Pesticide Tolerances: Pyraclostrobin
Federal Register: July 30, 2008 (Volume 73, Number 147)
Rules and Regulations
Page 44164-44168
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr30jy08-15
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180
EPA-HQ-OPP-2007-0214; FRL-8373-2
Pyraclostrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for combined residues of pyraclostrobin and its desmethoxy metabolite in or on the following commodities: Borage, seed; castor oil plant, seed; chinese tallowtree, seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame, seed; stokes aster, seed; sweet rocket, seed; tallowwood, seed; tea oil plant, seed; and vernonia, seed. It also increases the existing tolerance for residues of pyraclostrobin and its desmethoxy metabolite in or on sunflower. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 30, 2008. Objections and requests for hearings must be received on or before September 29, 2008, 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: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0214. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where indicated and select the ``Submit'' button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential
Business Information (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
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available 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 Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9443; e-mail address: kish.tony@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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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 those engaged in the following activities:
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 to provide 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.
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How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
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Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2007-0214 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before September 29, 2008.
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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0214, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: 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'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 (703) 305-5805.
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Petition for Tolerance
In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367- 3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7105) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.582 be amended by establishing tolerances for combined residues of the fungicide pyraclostrobin; carbamic acid, [2-[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy metabolite; (methyl-N-[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenylcarbamate, expressed as parent compound, in or on borage; castor oil plant; chinese tallowtree; crambe; cuphea; echium; euphorbia; evening primrose; flax seed; gold of pleasure; hare's ear mustard; jojoba; lesquerella; lunaria; meadowfoam; milkweed; mustard seed; niger seed; oil radish; poppy seed; rapeseed; rose hip; safflower; sesame; stokes aster; sunflower; sweet rocket; tallowwood; tea oil plant; and vernonia; each at 0.45 parts per million (ppm). That notice referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
No changes were made to the proposed tolerance levels; however, EPA modified the proposed commodity terms slightly (e.g., changing
``borage'' to ``borage, seed'', ``cuphea'' to ``cuphea, seed'', etc.) to conform to current nomenclature recommendations.
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Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for
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tolerances for combined residues of pyraclostrobin and its desmethoxy metabolite on borage, seed; castor oil plant, seed; chinese tallowtree, seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame, seed; stokes aster, seed; sunflower, seed; sweet rocket, seed; tallowwood, seed; tea oil plant, seed; and vernonia, seed; each at 0.45 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.
On March 24, 2008 the Agency published a Final Rule (73 FR 15425,
FRL-8355-4) establishing tolerances for residues of pyraclostrobin and its desmethoxy metabolite in or on avocado at 0.6 ppm; barley, grain at 1.4 ppm; canistel at 0.6 ppm; mango at 0.6 ppm; oat, grain at 1.2 ppm; oat, hay at 18 ppm; oat, straw at 15 ppm; papaya at 0.6 ppm; sapodilla at 0.6 ppm; sapote, black at 0.6 ppm; sapote, mamey at 0.6 ppm; and star apple at 0.6 ppm. When the Agency conducted the risk assessments in support of this tolerance action it assumed that pyraclostrobin residues would be present on all of the oilseed commodities requested in this petition as well as on all foods covered by the proposed and established tolerances. Residues on oilseeds were included because there was a pending petition for pyraclostrobin tolerances on oilseed commodities at the time. The decision to establish tolerances on oilseed commodities was deferred until now because the original notice of filing of this petition contained errors requiring revision and re- publication in the Federal Register. Since the oilseed commodities were included in the previous risk assessments, establishing the oilseed commodity tolerances will not change the most recent estimated aggregate risks resulting from use of pyraclostrobin, as discussed in the March 24, 2008 Federal Register. Refer to the March 24, 2008
Federal Register document, available at http://www.regulations.gov, for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the Federal Register document in support of this action.
Based on the risk assessments discussed in the final rule published in the Federal Register of March 24, 2008 (73 FR 15425, FRL-8355-4),
EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to pyraclostrobin residues.
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Other Considerations
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Analytical Enforcement Methodology
Adequate enforcement methods (an Liquid chromatography/mass/ spectrometry (LC/MS/MS) method (BASF Method D9808), and an high performance liquid chromatography/ultraviolet (HPLC/UV) method (BASF
Method D9904)) are available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
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International Residue Limits
No CODEX, Canadian or Mexican maximum residue limits (MRLs) have been established for residues of pyraclostrobin on the oilseed commodities associated with this petition.
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Conclusion
Therefore, tolerances are established for combined residues of pyraclostrobin carbamic acid, [2-[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy metabolite; methyl-N-[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxy]methyl]phenylcarbamate, expressed as parent compound, in or on borage, seed; castor oil plant, seed; chinese tallowtree, seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame, seed; stokes aster, seed; sweet rocket, seed; tallowwood, seed; tea oil plant, seed; and vernonia, seed; each at 0.45 ppm. The existing tolerance for combined residues of pyraclostrobin and its desmethoxy metabolite on sunflower at 0.3 ppm is revised to read ``sunflower, seed'' at 0.45 ppm.
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Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA 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, 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
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
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(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
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Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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.
Dated: July 10, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs. 0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. Section 180.582 is amended by revising the entry for sunflower to read sunflower, seed, and alphabetically adding the following commodities to the table in paragraph (a)(1) to read as follows:
Sec. 180.582 Pyraclostrobin; tolerances for residues.
(a) General. (1) * * *
Commodity
Parts per million
* * * * *
Borage, seed........................
0.45
* * * * *
Castor oil plant, seed..............
0.45
Chinese tallowtree, seed............
0.45
* * * * *
Crambe, seed........................
0.45
Cuphea, seed........................
0.45
Echium, seed........................
0.45
Euphorbia, seed.....................
0.45
Evening primrose, seed..............
0.45
Flax, seed..........................
0.45
* * * * *
Gold of pleasure, seed..............
0.45
* * * * *
Hare's ear mustard, seed............
0.45
* * * * *
Jojoba, seed........................
0.45
Lesquerella, seed...................
0.45
Lunaria, seed.......................
0.45
* * * * *
Meadowfoam, seed....................
0.45
Milkweed, seed......................
0.45
Mustard, seed.......................
0.45
Niger seed, seed....................
0.45
* * * * *
Oil radish, seed....................
0.45
* * * * *
Poppy, seed.........................
0.45
* * * * *
Rapeseed, seed......................
0.45
Rose hip, seed......................
0.45
* * * * *
Safflower, seed.....................
0.45
* * * * *
Sesame, seed........................
0.45
* * * * *
Stokes aster, seed..................
0.45
* * * * *
Sunflower, seed.....................
0.45
Sweet rocket, seed..................
0.45
Tallowwood, seed....................
0.45
Tea oil plant, seed.................
0.45
* * * * *
Vernonia, seed......................
0.45
* * * * *
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* * * * *
FR Doc. E8-17480 Filed 7-29-08; 8:45 am
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