issue-1997-05-16•Federal Register proposed rules — 1997-05-16
Federal Register proposed rules — 1997-05-16
issue-1997-05-16Federal Register proposed rules — 1997-05-16Proposed Regulation
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. 97-13047 Bromoxynil; Pesticide Tolerances; Extension of Comment Period
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Page 27002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13047]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300486A; FRL-5719-2]
RIN AC18
Bromoxynil; Pesticide Tolerances; Extension of Comment Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Extension of comment period.
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SUMMARY: Notice is hereby given that the period for filing public
comment on the proposed tolerances for bromoxynil and its metabolite
DBHA on cotton commodities, and for bromoxynil on animal commodities is
extended.
DATES: Public comments must be received on or before May 26, 1997.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information and Resources Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. In person, bring comments to Rm. 1132,
CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under Unit II. of this document. No Confidential
Business Information (CBI) should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Product Manager
(PM) 25, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 241, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 2, 1997 (62 FR 24065) (FRL-5617-5),
EPA issued a Notice of Proposed Rulemaking for establishment of
tolerances for residues of the herbicide bromoxynil and its metabolite
DBHA on cotton commodities; for establishment of tolerances for
residues of bromoxynil on poultry commodities (including eggs); and for
revision of tolerances for residues of bromoxynil on other meat
commodities and milk. Written comments on the proposed rule were to be
received on or before May 19, 1997. On May 6, 1997, the Union of
Concerned Scientists and the Environmental Defense Fund requested that
EPA extend this comment period from 17 to 60 days.
Under section 408(e) of the FFDCA, EPA is required to provide a 60-
day comment period on proposed rules unless EPA finds for good cause
that it would be in the public interest to provide a shorter period.
EPA shortened the comment period on the bromoxynil tolerances to 17
days based on the fact that previous notice had been provided on the
central issue of establishing a tolerance permitting use of bromoxynil
on cotton, and cotton growers faced a potential hardship if a decision
is not made expeditiously.
In their request for an extension of the comment period, the Union
of Concerned Scientists and the Environmental Defense Fund cited a
number of health issues and questions regarding interpretation of the
FFDCA safety standard. EPA does not believe these groups have shown
that it is not in the public interest to shorten the comment period.
EPA also does not think that the groups have demonstrated that the
comment period is inadequate to address the issues they have raised.
Nonetheless, EPA will extend the comment period for an additional 7
days. Comments will now be due on or before May 26, 1997.
II. Public Docket
The official record for the proposed rule, as well as the public
version, has been established for the proposal under docket control
number ``OPP-300486'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number OPP-300486. Electronic comments
on the proposed rule may be filed online at many Federal Depository
Libraries.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additive, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: May 12, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 97-13047 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 97-12951 Rail General Exemption AuthorityNonferrous Recyclables
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27003-27004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12951]
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DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
49 CFR Part 1039
[STB Ex Parte No. 561]
Rail General Exemption Authority--Nonferrous Recyclables
AGENCY: Surface Transportation Board, Transportation.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Interstate Commerce Commission (ICC) issued a notice of
proposed rulemaking (NPR) in Ex Parte No. 346 (Sub-No. 36) on August
23, 1994, published in the Federal Register on August 24, 1994, to
consider whether to exempt partially from regulation the rail
transportation of certain nonferrous recyclables. The ICC Termination
Act of 1995 significantly changed the basis for that notice.
Consequently, we are issuing a new NPR proposing a total exemption from
regulation for 29 nonferrous recyclable commodities. We are also
announcing a policy for the interim to govern the 11 nonferrous
recyclable commodities that were previously partially exempted.
Finally, in a separate decision served today, Ex Parte No. 346 (Sub-No.
36) is being discontinued.
DATES: Persons interested in participating in this proceeding as a
party of record by filing and receiving written comments must file a
notice of intent to participate by May 26, 1997. We will issue a
service list of the parties of record shortly thereafter. Comments and
replies must be served on all parties of record. Comments are due on
June 30, 1997 and replies are due on July 15, 1997.
ADDRESSES: Send an original plus 10 copies of notices of intent to
participate and pleadings referring to STB Ex Parte No. 561 to: Surface
Transportation Board, Office of the Secretary, Case Control Unit, 1925
K Street, N.W., Washington, DC 20423-0001.
FOR FURTHER INFORMATION CONTACT: Beryl Gordon, (202) 565-1600. [TDD for
the hearing impaired: (202) 565-1695.]
SUPPLEMENTARY INFORMATION: The Board's decision proposing these
regulations is available to all persons for a charge by phoning DC NEWS
& DATA, INC., at (202) 289-4357.
Environmental and Energy Considerations
We preliminarily conclude that, if an exemption is granted, it will
not significantly affect either the quality of the human environment or
the conservation of energy resources. We invite comments in this area.
Initial Regulatory Flexibility Analysis
Pursuant to 5 U.S.C. 605(b), the Board preliminarily concludes that
an exemption would not have a significant economic impact on a
substantial number of small entities. No new regulatory requirements
would be imposed, directly or indirectly, on such entities. The impact,
if any, would be to reduce the amount of paperwork and regulation. If
an exemption were granted, it would be based partly on a finding that
regulation of this transportation is not necessary to protect shippers
(including small shippers) from abuse of market power. See 49 U.S.C.
10502. Such a finding, if made, would indicate that a substantial
number of small entities would not be significantly affected. We invite
comments in this area.
List of Subjects in 49 CFR Part 1039
Agricultural commodities, Intermodal transportation, Manufactured
commodities, Railroads.
Decided: April 24, 1997.
By the Board, Chairman Morgan and Vice Chairman Owen.
Vernon A. Williams,
Secretary.
For the reasons set forth in the preamble, title 49, chapter X,
Part 1039 of the Code of Federal Regulations is proposed to be amended
as follows:
PART 1039--EXEMPTIONS
1. The authority citation for Part 1039 continues to read as
follows:
Authority: 5 U.S.C. 553; and 49 U.S.C. 10502 and 13301.
2. In Sec. 1039.11, paragraph (a) is proposed to be amended by
adding the following entries in numerical order to the table and by
revising the first sentence to the undesignated text following the
table to read as follows:
Sec. 1039.11 Miscellaneous commodities exemptions.
(a) * * *
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STCC No. STCC tariff Commodity
------------------------------------------------------------------------
* * * * *
20511............. 6001-X, eff............ Bread or other bakery
products exc. biscuits,
crackers, pretzels or
other dry bakery products
See 20521-20529.
1-1-96.................
22941............. ......do............... Textile waste, garnetted,
processed, or recovered or
recovered fibres or flock
exc. packing or wiping
cloths or rags. See 22994.
[[Page 27004]]
22973............. ......do............... Textile fibres, laps,
noils, nubs, roving,
sliver or slubs, prepared
for spinning, combed or
converted.
22994............. ......do............... Packing or wiping cloths or
rags (processed textile
wastes).
24293............. ......do............... Shavings or sawdust.
30311............. ......do............... Reclaimed rubber.
3229924........... ......do............... Cullet (broken glass).
33312............. ......do............... Copper matte, speiss, flue
dust, or residues, etc.
33322............. ......do............... Lead matte, speiss, flue
dust, dross, slag,
skimmings, etc.
33332............. ......do............... Zinc dross, residues,
ashes, etc.
33342............. ......do............... Aluminum residues, etc.
33398............. ......do............... Misc. nonferrous metal
residues, including solder
babbitt or type metal
residues.
40112............. ......do............... Ashes.
40212............. ......do............... Brass, bronze, copper or
alloy scrap, tailings, or
wastes.
40213............. ......do............... Lead, zinc, or alloy scrap,
tailings or wastes.
40214............. ......do............... Aluminum or alloy scrap,
tailings or wastes.
4021960........... ......do............... Tin scrap, consisting of
scraps or pieces of
metallic tin, clippings,
drippings, shavings,
turnings, or old worn-out
block tin pipe having
value for remelting
purposes only.
40221............. ......do............... Textile waste, scrap or
sweepings.
40231............. ......do............... Wood scrap or waste.
40241............. ......do............... Paper waste or scrap.
40251............. ......do............... Chemical or petroleum
waste, including spent.
40261............. ......do............... Rubber or plastic scrap or
waste.
4029114........... ......do............... Municipal garbage waste,
solid, digested and
ground, other than sewage
waste or fertilizer.
4029176........... ......do............... Automobile shredder
residue.
4111434........... ......do............... Bags, old, burlap, gunny,
istle (ixtle), jute, or
sisal, NEC.
41115............. ......do............... Articles, used, returned
for repair or
reconditioning.
42111............. ......do............... Nonrevenue movement of
containers, bags, barrels,
bottles, boxes, crates,
cores, drums, kegs, reels,
tubes, or carriers, NEC,
empty, returning in
reverse of route used in
loaded movement, and so
certified.
42112............. ......do............... Nonrevenue movement of
shipping devices,
consisting of blocking,
bolsters, cradles,
pallets, racks, skids,
etc., empty, returning in
reverse of route used in
loaded movement, and so
certified
42311............. ......do............... Revenue movement of
containers, bags, barrels,
bottles, boxes, crates,
cores, drums, kegs, reels,
tubes, or carriers, NEC.,
empty, returning in
reverse of route used in
loaded movement and so
certified.
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Also excepted from this exemption are those commodities previously
exempt, and any transportation service regarding which the Commission
has made a finding of market dominance. * * *
* * * * *
[FR Doc. 97-12951 Filed 5-15-97; 8:45 am]
BILLING CODE 4915-00-P
Complete official Federal Register PDF
FR Doc. 97-12949 Rail General Exemption AuthorityExemption of Nonferrous Recyclables and Railroad Rates on Recyclable Commodities
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27002-27003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12949]
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DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
49 CFR Part 1039
[Ex Parte No. 346 (Sub-No. 36)]
Rail General Exemption Authority--Exemption of Nonferrous
Recyclables and Railroad Rates on Recyclable Commodities
AGENCY: Surface Transportation Board, Transportation.
ACTION: Proposed rule, withdrawal.
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[[Page 27003]]
SUMMARY: The Surface Transportation Board is discontinuing the
rulemaking in Ex Parte No. 346 (Sub-No. 36).
DATES: This withdrawal is made on May 5, 1997.
FOR FURTHER INFORMATION CONTACT: Beryl Gordon, (202) 565-1600. [TDD for
the hearing impaired: (202) 565-1695.]
SUPPLEMENTARY INFORMATION: In a notice of proposed rulemaking (NPR) in
this proceeding served on August 23, 1994, and published in the Federal
Register on August 24, 1994 (59 FR 43529), the Interstate Commerce
Commission (ICC) solicited comments on a proposal to exempt partially
from regulation the rail transportation of 28 nonferrous recyclable
commodities. After the issuance of the NPR, the ICC Termination Act of
1995 (ICCTA), Pub. L. No. 104-88, 109 Stat. 803 was enacted. The ICCTA
significantly changed the basis for the NPR by eliminating former 49
U.S.C. 10731(e). Consequently, in Rail General Exemption Authority--
Nonferrous Recyclables, STB Ex Parte No. 561 (published elsewhere in
this section of the Federal Register), we are issuing a new NPR
proposing a total exemption from regulation for 29 nonferrous
recyclable commodities. Because we will consider a broader exemption in
STB Ex Parte No. 561, we are discontinuing this proceeding. The
comments previously filed in response to the NPR will be made part of
the record in STB Ex Parte No. 561 and need not be refiled.
Decided: April 24, 1997.
By the Board, Chairman Morgan and Vice Chairman Owen.
Vernon A. Williams,
Secretary.
[FR Doc. 97-12949 Filed 5-15-97; 8:45 am]
BILLING CODE 4915-00-P
Complete official Federal Register PDF
FR Doc. 97-12938 Administrative Review Process, Testing Elimination of the Fourth Step of Administrative Review in the Disability Claim Process (Request for Review by the Appeals Council)
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 26997-27000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12938]
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SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Regulations No. 4 and 16]
RIN 0960-AE58
Administrative Review Process, Testing Elimination of the Fourth
Step of Administrative Review in the Disability Claim Process (Request
for Review by the Appeals Council)
AGENCY: Social Security Administration.
ACTION: Proposed rules.
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SUMMARY: We propose to amend our rules to establish authority to test
elimination of the final step in the administrative review process used
in determining claims for Social Security and Supplemental Security
Income (SSI) benefits based on disability. If these proposed rules are
published in final, the right of appeal for a claimant who is included
in the test procedures and is dissatisfied with the decision of an
administrative law judge (ALJ) would be to file a civil action in
Federal district court, rather than to request the Appeals Council to
review the decision. We are proposing to test procedures that eliminate
the request for Appeals Council review in furtherance of the Plan for a
New Disability Claim Process that former Commissioner of Social
Security Chater approved in September 1994. Unless specified, all other
regulations relating to the disability determination process and the
administrative review process remain unchanged.
DATES: To be sure that your comments are considered, we must receive
them no later than June 16, 1997.
ADDRESSES: Comments should be submitted in writing to the Commissioner
of Social Security, P.O. Box 1585, Baltimore, MD 21235; sent by telefax
to (410) 966-2830; sent by E-mail to ``[email protected]''; or,
delivered to the Division of Regulations and Rulings, Social Security
Administration, 3-B-1 Operations Building, 6401 Security Boulevard,
Baltimore, MD 21235, between 8:00 a.m. and 4:30 p.m. on regular
business days. Comments may be inspected during these same hours by
making arrangements with the contact person shown below.
FOR FURTHER INFORMATION CONTACT: Harry J. Short, Legal Assistant,
Division of Regulations and Rulings, Social Security Administration,
6401 Security Boulevard, Baltimore, MD 21235, (410) 965-6243 for
information about these rules. For information on eligibility or
claiming benefits, call our national toll-free number, 1-800-772-1213.
SUPPLEMENTARY INFORMATION:
Background
The Social Security Administration (SSA) currently uses a four-step
process in deciding claims for Social Security benefits under title II
of the Social Security Act (the Act) and for SSI benefits under title
XVI of the Act. Claimants who are not satisfied with the initial
determination on their claims may request reconsideration. Claimants
who are not satisfied with the reconsidered determination may request a
hearing before an ALJ, and claimants who are dissatisfied with an ALJ's
decision may request review by the Appeals Council. Claimants who have
completed these four steps, and who are dissatisfied with the final
decision, may request judicial review of the decision by filing a civil
action in Federal district court. 20 CFR Secs. 404.900 and 416.1400.
SSA's Plan for a New Disability Claim Process (59 FR 47887,
September 19, 1994) anticipates establishment of a redesigned, two-step
process for deciding Social Security and SSI claims based on
disability. The redesign plan anticipates that the process for
determining disability can be significantly improved by strengthening
the steps of the process in which we make initial determinations and
provide dissatisfied claimants an opportunity for a hearing before an
ALJ, and by eliminating the reconsideration step and the step in which
claimants request the Appeals Council to review the decisions of ALJs.
In 20 CFR 404.906 and 416.1406 (60 FR 20023, April 24, 1995), we
have established authority to test, singly and in combination, several
model procedures for modifying the disability claims process. Under
that authority, we are currently testing, in isolation from other
possible changes, a modification of the initial determination step in
which a single decisionmaker, rather than a team composed of a
disability examiner and a medical consultant, makes the initial
determination of disability. In addition, under authority established
in 20 CFR 404.943 and 416.1443 (60 FR 47469, September 13, 1995), we
are also testing, in another model for evaluating a possible change in
isolation from other changes, use of an adjudication officer as the
focal point for all prehearing activities in disability cases in which
a claimant requests a hearing before an ALJ.
To assess how the above changes and other elements of the
disability redesign plan would work together in different combinations,
we initiated an integrated test on April 7, 1997, that combines model
procedures for major elements of the redesign plan. As presently
structured under existing testing authority (established in
Secs. 404.906, 404.943, 416.1406, and 416.1443 in combination), this
integrated model includes, in addition to models for the single
decisionmaker and the adjudication officer, a model for procedures to
provide a predecision interview conducted by the single decisionmaker
(at which a claimant for benefits based on disability will have an
opportunity to submit further evidence and have an interview with the
initial decisionmaker if the evidence does not support a fully
favorable initial disability determination), and a model to test
eliminating the reconsideration step in disability claims.
In order to increase our ability to assess the effects of possible
modifications of the disability claim process in combination, we are
proposing in these rules to amend our regulations to authorize testing
of an additional modification in our integrated model. We are proposing
to incorporate in this model additional
[[Page 26998]]
procedures to test elimination of the step in that process in which a
claimant requests the Appeals Council to review the hearing decision of
an ALJ.
Under the proposed rules, we will randomly select approximately one
half of the requests for an ALJ hearing in the integrated model for
potential inclusion in the proposed test procedures. The remaining
requests for hearing in the integrated model will be processed under
our existing regulations concerning the Appeals Council and judicial
review. This will enable us to assess other modifications tested in the
integrated model in association with both the proposed test procedures
for eliminating the request for Appeals Council review step and our
existing request for review procedures.
Under the proposed rules, we will eliminate the request for review
step (which has been established by agency regulations and is not
mandated by the Act) in a case in the integrated model if: (1) The case
has been randomly selected for inclusion in this aspect of the model,
and (2) an ALJ issues a decision in the case that is less than wholly
favorable to the claimant (i.e., unfavorable or only partially
favorable to the claimant). Cases in the integrated model in which an
ALJ issues a wholly favorable decision, dismisses a request for
hearing, or issues a recommended decision will not be included in the
proposed procedures. These cases will be processed under our existing
regulations concerning the Appeals Council and judicial review.
In a case to which the proposed rules apply, the appeal available
to the claimant from the ALJ's decision will be filing an action in
Federal district court. Requesting review by the Appeals Council will
be eliminated as an appeal and as a prerequisite to seeking judicial
review.
Our specific goals in testing elimination of the request for review
step will be to assess the effects of this change, as it functions in
conjunction with other modifications in the disability claim process
included in the integrated model, on: (1) Judicial workloads, and (2)
the legal sufficiency of decisions subjected to judicial review. We
consider the effects of the change in those respects to represent the
principal, practical issues bearing on the advisability of eliminating
the request for review step in connection with the planned, overall
redesign of the disability claim process.
SSA's disability redesign plan anticipates that the request for
Appeals Council review will be eliminated in conjunction with the
establishment of procedures to increase the number of ALJ decisions
that the Council will consider for quality review purposes under its
authority to review cases on its own motion. We are not including
procedures to test the enhanced own-motion functions anticipated for
the Appeals Council in these proposed rules. We are not including such
procedures because we wish to concentrate the proposed test on
producing information concerning the effects of eliminating the request
for Appeals Council review on judicial workloads and the legal
sufficiency of SSA's final decisions. In addition, we are preparing to
propose permanent rules to regulate existing procedures and establish
new procedures for referring cases to the Appeals Council for possible
review under its own-motion authority. Those proposed changes should
provide, if adopted in final, increased information regarding own-
motion review by the Council.
We propose to test the effect of eliminating the request for review
step on judicial workloads by comparing the rate at which civil actions
are filed by individuals whose claims are processed under the current
administrative review steps in the disability claims process--i.e., the
four step process--to the rate at which civil actions are filed in
cases selected for processing under the proposed test procedures. We
will also consider the rate at which civil actions are filed in cases
in the integrated model in which we retain the request for Appeals
Council review.
We propose to assess the effect of eliminating the request for
review on the legal sufficiency of final decisions by comparing the
rates at which, following the filing of civil actions in cases included
in the integrated model and in a control sample of cases processed
under the current administrative review steps in the disability claims
process, we request court-remand of a case within the period during
which the Commissioner of Social Security may file his answer to a
civil action under Sec. 205(g) of the Act. The Appeals Council, working
with agency counsel, will evaluate the claims in the integrated model
and in the control sample to identify instances in which a court should
be requested (as courts may be under existing procedures) to remand a
case for further administrative action.
We believe that, in conjunction with other modifications we are
testing in the integrated model, elimination of the request for review
step could have a significant beneficial effect on the disability
claims process and on our ability to adjudicate claims timely and
accurately. We place a high priority on speedily including a test of
the elimination of that step in our integrated model. The proposed
rules have the limited purpose of authorizing test procedures in a
relatively small number of cases (projected at approximately 1900) to
determine how elimination of the request for review step could affect
judicial workloads and the legal sufficiency of the agency's final
decisions. If we ultimately decide to proceed with elimination of this
step, we would publish a Notice of Public Rulemaking setting forth
detailed proposals concerning all the changes that would be made in the
administrative review process to eliminate the request for review by
the Appeals Council. Therefore, and because we have previously provided
the public with the opportunity to comment on all aspects of our basic
disability redesign plan, including the elimination of the request for
review step, we are providing a 30-day comment period for these
proposed rules rather than the 60-day period we usually provide. We
believe that a 30-day comment period is sufficiently long, in this
instance, to allow the public a meaningful opportunity to comment on
the proposed rules in accordance with Executive Order (E.O) 12866.
Proposed Regulations
We propose to add new Secs. 404.966 and 416.1466 to set forth
authority to test elimination of the step in the administrative review
process in which claimants for benefits based on disability request the
Appeals Council to review the decision of an ALJ. The proposed rules
specify in Secs. 404.966(a) and 416.1466(a) that testing of elimination
of the request for review step will be conducted in randomly selected
cases in which we have tested a combination of model procedures for
modifying the disability claim process as authorized in Secs. 404.906,
404.943, 416.1406 and 416.1443, and an ALJ has issued a decision that
is less than wholly favorable to the claimant.
Under proposed Secs. 404.966(b) and 416.1466(b), which describe the
effect of an ALJ's decision, the ALJ's decision will be binding unless
a party to the decision files a civil action, the Appeals Council
reviews the decision on its own motion under the authority provided in
20 CFR 404.969 and 416.1469, or the decision is revised by the
administrative law judge or the Appeals Council under the rules on
reopening final decisions in 20 CFR 404.987 and 416.1487. Under these
provisions, the appeal available to a party who is dissatisfied with
the decision of an ALJ will be to seek judicial review. As is true of
the
[[Page 26999]]
provisions of proposed Secs. 404.966 and 416.1466 as a whole, the
proposed provisions of Secs. 404.966(b) and 416.1466(b) pertain only to
those ALJ decisions that have been identified for inclusion in that
part of our integrated model in which the request for review by the
Appeals Council is eliminated.
Proposed Secs. 404.966(c) and 416.1466(c) describe the notice an
ALJ will issue to advise a party to a decision included in this part of
the integrated model of the right to file a civil action. Proposed
Secs. 404.966(d) and 416.1466(d) describe the right a party will have
to request the Appeals Council to grant an extension of time to file a
civil action.
Electronic Version
The electronic file of this document is available on the Federal
Bulletin Board (FBB) at 9:00 a.m. on the date of publication in the
Federal Register. To download the file, modem dial (202) 512-1387. The
FBB instructions will explain how to download the file and the fee.
This file is in WordPerfect and will remain on the FBB during the
comment period.
Regulatory Procedures
Executive Order 12866
We have consulted with the Office of Management and Budget (OMB)
and determined that these rules do not meet the criteria for a
significant regulatory action under E.O. 12866. Thus, they are not
subject to OMB review.
Regulatory Flexibility Act
We certify that these regulations will not have a significant
economic impact on a substantial number of small entities because these
rules affect only individuals. Therefore, a regulatory flexibility
analysis as provided in the Regulatory Flexibility Act, as amended, is
not required.
Paperwork Reduction Act
These regulations impose no new reporting or recordkeeping
requirements requiring OMB clearance.
(Catalog of Federal Domestic Assistance Program Nos. 96.001, Social
Security-Disability Insurance; 96.006, Supplemental Security Income)
List of Subjects
20 CFR Part 404
Administrative practice and procedure, Death benefits, Disability
benefits, Old-age, Survivors and Disability Insurance, Reporting and
recordkeeping requirements, Social security.
20 CFR Part 416
Administrative practice and procedure, Aged, Blind, Disability
benefits, Public assistance programs, Supplemental Security Income
(SSI), Reporting and recordkeeping requirements.
Dated: May 7, 1997.
John J. Callahan,
Acting Commissioner of Social Security.
For the reasons set out in the preamble, subpart J of part 404 and
subpart N of part 416 of chapter III of title 20 of the Code of Federal
Regulations are proposed to be amended as set forth below.
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950- )
20 CFR part 404, Subpart J, is amended as follows:
1. The authority citation for subpart J of part 404 continues to
read as follows:
Authority: Secs. 201(j), 205 (a), (b), (d)-(h), and (j), 221,
225, and 702(a)(5) of the Social Security Act (42 U.S.C. 401(j), 405
(a), (b), (d)-(h), and (j), 421, 425, and 902(a)(5)); 31 U.S.C.
3720A; sec. 5, Pub. L. 97-455, 96 Stat. 2500 (42 U.S.C. 405 note);
secs. 5, 6 (c)-(e), and 15, Pub. L. 98-460, 98 Stat. 1802 (42 U.S.C.
421 note).
2. New Sec. 404.966 is added under the undesignated center heading
``APPEALS COUNCIL REVIEW'' to read as follows:
Sec. 404.966 Testing elimination of the request for Appeals Council
review.
(a) Applicability and scope. Notwithstanding any other provision in
this part or part 422 of this chapter, we are establishing the
procedures set out in this section to test elimination of the request
for review by the Appeals Council. These procedures will apply in
randomly selected cases in which we have tested a combination of model
procedures for modifying the disability claim process as authorized
under Secs. 404.906 and 404.943, and an administrative law judge has
issued a decision (not including a recommended decision) that is less
than wholly favorable to you.
(b) Effect of an administrative law judge's decision. In a case to
which the procedures of this section apply, the decision of an
administrative law judge will be binding on all the parties to the
hearing unless --
(1) You or another party file an action concerning the decision in
Federal district court;
(2) The Appeals Council decides to review the decision on its own
motion under the authority provided in Sec. 404.969; or
(3) The decision is revised by the administrative law judge or the
Appeals Council under the procedures explained in Sec. 404.987.
(c) Notice of the decision of an administrative law judge. The
notice of decision the administrative law judge issues in a case
processed under this section will advise you and any other parties to
the decision that you may file an action in a Federal district court
within 60 days after the date you receive notice of the decision.
(d) Extension of time to file action in Federal district court. Any
party having a right to file a civil action under this section may
request that the time for filing an action in Federal district court be
extended. The request must be in writing and it must give the reasons
why the action was not filed within the stated time period. The request
must be filed with the Appeals Council. If you show that you had good
cause for missing the deadline, the time period will be extended. To
determine whether good cause exists, we will use the standards in
Sec. 404.911.
PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND
DISABLED
20 CFR Part 416, Subpart N, is amended as follows:
1. The authority citation for subpart N continues to read as
follows:
Authority: Sec. 702(a)(5), 1631, and 1633 of the Social Security
Act (42 U.S.C. 902(a)(5), 1383, and 1383b).
2. New Sec. 416.1466 is added under the undesignated center heading
``APPEALS COUNCIL REVIEW'' to read as follows:
Sec. 416.1466 Testing elimination of the request for Appeals Council
review.
(a) Applicability and scope. Notwithstanding any other provision in
this part or part 422 of this chapter, we are establishing the
procedures set out in this section to test elimination of the request
for review by the Appeals Council. These procedures will apply in
randomly selected cases in which we have tested a combination of model
procedures for modifying the disability claim process as authorized
under Secs. 416.1406 and 416.1443, and an administrative law judge has
issued a decision (not including a recommended decision) that is less
than wholly favorable to you.
(b) Effect of an administrative law judge's decision. In a case to
which the procedures of this section apply, the decision of an
administrative law judge will be binding on all the parties to the
hearing unless --
[[Page 27000]]
(1) You or another party file an action concerning the decision in
Federal district court;
(2) The Appeals Council decides to review the decision on its own
motion under the authority provided in Sec. 416.1469; or
(3) The decision is revised by the administrative law judge or the
Appeals Council under the procedures explained in Sec. 416.1487.
(c) Notice of the decision of an administrative law judge. The
notice of decision the administrative law judge issues in a case
processed under this section will advise you and any other parties to
the decision that you may file an action in a Federal district court
within 60 days after the date you receive notice of the decision.
(d) Extension of time to file action in Federal district court. Any
party having a right to file a civil action under this section may
request that the time for filing an action in Federal district court be
extended. The request must be in writing and it must give the reasons
why the action was not filed within the stated time period. The request
must be filed with the Appeals Council. If you show that you had good
cause for missing the deadline, the time period will be extended. To
determine whether good cause exists, we will use the standards in
Sec. 416.1411.
[FR Doc. 97-12938 Filed 5-15-97; 8:45 am]
BILLING CODE 4190-29-P
Complete official Federal Register PDF
FR Doc. 97-12935 Indian Highway Safety Program Competitive Grant Selection Criteria
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27000-27002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12935]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
25 CFR Part 181
RIN 1076-AD82
Indian Highway Safety Program Competitive Grant Selection
Criteria
AGENCY: Bureau of Indian Affairs, Interior.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Bureau of Indian Affairs (BIA) intends to make funds
available to federally recognized tribes on an annual basis for
financing tribal highway safety projects designed to reduce the
incidence of traffic accidents within Indian country. Due to the
limited funding available for the Indian Highway Safety Program, the
BIA will review and select from proposed tribal projects on a
competitive basis. The proposed rule presents the selection criteria.
DATES: Comments must be postmarked by July 15, 1997.
ADDRESSES: Comments should be sent to Program Administrator, Indian
Highway Safety Program, 505 Marquette Avenue, NW, Suite 1705,
Albuquerque, NM 87102.
FOR FURTHER INFORMATION CONTACT: Mr. Charles Jaynes, Chief, BIA
Division of Safety Management, (505) 248-5060.
SUPPLEMENTARY INFORMATION: This proposed rule sets forth the procedures
that will govern the BIA's selection of recipients of the Indian
Highway Safety Program grant. The BIA mails grant applications for a
given fiscal year to all tribal leaders by the end of February of the
preceding fiscal year. Applicants must submit completed applications by
the close of business on June 1. The BIA will review and evaluate each
complete and timely filed application. BIA seeks to fund as many
programs as possible and to the level practicable within the confines
of a limited program budget. The scarce amount of resources often
forces the BIA to limit funding to select portions of a proposed tribal
project.
We are publishing this proposed rule by the authority delegated by
the Secretary of the Interior to the Assistant Secretary--Indian
Affairs by 209 DM 8.
[[Page 27001]]
Our policy is to give the public an opportunity to participate in
the rulemaking process. Interested persons may submit written comments
to the location identified in the ADDRESSES section of the preamble. We
will consider all comments timely filed during the public comment
period, make any necessary revisions and issue the final rule.
