[Federal Register Volume 68, Number 29 (Wednesday, February 12, 2003)]
[Proposed Rules]
[Pages 7097-7101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3236]


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

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.

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

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: [email protected].

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 [email protected], 
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

[[Page 7099]]

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)).

[[Page 7100]]

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]
BILLING CODE 6560-50-S