Document ID: EPA-HQ-OPP-2007-0313-0003
Agency: epa
Document Type: Rule
Title: Glufosinate-ammonium; Pesticide Tolerance
Posted Date: 2007-07-25T04:00Z

[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations]               
[Page 40763-40766]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy07-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0313; FRL-8137-4]

 
Glufosinate-ammonium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of Glufosinate-ammonium in or on pistachio. Interregional Research 
Project No. 4 requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 25, 2007. Objections and 
requests for hearings must be received on or before September 24, 2007, 
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-2007-0313. 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 web site 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

[[Page 40764]]

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: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address:madden.barbara@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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 athttp://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the 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-2007-0313 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 24, 2007.
    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-2007-0313, 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'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 
Facility Docket telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1), 
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 7E7196) 
by Interregional Research Project No. 4, 500 College Road East, Suite 
201W, Princeton, NJ 08540-6635. The petition requested that 40 CFR 
180.473 be amended by establishing a tolerance for combined residues of 
the herbicide glufosinate-ammonium and its metabolites expressed as 
butanoic acid, 2-amino-4-(hydroxymethyl phosphinyl)-, monoammonium 
salt, 2-acetamido-4-methylphosphinico-butanoic acid and 3-
methylphosphinico-propionic acid, expressed as glufosinate free acid 
equivalents, in or on pistachio at 0.1 parts per million (ppm). That 
notice referenced a summary of the petition prepared by Bayer 
CropScience LP, 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.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the FFDCA defines ``safe'' an 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 the 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. . . 
.'' These provisions were added to the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in section 408(b)(2)(D), 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 tolerance 
for combined residues of glufosinate-ammonium and its metabolites on 
pistachio at 0.10 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

[[Page 40765]]

    On May 3, 2006 the Agency published a final rule (71 FR 25942, FRL-
8060-3) establishing tolerances for combined residues of glufosinate 
ammonium, butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, 
monoammonium salt, and its metabolite, 3-methylphosphinicopropionic 
acid in or on barley hay, barley straw, buckwheat fodder, buckwheat 
forage, oat forage, oat hay, oat straw, rye forage, rye straw, 
teosinte, triticale, wheat forage, wheat hay and wheat straw at 0.40 
ppm. On September 29, 2003, the Agency published a final rule (68 FR 
55833, FRL-7327-9) establishing tolerances for combined residues of 
glufosinate ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-,monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents, in or on bushberry 
subgroup, lingonberry, juneberry and salal at 0.15 ppm, cattle, fat at 
0.40 ppm, cattle, meat at 0.15 ppm, cattle, meat byproducts at 6.0 ppm, 
cotton, gin byproducts at 15 ppm, cotton, undelinted seed at 4.0 ppm, 
egg at 0.15 ppm, goat, fat at 0.40 ppm, goat, meat at 0.15 ppm, goat, 
meat byproducts at 6.0 ppm, hog, fat at 0.40 ppm, hog, meat at 0.15 
ppm, hog, meat byproducts at 6.0 ppm, horse, fat at 0.40 ppm, horse, 
meat at 0.15 ppm, horse, meat byproducts at 6.0 ppm, milk at 0.15 ppm, 
poultry, fat at 0.15 ppm, poultry, meat at 0.15 ppm, poultry, meat 
byproducts at 0.60 ppm, sheep, fat at 0.40 ppm, sheep, meat at 0.15 
ppm, and sheep, meat byproducts at 6.0 ppm, rice, grain at 1.0 ppm, 
rice, straw at 2.0 ppm, and rice, hull at 2.0 ppm.
    When the Agency conducted the risk assessments in support of the 
2003 and 2006 tolerance actions, it assumed that glufosinate-ammonium 
residues would be present on pistachio at 0.10 ppm, equivalent to the 
previously established tolerance for the tree nut crop group. Under 
current regulations, pistachio is not included in the tree nut crop 
group; however, the residue field trial data required to establish a 
tolerance on the tree nut crop group may be relied upon to establish a 
tolerance at the same level on pistachio. Since EPA assumed 
glufosinate-ammonium residues would be present on pistachio at 0.10 ppm 
in its most recent risk assessments, establishing the pistachio 
tolerance will not change the estimated aggregate risks resulting from 
use of glufosinate ammonium, as discussed in the May 3, 2006 (71 FR 
25942, FRL-8060-3) and September 29, 2003 (68 FR 55833, FRL-7327-9) 
Federal Registers. Refer to these Federal Register documents, 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 
documents in support of this action.
    Based on the risk assessments discussed in the final rules 
published in the Federal Registers of May 3, 2006 (71 FR 25942, FRL-
8060-3) and September 29, 2003, (68 FR 55833, FRL-7327-9), 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 glufosinate-ammonium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography) 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 is an established CODEX maximum residue limit (MRL) of 0.1 
ppm for residues of glufosinate-ammonium on tree nuts, including 
pistachios, which is consistent with the U.S. tolerance being 
established for pistachio. There are no Canadian or Mexican MRLs 
established for tree nuts or pistachio.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
glufosinate-ammonium, (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents, in or on pistachio 
at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this 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 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 6, 
2000) do not apply to this rule. In addition, This 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).

[[Page 40766]]

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: July 13, 2007.
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 180.473 is amended by alphabetically adding ``pistachio'' to 
the table in paragraph (a)(1) to read as follows:

Sec.  180.473  Glufosinate-ammonium; tolerances for residues.

    (a)(1) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Pistachio                                                           0.10
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-14170 Filed 7-24-07 8:45 am]

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