We certified to the Office of Management and Budget (OMB) that this
proposed rule meets the applicable standards provided in sections 3(a)
and 3(b)(2) of Executive Order 12988. This proposed rule is not a
significant rule under Executive Order 12866 and does not require
approval by the OMB. This proposed rule does not constitute a major
Federal action significantly affecting the human environment and,
therefore, no detailed statement is needed under the National
Environmental Policy Act of 1969. Furthermore, this proposed rule does
not have significant takings implications in accordance with Executive
Order 12630, does not have significant Federalism effects, and does not
have a significant economic impact of a substantial number of small
entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
Unfunded Mandates Act of 1996
This proposed rule imposes no unfunded mandates on any governmental
or private entity and is in compliance with the provisions of the
Unfunded Mandates Act of 1995.
Paperwork Reduction Act of 1995
Under 23 U.S.C. 402, the Department of Transportation (DOT) funds
both the DOT State Highway Safety Program and the BIA Indian Highway
Safety Program. The information contained in each grant application
under both programs is identical. The Indian Highway Safety Program
competitive grant application solicits only the information DOT
requires for its State Highway Safety Program and uses it for
substantially the same purpose of awarding Highway Safety Program funds
to applicants. OMB has reviewed and approved the information collection
requirements for the DOT State Highway Safety Program. See OMB Control
Number 2127-0003. No additional OMB authorization is needed.
The primary author of this document is Lawrence Archambeau, Bureau
of Indian Affairs.
List of Subjects in 25 CFR Part 181
Indians, Highways and roads, Highway safety.
For the reasons set forth in the preamble, Part 181 is proposed to
be added to 25 CFR subchapter H as follows:
PART 181--INDIAN HIGHWAY SAFETY PROGRAM
Sec.
181.01 Purpose.
181.02 Definitions.
181.03 Am I eligible to receive a program grant?
181.04 How do I obtain an application?
181.05 How are applications ranked?
181.06 How are applicants informed of the results?
181.07 Appeals.
Authority: 23 U.S.C. 402; 25 U.S.C. 13.
Sec. 181.01 Purpose.
This part will assist the BIA Indian Highway Safety Program
Administrator to disperse funds DOT/NHTSA has made available. The funds
assist selected tribes with their proposed Highway Safety Projects.
These projects are designed to reduce traffic crashes, reduce impaired
driving crashes, increase occupant protection education, provide
Emergency Medical Service training, and increase police traffic
services.
Sec. 181.02 Definitions.
Appeal means a written request for review of an action or the
inaction of an official of the BIA that is claimed to adversely affect
the interested party making the request.
Applicant means an individual or persons on whose behalf an
application for assistance and/or services has been made under this
part.
Application means the process through which a request is made for
assistance or services.
Grant means a written agreement between the BIA and the governing
body of an Indian tribe or Indian organization wherein the BIA provides
funds to the grantee to plan, conduct, or administer specific programs,
services, or activities and where the administrative and programmatic
provisions are specifically delineated.
Grantee means the tribal governing body of an Indian tribe or Board
of Directors of an Indian organization responsible for grant
administration.
Recipient means an individual or persons who have been determined
as eligible and are receiving financial assistance or services under
this part.
Sec. 181.03 Am I eligible to receive a program grant?
The Indian Highway Safety Program grant is available to any
federally recognized tribe. Because of the limited financial resources
available for the program, the Bureau of Indian Affairs (BIA) is unable
to award grants to all applicants. Furthermore, some grant recipients
may only be awarded a grant to fund certain aspects of their proposed
tribal projects.
Sec. 181.04 How do I obtain an application?
BIA mails grant application packages for a given fiscal year to all
federally recognized tribes by the end of February of the preceding
fiscal year. Additional application packages are available from the
Program Administrator, Indian Highway Safety Program, P.O. Box 2003,
Albuquerque, New Mexico 87103. Each application package contains the
necessary information concerning the application process, including
format, content, and filing requirements.
Sec. 181.05 How are applications ranked?
BIA ranks each timely filed application by assigning points based
upon four factors.
(a) Factor No. 1--Magnitude of the problem (Up to 50 points
available). In awarding points under this factor, BIA will take into
account the following:
(1) Whether a highway safety problem exists.
(2) Whether the problem is significant.
(3) Whether the proposed tribal project will contribute to
resolution of the identified highway safety problem.
(4) The number of traffic accidents occurring within the
applicant's jurisdiction over the previous 3 years.
(5) The number of alcohol-related traffic accidents occurring
within the applicant's jurisdiction over the previous 3 years.
(6) The number of reported traffic fatalities occurring within the
applicant's jurisdiction over the previous 3 years.
(7) The number of reported alcohol-related traffic fatalities
occurring within the applicant's jurisdiction over the previous 3
years.
(b) Factor No. 2--Countermeasure selection (Up to 40 points
available). In awarding points under this factor, BIA will take into
account the following:
(1) Whether the countermeasures selected are the most effective for
the identified highway safety problem.
(2) Whether the countermeasures selected are cost effective.
(3) Whether the applicant's objectives are realistic and
attainable.
(4) Whether the applicant's objectives are time framed and, if so,
whether the time frames are realistic and attainable.
(c) Factor No. 3--Tribal leadership and community support (Up to 10
points available). In awarding points under this factor, BIA will take
into account the following:
[[Page 27002]]
(1) Whether the applicant proposes using tribal resources in the
project.
(2) Whether the appropriate tribal governing body supports the
proposal plan, as evidenced by a tribal resolution or otherwise.
(3) Whether the community supports the proposal plan, as evidenced
by letters or otherwise.
(d) Factor No. 4--Past performance (+ or -10 points available). In
awarding points under this factor, BIA will take into account the
following:
(1) Financial and programmatic reporting requirements.
(2) Project accomplishments.
Sec. 181.06 How are applicants informed of the results?
BIA will send a letter to all applicants notifying them of their
selection or non-selection for participation in the Indian Highway
Safety Program for the upcoming fiscal year. BIA will explain to each
applicant not selected for participation the reason(s) for non-
selection.
Sec. 181.07 Appeals.
You may appeal actions taken by BIA officials under this part by
following the procedures in 25 CFR part 2.
Dated: May 6, 1997.
Ada E. Deer,
Assistant Secretary--Indian Affairs.
[FR Doc. 97-12935 Filed 5-15-97; 8:45 am]
BILLING CODE 4310-02-P
Complete official Federal Register PDF
FR Doc. 97-12918 Prevention of Significant Deterioration of Air Quality (PSD) Program: Permit Review Procedures for Sources That May Adversely Affect Air Quality in Non-Federal Class I Areas
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27158-27166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12918]
[[Page 27157]]
_______________________________________________________________________
Part VII
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 51 and 52
Prevention of Significant Deterioration of Air Quality (PSD) Program:
Permit Review Procedures for Sources That May Adversely Affect Air
Quality in Non-Federal Class I Areas; Proposed Rule
Federal Register / Vol. 62, No. 95 / Friday, May 16, 1997 / Proposed
Rules
[[Page 27158]]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 51 and 52
[FRL-5826-5]
RIN 2060-AH01
Prevention of Significant Deterioration of Air Quality (PSD)
Program: Permit Review Procedures for Sources That May Adversely Affect
Air Quality in Non-Federal Class I Areas
AGENCY: Environmental Protection Agency (EPA).
ACTION: Advance Notice of Proposed Rulemaking (ANPR).
-----------------------------------------------------------------------
SUMMARY: Under the Clean Air Act's PSD program, States and Tribes may,
with EPA approval, redesignate their lands as ``Class I'' areas to
enhance protection of their air quality resources. This notice requests
early public input on preliminary issues in clarifying the PSD permit
review procedures for new and modified major stationary sources that
may have an adverse effect on the air quality of these non-Federal
Class I areas. EPA seeks to develop clarifying PSD permit procedures
that are effective, efficient and equitable.
DATES: Comments. All public comments must be received by August 14,
1997.
Public Workshops. EPA will hold public workshops on this
rulemaking. A Federal Register notice announcing the dates of these
workshops will be published at least 30 days prior to the workshop.
ADDRESSES: Comments. Comments on this notice should be mailed (in
duplicate if possible) to: U.S. EPA, Air Docket Section, Air Docket A-
96-53; 401 M Street, S.W., Washington, D.C. 20460.
Public Workshops. EPA will hold public workshops in Phoenix,
Arizona and in Chicago, Illinois. A Federal Register notice announcing
the dates of these workshops will be published at least 30 days prior
to the workshops. Please contact the EPA official listed under FOR
FURTHER INFORMATION CONTACT if you are interested in participating in
the public workshops.
Public Docket. Supporting information for this rulemaking is
contained in Docket No. A-96-53. This docket is available for public
review and copying between 8:00 a.m. and 5:30 p.m., Monday through
Friday at the EPA's Air Docket Section, 401 M Street, S.W., Washington,
D.C.; Room M-1500. A reasonable fee may be charged for copying.
FOR FURTHER INFORMATION CONTACT: David LaRoche, U.S. EPA, Office of Air
and Radiation (6102), 401 M Street, S.W., Washington, D.C. 20460, (202)
260-7652.
SUPPLEMENTARY INFORMATION:
I. Overview
The PSD program authorizes States and Tribes to request
redesignation of their lands as ``Class I'' areas. Over the past twenty
years, only federally-recognized Tribes have sought redesignation under
this authority. EPA has approved Class I redesignations for the
Northern Cheyenne Indian Reservation, the Flathead Indian Reservation,
the Fort Peck Indian Reservation, and the Spokane Indian Reservation.
See 40 CFR 52.1382(c) and 52.2497(c). Recently, EPA approved Class I
redesignation of the Yavapai-Apache Reservation, located in the State
of Arizona. See 61 FR 56461 (Nov. 1, 1996) (to be codified at 40 CFR
52.150). EPA has proposed approval of the Forest County Potawatomi
Community request for redesignation located in the State of Wisconsin.
See 60 FR 33779 (June 29, 1995). EPA will provide opportunity for
public comment and hold a public hearing before it makes a final
decision on this proposed action.
During EPA's review of the Yavapai-Apache and Forest County
Potawatomi redesignation requests, nearby States submitted formal
objections to EPA. A common concern has been confusion about the PSD
permit review procedures that would apply in these States in the event
a Class I redesignation request is granted, and what EPA's specific
role would be in resolving any intergovernmental disputes that arise
over proposed permits for PSD sources that may adversely affect non-
federal Class I areas. In response to these concerns, EPA has initiated
this rulemaking to clarify the PSD permit review and dispute resolution
procedures for proposed new and modified major stationary sources
locating near non-Federal Class I areas.
The new procedures established in this rulemaking would apply for
any State or Tribal lands redesignated as Class I. Thus, the rulemaking
is intended to clarify PSD permit review procedures for proposed PSD
sources that may adversely affect the air quality of any State or
Tribal non-Federal Class I area, and would set forth more specific
procedures for EPA's resolution of any intergovernmental permit
disputes which may arise.
The discussion in part II below contains an overview of the PSD
program to help provide context and further understanding of the issues
presented in this notice. Part III of this notice examines preliminary
issues on which EPA seeks early public input. Part IV describes the
workshops EPA will hold to facilitate public input.
II. The PSD Program
The central purpose of the PSD program is to protect clean air
resources. Thus, the PSD program is an important air pollution
prevention program. The genesis of the program was a lawsuit to enjoin
EPA's approval of state implementation plans that allowed air quality
degradation in areas having air quality better than the national
ambient air quality standards. Sierra Club v. Ruckelshaus, 344 F.Supp.
253 (D.D.C. 1972), aff'd per curiam, 4 Env't Rep. Cases 1815 (D.C. Cir.
1972), aff'd by an equally divided court, sub. nom. Fri v. Sierra Club,
412 U.S. 541 (1973). The court granted the injunction reasoning that
the congressionally-declared purpose of the Clean Air Act to ``protect
and enhance'' the quality of the nation's air resources embodied a non-
degradation policy. Sierra Club, 344 F.Supp. at 255-56.
In response to the Sierra Club decision EPA adopted a PSD program.
See 39 FR 42510 (Dec. 5, 1974). The administrative program was
superseded by a congressionally-crafted program in the 1977 amendments
to the Clean Air Act. Public Law 95-95, 91 Stat. 685. EPA presently has
two sets of regulations implementing the 1977 statutory PSD program:
(1) 40 CFR 51.166 establishes the requirements for State-administered
PSD programs, and (2) 40 CFR 52.21 provides for Federal implementation
of PSD requirements in States not having approved programs and for
federally-recognized Indian Tribes.1
---------------------------------------------------------------------------
\1\ The 1990 amendments to the Clean Air Act made relatively
minor revisions to the PSD program. Pub. L. 101-549, 104 Stat. 2399.
Conforming changes have not been made to the implementing
regulations. Also, EPA has proposed rules under section 301(d) of
the Clean Air Act that would treat Federally-recognized Indian
Tribes in the same manner as States for purposes of numerous Clean
Air Act programs including the PSD program. 59 FR 43 956 (Aug. 25,
1994). Depending on their final form, these rules may allow Tribes
to administer Federally-approved PSD permit review programs in the
same way that States do.
---------------------------------------------------------------------------
A. PSD Areas
Areas nationwide are ``designated'' based on their air quality
status relative to the national ambient air quality standards (NAAQS).
The PSD program applies to areas designated ``attainment'' and
``unclassifiable'' under section 107 of the CAA, 42 U.S.C. Sec. 7407;
these are areas that meet the NAAQS, or areas that cannot be determined
on the basis
[[Page 27159]]
of available information as meeting or not meeting the NAAQS.
PSD areas are further categorized as Class I, II or III. The
classification of an area determines the maximum increase in pollutant
concentrations, or ``increment'' of air quality deterioration, allowed
over a baseline air quality concentration. Class I areas have the
smallest increments and therefore allow the least amount of air quality
deterioration. Conversely, Class III areas have the largest air quality
increments and allow the greatest deterioration. In all instances, the
NAAQS are the overarching air pollution concentration ceilings. That
is, regardless of the size of the increment, the NAAQS may not be
violated in a PSD area.
There are PSD increments for particulate matter, sulfur dioxide and
nitrogen dioxide. EPA's PSD regulations establish the incremental
amount of air quality deterioration allowed for these pollutants in
Class I, II and III areas. 40 CFR 51.166(c) and 52.21(c).
When Congress enacted the PSD program in 1977 it provided that
specified Federal lands, including certain national parks and
wilderness areas, must be designated as Class I areas and may not be
redesignated to another classification. Because they may not be
redesignated, these Federal areas are called mandatory Class I areas.
CAA Secs. 162 and 163, 42 U.S.C. Secs. 7472 and 7473.
The statute also carried forward as Class I areas any areas
redesignated as Class I under EPA's pre-1977 regulations. CAA Sec.
162(a). The Northern Cheyenne reservation was the only redesignated
Class I area affected by this provision. See Nance v. EPA, 645 F.2d 701
(9th Cir. 1981), cert denied, Crow Tribe of Indians v. EPA, 454 U.S.
1081 (1981).
All other PSD areas of the country were designated as Class II
areas under the 1977 Clean Air Act amendments. CAA Sec. 162(b). At the
same time, States and Tribes were authorized to seek redesignation of
their Class II areas as Class I or Class III. CAA Sec. 164, 42 U.S.C.
Sec. 7474. As noted, several Tribes have sought a Class I air quality
designation. Currently, there are no Class III areas.
B. PSD Sources
The PSD preconstruction review permit program applies to new and
modified major stationary sources. Construction, or subsequent
operation, of new major stationary sources and major modifications to
existing major stationary sources are prohibited unless the source
obtains a permit meeting PSD requirements.
Major stationary sources generally include sources that have the
potential to emit at least 250 tons of air pollution annually. 40 CFR
51.166(b)(1)(i)(b) and 52.21(b)(1)(i)(b). Major stationary sources also
include specific ``listed'' sources that have the potential to emit at
least 100 tons per year of air pollution. 40 CFR 51.166(b)(1)(i)(a) and
52.21(b)(1)(i)(a). The listed sources include, among other facilities,
coal-fired power plants (with more than 250 million British thermal
units per hour heat input), primary zinc and copper smelters, and
portland cement plants. Thus, the PSD program applies to relatively
large stationary sources.
Major modifications to existing major stationary sources are also
subject to the PSD preconstruction review permit program. Major
modifications include a physical or operational change at a major
stationary source that would result in a significant net emissions
increase in any regulated air pollutant. 40 CFR 51.166(b)(2) and
52.21(b)(2).
C. General PSD Preconstruction Review Permit Requirements
In broad overview, the PSD preconstruction review permit program
requires the owner or operator of a proposed source to adopt the best
available control technology (BACT) and analyze the air quality impacts
associated with the source. CAA Sec. 165(a), 42 U.S.C. Sec. 7475(a).
BACT is defined in section 169(3) of the CAA, 42 U.S.C. Sec. 7479(3) as
an emission limitation based on the maximum degree of pollutant
reduction that is achievable taking into account energy, environmental
and economic impacts.
The PSD air quality impact assessment involves several
considerations. Generally, the owner or operator of the proposed source
must demonstrate that it will not contribute to air pollution that
violates any NAAQS or PSD increment. CAA Sec. 165(a)(3). The source
must also analyze the ambient air quality, climate and meteorology,
terrain, soils and vegetation, and visibility at the site and in the
area potentially affected by its emission. CAA Sec. 165(e).
D. Special PSD Program Protection for Class I Areas
There are additional, special protections under the PSD program
that apply for Class I areas. As examined in more detail below, the
statute appears to distinguish between the preconstruction review
permit procedures that apply for Federal Class I areas and non-Federal
Class I areas. As a necessary prerequisite, the discussion below first
explores in more detail the delineation between Federal and non-Federal
Class I areas.
1. Federal Class I Areas
a. Mandatory Federal Class I Areas
The Clean Air Act provides two ways for Federal lands to be
designated as Class I--either by congressional mandate, or by EPA
approval of a State or Tribal request to redesignate Federal lands.
Congress specified certain Federal lands as mandatory Class I areas.
National parks larger than 6000 acres, national memorial parks and
national wilderness areas larger than 5000 acres, and international
parks that were in existence on August 7, 1977 are designated by
statute as mandatory Class I areas. CAA Sec. 162(a). These areas cannot
be redesignated.
b. Other Federal Class I Areas
Congress also authorized States and Tribes to seek redesignation of
other Federal public lands within their boundaries as Class I. These
are lands currently designated as Class II. To inform such
redesignation decisions, Congress directed the Federal Land Managers
(FLM) to review all national monuments, primitive areas and national
preserves and to recommend the areas having important air quality
related values (AQRVs) be redesignated as Class I. CAA Sec. 164(d). The
FLM is defined as the Secretary of the Federal Department with
authority over the lands.2 CAA Sec. 302(i), 42 U.S.C. Sec.
7602(i). The recommendations have not resulted in the redesignation of
any Federal lands from Class II to Class I. The only Federal Class I
areas that presently exist are the original mandatory areas.
---------------------------------------------------------------------------
\2\ The FLM authority has been delegated to other officials
within these Departments. For example, the Assistant Secretary for
Fish and Wildlife and Parks is the FLM for areas under the
jurisdiction of the National Park Service and the U.S. Fish and
Wildlife Service.
---------------------------------------------------------------------------
2. Non-Federal Class I Areas
Class I areas may also be created if EPA approves a State or Tribal
request to redesignate its own lands as Class I. The resulting areas
would be non-Federal Class I areas. The PSD permit review procedures
that apply to new or modified PSD sources that may adversely affect
these non-Federal Class I areas are the central focus of this notice.
As noted in part I, a few Tribes have exercised their discretion to
seek heightened air quality protection status under the PSD program by
requesting redesignation of lands within reservation boundaries as
Class I areas. States may similarly request
[[Page 27160]]
redesignation of their lands as Class I in accordance with the
procedures outlined at 40 CFR 51.166(g) and 52.21(g). Thus, the permit
review procedures developed in this rulemaking would apply equally for
all non-Federal Class I areas--State or Tribal.
It is important to understand the differences implied by the use of
the terms ``Federal'' and ``non-Federal'' areas. The PSD program treats
as ``Federal'' lands various national public lands that the Federal
government owns and for which it has stewardship responsibility. These
public lands include the following: national parks, national memorial
parks, national wilderness areas, national monuments, national
lakeshores and seashores, national primitive areas, national preserves,
national recreation areas, national wild and scenic rivers, national
wildlife refuges, and other similar national public lands. See, e.g.,
CAA Secs. 160(2), 162(a) and 164(a), (d). The term ``non-Federal''
refers to State lands or to lands within the boundaries of an Indian
reservation that are not Federal lands within the meaning of the CAA's
PSD program. See, e.g., CAA Sec. 164(c). For example, the legislative
history distinguishes between the ``Federal lands'' which the Federal
government manages as a ``property owner * * * under the stewardship of
various Federal agencies'' and tribal lands. Senate Comm. on
Environment and Public Works, 95th Cong., 2d Sess., A Legislative
History of the Clean Air Act Amendments of 1977 724 (Comm. Print 1978)
(statement of Senator Muskie).
In a recent proposal to reform the PSD program, EPA explained that
lands within reservation boundaries may or may not be Federal lands
within the meaning of the PSD program. In fulfilling its fiduciary
responsibility toward federally-recognized Indian Tribes, the Federal
government holds some Tribal lands in ``trust'' for the benefit of the
Tribe. Such lands may have a federal feature under Federal Indian law
but are not ``Federal'' lands within the meaning of the PSD program.
However, national public lands within reservation boundaries, such as
national monuments, are included within the term ``Federal'' lands. See
61 FR 38250, 38293, n. 71 (July 23, 1996). Thus, the PSD permit review
procedures for State lands and lands within Indian reservation
boundaries that are non-Federal or non-public lands and redesignated as
Class I are the subject of this notice.
3. PSD Permit Review Provisions for Federal and Non-Federal Class I
Areas
A congressionally-declared purpose of the PSD program is to
preserve, protect, and enhance the air quality in national parks,
national wilderness areas, national monuments, national seashores, and
other areas of special national or regional natural, recreational,
scenic, or historic value. CAA Sec. 160(2). To this end, Congress
established special PSD permit review procedures that apply to proposed
PSD sources whose emissions may adversely impact Federal Class I areas.
Based on the statutory text, statutory structure and legislative
history it appears that these special permit review procedures, set out
at section 165(d) of the CAA, are intended to apply only to Federal
lands originally designated, or subsequently redesignated, as Class I
areas. The legislative history indicates that these special
requirements were intended ``to provide additional protection for air
quality in areas where the Federal Government has a special stewardship
to protect the natural values of a national resource. Such areas are
the federally-owned class I areas under the bill.'' S. Rep. No. 127,
95th Cong., 1st Sess. at 34 (1977) (emphasis added).
The central focus of the permit review procedures for Federal Class
I areas is to protect the air quality related values (AQRVs) of these
areas. The Clean Air Act specifies that AQRVs include visibility. CAA
Sec. 165(d). The legislative history further provides that for Federal
Class I areas the term AQRVs includes ``the fundamental purposes for
which such lands have been established and preserved by the Congress
and the responsible Federal agency. For example, under the 1916 Organic
Act to establish the National Park Service (16 U.S.C. 1), the purpose
of such national park lands `is to conserve the scenery and the natural
and historic objects and the wildlife therein and to provide for the
enjoyment of the same in such manner and by such means as will leave
them unimpaired for the enjoyment of future generations.' '' S. Rep.
No. 127, 95th Cong., 1st Sess. 36 (1977).
Specifically, for Federal Class I areas, the statute places an
``affirmative responsibility'' on the FLM to protect the air quality
related values of Federal lands. CAA Sec. 165(d)(2)(B).
The FLMs protect AQRVs through a prescribed statutory role. If the
proposed source will cause or contribute to a violation of a Class I
increment, then the owner or operator must demonstrate to the
satisfaction of the FLM that the emissions will not adversely impact
AQRVs. If the FLM so certifies, then the permit may be issued.
Conversely, even if a proposed source will not cause or contribute to a
violation of a Class I increment, the FLM may nevertheless demonstrate
to the satisfaction of the permitting authority that the source will
have an adverse impact on AQRVs. If so demonstrated, then the permit
shall not be issued. CAA Sec. 165(d)(2)(C). Thus, compliance with the
Class I increments determines the burden of proof for demonstrating the
presence or absence of an adverse impact on AQRVs.
EPA recently proposed significant changes to its PSD and
nonattainment New Source Review (NSR) program. The proposal includes
revisions to the PSD permit review procedures for sources that may
adversely impact Federal Class I areas. See 61 FR 38250, 38282-38295
(July 23, 1996). The proposed revisions are intended to improve
coordination and cooperation, and clarify relative responsibilities
among FLMs, proposed sources, and permitting agencies.
Part III below examines whether EPA's permit review procedures for
non-Federal Class I areas should be similar to EPA's recent proposal
for Federal Class I areas in all respects or whether some differences
must or should exist. While, as noted above, section 165(d) contains
specific permit review procedures for Federal Class I areas, the Clean
Air Act does not contain such specific provisions for non-Federal Class
I areas. However, the CAA does contain provisions aimed at protecting
air quality in non-Federal Class I areas when a dispute arises between
affected States or Tribes. The Clean Air Act recognizes that a PSD
source proposing to locate in one jurisdiction can have adverse effects
on the air quality of another jurisdiction. By contrast with the
provisions that give the FLM responsibility for protecting Federal
Class I areas, any State or Tribal government, concerned that a
proposed source outside its jurisdiction may adversely impact the air
quality of a non-Federal Class I area, may seek to protect such area.
The Clean Air Act establishes a special dispute resolution process to
address such intergovernmental disagreements.
The Clean Air Act provides that the Governor of an affected State
or the Indian ruling body of an affected Indian Tribe may request the
EPA Administrator to enter negotiations with the parties involved to
resolve the dispute. If the parties are unable to reach agreement, the
Clean Air Act makes EPA the ultimate arbiter of the intergovernmental
dispute. Section 164(e) of the CAA establishes the special process for
resolving these
[[Page 27161]]
intergovernmental disputes, and reads in relevant part as follows:
[I]f a permit is proposed to be issued for any new major
emitting facility proposed for construction in any State which the
Governor of an affected State or governing body of an affected
Indian tribe determines will cause or contribute to a cumulative
change in air quality in excess of that allowed in this part within
the affected State or tribal reservation, the Governor or Indian
ruling body may request the Administrator to enter into negotiations
with the parties involved to resolve such dispute. If requested by
any State or Indian tribe involved, the Administrator shall make a
recommendation to resolve the dispute and protect the air quality
related values of the lands involved. If the parties involved do not
reach agreement, the Administrator shall resolve the dispute and his
determination, or the results of agreements reached through other
means, shall become part of the applicable plan and shall be
enforceable as part of such plan.
Thus, the broad contours of this provision include (but are not
limited to) intergovernmental PSD permit disputes over potential
impacts on non-Federal Class I areas.3 This provision is
codified in 40 CFR 52.21(t).
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\3\ Further, several additional provisions of the Clean Air Act
and PSD program are aimed at curbing interjurisdictional air
pollution transport. A purpose of the PSD program is to assure that
emissions from a source in one jurisdiction do not interfere with
PSD in another jurisdiction. CAA Sec. 160(4). State air quality
management plans are required to contain provisions that prohibit
in-State emissions from interfering with PSD measures in another
State. CAA Sec. 110(a)(2)(D). The interstate pollution abatement
provisions of the CAA direct State Implementation Plans (SIPs) to
require PSD sources to notify nearby States whose air pollution
levels may be affected by the source. CAA Sec. 126.
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In this rulemaking, EPA endeavors to clarify the PSD permit review
procedures in a manner that will facilitate amicable resolution of
intergovernmental disputes about potential impacts on non-Federal Class
I areas without the need for recourse to EPA. Additionally, EPA will
examine the methods EPA should consider and the procedures it should
employ in the event it is necessary for EPA to resolve an
intergovernmental PSD permit dispute. In resolving any
intergovernmental permit disputes EPA will act consistent with its
trust responsibilities toward Tribes.
III. Preliminary Issues
The overall objective of the rulemaking revisions addressed in this
notice is to clarify and improve the PSD permit review procedures
applicable to proposed sources that may adversely affect non-Federal
Class I areas.4 In developing these rules EPA will be guided
by the core purposes of the Clean Air Act and the PSD program. As
noted, the genesis of the PSD program was the non-degradation policy
embodied in section 101(b)(1) to ``protect and enhance'' air quality
resources to ``promote the public health and welfare.'' The
congressionally declared objectives of the PSD program include ensuring
that ``economic growth will occur in a manner consistent with the
preservation of existing clean air resources'' and ensuring that ``any
decision to permit increased air pollution'' is made ``only after
careful evaluation of all the consequences * * * and after adequate
procedural opportunities for informed public participation.'' CAA Sec.
160 (3) and (5), 42 U.S.C. 7470 (3) and (5). EPA seeks to develop
workable rules that consider preservation of existing clean air
resources and potential impacts on economic growth. EPA intends to
fashion rules that are clear, sensible and improve the PSD permit
process.
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\4\ EPA is not proposing to modify its rules on the PSD
redesignation process itself. The statute clearly prescribes the
process and the implementing regulations (i.e., 40 CFR 51.166(g) and
52.21(g)) provide adequate guidelines.
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EPA seeks public input on the following preliminary issues for use
in developing proposed revisions to its PSD permit review procedures at
40 CFR 51.166 and 52.21. EPA's public workshops, discussed in Part IV
of this document, will focus on these preliminary issues and other
issues raised by members of the public. EPA also encourages public
commenters to address the issues in their written submissions to the
Agency.
A. Scope of New Rulemaking Initiative
EPA seeks public input on the appropriate scope of this regulatory
initiative. Currently, after more than 20 years of authority to
redesignate, there are five non-Federal Class I areas. By contrast,
there are more than 150 mandatory Federal Class I areas. Thus, non-
Federal Class I areas are not nationally prevalent in the same manner
as Federal Class I areas.
EPA already has detailed PSD permit review procedures in place. In
addition, EPA's recent proposal to reform its PSD rules includes
proposed revisions related to permit review procedures for Federal and
non-Federal Class I areas. 61 FR 38282-38295. For example, EPA proposed
to define the term ``air quality related value'' for both Federal and
non-Federal Class I areas as ``a scenic, cultural, physical,
biological, ecological, or recreational resource which may be affected
by a change in air quality, as defined by the FLM for Federal lands and
as defined by a State or Indian Governing Body for non-Federal lands
within their respective jurisdictions.'' 61 FR 38283-38284.
