[Federal Register: February 12, 2003 (Volume 68, Number 29)]
[Proposed Rules]
[Page 7097-7101]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe03-18]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0274; FRL-7288-7]
Methoprene, Watermelon Mosaic Virus-2 Coat Protein, and Zucchini
Yellow Mosaic Virus Coat Protein; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: In this document, EPA is proposing to amend the exemption
expression for methoprene from the requirements of a tolerance when
used on food commodities as an insect larvicide, and to revoke all the
tolerances for methoprene because a recent EPA review finds that no
harm is expected to the public from exposure to residues of methoprene.
Therefore, these tolerances are no longer needed and their associated
uses are proposed to be covered by tolerance exemptions. Also, EPA is
proposing to revoke the exemptions for watermelon mosaic virus-2 coat
protein, and zucchini yellow mosaic virus coat protein and specific
portions of the viral genetic material when used as plant-incorporated
protectants in squash, because these exemptions are covered in other
sections of 40 CFR part 180. Because methoprene's 37 tolerances were
previously reassessed, the regulatory actions proposed in this document
do not contribute toward the Agency's tolerance reassessment
requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA)
section 408(q), as amended by the Food Quality Protection Act (FQPA) of
1996. By law, EPA is required by August 2006 to reassess the tolerances
in existence on August 2, 1996.
DATES: Comments, identified by docket ID number OPP-2002-0274, must be
received on or before April 14, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Barbara Mandula, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-7378; e-mail
address: mandula.barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2002-0274. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
[[Page 7098]]
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2002-0274. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP-2002-0274. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB), Office of Pesticide Programs (OPP),
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2002-0274.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2002-0274. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be
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disclosed except in accordance with procedures set forth in 40 CFR part
2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the proposed rule or
collection activity.
7. Make sure to submit your comments by the deadline in this
document.
8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
F. What Can I Do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f) if needed. The order would specify data needed and
the time frames for its submission, and would require that within 90
days some person or persons notify EPA that they will submit the data.
If the data are not submitted as required in the order, EPA will take
appropriate action under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to exempt methoprene from the requirement of a
tolerance, and therefore to revoke the existing tolerances for
methoprene. The other actions involve maintaining exemptions from the
requirement of a tolerance for specific pesticides, while removing
redundant portions of 40 CFR part 180 relating to those tolerance
exemptions.
1. Methoprene. EPA is proposing to revoke the tolerances in 40 CFR
180.359 for residues in or on specific food commodities for control of
hornflies because review of methoprene toxicity data indicate that
these tolerances are not necessary to protect human health or the
environment. An EPA Decision Document on Tolerance Reassessment for
Methoprene, prepared by EPA's Inert Ingredient Focus Group (IIFG) and
finalized in August 2002, finds that methoprene is of low toxicity.
More specifically, the document finds that methoprene is not
acutely toxic, and is neither irritating to skin or eyes, nor is it a
dermal sensitizer. Developmental toxicity was not observed in studies
with rabbits and mice. Methoprene is not carcinogenic in studies in
rats and mice, and is not mutagenic in the Ames assay or in the
dominant lethal assay. No adverse effects were seen in rats in a 2-year
study. Metabolism studies in rats, mice, guinea pigs, and cows indicate
rapid biodegradation of methoprene and its metabolites in mammals and
that its metabolites are incorporated into natural body constituents
(primarily fatty acids). The decision document concludes:
i. Determination of safety. Based on its review and evaluation of
the available information, EPA concludes that there is a reasonable
certainty that no harm will result to the general population, and to
infants and children from aggregate exposure to residues of methoprene.
ii. IIFG inert ingredient focus group recommendation/deferral to
BPPD management. At this time, 40 CFR 180.1033 specifies that
methoprene is exempt from the requirement of a tolerance in or on all
raw agricultural commodities when used to control mosquito larvae.
There are also numerical tolerances for specific commodities in 40 CFR
180.359.
