORKPLACE LITERACY PROGRAM
Definitions--Employment and Training Agency (Sec. 472.5)
Comments: One commenter mistakenly thought the proposed change,
which would clarify that employment and training agencies are nonprofit
agencies, would exclude from participation as partners profit-making
organizations that provide employment and training services. Other
commenters agreed with the proposed change to the definition of
``employment and training agency.''
Discussion: The proposed change would codify an existing program
practice that requires an education partner classified as an employment
and training agency to be a nonprofit entity. However, profit-makers
can continue to participate as partners under the classification
``business'' or ``industry'' organization. See Sec. 472.2(a)(1).
Profit-making organizations should note that a selection criterion in
Sec. 472.22(c)(4) requests applications to indicate the extent to which
training will be provided through the education partner classified
under Sec. 472.2(a)(2), rather than through the business or labor
partner classified under Sec. 472.2(a)(1), unless transferring this
activity to the business or labor partner is necessary and reasonable
within the framework of the applicant's proposed project.
Changes: None.
Project Director (Secs. 472.5 and 472.32(e))
Comments: Several commenters supported the regulations defining the
term ``project director'' and requiring that each project provide for a
director. Some of these commenters recommended additional regulations,
including requiring a full-time project director, specifying the
qualifications of a project director, and requiring that proposed
personnel demonstrate substantive experience, education, and training
in the workplace.
Discussion: Because the project director will be responsible for
the day-to-day operation of the project, the qualifications of that
person should be directly related to the specific requirements of the
project, and will naturally differ somewhat from project to project.
The Secretary strongly encourages applicants to hire project directors
with experience and training in project management and in fields
related to objectives of the project, but believes that a list of
standardized qualifications would limit the discretion of applicant
partnerships to hire directors who respond to the needs of the project.
The regulations do not specifically require a full-time project
director, and this may not be needed--especially in small projects.
However, each project must provide for a director who will devote
sufficient time to exercising day-to-day operational responsibility and
ensure that the project is well managed.
Changes: None.
Preapplications (Secs. 472.10 and 472.11)
Comment: One commenter suggested retaining Secs. 472.10 and 472.11,
which describe a preapplication process, because the process would save
time for projects that might not be appropriate for a national
competition. Another commenter supported the Department's proposal to
delete these sections because a preapplication would be a burdensome
paperwork requirement.
Discussion: Historically, these sections were included in the
regulations to authorize use of a preapplication process where it would
be helpful to applicants. However, the provision has never been needed,
and the Department does not foresee its use in the future.
Changes: None.
Preference for Small Business Partners (Sec. 472.21(e))
Comments: One commenter agreed that preference points should be
given for applications involving a small business, but thought that the
points should be given even if the business is not involved as a
project partner. The commenter stated that it is unrealistic to expect
small businesses to become partners because this would burden them with
paperwork, meetings, and unnecessary reports. Another commenter
suggested giving an additional preference to partnerships involving
small businesses with less than 100 or 250 employees.
Discussion: A small business can potentially be involved in a
workplace literacy project as a ``partner,'' a ``contractor,'' a
``helping organization,'' or a ``site.'' Each of these terms is defined
in 34 CFR 472.5, which clarifies that only a partner can receive
program funds and be fully involved in project policy and operations.
The Secretary believes that preference should be given only to those
partnerships that include small businesses as partners. To interpret
the preference more broadly would benefit applications that involve
large businesses as partners--and merely involve small businesses in a
less significant role. Each partnership agreement designates one of the
partners to serve as the project grantee. This partner is principally
responsible for project administration, including paperwork and
reports. Any small business partner that does not wish to serve as a
grantee can enter into an agreement designating another partner as the
grantee, and can thus avoid the paperwork burden. The Secretary has
adopted a definition of the term ``small business'' modeled on
regulations of the Small Business Administration and does not believe
it would be beneficial to modify that definition by giving an
additional preference to small businesses having particularly small
numbers of employees.
Changes: None.
Selection Criteria--Program Factors (Sec. 472.22(a)(5))
Comment: Section 472.22(a)(5) proposed adding language to a
selection criterion encouraging applicants to focus ``on improving
performance in jobs or job functions that have a broad representation
within the Nation's workforce so that the products can be adapted for
use by similar workplaces across the Nation.'' Several commenters
interpreted this language as a statement of the scope of services that
are allowable under the National Workplace Literacy Program, believed
that this scope had been defined too narrowly, and urged that it be
expanded to include a variety of activities. It was also suggested that
a project be permitted to provide any services identified in a needs
assessment. One commenter asked whether use of the term ``jobs or job
functions'' was intended to shift focus away from job-specific
competencies of current job titles to broader competencies that are
identified in the report issued by the Department of Labor Secretary's
Commission on Achieving Necessary Skills (SCANS). The commenter asked
that the Department clarify or define which jobs or job functions have
``broad representation within the Nation's workforce.'' Other
commenters stated that a broader scope of services is needed to meet
the National Education Goals.
Discussion: Section 472.22(a)(5) is a selection criterion used to
evaluate applications and is not a statement of the scope of allowable
program services. That scope is stated in Sec. 472.3, which reflects
sections 371(a)(1) and (3) of the Adult Education Act, and lists
allowable activities. Many activities mentioned by the commenters, such
as speaking, listening, reasoning, problem-solving, team building, GED
preparation, and meeting the literacy needs of adults with limited
English proficiency, are allowable under Sec. 472.3. Further guidance
on the scope of allowable activities is included in the notice inviting
applications published elsewhere in this issue of the Federal Register.
Generally, workplace literacy projects teach literacy skills needed in
the workplace that improve the productivity of the workforce. The
program is not a program of general adult education and cannot serve
needs that are not directly related to the workplace. At the same time,
projects serving needs that are directly related to the workplace are
encouraged to use creative approaches to stimulate workers' interests
and to develop individualized education plans that reflect workers'
goals. See Sec. 472.22(c)(2).
The purpose of the language encouraging a focus on nationally
representative jobs or job functions is to enhance the capability of a
project to demonstrate results that can be adapted by similar employers
and industries. Section 472.22(a)(5) was not proposed specifically to
respond to the recommendations of the SCANS report, nor was the report
intended to modify the scope of services under the workplace literacy
program. The Secretary believes that it is unnecessary to define by
regulation what jobs or job functions are broadly representative.
Applicants are encouraged to make their own evaluation of current and
future labor market conditions, and design a project that can help
similar workplaces in the future. This should assist in meeting
National Education Goal 5, that every adult American will be literate
and will possess the knowledge and skills necessary to compete in a
global economy and exercise the rights and responsibilities of
citizenship.
Changes: None.
Selection Criteria--Demonstration (Sec. 472.22(h)) (Proposed
Sec. 472.22(h)(1))
Comments: Several commenters agreed that the Department should
emphasize dissemination activities, and recommended the inclusion of
various other dissemination strategies. Two commenters were concerned
that dissemination activities could be hampered because the
instructional materials produced by a project might contain protected
information.
One commenter suggested that, because carrying out both the
demonstration and commitment activities described in proposed
Sec. 472.22(h)(1) and (2) would be overwhelming, applicants should be
asked to address only one of these criteria.
Discussion: The dissemination strategies listed in proposed
Sec. 472.22(h)(1) are among the regulatory changes designed to
transform the National Workplace Literacy Program into a true
demonstration program. See the previous discussion of the background of
these regulations and note also Sec. 472.31(c), which requires that a
project be independently evaluated for ``spread'' and
``transportability'' to other sites. Proposed Sec. 472.22(h)(1)
encouraged applicants to use certain dissemination strategies but was
not intended to preclude the use of additional strategies when they are
appropriate for a particular project.
The Secretary does not expect or anticipate that partnerships will
disseminate trade secrets or other protected information. However, a
project's dissemination activities should clearly benefit businesses
and workplaces outside of the partnership.
While, ideally, all partners will be involved in demonstration and
commitment activities, these activities may be accomplished through the
efforts of particular partners. The Secretary desires that the factors
listed in the criteria on ``Demonstration'' and ``Commitment'' be
reflected in an applicant's program design, management plan, and
budget. However, the Secretary does not anticipate that addressing both
criteria will be burdensome if partners adequately plan and budget for
them. Changes: The selection criterion ``Demonstration and commitment''
in proposed Sec. 472.22(h) has been separated into a criterion on
``Demonstration'' in Sec. 472.22(h) and a criterion on ``Commitment''
in Sec. 472.22(i). Also see the discussion on Sec. 472.22(i).
Selection Criteria--Commitment (Sec. 472.22(i)) (Proposed
Sec. 472.22(h)(2))
Comments: Several commenters opposed the criterion that encouraged
applicants to state how partners plan to establish a program of
workplace literacy services that can continue after Federal funding
ends. Many of these commenters believed this criterion would adversely
affect small businesses since they might not have the resources needed
to continue a workplace literacy project. Other commenters pointed out
that some businesses, especially small businesses, have short-term
training needs that can be met during the course of the project and,
therefore, would not need to continue the project. Still other
commenters thought that because small businesses would not be able to
continue a project, this criterion would nullify the five-point
preference given for partnerships that include a small business.
Some commenters supported the inclusion of the criterion on
commitment and indicated past success with this concept, but suggested
that small businesses be exempted. Other commenters believed that
expecting business partners to make a commitment to continue a project
that is unproven is unreasonable and could scare away potential
business partners. These commenters thought that commitment is best
sought and obtained during a successful project.
Some commenters suggested such alternative methods of demonstrating
commitment as release time for assessment and training, strategic
planning for capacity-building, training business partners to provide
workplace literacy, active participation of all partners, or gradual
assumption of costs.
Discussion: The Secretary acknowledges the many helpful comments on
this topic. Although proposed Sec. 472.22(h)(2) did not involve a
commitment to any unforeseeable or unnecessary post-project activities,
the Secretary wishes to avoid any implication that this is the case.
The Secretary also desires to preserve the competitive preference for
partnerships involving small businesses. Accordingly, the selection
criterion ``Demonstration and commitment'' in proposed Sec. 472.22(h)
has been separated into a criterion on ``Demonstration'' in
Sec. 472.22(h) and a criterion on ``Commitment'' in Sec. 472.22(i).
Moreover, Sec. 472.22(i) makes it clear that plans for continuing
workplace literacy after Federal funding ends should be based on
realistic forecasts of the literacy needs of partners and should take
into consideration a partner's capacity to continue services. To
emphasize this point, the criterion now provides a range of examples of
practical strategies for institutionalizing workplace literacy, many of
which can be carried out by small businesses. The criterion also
recognizes the importance of an applicant's commitment to
institutionalizing learning in the workplace specifically during the
project itself. These changes are intended to accommodate the
legitimate concerns of the commenters while preserving the overall
purpose of a selection criterion on commitment. The recently published
study Adult Literacy in America points out that some 90 million adults
demonstrate low levels of literacy and depicts a society in which the
vast majority of Americans do not have the skills needed to earn a
living in our increasingly technological society and international
marketplace. The Secretary believes that a commitment to
institutionalize learning will naturally lead to continuing efforts to
promote workplace literacy after Federal funding ends and will assist
in transforming American workplaces to meet the challenges of a world
market.
Changes: The selection criterion ``Demonstration and commitment''
in proposed Sec. 472.22(h) has been separated into a criterion on
``Demonstration'' in Sec. 472.22(h) and a criterion on ``Commitment''
in Sec. 472.22(i). The criterion on ``Commitment'' clarifies that
applicants are to develop practical strategies for institutionalizing
workplace literacy that are based on realistic forecasts of literacy
needs and the capacity of partners. The criterion also encourages
applicants to demonstrate a commitment to institutionalizing learning
in the workplace during the project.
Reporting (Sec. 472.30(b))
Comments: Numerous commenters expressed the view that a two-page
semi-annual performance and financial report would not be overly
burdensome. These commenters felt that the data would be a good
planning tool, would help projects monitor their progress, and would
contribute to the standardization of the workplace literacy program
nationwide. Other commenters suggested that the reports be made
available at the time of award so that data bases could be designed to
facilitate collection. Some commenters strongly advocated quarterly
reports that include, in addition to the information the Secretary
proposed collecting, a brief update on the success of the project in
achieving its objectives. Two commenters recommended annual reporting,
one because of the project's cycle for collecting evaluative data and
the other because of the possibility that the Department might not have
adequate staff resources to use the performance and financial data as
intended.