EPA has also proposed significance levels for all Class I areas. 61
FR 38291-38292. Under the proposal, PSD sources with a predicted
(modeled) air quality impact below the significance levels would be
excluded from the requirement to conduct a full Class I increment
analysis. EPA indicated that permitting authorities could use the
finding of an insignificant impact to determine that the source's
emissions would not contribute to an increment violation. However, an
impact below the significance level of the PSD increments would not
necessarily indicate that the proposed source also has an insignificant
impact on AQRVs.
In the pending rulemaking to reform the PSD program, EPA also
clarified the PSD requirements applicable to non-Federal lands
redesignated as Class I areas. 61 FR 38293-38295. EPA explained that
States and Tribes with non-Federal Class I areas may identify AQRVs for
their lands and may pursue protection of the AQRVs through the
intergovernmental dispute resolution provisions under section 164(e) of
the CAA. EPA proposed to adopt a regulation at 40 CFR 51.166(t) to
implement section 164(e), as a companion to the regulation currently in
place at 40 CFR 52.21(t). 61 FR 38293-38295. EPA also proposed to
define ``Federal Class I areas'' to clarify the distinctions between
Federal and non-Federal Class I areas. 61 FR 38293-38295.
As noted, section 164(e) provides that a State or Tribe may request
intergovernmental dispute resolution if a State or Tribe determines
that emissions from a proposed PSD source ``will cause or contribute to
a cumulative change in air quality in excess of that allowed in [the
PSD program] within the affected State or tribal reservation.'' Section
164(e) further provides that if requested by the State or Tribe
involved, EPA shall make a recommendation to resolve the dispute and
``protect the air quality related values of the lands involved.'' If
the parties do not reach agreement, EPA shall resolve the dispute and
its determination shall become part of the applicable plan. Because
section 164(e) specifically provides for protection of AQRVs, EPA has
previously explained its view that States and Tribes may seek
protection of AQRVs through these intergovernmental dispute resolution
provisions. [Letter to George Meyer, Wisconsin Department of Natural
Resources, from Valdas Adamkus, EPA
[[Page 27162]]
Regional Administrator for Region V (July 27, 1994).]
In the PSD reform proposal, EPA explained its interpretation of the
language authorizing intergovernmental dispute resolution if a proposed
source ``will cause or contribute to a cumulative change in air quality
in excess of that allowed in [the PSD program].'' EPA stated that a
State or Tribe may request intergovernmental dispute resolution when a
State or Tribe determines that a proposed source will cause or
contribute to a violation of the NAAQS or PSD increment or will harm
AQRVs identified by the State or Tribe. 61 FR 38294.
EPA believes its interpretation is supported by the plain language
of the statute and statutory structure. The statutory language at issue
is expansive--referring generally to ``changes in air quality.'' The
increments are a central limit on air quality deterioration established
under the PSD program and well within the ambit of this language. At
the same time, increments are explicitly referred to elsewhere in the
PSD provisions as ``maximum allowable increases'' and ``maximum
allowable concentrations'' of pollutants. CAA Secs. 163 & 165(a)(3)(A).
Thus, EPA believes that the language in section 164(e)is not confined
to PSD increments. The statutory text also appears to encompass adverse
impacts on AQRVs due to ``changes in air quality.'' EPA believes AQRVs
are properly a basis for initiating dispute resolution since their
protection is a stated purpose of the provision. 61 FR 38294. In other
words, to allow states or tribes to initiate intergovernmental dispute
resolution because of adverse impacts on AQRVs is consistent with the
statutory language in section 164(e) that calls for EPA to ``make a
recommendation to resolve the dispute and protect the air quality
related values of the land involved.'' Today, EPA seeks further public
comment on this interpretation.
The proposed revisions to reform the PSD program are the outgrowth
of extensive discussions with representatives of State and local
governments, regulated industry, Federal Land Managers, and
environmental organizations. EPA held a public hearing in September
1996 and has provided abundant opportunity for public comment. Except
for interpretation of section 164(e) discussed immediately above,
regarding the basis for initiating intergovernmental disputes, EPA does
not intend to reopen in this rulemaking the proposals advanced in the
separate rulemaking to reform the PSD program published on July 23,
1996 (61 FR 38250).
Thus, the question for this new rulemaking initiative is what
additional changes to the PSD permit program are needed to clarify and
improve the permit review procedures for proposed sources that may
adversely affect air quality in non-Federal Class I areas. EPA requests
public input on the appropriate scope of this rulemaking, considering
the previously proposed revisions to improve the PSD program and the
relatively small number of non-Federal Class I areas.
B. Improving Coordination Between Permitting Authorities and States or
Tribes With Non-Federal Class I Areas
The July 1996 proposed rules to reform the PSD program contained
provisions to address concerns about the PSD permit review procedures
for Federal Class I areas. 61 FR 38282-38295. The proposal is intended
to reduce delays and disputes associated with permitting near Federal
Class I areas by facilitating coordination between the FLM, the permit
applicant and the permit authority, and clarifying the relative roles
and responsibilities of the involved parties. A central goal of
improved coordination is to help identify potential disagreements early
in the permit process, when it is less disruptive. Roles are clarified
to ensure that responsibilities are reasonably, and mutually,
allocated.
EPA seeks public comment on whether some of the basic policy
concerns reflected in EPA's recent proposal to revise the PSD rules for
Federal Class I areas are also concerns that should be addressed when
developing proposed programmatic improvements for non-Federal Class I
areas. These basic policy concerns, as they apply to non-Federal Class
I areas, are outlined below. 5
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\5\ As noted, this notice does not seek public comment on EPA's
proposed revisions to the permit review procedures for Federal Class
I areas published on July 23, 1996 and already subjected to public
comment.
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1. Permit Application Coordination
A State or Tribe with a non-Federal Class I area will be aware of
sources proposing to locate within its jurisdiction and can work with
the permitting authority to review and resolve potential impacts on
non-Federal Class I areas. However, if the source is located in another
jurisdiction, a State or Tribe can only effectively protect its non-
Federal Class I area from potentially adverse effects if it knows about
the proposed source.
In its July 1996 proposed revisions to the PSD rules, EPA generally
proposed to require submittal of permit applications to the FLMs for
sources locating within 100 kilometers (km) of a Federal Class I area.
EPA also proposed to require basic source information concerning
sources locating more than 100 km from a Federal Class I area to be
input into an electronic database in lieu of transmitting entire permit
applications to the FLMs. The database enables the FLMs to review
information about proposed PSD sources and determine whether further
information about the project is needed. 61 FR 38287-38288.
EPA's current regulations generally require State-administered PSD
programs to send the public notice of PSD permits to any State or
Indian Governing Body whose lands may be affected by emissions from the
source or modification. 40 CFR 51.166(q)(2)(iv). The public notice
includes the following information: indicates that a PSD permit
application has been received, states the permitting authority's
preliminary determination to approve or deny the permit, describes the
degree of increment consumption that is expected, and addresses the
opportunity for comment at a public hearing as well as written public
comment.
EPA requests public comment on whether EPA should clarify when a
permit authority must provide an affected State or Tribe with a copy of
the public notice. EPA also requests comment addressing whether, when a
non-Federal Class I area may be affected, EPA should also require
permit authorities to provide affected States or Tribes with copies of
the permit application or other advance notice before the permit
authority makes a preliminary determination to grant or deny the
permit.
For example, commenters should address whether EPA should establish
standard procedures for permit application notification of sources that
may adversely affect non-Federal Class I areas, and how such
notification could be effectively and efficiently accomplished. Using
the distance between the proposed source and non-Federal Class I area
as a basis for determining whether coordination is necessary is
simplistic and clear. However, rigid distances alone can be over- and
under-inclusive. For example, if States or Tribes with non-Federal
Class I areas were required to be notified of all proposed sources
within 100 km of the Class I area, then this may place a burden on some
sources that do not threaten the area and exclude some
[[Page 27163]]
large sources that may impact the area. EPA seeks suggestions on how to
ensure that States and Tribes with non-Federal Class I areas receive
adequate information about proposed sources that may affect the areas
without placing undue burdens on PSD permit applicants and permit
agencies.
EPA also requests public comment on how to facilitate
intergovernmental coordination during the permit review process to
avoid the need for EPA to resolve disputes over potential impacts on
non-Federal Class I areas. EPA's July 1996 proposal contained several
potential revisions to the PSD rules that call for consultation between
the permitting authority and FLM at various key stages of the permit
process. 61 FR 38283-38295. Intergovernmental consultation may
facilitate resolution of concerns. Further, the earlier all parties are
aware of potential concerns, then the sooner the concerns can be
resolved and constructive discourse can begin. EPA requests public
comment addressing consultation and other measures that can be taken to
help resolve intergovernmental permit disputes at an early stage in the
permit process. Commenters should address whether consultation would be
productive, what alternative measures would be appropriate, and what
stages in the permit process consultation should be formalized.
2. Identifying and Disseminating Information About Air Quality Related
Values
As noted, EPA's July 1996 proposed PSD revisions define ``AQRVs''
for Federal and non-Federal lands as visibility or a scenic, cultural,
physical, biological, ecological, or recreational resource that may be
affected by a change in air quality, as defined by the Federal Land
Manager for Federal lands and as defined by the applicable State or
Indian Governing Body for non-Federal lands. 61 FR 38284. EPA's July
1996 notice sought public comment on this proposed definition and EPA
is not seeking further comment in today's notice.
However, EPA does request public input on measures to encourage
identification and dissemination of information about the AQRVs for
non-Federal lands. EPA's July 1996 proposal included provisions for the
public dissemination of information about the AQRVs for Federal lands.
61 FR 38283-86. EPA proposed to place responsibility on the FLM to
ensure that permit applicants and permit agencies have adequate
information about any AQRV which the FLM has identified. Public
commenters should address reasonable steps that can be taken by States
or Tribes with AQRVs to inform PSD permit agencies and applicants about
the AQRVs. Commenters should also suggest the type of information that
would be useful to potential permit applicants and permit agencies.
A related issue is the level of technical support that should
accompany identification of AQRVs. Technical or scientific information
about AQRVs may be necessary for a neighboring permit agency and permit
applicant to understand and address potential concerns. EPA requests
comments on whether EPA should propose rules addressing the technical
support information for AQRVs identified by a State or Tribe, and seeks
input on approaches that may be appropriate.
3. No Affirmative Responsibility to Protect AQRVs of Non-Federal Lands
As noted, the Clean Air Act places an affirmative responsibility on
FLMs to protect the AQRVs of Federal Class I areas. Thus, the FLM has a
special duty under Federal law to protect the air quality related
resources of Federal Class I areas.
However, it does not seem appropriate for a State or Tribe with a
non-Federal Class I area to be under a similar responsibility to
protect AQRVs. This is an area where a departure between Federal and
non-Federal lands seems appropriate. Because a decision by a State or
Tribe to seek redesignation of its lands as a Class I area is entirely
discretionary, EPA believes that it would be inappropriate to place an
affirmative responsibility on a State or Tribe to challenge permit
applications from proposed sources locating in other jurisdictions.
Thus, EPA is disinclined in this rulemaking to place any duty on an
affected State or Tribe to invoke the intergovernmental dispute
resolution process and intends to leave this entirely within the
State's or Tribe's discretion. EPA solicits public comment on this
proposed approach.
C. EPA Resolution of Intergovernmental Permit Disputes
When a State or Tribe does elect to invoke the dispute resolution
process, section 164(e) of the CAA makes EPA the arbiter of
intergovernmental PSD permit disputes. Section 164(e) of the CAA
provides that if the Governing Body of an affected Indian Tribe or the
Governor of an affected State determines that a proposed PSD source
``will cause or contribute to a cumulative change in air quality in
excess of that allowed [under the PSD program],'' the Tribe or State
may request EPA to enter into negotiations with the parties involved to
resolve the dispute. Then, if requested by a State or Tribe, EPA will
make a recommendation to resolve the dispute and protect the AQRV's of
the lands involved. If that does not lead to resolution, EPA is
ultimately called upon to resolve such disputes regardless of whether
the proposed permit is being reviewed under a State, Tribal, or
Federally administered program. EPA seeks public input on the issues
outlined below related to EPA's resolution of permit disputes about
potential air pollution impacts on non-Federal Class I areas.
1. EPA's Discretion to Fashion Reasonable Solutions
EPA has broad discretion in crafting solutions to intergovernmental
permit disputes under section 164(e) of the CAA. The key statutory text
in section 164(e) provides as follows:
If requested by any State or Indian tribe involved, the
Administrator shall make a recommendation to resolve the dispute and
protect the air quality related values of the lands involved. If the
parties involved do not reach agreement, the Administrator shall
resolve the dispute and his determination, or the results of
agreements reached through other means, shall become part of the
applicable plan and shall be enforceable as part of such plan.
Thus, Congress has directed EPA to ``make a recommendation to
resolve the dispute and protect the air quality related values of the
lands involved.'' If the parties cannot reach agreement, EPA is
authorized to ``resolve the dispute.'' The statute does not specify or
constrain the measures or methods EPA may employ to resolve the
dispute.
EPA's discretion to resolve disputes may mean that EPA draws from a
variety of methods in resolving any particular PSD permit dispute. This
will enable EPA to tailor a solution to the circumstances and issues
presented. For example, in the event that EPA is requested to resolve a
dispute involving a proposed source's potential impacts on AQRVs and
the affected governments disagree about the nature of the projected
effects, EPA may need to explore and resolve underlying technical and
scientific issues. EPA seeks comment on whether it should elaborate how
it might evaluate such technical or scientific disagreements.
Post-construction monitoring may be an effective way to resolve
some disputes conditionally. Where there are irreconcilable disputes
over the potential impact of a proposed source, post-construction
monitoring and subsequent evaluation provides a means
[[Page 27164]]
to ascertain actual source impacts and assess the need for any further
action.
EPA also requests comment on whether it should address measures
that could be employed to mitigate effects on AQRVs. In the July 1996
PSD rulemaking proposal, EPA explored methods to mitigate adverse
impacts on the AQRVs of Federal Class I areas to allow permitting of
sources that would otherwise face permit modification or denial. 61 FR
38290-38291. Similarly, if resolution of an intergovernmental permit
dispute necessitated permit modification or denial to protect the AQRVs
of non-Federal Class I areas, mitigation of source impacts through
emissions offsets from other sources or other mitigation techniques may
present a means to avoid harsher results.
It is also possible that a proposed source may not adversely impact
AQRVs but still exceed Class I increments. If that is the case, EPA may
consider whether, in certain circumstances and consistent with its
trust responsibilities toward tribes, it is within EPA's discretion
under section 164(e) to allow issuance of a permit that exceeds Class I
increments. It is unclear whether section 164(e) would authorize such
action by EPA. This issue is examined in more detail below.
As noted, the Class I increments are the most stringent PSD
increments. Therefore, it is conceivable that a proposed source could
exceed a Class I increment and yet not adversely impact AQRVs. The
Clean Air Act expressly recognizes this situation for Federal Class I
areas. As noted, under the specific statutory provisions for Federal
Class I areas at section 165(d)(2) of the CAA, a source's contribution
to the Class I increments determines who bears the burden of proof for
demonstrating the presence or absence of an adverse impact on AQRVs and
is not decisive of whether a permit may be issued. If a proposed source
will contribute to a Class I increment violation in a Federal Class I
area, then the owner or operator may nevertheless demonstrate to the
satisfaction of the FLM that the source will not adversely impact
AQRVs. Therefore, the FLM may conclude that AQRVs are not threatened
despite the Class I increment violation. If the FLM certifies that no
adverse impact will occur despite the source's violation of the Class I
increment, the permitting authority may issue a PSD permit provided the
source demonstrates compliance with the Class II increments (as well as
a more stringent three-hour sulfur dioxide concentration
level).6 CAA Sec. 165(d)(2)(C)(iv), 40 CFR 51.166(p)(4) and
52.21(p)(5). Thus, in limited circumstances for Federal Class I areas,
the Clean Air Act contemplates that a PSD permit could be issued for a
source that exceeds the Class I increments.
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\6\ The source must demonstrate compliance with a concentration
level for sulfur dioxide measured over three hours that is more
stringent than the Class II increment but less stringent than the
Class I increment. CAA Sec. 165(d)(2)(C)(iv), 40 CFR 51.166(p)(4)
and 52.21(p)(5). If the FLM declines to certify that no adverse
impact will occur, the permit must be denied or modified. If the
proposed source may not be constructed because of the sulfur dioxide
increment for periods of twenty-four hours or less, the Governor may
grant a variance of the increment if doing so will not adversely
affect AQRVs and the FLM concurs. If the Governor and FLM do not
agree, their respective recommendations may be transmitted to the
President who may grant the variance if it is in the national
interest and the facility meets specific limits on its sulfur
dioxide concentrations. CAA Sec. 165(d)(2)(D), 40 CFR 51.166 (p)(5)
through (p)(7) & 52.21 (p)(6) through (p)(8).
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However, section 164(e) does not contain a similar express
exemption of the Class I increments for non-Federal lands. Further,
other provisions of the Clean Air Act specify that a proposed source
must comply with increments to qualify for a PSD permit. For example,
as underscored, section 163 establishes the Class I increments
providing that ``the maximum allowable increase in concentrations of
sulfur dioxide and particulate matter shall not exceed'' certain
prescribed amounts. See also 40 CFR 51.166(c) and 52.21(c). Further,
section 165(a) directs PSD sources to demonstrate that emissions will
not contribute to an increment exceedance more than one time per year.
Thus, the absence of an explicit statutory exemption to the Class I
increments for non-Federal Class I areas would suggest that section
164(e) should not be construed to provide one.
Additionally, for non-Federal Class I areas, the Class I increments
appear to have relevance independent of AQRVs. The intergovernmental
dispute resolution provisions for non-Federal lands provide that a
State or Tribe may object to a proposed PSD permit if it determines
that emissions ``will cause or contribute to a cumulative change in air
quality in excess of that allowed [under Part C of the Act--the PSD
program] within the affected State or tribal reservation.'' CAA Sec.
164(e). As noted, EPA has previously proposed to interpret excess air
quality changes to include a proposed source's contribution to a NAAQS
violation, PSD increment violation or AQRV impact. 61 FR 38294. Thus,
EPA interprets this provision to direct EPA mediation, at the request
of a State or Tribe, when a State or Tribe determines that a proposed
source will cause or contribute to a violation of a NAAQS or increment,
or contribute to AQRV impacts. The bases for invoking the PSD
intergovernmental dispute provisions arguably suggest that Class I
increments should be among the concerns protected in resolving
disputes.
Further, for non-Federal Class I areas, there are additional
reasons to give the Class I increments consideration independent of
AQRVs. Because Congress gave States and Tribes broad latitude to seek
redesignation of non-Federal lands as Class I areas, States and Tribes
could seek redesignation to prevent incremental air quality
deterioration without regard to protection of AQRVs. In such a
situation, compliance with Class I increments enables States and Tribes
to advance public health and welfare concerns associated with air
quality degradation independent of AQRVs. Thus, EPA may be requested to
resolve a dispute involving only a PSD increment, where no AQRV has
been defined. In that case, it could be argued that EPA should never
waive a PSD increment in a non-Federal Class I area because the State's
or Tribe's goal in redesignating the area to Class I may have been
solely the protection of the increments.
At the same time, the section 164(e) dispute resolution provisions
direct EPA to ``make a recommendation to resolve the dispute and
protect the air quality related values of the lands involved.'' This
might suggest that AQRVs, not increments, are the principal focus of
protection under section 164(e). But, relying on the objective of
protecting AQRVs in section 164(e) as a basis for a Class I increment
exemption could be very broad since this explanation could conceivably
justify an exemption of the Class II or III increments. Perhaps in
exercising its administrative discretion under section 164(e) EPA would
be confined to a Class I increment exemption, by direct analogy to the
statutory exemption provisions for Federal Class I areas.
EPA requests comment on whether EPA should explore in this
rulemaking EPA's discretion to waive the Class I increments for non-
Federal Class I areas in resolving permit disputes under section 164(e)
of the CAA. While it is clear that such action is impermissible unless
AQRVs will also be protected, there may nevertheless be circumstances
when Class I increment violations occur that do not threaten AQRVs. EPA
also seeks comment on the circumstances under which it might be
appropriate for EPA to consider providing an exemption for a Class I
[[Page 27165]]
increment. EPA also requests comment on how to weigh competing concerns
in determining whether a Class I increment exclusion may be
appropriate. For example, if a State or Tribe with a Class I area was
very concerned about increases in direct particulate matter pollution,
perhaps it would be appropriate for EPA to consider an exclusion from
the short-term sulfur dioxide increment but not from PM-10.
In sum, EPA requests public comment on whether EPA should address
in this rulemaking some of the potential measures and tools that may be
employed to resolve intergovernmental disputes and, if so, what
approaches may be appropriate. Alternatively, it may be appropriate for
EPA to adopt very general rules that enable EPA to take any number of
actions depending upon the circumstances.
2. Dispute Resolution Procedures
EPA also seeks input on whether and to what extent EPA should
prescribe the procedures to be followed in resolving intergovernmental
permit disputes under section 164(e). For example, EPA is interested in
the public's views about whether EPA should establish a particular
dispute resolution process. Further, EPA requests comment on whether
EPA should address how the dispute resolution process relates to the
permit proceeding and how the resulting solution is implemented.
3. Incentives for Amicable Dispute Resolution
Ideally, intergovernmental permit disputes could be amicably
resolved without recourse to EPA. EPA seeks public comment on
incentives EPA could create for governments to resolve their concerns
amicably.
D. Miscellaneous Changes
EPA also seeks public input on any clarifying, administrative
changes EPA should make to its existing PSD regulations in light of the
distinctions between Federal and non-Federal Class I areas. Comments
regarding consistent use of terminology would be appropriate. For
example, the existing rules may generally refer to Class I areas where
the context implies that Federal Class I areas is the intended meaning.
Technical revisions may help avoid any confusion.
The public should also comment on whether EPA should make any
conforming regulatory changes to the Guideline on Air Quality Modeling
to clarify and improve the PSD permit procedures for non-Federal Class
I areas. The Guideline prescribes the air quality models employed to
estimate the air quality impacts of proposed PSD sources and is
codified at 40 CFR part 51, Appendix W.
E. Summary of the Principal Issues
To facilitate public input, EPA has summarized the issues raised
for comment in this notice.
1. Scope of Rulemaking. What regulatory changes should EPA consider
in this rulemaking beyond the PSD programmatic revisions proposed in
EPA's July 23, 1996 Federal Register notice (61 FR 38250)?
2. Analogy to Federal Class I Area Issues. To what extent should
EPA draw from the PSD permit review procedures proposed for Federal
Class I areas in the July 23, 1996 notice in considering rule changes
for non-Federal Class I?
3. Permit Application Notification. What effective, and efficient,
measures should EPA consider to ensure that States and Tribes with non-
Federal Class I areas receive adequate information about proposed
sources that may adversely impact such areas?
4. Intergovernmental Coordination. How can EPA facilitate
intergovernmental consultation and coordination during the permit
review process in a manner that helps avoid intergovernmental disputes?
5. Identifying AQRVs. What guidance, if any, should EPA provide
about the technical support that should accompany identification of
AQRVs by States and Tribes?
6. Disseminating Information about AQRVs. What methods should EPA
consider to ensure that States and Tribes with AQRVs provide adequate,
timely information about their AQRVs to permit applicants and permit
agencies?
7. Responsibility to protect AQRV. Should non-Federal land managers
have the same affirmative responsibility as Federal land managers to
protect AQRVs?
8. EPA Resolution of Intergovernmental Disputes. Should EPA specify
the procedures, measures and techniques that might be employed in
resolving intergovernmental permit disputes under section 164(e) and,
if so, which of these might be appropriate?
9. Waiver of Class I Increments. Should EPA explore in this
rulemaking EPA's discretion to waive the Class I increments for non-
Federal Class I areas in resolving permit disputes?
10. Dispute Resolution Procedures. What rules, if any, should EPA
consider to govern the manner in which EPA will conduct resolution of
intergovernmental permit disputes under section 164(e)?
11. Incentive for Amicable Intergovernmental Dispute Resolution.
How can EPA create incentives for amicable resolution of
intergovernmental permit disputes?
12. Additional Clarifying Regulatory Changes. What regulatory
revisions are necessary to clarify the distinction between Federal and
non-Federal Class I areas?
13. Regulatory Flexibility Act. What steps can EPA take in this
rulemaking to facilitate public participation by any small entities
that may be adversely affected and to mitigate any such impacts?
14. Paperwork Reduction Act. What steps can EPA take in this
rulemaking initiative to ensure that any informational requirements are
necessary and of practical utility, and to minimize the burden of any
information requirements?
IV. Public Workshops
EPA recognizes the complexities of the issues surrounding the PSD
permit application process. EPA seeks input from all interested members
of the public in formulating a reasonable, workable approach to the PSD
permit review procedures for sources potentially impacting non-Federal
Class I areas.
The preceding discussion has attempted to identify some major
issues in developing an approach to this rulemaking. However, these are
only preliminary ideas that do not necessarily exhaust all possible
issues and approaches regarding the PSD permit review process. EPA
wishes to engage in a public discussion about the PSD permit review
process and intends to hold public workshops that will provide
opportunity for interested members of the public to address the issues
raised in this notice and suggest additional approaches.
The first of these public workshops will be held in Phoenix,
Arizona and in Chicago, Illinois. A Federal Register notice announcing
specific dates, times, and locations of these workshops will be
published at least 30 days prior to the workshops. If there is public
interest, additional public workshops will be announced in the Federal
Register.
V. Additional Information
A. Public Docket
This rulemaking action involves promulgation or revision of PSD
regulations. Thus, the rulemaking is subject to the procedures in
section 307(d) of the CAA, 42 U.S.C. Sec. 7607(d), in accordance with
section 307(d)(1)(J). The public docket for this rulemaking action is
A-96-53. The docket is a file of information relied on by EPA in the
development of
[[Page 27166]]
regulations. All written comments and accompanying materials received
in response to this notice will be placed in the public docket. The
docket is available for public review and copying at EPA's Air Docket,
as indicated in the ADDRESSES section at the beginning of this
document.
B. Executive Order (EO) 12866
Section 3(f) of EO 12866 defines ``significant regulatory action''
for purposes of centralized regulatory review by the Office of
Management and Budget (OMB) to mean any regulatory action that is
likely to result in a rule that may:
(1) 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;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.
A draft of this ANPR and associated materials were reviewed by OMB
prior to publication. Information related to OMB's review of this ANPR
has been placed in the public docket referenced at the beginning of
this notice, including: (1) Materials provided to OMB in conjunction
with OMB's review of this ANPR; and (2) Materials that identify
substantive changes made between the submittal of a draft ANPR to OMB
and this notice, and that identify the changes that were made at the
suggestion or recommendation of OMB.
C. Regulatory Flexibility Act as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996
Under the RFA, 5 U.S.C. 601-612, EPA must prepare an initial
Regulatory Flexibility Analyses to accompany notices of proposed
rulemaking that assess the impact of proposed rules on small entities.
Small entities include small businesses, small not-for-profit
enterprises and government entities with jurisdiction over populations
of less than 50,000. However, the requirement of preparing such
analyses is inapplicable if the Administrator certifies that the rule
will not, if promulgated, have a significant economic impact on a
substantial number of small entities. 5 U.S.C. 605(b).
The regulatory revisions that are being considered in this
rulemaking initiative would affect the PSD permit review procedures for
new major stationary sources and major modifications to existing major
stationary sources. This regulatory initiative is also intended to
clarify and improve the existing rules. It is unclear at this stage of
the rulemaking process whether this rulemaking initiative may have a
significant adverse impact on a substantial number of small entities.
Nevertheless, EPA seeks public comment on steps EPA can take in this
rulemaking to facilitate public participation by any small entities
that may be adversely affected and to mitigate any such impacts.
D. Paperwork Reduction Act
EPA requests public comments on steps EPA can take in this
rulemaking initiative to ensure that any informational requirements are
necessary and of practical utility, and to minimize the burden of any
information requirements.
Dated: May 8, 1997.
Mary D. Nichols,
Assistant Administrator for Air and Radiation.
[FR Doc. 97-12918 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 97-12807 Insured State Nonmember Banks Which are Municipal Securities Dealers
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 26994-26997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12807]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 62, No. 95 / Friday, May 16, 1997 / Proposed
Rules
[[Page 26994]]
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FEDERAL DEPOSIT INSURANCE CORPORATION
12 CFR Part 343
RIN 3064-AC04
Insured State Nonmember Banks Which are Municipal Securities
Dealers
AGENCY: Federal Deposit Insurance Corporation (FDIC).
ACTION: Proposed rescission of rule.
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SUMMARY: As part of the FDIC's systematic review of its regulations and
written policies under section 303(a) of the Riegle Community
Development and Regulatory Improvement Act of 1994 (CDRI), the FDIC is
proposing to rescind its regulation that requires insured state
nonmember banks which are municipal securities dealers to file with the
FDIC certain information about those persons who are or seek to be
associated with these dealers as municipal securities principals or
municipal securities representatives. The FDIC has determined for a
number of reasons, including the fact that much of the same information
is available in the Municipal Securities Rulemaking Board's (MSRB)
regulation G-7, ``Information Concerning Associated Persons'', and that
the FDIC is not required by law to issue its own regulations governing
the professional qualification of these associated persons, to propose
rescission of the regulation because it is unnecessary and duplicative.
DATES: Comments must be received on or before July 15, 1997.
ADDRESSES: Written comments are to be addressed to the Office of the
Executive Secretary, Federal Deposit Insurance Corporation, 550 17th
Street, NW., Washington, DC 20429. Comments may be hand-delivered to
Room F-402, 1776 F Street, NW., Washington, DC 20429, on business days
between 8:30 a.m. and 5 p.m. (FAX number: (202) 898-3838; internet
address: [email protected]). Comments will be available for inspection
in the FDIC Public Information Center, Room 100, 801 17th Street, NW.,
Washington, DC, between 9 a.m. and 5 p.m. on business days.
FOR FURTHER INFORMATION CONTACT: Carol A. Mesheske, Chief, Special
Activities Section, (202) 898-6750, Division of Supervision; or Karen
L. Main, Senior Attorney, (202) 898-8838, Legal Division, Federal
Deposit Insurance Corporation, Washington, DC 20429.
