[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Rules and Regulations]
[Pages 34825-34829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14330]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0159; FRL-7309-5]


Methoprene, Watermelon Mosaic Virus-2 Coat Protein, and Zucchini 
Yellow Mosaic Virus Coat Protein; Final Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending the text of the exemption from the requirement 
of a tolerance for methoprene and is revoking all of the tolerances for 
residues 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 covered by tolerance exemptions. Also, EPA is revoking 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 later sections of 40 CFR part 
180. Because methoprene's 35 tolerances and the 2 exemptions from the 
virus materials were previously reassessed, the regulatory actions 
taken 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: This regulation is effective June 11, 2003. Objections and 
requests for hearings, identified by docket ID

[[Page 34826]]

number OPP-2003-0159, must be received on or before August 11, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit IV. 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit IIA. 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-2003-0159. 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.
    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. 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.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of February 12, 2003 (68 FR 7097) (FRL-
7288-7), EPA issued a proposed rule to amend the exemption expression 
for methoprene to indicate that methoprene is exempt from tolerances 
when used on food commodities as an insect larvicide, to revoke all the 
tolerances for residues of methoprene because they are no longer needed 
to protect the public, and 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 later sections of 40 CFR part 180. Also, the February 
12, 2003 proposal provided a 60-day comment period which invited public 
comment for consideration and for support of tolerance retention under 
FFDCA standards. No comments were received.
    On August 1, 2002, EPA concluded that there is a reasonable 
certainty that no harm will result to the general population, infants, 
and children from aggregate exposure to residues of methoprene based on 
its review and evaluation of available information and conservative 
assumptions that assumed the existence of a broad-based tolerance 
exemption; i.e., that methoprene can be used on all crop commodities. 
In addition, EPA determined that all methoprene tolerances in 40 CFR 
180.359 and its exemption in Sec.  180.1033 were considered to be 
reassessed. For reassessment counting purposes, the tolerance for the 
cereal grain milled fractions was counted as two to reflect the 
original tolerances found previously in 40 CFR 185.4150 and 186.4150. 
Methoprene is being granted a tolerance exemption for use as an insect 
larvicide on all food commodities based on the Agency's safety finding 
which supports tolerance exemption. The tolerances revoked by this 
final rule are no longer necessary for the continued use of methoprene 
as a pesticide. A copy of EPA's August 1, 2002 memo is available in e-
docket OPP-2002-0274.
    EPA is aware that revocation of some of the methoprene tolerances 
leads to or continues a lack of harmonization with some of the existing 
methoprene CODEX maximum residue limits (MRLs). For egg, the EPA 
tolerance of 0.1 ppm is being revoked while the CODEX MRL remains at 
0.05 milligrams/kilogram (mg/kg). For mushroom, EPA's tolerance of 1.0 
ppm is being revoked while the CODEX MRL remains at 0.2 mg/kg. For 
peanut, EPA's tolerance of 2.0 ppm is being revoked while the CODEX MRL 
remains at 2 mg/kg. For residues of methoprene in other food 
commodities, there was either a tolerance or there is a CODEX MRL, but 
not both; therefore, a lack of harmonization remains for residues in 
these other food commodities.
    EPA is revoking the methoprene tolerances in all food commodities 
because a thorough risk analysis has shown that these tolerances are 
not necessary to protect human health or the environment. Risk 
assessments were performed for oral exposure for acute, short-term, 
intermediate-term, and chronic exposures. No evidence of risk to 
adults, infants, or children were found, and the EPA review stated 
``There are no concerns for chronic dietary exposure.'' Similarly, the 
review states ``There are no concerns for any oral, dermal, or 
inhalation intermediate-term exosures to methoprene.'' The review 
concludes, ``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.'' In