Discussion: The Secretary considered requiring quarterly reports
for the National Workplace Literacy Program, but determined that they
would be burdensome for grantees. However, the Secretary believes that
annual reports would not provide sufficient information to ensure
program accountability and ready access to information that is
comparable across projects. Grantees will be required to submit brief
continuation applications annually in order to receive funding for the
second and third year of their projects.
The Secretary believes that the continuation application and a two-
page semi-annual report on progress and total spending for the
reporting period will be adequate. The reports will be made available
to grantees at the start of their projects to enable them to set up
appropriate recordkeeping procedures, and the Department will work with
grantees to ensure that reports are used appropriately both to monitor
and to improve projects.
Changes: None.
Evaluation (Sec. 472.31)
Comments: Several commenters thought that the requirement for
projects to have a third-party evaluator would be expensive,
burdensome, or too costly. Several other commenters supported the
evaluation requirement because a rigorous evaluation design is
essential to demonstrating impact and replicable results and would
strengthen projects. One commenter was concerned that tying student
learning gains to higher job productivity and performance would not
result in reliable or valid measures of the effectiveness of projects
because learning gains are not the only conditions affecting these
factors.
Discussion: Program experience over the life of the National
Workplace Literacy Program indicates that a third-party evaluation
enhances the quality of a project without being expensive, burdensome,
or too costly. The Secretary agrees with the comment that multiple
conditions, including learning gains, may contribute to measured
improvements in job productivity and performance. This comment supports
the need for a rigorous evaluation design that includes, insofar as
possible, controls for other variables that may also contribute to the
improvements measured. Evaluations of this rigor require highly trained
research and evaluation personnel who cannot always be found among
staff persons employed within funded projects.
Changes: None.
Start-up Period (Sec. 472.32(b))
Comments: Numerous commenters supported lengthening the grant
period to three years and extending the start-up period. However, one
commenter questioned the necessity of a six-month start-up period.
Discussion: The heightened emphasis on demonstration and
dissemination activities requires lengthening the grant period to three
years, and, as necessary, lengthening the time needed to establish a
project before services are provided to adult workers. Although
Sec. 472.32(b)(1) permits applicants to take up to a six-month start-up
period, Sec. 472.32(b)(2) requires applicants to ``minimize the start-
up period, if any, proposed for their projects.''
Changes: None.
Continuation of a Project After a Partner Withdraws (Sec. 472.34)
Comments: One commenter suggested that the regulations specifically
apply to business partners. Another commenter thought the regulations
favored projects with more than two partners, and requested greater
flexibility in the renegotiation of the scope of work of a grant. A
commenter suggested that a project be allowed to continue despite the
withdrawal of a partner, even if the conditions of Sec. 472.34 are not
satisfied. One commenter inquired whether all, or only one, of the
conditions outlined in Sec. 472.34 must be met by withdrawing partners.
Discussion: Although each partnership is required to designate one
partner as its applicant and grantee, an award is made on the basis of
the partnership agreement that is signed by all members of the
partnership and that binds the partners to every statement and
assurance made in the application, in addition to carrying out their
respective roles. It is therefore reasonable to expect that the
approved scope of work will continue to be carried out if a partner
withdraws, regardless of the type of partner withdrawing or the number
of partners in the original partnership. The regulations do not favor
projects with more than two partners. Section 472.34(b)(1) allows for
the full substitution of a partner even in the case of a two-party
partnership so long as the partnership continues to meet the
requirement in Sec. 472.2(b) that there be at least one education
partner and one business or labor partner. The Secretary wishes to
point out that the conditions in Sec. 472.34 are to be met by the
remaining partners. They are not conditions to be met by the
withdrawing partners as suggested by the commenter. Moreover, all of
the conditions described in Sec. 472.34 must be met before the
Secretary will allow a project to continue.
Changes: Section 472.34 has been changed to clarify that all of the
conditions described in this section must be met if a project is to be
allowed to continue after the withdrawal of a partner.
Union and Worker Involvement (Part 472)
Comments: Several commenters thought unions should be involved in
the development and implementation of projects. Some of these
commenters recommended requiring a written statement indicating
consultation with and concurrence by the union. Others suggested
requiring a statement from the union that it either agrees to full
partnership with the education partner and business partner or it
acknowledges the collaboration between the education and business
partner. One commenter suggested that points be awarded to proposals
with employer and union partnerships.
One commenter suggested that, in the absence of a union, workers
should be involved in planning the project. Another commenter suggested
that points be awarded to applications--(1) with effective plans to
involve workers in the educational provider's decision-making process;
and (2) that emphasize participatory teaching methods.
Several commenters thought that union and worker involvement would
improve the recruitment, interest, and commitment of the workforce, and
help to allay fears that a project would result in the loss of jobs for
employees failing to demonstrate learning gains.
Discussion: Section 371(a)(1) of the Act permits, but does not
require, a labor organization to be a partner in an application under
this program. This provision is reflected in Sec. 472.2(a) and (b). As
indicated in Sec. 472.2(c), a labor organization, like any partner,
must participate in a joint application for funding and sign a
partnership agreement. However, the Secretary does not believe that a
written statement regarding union consultation should be required of
partnerships that do not include a labor organization. Nevertheless,
the Secretary encourages all partnerships to involve workers and, as
appropriate, labor organizations in matters related to the project.
This arrangement should provide a number of benefits, including
allaying any concerns that workers may have about participating in a
project.
Changes: None.
Intergovernmental Review
These programs are subject to the requirements of Executive Order
12372 and the regulations in 34 CFR part 79. The objective of the
Executive order is to foster an intergovernmental partnership and a
strengthened federalism by relying on processes developed by State and
local governments for coordination and review of proposed Federal
financial assistance.
In accordance with the order, this document is intended to provide
early notification of the Department's specific plans and actions for
this program.
Assessment of Educational Impact
In the notice of proposed rulemaking, the Secretary requested
comments on whether the proposed regulations would require transmission
of information that is being gathered by or is available from any other
agency or authority of the United States.
Based on the response to the proposed rules and on its own review,
the Department has determined that the regulations in this document do
not require transmission of information that is being gathered by or is
available from any other agency or authority of the United States.
List of Subjects
34 CFR Part 462
Adult education, Business and industry, Labor unions, Reporting and
recordkeeping requirements, and Workplace literacy.
34 CFR Part 472
Adult education, Business and industry, Labor unions, Reporting and
recordkeeping requirements, and Workplace literacy.
Dated: January 3, 1994.
Richard W. Riley,
Secretary of Education.
(Catalog of Federal Domestic Assistance Number 84.198 National
Workplace Literacy Program. Catalog of Federal Domestic Assistance
Number has not been assigned for the State-Administered Workplace
Literacy Program.)
The Secretary amends Parts 462 and 472 of Title 34 of the Code of
Federal Regulations as follows:
PART 462--STATE-ADMINISTERED WORKPLACE LITERACY PROGRAM
1. The authority citation for part 462 continues to read as
follows:
Authority: 20 U.S.C. 1211a(b), unless otherwise noted.
2. Section 462.30 is amended by adding a new paragraph (c) to read
as follows:
Sec. 462.30 Who is eligible to apply to a State for an award?
* * * * *
(c) The partners shall enter into an agreement, in the form of a
single document signed by all partners, designating one member of the
partnership as the applicant and the subgrantee or contractor. The
agreement must also detail the role each partner plans to perform and
bind each partner to every statement and assurance made in the
application.
(Approved by the Office of Management and Budget under control
number 1830-0521)
3. Section 462.32 is revised to read as follows:
Sec. 462.32 What are the local application requirements?
A local partnership application, submitted to an SEA for funding
under the State-administered Workplace Literacy Program, must contain--
(a) The information in section 371(a)(4) of the Act; and
(b) A signed partnership agreement as described in Sec. 462.30(c).
(Approved by the Office of Management and Budget under OMB control
number 1830-0521)
(Authority: 20 U.S.C. 1211(b)(5))
PART 472--NATIONAL WORKPLACE LITERACY PROGRAM
4. The authority citation for Part 472 continues to read as
follows:
Authority: 20 U.S.C. 1211(a), unless otherwise noted.
Subpart B--[Removed and Revised]
5. Part 472 is amended by removing and reserving subpart B.
6. Section 472.5 is amended by revising paragraph (a) and the
definition of ``Employment and training agency'' in paragraph (b) and
by adding new definitions of ``Project director'' and ``Small
business'' to paragraph (b) in alphabetical order to read as follows:
Sec. 472.5 What definitions apply?
(a) The definitions in 34 CFR 460.4 apply to this part.
(b) * * *
Employment and training agency includes any nonprofit agency that
provides--as a substantial portion of its activity--employment and
training services, either directly or through contract.
* * * * *
Project director means the person with day-to-day operational
responsibility for the project.
* * * * *
Small business means a business entity that--
(1) Is organized for profit, with a place of business located in
the United States and that makes a significant contribution to the U.S.
economy through payment of taxes or use of American products,
materials, or labor, or both; and
(2) May be in the legal form of an individual proprietorship,
partnership, corporation, joint venture, association, trust or a
cooperative, except that if the form is a joint venture, there can be
no more than 49 percent participation by foreign business entities in
the joint venture; and
(3) Meets the requirements found in 13 CFR part 121 concerning
Standard Industrial Classification codes and size standards.
Sec. 472.20 [Amended]
7. Section 472.20 is amended by removing paragraph (c).
8. Section 472.21 is amended by revising paragraph (b) and adding a
new paragraph (e) to read as follows:
Sec. 472.21 How does the Secretary evaluate an application?
* * * * *
(b) The Secretary may award up to 100 points, including a reserved
10 points to be distributed in accordance with paragraph (d) of this
section, based on the criteria in Sec. 472.22.
* * * * *
(e) In addition to the points to be awarded based on the criteria
in Sec. 472.22, the Secretary awards five points to applications from
partnerships that include as a partner a small business that has signed
the partnership agreement.
9. Section 472.22 is amended by removing the word ``and'' after the
semicolon at the end of paragraph (a)(3); removing the period at the
end of paragraph (a)(4), and adding, in its place, ``; and''; adding a
new paragraph (a)(5); revising paragraph (b), introductory text;
revising paragraph (c)(1); removing the word ``and'' after the
semicolon at the end of paragraph (c)(3); removing the period at the
end of paragraph (c)(4), and adding, in its place, ``; and''; adding a
new paragraph (c)(5); revising paragraph (d), introductory text;
removing the word ``and'' after the semicolon at the end of paragraph
(d)(2)(iii); adding the word ``and'' after the semicolon at the end of
paragraph (d)(2)(iv); adding a new paragraph (d)(2)(v); revising
paragraph (e), introductory text; revising paragraph (e)(2)(i);
revising paragraph (f), introductory text; removing the word ``and''
after the semicolon at the end of paragraph (f)(4); removing the period
at the end of paragraph (f)(5), and adding, in its place, ``; and'';
adding a new paragraph (f)(6) and a ``Note to Sec. 472.22(f)(6)''
following the paragraph; revising paragraph (g), introductory text; and
adding a new paragraph (h) to read as follows:
Sec. 472.22 What selection criteria does the Secretary use?
(a) * * *
(5) Focuses on improving performance in jobs or job functions that
have a broad representation within the Nation's workforce so that the
products can be adapted for use by similar workplaces across the
Nation.
(b) Extent of need for the project. (10 points) * * *
* * * * *
(c) * * *
(1) Develop or use curriculum materials for adults based on
literacy skills needed in the workplace;
* * * * *
(5) Provide, and document for others, a program of training for
staff including, but not limited to, techniques of curriculum
development and special methods of teaching that are appropriate for
workplace environments.
