[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Proposed Rules]
[Pages 17236-17239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8001]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300985; FRL-6497-7]

RIN 2070-AB78


Fenthion, Methidathion, Naled, Phorate, and Profenofos; Proposed 
Revocation of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke 67 meat, milk, poultry, and egg 
tolerances for residues of the organophosphate pesticides fenthion, 
methidathion, naled, phorate, and profenofos. EPA determined that there 
are no reasonable expectations of finite residues in or on meat, milk, 
poultry, or eggs for the aforementioned organophosphate pesticides and 
announced on August 2, 1999, that those tolerances were reassessed 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). The regulatory 
actions proposed in this document are part of the Agency's 
reregistration program under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), and the tolerance reassessment requirements of 
the FFDCA. By law, EPA is required to

[[Page 17237]]

reassess 66% of the tolerances in existence on August 2, 1996, by 
August 2002, or about 6,400 tolerances. Since those 67 tolerances were 
previously reassessed, those reassessments were counted at that time. 
Consequently, no reassessments are counted here toward the August 2002 
review deadline of FFDCA section 408(q), as amended by the Food Quality 
Protection Act (FQPA) of 1996.

DATES: Comments, identified by docket control number OPP-300985, must 
be received on or before May 30, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPP-300985 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Dan Helfgott, Special Review 
and Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8054; fax 
number: (703) 308-8041; 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 categories and entities may include, but are not 
limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes are provided to assist you and others in determining whether or 
not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300985. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as Confidential Business Information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-300985 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 
20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected],'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-300985. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. 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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record 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.

[[Page 17238]]

    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 
control 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.

II. Background

A. What Action Is the Agency Taking?

    EPA is proposing to revoke specific meat, milk, poultry and egg 
tolerances for residues of fenthion, methidathion, naled, phorate, and 
profenofos because the Agency has concluded that there is no reasonable 
expectation of finite residues in or on the commodities associated with 
those tolerances.
    The determinations to revoke the tolerances listed in this document 
were made based on feeding studies submitted since the time that the 
tolerances were originally established. These feeding studies used 
exaggerated amounts of the compound (10x the dietary burden) and did 
not show measurable residues of the pesticides tested. Because there is 
no reasonable expectation of finite residues, these 67 tolerances are 
not required under the FFDCA and can be revoked. The Agency originally 
made the determination that there is no reasonable expectation of 
finite residues on fenthion, methidathion, naled, phorate, or 
profenophos for the 67 commodities listed below on July 11, 1999. EPA 
published a notice in the Federal Register on August 2, 1999 (64 FR 
41933) (FRL-6097-3) that these 67 tolerances were considered reassessed 
and had already been counted toward meeting the tolerance reassessment 
requirements listed in FFDCA section 408(q).
    1. Fenthion. EPA is proposing to revoke the tolerances in 40 CFR 
180.214 for residues of fenthion in or on poultry, fat; poultry, meat 
byproducts (mbyp); and poultry, meat. In 40 CFR 180.214, EPA is also 
proposing to remove the ``N'' designation from all entries to conform 
to current Agency administrative practice ( ``N'' designation means 
negligible residues).
    2. Methidathion. EPA is proposing to revoke the tolerances in 40 
CFR 180.298 for residues of methidathion in or on cattle, fat; cattle, 
mbyp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; 
hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; 
poultry, fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; 
sheep, meat; milk; and eggs. In 40 CFR 180.298, EPA is also proposing 
to remove the ``N'' designation from all entries to conform to current 
Agency administrative practice.
    3. Naled. EPA is proposing to revoke the tolerances in 40 CFR 
180.215 for residues of naled in or on cattle, fat; cattle, mbyp; 
cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, 
mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, 
fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, 
meat; milk; and eggs.
    4. Phorate. EPA is proposing to revoke the tolerances in 40 CFR 
180.206 for residues of phorate in or on cattle, fat; cattle, mbyp; 
cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, 
mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, 
fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, 
meat; milk; and eggs.
    5. Profenofos. EPA is proposing to revoke the tolerances in 40 CFR 
180.404 for residues of profenofos in or on poultry, fat; poultry, 
mbyp; poultry, meat; and eggs.