The methoprene risk assessment in the IIFG decision document used
conservative assumptions that assumed the existence of a broad-based
tolerance exemption. A broad-based tolerance exemption assumes that
methoprene can be used on all crop commodities and that these crop
commodities can be used as feed. The safety finding supports the
tolerance exemption approach.
Based on the IIFG report, EPA is proposing to revoke the tolerances
in 40 CFR 180.359 by removing that section from the CFR. EPA is also
proposing to exempt methoprene from the requirement of a tolerance in
or on all food commodities when methoprene is used as an insect
larvicide. (A copy of the IIFG report will be made available in the
docket for this proposed rule.)
2. Two virus coat proteins and the genetic material necessary to
produce the coat proteins in squash. EPA is proposing to revoke the
tolerance exemptions in 40 CFR 180.1132 for watermelon mosaic virus-2
coat protein, and zucchini yellow mosaic virus coat protein and
specific portions of the viral genetic material when used as plant-
incorporated protectants in squash because the tolerance exemptions are
duplicated in the more recent, broader 40 CFR 180.1184. The exemption
in 40 CFR 180.1184 includes all food commodities, rather than being
limited to squash. Therefore, 40 CFR 180.1132 is not needed to protect
human health and the environment.
B. What is the Agency's Authority for Taking these Actions
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et
seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes
the establishment of tolerances, exemptions from tolerance
requirements, modifications in tolerances, and revocation of tolerances
for residues of pesticide chemicals in or on raw agricultural
commodities and processed foods (21 U.S.C. 346(a)).
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C. When Do These Actions Become Effective?
The Agency is proposing that these actions become effective upon
publication of a final rule in the Federal Register. The only effect of
the rule will be to remove redundancies and inconsistencies 40 CFR part
180. No person or entity is expected to be adversely affected.
D. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006 to reassess the tolerances
in existence on August 2, 1996. As of November 20, 2002, EPA had
reassessed over 6,490 tolerances. All of the tolerances and tolerance
exemptions in this proposed rule have already been reassessed and
counted towards the total number of tolerances that EPA must reassess
by August 2006. Therefore, this rule will add zero tolerances to the
required total.
III. Are the Proposed Actions Consistent with International
Obligations?
The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically produced and imported
foods meet the food safety standards established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision (RED) documents. EPA has developed guidance concerning
submissions for import tolerance support (65 FR 35069, June 1, 2000)
(FRL-6559-3). This guidance will be made available to interested
persons. Electronic copies are available on the internet at http://www.epa.gov/.
On the Home Page select ``Laws, Regulations, and
Dockets,'' then select ``Regulations and Proposed Rules'' and then look
up the entry for this document under ``Federal Register--Environmental
Documents.'' You can also go directly to the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to revoke specific
tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted this type of action (i.e., a
tolerance revocation for which extraordinary circumstances do not
exist) from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this
proposed rule has been exempted from review under Executive Order 12866
due to its lack of significance, this proposed rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This proposed rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency previously assessed whether revocations of
tolerances might significantly impact a substantial number of small
entities and concluded that, as a general matter, these actions do not
impose a significant economic impact on a substantial number of small
entities. This analysis was published on December 17, 1997 (62 FR
66020), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration. Revocation of the tolerance exemptions
discussed in this Notice of Proposed Rulemaking would not have a
significant economic impact on a substantial number of small entities,
because the pesticides remain subject to existing tolerance exemptions.
Any comments about the Agency's determination should be submitted to
EPA along with comments on the proposal, and will be addressed prior to
issuing a final rule.
In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implication.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on
[[Page 7101]]
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 31, 2003.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
Sec. 180.359 [Removed]
2. Section 180.359 is removed.
3. Section 180.1033 is revised to read as follows:
Sec. 180.1033 Methoprene; exemption from the requirement of a
tolerance.
Methoprene is exempt from the requirement of a tolerance in or on
all food commodities when used to control insect larvae.
Sec. 180.1132 [Removed]
4. Section 180.1132 is removed.
[FR Doc. 03-3236 Filed 2-11-03; 8:45 am]
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