(d) Plan of operation. (15 points) * * *
* * * * *
(2) * * *
(v) A realistic time table for accomplishing project objectives;
* * * * *
(e) Applicant's experience and quality of key personnel. (8 points)
* * *
* * * * *
(2) * * *
(i) The qualifications, in relation to project requirements, of the
project director;
* * * * *
(f) Evaluation plan. (10 points) The Secretary reviews each
application to determine the quality of the plan for an independent
evaluation of the project, including the extent to which the
applicant's methods of evaluation--
* * * * *
(6) Will yield results that can be summarized and submitted to the
Secretary for review by the Department's Program Effectiveness Panel.
Note to Sec. 472.22(f)(6): The Program Effectiveness Panel (PEP) is
a mechanism the Department has developed for validating the
effectiveness of educational programs developed by schools,
universities, and other agencies. The PEP is composed of experts in the
evaluation of educational programs and in other areas of education, at
least two-thirds of whom are non-Federal employees who are appointed by
the Secretary. Regulations governing the PEP are codified in 34 CFR
parts 785-789. Specific criteria for PEP review are found in 34 CFR
786.12 or 787.12.
(g) Budget and cost-effectiveness. (7 points) * * *
* * * * *
(h) Demonstration. (5 points) The Secretary reviews each
application to determine the quality of the applicant's plan, during
the grant period, to disseminate the results of the project,
including--
(1) Demonstrating promising practices used by the project to others
interested in implementing these techniques;
(2) Conducting workshops or delivering papers at national
conferences or professional meetings; and
(3) Making available material that will help others implement
promising practices developed in the project.
(i) Commitment. (5 points) The Secretary reviews each application
to determine the quality of the applicant's plan to institutionalize
learning in the workplace based on promising practices demonstrated in
the project. In making this determination, the Secretary considers--
(1) The general, but realistic, forecast of literacy needs of
members of the partnership and the capacity of the partners;
(2) Activities that will increase, during the grant period, the
capacity of partners to provide a coherent program of learning in the
workplace; and
(3) Activities that will lead to the continued provision or
expansion of work-based literacy services built on successful outcomes
of the project. For example, the partners could--
(A) Integrate workplace literacy services into the long-term
planning of partner organizations;
(B) Create and implement policies and practices that encourage
worker participation in workplace literacy and other education and
training opportunities;
(C) Provide training that will enable partners to build a capacity
to furnish necessary workplace literacy services in the future;
(D) Establish relationships within the partnership or with other
entities that will continue provision of necessary workplace literacy
services after the project ends; or
(E) Plan, after the project has ended, to expand services to other
locations, divisions, or suppliers of the business or industry partners
or labor organizations.
(Approved by the Office of Management and Budget under OMB control
number 1830-0521)
10. Sections 472.30 and 472.31 are redesignated as Secs. 472.32 and
472.33, respectively.
11. A new Sec. 472.30 is added to read as follows:
Sec. 472.30 What are the reporting requirements?
(a) A recipient of a grant or cooperative agreement under this
program shall submit to the Secretary performance and financial
reports.
(b) These reports must be submitted at times required by the
Secretary and at least semi-annually.
(c) These reports must contain information required by the
Secretary.
(Authority: 20 U.S.C. 1211(a))
12. A new Sec. 472.31 and ``NOTE to Sec. 472.31'' are added to read
as follows:
Sec. 472.31 What are the evaluation requirements?
(a) Each recipient of a grant or cooperative agreement under this
program shall provide and budget for an independent evaluation of
project activities.
(b) The evaluation must be both formative and summative in nature.
(c) The evaluation must be based on student learning gains and the
effects on job advancement, job performance (including, for example,
such elements as productivity, safety, and attendance), and project and
product spread and transportability.
(d) A proposed project evaluation design for the entire project
period, expanding on the plans outlined in the application pursuant to
Sec. 472.22(f), must be submitted to the Secretary for review and
approval prior to the end of the first year of the project period.
(e) A summary of evaluation activities and results that can be
reviewed by the Department's Program Effectiveness Panel, as described
in 34 CFR parts 785-789, must be submitted to the Secretary during the
last year of the project period.
(f) If a grantee cooperates in a Federal evaluation of its project,
the Secretary may determine that the grantee fully or partially meets
the evaluation requirements of this section and the reporting
requirements in Sec. 472.30.
(Approved by Office of Management and Budget under OMB control
number 1830-0522)
(Authority: 20 U.S.C. 1211(a))
Note to Sec. 472.31: As used in Sec. 472.31(c)--
``Spread'' means the degree to which--
(1) Project activities and results are demonstrated to others;
(2) Technical assistance is provided to others to help them
replicate project activities and results;
(3) Project activities and results are replicated at other sites;
or
(4) Information and material about or resulting from the project
are disseminated; and
``Transportability'' means the ease by which project activities and
results may be replicated at other sites, such as through the
development and use of guides or manuals that provide step-by-step
directions for others to follow in order to initiate similar efforts
and reproduce comparable results.
13. Section 472.32, as redesignated, is amended by revising
paragraphs (b), (d)(1), and (e) to read as follows:
Sec. 472.32 What other requirements must be met under this program?
* * * * *
(b)(1) The project period may include a start-up period, not to
exceed six months, during which the project is being established and
prior to the time services are provided to adult workers.
(2) Applicants shall minimize the start-up period, if any, proposed
for their projects.
* * * * *
(d) * * *
(1) 100 percent of the administrative costs incurred in
establishing a project during the start-up period described in
paragraph (b) of this section by an SEA, LEA, or other entity described
in Sec. 472.2(a), that receives a grant under this part; and
* * * * *
(e) Each recipient of an award under this program shall provide for
a project director.
14. A new Sec. 472.34 is added to read as follows:
Sec. 472.34 Under what circumstances may a project continue if a
partner withdraws?
(a) A project may continue despite the withdrawal of a partner that
is unable to perform its role as outlined in the grant award document
if all of the following conditions are met:
(1) Written approval is given by the Secretary.
(2) The partnership continues to meet the requirements in
Sec. 472.2(b).
(3) The partnership will be able to complete the remainder of the
project.
(4) The partner's withdrawal will not cause a change in the scope
or objectives of the grant or cooperative agreement.
(b) In determining that the condition in paragraph (a)(4) of this
section is satisfied, the Secretary considers such factors as whether--
(1) A similar new partner will sign the partnership agreement and
agree to carry out the role of the withdrawing partner as described in
the grant agreement;
(2) One or more of the remaining partners will agree to carry out
the role of the withdrawing partner as described in the grant
agreement; or
(3) One or more of the remaining partners will expand its
activities as approved under the grant in order to compensate for the
activities that would have been carried out under the grant agreement
by the partner that is withdrawing without a change in the project's
scope or objectives.
(Authority: 20 U.S.C. 1211(a))
[FR Doc. 94-442 Filed 1-7-94; 8:45 am]
BILLING CODE 4000-01-P
Complete official Federal Register PDF
FR Doc. 94-429 Olives Grown in California and Imported Olives; Finalize the Establishment of Limited Use Olive Requirements During the 1993-94 Crop Year
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1270-1273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-429]
[[Page Unknown]]
[Federal Register: January 10, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
7 CFR Parts 932 and 944
[Docket Nos. FV93-932-1FIR and FV93-944-1FIR]
Olives Grown in California and Imported Olives; Finalize the
Establishment of Limited Use Olive Requirements During the 1993-94 Crop
Year
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Agriculture (Department) is adopting as a
final rule, without change, the provisions of an interim final rule
that authorizes the use of smaller sized olives in the production of
limited use styles for California olives. This rule is effective during
the 1993-94 crop year and establishes minimum grade and size
requirements for such olives in the order's rules and regulations. This
final rule also adopts, without change, the provisions of an interim
final rule that authorizes the importation of certain bulk olives into
the United States to be used in the production of limited use styles of
olives such as wedges, halves, slices, or segments. This action is
intended to allow more olives into fresh market channels and is
consistent with current market requirements. This action also updates
the Federal-State inspection office address list contained in the
import regulation.
EFFECTIVE DATE: February 9, 1994.
FOR FURTHER INFORMATION CONTACT: Caroline C. Thorpe, Marketing Order
Administration Branch, Fruit and Vegetable Division, AMS, USDA, P.O.
Box 96456, room 2525-S, Washington, DC 20090-6456; telephone (202) 720-
5127, or Terry Vawter, California Marketing Field Office, Fruit and
Vegetable division, AMS, USDA, 2202 Monterey Street, suite 102-B,
Fresno, CA 93721, telephone (209) 487-5901.
SUPPLEMENTARY INFORMATION: This rule is issued under Marketing
Agreement and 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.
This rule is also issued under section 8e of the Act, which
requires the Secretary of Agriculture to issue grade, size, quality, or
maturity requirements for certain listed commodities imported into the
United States that are the same as, or comparable to, those imposed
upon the domestic commodities under the Federal marketing orders.
The Department is issuing this rule in conformance with Executive
Order 12866.
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. This action is not intended to have retroactive
effect. This rule would 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 608(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 date of the entry of the ruling.
There are no administrative procedures which must be exhausted
prior to any judicial challenge to the provisions of import regulations
issued under section 8e of the Act.
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 5 handlers of California olives that will be subject to
regulation under the order during the current season, and there are
about 1,350 olive producers in California. There are approximately 25
importers of olives subject to the olive import regulation. Small
agricultural producers have been defined by the Small Business
Administration [13 CFR Sec. 121.601] as those whose annual receipts are
less than $500,000, and small agricultural service firms, have been
defined by the Small Business Administration as those having annual
receipts of less than $3,500,000. None of the domestic olive handlers
may be classified as small entities. The majority of olive producers
and importers may be classified as small entities.
This rule finalizes an interim final rule that establishes grade
and size requirements for olives grown in California, which are
authorized for limited use styles. The interim final rule was published
in the September 17, 1993, Federal Register [58 FR 48592], and provided
30 days to interested persons to file comments. No comments were
received.
This rule also finalizes an interim final rule that authorizes the
importation of smaller sized olives for limited uses. The interim final
rule was published in the September 17, 1993, Federal Register [58 FR
48595], and provided 30 days for interested persons to file comments.
No comments were received.
Nearly all of the olives grown in the United States are produced in
California. The growing areas are scattered throughout California with
most of the commercial production coming from inland valleys. In 1990,
about 77 percent of the production came from the San Joaquin Valley and
23 percent from the Sacramento Valley. California olives are primarily
used for canned ripe whole and whole pitted olives which are eaten out
of hand as hors d'oeuvres or used as an ingredient in cooking and in
salads. The canned ripe olive market is essentially a domestic market.
Very few shipments of California olives are exported.
Olive production has fluctuated from a low of 24,200 tons during
the 1972-73 crop year to a high of 168,500 tons during the 1992-93 crop
year. The California Olive Committee (committee) indicated that 1991-92
production totalled about 63,260 tons. The various varieties of olives
produced in California have alternate bearing tendencies with high
production one year and low the next. Total production for the 1992-93
crop year is approximately 163,500 tons. Total production for the 1993-
94 crop year is estimated to be 110,000 tons. However, based on past
production and marketing experience, the committee believes that
handlers will need smaller sized olives during the 1993-94 crop year to
meet market requirements for limited use styles of canned olives for
the 1993-94 year. Absent this action, olives which are smaller than
those authorized for whole and whole pitted canning uses would have to
be disposed of by handlers into non-canning uses such as crushing into
oil.
Paragraph (a)(3) of Sec. 932.52 of the order provides that
processed olives smaller than the sizes prescribed for whole and whole
pitted styles may be used for limited uses if recommended by the
committee and approved by the Secretary. Until October 1, 1991,
paragraph (a)(3) also prescribed minimum sizes, by variety group, which
could be authorized for use in the production of limited use styles by
the Secretary.
Effective October 1, 1991, certain non-canning size disposition
requirements specified in Sec. 932.51(a)(3) and minimum sizes
authorized for limited use specified in Sec. 932.52(a)(3) of the
marketing order were suspended. The committee may now recommend the use
of olives for limited uses that are smaller than those previously
permitted under the order. Minimum size and grade requirements may be
recommended annually by the committee and approved by the Secretary.
