[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Proposed Rules]
[Pages 33184-33188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14211]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0360; FRL-8874-7]
Tetrachlorvinphos; Proposed Extension of Time-Limited Interim
Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
[[Page 33185]]
ACTION: Proposed rule.
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SUMMARY: This document proposes the extension of time-limited interim
tolerances for the combined residues of the insecticide
tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl
phosphate, including its metabolites, 1-(2,4,5-trichlorophenyl)-ethanol
(free and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-
trichlorophenyl)-ethanediol, in or on multiple commodities which will
be identified later in this document, under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2011-0360, must be received on or before August 8, 2011.
ADDRESSES: Submit your comments, identified by docket ID number EPA-HQ-
OPP-2011-0360, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Tetrachlorvinphos; Proposed Extension of Time-
Limited Interim Pesticides, 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.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0360. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: 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., 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 either 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 hours of
operation of this Docket Facility are 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: Carmen Rodia, Registration Division
(7504P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone
number: (703) 306-0327; fax number: (703) 308-0029; 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:
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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
[[Page 33186]]
II. Background
Following the enactment of the Food Quality Protection Act of 1996
(FQPA), EPA reviewed and assessed under the new FQPA aggregate risk
standard, the existing tolerances of 31 organophosphates (OPs),
including tetrachlorvinphos (TCVP). In late December 2002, EPA reported
the results of its assessment of TCVP tolerances in its Tolerance
Reassessment Eligibility Decision (TRED) document, (67 FR 77491,
December 18, 2002) (FRL-7279-2).
The TCVP TRED concluded that the TCVP livestock residue studies
were not adequate, and recommended that the Agency require the
registrant to conduct and submit new magnitude of residue (MOR) studies
to support permanent TCVP tolerances. The TCVP TRED also recommended
the Agency revoke 4 existing tolerances in commodities supporting TCVP
uses that were no longer registered. Finally, the TRED recommended that
the Agency use existing TCVP metabolism studies to modify 5 existing
livestock tolerances (fat of cattle, hogs and poultry as well as eggs
and milk fat) and establish 11 tolerances for additional tissues of
cattle, hogs and poultry (such as meat, meat byproducts and kidney and
liver). Specifically, the TRED recommended that EPA establish 16 TCVP
tolerances as ``time-limited for a period of 18 months * * * to permit
sufficient time for the registrant to submit the required MOR
studies.'' TCVP TRED at 41. On February 6, 2004, EPA issued a Generic
Data Call-In Notice requiring the registrant to conduct and submit new
livestock MOR studies for meat, milk, poultry, and eggs.
On February 6, 2008, pursuant to section 408(e) of the FFDCA, EPA
proposed to revoke, modify and establish tolerances for 10 pesticides,
including TCVP (73 FR 6867) (FRL-8345-2). EPA explained that the
proposed tolerance actions were a ``follow-up to the Agency
reregistration program under Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and tolerance reassessment program under FFDCA
section 408(q).'' Id. As such, EPA proposed to implement the tolerance
recommendations made in the TCVP TRED by:
(1) Revising the tolerance expression in 40 CFR 180.252 to regulate
the residues of TCVP and its metabolites;
(2) Revise and establish 16 time-limited TCVP livestock tolerances
to reflect levels of TCVP and its metabolites in various metabolism
studies; and
(3) Revoke tolerances for residues of TCVP for goat fat and horse
fat. Specifically, EPA proposed to establish the 16 TCVP tolerances for
``18 months to permit time for the submission of additional MOR data to
support permanent tolerances.'' (73 FR 6867, February 6, 2008). Because
the Agency was taking action to establish tolerances in/on beef cattle,
hog and poultry commodities, EPA determined that the exception that
permitted the use of TCVP as an additive to beef cattle, dairy cattle,
horse and swine feed at certain rates was no longer necessary. On
September 17, 2008, EPA finalized the rule as proposed, establishing,
among other things, 16 time-limited tolerances for TCVP with an
expiration date of March 17, 2010 (73 FR 53732) (FRL-8375-2). For both
the proposal and the final rule, EPA determined that the ``increased
tolerances and new tolerances to be established are safe; i.e., there
is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue.'' (73 FR 53732, September
17, 2008).
