Butylate, Clethodim, Dichlorvos, Dicofol, Isopropyl Carbanilate, et al.; Tolerance Actions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is revoking specific tolerances, in follow-up to canceled uses or where a commodity is no longer a significant feed item, for butylate, clethodim, dichlorvos, dicofol, isopropyl carbanilate, methanearsonic acid, methomyl, naled, primisulfuron-methyl, tralomethrin, and ziram, and the tolerance exemption for pine oil. However, EPA will not revoke the dicofol tolerances on tea and tolerance exemptions for rotenone, derris, or cube roots at this time. Also, EPA is making minor revisions to the tolerance expressions for dicofol, methanearsonic acid, methomyl, and tralomethrin, revising the nomenclature of specific tolerances for butylate, methomyl, and tralomethrin, and removing expired tolerances for certain pesticide active ingredients, in accordance with current EPA practice. In addition, EPA is reinstating popcorn tolerances for metolachlor to remedy an inadvertent omission and cover existing registrations.

DATES:

This regulation is effective March 25, 2013. Objections and requests for hearings must be received on or before November 26, 2012, 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:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0171, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Joseph Nevola, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8037; email address: nevola.joseph@epa.gov.

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. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(g), 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. 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-2012-0171 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 26, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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 (excluding any CBI) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0171, 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.htm.

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

II. Background

A. What action is the agency taking?

In the Federal Register of May 9, 2012 (77 FR 27164) (FRL-9345-2), EPA issued a proposed rule, in follow-up to canceled uses or where a commodity is no longer a significant feed item, to revoke specific tolerances for butylate, clethodim, dichlorvos, dicofol, isopropyl carbanilate, methanearsonic acid, methomyl, naled, primisulfuron-methyl, tralomethrin, and ziram, and tolerance exemptions for rotenone, derris, cube roots, and pine oil. Also, it proposed minor revisions to the tolerance expressions for dicofol, methanearsonic acid, methomyl, and tralomethrin, revisions to the nomenclature of specific tolerances for butylate, methomyl, and tralomethrin, and removal of expired tolerances for certain pesticide active ingredients, in accordance with current EPA practice. In addition, it proposed to reinstate popcorn tolerances for metolachlor to remedy an inadvertent omission and cover existing registrations. Also, the proposed rule of May 9, 2012 provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards.

In this final rule, EPA is finalizing these tolerance actions, with the exception of the proposed revocations of tolerance exemptions for rotenone, derris, and cube roots, revocation of the dicofol tolerances on tea, and date of expiration/revocation proposed for the methomyl tolerance on grape. EPA is revoking tolerances for butylate, clethodim, dichlorvos, dicofol, isopropyl carbanilate, methanearsonic acid, methomyl, naled, primisulfuron-methyl, tralomethrin, and ziram, and the tolerance exemption for pine oil. The tolerance and tolerance exemption revocations for dichlorvos, naled, and pine oil are consistent with the recommendations in their individual Reregistration Eligibility Decisions (REDs) of 2006.

As part of the tolerance reassessment process, 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 RED for the active ingredient. REDs 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 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 are available on the Internet at http://www.regulations.gov and http://www.epa.gov/pesticides/reregistration/status.htm.

In this final rule, EPA is revoking certain tolerances and/or tolerance exemptions because either they are no longer needed or are associated with food uses that are no longer registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United States. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide active ingredient. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to issue a final rule revoking those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or legally treated domestic commodities.

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.

Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies:

1. Prior to EPA's issuance of a FFDCA section 408(f) order requesting additional data or issuance of a FFDCA section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.

2. EPA independently verifies that the tolerance is no longer needed.

3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under Food Quality Protection Act (FQPA).

This final rule does not revoke those tolerances or tolerance exemptions for which EPA received comments stating a need for the tolerance or tolerance exemption to be retained. Among the comments received by EPA, are the following:

i. Dicofol—Comment by Tea Association of the U.S.A., Inc. The commenter stated that dicofol is used in tea production in countries such as India, China, and Argentina, and requested that EPA not revoke the dicofol tolerances on tea but maintain them for importation purposes.