The sizes authorized herein are the same as those established for the
1992-93 crop year. The minimum sizes which could previously be
authorized for limited uses were established in a 1971 amendment to the
marketing order. Olives smaller than the prescribed minimum sizes which
could be authorized for limited uses had to be disposed of through less
profitable non-canning uses such as crushing for oil. Returns to
producers are lower on smaller fruit used for such purposes. The use of
smaller sized olives for limited use styles has been authorized in all
but two crop years since the order was instituted in 1965.
Since the 1971 amendment, there have been substantial changes
within the olive industry. In spite of the annual limited use
authorization, in recent years the industry has not been able to meet
market needs for its products, especially the limited use styles used
primarily by the food service industry. The demand for processed olives
and for limited use styles is expected to continue to increase. At the
same time, the industry has not been able to increase production to
meet market needs for canned ripe olives.
The committee conducted a study during the 1990-91 crop year to
determine the feasibility of utilizing smaller sized olives in the
production of limited use styles and to determine which sizes could be
efficiently processed into such styles. All olive handlers within the
industry participated in the study. All handlers reported that smaller
sizes can be efficiently processed into limited use styles. Advanced
technology in the form of better processing equipment is currently
available. The new technology allows handlers to process smaller olives
into limited use styles more efficiently than was possible in the past.
This action will help growers and handlers to meet the growing
market requirements for limited use style olives based upon current
conditions. The size requirements allow the use of sizes which would
otherwise have to be disposed of for non-canning use. In turn, growers
should receive a larger return from such olives.
By a mail ballot vote ending June 15, 1993, the committee
unanimously recommended establishment of grade and size regulations
during the 1993-94 crop year pursuant to paragraph (a)(3) of
Sec. 932.52 of the order. The grade requirements are the same as
established in recent seasons. The specific sizes for the variety
groups are the minimum sizes which are deemed desirable for use in the
production of limited use styles at this time. As in past years,
permitting the use of the smaller olives in the production of limited
use styles allowed handlers to take advantage of the strong market for
halved, segmented, sliced, and chopped canned ripe olives. Handlers
will be able to market more olives than would be permitted in the
absence of this relaxation in size requirements. This additional
opportunity is provided to maximize the use of the available olive
supplies and facilitate market expansion, thereby increasing returns to
growers. In the absence of this action, the smaller fruit would have to
be disposed of for less profitable, non-canning uses.
Section 8(e) of the Act requires that whenever grade, size,
quality, or maturity requirements are in effect for olives under a
domestic marketing order, imported olives must meet the same or
comparable requirements. This action allows smaller olives for limited
use styles under the marketing order. Therefore, a corresponding change
is needed in the olive import regulation.
Canned ripe olives, and bulk olives for processing into canned ripe
olives, imported into the United States must meet certain minimum grade
and size requirements specified in Olive Regulation 1 (7 CFR 944.401).
All canned ripe olives are required to be inspected and certified prior
to importation (release from custody of the United States Custom
Service), and all bulk olives for processing into canned ripe olives
must be inspected and certified prior to canning. ``Canned ripe
olives'' means olives in hermetically sealed containers and heat
sterilized under pressure, of two distinct types, ``ripe'' and ``green-
ripe'', as defined in the current U.S. Standards for Grades of Canned
Ripe Olives (7 CFR 52.3751-52.3764). The term does not include Spanish-
style green olives. Any lot of olives failing to meet the import
requirements may be exported or disposed of under the supervision of
the Processed Products Branch of the Fruit and Vegetable Division, with
the costs of certifying the disposal of the olives borne by the
importer. Any person may import up to 100 pounds (drained weight) of
canned ripe olives or bulk olives exempt from these grade and size
requirements.
This final rule modifies paragraph (b)(12) of the olive import
regulation (7 CFR 944.401 (b)(12)) to authorize the importation of bulk
olives which do not meet the minimum size requirements established for
olives for whole and whole pitted uses to be used in the production of
limited use styles for the 1993-94 season which begins August 1, 1993.
This rule also establishes size regulations for such olives in
paragraph (b)(12).
Import regulations issued under the Act are based on regulations
established under Federal marketing orders to regulate domestically
produced products. The grade and size requirements contained in the
olive import regulation are based on those in effect for olives grown
in California under Marketing Order No. 932. This action reflects a
recommendation by the committee to change the requirements for olives
for limited use styles grown in California. The committee works with
the Department in administering the marketing order program for
California olives.
Paragraph (a)(3) of Sec. 932.52 of the California olive marketing
order provides that processed olives smaller than the sizes prescribed
for whole and whole pitted styles may be used for limited uses if
recommended by the committee and approved by the Secretary. The sizes
are specified in terms of minimum weights for individual olives in
various size categories by variety groups. This is to recognize the
different sizing characteristics of the individual varieties and types
of California olives. Olives used in limited use styles are too small
to be desirable for use as whole or whole pitted canned olives because
their flesh-to-pit ratio is too low. However, they are satisfactory for
use in the production of limited use styles.
The committee unanimously recommended to authorize establishment of
minimum sizes for use in the production of limited use styles during
the 1993-94 season. These minimum sizes would be the same as those
established for the 1992-93 season. The sizes are specified in terms of
minimum weights for individual olives in various variety groups and are
the same for both domestic and imported olives. An extra category is
continued in the import regulation to apply comparable requirements for
varieties not grown domestically. The minimum sizes are as follows:
Variety Group I, except the Ascolano, Barouni, or St. Agostino
varieties--1/105 pound
Variety Group I of the Ascolano, Barouni, or St. Agostino
varieties--1/180 pound
Variety Group 2, except the Obliza variety--1/205 pound
Variety Group 2 of the Obliza variety--1/180 pound
Olives not identifiable as to variety or variety group--1/205 pound
Each of the categories includes a 35 percent tolerance for olives
weighing less than the specified minimum size.
This action is necessary because section 8e of the Act provides
that when domestically produced olives are regulated under a Federal
marketing order, imported olives must meet the same or comparable
grade, size, quality, and maturity requirements. Thus, authorizing the
use of smaller sized California olives in the production of limited use
styles and establishing size regulations for such olives requires that
the same or comparable regulations be issued for imported bulk olives.
Permitting the use of smaller olives in the production of limited
use styles will allow importers to take better advantage of the strong
market for halved, segmented, sliced, and chopped canned ripe olives.
Importers will be able to import and market more olives than would be
permitted in the absence of this relaxation in size requirements. This
additional opportunity is provided to maximize the use of the available
olive supply and facilitate market expansion. In the absence of this
action, the smaller fruit could not be imported for limited uses, and
would have to be disposed of through less profitable, non-canning uses
under the supervision of the inspection service or exported.
A change in paragraph (c) to be implemented indefinitely, updates
the list of regional inspection offices listed in the import
regulation. The change reflects consolidation of the Southeastern and
Central offices into the Eastern Regional Office and the relocation of
the Western Regional Office.
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.
In accordance with section 8e of the Act, the U.S. Trade
Representative has concurred with the issuance of this final rule.
After consideration of all relevant matter presented, the
information and recommendations submitted by the committee, and other
information, it is found that finalizing the interim final rules,
without change, as published in the Federal Register [FR 58 48592 and
48595], will tend to effectuate the declared policy of the Act.
List of Subjects
7 CFR Part 932
Marketing agreements, Olives, Reporting and recordkeeping
requirements.
List of Subjects
7 CFR Part 944
Avocados, Food grades and standards, Grapefruit, Grapes, Imports,
Kiwifruit, Limes, Olives, and Oranges.
For the reasons set forth in the preamble 7 CFR parts 932 and 944
are amended as follows:
1. The authority citation for 7 CFR Parts 932 and 944 are revised
to read as follows:
Authority: 7 U.S.C. 601-674.
PART 932--OLIVES GROWN IN CALIFORNIA
2. Accordingly, the interim final rule revising the provisions of
Sec. 932.153, which was published in the September 17, 1993, Federal
Register [58 FR 48592], is adopted as a final rule without change.
PART 944--FRUITS; IMPORT REGULATIONS
3. Accordingly, the interim final rule amending the provisions of
Sec. 944.401, which was published in the September 17, 1993, Federal
Register [58 FR 48595], is adopted as a final rule without change.
Dated: January 3, 1994.
Robert C. Keeney,
Deputy Director, Fruit and Vegetable Division.
[FR Doc. 94-429 Filed 1-7-94; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 94-428 Navel and Valencia Oranges Grown in Arizona and Designated Parts of California; Suspension of Form 8 and Form 3
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1268-1269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-428]
[[Page Unknown]]
[Federal Register: January 10, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
7 CFR Parts 907 and 908
[FV93-907-4IFR]
Navel and Valencia Oranges Grown in Arizona and Designated Parts
of California; Suspension of Form 8 and Form 3
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Interim final rule; suspension.
-----------------------------------------------------------------------
SUMMARY: This rule invites comments on changes to the reporting
requirements currently prescribed under the California-Arizona navel
and Valencia orange marketing orders. This rule suspends language in
the orders and in the orders' rules and regulations to discontinue the
use of Form 8 (Certificate of Assignment of Allotment) and Form 3
(Daily Manifest Report of Oranges Subject to Allotment), and will
reduce the burden of information collection requirements currently
provided for under the marketing orders.
DATES: Effective Date: January 10, 1994.
Comments received by February 9, 1994, will be considered prior to
issuance of a final action.
ADDRESSES: Interested persons are invited to submit written comments
concerning this action. Comments must be sent in triplicate to the
Docket Clerk, Fruit and Vegetable Division, AMS, USDA, room 2525-S,
P.O. Box 96456, Washington, DC 20090-6456. All comments should
reference the docket number and the date and page number of this issue
of the Federal Register and will be made available for public
inspection in the Office of the Docket Clerk during regular business
hours.
FOR FURTHER INFORMATION CONTACT: Maureen Pello, California Marketing
Field Office, Marketing Order Administration Branch, F&V, AMS, USDA,
2202 Monterey Street, suite 102B, Fresno, California 93721; telephone:
(209) 487-5901; or Christian Nissen, Marketing Specialist, Marketing
Order Administration Branch, F&V, AMS, USDA, room 2522-S, P.O. Box
96456, Washington, DC 20090-6456; telephone: (202) 720-5127.
SUPPLEMENTARY INFORMATION: This document is issued under Marketing
Order Nos. 907 and 908 [7 CFR parts 907 and 908], as amended,
regulating the handling of navel and Valencia oranges grown in Arizona
and designated parts of California, hereinafter referred to as the
``orders.'' These 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 is issuing this rule in conformance
with Executive Order 12866.
This action has been reviewed under Executive Order 12778, Civil
Justice Reform. This action is not intended to have retroactive effect.
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 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 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 approximately 140 handlers of navel oranges and 125
handlers of Valencia oranges who are subject to regulation under the
respective marketing order and approximately 3,750 producers of navel
oranges and 3,700 producers of Valencia oranges in the regulated areas.
Small agricultural service firms have been defined by the Small
Business Administration [13 CFR 121.601] as those having annual
receipts of less than $3,500,000, and small agricultural producers are
defined as those whose annual receipts are less than $500,000. The
majority of handlers and producers of California-Arizona navel and
Valencia oranges may be classified as small entities.
This rule invites comments on two changes to the reporting
requirements currently prescribed under the California-Arizona orange
marketing orders. This rule suspends language in the orders and in the
orders' rules and regulations to discontinue the use of Form 8
(Certificate of Assignment of Allotment) and Form 3 (Daily Manifest
Report of Oranges Subject to Allotment). These changes were unanimously
recommended by the committees.
Currently, sections 907.58 and 908.58 of the navel and Valencia
orange marketing orders specify that, for the handling of oranges other
than by rail car (primarily truck shipments), handlers issue to the
consignee an assignment of allotment certificate covering each quantity
of oranges so handled. Sections 907.112 and 908.112 of the orders'
rules and regulations require handlers to submit such information on
Form 8. Handlers are also required to segregate the information on Form
8 by size of oranges shipped and destination (i.e., U.S. and Alaska or
Canada).
