
[Federal Register: April 7, 2010 (Volume 75, Number 66)]
[Rules and Regulations]               
[Page 17571-17573]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap10-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0673; FRL-8817-4]

 
Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the current tolerance for combined 
residues of pendimethalin and its metabolite, expressed as 
pendimethalin equivalents, in or on alfalfa forage. BASF Corporation 
requested this tolerance amendment under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 7, 2010. Objections and 
requests for hearings must be received on or before June 7, 2010, 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-2009- 0673. All documents in the 
docket are listed in the docket index available at http://
www.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: Jim Tompkins, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5697; e-mail address: tompkins.jim@epa.gov.

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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2009-0673 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 
June 7, 2010. 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 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-2009-0673, 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 Facility'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 January 6, 2010 (75 FR 864) (FRL-8801-
5), 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 
9F7576) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.361 be amended by 
increasing the tolerance for the combined residues of the herbicide 
pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], 
and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl 
alcohol, in or on alfalfa, forage from 3.0 parts per million (ppm) to 
3.5 (ppm). That notice referenced a summary of the petition

[[Page 17572]]

prepared by BASF Corporation, the registrant, which is available 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.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 combined residues of 
pendimethalin and its metabolite including exposure resulting from the 
tolerance established by this action. EPA's assessment of exposures and 
risks associated with pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-
2,6-dinitrobenzenamine] and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol follows.
    On January 27, 2010, the Agency published a final rule (75 FR 4279, 
FRL-8804-2) establishing tolerances for combined residues of 
pendimethalin and its metabolite in or on various grass commodities in 
crop group 17. When the Agency conducted the risk assessment in support 
of the January, 2010 tolerance action, it considered the use of 
pendimethalin on alfalfa, including potential residues of pendimethalin 
and its metabolite in or on alfalfa hay and forage. EPA also considered 
the potential for secondary residues of pendimethalin in livestock 
commodities from consumption of treated alfalfa hay and forage and 
determined that there was no reasonable expectation of finite residues 
to occur. Since alfalfa hay and alfalfa forage are both categorized as 
roughage, EPA assessed the pendimethalin dietary burden of livestock 
using the higher (more conservative) of the two tolerances (alfalfa hay 
at 4.0 ppm). Increasing the tolerance for alfalfa forage to 3.5 ppm 
will not affect the estimated livestock dietary burden or the estimated 
aggregate risks resulting from use of pendimethalin, as discussed in 
the January 27, 2010 (75 FR 4279-4284, FRL-8804-2) Federal Register. 
Refer to this 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.
    Therefore, based on the risk assessments discussed in the final 
rule published in the Federal Register of January 27, 2010 (75 FR 4279, 
FRL-8804-2), EPA concludes that there is a reasonable certainty that no 
harm will result to the general population, or to infants and children 
from aggregate exposure to pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, using liquid chromatography/mass 
spectrometry analysis (LC/MS/MS), 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: 
residuemethods@epa.gov

B. International Residue Limits

    There are no established or proposed Codex maximum residue limits 
(MRLs) for pendimethalin.

C. Revisions to Petitioned-for Tolerances

    EPA has revised the pendimethalin tolerance expression for the new 
and existing tolerances to clarify the chemical moieties that are 
covered by the tolerances and specify how compliance with the 
tolerances is to be measured. The revised tolerance expression makes 
clear that the tolerances cover residues of pendimethalin and its 
metabolites and degradates, but that compliance with the tolerance 
levels will be determined by measuring only pendimethalin, [N- (1-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 
4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, calculated 
as the stoichiometric equivalent of pendimethalin.
    EPA has determined that it is reasonable to make this change final 
without prior proposal and opportunity for comment, because public 
comment is not necessary, in that the change has no substantive effect 
on the tolerance, but rather is merely intended to clarify the existing 
tolerance expression.

D. Response to Comments

    EPA received comments from an anonymous submitter objecting to 
pesticides and other ``toxic'' chemicals generally and recommending 
against any tolerances greater than zero for this product. 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 submitter's comments 
appear 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.

V. Conclusion

    Therefore, a tolerance is established for residues of 
pendimethalin, including its metabolites and degradates, in or on the 
alfalfa, forage at 3.5 ppm. Compliance with the tolerance level is to 
be determined by measuring only pendimethalin, [N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(ethylpropyl) 
amino]-2-methyl-3,5-dinitrobenzyl alcohol, calculated as the 
stoichiometric equivalent of pendimethalin, in or on alfalfa, forage.

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,

[[Page 17573]]

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. 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 (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: March 26, 2010.
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 180.361, revise the introductory text and the entry for 
Alfalfa, forage in the table in paragraph (a) to read as follows:


 Sec.  180.361   Pendimethalin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide pendimethalin, including its metabolites and degradates, in 
or on the commodities. Compliance with the tolerance levels specified 
in the following table below is to be determined by measuring only 
pendimethalin, [N- (1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine], and its metabolite, 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric 
equivalent of pendimethalin, in or on the following commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage.....................                                 3.5
                                * * * * *
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[FR Doc. 2010-7740 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S