SUPPLEMENTARY INFORMATION:
I. Background
The FDIC adopted part 343 as a final rule on August 8, 1977. 42 FR
40891 (August 12, 1977), and it became effective on October 31, 1977.
42 FR 46275 (September 15, 1977). Part 343 requires insured state
nonmember banks and certain of their subsidiaries, departments and
divisions, as specified in section 3(a)(34)(A)(iii) of the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) (Act), which are municipal
securities dealers, as defined in section 3(a)(30) of the Act, to file
with the FDIC information about persons who are associated with them as
municipal securities principals or municipal securities
representatives.
The Securities Acts Amendments of 1975 (Pub. L. 95-29) amended the
Act to provide for the creation of the MSRB and delegated
responsibility to it to formulate rules regulating the activities of
municipal securities dealers. However, the Act distributes authority to
enforce MSRB rules among the Securities and Exchange Commission (SEC),
the Office of the Comptroller of the Currency (OCC), the Federal
Reserve Board (FRB) and the FDIC. As specified in section
3(a)(34)(A)(iii) of the Act, the FDIC is authorized to enforce
compliance with MSRB rules by an insured state nonmember bank, a
subsidiary or a department or a division thereof, which is a municipal
securities dealer (hereinafter referred to as a ``state nonmember bank
municipal securities dealer'').
One of the areas in which the Act directs the MSRB to promulgate
rules is the qualification of persons associated with municipal
securities dealers as municipal securities principals and municipal
securities representatives as those positions are defined in MSRB Rule
G-3. Paragraph (b) of MSRB Rule G-7 requires persons who are or seek to
be associated with municipal securities dealers as municipal securities
principals or municipal securities representatives to provide certain
background information and conversely, requires the municipal
securities dealers to obtain the information from such persons.
Generally, the information required to be disclosed relates to
employment history and professional background including any
disciplinary sanctions and any claimed bases for exemption from MSRB
examination requirements. Paragraph (b) of MSRB Rule G-7 provides that
a ``completed Form U-4 or similar form prescribed * * * in the case of
a bank dealer, by the appropriate regulatory agency, containing the
foregoing information, shall satisfy the requirements of this
paragraph.'' The FDIC has developed, in conjunction with the OCC and
the FRB (collectively, the Banking Agencies), Form MSD-4 to satisfy the
requirements of paragraph (b) of the MSRB's Rule G-7.
Under paragraph (c) of MSRB Rule
G-7, a person who is or seeks to be associated with a municipal
securities dealer is required to furnish the dealer with a statement
correcting information furnished under paragraph (b) of MSRB Rule G-7
to the extent that such information becomes materially inaccurate or
incomplete. To maintain the accuracy of the information which is filed
on Form MSD-4, the FDIC requires state nonmember bank municipal
securities dealers to file with the FDIC copies of statements such
dealers receive pursuant to paragraph (c) of MSRB Rule G-7 and Form
MSD-5s for municipal securities principals and municipal securities
representatives whose association with such dealers terminates. Form
MSD-5 is a notification by a municipal securities dealer that a
municipal securities principal's or a municipal securities
representative's association with the dealer has terminated and the
reasons for such termination. The informational requirements discussed
above, as set forth in part 343, track very closely the corresponding
requirements described in MSRB Rule G-7, paragraphs (b) and (c).
There are also record retention requirements contained in
paragraphs (e) and (f) of the MSRB's Rule G-7. The FDIC has imposed a
virtually identical requirement on state nonmember bank
[[Page 26995]]
municipal securities dealers in section 343.3(d).
Paragraph (g) of the MSRB's Rule
G-7 requires every bank municipal securities dealer to file with the
appropriate regulatory agency for such bank dealer ``such of the
information prescribed by this rule as such * * * agency * * * shall by
rule or regulation require''. The FDIC requires that each such state
nonmember municipal securities dealer file Form MSD-4s, the statements
described in paragraph (c) of MSRB Rule G-7 and Form MSD-5s with the
FDIC for each person associated with the dealer as a municipal
securities principal or municipal securities representative. The filing
of Form MSD-4s, MSRB Rule G-7(c) statements and Form MSD-5s with the
FDIC constitute ``reports'', ``applications'' or ``documents'' within
the meaning of section 32(a) of the Act and constitute filings with the
SEC for purposes of section 17(c)(1) of the Act. Section 17(c)(1) of
the Act requires every municipal securities dealer which files an
application, notice, report or document with the FDIC to file a copy of
such application, notice, report or document with the SEC.
The FDIC's part 343 is identical in all significant respects to the
comparable regulations adopted by the FRB (Sec. 208.8j) and the OCC
(part 10). The Banking Agencies also cooperated in drafting the forms.
Part 343 has not been amended by the FDIC in any significant manner
since its adoption in August 1977.
II. Basis for Rescission
A. Implementing Regulations Are Not Required by the Act
Section 23(a)(1) of the Act states that the FDIC shall have power
``to make such rules and regulations as may be necessary or appropriate
to implement the provisions of this title for which (it is)
responsible''. (Emphasis supplied.) Therefore, although section
15B(b)(2)(A) requires the MSRB to promulgate regulations addressing the
qualification of persons who are or seek to be associated with bank
municipal securities dealers, there is no corresponding statutory
requirement imposed upon the Banking Agencies, including the FDIC. The
FDIC may exercise its discretion to determine whether it is necessary
or appropriate to adopt regulations such as part 343 or, in this case,
to decide that such a regulation is no longer necessary or appropriate.
The FDIC has determined that part 343 is no longer necessary to ensure
that the requisite qualification information is provided to the state
nonmember bank municipal securities dealers by persons who are or seek
to be associated with the subject bank municipal securities dealers,
and therefore, is proposing to rescind part 343 for the reasons
discussed herein.
B. MSRB's Rule G-7 Requires the Provision of Much of the Same
Information as Section 343.3
As described in Section I. Background, paragraph (b) of the MSRB's
Rule G-7 requires bank municipal securities dealers to obtain certain
information from persons who are or seek to be associated with them as
municipal securities principals or municipal securities
representatives. The MSRB's Rule G-7 provides that a form prescribed by
the appropriate regulatory agency, containing the information set forth
in paragraph (b), will satisfy the requirements of that paragraph. The
FDIC, in cooperation with the other Banking Agencies, has created Form
MSD-4s and Form MSD-5s to satisfy the requirements of paragraph (b) of
MSRB Rule G-7. Although the FDIC proposes to rescind part 343, the Form
MSD-4s and MSD-5s will continue to be provided to state nonmember bank
municipal securities dealers to satisfy the requirements of the MSRB
Rule G-7, paragraph (b) by the FDIC. The forms have detailed
instructions and provide guidance regarding their completion and filing
information. Additionally, the statements mandated in Sec. 343.3 to
correct information which has been previously submitted on a Form MSD-4
are required by MSRB Rule G-7, paragraph (c). Therefore, there is no
need to retain this redundant regulatory requirement. Moreover, a
separate recordkeeping requirement in Sec. 343.3(d) is unnecessary
because substantially similar requirements are found in MSRB Rule G-7,
paragraphs (e) and (f).
C. Rescission Promotes the Long-Term Goal of Adopting the NASD's Form U
and Consolidating Data Bases at the NASD
The FDIC announced in the preamble to the proposed part 343 when it
was published in the Federal Register on March 30, 1977 (42 FR 16823)
that the Banking Agencies were planning to forward the Form MSD-4s, the
MSRB Rule G-7(c) statements and the Form MSD-5s that they would receive
to the National Association of Securities Dealers (NASD) for computer
processing. The NASD has maintained data for many years on personnel in
the securities industry similar to the information disclosed about
municipal securities principals and municipal securities
representatives. It was expected that disciplinary and qualification
data disclosed on Form MSD-4s, MSRB Rule G-7(c) statements and Form
MSD-5s would be interfaced with the securities personnel data bank
already maintained by the NASD. Although this integration of the two
data bases has not yet been realized, the Banking Agencies' working
group has again recognized this objective as a long-term goal and are
working to achieve this data base integration. One of the first steps
is the adoption of the NASD's Form U-4 to replace the Form MSD-4s and
Form MSD-5s which the Banking Agencies currently provide to their
respective constituent bank municipal securities dealers. This is an
objective that the Banking Agencies' working group is continuing to
pursue. Representatives, whether associated with a securities broker or
dealer or a bank municipal securities dealer, are subject to the same
general MSRB qualification requirements. Developing a more nearly
uniform process for all municipal securities associated persons would
reduce overall regulatory costs by eliminating the use of duplicative
forms for individuals with dual registrations (e.g., for dual employees
in bank municipal securities dealers and non-bank municipal securities
dealers) and by promoting industry-wide qualification standards.
Moreover, the state nonmember bank municipal securities dealers
must already be knowledgeable of and familiar with the SEC's, the
MSRB's and the NASD's rules and regulations in order to comply with the
bank municipal securities dealer registration requirements (section
15B(a) of the Act) and other requirements imposed upon bank and non-
bank participants in the municipal securities market. The Banking
Agencies' long-term goal is to have all participants in the municipal
securities markets register and file required forms and information
with the NASD; therefore, the FDIC believes that it is no longer
necessary to maintain a separate regulation which governs a small
segment of the municipal securities market participants (persons who
are or seek to be associated with bank municipal securities dealers)
when the informational requirements and recordkeeping requirements are
already provided in the MSRB's Rule G-7. The state nonmember bank
municipal securities dealers are generally familiar with Rule G-7, and
look to the MSRB, the NASD and the SEC for the information filing,
recordkeeping and other regulatory requirements in the municipal
securities area.
[[Page 26996]]
D. The Number of Covered Entities is Declining
The FDIC has jurisdiction over the state nonmember bank municipal
securities dealers. The FDIC has noted a steady decline in the number
of state nonmember bank municipal securities dealers over the last
several years. As a result of consolidation in the industry as well as
the inactivity of some banks previously registered as bank municipal
securities dealers (who are then requested to de-register), the number
of state nonmember bank municipal securities dealers has declined to
approximately 28. In the interests of efficiency and reducing
duplicative regulatory requirements for this small number of covered
entities, the FDIC would propose to rescind its part 343 and to have
the covered bank municipal securities dealers rely upon the MSRB's Rule
G-7. As discussed hereinabove, the informational requirements and
recordkeeping requirements of Sec. 343.3 of the FDIC's regulations are
also found in the MSRB's Rule G-7, paragraphs (b), (c), (e) and (f).
However, the filing requirement found in paragraph (g) of Rule G-7
is dependent upon the FDIC's having a filing requirement in place. If
the proposed rescission of part 343 is effected, then the requirement
to file the Form MSD-4s, the MSRB Rule G-7(c) statements and the Form
MSD-5s with the FDIC, as the ``appropriate regulatory agency'', will no
longer exist. The corresponding filing requirement in section 17(c)(1)
of the Act will also be eliminated. Section 17(c)(1) states that,
``(e)very * * * municipal securities dealer for which the (SEC) is not
the appropriate regulatory agency shall * * * file with the (SEC) a
copy of any application, notice, proposal, report, or document filed
with such appropriate regulatory agency by reason of its being a * * *
municipal securities dealer. The elimination of the filing requirement
vis-a-vis the FDIC will, therefore, no longer trigger the corresponding
filing of these forms with the SEC. The filing of these forms with the
FDIC are for informational purposes only, the number of covered
entities is very small and it is expected that in the future these
informational filings will be provided to the NASD to be added to a
master data base. Therefore, the FDIC believes that the deletion of
this regulatory requirement will not have adverse consequences.
The forms are still required to be completed and maintained by the
individual state nonmember bank municipal securities dealers and are
reviewed by the FDIC during the regular examination process. The
instructions to the forms provide the name and address of the
appropriate regulatory agency, and direct the bank municipal securities
dealer to file the requisite information with the appropriate
regulatory agency. It is expected that covered entities will continue
to forward the completed forms and statements to the FDIC.
E. Rescission Furthers the Goals of the CDRI Initiative
The FDIC is conducting a systematic review of its regulations and
written policies. Section 303(a) of the CDRI (12 U.S.C. 4803(a))
requires the Banking Agencies each to streamline and modify its
regulations and written policies in order to improve efficiency, reduce
unnecessary costs and eliminate unwarranted constraints on credit
availability. Section 303(a) also requires each of the Banking Agencies
to remove inconsistencies and outmoded and duplicative requirements
from its regulations and written policies. As part of this review, and
in consultation with the OCC and the FRB, the FDIC has determined that
part 343 is duplicative of many of the requirements of the MSRB's Rule
G-7 and that certain efficiencies will be realized by having its state
nonmember bank municipal securities dealers rely upon the MSRB's Rule
G-7 rather than refer to and comply with part 343. The FDIC's written
policies and regulations would be streamlined by its elimination.
Section 303(a)(2) of the CDRI requires the FDIC ``to work jointly
with the other federal banking agencies to make uniform all regulations
* * * implementing common statutory or supervisory policies.'' The FDIC
and the FRB both intend to rescind their respective regulations
governing the qualification requirements of the persons who are or
seeking to be associated with the bank municipal securities dealers;
part 343 and Sec. 208.8(j), respectively. However, the OCC intends to
retain its comparable regulation, part 10, but to add a cross-reference
to the MSRB's rules. Therefore, the Banking Agencies have succeeded in
moving toward the objective stated in section 303(a)(2) of the CDRI as
well as accomplishing the overall goal of eliminating duplicative and
unnecessary regulations.
III. Request for Public Comment
The FDIC is hereby requesting comment during a 60-day comment
period on all aspects of this proposed rescission of part 343. As
discussed above, the rescission of part 343 will eliminate the
regulatory requirement that state nonmember bank municipal securities
dealers file the Form MSD-4s, the MSRB Rule G-7(c) statements and the
Form MSD-5s with the FDIC. Thus, comment is sought on whether the
rescission of this filing requirement would create a regulatory gap
that would have harmful effects on banking. Additionally, some have
voiced concern that the state nonmember bank municipal securities
dealers are accustomed to referring to the FDIC's part 343 for guidance
in the municipal securities area for these informational filing and
recordkeeping requirements. Will the elimination of part 343 actually
result in imposing a hardship on the covered entities by deleting a
handy reference source for them?
IV. Paperwork Reduction Act
The collection of information requirements (embodied in the Form
MSD-4, the MSRB Rule G-7(c) statements and the Form MSD-5) contained in
part 343 have been approved by the Office of Management and Budget
pursuant to the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). The
proposed rescission of part 343 would not, however, alter the
requirement under the MSRB's Rule
G-7 that bank municipal securities dealers collect the prescribed
information from the persons who are or seek to be associated with them
as municipal securities principals or municipal securities
representatives.
V. Regulatory Flexibility Act
Under section 605(b) of the Regulatory Flexibility Act (RFA) (5
U.S.C. 605(b)), the regulatory flexibility analysis otherwise required
under section 603 of the RFA (5 U.S.C. 603) is not required if the head
of the agency certifies that the rule will not have a significant
economic impact on a substantial number of small entities and the
agency publishes such certification and a statement providing the
factual basis for such certification in the Federal Register along with
the proposed rule.
The FDIC estimates that, currently, there are 28 state nonmember
bank municipal securities dealers under its jurisdiction, none of which
are under $100 million in assets. The proposed rescission of part 343
would result in the elimination of duplicative and unnecessary
informational requirements found in the FDIC's regulation, and allow
the covered entities to refer to the MSRB's Rule G-7 requirements
instead. The proposed rescission would have the effect of reducing
costs and burden for the state nonmember bank municipal securities
dealers. Thus, the FDIC Board
[[Page 26997]]
of Directors (Board) hereby certifies that the proposed rescission
would not have a significant economic impact on a substantial number of
small entities 1 within the meaning of the RFA. Therefore,
the provisions of the RFA regarding an initial and final regulatory
flexibility analysis (Id. at 603 and 604) do not apply here.
---------------------------------------------------------------------------
\1\ The definition of ``small business entity'' derives from the
definition of a ``small business concern.'' Part 121 of the Small
Business Administration's rules and regulations (13 CFR part 121)
provides that any national bank or commercial bank, savings
association, or credit union with assets of $100 million or less
qualifies as a small business concern.
---------------------------------------------------------------------------
List of Subjects in 12 CFR Part 343
Banks, banking, Reporting and recordkeeping requirements,
Securities.
The Board of Directors of the Federal Deposit Insurance Corporation
hereby proposes to remove part 343 of title 12 of the Code of Federal
Regulations.
PART 343--[REMOVED AND RESERVED]
1. Part 343 is removed and reserved.
Dated at Washington, DC this 29th day of April, 1997.
By order of the Board of Directors.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Deputy Executive Secretary.
[FR Doc. 97-12807 Filed 5-15-97; 8:45 am]
BILLING CODE 6714-01-P
Complete official Federal Register PDF
FR Doc. 97-12786 Plant-Pesticides; Nucleic Acids; Supplemental Notice of Proposed Rulemaking
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27142-27149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12786]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300371A; FRL-5716-7]
RIN 2070-AC02
Plant-Pesticides; Nucleic Acids; Supplemental Notice of Proposed
Rulemaking
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: This document announces the availability of information for
additional public comment regarding a proposed exemption from the
requirement of a tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA) for residues of nucleic acids (i.e., deoxyribonucleic acid
and ribonucleic acid) produced in plants as part of a plant-pesticide.
Comments on this document may also affect EPA's final determination on
three proposed exemptions under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). In 1994, EPA proposed to exempt from the
requirement of tolerance residues of nucleic acids produced in plants
as part of a plant-pesticide because such a tolerance would not be
necessary to protect the public health. Since publication of the
proposal, Congress enacted the Food Quality Protection Act (FQPA) which
amended FFDCA and FIFRA. EPA is issuing this document today to provide
the public with an opportunity to comment on EPA's analysis of how
certain FQPA amendments to FFDCA and FIFRA apply to the proposed
exemption from the requirement of a tolerance for residues of nucleic
acids produced in plants as part of a plant-pesticide. EPA believes
that it considered most of the substantive issues associated with the
FQPA amendments when it issued the proposal in 1994. EPA is, thus, in
this document, specifically seeking comment only on its evaluation of
the requirements imposed by FQPA that the Agency did not address in the
proposal.
DATES: Comments, identified by the docket control number ``OPP-
300371A,'' must be received on or before June 16, 1997.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person deliver comments to:
Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA
22202.
Comments and data may also be submitted electronically by following
the instructions under Unit VI. of this document. No Confidential
Business Information (CBI) should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: Elizabeth Milewski, Office of Science,
Coordination and Policy, Office of Prevention, Pesticides and Toxic
Substances (7101), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, Telephone: (202) 260-6900, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
EPA issued in the November 23, 1994 Federal Register a package of
five separate Federal Register proposals (59 FR 60496, 60519, 60535,
60542 and 60545) (FRL-4755-2, FRL-4755-3, FRL-4758-8, FRL-4755-5, and
FRL-4755-4) which together described EPA's approach to substances
produced in plants that enable the plants to resist pests or disease.
EPA's package of proposals indicated that these substances are
pesticides under section 2 of FIFRA (7 U.S.C. 136(u)) if they are
``intended for preventing, destroying, repelling, or mitigating any
pest'' or if they are ``. . . intended for use as a plant regulator,
defoliant, or desiccant'' regardless of whether the pesticidal
capabilities evolved in the plants or were introduced by breeding or
through the techniques of modern biotechnology. These substances, and
the genetic material necessary to produce them, were designated
``plant-pesticides'' by EPA in the November 23, 1994, Federal Register
notices. The notices defined a ``plant-pesticide'' as ``a pesticidal
substance that is produced in a living plant and the genetic material
necessary for the production of the pesticidal substance where the
pesticidal substance is intended for use in the living plant'' (59 FR
at 60534).
One of the five documents (59 FR 60542) proposed to exempt from the
requirement of a tolerance residues of nucleic acids (i.e.,
deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)) when such
nucleic acids are produced in plants as part of a plant-pesticide
(i.e., the genetic material necessary to produce the pesticidal
substance). This supplemental notice addresses the nucleic acids
portion of plant-pesticides produced in food plants. Because FQPA
modified FIFRA ( 7 U.S.C. 136 et seq.) by incorporating the FFDCA
safety standard into the FIFRA test for determining whether a pesticide
poses an unreasonable adverse effect, comments on this supplemental
notice may also affect EPA's final determination on proposed exemptions
under FIFRA for three categories of plant-pesticides (59 FR at 60535):
(1) Those that are derived from a plant that is sexually compatible
with the recipient plant, (2) those that act primarily by affecting the
plant, and (3) those that are coat proteins from plant viruses.
EPA is publishing this supplemental notice to ensure that the
public has had adequate opportunity to comment on certain new
considerations raised by the FQPA amendments to FFDCA as these
considerations relate to the proposed exemption from a tolerance for
residues of the nucleic acid portion of plant-pesticides produced in
food plants. In evaluating a pesticide chemical residue for exemption
from FFDCA tolerance requirements, EPA must now explicitly address
certain factors, and make a determination that there is a reasonable
certainty that aggregate exposure to the residue will cause no harm to
the public. The factors to be considered are iterated in Unit II. of
this supplemental notice. EPA's evaluation of these factors relative to
the proposed exemption (59 FR 60535) is contained in Unit IV. of this
supplemental notice. Consistent with FFDCA section 408(c)(2)(B), EPA
has reviewed the available scientific data and other relevant
information in support of this action. In today's supplemental notice,
EPA requests comment only on the new conclusions identified in Unit
V.C.
In light of FQPA, EPA is engaged in a process, including
consultation with registrants, states, and other interested
stakeholders, to make decisions on the
[[Page 27143]]
new policies and procedures that will be appropriate as a result of
enactment of FQPA. In establishing this exemption from the requirement
of a tolerance for residues of nucleic acids produced in plants as part
of a plant-pesticide, EPA does not intend to set precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. This exemption from the requirement of a
tolerance will not restrict EPA's options with regard to general
procedures and policies for implementation of the amended FFDCA section
408.
II. Statutory Authority
Under FFDCA, EPA regulates pesticide chemical residues by
establishing tolerances limiting the amounts of residues that may be
present in food, or by establishing exemptions from the requirement of
a tolerance for such residues. Pesticide chemical residues subject to
regulation under FFDCA are defined by reference to the definition of
pesticide under FIFRA. FFDCA section 201(q)(1) defines a ``pesticide
chemical residue'' to mean the residue in or on food of a pesticide
chemical or other added substance resulting primarily from the
metabolism or degradation of a pesticide chemical (21 U.S.C. 321
(q)(2)). A ``pesticide chemical'' means ``any substance that is a
pesticide within the meaning of the Federal Insecticide, Fungicide, and
Rodenticide Act, including all active and inert ingredients of such
pesticide'' (21 U.S.C. 321(q)(1)).
FIFRA authorizes EPA to regulate the sale and distribution of
pesticides in the United States and to exempt a pesticide from the
requirements of FIFRA if it is not of a character requiring regulation
(7 U.S.C. 136a(a) and 136w(b)). FIFRA section 2(u) defines
``pesticide'' as: (1) ``any substance or mixture of substances intended
for preventing, destroying, repelling, or mitigating any pest, (2) any
substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer''
(7 U.S.C. 136(u)).
FQPA amends both FFDCA and FIFRA. FQPA, which took effect on August
3, 1996, among other things, amends FIFRA such that a registration
cannot be issued for a pesticide to be used on or in food unless the
residue of the pesticide in food qualifies for a tolerance or exemption
from the requirement for a tolerance. FQPA modified FIFRA section 2(bb)
by incorporating the FFDCA section 408 safety standard into the test
for determining whether a pesticide poses an unreasonable adverse
effect (7 U.S.C. 136(bb)). FIFRA section 2(bb) defines the term
``unreasonable adverse effects on the environment'' to mean (1) any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide, or (2) a human dietary risk from residues that result
from a use of a pesticide in or on any food inconsistent with the
standard under section 408 of the FFDCA. Thus, a pesticide used in or
on food that does not meet the FFDCA section 408 safety standard also
would pose an unreasonable adverse effect under FIFRA and would not
qualify for an exemption from the requirements of FIFRA under FIFRA
section 25(b)(2).
FQPA amends FFDCA section 408(c)(2)(A)(i) to allow EPA to establish
an exemption from the requirement of a tolerance for a ``pesticide
chemical residue'' only if EPA determines that the exemption is
``safe'' (21 U.S.C. 346a(c)(2)(A)(i)). Section 408(c)(2)(A)(ii) defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information'' (21 U.S.C. 346a(c)(2)(A)(ii)).
This includes exposure through drinking water, but does not include
occupational exposure. In establishing an exemption from the
requirement of a tolerance, FFDCA section 408(c), like the statute
prior to FQPA, does not require EPA to consider benefits that might be
associated with use of the pesticide chemical.
FFDCA section 408 requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing an exemption and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue'' (21 U.S.C.
346a(b)(2)(C)(ii)(I)) and (c)(2)(B). Section 408(b)(2)(D) specifies
other, general factors EPA is to consider in establishing an exemption.
Section 408(c)(3)(B) prohibits an exemption unless there is either a
practical method for detecting and measuring levels of pesticide
chemical residue in or on food or there is no need for such a method
(21 U.S.C. 346a(c)(3)(B)).
Specifically, EPA must consider the following in deciding whether
to grant an exemption:
1. The validity, completeness, and reliability of the available
data from studies of the pesticide chemical and chemical pesticide
residue.
2. Nature of any toxic effect shown to be caused by the pesticide
chemical or residues in studies.
3. Available information concerning the relationship of the results
of such studies to human risk.
4. Available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers).
5. Available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of toxicity.
6. Available information concerning the aggregate exposure levels
of consumers to the pesticide chemical residue and to other related
substances, including dietary exposure and non-occupational exposures.
7. Available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers.
8. Such information as the Administrator may require on whether the
pesticide chemical may have an effect in humans that is similar to an
effect produced by a naturally-occurring estrogen or other endocrine
effects.
9. Safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of animal
experimentation data (21 U.S.C. 346a(b)(2)(D)).
Additionally, with respect to exposure of infants and children,
consistent with section 408(b)(2)(C), EPA must assess the risk of the
pesticide based on available information concerning:
1. Consumption patterns that are likely to result in
disproportionately high consumption of food with pesticide residues.
2. Special susceptibility of infants and children to such residues.
3. Cumulative effects of residues with other substances that have a
common mechanism of toxicity (21 U.S.C. 346a(b)(2)(C) and (c)(2)(B)).
III. Summary of Proposed Regulation
The proposal (59 FR 60542) described how EPA would view: (1)
Deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), (2) nucleic
acid analogues (e.g., altered purine or pyrimidine bases) that may be
considered ``nucleic acids'' by their chemical composition, and (3) DNA
sequences that code for the RNA complement (anti-sense) of the
messenger RNA (mRNA) for an essential enzyme or other component of an
obligate parasite.
[[Page 27144]]
In the November 23, 1994 Federal Register, EPA proposed to exempt
nucleic acids (i.e., deoxyribonucleic acid (DNA) and ribonucleic acid
(RNA)) from the requirement of a tolerance when such nucleic acids are
produced in plants as part of a plant-pesticide (59 FR 60542). In the
proposal, EPA stated that the proposed exemption from the requirement
of a tolerance for the nucleic acids portion of plant-pesticides
produced in food plants is based on the ubiquity of nucleic acids in
all forms of life, their presence in human and domestic animal food and
the consequent large scale exposure of the human population with no
evidence nucleic acids have caused any adverse health effects when
consumed as part of a food plant. The Agency knows of no instance where
nucleic acids naturally occurring in plants have been associated with
any toxic effects related to the consumption of foods.
In the 1994 proposal, EPA recognized that nucleic acid analogues
(e.g., altered purine or pyrimidine bases) may be considered ``nucleic
acids'' by their chemical composition. Certain analogues are being
developed as therapeutic agents for human diseases and nucleic acid
analogues could conceivably be developed as pesticides. The proposed
exemption does not extend to such nucleic acid analogues. The 1994
proposal only proposed to exempt the naturally occurring, non-modified
nucleic acids (ribosides or deoxyribosides of A, T, G, C, and U) and
polymers of such substances commonly found in living cells that encode
the information necessary to make the pesticidal substances produced by
plants.
The 1994 proposal also discussed how EPA proposed to view the
introduction into plants of DNA sequences that code for the RNA
complement (anti-sense) of the messenger RNA (mRNA) for an essential
enzyme or component of an obligate parasite. One mechanism by which
this RNA complement or anti-sense RNA is believed to work is to bind to
the target mRNA and prevent it from binding to ribosomes, effectively
terminating synthesis of the essential enzyme or other enzymes for
making other essential cellular components necessary to survival of the
parasite. This methodology is currently being developed for introducing
pest-resistance into plants. As was noted in the proposed exemption,
the Agency believes that the introduction and expression in plants of
nucleic acids in this anti-sense technology do not present a hazard to
the public health and such nucleic acids would qualify for this food
tolerance exemption.
IV. Risk Assessment and Safety Determinations
A. Risk Assessment in Proposal
This unit reviews the analysis that EPA used to support its 1994
proposal (59 FR 60535) to exempt nucleic acids (DNA and RNA, including
DNA and RNA used in anti-sense technology) produced in plants as part
of a plant-pesticide from the requirement of a tolerance under FFDCA.
EPA also relied upon the analysis in the 1994 FFDCA proposal to
evaluate human dietary risks in support of its proposal (59 FR 60519)
to exempt three categories of plant-pesticides (59 FR at 60535) from
most FIFRA requirements. Non-dietary human risks from exposure to
nucleic acids as part of plant-pesticides were examined under the
analysis for the proposed FIFRA exemption and are discussed in this
supplemental notice only as they pertain to the dietary risks.
EPA's 1994 proposal (59 FR 60542) to exempt nucleic acids produced
in plants as part of a plant-pesticide from the requirement of a
tolerance was based on the ubiquity of nucleic acids and their presence
in human and domestic animal food without observed adverse health
effects.
Nucleic acids encode the information necessary for the functioning
of the organism. Chemically, nucleic acids occur in two types:
deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). DNA and RNA can
be thought of as a ``tape'' containing information. DNA and RNA are
polymers composed of small units, called ``nucleotides.'' A nucleotide
is made up of a sugar, a phosphate group, and one of four heterocyclic
bases. The heterocyclic bases in DNA are adenine, thymine, cytosine,
and guanine. The heterocyclic bases in RNA are adenine, uracil,
cytosine and guanine. The sugars and phosphates form a long chain or
``backbone'' with one heterocyclic base attached to each sugar. The
information encoded in the nucleic acid is determined by the sequence
in which the heterocyclic bases are attached to the sugar-phosphate
backbone. Thus, the ``genetic material necessary for the production of
the pesticidal substance'' are the nucleic acids encoding the
information necessary for a plant cell to make the pesticidal
substance.