Since the inception of the orders, the committees have utilized
Form 8 primarily for tracking and verifying truck shipments of oranges
that were subject to volume regulation. However, with the volume
regulation features of the orders suspended [58 FR 53,114; October 14,
1993], the committees believe that continued submission of Form 8
creates an additional burden on handlers that is unnecessary.
According to the committees, many handlers have long questioned the
value of Form 8 (commonly referred to in the industry as ``the daily
truck ticket'') during periods of no volume regulation. Shipment
information from Form 8 is transferred to Form 4 (Weekly Report).
Handlers maintain their own manifest records of these shipments and,
without weekly volume regulation, Form 4 provides similar data with the
exception of number of cartons shipped by size. The committees plan on
requesting size information from handlers as needed on a voluntary
basis and anticipate revising the weekly Form 4 at a later time to
provide for the collection of size information.
Thus, the committees believe that continued submission of Form 8,
particularly during periods of no volume regulation, is not necessary.
Accordingly, the committees have recommended suspending sections 907.58
and 908.58 of the orders and Secs. 907.112 and 908.112 of the orders'
rules and regulations so that Form 8 will be discontinued.
The second change that the committees recommended concerns Form 3
(Daily Manifest Report of Oranges Subject to Allotment). Currently,
sections 907.71 and 908.71 of the orange orders provide that handlers
furnish to the committees information regarding cartons of oranges
handled, segregated by size, within 24 hours of shipment. Handlers must
also indicate whether the shipments were destined to points in the U.S.
and Alaska or Canada. Sections 907.141 and 908.141 of the orders' rules
and regulations require handlers to submit this information for rail
car shipments on Form 3.
The information collected on Form 3 is similar to the information
collected on Form 8 described earlier, but pertains to rail car
shipments rather than truck shipments. Again, this information has
historically been utilized primarily for tracking and verifying
shipments of oranges that were subject to volume regulation. However,
with the volume regulation features of the orders suspended, the
committees believe that continued submission of Form 3, like Form 8,
creates an additional burden on handlers that is unnecessary. Handlers
are also required to submit similar information on rail car shipments
on the weekly Form 4. As with size information pertaining to truck
shipments, the committees plan on requesting size information from
handlers for rail car shipments on a voluntary basis until the weekly
Form 4 is appropriately revised.
Like Form 8, the committees believe that continued submission of
Form 3, particularly during periods of no volume regulation, is not
necessary. Accordingly, the committees have recommended suspending
Secs. 907.71 and 908.71 of the orders and Secs. 907.141 and 908.141 of
the orders' rules and regulations so that Form 3 will be discontinued.
Based on these considerations, 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 contained in the referenced
sections 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 0581-0116 for navel oranges and 0581-0121 for
Valencia oranges. This rule will reduce the reporting burden on
approximately 265 handlers of navel and Valencia oranges who have been
completing Form 8, taking about .40 hour to complete each report. This
rule will also reduce the reporting burden on about 80 orange handlers
who ship by rail at some point during a season and utilize Form 3,
taking about 0.20 hours to complete each report.
After consideration of all relevant material presented, including
the committee's recommendation, and other available 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)
Handlers are currently shipping navel oranges and these actions will
reduce the burden of information collection placed on such handlers;
(2) the committees unanimously recommended these actions at public
meetings and all interested persons had an opportunity to provide
input; (3) these actions relax reporting requirements; (4) California-
Arizona orange handlers are aware of this action and need no additional
time to comply with the relaxed requirements; and (5) this action
provides a 30-day comment period and any comments received will be
considered prior to finalization of this action.
List of Subjects in 7 CFR Parts 907 and 908
Marketing agreements, Oranges, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, 7 CFR parts 907 and 908
are amended as follows:
PART 907--NAVEL ORANGES GROWN IN ARIZONA AND DESIGNATED PARTS OF
CALIFORNIA
1. The authority citation for both 7 CFR parts 907 and 908
continues to read as follows:
Authority: 7 U.S.C. 601-674.
2. Sections 907.58, 907.71, 907.112, and 907.141 are suspended in
their entirety.
PART 908--VALENCIA ORANGES GROWN IN ARIZONA AND DESIGNATED PARTS OF
CALIFORNIA
3. Sections 908.58, 908.71, 908.112, and 908.141 are suspended in
their entirety.
Dated: January 3, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-428 Filed 1-7-94; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 94-425 Grading and Inspection, General Specifications for Approved Plants and Standards for Grades of Dairy Products; United States Standards for Grades of Whipped Butter
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1263-1266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-425]
Federal Register / Vol. 59, No. 6 / Monday, January 10, 1994 /
[[Page Unknown]]
[Federal Register: January 10, 1994]
VOL. 59, NO. 6
Monday, January 10, 1994
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 58
[DA-92-18]
Grading and Inspection, General Specifications for Approved
Plants and Standards for Grades of Dairy Products; United States
Standards for Grades of Whipped Butter
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule promulgates new United States Standards for
Grades of Whipped Butter. These standards establish quality criteria
for grade determination and optional microbiological and keeping-
quality tests for whipped butter.
The Department has determined that the grading of butter sold in
consumer-size packages bearing USDA official identification (grade-
label) should be conducted when the product is in the final package.
Previously, the quality of whipped butter was evaluated prior to the
whipping process using the U.S. Standards for Grades of Butter. The
U.S. Standards for Grades of Whipped Butter change this procedure.
EFFECTIVE DATE: February 9, 1994.
FOR FURTHER INFORMATION CONTACT: Diane D. Lewis, 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 this action will
not increase costs to those utilizing the standards.
The Department is issuing this rule in conformance with Executive
Order 12866.
In 1991, the Department evaluated the procedures used to assign
U.S. grades to butter in consumer-size packages. The Department
concluded that grading of the product should be conducted in the final
package because the evaluation of whipped butter at that time is more
accurate.
Previously, the procedure for evaluating grade-label whipped butter
was to either grade the butter in the bulk form prior to whipping or
obtain a sample of fresh butter taken during the manufacturing process
and evaluate it. These methods are changed by this action because of
the Department's decision to conduct grading in the final package. The
new standards have received general support from many of the
manufacturers of whipped butter who utilize the USDA grade-label
program, as well as from the American Butter Institute. In addition,
the standards were field-tested by the Dairy Grading Branch and found
to be satisfactory.
In view of the need for new standards, the Department published on
June 30, 1993 (58 FR 34937) proposed United States Standards for
Whipped Butter. Except for minor format changes, the standards
contained in this final rule are the same as those set forth in the
proposal. The new standards establish the following.
1. Provide Quality Specifications for Whipped Butter at Two U.S. Grade
Levels: U.S. Grade AA and U.S. Grade A
Whipped butter is produced by uniformly incorporating air or inert
gas into butter to improve its spreadability characteristics. The
percent overrun, based on buyer or consumer preference, is usually
between 50 and 100 percent. Market analysis conducted during the
development of these standards supports the opinion that consumers
prefer the higher quality products. Therefore, standards are
established for quality designations at two levels: U.S. Grade AA and
U.S. Grade A.
2. Define Flavor Characteristics
Production and processing practices influence flavor
characteristics in whipped butter. To manufacture whipped butter with a
highly pleasing flavor, the raw milk and cream must be free of
objectionable flavors. This final rule defines acceptable flavor
characteristics to assist the graders in identifying and classifying
the flavor.
3. Define Body, Color, and Salt Characteristics and Establish
Disratings
Just as production and processing practices influence the flavor of
whipped butter, they also influence body, color, and salt
characteristics. This final rule describes distinguishing body, color,
and salt characteristics and establishes disratings which are used to
determine the U.S. grade.
4. Illustrate How Flavor, Body, Color, and Salt Characteristics
Influence Grade Determination
These standards provide step-by-step instructions in determining
the final grade of whipped butter. The U.S. grade of whipped butter is
determined on the basis of classifying first the flavor
characteristics. Then body, color, and salt characteristics are noted
and disratings established. When total disratings exceed the permitted
amount identified in the standards, the final U.S. grade is lowered.
5. Establish Optional Microbiological and Keeping-Quality Tests (Not
Mandatory for Grade Designation)
Since 1975, the General Specifications for Dairy Plants Approved
for USDA Inspection and Grading Service have required microbiological
and keeping-quality testing of whipped butter bearing USDA official
identification. The market analysis conducted during the development of
these standards revealed that the industry utilized tighter
microbiological specifications for proteolytic and yeast and mold
counts than those listed in the ``General Specifications''. To be more
aligned with current industry standards, this final rule tightens these
microbiological requirements. This final rule also incorporates these
same tests as optional tests (not mandatory for grade designation) in
the United States Standards for Grades of Whipped Butter.
This final rule also makes corollary changes in the General
Specifications for Dairy Plants Approved for USDA Inspection and
Grading Service (subpart B of 7 CFR part 58) to conform the definition
and grade designations of whipped butter set forth therein with the new
United States Standards for Grades of Whipped Butter (in subpart G of 7
CFR part 58).
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 whipped butter 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. This
action makes minor format changes for purposes of clarity to Tables I
and III to the format that appeared in the proposed rule.
Public Comments
On June 30, 1993, the Department published a proposed rule (58 FR
34937) to promulgate the United States Standards for Whipped Butter.
The public comment period closed August 30, 1993. No comments were
received during this time.
List of Subjects in 7 CFR Part 58
Dairy products, Food grades and standards, Food labeling, Reporting
and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 58 is amended
as follows:
PART 58--[AMENDED]
1. The authority citation for 7 CFR part 58 continues to read as
follows:
Authority: Agricultural Marketing Act of 1946, Secs. 202-208, 60
Stat. 1087, as amended; 7 U.S.C. 1621-1627, unless otherwise noted.
2. In subpart B, Sec. 58.305 (f) is revised to read as follows:
Sec. 58.305 Meaning of words.
* * * * *
(f) Whipped butter. The food product is made by the uniform
incorporation of air or inert gas into butter.
Sec. 58.323 [Removed and Reserved].
3. In subpart B, Sec. 58.323 is removed and reserved.
4. In subpart B, Sec. 58.346 is revised to read as follows:
Sec. 58.346 Whipped butter.
(a) The quality requirements for whipped butter shall be in
accordance with the U.S. Standards for Grades of Whipped Butter for
U.S. Grade AA and U.S. Grade A, respectively.
(b) Whipped butter shall also be subject to the following
specifications when sampled and tested in accordance with Sec. 58.336
and Sec. 58.337, respectively:
(1) Proteolytic count, not more than 50 per gram; yeast and mold
count, not more than 10 per gram; coliform count, not more than 10 per
gram; and keeping-quality test, satisfactory after 7 days at 70 deg.F.
(2) Optional except when required or requested: Copper content, not
more than 0.3 ppm; iron content, not more than 1.0 ppm; enterococci,
not more than 10 per gram.
5. A new Subpart G--United States Standards for Grades of Whipped
Butter is added to read as follows:
Subpart G--United States Standards for Grades of Whipped Butter
Definitions
Sec.
58.2425 Whipped butter.
58.2426 Butter.
58.2427 Cream.
U.S. Grades
58.2428 Nomenclature of U.S. grades.
58.2429 Basis for determination of U.S. grade.
58.2430 Specifications for U.S. grades.
58.2431 Relationship of U.S. grade of whipped butter to the flavor
classifications as affected by disratings in body, color, and salt
characteristics.
58.2432 Optional tests.
58.2433 U.S. grade not assignable.
58.2434 Test methods.
Explanation of Terms
58.2435 Explanation of terms.
Subpart G--United States Standards for Grades of Whipped Butter\1\
---------------------------------------------------------------------------
\1\Compliance with these standards does not excuse failure to
comply with provisions of the Federal Food, Drug and Cosmetic Act.
---------------------------------------------------------------------------
Definitions
Sec. 58.2425 Whipped butter.
Whipped butter is the food product made by the uniform
incorporation of air or inert gas into butter.
Sec. 58.2426 Butter.
The food product usually known as butter, and which is made
exclusively from milk or cream, or both, with or without common salt,
with or without additional coloring matter, and containing not less
than 80 percent by weight of milkfat, all tolerances having been
allowed for.