B. What Is the Agency's Authority for Taking This Action?

    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)). Without a tolerance 
or exemption, food containing pesticide residues is considered to be 
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. 
If food containing pesticide residues is considered to be 
``adulterated,'' you may not distribute the product in interstate 
commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be 
sold and distributed, the pesticide must be registered under FIFRA (7 
U.S.C. et seq.) Food-use pesticides not registered in the United States 
have tolerances for residues of pesticides in or on commodities 
imported into the United States.
    When EPA establishes tolerances for pesticide residues in or on raw 
agricultural commodities, consideration must be given to the possible 
residues of those chemicals in meat, milk, poultry, and/or eggs 
produced by animals that are fed agricultural products (for example, 
grain or hay) containing pesticide residues (40 CFR 180.6). When 
considering this possibility, EPA can conclude that:
    1. Finite residues will exist in meat, milk, poultry and/or eggs.
    2. There is a reasonable expectation that finite residues will 
exist.
    3. There is a reasonable expectation that finite residues will not 
exist. If there is no reasonable expectation of finite pesticide 
residues in or on meat, milk, poultry, or eggs, tolerances do not need 
to be established for these commodities (40 CFR 180.6(b) and 40 CFR 
180.6(c)).
    EPA has evaluated the meat, milk, poultry, and egg tolerances 
listed in the table in this proposed rule and has concluded that there 
is no reasonable expectation of finite residues of the listed 
organophosphate pesticides in or on those commodities.

C. When Do These Actions Become Effective?

    EPA is proposing that these actions become effective 90 days 
following publication of a final rule in the Federal Register. EPA has 
proposed delaying the effectiveness of these revocations for 90 days 
following the publication of a final rule to ensure that all affected 
parties receive notice of EPA's actions. If you have comments regarding 
the effective date, please submit comments as described under the 
SUPPLEMENTARY INFORMATION section of this document.

D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required to reassess 66% or about 6,400 of the 
tolerances in existence on August 2, 1996, by August 2002. EPA is also 
required to assess the remaining tolerances by August 2006. As of 
February 1, 2000, EPA has reassessed 3,430 tolerances. While this 
document proposes to revoke 67 tolerances, those 67 tolerances have 
been previously counted as reassessed and none are counted here toward 
the August 2002 review deadline of FFDCA section 408(q), as amended by 
FQPA in 1996.

III. Are the Proposed Actions Consistent With International 
Obligations?

    The tolerance revocations in this proposal are not discriminatory. 
EPA has evaluated the meat, milk, poultry,

[[Page 17239]]

and egg tolerances listed in the table in the regulatory text and has 
concluded that there is no reasonable expectation of finite residues of 
the listed organophosphate pesticides in or on those commodities, 
whether domestic or imported.
    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 documents.

IV. How Do the Regulatory Assessments Requirements Apply to This 
Action?

    In this document, EPA is proposing to revoke specific meat, milk, 
poultry, and egg 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). This action 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 prior consultation as specified by 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 27655, May 19, 1998); 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 require OMB 
review or any 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. The factual basis and the 
Agency's certification under section 605(b) for tolerance revocations 
published on December 17, 1997 (62 FR 66020), and was provided to the 
Chief Counsel for Advocacy of the Small Business Administration. Since 
no extraordinary circumstances exist as to the present revocation that 
would change EPA's previous analysis, the Agency is able to reference 
the general certification. 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 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 FFDCA section 
408(n)(4).

List of Subjects in 40 CFR Part 180

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

    Dated: March 23, 2000.
Jack E. Housenger, Acting
Director, Special Review and Reregistration 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), 346a and 371.


Sec. 180.206  [Amended]

    2. In Sec. 180.206, by removing from the table in paragraph (a) the 
entries for cattle, fat; cattle, mbyp; cattle, meat; eggs; goats, fat; 
goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, 
fat; horses, mbyp; horses, meat; milk (negligible residue); poultry, 
fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; and sheep, 
meat.


Sec. 180.214  [Amended]

    3. In Sec. 180.214, by removing the entries for poultry, fat; 
poultry, mbyp; and poultry, meat; and by removing the ``(N)'' 
designation from the entry ``milk'' in the table under paragraph (a).


Sec. 180.215  [Amended]

    4. In Sec. 180.215, by removing from the table in paragraph (a) the 
entries for cattle fat; cattle, mbyp; cattle, meat; eggs; goats, fat; 
goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, 
fat; horses, mbyp; horses, meat; milk; poultry, fat; poultry, mbyp; 
poultry, meat; sheep, fat; sheep, mbyp; and sheep, meat.


Sec. 180.298  [Amended]

    5. In Sec. 180.298, by removing paragraph (a)(2), and redesignating 
paragraph (a)(1) as (a), and by removing the ``(N)'' designation 
wherever it appears from any entry in the table under paragraph (a).


Sec. 180.404  [Amended]

    6. In Sec. 180.404, by removing the entries for poultry, fat; 
poultry, mbyp; poultry, meat; and eggs; and redesignating the existing 
paragraph as paragraph (a) and adding and reserving paragraphs (b), 
(c), and (d) to read as follows:
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-8001 Filed 3-30-00; 8:45 am]
BILLING CODE 6560-50-F