Source: http://thefederalregister.com/2012/10/05/2012-24646.html
Timestamp: 2017-12-17 04:12:00
Document Index: 525447474

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 2', '§ 180', '§ 180']

Federal Register | Trinexapac-ethyl; Pesticide Tolerances
[EPA-HQ-OPP-2010-0524; FRL-9363-4]
RIN 2070-ZA16
Trinexapac-ethyl; Pesticide Tolerances
SUMMARY: This regulation establishes tolerances for residues of trinexapac-ethyl in or on multiple commodities and modifies existing tolerance levels and commodity definitions for trinexapac-ethyl, which are identified and discussed later in this document. EPA proposed these tolerances and noted amendments under the Federal Food, Drug, and Cosmetic Act (FFDCA) in order to correct inadvertent errors in the final rule tolerance table for trinexapac-ethyl that published in theFederal Registeron March 2, 2012.
DATES: This regulation is effective October 5, 2012. Objections and requests for hearings must be received on or before December 4, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of theSUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2010-0524, is available athttp://www.regulations.govor 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 athttp://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Bethany Benbow, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-8072; email address:benbow.bethany@epa.gov.
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-2010-0524 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 December 4, 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-2010-0524, by one of the following methods:
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets. II. Background
In theFederal Registerof July 13, 2012 (77 FR 41346) (FRL-9353-9), EPA issued a proposed rule pursuant to FFDCA section 408(e), 21 U.S.C. 346a (d)(3). The Agency-initiated rule proposed that 40 CFR 180.662 be amended by establishing tolerances for trinexapac-ethyl in or on barley, bran at 2.5 ppm; sugarcane, molasses at 2.5 ppm; and wheat, bran at 6.0 ppm. The rule also proposed amending the existing trinexapac-ethyl tolerances for wheat, forage from 1.5 to 1.0 ppm and wheat, middlings from 6.5 to 10.5 ppm, as well as changing the existing commodity definition for “hog, kidney” to “hog, meat by-products” in order to correct inadvertent errors in the final rule tolerance table for trinexapac-ethyl that was published in theFederal Registeron March 2, 2012 (77 FR 12740) (FRL-9337-9). The proposed rule included a summary of the exposure assessment prepared by the Agency and explained the basis for EPA's conclusion that there is a reasonable certainty that no harm will result to the general population or to infants and children, as a result of aggregate exposure to trinexapac-ethyl residues. A comment was received in response to the proposed rule. EPA's response to that comment is discussed below in Unit III.
III. Response to Comment
An anonymous citizen objected to the presence of any pesticide residues on food. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) contemplates that tolerances greater than zero may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.
Given that EPA received no meaningful comment on its proposal and based on the information, analysis, and conclusions in the July 13, 2012 proposal (77 FR 41346) (FRL-9353-9), tolerances are established, as proposed, for residues of trinexapac-ethyl, in or on barley, bran at 2.5 ppm; sugarcane, molasses at 2.5 ppm; and wheat, bran at 6.0 ppm. In addition, as proposed, the tolerance level for wheat, forage is revised from 1.5 to 1.0 ppm, the tolerance level for wheat, middlings is revised from 6.5 to 10.5 ppm and the commodity definition, “hog, kidney” is revised to “hog, meat by-products.”
This final rule establishes tolerances under FFDCA section 408(d) on EPA's own initiative. 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. 3501et 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).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), the Agency hereby certifies that these proposed tolerances will not have significant negative economic impact on a substantial number of small entities. Establishing a pesticide tolerance or an exemption from the requirement of a pesticide tolerance is, in effect, the removal of a regulatory restriction on pesticide residues in food, and thus such an action will not have any negative economic impact on any entities, including small entities.
Dated: September 25, 2012. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs.
2. In § 180.662, the table in paragraph (a) is amended by: i. Alphabetically adding the following commodities: “Barley, bran”, “Sugarcane, molasses”, and “Wheat, bran”. ii. Removing the entry for “Hog, kidney” and adding in alphabetical order an entry for “Hog, meat by-products”. iii. Revising the entries for “Wheat, forage” and “Wheat, middlings”.
§ 180.662 Trinexapac-ethyl; tolerances for residues.
Barley, bran 2.5 ***** Hog, meat by-products 0.03 ***** Sugarcane, molasses 2.5 Wheat, bran 6.0 Wheat, forage 1.0 ***** Wheat, middlings 10.5 *****