Sec. 58.2427 Cream.
The term cream when used in this subpart G means cream separated
from milk produced by healthy cows. The cream shall be pasteurized at a
temperature of not less than 165 deg.F and held continuously in a vat
at such temperature for not less than 30 minutes; or pasteurized at a
temperature of not less than 185 deg.F for not less than 15 seconds; or
pasteurized by other approved methods giving equivalent results.
U.S. Grades
Sec. 58.2428 Nomenclature of U.S. grades.
The nomenclature of U.S. grades is as follows:
(a) U.S. Grade AA.
(b) U.S. Grade A.
Sec. 58.2429 Basis for determination of U.S. grade.
The U.S. grade of whipped butter is determined on the basis of
classifying first the flavor characteristics and then the
characteristics in body, color, and salt of a representative sample.
Flavor is the basic quality factor in grading whipped butter and is
determined organoleptically by smell and taste. The flavor
characteristic and intensity is identified and rated according to the
applicable classification contained in Table I in Sec. 58.2430. When
more than one flavor characteristic is discernible in a sample of
whipped butter, the flavor classification of the sample shall be
established on the basis of the flavor that carries the lowest rating.
Body, color, and salt characteristics are then noted and disratings are
made in accordance with the established classification in Table II in
Sec. 58.2430. The final U.S. grade for the sample is then established
in accordance with the flavor classification, subject to permitted
disratings for body, color, and salt as outlined in Sec. 58.2431.
Sec. 58.2430 Specifications for U.S. grades.
The specifications for the U.S. grades of whipped butter are as
follows:
(a) U.S. Grade AA. U.S. Grade AA whipped butter conforms to the
following: Shall possess a fine and highly pleasing butter flavor.
Whipped butter may also have a lactic culture flavor. May possess a
slight feed, or a definite cooked flavor. The permitted disratings in
body, color, and salt characteristics are limited to one-half (\1/2\).
For detailed specifications and classification of flavor
characteristics, see Table I of this section. For body, color, and salt
disratings, see Table II of this section.
(b) U.S. Grade A. U.S. Grade A whipped butter conforms to the
following: Shall possess a pleasing and desirable butter flavor.
Whipped butter may also have a lactic culture flavor. May possess to a
slight degree the following flavors: acid, aged, bitter, coarse, flat,
smothered, and storage. May possess a definite feed flavor. The
permitted disratings in body, color, and salt characteristics are
limited to one-half (\1/2\). For detailed specifications and
classification of flavor characteristics, see Table I of this section.
For body, color, and salt disratings, see Table II of this section.
(c) General. Whipped butter of all U.S. grades shall be free from
foreign materials and visible mold. When total disratings exceed the
permitted amount, the final U.S. grade shall be lowered one grade level
for each additional one-half (\1/2\) disrating.
Table I.--Classification of Flavor With Corresponding U.S. Grade
------------------------------------------------------------------------
U.S. grade
designation
Flavor characteristics\1\ ---------------
AA A
------------------------------------------------------------------------
Acid.................................................... -- S
Aged.................................................... -- S
Bitter.................................................. -- S
Coarse.................................................. -- S
Cooked.................................................. D ......
Feed.................................................... S D
Flat.................................................... -- S
Smothered............................................... -- S
Storage................................................. -- S
------------------------------------------------------------------------
\1\When more than one flavor is discernible in a sample of whipped
butter, the flavor classification of the sample shall be established
on the basis of the flavor that carries the lowest rating.
(--) = Not Permitted
S = Slight
D = Definite
Table II.--Characteristics and Disratings in Body, Color and Salt
------------------------------------------------------------------------
Disratings
Characteristics -----------------------
Slight Definite
------------------------------------------------------------------------
Body:
Free moisture................................. \1/2\ 1
Mealy or grainy............................... \1/2\ 1
Color:
Color specks.................................. 1 1\1/2\
Mottled....................................... \1/2\ 1
Wavy.......................................... \1/2\ 1
Salt:
Gritty........................................ 1 1\1/2\
Sharp......................................... 1 1\1/2\
------------------------------------------------------------------------
Sec. 58.2431 Relationship of U.S. grade of whipped butter to the
flavor classifications as affected by disratings in body, color, and
salt characteristics.
When the disratings for body, color, and salt exceed the permitted
amount of (\1/2\) for any flavor classification, the final U.S. grade
shall be lowered accordingly:
Table III
------------------------------------------------------------------------
Flavor classification Total disratings U.S. grade
------------------------------------------------------------------------
AA......................... \1/2\ AA
AA......................... 1 A
AA......................... 1\1/2\ (*)
A.......................... \1/2\ A
A.......................... 1 (*)
------------------------------------------------------------------------
(*)=No U.S. grade assigned.
Sec. 58.2432 Optional tests.
(a) There are optional tests (not mandatory for grade designation)
that may be made on whipped butter that can be requested by the buyer
or seller. If requested, the product must comply with the
microbiological and keeping-quality specifications as follows:
Proteolytic count--not more than 50 per gram
Yeast and mold count--not more than 10 per gram
Coliform count--not more than 10 per gram
Keeping-quality test--satisfactory after 7 days at 70 deg.F.
(b) All required tests, and optional tests when specified, shall be
performed in accordance with the test methods identified in
Sec. 58.2434.
Sec. 58.2433 U.S. grade not assignable.
Whipped butter shall not be assigned a U.S. grade for one or more
of the following reasons:
(a) The butter fails to meet or exceed the requirements for U.S.
Grade A.
(b) The butter, when tested, does not comply with the provisions of
the Federal Food, Drug, and Cosmetic Act, or the minimum milkfat
requirements of 80.0 percent.
(c) The butter is produced in a plant that is rated ineligible for
USDA grading service or is not USDA-approved.
Sec. 58.2434 Test methods.
Testing methods contained in the latest edition of the ``Standard
Methods for the Examination of Dairy Products'' or the ``Official
Methods of Analysis of the Association of Official Analytical
Chemists'' are used to determine bacterial estimates and milkfat
content.
Explanation of Terms
Sec. 58.2435 Explanation of terms.
(a) With respect to flavor intensity and characteristics:
(1) Slight. Detected only upon critical examination.
(2) Definite. Not intense but detectable.
(3) Acid. Lacks a delicate flavor or aroma and is associated with
an acid condition but there is no indication of sourness.
(4) Aged. Characterized by lack of freshness.
(5) Bitter. Astringent, similar to taste of quinine and produces a
puckery sensation.
(6) Coarse. Lacks a fine, delicate, smooth flavor.
(7) Cooked. Smooth, nutty-like characteristic resembling a custard
flavor.
(8) Feed. Aromatic flavor characteristic of the feed eaten by cows.
(9) Flat. Lacks natural butter flavor.
(10) Smothered. Suggestive of improperly cooked cream.
(11) Storage. Characterized by a lack of freshness and more
intensified than ``aged'' flavor.
(b) With respect to body:
(1) Free moisture. ``Free moisture'' is present when beads of
moisture are visible on the surface of the sample. The intensity is
described as ``slight'' when the droplets or beads of moisture are
barely visible, few in number, and about the size of a pinhead; and
``definite'' when the moisture droplets are clearly visible, more
numerous, and are somewhat larger in size.
(2) Mealy or grainy. A ``mealy'' or ``grainy'' condition imparts a
granular consistency when the whipped butter is melted on the tongue.
The intensity is described as ``slight'' when the mealiness or
graininess is barely detectable; and ``definite'' when the mealiness or
graininess is clearly detectable.
(c) With respect to color:
(1) Mottled. ``Mottled'' appears as a dappled condition with spots
of lighter and deeper shades of yellow. The intensity is described as
``slight'' when the small spots of different shades of yellow,
irregular in shape, are barely discernible on the sample of whipped
butter; and ``definite'' when the mottles are more clearly discernible.
(2) Color specks. ``Specks'' usually appear in whipped butter as
small white or yellow spots. The intensity is described as ``slight''
when the spots are few in number; and ``definite'' when they are
noticeable in larger numbers.
(3) Wavy. ``Wavy'' color in whipped butter is an unevenness in the
color that appears as waves of different shades of yellow. The
intensity is described as ``slight'' when the waves are barely
discernible; and ``definite'' when they are readily noticeable.
(d) With respect to salt:
(1) Gritty. A ``gritty'' salt condition imparts a sand-like feeling
on the tongue due to grains of undissolved salt. The intensity is
described as ``slight'' when only a few grains of undissolved salt are
detected; and ``definite'' when the condition is more readily
noticeable.
(2) Sharp. ``Sharp'' salt is characterized by taste sensations
suggestive of salt. The intensity is described as ``slight'' when the
salt taste predominates in flavor; and ``definite'' when the taste
distinctly predominates in flavor.
Dated: January 3, 1994.
Lon Hatamiya,
Administrator.
[FR Doc. 94-425 Filed 1-7-94; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 94-422 Lemons Grown in California and Arizona; Increase in the Organic Exemption Provision
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1269-1270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-422]
[[Page Unknown]]
[Federal Register: January 10, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
7 CFR Part 910
[FV93-910-3 FIR]
Lemons Grown in California and Arizona; Increase in the Organic
Exemption Provision
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document finalizes without change an interim final rule
that amended the rules and regulations established under the marketing
order covering California-Arizona lemons to increase from 350 to 500
cartons per week, the amount of organic lemons handlers may ship
without regard to volume and size regulations. The marketing order
regulates the handling of lemons grown in California and Arizona and is
administered locally by the Lemon Administrative Committee (Committee).
This final rule recognizes additional opportunity to market organic
lemons to organic or health food wholesalers and retailers.
EFFECTIVE DATE: February 9, 1994.
FOR FURTHER INFORMATION CONTACT: Kellee J. Hopper, Marketing
Specialist, California Marketing Field Office, Marketing Order
Administration Branch, F&V, AMS, USDA, 2202 Monterey Street, suite
102B, Fresno, California, 93721; telephone: (209) 487-5901; or Kenneth
G. Johnson, Marketing Specialist, Marketing Order Administration
Branch, F&V, AMS, USDA, room 2522-S, P.O. Box 96456, Washington, DC
20090-6456: telephone: (202) 720-5127.
SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Order
No. 910 [7 CFR part 910], as amended, regulating the handling of lemons
grown in California and Arizona, hereinafter referred to as the
``order.'' This 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 is issuing this rule in conformance with Executive
Order 12866.
This rule has been reviewed under Executive Order 12778, Civil
Justice 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 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 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 approximately 2,000 producers of lemons in the production
area and approximately 70 handlers subject to regulation under the
marketing order. 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 $3,500,000.
The majority of these handlers and producers may be classified as small
entities.
Section 910.80 of the order authorizes the Committee, with the
approval of the Secretary, to establish minimum quantities and types of
shipments which shall be free from regulation under this order. Section
910.180(d)(3) of the administrative rules and regulations prescribes
procedures governing exemption from volume and size regulations for
organic lemons handled in minimum quantities.
On July 23, 1993, Mr. Rich Hart, President of Rainbow Valley
Orchards, sent a letter to the Committee requesting an increase in the
amount of organic lemons a handler may ship free of order regulations
to 500 cartons per week. Currently, handlers can ship up to 350 cartons
of such lemons weekly. At its August 3, 1993, meeting, the Committee
recommended increasing the organic exemption provision from 350 to 500
cartons per week that handlers may ship to organic or health food
wholesalers and retailers without regard to volume and size
regulations. The vote on the recommendation was 12 in favor and 1
abstention. The person who abstained expressed a concern with the
definition of organic.
Shippers of organic lemons have indicated that organic fruit
markets can absorb more fruit than in the past, and that they need to
take advantage of the additional marketing opportunity. The Committee
expects the increase in shipments allowed will provide shipping
flexibility for organic shippers and will facilitate the marketing of
organic lemons. The Committee also believes that sales of organic
lemons will not adversely impact sales of regulated lemons.
The interim final rule was issued on October 4, 1993, with an
effective date of October 8, 1993, and published in the Federal
Register [58 FR 52401, October 8, 1993]. The interim final rule
provided a 30-day comment period ending November 8, 1993, and no
comments were received.