It was EPA's intention that upon submission of the required TCVP
MOR studies, the time-limited tolerances would be extended to allow EPA
sufficient time to review the data with the expectation that the data
would support the establishment of permanent tolerances. Prior to March
17, 2010, the registrant did in fact submit MOR data in cattle (MRID
47193001), MOR data in poultry (MRID 47589301), and the livestock
validation methodology (MRID 47369201). However, due to a mistake on
the part of EPA, the data were not reviewed in a timely manner.
Compounding this error, EPA also failed to extend the time-limited
tolerances to allow for the Agency to review the data and make a
determination with respect to converting the time-limited tolerances
into permanent tolerances.
Accordingly, in order to remedy the Agency's mistake and to be
consistent with its original proposal and final rule establishing the
TCVP time-limited tolerances, EPA is proposing to extend the expired
time-limited tolerances for another 18 months to allow EPA to review
the livestock MOR data submitted by the registrant as well as
subsequent submissions, including storage stability data (MRID
47589301) to support the previously submitted MOR data in poultry,
storage stability data (MRID 48378101) to support the previously
submitted MOR data in cattle, and a waiver request for MOR data in
swine.
In the TCVP TRED, EPA ``found that, apart from consideration of the
potential cumulative risks from all of the OPs, each of the tolerances
would meet the FFDCA safety standard. EPA has not considered the impact
of these cumulative risks in the reassessment of these tolerances and
has determined that these tolerances make, at most, only a negligible
contribution to the overall risks from OPs. Therefore, these tolerances
can be maintained regardless of the outcome of the OP cumulative
assessment and any potential regulatory action taken as a result of
that assessment. Accordingly, EPA ``believes it is appropriate to
consider these tolerances reassessed for the purposes of section 408(q)
of FQPA as of July 23, 2002.'' (67 FR 52985, August 14, 2002) (FRL-
7192-4).
Among the factors EPA considered in making the decision to reassess
these tolerances were extensive livestock feeding/metabolism studies as
well as extensive monitoring data that was in agreement with the
livestock feeding/metabolisms studies. In sum, there were very few
detectable residues in the OP monitoring data for animal commodities.
EPA relied upon extensive monitoring data from the U.S. Department of
Agriculture's (USDA) Pesticide Data Program (PDP) and U.S. Food and
Drug Administration's (FDA) Total Diet Study (TDS) covering residues of
multiple OPs in meats and poultry. The residue monitoring data showed
infrequent detections, and those residues were detected at low levels.
Out of approximately 400 meat samples analyzed by the TDS for multiple
OPs from 1991-1999, only 9 samples detected any OP residues (the
residues ranged between 0.002 ppm and 0.009 ppm). Out of the
approximately 500 poultry samples analyzed by PDP for multiple OPs from
1997-2000, only 1 sample detected an OP residue (0.01 ppm) for a
pesticide that currently has a tolerance. Id. For milk and eggs,
extensive monitoring data were available from USDA's PDP and FDA's TDS.
The residue monitoring data showed no detectable OP residues in milk
(there was only 1 trace sample detected out of approximately 1,800
samples analyzed by PDP for multiple OPs from 1996-1998). The residue
monitoring for eggs also showed no detectable OP residues (only 1 trace
sample was detected out of approximately 1,300 samples analyzed by TDS
for multiple OPs from 1992-1998). Id.
In July of 2006, EPA completed the OP cumulative risk assessment
(CRA), using the best available monitoring data. The updated USDA PDP
data indicated that OP residues would not be expected to occur in
significant amounts in meat
[[Page 33187]]
or milk. The analysis in the OP CRA indicated that animal commodities
do not significantly contribute to OP dietary exposure and total OP
dietary risk. This characterization was supported by additional
information, including the updated TDS data. On July 31, 2006, EPA
finalized the TCVP reregistration eligibility determination by
concluding that the pesticide tolerances covered by the IREDs and TREDs
that were pending the result of the OP CRA--including TCVP tolerances,
meet the safety standard under section 408(b)(2) of the FFDCA.
In 2008, EPA confirmed that USDA PDP analyses of livestock
commodities, including milk, poultry, pork, and beef, through 2005
showed virtually no detectable residues of TCVP (except for 2 lone milk
samples detected at levels just above the LOQ (less than one part per
billion), detected out of approximately 5,200 samples analyzed by PDP
for multiple OPs from 2001-2005. Furthermore, the USDA Food Safety and
Inspection Service (FSIS) monitors meat for residues of
tetrachlorvinphos, and there have been no detections of
tetrachlorvinphos from 2000-2009.
