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Rule

Extension of Tolerances for Emergency Exemptions (Multiple Chemicals)

Action

Final Rule.

Summary

This regulation extends time-limited tolerances for the pesticides listed in this document. These actions are in response to EPA's granting of emergency exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of these pesticides. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA.

 

Table of Contents Back to Top

DATES: Back to Top

This regulation is effective December 13, 2012. Objections and requests for hearings must be received on or before February 11, 2013], 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: Back to Top

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0825, 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: Back to Top

See the table in this unit for the name of a specific contact person. The following information applies to all contact persons: Emergency Response Team, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

Pesticide/CFR citation Contact person
1-Naphthaleneacetic acid 40 CFR 180.155 Keri Grinstead, grinstead.keri@epa.gov, (703) 308-8373.
Kasugamycin 40 CFR 180.614 Keri Grinstead, grinstead.keri@epa.gov, (703) 308-8373.
Mandipropamid 40 CFR 180.637 Debra Rate, rate.debra@epa.gov, (703) 306-0309.

SUPPLEMENTARY INFORMATION: Back to Top

I. General Information Back to Top

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 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-2012-0825 in the subject line on the first page of your submission. All requests must be in writing, and must be received by the Hearing Clerk on or before February 11, 2013. 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 Confidential Business Information (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-2012-0825, 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 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 and Statutory Findings Back to Top

EPA published final rules in the Federal Register for each chemical listed. The initial issuance of these final rules announced that EPA, on its own initiative, under FFDCA section 408, 21 U.S.C. 346a, was establishing time-limited tolerances.

EPA established the tolerances because FFDCA section 408(l)(6) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or time for public comment.

EPA received requests to extend the use of these chemicals for this year's growing season. After having reviewed these submissions, EPA concurs that emergency conditions exist. EPA assessed the potential risks presented by residues for each chemical. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18.

The data and other relevant material have been evaluated and discussed in the final rules originally published to support these uses. Based on that data and information considered, the Agency reaffirms that extension of these time-limited tolerances will continue to meet the requirements of FFDCA section 408(l)(6). Therefore, each of these time-limited tolerances is extended until the date specified below, when each will expire and become automatically revoked. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on the date listed, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on the commodity after that date will not be unlawful, provided the residue is present as a result of an application or use of a pesticide at a time and in a manner that was lawful under FIFRA, the tolerance was in place at the time of the application, and the residue does not exceed the level that was authorized by the tolerance. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Tolerances for the use of the following pesticide chemicals on specific commodities are being extended:

1-Naphthaleneacetic acid. EPA has authorized under FIFRA section 18 the use of 1-naphthaleneacetic acid on avocado tree limbs that have been pruned or cut back to a stump to suppress excess branch growth (suckering) in California. This regulation extends a time-limited tolerance for the combined residues of the plant growth regulator, 1-naphthaleneacetic acid and its conjugates calculated as 1-naphthaleneacetic acid from the application of 1-naphthaleneacetic acid, its ammonium, sodium, or potassium salts, ethyl ester, and acetamide in or on avocado at 0.05 ppm for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2015. A time-limited tolerance was originally published in the Federal Register of August 12, 2009 (74 FR 40513) (FRL-8428-3).

Kasugamycin. EPA has authorized under FIFRA section 18 the use of kasugamycin on apples for control of fire blight in Michigan. This regulation extends a time-limited tolerance for residues of the fungicide kasugamycin in or on apple at 0.05 ppm for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2015. A time-limited tolerance was originally published in the Federal Register of April 14, 2010 (75 FR 19268) (FRL-8808-7).

Mandipropamid. EPA has authorized under FIFRA section 18 the use of mandipropamid on basil for control of downy mildew in Illinois. This regulation extends a time-limited tolerance for the combined residues of the fungicide mandipropamid and its metabolites in or on basil, fresh at 20 ppm and basil, dried at 240 ppm for an additional 3-year period. These tolerances will expire and are revoked on December 31, 2015. A time-limited tolerance was originally published in the Federal Register of September 9, 2011 (76 FR 55799) (FRL-8886-8).

III. International Residue Limits Back to Top

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 1-naphthaleneacetic acid in or on avocados.

The Codex has not established a MRL for kasugamycin in or on apples.

The Codex has not established MRLs for mandipropamid in or on basil commodities.

IV. Statutory and Executive Order Reviews Back to Top

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 final rule has been exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). 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.), 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).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final 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.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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.).

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).

V. Congressional Review Act Back to Top

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 Back to Top

Dated: December 7, 2012.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

begin regulatory text

PART 180—[AMENDED] Back to Top

end regulatory text

1. The authority citation for part 180 continues to read as follows:

Authority: Back to Top

21 U.S.C. 321(q), 346a and 371.

begin regulatory text

2.In § 180.155, revise the table in paragraph (b) to read as follows:

§ 180.155 1-Naphthaleneacetic acid; tolerances for residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date
Avocado 0.05 12/31/15

* * * * *

3.In § 180.614, revise the table in paragraph (b) to read as follows:

§ 180.614 Kasugamycin; tolerances for residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date
Apple 0.05 12/31/15

* * * * *

4.In § 180.637, revise the table in paragraph (b) to read as follows:

§ 180.637 Mandipropamid; tolerances for residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date
Basil, dried 240 12/31/15
Basil, fresh 20 12/31/15

* * * * *

end regulatory text

[FR Doc. 2012-30109 Filed 12-12-12; 8:45 am]

BILLING CODE 6560-50-P

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