The interim final rule amended the rules and regulations of the
lemon marketing order. This rule modifies language in the order's rules
and regulations to increase from 350 to 500 cartons per week, the
amount of organic lemons handlers may ship free of order regulations.
Based on these considerations, the Administrator of the AMS has
determined that this action will not have a significant economic impact
on a substantial number of small entities.
In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.
Chapter 35), the information collection requirements that are contained
in this rule have been previously approved by the Office of Management
and Budget (OMB) and have been assigned OMB No. 0581-0120.
After consideration of all relevant matter presented, including the
information and recommendations submitted by the Committee and other
available information, it is hereby found that this rule as hereinafter
set forth will tend to effectuate the declared policy of the Act.
List of Subjects in 7 CFR Part 910
Lemons, Marketing agreements, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, 7 CFR part 910 is
amended as follows:
1. The authority citation for 7 CFR part 910 continues to read as
follows:
Authority: 7 U.S.C. 601-674.
PART 910--LEMONS GROWN IN CALIFORNIA AND ARIZONA
2. Accordingly, the interim final rule amending Sec. 910.180, which
was published in the Federal Register [58 FR 52401, October 8, 1993],
is adopted as a final rule without change.
Dated: January 3, 1994.
Robert C. Keeney,
Deputy Director, Fruit and Vegetable Division.
[FR Doc. 94-422 Filed 1-7-94; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 94-421 Finalization of Interim Final Rules for Specified Marketing Orders (Oranges, Grapefruit, and Papayas)
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1266-1268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-421]
[[Page Unknown]]
[Federal Register: January 10, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
7 CFR Parts 906 and 928
[Docket Nos. FV93-906-1, Amendment 1; and FV93-928-2, Amendment 1]
Finalization of Interim Final Rules for Specified Marketing
Orders (Oranges, Grapefruit, and Papayas)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Agriculture (Department) is adopting as a
final rule, without change, the provisions of the interim final rules
that authorized expenses and established assessment rates for the Texas
Valley Citrus Committee and the Papaya Administrative Committee
(Committees) under Marketing Order Nos. 906 and 928, respectively.
Authorization of these budgets enables the Committees to incur expenses
that are reasonable and necessary to administer their respective
programs. Funds to administer these programs are derived from
assessments on handlers.
EFFECTIVE DATE: Section 906.233 is effective August 1, 1993, through
July 31, 1994; Sec. 928.233 is effective July 1, 1993, through June 30,
1994.
FOR FURTHER INFORMATION CONTACT: Britthany E. Beadle, Marketing Order
Administration Branch, F&V, AMS, USDA, P.O. Box 96456, room 2524-S,
Washington, DC 20090-6456; telephone: (202) 720-5127; Belinda Garza
(Sec. 906.233), McAllen Marketing Field Office, Marketing Order
Administration Branch, Fruit and Vegetable Division, AMS, USDA, 1313 E.
Hackberry, McAllen, TX 78501, telephone: (512) 682-2833; or Kurt J.
Kimmel (Sec. 928.233), California Marketing Field Office, Marketing
Order Administration Branch, Fruit and Vegetable Division, AMS, USDA,
2202 Monterey Street, suite 102 B, Fresno, CA 93721, telephone: (209)
487-5901.
SUPPLEMENTARY INFORMATION: This final rule is issued under Marketing
Agreement and Marketing Order No. 906 [7 CFR part 906] regulating the
handling of oranges and grapefruit grown in the lower Rio Grande Valley
in Texas; and Marketing Agreement and Marketing Order No. 928, as
amended [7 CFR part 928] regulating the handling of papayas grown in
Hawaii. The marketing 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 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, oranges and grapefruit grown in Texas and papayas grown in
Hawaii are subject to assessments. It is intended that the assessment
rates specified herein will be applicable to all assessable oranges,
grapefruit, and papayas handled during the 1993-94 fiscal year,
beginning August 1, 1993, through July 31, 1994 (M.O. 906), and July 1,
1993, through June 30, 1994 (M.O. 928). 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 requesting a modification of the order or to be exempted
therefrom. Such 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 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 approximately 135 handlers of oranges and grapefruit, and
120 handlers of papayas subject to regulation under their respective
marketing orders each season. In addition, there are approximately
2,500 orange and grapefruit producers in Texas, and 300 papaya
producers in Hawaii. 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
$3,500,000. The majority of the orange, grapefruit, and papaya
producers and handlers may be classified as small entities.
The respective marketing orders require that the assessment rates
for a particular fiscal year shall apply to all assessable oranges,
grapefruit, and papayas handled from the beginning of such year. An
annual budget of expenses is prepared by each Committee and submitted
to the Department for approval. The members of the Committees are
handlers and producers of the regulated commodities. They are familiar
with the Committees' needs and with the costs for goods, services, and
personnel in their local areas and are thus in a position to formulate
appropriate budgets. The budgets are formulated and discussed in public
meetings. Thus, all directly affected persons have an opportunity to
participate and provide input.
The assessment rates recommended by the Committees are derived by
dividing anticipated expenses by expected shipments of oranges,
grapefruit, and papayas. Because these rates are applied to actual
shipments, they must be established at rates which will produce
sufficient income to pay the Committees' expected expenses. The
recommended budgets and rates of assessment are usually acted upon by
the Committees shortly before a season starts, and expenses are
incurred on a continuous basis. Therefore, the budget and assessment
rate approval must be expedited so that the Committees will have funds
to pay their expenses.
An interim final rule was issued for the Texas Valley Citrus
Committee (TVCC), on July 7, 1993, and published in the Federal
Register [58 FR 37635, July 13, 1993] effective for the period August
1, 1993, through July 31, 1994, with a 30-day comment period ending
August 12, 1993. The interim final rule authorized expenses of $984,319
and an assessment rate of $0.15 per \7/10\ bushel carton for the 1993-
94 fiscal year. No comments were filed on the expenses and assessment
rate in the interim final rule.
The TVCC met again on August 3, 1993, and unanimously recommended
increasing authorized expenses to $1,180,925, a $196,606 increase from
the previously authorized amount. The TVCC also unanimously recommended
increasing the assessment rate from $0.15 per \7/10\ bushel carton to
$0.18 per \7/10\ bushel carton, a $0.03 increase per \7/10\ bushel
carton from the previously established assessment rate.
An amended interim final rule was issued on October 7, 1993, and
published in the Federal Register [58 FR 53111, October 14, 1993]
effective for the period August 1, 1993 through July 31, 1994, and
provided a 30-day comment period. This amended interim final rule
increased authorized expenses to $1,180,925, and increased the
assessment rate to $0.18 per \7/10\ bushel carton of assessable oranges
and grapefruit for the 1993-94 fiscal year under the order. The
$196,606 expense increase is necessary to provide additional funds for
order operations, including $172,606 to fund increased administrative
and compliance expenses, primarily for the maintenance of road guard
stations, and $24,000 to cover a shortfall in the Mexican Fruit Fly
support program. The increase in the assessment rate along with the
withdrawal of additional funds from the TVCC's reserves, will
adequately fund the increased expenses.
An amended interim final rule was issued for the Papaya
Administrative Committee (PAC), on June 14, 1993, and published in the
Federal Register [58 FR 33759, June 21, 1993] effective for the period
July 1, 1993, through June 30, 1994, with a 30-day comment period
ending July 21, 1993. The interim final rule authorized expenses of
$700,580 and an assessment rate of $0.0085 per pound of fresh papayas
for the 1993-94 fiscal year. No comments were filed on the expenses and
assessment rate in the interim final rule.
However, the PAC met again on August 13, 1993, and unanimously
recommended decreasing authorized expenses from $700,580 to $597,860, a
$102,720 decrease in expenses from the authorized amount. The PAC also
unanimously recommended decreasing the assessment rate from $0.0085 to
$0.0069, a $0.0016 decrease in the assessment rate, based upon 58
million pounds of fresh papayas, from the previously established
assessment rate.
An amended interim final rule was issued on October 7, 1993, and
published in the Federal Register [58 FR 53117, October 14, 1993]
effective for the period July 1, 1993, through June 30, 1994, and
provided a 30-day comment period. This amended interim final rule
decreased authorized expenses to $597,860, and reduced the assessment
rate to $0.0069 per pound of fresh papayas for the 1993-94 fiscal year
under the order. Program income for the PAC decreased from $701,660 to
$599,356, a $102,304 decrease from the previous estimate. Major program
income reductions come from a $92,800 decrease in assessment income due
to the lower assessment rate and a $9,504 reduction in income from the
Department's Foreign Agricultural Service.
The $102,720 decrease in expenses results from reductions in a
number of expense items. Major expense reductions include expenditures
for salaries and wages, office rent, auto expenses, and Japanese
advertising and promotion. The projected income over expenses has
increased from $1,080 to $1,496, a $416 increase from the previous
amount. The excess funds will be added to the PAC's operational
reserve.
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 orders. 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.
The amended interim final rules were published in the Federal
Register [58 FR 53111 October 14, 1993], for 7 CFR part 906, and [58 FR
53117, October 14, 1993], for 7 CFR part 928. Each interim final rule
provided a 30-day comment period for interested persons. No comments
were received.
It is found that the specified expenses for the marketing orders
covered in this rule are reasonable and likely to be incurred and that
such expenses and the specified assessment rates to cover such expenses
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 action until 30 days after publication in the
Federal Register [5 U.S.C. 553]. The Committees need to have sufficient
funds to pay their expenses which are incurred on a continuous basis.
The 1993-94 fiscal years for the programs began on August 1, 1993, for
Texas citrus and July 1, 1993, for Hawaii papayas. The marketing orders
require that the rates of assessment for the fiscal year apply to all
assessable oranges, grapefruit, and papayas handled during the fiscal
years. In addition, handlers are aware of these actions which were
recommended by the Committees at public meetings and published in the
Federal Register as interim final rules. No comments were received
concerning the two interim final rules that are adopted in this action
as final rules without change.
List of Subjects
7 CFR Part 906
Grapefruit, Marketing agreements, Oranges, Reporting and
recordkeeping requirements.
7 CFR Part 928
Marketing agreements, Papayas, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, 7 CFR parts 906 and 928
are hereby amended as follows:
1. The authority citation for 7 CFR parts 906 and 928 continue to
read as follows:
Authority: 7 U.S.C. 601-674.
PART 906--ORANGES AND GRAPEFRUIT GROWN IN LOWER RIO GRANDE VALLEY
IN TEXAS
2. For the reasons set forth in the preamble, the interim final
rule revising Sec. 906.233 which was published at 58 FR 53111, is
adopted as a final rule without change.
PART 928--PAPAYAS GROWN IN HAWAII
3. For the reasons set forth in the preamble, the interim final
rule revising Sec. 928.233 which was published at 58 FR 53117, is
adopted as a final rule without change.
Dated: January 3, 1994.
Robert C. Keeney,
Deputy Director, Fruit and Vegetable Division.
[FR Doc. 94-421 Filed 1-7-94; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 94-420 Milk in the Southwest Plains Marketing Area; Suspension of Certain Provisions of the Order
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1273-1274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-420]
[[Page Unknown]]
[Federal Register: January 10, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
7 CFR Part 1106
[DA-94-03]
Milk in the Southwest Plains Marketing Area; Suspension of
Certain Provisions of the Order
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Suspension of rule.
-----------------------------------------------------------------------
SUMMARY: This document suspends indefinitely certain portions of a
provision of the Southwest Plains Federal milk marketing order (Order
106), beginning on the date this document is published in the Federal
Register. The suspension will allow transfers of Class I fluid milk
products from a distributing plant to other plants regulated under
Order 106 to be counted as part of the distributing plant's route sales
for the purpose of determining the plant's pool status under the order.
The suspension was requested by Associated Milk Producers, Inc. (AMPI),
and Mid-America Dairymen, Inc. (Mid-America), who stated that it was
necessary to restore equity among producers supplying handlers
regulated under Order 106.
EFFECTIVE DATE: January 10, 1994.