Nucleic acids are also the chemical basis for heritable traits.
When nucleic acids encoding the genetic information needed for the
production of a pesticidal substance is stably integrated into the
plant, that plant and its progeny will have the potential to produce
the pesticidal substance.
Nucleic acids are widespread in foods and have not, by themselves,
been associated with toxic or pathogenic effects on animals or humans.
None of the constituents of nucleic acids are known to be acute
toxicants, but like proteins and other normal constituents of food, may
cause indirect, adverse metabolic effects if consumed exclusively at
high doses over a long period of time in the absence of a normal
balanced diet. Nucleic acids never occur at these high amounts in food
plants and have not been associated with any toxic effects related to
consumption of foods.
In the proposal, the Agency made clear that it is not proposing to
exempt nucleic acid analogues from the requirement of a food tolerance.
These analogues are not naturally occurring and those used as
therapeutic agents frequently have significant toxicity associated with
their use. The intent of EPA's 1994 proposal was to exempt only the
naturally occurring, non-modified nucleic acids, and polymers of such
substances, commonly found in living cells that serve as the mechanisms
of encoding traits associated with pesticidal substances produced by
plants.
EPA proposed to extend this exemption (59 FR 60542) from the
requirement of a tolerance to the mRNA used in anti-sense technology
based on the consideration that these mRNAs are analogous to naturally
occurring, non-modified nucleic acid polymers commonly found in living
cells. The rationale applied in the proposal to other naturally
occurring, non-modified nucleic acid polymers applies equally to these
mRNAs; the ubiquity of nucleic acids and their presence in human and
domestic animal food and no observed adverse health effects associated
with consumption of foods containing nucleic acids.
B. Risk Assessment in Light of Amendment to FFDCA
After EPA issued its proposed exemption from the requirement of a
tolerance for nucleic acids produced in plants as part of a plant-
pesticide (59 FR 60542), Congress enacted FQPA and amended certain
FFDCA provisions governing pesticide chemical residues and FIFRA
provisions governing pesticides (See Unit II. of this supplemental
notice). Congress revised the specific wording of the section 408
standard for exemptions and provided more specific guidance regarding
some of the factors that EPA should consider in establishing such
exemptions (see
[[Page 27145]]
Unit II. of this supplemental notice). When EPA proposed the exemption
for residues of nucleic acids produced in plants as part of a plant-
pesticide (59 FR 60535), it considered most of the safety factors
spelled out in FQPA even though the Agency may not have explicitly
discussed all those factors using the terminology specified in the FQPA
amendments. This supplemental notice describes how the Agency took
account of most of the FQPA factors in issuing its 1994 proposal to
exempt from the requirement of a tolerance nucleic acids produced in
plants as part of a plant-pesticide, and indicates which factors were
considered in that proposal. The information the Agency relied on in
considering these factors is part of the public record which was
available to the public when EPA issued the proposed exemption from the
requirement of a food tolerance. The supplemental notice also
identifies the factors that were not considered in the proposal.
Because FQPA amended FIFRA by incorporating the section 408 safety
standard, commenters should be aware that comments on this supplemental
notice may also affect EPA's final determination on the proposed
exemptions (59 FR at 60535) under FIFRA for three categories of plant-
pesticides: (1) Those that are derived from plants sexually compatible
with the recipient plant, (2) those that act primarily by affecting the
plant, and (3) those that are coat proteins from plant viruses.
1. Validity, completeness, and reliability of available data. EPA
considered in 1994 the validity, completeness, and reliability of the
available data with regard to nucleic acids produced in plants as part
of a plant-pesticide in the proposals (59 FR 60519 and 60542) and has
described the evaluation in Unit IV.A. of this supplemental notice.
2. Nature of toxic effect. EPA in 1994 considered the nature of the
toxic effects caused by nucleic acids produced in plants as part of a
plant-pesticide in the proposals (59 FR 60519 and 60542) and has
described its evaluation in Unit IV.A. of this supplemental notice.
3. Relationship of studies to humans. EPA in 1994 considered the
available information concerning the relationship of available data on
toxicity of nucleic acids produced in plants as part of a plant-
pesticide to humans when it issued the proposal to exempt these
substances from the requirement of a tolerance. EPA has summarized its
evaluation in Unit IV.A. of this supplemental notice. The nature of the
toxic effect of nucleic acids was assessed in light of the known
presence of nucleic acids in all consumed foods (Ref. 1) and the
history of human consumption of food derived from crop plants, and from
products such as meat and milk from animals that consume forage and
other crops (e.g., corn and other grains) that contain residues of
nucleic acids. EPA determined in the proposal that nucleic acids
produced in plants as part of a plant-pesticide do not have a toxic
effect and have no adverse effects to humans. Because knowledge of
human consumption of food containing nucleic acids was available and
adequately addressed the issues of hazard and exposure, the Agency did
not use, for the proposed exemption (59 FR 60542), data generated in
the laboratory through animal testing.
4. Dietary consumption patterns. EPA considered in the 1994
proposal the available information on the varying dietary consumption
patterns of major identifiable consumer subgroups as it pertains to
nucleic acids in food from plants. As described in the 1994 proposal,
nucleic acids are ubiquitous in nature and in the food supply. Nucleic
acids that make up the genetic material in plant-pesticides will not
alter this baseline consumption pattern of nucleic acids. The Agency's
evaluation is summarized in Unit IV.A. of this supplemental notice.
5. Available information concerning cumulative effects of the
pesticide chemical residue and other substances that have a common
mechanism of toxicity. EPA in 1994 examined the available information
on the cumulative effect of nucleic acids in food from plants and other
substances that have a common mechanism of toxicity. EPA summarizes
this information and its analysis in Unit IV.A. of this supplemental
notice.
Nucleic acids are widespread in food and have not been associated
with direct toxic or pathogenic effects to animals or humans. Because
nucleic acids in foods have no human toxicity, no cumulative effects
can be identified for nucleic acids produced in plants as part of a
plant-pesticide. FQPA also directs the Agency to examine whether there
are other substances that have a common mechanism of toxicity with
nucleic acids produced in plants as part of a plant-pesticide. Based on
available information which indicates that nucleic acids in food have
no human toxicity, EPA is not aware of any other substances that might
have a common mechanism of human toxicity with nucleic acids produced
in plants as part of a plant-pesticide.
EPA is not aware of any substances outside of the food supply that
may have a common mechanism of toxicity with nucleic acids produced in
plants as part of a plant-pesticide since nucleic acids in plant food
are not toxic. EPA has identified nucleic acid analogues as substances
having some level of toxicity; however, their mechanism of toxicity is
not cumulative with that of naturally occurring nucleic acids (DNA and
RNA).
EPA considered the safety of foods containing residues of nucleic
acids when it issued the proposal and is not requesting additional
comment on that topic. Comments are only requested on EPA's conclusion
that there are no substances outside of the food supply that may have a
cumulative toxic effect with residues of nucleic acids produced in
plants as part of a plant-pesticide.
6. Aggregate exposures of consumers including non-occupational
exposures. EPA considered the available information on the aggregate
exposure level of consumers to nucleic acids produced in plants as part
of a plant-pesticide in the 1994 FFDCA and FIFRA proposals (59 FR 60519
and 60542). This included a consideration of exposures from dietary
sources (59 FR 60542) as well as from other non-occupational sources
(59 FR 60519). As indicated in EPA's policy statement, ``plant-
pesticides are likely to present a limited exposure of the pesticidal
substance to humans. In most cases, the predominant, if not the only,
exposure route will be dietary. Significant respiratory and dermal
exposures will be unlikely'' (59 FR at 60513). As explained in the
FFDCA and FIFRA proposals and EPA's policy statement (59 FR 60496) and
associated dockets, plant-pesticides present negligible exposure of
pesticidal substances to humans outside of the dietary route because
the substances are in the plant tissue and thus are found either within
the plant or in close proximity to the plant. This is particularly true
for the nucleic acid portion of plant-pesticides. EPA considered
dietary exposure to nucleic acids produced in plants as part of a
plant-pesticide in the proposed FFDCA exemption (59 FR 60542) and
summarized its evaluation in Unit IV.A. of this supplemental notice.
Despite EPA's belief that, because of the nature of nucleic acids
produced in plants as part of a plant-pesticide, there is little
likelihood of exposure other than through the dietary route, EPA in
this supplemental notice sets forth in greater detail its
considerations concerning other exposure routes. With regard to the
dermal route of exposure, nucleic acids produced in plants as part of a
plant-pesticide may in some cases be present in sap or other exudates
from the plant or the food and thus may
[[Page 27146]]
present some limited opportunity for dermal exposure to persons coming
physically into contact with the plant or raw agricultural food from
the plant. Individuals preparing meals are those most likely to
experience dermal contact with the substances on a non-occupational
basis. However, on a per person basis, the potential amounts involved
in these exposures are negligible in comparison to potential exposure
through the dietary route. Moreover, substances that occur naturally in
food, including the nucleic acids produced in plants as part of plant-
pesticides, are unlikely to cross the barrier provided by the skin.
This is particularly true for nucleic acids produced in plants as part
of a plant-pesticide as they are large polymers.
With regard to exposure through inhalation, nucleic acids produced
in plants as part of a plant-pesticide may in some cases be present in
pollen and some individuals (those near enough to farms, nurseries, or
other plant-growing areas to be exposed to wind-blown pollen) may be
exposed, through inhalation, to the pollen. On a per person basis, the
potential amounts of pollen involved in these exposures are negligible
in comparison to potential exposure through the dietary route.
Moreover, it is unlikely that exposure to the pollen is equivalent to
exposure to nucleic acids produced in plants as part of a plant-
pesticide. In pollen, nucleic acids will likely be integrated into the
tissue of the pollen grain and not bound to the surface of the pollen
grain. Pollen grains and the substances that occur naturally in pollen
are unlikely to cross the barrier provided by the mucous membrane of
the respiratory tract and thus are not additive to dietary exposure.
EPA also evaluated potential non-occupational exposures in drinking
water. As noted in the preceding paragraphs, the substances in plants
or parts of plants, including nucleic acids produced in plants as part
of a plant-pesticide, are produced inside the plant itself. Nucleic
acids are an integral part of the living tissue of the plant. When the
plant dies or a part is removed from the plant, microorganisms
colonizing the tissue immediately begin to digest it, using the
components of the tissue (including nucleic acids produced in plants as
part of plant-pesticides) as building blocks for making their own
tissues or for fueling their own metabolisms. Nucleic acids produced in
plants as part of a plant-pesticide are subject to the same processes
of degradation and decay that all organic matter undergoes. This
turnover of biochemical materials in nature through a process of
degradation occurs fairly rapidly. Indeed, nucleic acids are highly
unstable outside of the cellular environment and are very quickly
broken down. Therefore, nucleic acids produced in plants as part of a
plant-pesticide do not persist in the environment or bioaccumulate.
There is no indication that naturally occurring nucleic acids produced
in plants as part of plant-pesticides, are resistant to this
degradation. Because of the very rapid turnover of these substances,
even if they reach surface waters (e.g., through plant parts falling
into bodies of water), they are unlikely to present anything other than
a very negligible exposure in drinking water drawn either from surface
or ground water sources. Therefore, the potential for non-dietary
exposure (i.e., non-food oral, dermal and inhalation) in non-
occupational settings is extremely limited and EPA expects such
exposure to be negligible.
With regard to exposure to ``other related substances,'' EPA is not
aware of any other substances either in food or outside the food supply
that may be related, via a common mechanism of toxicity, to nucleic
acids produced in plants as part of a plant-pesticide since nucleic
acids are not toxic. With regard to non-occupational exposure through
routes other than dietary exposure, since nucleic acids have no
mechanism of toxicity, EPA is not aware of substances in food or
outside the food supply that may be related via a common mechanism of
toxicity to the nucleic acids that are produced in plants as a plant-
pesticide. No evidence indicates that adverse effects due to aggregate
exposure of nucleic acids with these substances through the dietary,
non-food oral, dermal and inhalation routes occurs.
EPA considered exposure to nucleic acids produced in plants as a
part of a plant-pesticide when it issued the proposal and it is not
requesting additional comment on this topic. Comments are requested
only on EPA's conclusion that there are no additional substances
outside the food supply that are related, via a common mechanism of
toxicity, to residues of nucleic acids produced in plants as part of a
plant-pesticide for which EPA must consider exposure in aggregate with
nucleic acids.
7. Sensitivities of subgroups. In 1994, EPA considered available
information on the sensitivities of subgroups as it pertains to the
nucleic acids produced in plants as part of a plant-pesticide in the
proposal (59 FR 60542). The Agency's evaluation is summarized in Unit
IV.A. of this supplemental notice.
8. Naturally occurring estrogen or other endocrine effects. FFDCA
now directs EPA, in establishing an exemption from the requirement of a
tolerance, to consider ``such information as the Administrator may
require on whether the pesticide chemical may have an effect in humans
that is similar to an effect of a naturally occurring estrogen or other
endocrine effect'' (21 U.S.C. 346(a)(q)). Congress allowed EPA 2 years
to establish a screening program to determine whether certain pesticide
chemicals may have estrogenic effects and an additional year to
implement the program (21 U.S.C. 408(p)). As part of the screening and
implementation process, EPA is determining what information might be
required and how it will address estrogenic effects from pesticide
residues in general.
Based on available information concerning their structure and mode
of action, EPA does not expect nucleic acids produced in plants as part
of a plant-pesticide to cause estrogen or other endocrine effects.
There is some information on estrogenic effects by exposure to
pesticides but the data are limited and do not pertain to nucleic
acids. If EPA becomes aware of a potential for estrogenic or endocrine
effect from exposure to nucleic acids produced in plants as part of a
plant-pesticide, EPA will reexamine this tolerance exemption in light
of that information.
9. Safety factors. In the 1994 proposal, EPA did not rely on the
available animal data in reaching its determination that a tolerance is
not necessary to protect the public from nucleic acids produced in
plants as part of a plant-pesticide (59 FR 60542). As discussed in Unit
IV.A. of this supplemental notice, EPA relied on the long history of
safe human consumption of food containing nucleic acids produced in
plants as part of a plant-pesticide and in food derived from animals
that consume forage and other crops (e.g., corn and other grains). EPA
continues to believe that long-term evidence of human consumption, not
animal experimentation data, is the appropriate information base for
the proposed exemption (59 FR 60542). Because EPA did not rely on
animal experimentation data, the Agency did not consider which safety
factors would be appropriate to use in assessing risk to humans based
on data generated through experiments on animals.
10. Infants and children.--a. Dietary consumption patterns. In the
1994 proposal (59 FR 60542), EPA considered available information on
the dietary consumption pattern of infants and children as it pertains
to nucleic acids produced in plants as part of a plant-
[[Page 27147]]
pesticide and has summarized the evaluation in Unit IV.A. of this
supplemental notice. The range of foods consumed by infants and
children is in general more limited than the range of foods consumed by
adults. Most newborns rely on milk products for nutrition, although
some infants are fed soy-based products. Infants begin as early as 4-
months of age to consume specific types of solid foods. Subsequent to 4
months of age, apart from processing to facilitate swallowing, the
diets of infants are based on foods consumed by the general adult
population albeit in different proportions. As infants and children
mature, more and more of the foods normally consumed by adults become
part of their diets and the relative proportions of the different types
of food consumed changes to more closely resemble an adult diet. All
foods consumed by infants and children contain nucleic acids.
b. Special susceptibility. In the 1994 proposal (59 FR 60542), EPA
considered available information on the potential for susceptibility of
infants and children, including pre- and post-natal toxicity, as these
factors pertain to the nucleic acids produced in plants as part of a
plant-pesticide. There is no scientific evidence that nucleic acids as
a component of food would have a different effect on children than they
would on the adult population. EPA summarizes its analysis of the
effect of consumption in food of nucleic acids on human health in Unit
IV.A. of this supplemental notice.
c. Cumulative effects of residues with other substances with a
common mechanism of toxicity. In the 1994 proposal (59 FR 60542), EPA
examined the available information on the cumulative effect of residues
of nucleic acids produced in plants as part of a plant-pesticide as
well as other substances in food that may have a common mechanism of
toxicity. The Agency's consideration in the proposal of the effects of
the residues of nucleic acids produced in plants as part of a plant-
pesticide on the general population also included consideration of
effects for infants and children. See Unit IV.B.5. of this supplemental
notice for a discussion of cumulative effects of nucleic acids and
other substances that have a common mechanism of toxicity.
Because EPA already considered the safety of food containing
residues of nucleic acids produced in plants as part of a plant-
pesticide and other constituents of food when it issued the proposal
(59 FR 60542), the Agency is not requesting additional comment on that
topic. Comments are requested only on EPA's conclusion that there are
no substances outside of the food supply with a common mechanism of
toxicity to the residues of nucleic acids produced in plants as part of
a plant-pesticide.
d. Margin of safety. In determining whether the residues of nucleic
acids produced in plants as part of a plant-pesticide are safe, FFDCA
section 408(b)(2)(C) directs EPA to apply a tenfold margin of safety
for the residues and other sources of exposure to infants and children
to account for potential pre- and post-natal toxicity and completeness
of data on threshold effects with respect to exposure and toxicity to
infants and children, unless a different margin will be safe. In
proposing the exemption, EPA based its assessment of exposure and
toxicity upon reliable information (Ref. 1) including the long history
of safe human consumption of food containing residues of nucleic acids
produced in plants as part of a plant-pesticide and other substances in
food, and the unique nature of plant-pesticides. EPA did not rely on
animal data. EPA relied on observations concerning whole food
consumption by humans and did not rely on single entity testing,
wherein substances are isolated from a plant source, and fed to animals
at high concentrations (Ref. 1). EPA relied on the vast base of the
human experience with actual food consumption rather than limited
testing situations. EPA thus, did not utilize animal or other studies
that would yield data that could be subjected to an additional margin
of safety. (See Units IV.A. and IV.B.3. of this supplemental notice).
As a result, the FQPA amendments to FFDCA do not affect EPA's analysis.
C. Safety Determinations in Light of FFDCA Amendment
Based on the information discussed in the 1994 proposals (59 FR
60496 through 60547), the discussion in Unit IV.A. and the analysis in
Unit IV.B. of this supplemental notice, EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. population in
general, and U.S. infants and children, from aggregate exposure to
residues of nucleic acids produced in plants as part of a plant-
pesticide, including all anticipated dietary exposures and all other
exposures for which there is reliable information. Under the proposed
exemption from the requirement for a tolerance (59 FR 60542), EPA would
exempt residues of nucleic acids produced in plants as part of a plant-
pesticide. Extensive use and experience show the safety of foods
containing these substances. No evidence, in the many years of human
experience with the growing and consumption of food from plants
containing residues of nucleic acids produced in plants as part of a
plant-pesticide, indicates that adverse effects due to aggregate
exposure through the dietary, non-food oral, dermal and inhalation
routes occur.
The conclusion that residues of nucleic acids produced in plants as
part of a plant-pesticide should be exempt from tolerance requirements
under the FFDCA section 408 safety standard also lends support to EPA's
proposed FIFRA exemptions (59 FR 60519) with respect to human dietary
risks. These exemptions are: (1) Plant-pesticides that are derived from
a plant that is sexually compatible with the recipient plant, (2)
plant-pesticides that act primarily by affecting the plant, and (3)
plant-pesticides that are coat proteins from plant viruses (59 FR at
60535). In the FIFRA proposal, EPA utilized two criteria to determine
whether plant-pesticides should be exempt; (1) whether they posed a low
probability of risk, and (2) whether they caused unreasonable adverse
effects on the environment. Based upon the determination that residues
of the three categories of pesticidal substances subject to the
proposed exemptions (59 FR 60535) and the nucleic acid component of a
plant-pesticide (59 FR 60542) meet the FFDCA section 408 safety test,
EPA concludes plant-pesticides in the three proposed categories of
exemption would pose only a low probability of human dietary risk and
also would not pose an unreasonable adverse effect with respect to such
risks.
D. Other Considerations.
When the Agency proposed to establish an exemption from the
requirement of a tolerance for nucleic acids produced in plants as part
of a plant-pesticide (59 FR 60542), EPA did not propose any numerical
limitation on the amount of nucleic acids that could be present in food
containing these residues. EPA consulted in 1994 with the Department of
Health and Human Services (DHHS) in developing the proposed exemption
and this supplemental notice and will consult with the Secretary of HHS
prior to issuing the final rule. Because the 1994 proposal was an
exemption from the requirement of a tolerance, the Agency has concluded
that an analytical method for detecting and measuring the levels of the
residues of nucleic acids in or on food is not required.
[[Page 27148]]
V. Comments
A. Confidential Business Information
Information submitted as a comment concerning this supplemental
notice may be claimed confidential by marking any part or all of that
information as ``Confidential Business Information'' (CBI). CBI should
not be submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice.
B. 30-Day Comment Period
EPA is allowing a 30-day comment period because it has determined
that such a period will provide the public with an adequate opportunity
to respond to the additional issues raised in this supplemental notice.
FFDCA and FIFRA do not specify a comment period for this type of
notice. EPA has decided that a 30-day comment period is reasonable
because this supplemental notice raises very few new issues that were
not already available for public comment. As discussed in Unit IV. of
this supplemental notice, EPA effectively considered most of the
factors required by the FQPA amendments of FFDCA and FIFRA relevant to
the proposed exemptions when it issued the proposed package of notices
describing EPA's approach in 1994 (59 FR 60496, 60519, 60535, 60542 and
60545). At that time, the public had an opportunity to review both the
Agency's rationale for the proposals and the underlying support
documents during a 90-day public comment period. Only a limited number
of new issues have been raised by the FQPA amendments to FFDCA and
FIFRA and the Agency continues to rely upon the information already in
the docket for the 1994 proposals and thus 30 days should provide
adequate time for public comment. In addition, EPA believes that it is
in the interest of the public to publish the final exemption from the
requirement of a tolerance in a timely manner.
C. Request for Comments
Interested persons are invited to submit written comments on the
new issues raised in this supplemental notice specifically on:
(1) EPA's conclusion that there are no substances outside of the
food supply that may have a cumulative toxic effect with residues of
nucleic acids produced in plants as part of a plant-pesticide.
(2) EPA's conclusion that there are no additional substances
outside the food supply that are related, via a common mechanism of
toxicity, to residues of nucleic acids produced in plants as part of a
plant-pesticide for which EPA must consider exposure in aggregate with
nucleic acids.
Commenters who possess information on nucleic acids causing
estrogenic effects are requested to send such information to EPA.
In this supplemental notice, EPA describes in greater detail the
rationale supporting the statement made in the 1994 Federal Register
(59 FR at 60513) that ``plant-pesticides are likely to present a
limited exposure of pesticidal substances to humans. In most cases, the
predominant, if not the only route of exposure will be dietary.
Significant respiratory and dermal exposures will be unlikely.'' No
comments were received on this statement during the official comment
period. Commenters may comment on this more detailed rationale.
In this supplemental notice, EPA also describes in greater detail
how the rationale presented in the 1994 Federal Register (59 FR at
60538) concerning the safety for human consumption of food containing
nucleic acids produced in plants as part of a plant-pesticide applies
to infants and children. No comments were received on this statement
during the official comment period. Commenters may comment on this more
detailed rationale specifically addressing infants and children as part
of the larger human population.
VI. Public Docket
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number number ``OPP-300371A'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number ``OPP-300371A.'' Electronic comments on
this supplemental notice may be filed online at many Federal Depository
Libraries.
VII. References
(1) International Food Biotechnology Council, 1990. Biotechnologies
and food; Assuring the safety of foods produced by genetic
modification. In: Regulatory Toxicology and Pharmacology. Vol. 12.
Academic Press, New York.
VIII. Regulatory Assessment Requirements
This supplemental notice merely seeks additional comments on the
proposed rules with regard to the potential impact that the new
statutory amendments imposed by the August 3, 1996 Food Quality
Protection Act (FQPA) might have on the provisions as proposed. As
such, this notice does not contain any new proposed requirements that
would require additional consideration by the Office of Management and
Budget (OMB) under Executive Order 12866, entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993) or the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. It does not require any other action
under Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993), Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). The
Agency's activities related to these regulatory assessment requirements
are discussed in the proposed rules.
EPA did not consider Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Pub. L. 104-4) at the proposal stage because the
proposed rules were issued prior to its enactment. Although this
supplemental notice is not subject to UMRA because it neither proposes
or finalizes any regulatory requirements, the applicability of the UMRA
requirements will be addressed in the final rules.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Plants, Plant-
pesticides, Reporting and recordkeeping requirements.
[[Page 27149]]
Dated: May 7, 1997.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 97-12786 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 97-12785 Plant-Pesticides; Viral Coat Proteins; Supplemental Notice of Proposed Rulemaking
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27149-27155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12785]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300367A; FRL-5716-6]
RIN 2070-AC02
Plant-Pesticides; Viral Coat Proteins; Supplemental Notice of
Proposed Rulemaking
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This document announces the availability of information for
additional public comment regarding the proposed exemption from the
requirement of a tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA) for residues of coat proteins from plant viruses when these
coat proteins are produced and used as plant-pesticides in plants or
plant parts used as raw agricultural commodities. Comments on this
document may also affect EPA's final determination on a proposed
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) for this same category of plant-pesticides. In 1994, EPA
proposed to exempt from the requirement of a tolerance viral coat
proteins produced in plants as part of a plant-pesticide because a
tolerance would not be necessary to protect the public health. Since
publication of the proposal, Congress enacted the Food Quality
Protection Act (FQPA) which amended FFDCA and FIFRA. EPA is issuing
this document today to provide the public with an opportunity to
comment on EPA's analysis of how certain FQPA amendments to FFDCA and
FIFRA apply to the proposed exemption from the requirement of a
tolerance for viral coat proteins produced in plants as part of a
plant-pesticide. EPA believes that it considered most of the
substantive issues associated with the FQPA amendments when it issued
the proposal in 1994. EPA is thus, in this document, specifically
seeking comment only on its evaluation of the requirements imposed by
FQPA that the Agency did not address in that proposal.
DATES: Comments, identified by the docket number ``OPP-300367A,'' must
be received on or before June 16, 1997.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person deliver comments to:
Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under Unit VI. of this document. No Confidential
Business Information (CBI) should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: Elizabeth Milewski, Office of Science,
Coordination and Policy, Office of Prevention, Pesticides and Toxic
Substances (7101), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, Telephone: (202) 260-6900, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
EPA issued in the November 23, 1994 Federal Register a package of
five separate Federal Register proposals (59 FR 60496, 60519, 60535,
60542 and 60545) (FRL-4755-2, FRL-4755-3, FRL-4758-8, FRL-4755-5, and
FRL-4755-4) which together described EPA's approach to substances
produced in plants that enable the plants to resist pests or disease.
EPA's package of proposals indicated that these substances are
pesticides under section 2 of FIFRA (7 U.S.C. 136(u)) if they are
``intended for preventing, destroying, repelling, or mitigating any
pest'' or if they are `` . . . intended for use as a plant regulator,
defoliant, or desiccant'' regardless of whether the pesticidal
capabilities evolved in the plants or were introduced by breeding or
through the techniques of modern biotechnology. These substances, and
the genetic material necessary to produce them, were designated
``plant-pesticides'' by EPA in the November 23, 1994 Federal Register
documents. The notices defined a ``plant-pesticide'' as ``a pesticidal
substance that is produced in a living plant and the genetic material
necessary for the production of the pesticidal substance where the
pesticidal substance is intended for use in the living plant'' (59 FR
at 60534). Viral coat proteins produced in plants for viral coat
protein mediated viral resistance are considered plant-pesticides
because of their intended role in plant resistance to viral infection.
One of the five notices (59 FR 60545) proposed to exempt viral coat
proteins produced in plants as part of a plant-pesticide, or segments
of coat proteins, from the FFDCA (21 U.S.C. 346a) requirement of a
tolerance based upon an evaluation of the potential for new dietary
exposures to the substances when they are produced in plants, or in
plant parts, used as food or feed. EPA stated in the proposed exemption
that a tolerance is not necessary to protect the public health for
these pesticidal substances because no new dietary exposures are likely
to occur for viral coat proteins produced in plants as part of a plant-
pesticide. For pesticidal substances in this category, many years of
human experience with consumption of food containing plant viruses
suggest that these pesticidal substances present negligible risk.
Specifically, EPA proposed that ``residues of coat proteins from plant
viruses, or segments of the coat proteins, produced in living plants as
plant-pesticides are exempt from the requirement of a tolerance'' (59
FR at 60547).
This supplemental notice addresses the coat protein portion of the
plant-pesticide produced in food plants. A companion supplemental
notice issued elsewhere in today's Federal Register addresses the
proposed exemption for the nucleic acid component of plant-pesticides
with regard to the FQPA amendments to FFDCA. Because FQPA modified
FIFRA (7 U.S.C. 136 et seq.) by incorporating the FFDCA safety standard
into the FIFRA test for determining whether a pesticide poses an
unreasonable adverse effect, comments on this supplemental notice may
also affect EPA's final determination on a proposed exemption under
FIFRA (59 FR at 60535) for plant-pesticides that are coat proteins from
plant viruses.
EPA is publishing this supplemental notice to ensure that the
public has had adequate opportunity to comment on certain new
considerations raised by the FQPA amendments to FFDCA as these
considerations relate to the proposed exemption from a tolerance for
residues of viral coat proteins produced in plants as part of a plant-
pesticide. In evaluating a pesticide chemical residue for exemption
from FFDCA tolerance requirements, EPA must now explicitly address
certain factors, and make a determination that there is a reasonable
certainty that aggregate exposure to the residue will cause no harm to
the public. The factors to be considered are iterated in Unit II. of
this supplemental notice. EPA's evaluation of these factors
[[Page 27150]]
relative to the proposed exemption (59 FR 60545) is contained in Unit
IV. of this supplemental notice. Consistent with FFDCA section
408(c)(2)(B), EPA has reviewed the available scientific data and other
relevant information in support of this action. In today's supplemental
notice, EPA requests comment only on the new conclusions identified in
Unit V.C. of this supplemental notice.
In light of FQPA, EPA is engaged in a process, including
consultation with registrants, states, and other interested
stakeholders, to make decisions on the new policies and procedures that
will be appropriate as a result of enactment of FQPA. In establishing
this exemption from the requirement of a tolerance for residues of
viral coat proteins produced in plants as part of a plant-pesticide,
EPA does not intend to set precedents for the application of section
408 and the new safety standard to other tolerances and exemptions.