Agency response. EPA will not revoke the dicofol tolerances in 40 CFR 180.163(a)(1) on “tea, dried” and “tea, plucked leaves” at this time. EPA will address the tea tolerances and the comment received on them in a future document to be published in the Federal Register. However, EPA is finalizing all other amendments (including all other tolerance revocations) proposed concerning dicofol in the Federal Register of May 9, 2012 (77 FR 27164).

ii. Methomyl—Comments by DuPont Crop Protection and the California Grape and Tree Fruit League (CGTFL). DuPont Crop Protection commented that one year is not sufficient time to exhaust methomyl existing stocks for use on grapes. DuPont requested that EPA extend the expiration/revocation date for the methomyl tolerance on grape by a minimum of 3 years (from June 8, 2013 to June 8, 2016). The CGTFL represents California's table grape and deciduous tree fruit growers, packers, and shippers. The CGTFL requested additional time to exhaust existing stocks and suggested a more appropriate expiration/revocation date for the methomyl tolerance on grape would be December 31, 2020.

Agency response. Based upon the comments received by EPA regarding requests for additional time to exhaust existing methomyl end-use stocks for use in or on grapes, and on the Agency's review of methomyl use, EPA is extending the expiration/revocation of the methomyl tolerance in 40 CFR 180.253(a) on grape by more than 3 years from June 8, 2013 to December 31, 2016.

iii. Rotenone—Comments by CERES GmbH, Frutban S.A., Dole Fresh Fruit International, Ltd. (DFFI), and DFFI-Costa Rica. Multiple comments from CERES GmbH (a company headquartered in Germany which offers international certification for organic farming and food processing), Frutban S.A. (an organic banana farm in Ecuador), DFFI, and DFFI-Costa Rica, were received which expressed concerns with EPA's proposal to revoke the U.S. tolerance exemptions for rotenone based insecticides. The commenters stated that there are lots of farmers (especially organic farmers) who rely on rotenone based insecticides on various commodities imported into the United States.

Agency response. Based on the multiple comments by CERES GmbH, Frutban S.A., DFFI, and DFFI-Costa Rica, which stated a continued need for the tolerance exemptions for rotenone for importation purposes into the United States, EPA will not revoke the tolerance exemptions in 40 CFR 180.905 (when applied to growing crops in accordance with good agricultural practice) for rotenone or derris or cube roots at this time. However, because there are no longer any active food-use registrations in the United States and no comments were received by EPA which expressed a need for more time to exhaust existing stocks for domestic use, EPA is not changing its previous determination (as stated in the proposed rule of May 9, 2012) that existing stocks in the United States will be exhausted by August 11, 2012. EPA will note in 40 CFR 180.905 that the tolerance exemptions for rotenone, derris, and cube roots have no U.S. registrations as of March 23, 2011. Also, retaining these tolerance exemptions may require submission of data to demonstrate their safety. EPA believes that residue data from foreign countries, and perhaps other data, may be needed to support import tolerance exemptions for rotenone or derris or cube roots. For example, domestic U.S. residue data are not likely to be representative of growing conditions and use patterns in other countries. EPA published guidances on pesticide import tolerances and residue data for imported food in the Federal Register notices of April 5, 2006 (71 FR 17099) (FRL-7772-1) and June 1, 2000 (65 FR 35069) (FRL-6559-3).

EPA did not receive any specific comments, during the 60-day comment period, on the following pesticide active ingredients: Butylate, clethodim, dichlorvos, (dicofol with the exception of tea), isopropyl carbanilate, naled, primisulfuron-methyl, tralomethrin, and ziram, and pine oil, and any of the active ingredients associated with the removal of expired tolerances. Therefore, with the exception of the changes described in the Agency responses to comments in this final rule, EPA is finalizing the amendments proposed concerning the pesticide active ingredients in the Federal Register of May 9, 2012 (77 FR 27164) (FRL-9345-2). For a detailed discussion of the Agency's rationale for the finalized tolerance actions, refer to the proposed rule of May 9, 2012.