FOR FURTHER INFORMATION CONTACT: Nicholas Memoli, Marketing Specialist,
USDA/AMS/Dairy Division, Order Formulation Branch, room 2971, South
Building, P.O. Box 96456, Washington, DC 20090-6456, (202) 690-1932.
SUPPLEMENTARY INFORMATION: Prior document in this proceeding: Notice of
Proposed Suspension: Issued November 23, 1993; published November 30,
1993 (58 FR 63120).
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 final rule would not have a
significant economic impact on a substantial number of small entities.
This suspension will lessen the opportunity for disorderly marketing
conditions and will tend to ensure that dairy farmers continue to have
their milk priced under the order and thereby receive the benefits that
accrue from such pricing.
The Department is issuing this 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 the 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 law and request 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 the rules of practice and
procedure governing the formulation of marketing agreements and
marketing orders (7 CFR part 900).
Notice of proposed rulemaking was published in the Federal Register
on November 30, 1993 (58 FR 63120), concerning the proposed suspension
of certain words from the route disposition definition of Order 106.
The public was afforded the opportunity to comment on the notice by
submitting written data, views, and arguments by December 7, 1993. One
comment letter was received.
After consideration of all relevant material, including the
proposal in the notice and other available information, it is hereby
found and determined that the following provision of the order
regulating the handling of milk in the Southwest Plains marketing area
will not tend to effectuate the declared policy of the Act for an
indefinite period commencing with the publication of this document in
the Federal Register:
In Sec. 1106.3, the parenthetical phrase ``(except to a plant)''.
Statement of Consideration
This document will suspend certain words from the route disposition
definition of the order. The effect of this change will be to include
transfers of fluid milk products to other plants regulated under Order
106 in determining if the transferor plant meets the pool qualification
requirements specified in Sec. 1106.7(a) of the order.
According to Mid-America and AMPI, two cooperative associations
representing a substantial number of producers whose milk is pooled
under Order 106, a Tulsa, Oklahoma, handler receiving milk from non-
member producers is also supplied supplemental milk from cooperative
associations that pool milk on the Southwest Plains milk order. The
proponents argued that as a result of excluding transfers of fluid milk
products to other plants regulated under Order 106, the handler has
been a partially regulated plant in recent months and could be again in
the future. Mid-America and AMPI explained that, since the handler's
Class I utilization is higher than the market's average, the handler
has been able to pay its non-member producers a price in excess of the
order's blend price. In addition to the inequity resulting from this
price disparity, AMPI, during the month of September, was required to
depool milk that it had diverted from the Tulsa plant because the plant
otherwise would have failed to qualify as a pool plant during the month
of September. This resulted in additional financial loss to the
cooperative.
A letter supporting the suspension was filed on behalf of the
proponents. There were no comment letters received in opposition to the
suspension.
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;
(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 to interested parties,
and they were afforded opportunity to file written data, views, or
arguments concerning this suspension.
Therefore, good cause exists for making this order effective upon
publication in the Federal Register.
List of Subjects in 7 CFR Part 1106
Milk marketing orders.
For the reasons set forth in the preamble, title 7, part 1106 is
amended as follows:
PART 1106--MILK IN THE SOUTHWEST PLAINS MARKETING AREA
1. The authority citation for 7 CFR part 1106, continues to read as
follows:
Authority: Secs. 1-19, 48 Stat. 31, as amended; 7 U.S.C. 601-
674.
Sec. 1106.3 [Suspended]
2. In Sec. 1106.3 the phrase ``(except to a plant)'' is suspended.
Dated: January 3, 1994.
Patricia Jensen,
Acting Assistant Secretary.
[FR Doc. 94-420 Filed 1-7-94; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 94-221 Federal Old-Age, Survivors and Disability Insurance and Supplemental Security Income; Listing of Impairments—Respiratory System
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1274-1275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-221]
[[Page Unknown]]
[Federal Register: January 10, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Social Security Administration
20 CFR Parts 404 and 416
[Regulations No. 4 and 16]
RIN 0960-AB00
Federal Old-Age, Survivors and Disability Insurance and
Supplemental Security Income; Listing of Impairments--Respiratory
System
AGENCY: Social Security Administration, HHS.
ACTION: Correction to final rules.
-----------------------------------------------------------------------
SUMMARY: This document contains corrections to the final rules
published Thursday, October 7, 1993 (58 FR 52346). The rules revised
the criteria in the Listing of Impairments (the listings) that we use
to evaluate respiratory impairments for adults and children who claim
Social Security benefits or supplemental security income payments based
on disability under titles II and XVI of the Social Security Act.
EFFECTIVE DATE: October 7, 1993.
FOR FURTHER INFORMATION CONTACT: Sandy Bond, Office of Regulations,
Social Security Administration, 6401 Security Boulevard, Baltimore, MD
21235, (410) 965-1794.
SUPPLEMENTARY INFORMATION:
Background
The final rules that are the subject of these corrections revised
the respiratory listings to reflect advances in medical knowledge,
treatment, and methods of evaluating respiratory impairments.
The final rules, as published, contain a number of errors and
omissions in several tables and cross-references which require
correction.
Accordingly, the publication on October 7, 1993, of the final
rules, which were the subject of FR Doc. 93-24238, is corrected as
follows:
Appendix 1 [Amended]
1. On page 52361, in the first column, in listing 3.00E, the first
sentence after the introductory text is corrected by adding the words
``and paragraph A of 3.04'' after the words ``paragraph A and B of
3.02''.
2. On page 52361, in the third column, in listing 3.00E, the first
sentence of the last paragraph is corrected by adding the words ``and
3.04'' after the words ``in 3.02''.
3. On page 52364, in the second column, in listing 3.04C., in table
IV, the last entry in the second column, ``71 or less'', is corrected
to read ``71 or more''.
Dated: December 21, 1993.
Neil J. Stillman,
Deputy Assistant Secretary for Information Resources Management.
[FR Doc. 94-221 Filed 1-7-94; 8:45 am]
BILLING CODE 4190-29-P
Complete official Federal Register PDF
FR Doc. 94-11 Collection of Debts by Federal Tax Refund Offset
[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Rules and Regulations]
[Pages 1277-1278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11]
[[Page Unknown]]
[Federal Register: January 10, 1994]
=======================================================================
-----------------------------------------------------------------------
GENERAL SERVICES ADMINISTRATION
41 CFR Part 105-57
Collection of Debts by Federal Tax Refund Offset
AGENCY: General Services Administration.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document amends the General Services Administration (GSA)
Regulations by adding procedures to implement the Federal Tax Refund
Offset Program in GSA. Participation in the program is mandated by the
Cash Management Improvement Act amendments of 1992. The GSA expects to
improve the collection of delinquent debts due the agency by
participation in the Federal Tax Refund Offset Program.
EFFECTIVE DATE: January 10, 1994.
FOR FURTHER INFORMATION CONTACT:
Bernie Kanzler, Office of Finance, Financial Information Control
Division (BCD), (202-501-2923).
SUPPLEMENTARY INFORMATION: The General Services Administration (GSA)
has determined that this rule is not a significant rule for the
purposes of Executive Order (E.O.) 12866 of September 10, 1993, because
it is not likely to result in an economic impact exceeding $100 million
or more, to have a material adverse effect on the economy, environment
or safety, to interfere with the actions of another agency, to
materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs, or to raise novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in E.O. 12866. Therefore, a regulatory assessment
has not been prepared. GSA has based all administrative decisions
underlying this rule on adequate information concerning the need for
and the consequence of this rule; has determined that the potential
benefits to society from this rule outweigh the potential costs; has
maximized the net benefits; and has chosen the alternative approach
involving the least net cost to society.
Regulatory Flexibility Act
The General Services Administration has determined that this rule
will not have a significant economic impact on a substantial number of
small entities under the Regulatory Flexibility Act, 5 U.S.C. 601 et
seq.).
List of Subjects in 41 CFR Part 105-57
Administrative practice and procedure, Claims, Income taxes.
Accordingly, 41 CFR chapter 105 is amended by adding part 105-57 to
read as follows:
PART 105-57--COLLECTION OF DEBTS BY TAX REFUND OFFSET
Sec.
105-57.001 Purpose.
105-57.002 Applicability and scope.
105-57.003 Administrative charges.
105-57.004 Reasonable attempt to notify.
105-57.005 Notice requirement before offset.
105-57.006 Consideration of evidence.
105-57.007 Change in conditions after submission to IRS.
Authority: 31 U.S.C. 3720A.
Sec. 105-57.001 Purpose.
This part establishes procedures for the General Services
Administration (GSA) to refer past due debts to the Internal Revenue
Service (IRS) for offset against income tax refunds of taxpayers owing
debts to GSA.
Sec. 105-57.002 Applicability and scope.
(a) This part implements 31 U.S.C. 3720A which authorizes the IRS
to reduce a tax refund by the amount of a past due legally enforceable
debt owed to the United States.
(b) For purposes of this section, a past due legally enforceable
debt referable to the IRS is a debt which is owed to the United States
and:
(1) Has been delinquent for at least three months but, except in
the case of a judgment debt, has not been delinquent more than ten
years at the time the offset is made;
(2) With respect to which, GSA has given the taxpayer at least 60
days, from the date of notification, to present evidence that all or
part of the debt is not past due or legally enforceable, has considered
such evidence, and has determined that the debt is past due and legally
enforceable;
(3) Cannot be currently collected pursuant to the salary offset
provisions of 5 U.S.C. 5514(a)(1);
(4) Cannot be currently collected pursuant to the administrative
offset provisions of 31 U.S.C. 3716;
(5) Has been disclosed by GSA to a credit reporting agency,
including a consumer reporting agency as authorized by 31 U.S.C.
3711(f);
(6) With respect to which, GSA has notified, or has made a
reasonable attempt to notify, the taxpayer that the debt is past due
and, unless repaid within 60 days thereafter, will be referred to the
IRS for offset against any income tax refunds due the taxpayer;
(7) Is at least $25.00;
(8) All other requirements of 31 U.S.C. 3720A and the Department of
the Treasury regulations relating to eligibility of a debt for tax
refund offset, at 26 CFR 301.6402-6T, have been satisfied.
Sec. 105-57.003 Administrative charges.
All administrative charges incurred in connection with the referral
of debts to the IRS will be added to the debt, thus increasing the
amount of the offset.
Sec. 105-57.004 Reasonable attempt to notify.
In order to constitute a reasonable attempt to notify the debtor,
GSA must have used a mailing address for the debtor obtained from the
IRS pursuant to the Internal Revenue Code, 26 U.S.C. 6103 (m)(2) or
(m)(4), within one year preceding the attempt to notify the debtor.
Sec. 105-57.005 Notice requirement before offset.
The notification provided by GSA to the debtor will inform the
debtor how to go about presenting evidence to GSA that all or part of
the debt is either not past due or is not legally enforceable.
Sec. 105-57.006 Consideration of evidence.
Evidence submitted by the debtor will be considered by officials or
employees of GSA. Any determination that an amount of such debt is past
due and legally enforceable will be made by such officials or
employees. Evidence that the debt is affected by a bankruptcy
proceeding involving the debtor shall bar referral of the debt.
Sec. 105-57.007 Change in conditions after submission to IRS.
If the amount of a debt is reduced after submission by GSA and
offset by IRS, GSA will refund to the debtor any excess amount and will
promptly notify IRS of the refund. GSA will also promptly notify the
IRS if, after submission of a debt to the IRS for offset, GSA:
(a) Determines that an error has been made with respect to the
information submitted;
(b) Receives a payment or credits a payment to an account
submitted; or
(c) Receives notification that the debtor has filed for bankruptcy
under Title 11 of the United States Code or has been adjudicated
bankrupt and the debt has been discharged.
Dated: November 30, 1993.
Dennis J. Fischer,
Chief Financial Officer.
[FR Doc. 94-11 Filed 1-7-94; 8:45 am]
BILLING CODE 6820-34-M
Continua la tua ricerca in ChatGPT o Claude
Collega Omnilex per cercare nel corpus legale dal tuo assistente IA.