2013-13818. Tetrachlorvinphos; Proposed Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

This regulation proposes to amend the existing time-limited interim tolerances by converting them to permanent tolerances for the combined residues of the insecticide tetrachlorvinphos, including its metabolites, in or on multiple commodities identified in this document, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

Comments must be received on or before August 12, 2013.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2011-0360, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Carmen Rodia, Registration Division (7504P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; email 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

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 email. 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

A detailed summary of the background related to EPA's extension of the time-limited interim tolerances for the combined residues of the insecticide tetrachlorvinphos, including its metabolites, in or on multiple commodities can be found in the Federal Register documents of August 14, 2002 (67 FR 52985) (FRL-7192-4); February 6, 2008 (73 FR 6867) (FRL-8345-2); September 17, 2008 (73 FR 53732) (FRL-8375-2); June 8, 2011 (76 FR 33184) (FRL-8874-7); September 16, 2011 (76 FR 57657) (FRL-8887-5); March 6, 2013 (78 FR 14487) (FRL-9380-8); and March 13, 2013 (78 FR 15880) (FRL-9380-9). The referenced documents in this unit are available in the docket for this proposed rule under docket ID number EPA-HQ-OPP-2011-0360 at http://www.regulations.gov.

III. Proposal

EPA, on its own initiative, under FFDCA section 408(e), 21 U.S.C. 346a(e), is proposing to amend the existing time-limited interim tolerances by converting them to permanent tolerances for the combined residues of the insecticide tetrachlorvinphos, including its metabolites, in or on cattle, fat (of which no more than 0.1 parts per million (ppm) is tetrachlorvinphos per se) at 0.2 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. The existing time-limited interim tolerances in 40 CFR 180.252 expire on August 18, 2013.

As discussed in the previous rulemakings, these time-limited interim tolerances for tetrachlorvinphos, and its metabolites, have been determined to be safe based on previously submitted magnitude of residue data. (See Unit II. for citations to previously published documents concerning magnitude of residue data.) In order to support making these tolerances permanent, EPA required the submission of new magnitude of residue data. The registrant submitted livestock magnitude of residue data, storage stability data to support previously submitted magnitude of residue data in poultry and cattle, and a waiver request for the swine magnitude of residue data. Based on that data, EPA has concluded that the data confirm previous findings made by the Agency with regard to the level of residues of tetrachlorvinphos in livestock commodities and consequently, the safety finding for these tolerances.

Therefore, EPA concludes that the submitted data supports the Agency's current proposal to amend these existing time-limited tolerances to be permanent tolerances.

IV. Statutory and Executive Order Reviews

This proposed rule proposes to amend tolerances under FFDCA section 408(e). 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) (2 U.S.C. 1501 et seq.). 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) (15 U.S.C. 272 note).

Pursuant to the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations 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. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were 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 proposed rule, the Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. In fact, this proposed rule will have no impact because it merely maintains the status quo by amending the existing time-limited interim tolerances by converting them to permanent tolerances. Any comments about the Agency's determination should be submitted to EPA along with comments on the proposed rule, 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 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 FFDCA section 408(n)(4). 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 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 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: June 5, 2013.

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. In § 180.252, revise the table in paragraph (a) to read as follows:

§ 180.252

Tetrachlorvinphos; tolerances for residues.

(a) * * *

Commodity	Parts per million
Cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se)	0.2
Cattle, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se)	1.0
Cattle, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.5
Cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se)	2.0
Cattle, meat byproducts, except kidney and liver	1.0
Egg (of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.2
Hog, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se)	0.2
Hog, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se)	1.0
Hog, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.5
Hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se)	2.0
Hog, meat byproducts, except kidney and liver	1.0
Milk, fat (reflecting negligible residues in whole milk and of which no more than 0.05 ppm is tetrachlorvinphos per se)	0.05
Poultry, fat (of which no more than 7.0 ppm is tetrachlorvinphos per se)	7.0
Poultry, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se)	2.0
Poultry, meat (of which no more than 3.0 ppm is tetrachlorvinphos per se)	3.0
Poultry, meat byproducts, except liver	2.0

* * * * *