This exemption from the requirement of a tolerance will not restrict
EPA's options with regard to general procedures and policies for
implementation of the amended FFDCA section 408.
II. Statutory Authority
Under FFDCA, EPA regulates pesticide chemical residues by
establishing tolerances limiting the amounts of residues that may be
present in food, or by establishing exemptions from the requirement of
a tolerance for such residues. Pesticide chemical residues subject to
regulation under FFDCA are defined by reference to the definition of
pesticide under FIFRA. FFDCA section 201(q)(1) defines a ``pesticide
chemical residue'' to mean the residue in or on food of a pesticide
chemical or other added substance resulting primarily from the
metabolism or degradation of a pesticide chemical (21 U.S.C. 321
(q)(2)). A ``pesticide chemical'' means ``any substance that is a
pesticide within the meaning of the Federal Insecticide, Fungicide, and
Rodenticide Act, including all active and inert ingredients of such
pesticide'' (21 U.S.C. 321(q)(1)).
FIFRA authorizes EPA to regulate the sale and distribution of
pesticides in the United States and to exempt a pesticide from the
requirements of FIFRA if it is not of a character requiring regulation
(7 U.S.C. 136a(a) and 136w(b)). FIFRA section 2(u) defines
``pesticide'' as: (1) ``any substance or mixture of substances intended
for preventing, destroying, repelling, or mitigating any pest, (2) any
substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer''
(7 U.S.C. 136(u)).
FQPA amends both FFDCA and FIFRA. FQPA, which took effect on August
3, 1996, among other things, amends FIFRA such that a registration
cannot be issued for a pesticide to be used on or in food unless the
residue of the pesticide in food qualifies for a tolerance or exemption
from the requirement for a tolerance. FQPA modified FIFRA section 2(bb)
by incorporating the FFDCA section 408 safety standard into the test
for determining whether a pesticide poses an unreasonable adverse
effect (7 U.S.C. 136(bb)). FIFRA section 2(bb) defines the term
``unreasonable adverse effects on the environment'' to mean (1) any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide, or (2) a human dietary risk from residues that result
from a use of a pesticide in or on any food inconsistent with the
standard under section 408 of the FFDCA. Thus, a pesticide used in or
on food that does not meet the FFDCA section 408 safety standard also
would pose an unreasonable adverse effect under FIFRA and would not
qualify for an exemption from the requirements of FIFRA under FIFRA
section 25(b)(2).
FQPA amends FFDCA section 408(c)(2)(A)(i) to allow EPA to establish
an exemption from the requirement of a tolerance for a ``pesticide
chemical residue'' only if EPA determines that the exemption is
``safe'' (21 U.S.C. 346a(c)(2)(A)(i)). Section 408(c)(2)(A)(ii) defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information'' (21 U.S.C. 346a(c)(2)(A)(ii)).
This includes exposure through drinking water, but does not include
occupational exposure. In establishing an exemption from the
requirement of a tolerance, FFDCA section 408(c), like the statute
prior to FQPA, does not require EPA to consider benefits that might be
associated with use of the pesticide chemical.
FFDCA section 408 requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing an exemption and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue'' (21 U.S.C.
346a(b)(2)(C)(ii)(I)) and (c)(2)(B). Section 408(b)(2)(D) specifies
other, general factors EPA is to consider in establishing an exemption.
Section 408(c)(3)(B) prohibits an exemption unless there is either a
practical method for detecting and measuring levels of pesticide
chemical residue in or on food or there is no need for such a method
(21 U.S.C. 346a(c)(3)(B)).
Specifically, EPA must consider the following in deciding whether
to grant an exemption:
1. The validity, completeness and reliability of the available data
from studies of the pesticide chemical and pesticide chemical residue.
2. Nature of any toxic effect shown to be caused by the pesticide
chemical or residues in studies.
3. Available information concerning the relationship of the results
of such studies to human risk.
4. Available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers).
5. Available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of toxicity.
6. Available information concerning the aggregate exposure levels
of consumers to the pesticide chemical residue and to other related
substances, including dietary exposure and non-occupational exposures.
7. Available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers.
8. Such information as the Administrator may require on whether the
pesticide chemical may have an effect in humans that is similar to an
effect produced by a naturally-occurring estrogen or other endocrine
effects.
9. Safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of animal
experimentation data (21 U.S.C. 346a(b)(2)(D)).
Additionally, with respect to exposure of infants and children,
consistent with section 408(b)(2)(C), EPA must assess the risk of the
pesticide based on available information concerning:
1. Consumption patterns that are likely to result in
disproportionately high consumption of food with pesticide residues.
2. Special susceptibility of infants and children to such residues.
3. Cumulative effects of residues with other substances that have a
common mechanism of toxicity (21 U.S.C. 346a(b)(2)(C) and (c)(2)(B)).
III. Summary of Proposed Rule
In the November 23, 1994 Federal Register, EPA proposed to exempt
from
[[Page 27151]]
the requirement of a tolerance coat proteins from plant viruses, or
segments of such proteins when these proteins, or segments of these
proteins, are produced in plants for the purpose of protecting plants
against viral disease. Coat proteins are those substances that viruses
produce to encapsulate and protect their genetic material. When the
genetic material encoding the coat protein is introduced into a plant's
genome, the plant is able to resist infections by the virus donating
the genetic material for the coat protein (as well as infections by
virus strains closely related to the donor virus). This resistance is
termed viral coat protein mediated resistance or vcp-mediated
resistance.
IV. Risk Assessment and Safety Determinations
A. Risk Assessment in Proposal
EPA's rationale for its 1994 proposal for an exemption from the
requirement of a tolerance for viral coat proteins was based on the
following points: (1) Virus-infected plants have always been a part of
the human and domestic animal food supply since most crops are
frequently infected with plant viruses and food from these crops have
been and are being consumed without detectable adverse human health
effects. (2) Plant viruses have never been shown to be infectious to
humans, including children and infants, or mammals. Plant viruses are
not able to replicate in mammals or other vertebrates, limiting the
possibility of human infection. In addition, this exemption applies
only to the portion of the viral genome coding for the whole coat
protein or a segment of the coat protein which will be expressed in the
plant. The coat protein or a segment of the coat protein by itself is
incapable of forming infectious particles. Since whole, intact plant
viruses are not known to cause deleterious human health effects, it is
reasonable to assume that a subunit of these viruses likewise will not
cause adverse human health effects when consumed at rates currently
found in the food supply.
In developing its regulatory approach for plant-pesticides, EPA
requested the advice of a subpanel, composed of experts in the relevant
scientific disciplines, of the FIFRA Scientific Advisory Panel (SAP).
On December 18, 1992, the SAP subpanel was convened to review a draft
policy statement for plant-pesticides and respond to a series of
scientific questions posed by the Agency. One question that the Agency
asked the SAP subpanel was whether coat proteins from plant viruses
might present a dietary risk. In answer to the question, the subpanel
stated that ``[s]ince viruses are ubiquitous in the agricultural
environment at levels higher than will be present in transgenic plants,
and there has been a long history of `contamination' of the food supply
by virus coat protein, there is [a] scientific rationale for exempting
transgenic plants expressing virus coat protein from the requirement of
a tolerance.''
As described in the proposed regulation (59 FR 60545), entire
infectious particles of the plant viruses, including the coat protein
component, have been and are being consumed by humans with no observed
adverse effects. Virus-infected food plants have always been a part of
the human and domestic animal food supply (Refs. 1, 2, 3, and 4). For
example, at the beginning of this century virtually every commercial
cultivar of potatoes grown in the United States and Europe was infected
with either one or some complex of potato viruses (Ref. 1).
All plants have viruses that can infect them. While some viruses
may be limited to certain tissues (e.g., the vascular system) or organs
(e.g., roots), most plant viruses are found throughout the various
organs and tissues of plants. Viruses, including the coat protein
component, are found in the fruit, leaves, and stems of most plants.
The long history of inadvertent mammalian consumption of the entire
plant virus particle in foods with no observed ill effects presents a
strong argument to support the human and domestic animal safety of the
entire virus in foods. Concentrations of the virus particles in
infected plants vary widely according to the host plant, length of
infection, and the reproductive life cycle of the virus itself. In
general, EPA anticipates that the amounts of viral coat protein
consumed in the diet due to the production of viral coat proteins in
vcp-mediated resistance will be similar to the amounts of viral coat
proteins currently consumed.
Plant pathogenic viruses have never been shown capable of infecting
or replicating in vertebrates (Refs. 1, 2, and 5). Intact, infectious,
whole plant viruses, therefore, are not infectious to humans, including
children and infants. Given that the complete virus is not infectious
to vertebrates, it is reasonable to assume that a noninfectious
subcomponent (i.e., a coat protein or a segment of a coat protein) of
the virus would not be hazardous to humans or animals.
B. Risk Assessment in Light of Amendment to FFDCA
After EPA issued its proposed exemption from the requirement of a
tolerance for viral coat proteins produced in plants as part of a
plant-pesticide (59 FR 60545), Congress enacted FQPA and amended
certain FFDCA provisions governing pesticide chemical residues and
FIFRA provisions governing pesticides (See Unit II. of this
supplemental notice). Congress revised the specific wording of the
section 408 standard for exemptions and provided more specific guidance
regarding some of the factors that EPA should consider in establishing
such exemptions (see Unit II. of this supplemental notice). When EPA
proposed the exemption for residues of viral coat proteins produced in
plants as part of a plant-pesticide, or segments of such proteins, it
considered most of the safety factors spelled out in FQPA even though
the Agency may not have explicitly discussed all those factors using
the terminology specified in the FQPA amendments. This supplemental
notice describes how the Agency took account of most of the FQPA
factors in issuing its 1994 proposal to exempt viral coat proteins, or
segments of such proteins, produced in plants as part of a plant-
pesticide and indicates which factors were considered in that proposal.
The information the Agency relied on in considering these factors is
part of the public record which was available to the public when EPA
issued the proposed exemption from the requirement of a food tolerance.
This supplemental notice also identifies the factors that were not
considered in the proposal. Because FQPA amended FIFRA by incorporating
the section 408 safety standard, commenters should be aware that
comments on this supplemental notice may also affect EPA's final
determination on the proposed exemption (59 FR 60519) under FIFRA for
viral coat proteins produced in plants as plant-pesticides.
1. Available data. EPA considered in 1994, the validity,
completeness and reliability of the available data with regard to coat
proteins from plant viruses in the proposals (59 FR 60519 and 60545)
and has summarized the evaluation in Unit IV.A. of this supplemental
notice.
2. Nature of toxic effect. EPA in 1994 considered the nature of the
toxic effects caused by viral coat proteins produced in plants as part
of a plant-pesticide in the proposals (59 FR 60519 and 60545) and has
summarized its evaluation in Unit IV.A. of this supplemental notice.
[[Page 27152]]
3. Relationship of studies to humans. EPA in 1994 considered the
available information concerning the relationship to humans of toxic
effects of viral coat proteins produced in plants as part of a plant-
pesticide when it issued the proposals (59 FR 60519 and 60545) and has
summarized that evaluation in Unit IV.A. of this supplemental notice.
EPA based its evaluation on the history of human consumption of food
derived from crop plants, and from products such as meat and milk from
animals that consume forage and other crops (e.g., corn and other
grains) that contain residues of pesticidal substances that are the
subject of the proposed exemption. Because knowledge of human
consumption of food from virus infected crop plants (as well as meat
and milk products derived from animals eating such plants) was
available and adequately addressed the issues of hazard and exposure,
the Agency did not use, for the proposed exemption (59 FR 60545), data
generated in the laboratory through animal testing.
4. Dietary consumption patterns. EPA considered in the 1994
proposal the available information on the varying dietary consumption
patterns of major identifiable consumer subgroups as it pertains to
consumption of food from virus infected plants. The Agency's evaluation
is summarized in Unit IV.A. of this supplemental notice.
5. Available information concerning cumulative effects of the
pesticide chemical residue and other substances that have a common
mechanism of toxicity. EPA has examined the available information on
the cumulative effect of consuming virus infected plants and other
substances in plants that may have a common mechanism of human
toxicity. EPA summarizes this information and its analysis in Unit
IV.A. of this supplemental notice.
Viral coat proteins are nontoxic proteins widespread in food. They
have not been associated with toxic or pathogenic effects to animals or
humans. Because viral coat proteins in foods have no known human
toxicity, no cumulative effects can be identified for viral coat
proteins produced in plants as part of a plant-pesticide. FQPA also
directs the Agency to examine whether there are other substances that
have a common mechanism of toxicity with residues of viral coat
proteins produced in plants as part of a plant-pesticide. Based on
available information which indicates that viral coat proteins in food
have no human toxicity, EPA is not aware of any other substances that
might have a common mechanism of human toxicity with residues of viral
coat proteins produced in plants as part of a plant-pesticide.
Experience with residues of viral coat proteins in the current food
supply gives no indication of human or animal toxicity. If information
becomes available that indicates this finding is not appropriate, EPA
will consider the validity of the new information and act to amend this
tolerance exemption as needed.
EPA is not aware of any substances outside of the food supply that
may have a common mechanism of toxicity with residues of viral coat
proteins produced in plants as part of a plant-pesticide since viral
coat proteins are not toxic to humans or animals.
EPA considered the safety of foods containing residues of viral
coat proteins when it issued the proposal and is not requesting
additional comment on that topic. Comments are only requested on EPA's
conclusion that there are no substances outside of the food supply that
may have a cumulative toxic effect with residues of viral coat proteins
produced in plants as part of a plant-pesticide.
6. Aggregate exposures including non-occupational exposures. EPA
has considered the available information on the aggregate exposure
level of consumers to viral coat proteins produced in plants as part of
a plant-pesticide in the 1994 FFDCA and FIFRA proposals (59 FR 60519
and 60545). This included a consideration of exposures from dietary
sources (59 FR 60545) as well as from other non-occupational sources
(59 FR 60519). As indicated in EPA's policy statement, ``plant-
pesticides are likely to present a limited exposure of the pesticidal
substance to humans. In most cases, the predominant, if not the only,
exposure route will be dietary. Significant respiratory and dermal
exposures will be unlikely'' (59 FR at 60513). As explained in the
FFDCA and FIFRA proposals and EPA's policy statement (59 FR 60496) and
associated dockets, plant-pesticides present negligible exposure of
pesticidal substances to humans outside of the dietary route because
the substances are in the plant tissue and thus are found either within
the plant or in close proximity to the plant. EPA considered dietary
exposure to residues of viral coat proteins produced in plants as part
of a plant-pesticide in the proposed FFDCA exemption (59 FR 60545) and
summarized its evaluation in Unit IV.A. of this supplemental notice.
Despite EPA's belief that, because of the nature of viral coat
proteins produced in plants as part of a plant-pesticide, there is
little likelihood of exposure other than through the dietary route, EPA
in this supplemental notice sets forth in greater detail its
considerations concerning other exposure routes. With regard to the
dermal route of exposure, viral coat proteins produced in plants as
part of a plant-pesticide may in some cases be present in sap or other
exudates from the plant or the food and thus may present some limited
opportunity for dermal exposure to persons coming physically into
contact with the plant or raw agricultural food from the plant.
Individuals preparing meals are those most likely to experience dermal
contact with the substances on a non-occupational basis. However, on a
per person basis, the potential amounts involved in these exposures are
negligible in comparison to potential exposure through the dietary
route. Moreover, substances that occur naturally in food, including
viral coat proteins produced in plants as part of a plant-pesticide,
are unlikely to cross the barrier provided by the skin.
With regard to exposure through inhalation, viral coat proteins
produced in plants as part of a plant-pesticide may in some cases be
present in pollen and some individuals (those near enough to farms,
nurseries or other plant-growing areas to be exposed to wind-blown
pollen) may be exposed, through inhalation, to the pollen. On a per
person basis, the potential amounts of pollen involved in these
exposures are negligible in comparison to potential exposure through
the dietary route. It is unlikely that exposure to the pollen is
equivalent to exposure to viral coat proteins produced in plants as
part of a plant-pesticide. When present in pollen, the viral coat
proteins produced in plants as part of plant-pesticides will likely be
integrated into the tissue of the pollen grain and not likely to be
bound to the surface of the pollen grain. Pollen grains and the
substances that occur naturally in pollen are unlikely to cross the
barrier provided by the mucous membrane of the respiratory tract and
thus are not additive to dietary exposure. Some viruses are transmitted
by wind-borne vectors, i.e., pollen or fungal spores and individuals
near enough to farms, nurseries or other plant-growing areas to be
exposed to these wind-blown vectors may be exposed, through inhalation,
to the whole virus particle. Since no evidence suggests that exposure
to whole plant viruses borne by wind-blown pollen or fungal spores
results in adverse effects, it is unlikely that exposure to pollen that
may contain viral coat proteins produced in plants as part of a plant-
[[Page 27153]]
pesticide would result in adverse effects.
EPA also evaluated potential non-occupational exposures in drinking
water. As noted in the preceding paragraphs, most substances in plants
or parts of plants, including viral coat proteins produced in plants as
part of a plant-pesticide, are found only inside the plant itself.
Viral coat proteins produced in plants as part of a plant-pesticide are
an integral part of the living tissue of the plant. When the plant dies
or a part is removed from the plant, microorganisms colonizing the
tissue immediately begin to digest it, using the components of the
tissue (including viral coat proteins produced in plants as part of a
plant-pesticide) as building blocks for making their own tissues or for
fueling their own metabolisms. Viral coat proteins, or segments of
these proteins, produced in plants as part of a plant-pesticide are
subject to the same processes of degradation and decay that all organic
matter undergoes. This turnover of biochemical materials in nature
through a process of degradation occurs fairly rapidly. Therefore,
viral coat proteins produced in plants as part of a plant-pesticide do
not persist in the environment or bioaccumulate. There is no indication
that naturally occurring plant biochemical compounds, including viral
coat proteins produced in plants as part of plant-pesticides, are
particularly resistant to this degradation. Because of the rapid
turnover of these substances, even if they reach surface waters, they
are unlikely to present anything other than a very negligible exposure
in drinking water drawn from either surface or ground water sources.
Therefore, the potential for non-dietary exposure (i.e., non-food oral,
dermal and inhalation) in non-occupational settings is limited and EPA
expects such exposure to be negligible.
With regard to exposure to ``other related substances,'' EPA is not
aware of any other substances either in food or outside the food supply
that may be related, via a common mechanism of toxicity, to viral coat
proteins produced in plants as part of a plant-pesticide since viral
coat proteins are not toxic to humans or animals. With regard to non-
occupational exposure through routes other than dietary exposure, since
viral coat proteins are not toxic, EPA is not aware of substances
outside the food supply that may be related via a common mechanism of
toxicity to the viral coat proteins produced in plants as part of a
plant-pesticide. No evidence indicates that adverse effects due to
aggregate exposure of viral coat proteins with such substances through
the dietary, non-food oral, dermal and inhalation routes occurs.
EPA considered exposure to residues of viral coat proteins produced
in plants as part of a plant-pesticide when it issued the proposal and
is not requesting additional comment on that topic. Comments are only
requested on EPA's conclusion that there are no substances outside of
the food supply that are related, via a common mechanism of action, to
residues of viral coat proteins produced in plants as part of a plant-
pesticide for which EPA must consider exposure in aggregate with viral
coat proteins.
7. Sensitivities of subgroups. In 1994, EPA considered available
information on the sensitivities of subgroups as it pertains to viral
coat proteins produced in plants as part of a plant-pesticide in the
proposal (59 FR 60545). The Agency's evaluation is summarized in Unit
IV.A. of this supplemental notice.
8. Naturally occurring estrogen or other endocrine effects. FFDCA
now directs EPA, in establishing an exemption from the requirement of a
tolerance, to consider ``such information as the Administrator may
require on whether the pesticide chemical may have an effect in humans
that is similar to an effect of a naturally-occurring estrogen or other
endocrine effect'' (21 U.S.C. 346(a)(q)). Congress allowed EPA 2 years
to establish a screening program to determine whether certain pesticide
chemicals may have estrogenic effects and an additional year to
implement the program (21 U.S.C. 408(p)). As part of the screening and
implementation process, EPA is determining what information might be
required and how it will address estrogenic effects from pesticide
residues in general.
There is some information on estrogenic effects by exposure to
pesticides but the data are limited and do not pertain to viral coat
proteins. Based on available information concerning the presence of
viruses in the food supply with no detectable adverse human health
effects, EPA does not expect viral coat proteins expressed in plants as
part of a plant-pesticide to cause estrogen or other endocrine effects.
If EPA becomes aware of a potential for estrogenic or endocrine effect
from exposure to viral coat proteins produced in plants as part of a
plant-pesticide, EPA will reexamine this tolerance exemption in light
of that information.
9. Safety factors. In the 1994 proposal, EPA did not rely on the
available animal data in reaching its determination that a tolerance is
not necessary to protect the public from viral coat proteins produced
in plants as part of a plant-pesticide (59 FR 60545). As discussed in
Unit IV.A. of this supplemental notice, EPA relied on the long history
of safe human consumption of food containing plant viruses and
consumption of food derived from animals that consume forage and other
crops (e.g., corn and other grains) that are also likely to contain
plant viruses. EPA continues to believe that long-term evidence of
human consumption, not animal experimentation data, is the appropriate
information base for the proposed exemption (59 FR 60545). Because EPA
did not rely on animal experimentation data, the Agency did not
consider which safety factors would be appropriate to use in assessing
risk to humans based on data generated through experiments on animals.
10. Infants and children.--a. Dietary consumption patterns. In the
1994 proposal (59 FR 60545), EPA considered available information on
the dietary consumption pattern of infants and children as it pertains
to viral coat proteins in food and has summarized the evaluation in
Unit IV.A. of this supplemental notice. The range of foods consumed by
infants and children is in general more limited than the range of foods
consumed by adults. Most newborns rely on milk products for nutrition,
although some infants are fed soy-based products. Infants begin as
early as 4-months of age to consume specific types of solid foods
containing residues of pesticidal substances that are the subject of
the proposed exemption. Subsequent to 4 months of age, apart from
processing to facilitate swallowing, the diets of infants are based on
foods consumed by the general adult population albeit in different
proportions. As infants and children mature, more and more of the foods
normally consumed by adults become part of their diets and the relative
proportions of the different types of food consumed changes to more
closely resemble an adult diet. Since plant viruses are ubiquitous in
plant foods, EPA concluded that infants and children are exposed as
part of a normal diet to viral coat proteins. There is no evidence that
such exposure leads to any harm.
b. Special susceptibility. In the 1994 proposal (59 FR 60545), EPA
considered available information on the potential for susceptibility of
infants and children, including pre- and post-natal toxicity, as these
factors pertain to viral coat proteins produced in plants as part of a
plant-pesticide. There is no scientific evidence that viral coat
proteins as a component of food would have a different effect on
children than
[[Page 27154]]
they would on the adult population. EPA summarizes its analysis of the
effect of consumption in food of viral coat proteins on human health in
Unit IV.A. of this supplemental notice.
c. Cumulative effects of residues with other substances with a
common mechanism of toxicity. In the 1994 proposal (59 FR 60545), EPA
examined the available information on the cumulative effect of residues
of viral coat proteins produced in plants as part of a plant-pesticide
as well as other substances in food that may have a common mechanism of
toxicity. The Agency's consideration in the proposal of the effects of
the residues of viral coat proteins produced in plants as part of a
plant-pesticide on the general population also included consideration
of effects for infants and children. See Unit IV.B.5. of this
supplemental notice for a discussion of cumulative effects of viral
coat proteins and other substances that have a common mechanism of
toxicity.
EPA considered the safety of foods containing residues of viral
coat proteins when it issued the proposal and it is not requesting
additional comment on that topic. Comments are only requested on EPA's
conclusion that there are no substances outside of the food supply that
may have a cumulative toxic effect with residues of viral coat proteins
produced in plants as part of a plant-pesticide.
d. Margin of safety. In determining whether the residues of viral
coat proteins produced in plants as part of a plant-pesticide are safe,
FFDCA section 408(b)(2)(C) directs EPA to apply a tenfold margin of
safety for the residues and other sources of exposure to infants and
children to account for potential pre- and post-natal toxicity and
completeness of data on threshold effects with respect to exposure and
toxicity to infants and children, unless a different margin will be
safe. In proposing the exemption, EPA based its assessment of exposure
and toxicity upon reliable information including the long history of
safe human consumption of food containing residues of viral coat
proteins produced in plants as part of a plant-pesticide and other
substances in food, and the unique nature of plant-pesticides. EPA did
not rely on animal data. EPA relied on observations concerning whole
food consumption by humans and did not rely on single entity testing,
wherein animals are exposed to high concentrations of substances
isolated from a plant source. EPA relied on the vast base of the human
experience with actual food consumption rather than limited testing
situations involving exposure to high concentrations of viral coat
proteins. EPA, thus, did not utilize animal or other studies that would
yield data that could be subjected to an additional margin of safety.
(See Units IV.A. and IV.B.3. of this supplemental notice). As a result,
the FQPA amendments to FFDCA do not affect EPA's analysis.
C. Safety Determinations in Light of FFDCA Amendment.
Based on the information discussed in the 1994 proposals (59 FR
60496 through 60547), the discussion in Unit IV.A. and the analysis in
Unit IV.B. of this supplemental notice, EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. population in
general, and U.S. infants and children, from aggregate exposure to
residues of viral coat proteins produced in plants as part of a plant-
pesticide, including all anticipated dietary exposures and all other
exposures for which there is reliable information. Under the proposed
exemption from the requirement for a tolerance (59 FR 60545), EPA would
exempt residues of viral coat proteins produced in plants as part of a
plant-pesticide. Extensive use and experience show the safety of foods
containing these substances. No evidence, in the many years of human
experience with the growing and consumption of food from plants
containing viral coat proteins, indicates that adverse effects due to
aggregate exposure through the dietary, non-food oral, dermal and
inhalation routes occur.
The conclusion that residues of viral coat proteins produced in
plants as part of a plant-pesticide should be exempt from tolerance
requirements under the FFDCA section 408 safety standard also lends
support to one of EPA's proposed FIFRA exemptions (59 FR 60519) with
respect to human dietary risks: plant-pesticides that are coat proteins
from plant viruses (59 FR at 60535). In the FIFRA proposal, EPA
utilized two criteria to determine whether plant-pesticides should be
exempt; (1) whether they posed a low probability of risk, and (2)
whether they caused unreasonable adverse effects on the environment.
Based upon the determination that residues of viral coat proteins (59
FR 60545) and the nucleic acid component of a plant-pesticide (59 FR
60542) meet the FFDCA section 408 safety test, EPA concludes viral coat
proteins produced in plants as part of a plant-pesticide would pose
only a low probability of human dietary risk and also would not pose an
unreasonable adverse effect with respect to such risks.
D. Other Considerations
When the Agency proposed to establish an exemption from the
requirement of a tolerance for viral coat proteins produced in plants
as part of a plant-pesticide (59 FR 60545), EPA did not propose any
numerical limitation on the amount of viral coat proteins that could be
present in food containing these residues. EPA consulted in 1994 with
the Department of Health and Human Services (DHHS) in developing the
proposed exemption and this supplemental notice, and will consult with
the Secretary of HHS prior to issuing the final rule. Because the 1994
proposal was an exemption from the requirement of a tolerance, the
Agency has concluded that an analytical method for detecting and
measuring the levels of the residues of viral coat proteins in or on
food is not required.
V. Comments
A. Confidential Business Information
Information submitted as a comment concerning this supplemental
notice may be claimed confidential by marking any part or all of that
information as ``Confidential Business Information'' (CBI). CBI should
not be submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice.
B. 30-Day Comment Period
EPA is allowing a 30 day-comment period because it has determined
that such a period will provide the public with an adequate opportunity
to respond to the additional issues raise in this supplemental notice.
FFDCA and FIFRA do not specify a comment period for this type of
notice. EPA has decided that a 30-day comment period is reasonable
because this supplemental notice raises very few new issues that were
not already available for public comment. As discussed in Unit IV. of
this supplemental notice, EPA effectively considered most of the
factors required by the FQPA amendments of FFDCA and FIFRA relevant to
the proposed exemptions when it issued the proposed package of notices
describing EPA's approach in 1994 (59 FR 60496, 60519, 60535, 60542 and
60545). At that time, the public had an opportunity to review both the
Agency's rationale for the proposals and the underlying support
documents during a 90-day public comment
[[Page 27155]]
period. Only a limited number of new issues have been raised by the
FQPA amendments to FFDCA and FIFRA and the Agency continues to rely
upon the information already in the docket for the 1994 proposals and
thus 30 days should provide adequate time for public comment. In
addition, EPA believes that it is in the interest of the public to
publish the final exemption from the requirement of a tolerance in a
timely manner.
C. Request for Comments
Interested persons are invited to submit written comments on the
new issues raised in this supplemental notice specifically on:
(1) EPA's conclusion that there are no substances outside of the
food supply that may have a cumulative toxic effect with residues of
viral coat proteins produced in plants as part of a plant-pesticide.
(2) EPA's conclusion that there are no substances outside of the
food supply that are related via a common mechanism of toxicity to
residues of viral coat proteins produced in plants as part of a plant-
pesticide to which humans might be exposed through non-occupational
routes of exposure.
Commenters who possess information on viral coat proteins causing
estrogenic effects are requested to send such information to EPA.
In this supplemental notice, EPA describes in greater detail the
rationale supporting the statement made in the 1994 Federal Register
(59 FR at 60513) that ``plant-pesticides are likely to present a
limited exposure of pesticidal substances to humans. In most cases, the
predominant, if not the only route of exposure will be dietary.
Significant respiratory and dermal exposures will be unlikely.'' No
comments were received on this statement during the official comment
period. Commenters may comment on this more detailed rationale for
viral coat proteins.
In this supplemental notice, EPA also describes in greater detail
how the rationale presented in the 1994 Federal Register (59 FR at
60538) concerning the safety for human consumption of food containing
viral coat proteins applies to infants and children. No comments were
received on this rationale during the official comment period.
Commenters may comment on this more detailed rationale specifically
addressing infants and children as part of the larger human population.
VI. Public Docket
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number ``OPP-300367A'' including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number ``OPP-300367A.'' Electronic
comments on this supplemental notice may be filed online at many
Federal Depository Libraries.
VII. References
(1) Gibbs, A. and B Harrison. 1976. Plant Virology: The Principles,
Chap. 1. J. Wiley Sons, New York.