[[Page 34827]]

addition, EPA's risk assessment was based on conservative assumptions 
that assumed the existence of the tolerance exemption.
    Therefore, EPA is amending 40 CFR 180.1033 to exempt methoprene 
from the requirement of a tolerance by revising the commodities from 
``raw agricultural'' to ``food'' and the use of control from 
``mosquito'' to ``insect'' larvae. Because they are no longer needed, 
EPA is revoking all 35 tolerances for methoprene in 40 CFR 180.359, 
including: barley; buckwheat; cattle, fat; cattle, meat; cattle, meat 
byproducts; cereal grain milled fractions (except flour and rice 
hulls); corn (except popcorn and sweetcorn); egg; goat, fat; goat, 
meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; 
horse, fat; horse, meat; horse, meat byproducts; milk; millet; 
mushroom; oat; peanut; poultry, fat; poultry, meat; poultry, meat 
byproducts; rice; rice, hulls; rye; sheep, fat; sheep, meat; sheep, 
meat byproducts; sorghum (milo); and wheat in Sec.  180.359(a)(1), and 
feed supplement tolerances for beef cattle and dairy cattle in Sec.  
180.359(a)(2).
    On July 9, 2002, EPA concluded that exemptions in 40 CFR 180.1132 
watermelon mosaic virus-2 coat protein and zucchini yellow mosaic virus 
coat protein, and the genetic material necessary for the production of 
these proteins in or on summer squash were superseded by the exemption 
in 40 CFR 180.1184 in or on all food commodities. In addition, the 
Agency determined that these two exemptions were considered to be 
reassessed. Therefore, EPA is revoking the exemptions in 40 CFR 
180.1132 because they are no longer needed. This final rule does not 
change availability or use of the pesticides mentioned. A copy of the 
July 9, 2002 memo is in the docket for this action.

B. What is the Agency's Authority for Taking this Action?

    It is EPA's general practice to propose revocation of tolerances 
for residues of pesticide active ingredients on crop uses if a 
numerical tolerance is being replaced by a tolerance exemption for 
those uses, or if the tolerance statement is redundant or has been 
superceded. EPA also proposes revocation of tolerances for which FIFRA 
registrations no longer exist. EPA has historically been concerned that 
retention of tolerances that are not necessary to cover residues in or 
on legally treated foods may encourage misuse of pesticides within the 
United States. Nonetheless, EPA will establish and maintain tolerances 
even when corresponding domestic uses are canceled if the tolerances, 
which EPA refers to as ``import tolerances,'' are necessary to allow 
importation into the United States of food containing such pesticide 
residues. However, where there are no imported commodities that require 
these import tolerances, the Agency believes it is appropriate to 
revoke tolerances for unregistered pesticides in order to prevent 
potential misuse.

C. When Do These Actions Become Effective?

    The actions in this final rule are effective on the date of its 
publication in the Federal Register. The only effect of the final rule 
will be to remove redundancies and inconsistencies in 40 CFR part 180. 
No person or entity is expected to be adversely affected. This final 
rule does not change the regulatory status of any registered products.

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 May 7, 2003, EPA has reassessed 
over 6,500 tolerances. In this final rule, EPA is revoking 35 
tolerances and 2 exemptions. These tolerances and exemptions were 
previously reassessed and counted as described in Unit II.A.

III. Are There Any International Trade Issues Raised by this Final 
Action?

    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex 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. 
When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain in a Federal 
Register document the reasons for departing from the Codex level. EPA's 
effort to harmonize with Codex MRLs is summarized in the tolerance 
reassessment section of individual REDs. The U.S. 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 and 
Regulations,'' 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. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0159 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before August 
11, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked

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confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IV.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0159, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

V. Statutory and Executive Order Reviews

    This final rule revokes tolerances established under section 408(d) 
of the FFDCA. 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 rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this 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 final 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. Taking into account this analysis, and 
available information concerning the pesticides listed in this rule, I 
certify that this action will not have a significant economic impact on 
a substantial number of small entities. Specifically, the pesticides 
mentioned in this rule have tolerance exemptions and will therefore 
remain available after this rule becomes effective. 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 final 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 rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination

[[Page 34829]]

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 implications.'' 
``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 rule will not have substantial direct effects on tribal 
governments, on 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 rule.

VI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 21, 2003.
 James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
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 and 180.1132  [Removed]

0
2. Sections 180.359 and 180.1132 are removed.

0
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.
[FR Doc. 03-14330 Filed 6-10-03; 8:45 am]
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