Document ID: EPA-HQ-OPP-2007-0261-0015
Agency: epa
Document Type: Rule
Title: Methamidophos; Tolerance Actions
Posted Date: 2009-11-04T05:00Z

[Federal Register: November 4, 2009 (Volume 74, Number 212)]
[Rules and Regulations]               
[Page 57078-57081]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no09-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0261; FRL-8796-1]

 
Methamidophos; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking tolerances for the insecticide methamidophos 
on cucumber, eggplant and melon. The regulatory actions finalized in 
this document are in follow-up to the Agency's reregistration program 
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 
and tolerance reassessment program under section 408(q) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 4, 2009. Objections and 
requests for hearings must be received on or before January 4, 2010, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0261. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Joy Schnackenbeck, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8072; e-mail 
address: schnackenbeck.joy@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 57079]]

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0261 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 January 4, 2010.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2007-0261, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of May 23, 2007 (72 FR 28912) (FRL-8130-8), 
EPA issued a proposed rule concerning tolerance actions for certain 
pesticide active ingredients, including methamidophos. In that proposed 
rule, the Agency proposed to revoke specific tolerances for residues of 
the insecticide methamidophos, which included tolerances in 40 CFR 
180.315(a) on broccoli, cabbage, cucumber, eggplant and melon because 
there were no active U.S. registrations and therefore, the tolerances 
were no longer needed. Also, the proposal of May 23, 2007 provided a 
60-day comment period which invited public comment for consideration 
and for support of tolerance retention under FFDCA standards. EPA only 
received comments regarding the methamidophos tolerance revocations 
from Bayer CropScience and the Canadian Horticultural Council 
requesting EPA to reconsider their proposal to revoke the tolerances of 
methamidophos on cabbage and broccoli in order to allow imports of 
these commodities from Canada. In the September 26, 2007 Federal 
Register (72 FR 54574) (FRL-8147-6), EPA issued a final rule in follow 
up to the May 23, 2007 proposal. In that final rule, EPA included an 
announcement that the Agency would not take action on methamdiophos 
tolerances, at that time based on the comments received during the 
public comment period.
    In this final rule, EPA is now proceeding to revoke tolerances for 
residues of methamidophos in or on cucumber, eggplant and melon. EPA is 
finalizing these tolerance actions in order to implement the tolerance 
recommendations made during the reregistration and tolerance 
reassessment processes (including follow-up on canceled or additional 
uses of pesticides). As part of these processes, EPA is required to 
determine whether each of the amended tolerances meets the safety 
standard of FFDCA. The safety finding determination of ``reasonable 
certainty of no harm'' is discussed in detail in each Reregistration 
Eligibility Decision (RED) and Report on Food Quality Protection Act 
(FQPA) Tolerance Reassessment Progress and Interim Risk Management 
Decision (TRED) for the active ingredient. REDs and TREDs recommend the 
implementation of certain tolerance actions, including modifications, 
to reflect current use patterns, to meet safety findings and change 
commodity names and groupings in accordance with new EPA policy. 
Printed copies of many REDs and TREDs may be obtained from EPA's 
National Service Center for Environmental Publications (EPA/NSCEP), 
P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-
9198; fax number: 1-513-489-8695; Internet at http://www.epa.gov/
ncepihom and from the National Technical Information Service (NTIS), 
5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-
553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic 
copies of REDs and TREDs are available on the Internet at http://
www.regulations.gov and http:// www.epa.gov/pesticides/reregistration/
status.htm.
    This final rule does not revoke those tolerances for which EPA 
received comments stating a need for the tolerance to be retained. In 
response to the proposal published in the Federal Register of (May 23, 
2007) (72 FR 28912), EPA received no comments during the 60-day public 
comment period for the proposed revocation of methamidophos tolerances 
on cucumber, eggplant and melon. Therefore, EPA is revoking the 
tolerances in 40 CFR 180.315(a) on cucumber, eggplant, and melon.