(2) Matthews, R.E.F. 1981. Plant Virology. Chaps. 12, 16, and 19.
Second edition, Academic Press, New York.
(3) Provvidenti, R., R.W. Robinson, and H.M. Munger. 1984.
Occurrence of Zucchini Yellow Mosaic Virus in Curcubits from
Connecticutt, New York, Florida and California, Plant Disease 68:443-
446.
(4) Beemster, A.B.R. and J.A. de Bokx. 1987. Survey of Properties
and Symptoms of Potato Viruses, pp. 84-93 In: Viruses of Potatoes and
Seed Potato Production; J.A. de Bokx and J.P.H. vanderWant. PuDOC,
Wageningen, The Netherlands.
(5) Brun, G. 1991. Rhabdoviridae, Chap. 17, pp. 443-460; In: Atlas
of Invertebrate Viruses, eds. J.R. Adams and J.R. Bonami. CRC Press,
Boca Raton, FL.
VIII. Regulatory Assessment Requirements
This supplemental notice merely seeks additional comments on the
proposed rules with regard to the potential impact that the new
statutory amendments imposed by the August 3, 1996 Food Quality
Protection Act (FQPA) might have on the provisions as proposed. As
such, this notice does not contain any new proposed requirements that
would require additional consideration by the Office of Management and
Budget (OMB) under Executive Order 12866, entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993) or the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. It does not require any other action
under Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993), Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). The
Agency's activities related to these regulatory assessment requirements
are discussed in the proposed rules.
EPA did not consider Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Pub. L. 104-4) at the proposal stage because the
proposed rules were issued prior to its enactment. Although this
supplemental notice is not subject to UMRA because it neither proposes
or finalizes any regulatory requirements, the applicability of the UMRA
requirements will be addressed in the final rules.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Plants, Plant-
pesticides, Reporting and recordkeeping requirements
Dated: May 7, 1997.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 97-12785 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 97-12784 Plant-Pesticides; Supplemental Notice of Proposed Rulemaking
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Pages 27132-27142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12784]
[[Page 27131]]
_______________________________________________________________________
Part VI
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 180
Plant-Pesticides, Supplemental Notice; Proposed Rule
Plant-Pesticides; Nucleic Acids; Proposed Rule
Plant-Pesticides; Viral Coat Proteins; Proposed Rule
Federal Register / Vol. 62, No. 95 / Friday, May 16, 1997 / Proposed
Rules
[[Page 27132]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300368A; FRL-5717-2]
RIN 2070-AC02
Plant-Pesticides; Supplemental Notice of Proposed Rulemaking
AGENCY: Environmental Protection Agency (EPA).
ACTION: Supplemental notice of proposed rulemaking.
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SUMMARY: This document announces the availability of information for
additional public comment regarding a proposed exemption from the
requirement of a tolerance under the Federal Food, Drug, and Cosmetic
Act (FFDCA) for pesticidal substances that are a component of certain
plant-pesticides, i.e., those plant-pesticides that are derived from
closely related plants. Comments on this document may also affect EPA's
final determination on a proposed exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) for this same
category of plant-pesticides. In 1994, EPA proposed to exempt from the
requirement of a tolerance the pesticidal substance portion of plant-
pesticides moved between closely related plants because a tolerance
would not be necessary to protect the public health. Since publication
of the proposal, Congress enacted the Food Quality Protection Act
(FQPA) which amended FFDCA and FIFRA. EPA is issuing this document
today to provide the public with an opportunity to comment on EPA's
analysis of how certain FQPA amendments to FFDCA and FIFRA apply to the
proposed exemption from the requirement of a tolerance for pesticidal
substances moved between closely related plants. EPA believes that it
considered most of the substantive issues associated with the FQPA
amendments when it issued the proposals in 1994. EPA is thus, in this
document, specifically seeking comment only on its evaluation of the
requirements imposed by FQPA that the Agency did not address in the
proposals.
DATES: Comments, identified by the docket control number ``OPP-
300368A,'' must be received on or before June 16, 1997.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person deliver comments to:
Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under Unit IV.D. of this document. No Confidential
Business Information (CBI) should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: By mail: Elizabeth Milewski, Office of
Science, Coordination and Policy, Office of Prevention, Pesticides and
Toxic Substances (7101), Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460, Telephone: (202) 260-6900, e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
EPA issued in the November 23, 1994 Federal Register a package of
five separate Federal Register proposals (59 FR 60496, 60519, 60535,
60542 and 60545) (FRL-4755-2, FRL-4755-3, FRL-4758-8, FRL-4755-5, and
FRL-4755-4) which together described EPA's approach to substances
produced in plants that enable the plants to resist pests or disease.
EPA's package of proposals indicated that these substances are
pesticides under section 2 of FIFRA (7 U.S.C. 136(u)) if they are
``intended for preventing, destroying, repelling, or mitigating any
pest'' or if they are ``. . . intended for use as a plant regulator,
defoliant, or desiccant'' regardless of whether the pesticidal
capabilities evolved in the plants or were introduced by breeding or
through the techniques of modern biotechnology. These substances, and
the genetic material necessary to produce them, were designated
``plant-pesticides'' by EPA in the November 23, 1994 Federal Register
notices. The proposals defined a ``plant-pesticide'' as ``a pesticidal
substance that is produced in a living plant and the genetic material
necessary for the production of the pesticidal substance where the
pesticidal substance is intended for use in the living plant'' (59 FR
at 60534).
One of the five documents (59 FR 60535) proposed to exempt the
pesticidal substance portion of plant-pesticides moved between closely
related plants from the FFDCA (21 U.S.C. 346a) requirement of a
tolerance based upon an evaluation of the potential for new dietary
exposures to the substances when they are produced in plants, or in
plant parts, used as food or feed. EPA proposed in the same Federal
Register (59 FR at 60537) to define closely related plants as plants
that are sexually compatible. In the proposal, sexually compatible,
when referring to plants, means capable of forming a viable zygote
through the fusion of two gametes, including the use of bridging
crosses and/or wide crosses. EPA stated in the proposed exemption that
a tolerance is not necessary to protect the public health for these
pesticidal substances because no new dietary exposures are likely to
occur for pesticidal substances moved between sexually compatible
plants. For pesticidal substances in this category, many years of
experience of human use suggest that under normal dietary conditions
these pesticidal substances present negligible risk. Specifically, EPA
proposed that ``residues of pesticidal substances produced in living
plants as plant-pesticides are exempt from the requirement of a
tolerance if the genetic material that encodes for a pesticidal
substance or leads to the production of a pesticidal substance is
derived from plants that are sexually compatible with the recipient
plant and has never been derived from a source that is not sexually
compatible with the recipient plant'' (59 FR at 60542).
This supplemental notice addresses the pesticidal substance portion
of plant-pesticides produced in food plants. A companion supplemental
notice issued elsewhere in today's Federal Register addresses the
proposed exemption for the nucleic acid component of plant-pesticides
with regard to the FQPA amendments to FFDCA.
Because FQPA modified FIFRA (7 U.S.C. 136 et seq.) by incorporating
the FFDCA safety standard into the FIFRA test for determining whether a
pesticide poses an unreasonable adverse effect, comments on these
supplemental notices may also affect EPA's final determination on the
proposed exemption (59 FR 60519) under FIFRA for plant-pesticides that
are derived from plants sexually compatible with the recipient plant.
EPA is issuing this supplemental notice, as well as the companion
supplemental notice on nucleic acids to ensure that the public has had
adequate opportunity to comment on certain new considerations raised by
the FQPA amendments to FFDCA as these considerations relate to the
proposed exemption from tolerance for residues of pesticidal substances
derived from sexually compatible plants. In evaluating a pesticide
chemical residue for exemption from FFDCA tolerance requirements, EPA
must now explicitly address certain factors, and make a determination
that there is a reasonable certainty that aggregate exposure to the
[[Page 27133]]
residue will cause no harm to the public. The factors to be considered
are iterated in Unit II. of this supplemental notice. EPA's evaluation
of these factors relative to the proposed exemption (59 FR 60535) is
contained in Unit IV. of this supplemental notice. Consistent with
FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific
data and other relevant information in support of this action. In
today's supplemental notice, EPA requests comment only on the new
conclusions identified in Unit V.C. of this supplemental notice.
In light of FQPA, EPA is engaged in a process, including
consultation with registrants, states, and other interested
stakeholders, to make decisions on the new policies and procedures that
will be appropriate as a result of enactment of FQPA. In establishing
this exemption from the requirement of a tolerance for pesticidal
substances derived from sexually compatible plants, EPA does not intend
to set precedents for the application of section 408 and the new safety
standard to other tolerances and exemptions. This exemption from the
requirement of a tolerance will not restrict EPA's options with regard
to general procedures and policies for implementation of the amended
FFDCA section 408.
II. Statutory Authority
Under FFDCA, EPA regulates pesticide chemical residues by
establishing tolerances limiting the amounts of residues that may be
present in food, or by establishing exemptions from the requirement of
a tolerance for such residues. Pesticide chemical residues subject to
regulation under FFDCA are defined by reference to the definition of
pesticide under FIFRA. FFDCA section 201(q)(1) defines a ``pesticide
chemical residue'' to mean the residue in or on food of a pesticide
chemical or other added substance resulting primarily from the
metabolism or degradation of a pesticide chemical (21 U.S.C.
321(q)(2)). A ``pesticide chemical'' means ``any substance that is a
pesticide within the meaning of the Federal Insecticide, Fungicide, and
Rodenticide Act, including all active and inert ingredients of such
pesticide'' (21 U.S.C. 321(q)(1)).
FIFRA authorizes EPA to regulate the sale and distribution of
pesticides in the United States and to exempt a pesticide from the
requirements of FIFRA if it is not of a character requiring regulation
(7 U.S.C. 136a(a) and 136w(b)). FIFRA section 2(u) defines
``pesticide'' as: (1) ``any substance or mixture of substances intended
for preventing, destroying, repelling, or mitigating any pest, (2) any
substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer''
(7 U.S.C. 136(u)).
FQPA amends both FFDCA and FIFRA. FQPA, which took effect on August
3, 1996, among other things, amends FIFRA such that a registration
cannot be issued for a pesticide to be used on or in food unless the
residue of the pesticide in food qualifies for a tolerance or exemption
from the requirement for a tolerance. FQPA modified FIFRA section 2(bb)
by incorporating the FFDCA section 408 safety standard into the test
for determining whether a pesticide poses an unreasonable adverse
effect (7 U.S.C. 136(bb)). FIFRA section 2(bb) defines the term
``unreasonable adverse effects on the environment'' to mean (1) any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide, or (2) a human dietary risk from residues that result
from a use of a pesticide in or on any food inconsistent with the
standard under section 408 of the FFDCA. Thus, a pesticide used in or
on food that does not meet the FFDCA section 408 safety standard also
would pose an unreasonable adverse effect under FIFRA and would not
qualify for an exemption from the requirements of FIFRA under FIFRA
section 25(b)(2).
FQPA amends FFDCA section 408(c)(2)(A)(i) to allow EPA to establish
an exemption from the requirement of a tolerance for a ``pesticide
chemical residue'' only if EPA determines that the exemption is
``safe'' (21 U.S.C. 346a(c)(2)(A)(i)). Section 408(c)(2)(A)(ii) defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information'' (21 U.S.C. 346a(c)(2)(A)(ii)).
This includes exposure through drinking water, but does not include
occupational exposure. In establishing an exemption from the
requirement of a tolerance, FFDCA section 408(c), like the statute
prior to FQPA, does not require EPA to consider benefits that might be
associated with use of the pesticide chemical.
FFDCA section 408 requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing an exemption and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue'' (21 U.S.C.
346a(b)(2)(C)(ii)(I)) and (c)(2)(B). Section 408(b)(2)(D) specifies
other, general factors EPA is to consider in establishing an exemption.
Section 408(c)(3)(B) prohibits an exemption unless there is either a
practical method for detecting and measuring levels of pesticide
chemical residue in or on food or there is no need for such a method
(21 U.S.C. 346a(c)(3)(B)).
Specifically, EPA must consider the following in deciding whether
to grant an exemption:
1. The validity, completeness, and reliability of the available
data from studies of the pesticide chemical and pesticide chemical
residue.
2. Nature of any toxic effect shown to be caused by the pesticide
chemical or residues in studies.
3. Available information concerning the relationship of the results
of such studies to human risk.
4. Available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers).
5. Available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of toxicity.
6. Available information concerning the aggregate exposure levels
of consumers to the pesticide chemical residue and to other related
substances, including dietary exposure and non-occupational exposures.
7. Available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers.
8. Such information as the Administrator may require on whether the
pesticide chemical may have an effect in humans that is similar to an
effect produced by a naturally-occurring estrogen or other endocrine
effects.
9. Safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of animal
experimentation data (21 U.S.C. 346a(b)(2)(D).
Additionally, with respect to exposure of infants and children,
consistent with section 408(b)(2)(C), EPA must assess the risk of the
pesticide based on available information concerning:
1. Consumption patterns that are likely to result in
disproportionately high consumption of food with pesticide residues.
2. Special susceptibility of infants and children to such residues.
3. Cumulative effects of residues with other substances that have a
common
[[Page 27134]]
mechanism of toxicity (21 U.S.C. 346a(b)(2)(C) and (c)(2)(B)).
III. Summary of Proposed Regulations
This supplemental notice affects three of the proposals that
appeared in the November 23, 1994 Federal Register: (1) A proposal
under FFDCA to exempt from the requirement of a tolerance, residues of
the pesticidal substance portion of any plant-pesticide that is derived
from a plant that is sexually compatible with the recipient plant (59
FR 60535); (2) a companion proposal (59 FR 60542) under FFDCA to exempt
``residues of nucleic acids produced in living plants as part of a
plant-pesticide''; and (3) a proposal (59 FR 60519) under FIFRA to
exempt from most of the requirements of FIFRA, plant-pesticides derived
from a plant that is sexually compatible with the recipient plant.
In the November 23, 1994 Federal Register, the Agency proposed to
exempt from the FFDCA requirement of a tolerance (59 FR 60535) and most
requirements of FIFRA (59 FR 60519) pesticidal substances moved between
plants that are closely related. EPA discussed two options for
describing plants that are closely related: (1) Plants that are
sexually compatible, or (2) plants that are within the same taxonomic
genus or are sexually compatible. Sexual compatibility would include
use of techniques such as wide and bridging crosses. EPA's preferred
approach for describing closely related plants was the option based on
sexual compatibility alone. Thus, EPA proposed that plant-pesticides
derived from plants that are sexually compatible would be exempt from
most FIFRA requirements, and residues of pesticidal substances that are
derived from sexually compatible plants would be exempted from the
FFDCA requirement of a tolerance.
The rationale underlying the proposed exemptions is that plants in
a sexually compatible population are likely to have the same
information encoded in their genetic material and to share traits in
common. Groups of plants having a common pool of genetic material have
resulted from the processes of evolution. Generations of directed
breeding to produce improved crops for cultivation have tended to
increase the relatedness of agricultural crop plants and reduce the
variability in the common pools of genetic information of crop plants.
Because sexually compatible plants share a common pool of genetic
material, movement of genetic material encoding pesticidal substances
between plants in a sexually compatible population is unlikely to
result in novel environmental or dietary exposures. If a crop plant
normally produces a pesticidal substance, humans consuming the crop,
and organisms coming into contact with the plant, have been exposed to
that substance in the past, perhaps over long periods of time. No new
exposures are likely to occur. Because of the high degree of
relatedness among plants comprising sexually compatible populations,
the potential for new human exposures, either dietary or environmental,
is low for pesticidal substances in sexually compatible plants or plant
parts used as food or feed. Under the exemptions for plant-pesticides
derived from sexually compatible plants, EPA exempts from the FFDCA
requirement of a tolerance those plant-pesticides that are normally a
component of (not new to) the recipient plant. EPA believes that crops
grown for food in the U.S. today would qualify for this exemption (59
FR at 60535 and 60542) based on the standard of relatedness as
described by sexual compatibility.
The proposed exemption from the requirement of a tolerance (59 FR
60535) was examined within the context of the food supply and dietary
consumption. Many substances having pesticidal activity occur naturally
at low concentrations in the edible parts of plants and have long been
accepted as part of the human diet. Extensive use and experience show
the safety of foods containing these substances. Although very large
numbers of plant varieties are used and large numbers of varieties are
introduced into agricultural use each year, there are only a few
examples of plant varieties causing food safety concerns.
Based on these considerations, and as required by the FFDCA prior
to enactment of the FQPA, EPA concluded that plant-pesticides found in
the current food supply would present no hazard under potential use
conditions and, hence, a tolerance would not be necessary to protect
the public health.
EPA's alternative option for describing relatedness in plants (59
FR at 60537) used both sexual compatibility and taxonomy (genus). Under
this alternative option, if a plant-pesticide was derived from a plant
classified in the same genus as the recipient plant or if the donor
plant was sexually compatible with the recipient plant, that plant-
pesticide would be exempt. The assumption underlying this alternative
option was that the taxonomic grouping of genus correlated to a
relatively high degree of relatedness. This option was not EPA's
preferred approach, because even though plants grouped within a genus
may be fairly closely related, certain species within a genus may never
have contributed traits to plants currently found in the food supply
and thus no known dietary exposure exists for traits from such plants.
Therefore, EPA preferred the option based on sexual compatibility alone
which EPA believes best describes plant-pesticides found in the food
supply.
In the 1994 Federal Register (59 FR 60535), EPA also proposed to
exempt from the requirement of a tolerance a second category of
pesticidal substances. This second category consists of pesticidal
substances that are derived from food plants that are not closely
related to the recipient plant but which would not result in
significantly different dietary exposures when produced in the
recipient plant. This second category will not be addressed in this
supplemental notice but will be addressed in a separate Federal
Register in the future.
IV. Risk Assessment and Safety Determinations
A. Risk Assessment in the 1994 Proposal
This section reviews the analysis that EPA used to support its 1994
proposal (59 FR 60535) to exempt pesticidal substances derived from
sexually compatible plants from the requirement of a food tolerance
under the FFDCA. EPA also relied upon the analysis in the 1994 FFDCA
proposal to evaluate human dietary risks in support of its proposal (59
FR 60519) to exempt plant-pesticides from sexually compatible plants
from most FIFRA requirements. Non-dietary human risks from exposure to
such pesticidal substances were examined under the analysis for the
proposed FIFRA exemption and are discussed in this supplemental notice
only as they pertain to the dietary risks.
When EPA proposed in 1994 to exempt residues of pesticidal
substances that are derived from sexually compatible plants from the
requirement of a tolerance (59 FR 60535), it concluded that a food
tolerance for such substances would not be necessary to protect the
public health because such substances presented no significant hazards
under potential use conditions. EPA based this conclusion upon its
analysis of potential dietary exposure, hazard and risk from
consumption of plants that contain these substances. EPA recognized and
relied on the long history of human experience with growing and
consuming plants for food and with the procedures of plant breeding.
Plant breeding combines the scientific knowledge of experimental
laboratory disciplines such as plant
[[Page 27135]]
physiology, plant genetics, and phytopathology into a practical field
science that develops new plant cultivars for use in agriculture. EPA
has used these bases of knowledge and experience in its estimation of
exposures and hazards of the residues of pesticidal substances
addressed by this supplemental notice as well as for the 1994 proposal.
EPA concluded in the 1994 proposal (59 FR 60535) that the vast
majority of plant varieties developed by plant breeders using traits
from sexually compatible plants produce foods that are safe for human
consumption. This conclusion is based on the experience of consuming
crops resulting from scientific breeding as well as the historical
consumption of crops since the prehistorical origins of agriculture.
These foods undoubtedly contain(ed) pesticidal substances (and the
genetic material necessary to produce them) and share a history of safe
consumption. In addition, appropriate processing procedures are widely
known and are routinely used by consumers in preparation of food from
such sources, including those foods which require specific processing/
preparation steps to avoid dietary problems.
In the 1994 proposal, EPA stated that many substances having
pesticidal activity occur naturally at low concentrations in the edible
parts of plants and have long been accepted as part of the human diet.
Extensive use and experience show the safety of foods containing these
substances. For many foods, the naturally-occurring toxicants they may
contain, some of which might be pesticidal in function, are known.
Also, the established practices that plant breeders employ in selecting
and developing new plant varieties, such as chemical analyses, taste-
testing, and visual analyses, have historically proven to be reliable
for ensuring food safety. That there are few documented cases of new
plant cultivars causing food safety problems despite the large numbers
of new varieties introduced into commerce each year, is a reflection of
the effectiveness of this process (59 FR at 60538).
Plant varieties for the food market have been developed by breeders
seeking better products, higher yields, and other desirable crop
characteristics. In this process, it has been common agricultural
practice to move traits among sexually compatible food plant varieties
as well as to introduce traits from sexually compatible wild relatives
into plant varieties that are used as food plants. This type of
breeding process has been used on most sexually compatible crop plants,
and tended to increase the extent of relatedness among plant varieties
in agricultural crops. The 1994 proposal is based on experience with
the exposure of human populations to crops developed through the
breeding process, i.e., crops developed through 50 to 100 years of
scientific breeding among sexually compatible plant populations using
Mendelian genetics. The sexually compatible, wild relatives of
cultivated plants that are used in this process do not themselves
necessarily have any history of human consumption but have safely
contributed traits through sexual recombination to cultivars on the
market. For example, wild species of tomatoes have been used, in plant
breeding, as a source of increased resistance to economically important
diseases in tomato (Ref. 1). Sexually compatible crop varieties of the
same plant species are also crossed with each other to achieve better
pest resistance in their progeny. Food plant varieties developed in
this way have been introduced, cultivated, and consumed by humans for
many years with very few observed adverse affects (59 FR at 60538).
If a food plant or its close relative normally produces a
pesticidal substance, humans have likely been exposed to that substance
in the past. Experience with both growing agricultural plants and
consuming food from plants which undoubtedly contain pesticidal
substances demonstrates the safety of the current food supply,
including substances in the food supply that may be plant-pesticides.
The Agency believes this experience combined with the knowledge of
plant genetics, plant physiology, phytopathology and plant breeding are
the appropriate considerations in evaluating the potential risks of
residues of the pesticidal substances proposed for the tolerance
exemption (59 FR 60535).
The residues of the pesticidal substances that are the subject of
the proposed exemption have evolved in populations of sexually
compatible plants. They are part of the metabolic cycles of these
plants. They are thus subject to the processes of degradation and decay
that all organic matter undergoes. They are not likely to persist in
the environment nor bioaccumulate in the tissues of living organisms.
Because they do not persist, the potential for new exposures to the
residues to occur, beyond direct physical exposures to the plant, would
be limited. As noted in the proposal (59 FR at 60516), plant-pesticides
present negligible exposure of the pesticidal substances to humans
outside the dietary route because the substances are in the plant
tissue and thus are found either within the plant or in close proximity
to the plant. In contrast, applied synthetic chemicals have much
greater potential for new dietary exposures. Prior to the use of
synthetic pesticides, there may be very little scientific experience
with the new pesticidal substance or even a complete lack of known
dietary exposure to the pesticidal substance.
EPA evaluated the potential risks of a pesticidal substance derived
from a closely-related plant relative based upon the unique
characteristics of plant-pesticides. In evaluating the pesticidal
substance component of plant-pesticides, EPA took into account
available knowledge from a number of scientific disciplines.
Experimental data in the area of plant genetics provided an estimate of
the exchange, between plants, of genetic material that is necessary for
the production of the pesticidal substances. EPA also considered
information from the field of plant physiology regarding plant
metabolism, the production of substances that may have pesticidal
effects, and conditions that may limit the production of such
substances. This information provided a basis for EPA's estimation of
the physiological limitations to production of substances that may have
a pesticidal effect. The Agency also used experimental data derived
from the science of phytopathology to characterize the disease and pest
resistant mechanisms known to occur in plants. All of these bases of
knowledge and experience were integral to EPA's assessment of exposures
and hazards associated with pesticidal substances.
EPA considered whether there are variations in the levels of
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) within and between plant varieties, and thus variation in
exposure that might affect the Agency's determination that pesticidal
substances that are the subject of the proposed exemption present
negligible risk. The amount of pesticidal substance produced by plants
normally varies among members of a closely related population (even
within a single variety), because of the effects of conditions such as
genetic constitution and environment (e.g., weather) on trait
expression. This variation in turn leads to differences in the levels
and types of exposure to the pesticidal substance. Since such variation
is a natural phenomenon common to all plants, humans have been and are
always exposed to varying levels of the pesticidal substances that are
the subject
[[Page 27136]]
of this exemption when they consume food from plants.
EPA also considered the constraints upon the extent to which any
substance can be increased in highly managed food crop plants without
unwanted effects on other, desirable characteristics of the plant such
as yield or palatability. In general, breeders balance a number of
characteristics (e.g., yield, palatability, uniformity of seed drop) in
developing marketable plant varieties. Plants have, as do all
organisms, only a limited capacity to express a particular trait
without an unacceptable drain on energy reserves. Greatly increased
levels of a pesticidal substance would, in general, only be
accomplished at the expense of expressing other agriculturally
desirable traits (e.g., yield). EPA does not believe that levels of
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) will be increased to a point that will result in an
adverse dietary effect. EPA has extensively evaluated whether
quantitative changes in levels of the pesticidal substances that are
the subject of the proposed exemption would warrant regulation by the
setting of a food tolerance. EPA has determined that changes in the
levels of these pesticidal substances present a reasonable certainty of
causing no harm because the highest levels likely to be attained in
plants are not likely to result in overall significantly different
dietary exposures. EPA does not anticipate that attempts to increase
the levels of these pesticidal substances would lead to a significantly
different spectrum of exposure than that with which there is
substantial experience.
The evaluation of potential dietary risk associated with the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) were considered within the context of the food supply and
dietary consumption patterns. The residues of pesticidal substances
that are the subject of the proposed exemption are components of a
human diet. In developing the proposal, the Agency considered that the
diet includes all of the food items that are customarily eaten by human
populations or subpopulations. The consumption of food plants is part
of a balanced and varied diet. Individuals recognize and are familiar
with the plant crop derived food they consume and, based on prior
experience with food, individuals avoid potential exposures to foods
containing substances they know, either through personal experience or
through acquired knowledge, cause them problems. Since the proposed
exemption will not affect the current pattern of exposure to the
pesticidal substances that are the subject of the proposed exemption,
the current method whereby sensitive individuals recognize and avoid
foods known to cause them problems will not be altered. As noted in the
proposal (59 FR at 60505), ``consumer experience with the handling and
preparation of food from these plants contributes to the safety of food
from these plants.
The approach used by EPA to evaluate the dietary risk posed by the
pesticidal substance component of plant-pesticides derived from
sexually compatible plants (59 FR 60535) differs somewhat from the
approach the Agency uses for other pesticides. For more traditional
pesticides, EPA's risk evaluation relies on, for the most part, data
generated by testing in laboratories using representative, single
species animal model systems to estimate risk end-points such as
toxicity and carcinogenicity. Conclusions from data generated from
these single species testing systems are then extrapolated to
conclusions concerning hazards to humans, including conclusions on
dietary hazards presented by chemical pesticide residues in crops and
domestic animals used as food sources for humans. Mathematical models,
as well as experimental data, on pesticide residues, provide
information on exposure. Exposure and hazard considerations are
combined to quantify the potential risk associated with a traditional
pesticide. Safety factors are often used in the risk assessment as an
added measure of caution when toxicity data from surrogate animal
testing are used to estimate human toxicity. Such safety factors are
not necessary in risk assessment when data on human effects is directly
available, as is the case for the proposed exemption from the
requirement of a tolerance for residues of pesticidal substances
derived from sexually compatible plants.
The approach to assessing risk described in the preceding paragraph
is appropriate for analyzing risks posed by pesticide residues from
pesticides such as chemical pesticides, pesticides extracted from
plants, and some types of non-exempt plant-pesticides. For example,
some chemicals used as pesticides may have no history of safe dietary
consumption because they were created by humans and are synthetic.
Single species animal testing may provide the only data on the effect
of these pesticides on living organisms. Chemical pesticides that do
not occur in nature, but are a product of human intervention, may not
necessarily be subject to the processes by which biotic substances are
degraded or cycled in nature. Thus, they may persist in the environment
for long periods of time and may bioaccumulate in the tissues of living
organisms.
The risk assessment methodology appropriate for such chemicals is
not appropriate for the pesticidal substances that evolved in the plant
and are the subject of the proposed exemption (59 FR 60535). Plant-
pesticides derived from sexually compatible plants differ from more
traditional pesticides in a number of ways. As noted in the proposal
(59 FR at 60511), the major characteristic of plant-pesticides that is
different from traditional pesticides is that the plant itself produces
the pesticidal substance rather than the pesticide being applied to the
plant. Thus, the exposure pattern may be very different for plant-
pesticides than for traditional pesticides both because of how the
pesticide is produced and the biology of plants. . . . the potential
for causing adverse health effects may be more circumscribed than for
traditional pesticides because, in many cases, the only significant
route of human exposure may be oral.'' Several conditions limit the
potential for exposure to plant-pesticides as compared to traditional
pesticides. These include that: (1) Exposure with plant-pesticides
would be primarily through one route (dietary), (2) production of the
pesticidal substance is limited by the plant's physiological
constraints, (3) plant-pesticides derived from sexually compatible
plants are integral parts of a plant's metabolism and thus are
compatible with the biological processes of other organisms. Because of
their biotic nature, the pesticidal substances that are the subject of
the proposed exemption do not persist in the environment nor do they
bioaccumulate in the tissues of living organisms. Thus, the number of
routes of exposure that must be considered in performing a risk
assessment are reduced since the primary route of exposure to plant-
pesticides will be ingestion of plant tissues that contain the
pesticidal substances that are the subject of the proposed exemption.
When EPA proposed to exempt residues of pesticidal substances
derived from sexually compatible plants from the requirement of a
tolerance (59 FR 60535), it considered health risks to the general
population, which included infants and children. Children and infants,
like adults, have been consuming food containing the pesticidal
substances that are the subject of the proposed exemption. There is no
evidence such pesticidal substances, as a component of food, present a
different level of dietary risk for infants and children than they
would for the adult
[[Page 27137]]
population. EPA's risk assessment in the proposed exemption included
subgroups as part of the general population, (i.e., infants and
children and the effects of culture on diet), and allowed for
consumption pattern differences of such subgroups. For infants and
children and other subgroups, EPA relied on the human experience base
that it describes in summary form in this supplemental notice. On the
basis of its analysis, EPA determined that a tolerance would not be
necessary to protect the health of infants and children because
pesticidal substances derived from sexually compatible plants would not
pose significant new dietary exposures and experience indicates that
plant-pesticides that are the subject of the exemption present no
hazard under the use conditions.
