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EPA ID: [EPA-HQ-OPP-2007-0214; FRL-8373-2]
SUBJECT CATEGORY: Pyraclostrobin; Pesticide Tolerances
DOCUMENT 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).
SUMMARY: Pyraclostrobin,
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:
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.
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 eCFR site at http://www.gpoaccess.gov/ecfr. C. 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 EPAHQOPP20070214 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 EPAHQOPP20070214, by one of the following methods:
In the Federal Register of June 13, 2008 (73 FR 33814) (FRL8367
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(4chlorophenyl)1Hpyrazol3
yl]oxy]methyl]phenyl]methoxy, methyl ester and its desmethoxy metabolite; (methylN[[[1(4chlorophenyl)1Hpyrazol3
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.
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 petitionedfor [[Page 44166]]
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, FRL83554) 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, FRL83554),
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.
IV. Other Considerations
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 207555350; telephone number: (410) 3052905; email address:
residuemethods@epa.gov. B. 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.
Therefore, tolerances are established for combined residues of
pyraclostrobin carbamic acid, [2[[[1(4chlorophenyl)1Hpyrazol3
yl]oxy]methyl]phenyl]methoxy, methyl ester and its desmethoxy metabolite; methylN[[[1(4chlorophenyl)1Hpyrazol3
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.
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 LowIncome 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 1044).
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
[[Page 44167]]
(NTTAA), Public Law 104113, section 12(d) (15 U.S.C. 272 note). VII. 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).
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. 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 180.582 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 * * * * *
[[Page 44168]]
* * * * *
[FR Doc. E817480 Filed 72908; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Tony Kish, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3089443; email address: kish.tony@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 47 CFR Part 73 26 CFR Part 1 40 CFR Part 180 33 CFR Part 117 50 CFR Part 17 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 44 CFR Part 65 50 CFR Part 660 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 6 CFR Part 5 40 CFR Part 271 47 CFR Part 64 40 CFR Parts 52 and 81 50 CFR Part 665 44 CFR Part 64 10 CFR Part 50 49 CFR Part 571 47 CFR Part 76