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 revoking tolerances as follow-up on canceled uses of pesticides, which is consistent with the tolerance recommendations made in certain REDs.

C. When do these actions become effective?

As stated in the DATES section, this regulation is effective 180 days after the date of publication in the Federal Register. EPA is delaying the effective date of these finalized actions to allow a reasonable interval for producers in exporting members of the World Trade Organization's Sanitary and Phytosanitary Measures Agreement to adapt to the requirements of a final rule. With the exception of butylate, dicofol, methanearsonic acid (and salts), methomyl, tralomethrin, and ziram, EPA believes that existing stocks of the canceled or amended pesticide products labeled for the uses associated with the revoked tolerances and tolerance exemptions have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade. EPA is revoking certain tolerances for butylate, dicofol, methanearsonic acid (and salts), methomyl, tralomethrin, and ziram with expiration/revocation dates. EPA believes that these revocation dates allow users to exhaust stocks and allow sufficient time for passage of treated commodities 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(1)(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. International Residue Limits

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 (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations 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.

The Codex has not established a MRL for butylate, isopropyl carbanilate (also called propham), methanearsonic acid (and salts), metolachlor, naled, pine oil, primisulfuron-methyl, rotenone (or derris or cube roots), tralomethrin, or MRL for clethodim in or on soybean soapstock, or MRL for dichlorvos on tomato.

The Codex has not established a MRL for ziram per se, but has MRLs for total dithiocarbamates (which includes the dithiocarbamate ziram), determined as carbon disulfide. However, there is no MRL for total dithiocarbamates in or on blackberry.

The Codex has established a MRL for methomyl in or on grapes at 5 milligrams/kilogram (mg/kg). This MRL is the same as the tolerance established for methomyl on grapes in the United States.

The Codex has established MRLs for dicofol in or on cattle meat at 3 mg/kg, eggs at 0.05 mg/kg, poultry meat and cottonseed at 0.1 mg/kg, and cherries at 5 mg/kg. These MRLs and some others are the same as the tolerances established for dicofol in the United States.

The Codex has established MRLs for dicofol in or on various other commodities, including beans, dry at 0.1 mg/kg, citrus fruits at 5 mg/kg, hops, dry at 50 mg/kg, melons, except watermelon at 0.2 mg/kg, pecans and walnuts at 0.01 mg/kg, and peppers and summer squash at 1 mg/kg. These MRLs are all covered by U.S. tolerances at higher levels. These MRLs are different than the tolerances established for dicofol in the United States because of differences in use patterns and/or good agricultural practices.

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) (2 U.S.C. 1501 et seq.). 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 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 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 FFDCA section 408(n)(4). 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

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action 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

Therefore, 40 CFR chapter I is 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 180.116 is amended by revising the table in paragraph (a) to read as follows:

3. Sections 180.133 and 180.144 are removed.

4. Section 180.163 is amended by revising the section heading and paragraph (a) to read as follows:

5. Sections 180.173, 180.180, and 180.214 are removed.

6. Section 180.215 is amended by removing the entry for “Lettuce” from the table in paragraph (a)(1).

7. Section 180.221 is removed.

8. Section 180.232 is amended by revising the table in paragraph (a) to read as follows:

9. Section 180.235 is amended by removing the entry for “Tomato, postharvest (residues expressed as naled)” from the table in paragraph (a)(1).

10. Section 180.239 is removed.

11. Section 180.253 is amended by revising paragraphs (a) and (c) to read as follows:

12. Section 180.289 is amended by revising paragraph (a) to read as follows:

13. Section 180.319 is revised to read as follows:

14. Section 180.368 is amended by alphabetically adding the following entries to the table in paragraph (a)(1) to read as follows:

15. Section 180.422 is amended by revising paragraph (a) to read as follows:

16. Section 180.452 is amended by removing the entries for “Corn, sweet, forage” and “Corn, sweet, stover” from the table in paragraph (a).

17. Section 180.458 is amended by removing the entry for “Soybean, soapstock” from the table in paragraph (a).

18. Sections 180.536 and 180.550 are removed.

19. Section 180.905 is revised to read as follows:

20. Section 180.1035 is removed.