[Federal Register Volume 73, Number 128 (Wednesday, July 2, 2008)]
[Rules and Regulations]
[Pages 37850-37852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15010]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0192; FRL-8364-1]


Atrazine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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).

DATES: This regulation is effective July 2, 2008. Objections and 
requests for hearings must be received on or before September 2, 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-2006-0192. 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 
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: Hope Johnson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5410; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

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. 
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.

B. 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.

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 EPA-HQ-OPP-2006-0192 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 
EPA-HQ-OPP-2006-0192, 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

[[Page 37851]]

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.

II. Petition for Tolerance

    In the Federal Register of August 15, 2006 (71 FR 46911) (FRL-8064-
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-
chloro-4-ethylamino-6-isopropylamino-s-triazine, 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 petitioned-for 
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-
8065-4) 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 atrazine-related 
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 EPA-HQ-OPP-2005-0481. 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

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Syngenta Analytical Methods AG-
601, AG-484, AG-564 (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 20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

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.

C. Response to Comments

    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 63096-63098 October 29, 2004; for the Agency's response 
to these objections.

D. Revisions to Petitioned-For Tolerances

    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.''

V. Conclusion

    Therefore, tolerances are established for residues of atrazine, 2-
chloro-4-ethylamino-6-isopropylamino-s-triazine, in or on vegetable, 
leafy, except brassica, group 4 at 0.25 ppm.

VI. 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

[[Page 37852]]

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 (NTTAA), Public Law 104-113, 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).

List of Subjects in 40 CFR Part 180

    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.

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 180.220 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, 2-chloro-4-
ethylamino-6-isopropylamino-s-triazine, 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
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Vegetable, leafy, except brassica, group 4...........               0.25
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[FR Doc. E8-15010 Filed 7-1-08; 8:45 am]
BILLING CODE 6560-50-S