III. Proposal
EPA on its own initiative, under section 408(e) of the FFDCA, 21
U.S.C. 346a(e), is proposing to extend the dates of expiration/
revocation for the time-limited interim tolerances for the combined
residues of the insecticide tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate, including its metabolites,
1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or
on cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per
se) at 0.2 parts per million (ppm); cattle, kidney (of which no more
than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; cattle, liver
(of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5
ppm; cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos
per se) at 2.0 ppm; cattle, meat byproducts, except kidney and liver at
1.0 ppm; egg (of which no more than 0.05 ppm is tetrachlorvinphos per
se) at 0.2 ppm; hog, fat (of which no more than 0.1 ppm is
tetrachlorvinphos per se) at 0.2 ppm; hog, kidney (of which no more
than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; hog, liver (of
which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5 ppm;
hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se)
at 2.0 ppm; hog, meat byproducts, except kidney and liver at 1.0 ppm;
milk, fat (reflecting negligible residues in whole milk and of which no
more than 0.05 ppm is tetrachlorvinphos per se) at 0.05 ppm; poultry,
fat (of which no more than 7.0 ppm is tetrachlorvinphos per se) at 7.0
ppm; poultry, liver (of which no more than 0.05 ppm is
tetrachlorvinphos per se) at 2.0 ppm; poultry, meat (of which no more
than 3.0 ppm is tetrachlorvinphos per se) at 3.0 ppm; and poultry, meat
byproducts, except liver at 2.0 ppm, for a period of 18 months
following the date of publication of the final rule in the Federal
Register, in order to provide the Agency with additional time to
complete the reviews of the submitted livestock MOR data, storage
stability data, and the waiver request for the swine MOR data.
IV. Statutory and Executive Order Reviews
This proposed rule establishes a tolerance under section 408(e) of
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions 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, entitled 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) (Pub. L. 104-4). Nor does
it require any special considerations under 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 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). Since
tolerances are being established under section 408(e) of the FFDCA,
such as the tolerance in this proposed rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. The Agency
hereby certifies that this proposed action will not have significant
negative economic impact on a substantial number of small entities. 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 9, 2000). Executive Order 3175 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 proposed 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
[[Page 33188]]
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: May 26, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I 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.
2. Section 180.252 is revised to read as follows:
Sec. 180.252 Tetrachlorvinphos; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the insecticide tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate, including its metabolites,
1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or
on the following commodities:
------------------------------------------------------------------------
Parts per Expiration/revocation
Commodity million date
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Cattle, fat (of which no more 0.2 [date 18 months from the
than 0.1 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Cattle, kidney (of which no more 1.0 [date 18 months from the
than 0.05 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Cattle, liver (of which no more 0.5 [date 18 months from the
than 0.05 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Cattle, meat (of which no more 2.0 [date 18 months from the
than 2.0 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Cattle, meat byproducts, except 1.0 [date 18 months from the
kidney and liver. date of Final tolerance
publication].
Egg (of which no more than 0.05 0.2 [date 18 months from the
ppm is tetrachlorvinphos per date of Final tolerance
se). publication].
Hog, fat (of which no more than 0.2 [date 18 months from the
0.1 ppm is tetrachlorvinphos date of Final tolerance
per se). publication].
Hog, kidney (of which no more 1.0 [date 18 months from the
than 0.05 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Hog, liver (of which no more 0.5 [date 18 months from the
than 0.05 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Hog, meat (of which no more than 2.0 [date 18 months from the
2.0 ppm is tetrachlorvinphos date of Final tolerance
per se). publication].
Hog, meat byproducts, except 1.0 [date 18 months from the
kidney and liver. date of Final tolerance
publication].
Milk, fat (reflecting negligible 0.05 [date 18 months from the
residues in whole milk and of date of Final tolerance
which no more than 0.05 ppm is publication].
tetrachlorvinphos per se).
Poultry, fat (of which no more 7.0 [date 18 months from the
than 7.0 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Poultry, liver (of which no more 2.0 [date 18 months from the
than 0.05 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Poultry, meat (of which no more 3.0 [date 18 months from the
than 3.0 ppm is date of Final tolerance
tetrachlorvinphos per se). publication].
Poultry, meat byproducts, except 2.0 [date 18 months from the
liver. date of Final tolerance
publication].
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2011-14211 Filed 6-7-11; 8:45 am]
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