2011-14211. Tetrachlorvinphos; Proposed Extension of Time-Limited Interim Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

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 [phone].

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 [phone].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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.

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 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 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:

§ 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:

Commodity	Parts per million	Expiration/revocation date
Cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se)	0.2	[date 18 months from the date of Final tolerance publication].
Cattle, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se)	1.0	[date 18 months from the date of Final tolerance publication].
Cattle, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.5	[date 18 months from the date of Final tolerance publication].
Cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se)	2.0	[date 18 months from the date of Final tolerance publication].
Cattle, meat byproducts, except kidney and liver	1.0	[date 18 months from the date of Final tolerance publication].
Egg (of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.2	[date 18 months from the date of Final tolerance publication].
Hog, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se)	0.2	[date 18 months from the date of Final tolerance publication].
Hog, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se)	1.0	[date 18 months from the date of Final tolerance publication].
Hog, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.5	[date 18 months from the date of Final tolerance publication].
Hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se)	2.0	[date 18 months from the date of Final tolerance publication].
Hog, meat byproducts, except kidney and liver	1.0	[date 18 months from the date of Final tolerance publication].
Milk, fat (reflecting negligible residues in whole milk and of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.05	[date 18 months from the date of Final tolerance publication].
Poultry, fat (of which no more than 7.0 ppm is tetrachlorvinphos per se)	7.0	[date 18 months from the date of Final tolerance publication].
Poultry, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se)	2.0	[date 18 months from the date of Final tolerance publication].
Poultry, meat (of which no more than 3.0 ppm is tetrachlorvinphos per se)	3.0	[date 18 months from the date of Final tolerance publication].
Poultry, meat byproducts, except liver	2.0	[date 18 months from the date of Final tolerance publication].

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]