B. Risk Assessment in Light of Amendment to FFDCA
After EPA issued its proposed exemption from the requirement of a
tolerance for plant-pesticides derived from sexually compatible plants
(59 FR 60535), Congress enacted FQPA and amended certain FFDCA
provisions governing pesticide chemical residues and FIFRA provisions
governing pesticides (See Unit II. of this supplemental notice).
Congress revised the specific wording of the section 408 standard for
exemptions and provided more specific guidance regarding some of the
factors that EPA should consider in establishing such exemptions (see
Unit II. of this supplemental notice). When EPA proposed the exemption
for residues of pesticidal substances derived from sexually compatible
plants (59 FR 60535), it considered most of the safety factors spelled
out in FQPA even though the Agency may not have explicitly discussed
all those factors using the terminology specified in the FQPA
amendments. This supplemental notice describes how the Agency took
account of most of the FQPA factors in issuing its 1994 proposal to
exempt pesticidal substances derived from sexually compatible plants
and indicates which factors were considered in that proposal. The
information the Agency relied on in considering these factors is part
of the public record which was available to the public when EPA issued
the proposed exemption from the requirement of a food tolerance. The
supplemental notice also identifies the factors that were not
considered in the proposal. Because FQPA amended FIFRA by incorporating
the section 408 safety standard, commenters should be aware that
comments on this supplemental notice may also affect EPA's final
determination on the proposed exemption (59 FR 60519) under FIFRA for
plant-pesticides that are derived from plants sexually compatible with
the recipient plant.
1. Validity, completeness, and reliability of available data. EPA
considered in 1994 the validity, completeness, and reliability of the
available data with regard to pesticidal substances derived from
sexually compatible plants in the proposals (59 FR 60519 and 60535) and
has summarized the evaluation in Unit IV.A. of this supplemental
notice.
2. Nature of toxic effect. EPA in 1994 considered the nature of the
toxic effects caused by pesticidal substances derived from sexually
compatible plants in the proposals (59 FR 60519 and 60535) and has
summarized its evaluation in Unit IV.A. of this supplemental notice.
3. Relationship of studies to humans. EPA in 1994 considered the
available information concerning the relationship to humans of toxic
effects of pesticidal substances that are the subject of the proposed
exemption when it issued the proposals (59 FR 60519 and 60535) and has
summarized that evaluation in Unit IV.A. of this supplemental notice.
EPA based its evaluation on the history of human consumption of food
derived from crop plants, and from products such as meat and milk from
animals that consume forage and other crops (e.g., corn and other
grains) that contain residues of pesticidal substances that are the
subject of the proposed exemption (59 FR 60535). Because knowledge of
human consumption of food derived from sexually compatible plants was
available and adequately addressed the issues of hazard and exposure,
the Agency did not use, for the proposed exemption (59 FR 60535), data
generated in the laboratory through animal testing.
4. Dietary consumption patterns. EPA considered in the 1994
proposal (59 FR 60535) the available information on the varying dietary
consumption patterns of major identifiable consumer subgroups as it
pertains to pesticidal substances derived from sexually compatible
plants. The Agency's evaluation is summarized in Unit IV.A. of this
supplemental notice.
5. Available information concerning cumulative effects of the
pesticide chemical residue and other substances that have a common
mechanism of toxicity. In the 1994 proposal (59 FR 60535), EPA examined
available information on the cumulative effect of pesticidal substances
derived from sexually compatible plants as well as other substances
present in food that may have a common mechanism of toxicity with such
pesticidal substances. EPA summarizes this information and its analysis
in Unit IV.A. of this supplemental notice.
With regard to the pesticidal substance itself, the proposal notes
(59 FR at 60505) that this exemption ``is based upon the premise that
new dietary exposures would not likely arise for plant-pesticides
produced in food plants if the genetic material leading to the
production of the plant-pesticide is derived from sexually compatible
plants.'' Thus, the proposal would exempt residues of pesticidal
substances that are normally components of (not new to) food from
plants in sexually compatible populations. As discussed in Unit IV.A.
of this supplemental notice, differences in the levels of pesticidal
substances present may occur between plants in a sexually compatible
population. EPA determined in the proposals that changes in the levels
of these pesticidal substances are not likely to result in overall
significantly different dietary exposures. As noted in the proposal (59
FR at 60538) ``[e]xtensive use and experience show the safety of foods
containing these substances.'' If, however, information becomes
available that indicates this finding is no longer consistent with the
FFDCA exemption standard for a pesticidal substance in this category,
EPA will consider the validity of the new information and act to amend
this tolerance exemption as necessary to protect the public health. In
the 1994 proposal (59 FR at 60535), EPA is proposing a requirement that
any person who sells or distributes plant-pesticides that have been
exempted must report to EPA any information that comes into their
possession regarding unreasonable adverse effects of an exempted plant-
pesticide on human health or the environment.
With regard to substances in food that may share a common mechanism
of toxicity with the residues of the pesticidal substances that are the
subject of the proposed exemption (59 FR 65035), EPA considered the
effects of these substances when it addressed the safety of food. Food
from plants has thousands of constituents. Thus, EPA cannot rule out
the possibility that the foods humans consume would also contain
substances that have a common mechanism of action with the pesticidal
substances that are the subject of the proposed exemption. However,
because sexually compatible plants share a common pool of genetic
material, any substances that may share a common mechanism of toxicity
with the pesticidal substances that are the subject
[[Page 27138]]
of the proposed exemption (59 FR 60535) are normally components of (not
new to) food from plants in sexually compatible populations. As
discussed in the 1994 preamble and supporting record for the proposal,
food from plants in sexually compatible populations have historically
been safely consumed by humans either directly, or indirectly in
products such as meat and milk that are derived from animals that
consume forage and other crops (e.g., corn and other grains). The
history of safe consumption indicates that any cumulative effects
between substances in food that may have a common mechanism of toxicity
with the pesticidal substances that are the subject of the proposed
exemption present a very low probability of human risk. The analysis
made in the preceding paragraph concerning potential increases in
levels of pesticidal substances apply equally to constituents of food
that may have a common mechanism of action with the pesticidal
substances that are the subject of this exemption (59 FR 60535).
Variation in the levels of these substances are not likely to result in
overall significantly different dietary exposures. As noted in the
proposal (59 FR at 60538) ``plant varieties that meet the sexually
compatible standard produce food that is safe for human consumption
and/or appropriate processing procedures are widely known and routinely
used by consumers in preparation of food from such sources.'' However,
should EPA in the future identify substances with a common mechanism of
toxicity with the plant-pesticides that are the subject of the proposed
exemption, both FIFRA and FFDCA give the Agency adequate authority to
take appropriate action to address any risks to humans health.
EPA is not aware of any other substances outside of the food supply
that may have a common mechanism of toxicity with the residues of the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535), although it cannot rule out the possibility. Should EPA
in the future identify substances with a common mechanism of toxicity
other than those found in the parts of plants used as food, both FIFRA
and FFDCA give the Agency adequate authority to take appropriate action
to address any risks to humans health.
Because EPA already considered the safety of food containing
residues of pesticidal substances derived from sexually compatible
plants and other constituents of food that may share a common mechanism
of toxicity with those residues when it issued the proposal (FR 60535),
it is not requesting additional comment on that topic. Comments are
requested only on the new issue of whether there are any substances
outside of the food supply that have a common mechanism of toxicity
with the residues of the pesticidal substances that are the subject of
the proposed exemption, and the effects of any such substances on human
health.
6. Aggregate exposures of consumers including non-occupational
exposures. EPA considered the available information on the aggregate
exposure level of consumers to pesticidal substances in the plant-
pesticides to be exempt in the 1994 FFDCA and FIFRA proposals (59 FR
60519 and 60535). This included a consideration of exposures from
dietary sources (59 FR 60535) as well as from other non-occupational
sources (59 FR 60519). As indicated in EPA's policy statement, ``plant-
pesticides are likely to present a limited exposure of the pesticidal
substance to humans. In most cases, the predominant, if not the only,
exposure route will be dietary. Significant respiratory and dermal
exposures will be unlikely'' (59 FR at 60513). As explained in the
FFDCA and FIFRA proposals and the EPA's policy statement (59 FR 60494)
and associated dockets, plant-pesticides present negligible exposure of
pesticidal substances to humans outside of the dietary route because
the substances are in the plant tissue and thus are found either within
the plant or in close proximity to the plant. EPA considered dietary
exposure to the pesticidal substances in the proposed FFDCA exemption
(59 FR 60535) and summarized its evaluation in Unit IV.A. of this
supplemental notice.
Despite EPA's belief that, because of the nature of plant-
pesticides, there is little likelihood of exposure other than through
the dietary route, EPA in this supplemental notice sets forth in
greater detail its considerations concerning other exposure routes.
With regard to the dermal route of exposure, the pesticidal substances
that are the subject of the proposed exemption (59 FR 60535) may in
some cases be present in sap or other exudates from the plant or the
food and thus may present some limited opportunity for dermal exposure
to persons coming physically into contact with the plant or raw
agricultural food from the plant. Individuals preparing meals are those
most likely to experience dermal contact with the substances on a non-
occupational basis. However, on a per person basis, the potential
amounts involved in these exposures are negligible in comparison to
potential exposure through the dietary route. Moreover, substances that
occur naturally in food, including the pesticidal substances that are
the subject of the proposed exemption, are unlikely to cross the
barrier provided by the skin and thus the responses seen on rare
occasions to substances in food are most likely to be localized skin
irritations. Whether these irritations are caused by the pesticidal
substance component of plant-pesticides is unknown but given the
thousands of constituents of any food of plant origin, the probability
that substances other than the plant-pesticides are the irritants is
very high. Because substances present in food are unlikely to pass
through the skin, dermal exposures are not additive to dietary
exposures.
With regard to exposure through inhalation, the pesticidal
substances may in some cases be present in pollen and some individuals
(those near enough to farms, nurseries or other plant-growing areas to
be exposed to wind-blown pollen) may be exposed, through inhalation, to
the pollen. On a per person basis, the potential amounts of pollen
involved in these exposures are negligible in comparison to potential
exposure through the dietary route. Moreover, it is unlikely that
exposure to the pollen is equivalent to exposure to the pesticidal
substance. The pesticidal substance will not in every case be present
in the pollen. When it is present in pollen, the pesticidal substance
will be integrated into the tissue of the pollen grain. EPA cannot rule
out the possibility that in some cases, the pesticidal substance or
some piece of the pesticidal substance might be bound to the surface of
the pollen grain (as opposed to the more likely circumstance of the
substance being within the pollen grain). If the substance is bound to
the surface of the pollen, lung or respiratory tract tissue in humans
might be exposed to the pesticidal substance. Substances that occur
naturally in pollen, including the pesticidal substances that are the
subject of the proposed exemption, are unlikely to cross the barrier
provided by the mucous membrane of the respiratory tract and thus are
not additive to dietary exposure.
EPA also evaluated potential non-occupational exposures in drinking
water. As noted in the preceding paragraphs, the substances in plants
or parts of plants, including the pesticidal substances that are the
subject of the proposed exemption (59 FR 60535), are produced inside
the plant itself. The pesticidal substances are integrated into and an
integral part of the living tissue of the plant. When the plant dies or
a part is removed from the plant,
[[Page 27139]]
microorganisms colonizing the tissue immediately begin to digest it,
using the components of the tissue (including any pesticidal substances
in the tissue) as building blocks for making their own tissues or for
fueling their own metabolisms. The pesticidal substances that EPA
proposed to exempt are subject to the same processes of degradation and
decay that all organic matter undergoes. This turnover of biochemical
materials in nature through a process of degradation occurs fairly
rapidly. Therefore, these pesticidal substances do not persist in the
environment or bioaccumulate. There is no indication that naturally
occurring plant biochemical compounds, including the pesticidal
substances that are the subject of the proposed exemption, are
resistant to this degradation. Because of the fairly rapid turnover of
these substances, even if they reach surface waters (through pollen
dispersal or parts of the plants (leaves, fruits etc.) falling into
bodies of water), they are unlikely to present anything other than a
negligible exposure in drinking water drawn from surface water sources.
Should they resist degradation long enough to enter groundwater, they
are unlikely to present anything other than a negligible exposure in
drinking water drawn from groundwater. Therefore, although a potential
for non-dietary exposure (i.e., non-food oral, dermal and inhalation)
in non-occupational settings may exist, EPA expects such exposure to be
negligible.
With regard to exposure to ``other related substances,'' EPA is not
aware of any other substances that may be related, via a common
mechanism of toxicity, to the pesticidal substances that are the
subject of the proposed exemption (59 FR 60535), other than related
substances that are present in parts of plants used as food. Thousands
of substances are present in the edible parts of plants. These may
include substances related, via a common mechanism of toxicity, to the
pesticidal substances that are the subject of the proposed exemption.
These related substances have long been accepted as part of the human
diet. Extensive use and experience show the safety of foods containing
these substances. It also shows the safety of these substances consumed
in aggregate through the dietary route with the pesticidal substances
that are the subject of the proposed exemption. With regard to non-
occupational exposure through routes other than dietary exposure, no
evidence, in the many years of human experience with the growing and
consumption of food from plants that may contain substances that may be
related via a common mechanism of toxicity to the pesticidal substances
that are the subject of the proposed exemption, indicates that adverse
effects due to aggregate exposure through the dietary, non-food oral,
dermal and inhalation routes occurs.
Should EPA in the future identify substances related via a common
mechanism of toxicity to the pesticidal substances that are the subject
of the proposed exemption, FIFRA and the FFDCA provide the Agency
adequate authority to take appropriate action to address any risks
associated with those related substances. Substances that are isolated
from the plant's tissues, concentrated and then applied topically as
pesticides to the plant or to food would not be covered by the proposed
exemption (59 FR 60535), but would be subject to the tolerance
requirements of FFDCA.
Because the Agency already considered exposure to the pesticidal
substances that are the subject of the proposed exemption (59 FR 60535)
and to substances related via a common mechanism of toxicity to these
pesticidal substances in food when it issued the proposal, it is not
requesting additional comment on this topic. Comments are requested
only on the issue of whether there are additional substances outside
that food supply that are related, via a common mechanism of toxicity,
to residues of the pesticidal substances that are the subject of the
proposed exemption and the effects of exposure to any such substances
on human health.
7. Sensitivities of subgroups. In 1994, EPA considered available
information on the sensitivities of subgroups as it pertains to the
pesticidal substances derived from sexually compatible plants in the
proposal (59 FR 60535) and has summarized the evaluation in Unit IV.A.
of this supplemental notice.
8. Naturally occurring estrogen or other endocrine effects. FFDCA
now directs EPA, in establishing an exemption from the requirement of a
tolerance, to consider ``such information as the Administrator may
require on whether the pesticide chemical may have an effect in humans
that is similar to an effect of a naturally occurring estrogen or other
endocrine effect'' (21 U.S.C. 346(a)(q)). Congress allowed EPA 2 years
to establish a screening program to determine whether certain pesticide
chemicals may have estrogenic effects and an additional year to
implement the program (21 U.S.C. 408(p)). As part of the screening and
implementation process, EPA is determining what information might be
required and how it will address estrogenic effects from pesticide
residues in general.
While there is some information on estrogenic effects from exposure
to certain pesticides, the data are limited. It is known that certain
food plants contain estrogen mimics, termed phytoestrogens. Such
phytoestrogens are currently being consumed by humans in food derived
from plants. EPA cannot rule out the possibility that such
phytoestrogens could be used as plant-pesticides. Potential exposure of
humans via consumption of plant tissue to phytoestrogens exerting
estrogenic effects and used as plant-pesticides may need to be
considered when the issue of endocrine disruptors is examined by EPA.
If dietary exposure to phytoestrogens (that are also plant-pesticides)
is discovered to be a significant factor, the Agency will re-examine
this proposed exemption from the requirement of a tolerance (59 FR
60535) in light of that information.
9. Safety factors. In the 1994 proposal, EPA did not rely on the
available animal data in reaching its determination that a tolerance is
not necessary to protect the public from pesticidal substances derived
from sexually compatible plants (59 FR 60535). As discussed in Unit
IV.A. of this supplemental notice, EPA relied on the long history of
safe human consumption of the pesticidal substances that are the
subject of the proposed exemption in food from sexually compatible
plant populations and in food derived from animals that consume forage
and other crops (e.g., corn and other grains). EPA continues to believe
that long-term evidence of human consumption, not animal
experimentation data, is the appropriate information base for the
proposed exemption (59 FR 60535). Because EPA did not rely on animal
experimentation data, the Agency did not consider which safety factors
would be appropriate to use in assessing risk to humans based on data
generated through experiments on animals.
10. Infants and children.--a. Dietary consumption patterns. In the
1994 proposal (59 FR 60535), EPA considered available information on
the dietary consumption pattern of infants and children as pertains to
the pesticidal substances derived from sexually compatible plants and
has summarized the evaluation in Unit IV.A. of this supplemental
notice. The range of foods consumed by infants and children is in
general more limited than the range of foods consumed by adults. Most
newborns rely on milk products for nutrition, although some infants are
fed soy based products. Infants begin as early as 4-months of age to
consume
[[Page 27140]]
specific types of solid foods containing residues of pesticidal
substances that are the subject of the proposed exemption. Subsequent
to 4 months of age, apart from processing to facilitate swallowing, the
diets of infants are based on foods consumed by the general adult
population albeit in different proportions. As infants and children
mature, more and more of the foods normally consumed by adults become
part of their diets and the relative proportions of the different types
of food consumed changes to more closely resemble an adult diet.
b. Special susceptibility. In the 1994 proposal (59 FR 60535), EPA
considered available information on the potential for susceptibility of
infants and children, including pre- and post-natal toxicity, as these
factors pertain to the pesticidal substances derived from sexually
compatible plants and has summarized the evaluation in Unit IV.A. of
this supplemental notice.
c. Cumulative effects of residues with other substances with a
common mechanism of toxicity. In the 1994 proposal (59 FR 60535), EPA
examined the available information on the cumulative effect of residues
of pesticidal substances derived from sexually compatible plants as
well as other substances in food that may have a common mechanism of
toxicity. The Agency's consideration in the proposal of the effects of
the residues of pesticidal substances that are the subject of the
proposed exemption (59 FR 60535) for the general population also
included consideration of effects for infants and children. See Unit
IV.B.5. of this supplemental notice for a discussion of cumulative
effects of the pesticide chemical residues and other substances that
have a common mechanism of toxicity.
Because EPA already considered the safety of food containing
residues of pesticidal substances derived from sexually compatible
plants and other constituents of food when it issued the proposal (FR
60535), the Agency is not requesting additional comment on that topic.
Comments are requested only on the new issue of whether there are any
substances outside of the food supply with a common mechanism of
toxicity to the residues of the pesticidal substances that are the
subject of the proposed exemption and the effects of any such
substances on infants and children.
d. Margin of safety. In determining whether the residues of the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535) are safe, FFDCA section 408(b)(2)(C) directs EPA to apply
a tenfold margin of safety for the residues and other sources of
exposure to infants and children to account for potential pre- and
post-natal toxicity and completeness of data on threshold effects with
respect to exposure and toxicity to infants and children, unless a
different margin will be safe. In proposing the exemption, EPA based
its assessment of exposure and toxicity upon reliable information (Ref.
1) including the long history of safe human consumption of food
containing residues of the pesticidal substances that are the subject
of the proposed exemption and other substances in food that may have a
common mechanism of toxicity, and the unique nature of plant-
pesticides. EPA did not rely on animal data. EPA relied on observations
concerning whole food consumption by humans and did not rely on single
entity testing, wherein substances are isolated from a plant source,
and fed to animals at high concentrations (Ref. 1). EPA relied on the
vast experiential base of actual food consumption patterns rather than
limited testing situations. EPA thus, did not utilize animal or other
studies that would yield data that could be subjected to an additional
margin of safety. (See Units IV.A. and IV.B.3. of this supplemental
notice). As a result, the FQPA amendments to FFDCA do not affect EPA's
analysis.
C. Safety Determinations in Light of FFDCA Amendment
Based on the information discussed in the 1994 proposals (59 FR
60496 through 60547), the discussion in Unit IV.A. and the analysis in
Unit IV.B. of this supplemental notice, EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. population in
general, and U.S. infants and children, from aggregate exposure to
residues of pesticidal substances derived from sexually compatible
plants, including all anticipated dietary exposures and all other
exposures for which there is reliable information. Under the proposed
exemption from the requirement for a tolerance (59 FR 60535), EPA would
exempt residues of pesticidal substances that are normally components
of (not new to) food from plants in sexually compatible populations.
Extensive use and experience show the safety of foods containing these
substances. No evidence, in the many years of human experience with the
growing and consumption of food from plants containing the pesticidal
substances that are the subject of the proposed exemption (59 FR
60535), indicates that adverse effects due to aggregate exposure
through the dietary, non-food oral, dermal and inhalation routes occur.
The conclusion that residues of pesticidal substances derived from
sexually compatible plants should be exempt from tolerance requirements
under the FFDCA section 408 safety standard also lends support to EPA's
proposed FIFRA exemption (59 FR 60519) for plant-pesticides derived
from sexually compatible plants with respect to human dietary risks. In
the FIFRA proposal, EPA utilized two criteria to determine whether
plant-pesticides should be exempt: (1) Whether they posed a low
probability of risk, and (2) whether they caused unreasonable adverse
effects on the environment. Based upon the determination that residues
of pesticidal substances subject to the proposed exemption (59 FR
60535) and the nucleic acid component of plant-pesticides (59 FR 60542)
meet the FFDCA section 408 safety test, EPA concludes plant-pesticides
derived from sexually compatible plants would pose only a low
probability of human dietary risk and also would not pose an
unreasonable adverse effect with respect to such risks.
D. Other Considerations
When the Agency proposed to establish an exemption from the
requirement of a tolerance for residues of pesticidal substances
derived from sexually compatible plants (59 FR 60535), EPA did not
propose any numerical limitation on the amount of pesticidal substance
that could be present in food containing these residues. EPA consulted
in 1994 with the Department of Health and Human Services (DHHS) in
developing the proposed exemption (59 FR 60535) and this supplemental
notice and will consult with the Secretary of HHS prior to issuing the
final rule. Because the 1994 proposal was for the exemption from the
requirement of a tolerance, the Agency has concluded that an analytical
method for detecting and measuring the levels of the residues of the
subject pesticidal substances in or on food is not required.
V. Comments
A. Confidential Business Information
Information submitted as comments concerning this supplemental
notice may be claimed confidential by marking any part or all of that
information as ``Confidential Business Information'' (CBI). CBI should
not be submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in
[[Page 27141]]
40 CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
B. 30-Day Comment Period
EPA is allowing a 30-day comment period because it has determined
that such a period will provide the public with an adequate opportunity
to respond to the additional issues raised in this supplemental notice.
FFDCA and FIFRA do not specify a comment period for this type of
notice. EPA has decided that a 30-day comment period is reasonable
because this supplemental notice raises very few new issues that were
not already available for public comment. As discussed in Unit IV. of
this supplemental notice, EPA effectively considered most of the
factors required by the FQPA amendments of FFDCA and FIFRA relevant to
the proposed exemptions when it issued the proposed package of notices
describing EPA's approach in 1994 (59 FR 60496, 60519, 60535, 60542 and
60545). At that time, the public had an opportunity to review both the
Agency's rationale for the proposals and the underlying support
documents during a 90-day public comment period. Only a limited number
of new issues have been raised by the FQPA amendments to FFDCA and
FIFRA and the Agency continues to rely upon the information already in
the docket for the 1994 proposals and thus 30 days should provide
adequate time for public comment. In addition, EPA believes that it is
in the interest of the public to publish the final exemption from the
requirement of a tolerance in a timely manner.
C. Request for Comments
Interested persons are invited to submit written comments on the
new issues raised in this supplemental notice specifically on:
(1) Whether there are substances, outside of the food supply,
sharing a common mechanism of toxicity with pesticidal substances that
are derived from sexually compatible plants. Commenters are asked to
submit information on the cumulative effects of such substances and the
pesticidal substances that are the subject of the proposed exemption
(59 FR 60535).
(2) Whether there are substances, outside of the food supply,
related via a common mechanism of toxicity to pesticidal substances
that are derived from sexually compatible plants, to which humans might
be exposed through non-occupational routes of exposure. Commenters are
asked to describe routes through which such exposure might occur,
including exposure to major identifiable subgroups of human populations
(e.g., infants and children). If such routes are identified, commenters
are requested to provide information on the nature and levels of the
expected exposure.
Entities may also offer comments on issues V.C.1. and V.C.2. above
as they apply to Option 2 as described in the November 23, 1994 Federal
Register (59 FR at 60537) ``Plant-pesticides derived from plants within
the same genus or from sexually compatible plants'' under the revised
FFDCA section 408 safety standard. The Agency will not consider
comments that address issues or information already presented for
public comment in the proposed rule issued in the November 23, 1994,
Federal Register.
Commenters who possess information on substances occurring in food
that may have estrogenic effects and may be used as plant-pesticides
are requested to send such information to EPA.
In this supplemental notice, EPA describes in greater detail the
rationale supporting the statement made in the 1994 Federal Register
(59 FR at 60513) that ``plant-pesticides are likely to present a
limited exposure of pesticidal substances to humans. In most cases, the
predominant, if not the only route of exposure will be dietary.
Significant respiratory and dermal exposures will be unlikely.'' No
comments were received on this statement during the official comment
period. Commenters may comment on this more detailed rationale.
In this supplemental notice, EPA also describes in greater detail
how the rationale presented in the 1994 Federal Register (59 FR at
60538) concerning the safety for human consumption of food from plants
that meet the sexually compatible standard applies to infants and
children. No comments were received on this statement during the
official comment period. Commenters may comment on this more detailed
rationale specifically addressing infants and children as part of the
larger human population.
VI. Public Docket
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number ``OPP-300368A'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number ``OPP-300368A.'' Electronic
comments on this supplemental notice may be filed online at many
Federal Depository Libraries.
VII. References
(1) International Food Biotechnology Council, 1990. Biotechnologies
and food; Assuring the safety of foods produced by genetic
modification. In: Regulatory Toxicology and Pharmacology. Vol 12.
Academic Press, New York.
VIII. Regulatory Assessment Requirements
This supplemental notice merely seeks additional comments on the
proposed rules with regard to the potential impact that the new
statutory amendments imposed by the August 3, 1996 Food Quality
Protection Act (FQPA) might have on the provisions as proposed. As
such, this notice does not contain any new proposed requirements that
would require additional consideration by the Office of Management and
Budget (OMB) under Executive Order 12866, entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993) or the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. It does not require any other action
under Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993), Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). The
Agency's activities related to these regulatory assessment requirements
are discussed in the proposed rules.
EPA did not consider Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Pub. L. 104-4) at the proposal stage because the
proposed rules were
[[Page 27142]]
issued prior to its enactment. Although this supplemental notice is not
subject to UMRA because it neither proposes or finalizes any regulatory
requirements, the applicability of the UMRA requirements will be
addressed in the final rules.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Plants, Plant-
pesticides, Reporting and recordkeeping requirements.
Dated: May 7, 1997.
Lynn R. Goldman
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 97-12784 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 97-12324 Regulations implementing the Federal Coal Mine Health and Safety Act of 1969, as Amended; Extension of Comment Period; Additions to the Record
[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Proposed Rules]
[Page 27000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12324]
=======================================================================
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DEPARTMENT OF LABOR
Employment Standards Administration
20 CFR Parts 718, 722, 725, 726 and 727
[RIN 1215-AA99]
Regulations implementing the Federal Coal Mine Health and Safety
Act of 1969, as Amended; Extension of Comment Period; Additions to the
Record
AGENCY: Employment Standards Administration, Labor.
ACTION: Proposed rule; extension of comment period; additions to the
record.
-----------------------------------------------------------------------
SUMMARY: This document extends the period for filing comments regarding
the proposed rule to amend and revise the regulations implementing the
Black Lung Benefits Act. This action is taken to permit additional
comment from interested persons. In addition, this document informs all
interested persons that the Department is adding three medical articles
to the official rulemaking record and invites comments on those
articles.
DATES: Comments must be received on or before August 21, 1997.
ADDRESSES: Send written comments on the proposed rule to James L.
DeMarce, Director, Division of Coal Mine Worker's Compensation, Room C-
3520, Frances Perkins Building, 200 Constitution Ave., NW., Washington,
DC 20210.
FOR FURTHER INFORMATION CONTACT:
James L. DeMarce, (202) 219-6692.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 22, 1997
(62 FR 3338-3435), the Department of Labor published a proposed rule
intended to amend and revise the regulations implementing the Black
Lung Benefit Act, subchapter IV of the Federal Coal Mine Health and
Safety Act of 1969, as amended. Interested persons were requested to
submit comments on or before March 24, 1997. In the Federal Register of
February 24, 1997 (62 FR 8201), the Department extended the comment
period through May 23, 1997. The trade association representing coal
mine operators has requested that the Department once again extend the
comment period. The trade association seeks additional time to analyze
existing medical evidence and submit its analysis to peer review. The
Department deems it desirable to extend the comment period for all
interested persons. Therefore, the comment period for the proposed
rule, amending and revising 20 CFR Parts 718, 722, 725, 726 and 727, is
extended through August 21, 1997.
In addition, following publication of the proposed rule, the
Department learned of three medical articles relevant to its proposed
revision of the definition of the term ``pneumoconiosis'' at 20 CFR
718.201. See 62 FR 3343-44 (discussion), 3376 (definition). Those
articles are: Becklake, M., ``Occupational Exposures: Evidence for a
Causal Association with Chronic Obstructive Pulmonary Disease,''
American Review of Respiratory Disease, 140: S85-S91, 1989; ``Coal Dust
and Compensation,'' The Lancet, Vol. 335, No. 8685, pp. 322-324 (Feb.
10, 1990); and Wright, J. et al., ``State of the Art: Diseases of the
Small Airways,'' American Review of Respiratory Diseases, 146: 240-262,
1992. The Department gives notice of its inclusion of these articles in
the official rule-making record, and invites comments on them. Copies
of the articles may be reviewed at the Department of Labor.
Signed at Washington, D.C. this 5th day of May, 1997.
Bernard E. Anderson,
Assistant Secretary for Employment Standards.
[FR Doc. 97-12324 Filed 5-15-97; 8:45 am]
BILLING CODE 4510-27-M
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