Document ID: EPA-HQ-OPP-2008-0937-0007
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Quinclorac
Posted Date: 2010-09-16T04:00Z

[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Rules and Regulations]               
[Page 67088-67090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de09-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0937; FRL-8800-7]

 
Quinclorac; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
quinclorac in or on grass, forage at 150 ppm and grass, hay at 130 ppm. 
BASF Corporation requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and 
requests for hearings must be received on or before February 16, 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-2008-0937. 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: 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: johnson.hope@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-2008-0937 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 February 16, 2010.
    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-2008-0937, 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 April 8, 2009 (74 FR 15974) (FRL-8407-
4), 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 
8F7442) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.463 be amended by establishing tolerances for residues of the 
herbicide quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on 
grass, forage at 105 and grass, hay at 70 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.
    Based upon review of the data supporting the petition, EPA has 
concluded that 40 CFR 180.463 can be amended by establishing tolerances 
for residues of the herbicide quinclorac in or on grass, forage at 150 
ppm and grass, hay at 130 ppm instead of the petitioned for 105 ppm on 
grass, forage and 70 ppm on grass, hay. The reason for these changes 
are explained in Unit IV.C.

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

[[Page 67089]]

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 quinclorac on grass, forage at 150 ppm and 
grass, hay at 130 ppm. EPA's assessment of exposures and risks 
associated with establishing tolerances follows.
    In the Federal Register of October 7, 2009 (74 FR 51485) (FRL-8434-
3) the Agency published a final rule establishing tolerances for 
residues of quinclorac in or on cranberry at 15.0 ppm. The Agency 
conducted risk assessments to support that tolerance action.
    The risk assessment associated with this 8F7442 petition request on 
grass, forage and grass, hay assessed the possibility that grass, 
forage and hay can be used as livestock feed stuffs and found that the 
current tolerances established for quinclorac for livestock commodities 
are adequate to cover the proposed new use on pasture and rangeland. In 
addition, the drinking water assessment conducted concluded that 
Estimated Drinking Water Concentrations (EDWCs) of quinclorac in 
surface water and ground water resulting from the new use are less than 
the previously assessed EDWCs from the use on cranberry. No new 
residential uses are requested in the 8F7442 petition. Therefore, no 
change in the dietary exposure (from food and water) is expected, and 
establishing tolerances on grass, forage and grass, hay will not change 
the most recent estimated aggregate risks resulting from use of 
quinclorac, as discussed in the October 7, 2009 Federal Register. Refer 
to the October 7, 2009 Federal Register document 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, along with the risk assessment completed 
on this petition request in support of this action. The risk assessment 
completed for this petition request can be found at http://
www.regulations.gov in document ``Human Health Risk Assessment for 
Quinclorac New Use on Pasture/Rangeland'' in docket ID number EPA-HQ-
OPP-2008-0937.
    Therefore, based on the risk assessment discussed in the final rule 
published in the Federal Register of October 7, 2009, and the risk 
assessment completed in support of this petition request, 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 quinclorac residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods utilizing gas chromatography with 
electron capture detection (GC/ECD), are available to enforce the 
tolerance expression on plant (BASF Mehod A8902, Master Record 
Identification Number (MRID) 41063537) and livestock commodities (BASF 
Method 268/1, MRID 41063536), and the limit of quantitation (LOQ) for 
quinclorac is 0.05 ppm by these methods. Both methods have undergone 
successful agency method validation trials and have been submitted to 
the Food and Drug Administration (FDA) for publication in PAM II as the 
tolerance enforcement methods. Furthermore, the available FDA multi-
residue method (MRM) testing data indicate that quinclorac is 
completely recovered using Method 402 in PAM, Vol. 1.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) established for quinclorac on grass, forage and grass, hay.

C. Revisions to Petitioned-For Tolerances

    Review of available field trial data indicate that the proposed 
tolerances for grass, forage at 105 ppm and grass, hay at 70 ppm are 
too low; tolerances of 150 ppm and 130 ppm, respectively, are 
appropriate based on the results of analysis of the field trial data 
using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data.

V. Conclusion

    Therefore, tolerances are established for residues of quinclorac, 
3,7-dichloro-8-quinolinecarboxylic acid, in or on grass, forage at 150 
ppm and grass, hay at 130 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, 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,

[[Page 67090]]

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: December 8, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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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 180.463 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:

Sec.  180.463  Quinclorac; tolerances for residues.

     (a) * * *

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                      Commodity                        Parts per million
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                                * * * * *
Grass, forage........................................                150
Grass, hay...........................................                130
                                * * * * *
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[FR Doc. E9-30033 Filed 12-17-09; 8:45 am]

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