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EPA ID: [EPA-HQ-OPP-2006-0192; FRL-8364-1]
SUBJECT CATEGORY: Atrazine; Pesticide Tolerances
DOCUMENT SUMMARY: This regulation establishes tolerances for residues of atrazine in or on vegetable, leafy, except brassica, group 4. Syngenta Crop Protection Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
SUMMARY: Atrazine; Pesticide Tolerances,
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 EPAHQOPP20060192 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 2, 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 EPAHQOPP20060192, by one of the following methods:
In the Federal Register of August 15, 2006 (71 FR 46911) (FRL8064
1), 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
6F7022) by Syngenta Crop Protection Inc., P.O. Box 18300, Greensboro,
NC 27409. The petition requested that 40 CFR 180.220 be amended by
establishing tolerances for residues of the herbicide atrazine, 2 chloro4ethylamino6isopropylaminostriazine, in or on leafy
vegetables (excluding brassica) at 0.60 parts per million (ppm). That
notice referenced a summary of the petition prepared by Syngenta Crop
Protection Inc., the registrant, which is available to the public in
the docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
concluded that a tolerance level of 0.25 ppm shall be established for
the raw agricultural commodities vegetable, leafy, except brassica,
group 4. The reason for these changes are explained in Unit IV.D. III. 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 petitionedfor tolerances for residues of atrazine on vegetable, leafy, except brassica, group 4 at 0.25 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance were discussed in the Notice published in the Federal Register of June 21, 2006 (71 FR 35664) (FRL 80654) which made available the cumulative risk assessment for the chlorinated triazine pesticides, which include atrazine. The Agency concluded that the cumulative risks associated with the chlorinated triazine pesticides are below the Agency's level of concern. In the risk assessment for the inadvertant residues of atrazine on leafy vegetables, EPA concluded that the food related exposures to atrazine from leafy vegetables are insignificant. Thus, the atrazinerelated risks calculated in the triazine cumulative risk assessment will be unchanged by this action. The triazine cumulative risk assessment can be accessed at http://www.regulations.gov under docket identification (ID) number EPAHQOPP20050481. Based on the risk assessment discussed in the above notice, 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 atrazine residues. IV. Other Considerations
Adequate enforcement methodology (Syngenta Analytical Methods AG 601, AG484, AG564 (plants), Method III in Pam Vol. II (milk) and Method I in PAM Vol. II (meat)) is available to enforce the tolerance expression. The method 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
The Codex Alimentarius Commission has not proposed or established maximum residue limits (MRLs) for residues of atrazine in or on agricultural commodities.
Several comments were received from a private citizen objecting to pesticide body load, animal testing, establishing tolerances, and pesticide residues. The Agency has received these same comments from this commenter on numerous previous occasions. Refer to the following Federal Register cites: 70 FR 37686, June 30, 2005; 70 FR 1354, January 7, 2005; 69 FR 6309663098 October 29, 2004; for the Agency's response to these objections.
Based upon review of the data supporting the petition, EPA has concluded that a tolerance level of 0.25 ppm on leafy vegetables (excluding brassica) is more appropriate than 0.60 ppm as it covers the maximum residue level found in the study submitted, while retaining the capability of detecting instances of misuse. The Agency is revising the raw agricultural commodities nomenclature for ``leafy vegetables (excluding brassica)'' to ``vegetable, leafy, except brassica, group 4.''
Therefore, tolerances are established for residues of atrazine, 2 chloro4ethylamino6isopropylaminostriazine, in or on vegetable, leafy, except brassica, group 4 at 0.25 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
[[Page 37852]]
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 (NTTAA), Public Law 104113, section 12(d) (15 U.S.C. 272 note).
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: June 23, 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 180.220 is amended by adding text to paragraph (d) to read as follows:
Sec. 180.220 Atrazine; tolerances for residues.
* * * * *
(d) Indirect or inadvertant residues. Tolerances are established for indirect or inadvertant residues of atrazine, 2chloro4
ethylamino6isopropylaminostriazine, in or on the following raw
agricultural commodity when present therein as a result of application
of atrazine to the growing crops in paragraph (a) of this section:
Commodity Parts per million
Vegetable, leafy, except brassica, group 4........... 0.25 [FR Doc. E815010 Filed 7108; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Hope Johnson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3055410; email address: johnson.hope@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 50 CFR Part 665 47 CFR Part 76 50 CFR Part 229 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522