[[Page 57080]]

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

    EPA may issue a regulation establishing, modifying, or revoking a 
tolerance under FFDCA section 408(e). In this final rule, EPA is and 
revoking tolerances to implement the tolerance recommendations made 
during the reregistration and tolerance reassessment processes, and as 
follow-up on canceled uses of pesticides. As part of these processes, 
EPA is required to determine whether each of the amended tolerances 
meets the safety standards under FFDCA. The safety finding 
determination is found in detail in each post-FQPA RED and TRED for the 
active ingredient. REDs and TREDs recommend the implementation of 
certain tolerance actions, including modifications to reflect current 
use patterns, to meet safety findings, and change commodity names and 
groupings in accordance with new EPA policy.
    EPA has issued a post-FQPA RED for methamidophos. REDs and TREDs 
contain the Agency's evaluation of the database for these pesticides, 
including statements regarding additional data on the active 
ingredients that may be needed to confirm the potential human health 
and environmental risk assessments associated with current product 
uses, and REDs state conditions under which these uses and products 
will be eligible for reregistration. The REDs and TREDs recommended the 
establishment, modification, and/or revocation of specific tolerances. 
RED and TRED recommendations such as establishing or modifying 
tolerances, and in some cases revoking tolerances, are the result of 
assessment under the FFDCA standard of ``reasonable certainty of no 
harm.'' However, tolerance revocations recommended in REDs and TREDs 
that are made final in this document do not need such assessment when 
the tolerances are no longer necessary.
    EPA's general practice is to revoke tolerances for residues of 
pesticide active ingredients on crops for which FIFRA registrations no 
longer exist and on which the pesticide may therefore no longer be used 
in the United States. 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.
    When EPA establishes tolerances for pesticide residues in or on raw 
agricultural commodities, the Agency gives consideration to possible 
pesticide residues in meat, milk, poultry, and/or eggs produced by 
animals that are fed agricultural products (for example, grain or hay) 
containing pesticides residues (40 CFR 180.6). If there is no 
reasonable expectation of finite pesticide residues in or on meat, 
milk, poultry, or eggs, then tolerances do not need to be established 
for these commodities (40 CFR 180.6(b) and (c)).

C. When Do These Actions Become Effective?

    These actions become effective on the date of publication of this 
final rule in the Federal Register. The tolerances revoked in this rule 
are associated with uses that have been canceled for several years. The 
Agency believes that treated commodities have had sufficient time for 
passage through the channels of trade.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this final rule, and that 
are in the channels of trade following the tolerance revocations, shall 
be subject to FFDCA section 408(l)(5), as established by FQPA. Under 
this unit, any residues of these pesticides in or on such food shall 
not render the food adulterated so long as it is shown to the 
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA.
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates that the 
pesticide was applied to such food.

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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international Maximum Residue Limits (MRLs) established 
by the Codex Alimentarius Commission, as required by section 408(b)(4) 
of FFDCA. The Codex Alimentarius is a joint U.N. Food and Agriculture 
Organization/World Health Organization food standards program, and it 
is recognized as an international food safety standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level in a notice published for public 
comment. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual REDs and TREDs, and in the 
Residue Chemistry document which supports the RED and TRED, as 
mentioned in the proposed rule cited in Unit II.A. Specific tolerance 
actions in this rule and how they compare to Codex MRLs (if any) is 
discussed in Unit II.A. of the proposed rule.

IV. Statutory and Executive Order Reviews

    In this final rule, EPA revokes 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 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, entitled 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) (Pub. L. 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

[[Page 57081]]

consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-13, 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) (FRL-5753-1), 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, the Agency hereby certifies that this 
final rule will not have a significant economic impact on a substantial 
number of small entities. In a memorandum dated May 25, 2001, EPA 
determined that eight conditions must all be satisfied in order for an 
import tolerance or tolerance exemption revocation to adversely affect 
a significant number of small entity importers, and that there is a 
negligible joint probability of all eight conditions holding 
simultaneously with respect to any particular revocation. (This Agency 
document is available in the docket of the proposed rule, as mentioned 
in Unit II.A.) Furthermore, for the pesticides named in this final 
rule, the Agency knows of no extraordinary circumstances that exist as 
to the present revocations that would change EPA's previous analysis. 
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 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 with Indian Tribal Governments (65 FR 67249, November 9, 
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.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: October 23, 2009.
Steven Bradbury,
Acting 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), 346a and 371

Sec.  180.315  [Amended]

0
2. Section 180.315 is amended by removing the entries ``cucumber,'' 
``eggplant,'' and ``melon'' from the table in paragraph (a).

[FR Doc. E9-26603 Filed 11-03-09; 8:45 am]

BILLING CODE 6560-50-S