Document ID: EPA-HQ-OPP-2006-0323-0003
Agency: epa
Document Type: Rule
Title: Glyphosate; Pesticide Tolerance
Posted Date: 2007-05-02T04:00Z

[Federal Register: May 2, 2007 (Volume 72, Number 84)]
[Rules and Regulations]               
[Page 24188-24190]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02my07-5]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0323; FRL-8122-8]

 
Glyphosate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerance expression for glyphosate 
to include the dimethylamine (DMA) salt of glyphosate. Dow AgroScienes, 
LLC requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective May 2, 2007. Objections and 
requests for hearings must be received on or before July 2, 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-2006-0323. 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 
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 telephone number 
is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-305-5704; e-mail address: walters.vickie.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

[[Page 24189]]

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 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-2006-0323 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 July 2, 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-2006-0323, 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 
Docket telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of February 7, 2007 (72 FR 5706) (FRL-8111-
8), 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 
6F7025) by Dow AgroSciences, LLC, 9330 Zionsville Rd, Indianapolis, IN 
46268 . The petition requested that 40 CFR 180. 364 (a) be amended by 
adding glyphosate dimethylammoniun salt or dimethalamine salt of 
glyphosate (n-phosphonemethyl)glycine resulting from the application of 
glyphosate and the isopropylamine salt of glyphosate, ethanolamine salt 
of glyphosate, and the ammonium potassium salt of glyphosate. That 
notice referenced a summary of the petition prepared by Dow 
AgroSciences, LLC, the registrant, which has been placed in the public 
docket, http://www.regulations.gov. Dow requested this change to 

support registration of pesticide products containing the dimethylamine 
salt of glyphosate. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA is 
revising the tolerance expression for 40 CFR 180.364 (a) to read: 
``Tolerances are established for residues of glyphosate N-
(phosphonomethyl)glycine resulting from the application of glyphosate, 
the isoprpylamine salt of glyphosate, the ethanolamine salt of 
glyphosate, and the dimethylamine salt of glyphosate, the ammonium salt 
of glyphosate, the potassium salt of glyphosate, in or on the following 
food commodities:'' This change corrects a spelling error that occurred 
in the notice of filing and deletes glyphosate dimethylammonium salt, 
as this is another name for the dimethylamine salt of glyphosate.

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'' 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 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- revising the 
tolerance expression for 40 CFR 180.364 (a) to read: ``Tolerances are 
established for residues of glyphosate N-(phosphonomethyl)glycine 
resulting from the application of glyphosate, the isopropylamine salt 
of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine 
salt of glyphosate, the ammonium salt of glyphosate, and the potassium 
salt of glyphosate, in or on the following food commodities.'' The DMA 
salt of glyphosate dissociates to glyphosate and the dimethylamine ion. 
Because the DMA salt disassociates to glyphosate acid, as does the 
currently listed salts, no increased tolerances or risks are expected 
from the addition of the dimethylamine salt of glyphosate to the 
tolerance expression. Toxicological profile and current risk 
assessments for glyphosate are discussed in the final rule published in 
the Federal Register of December 20, 2006 (71 FR 76180) (FRL-8105-9) 
which established tolerances for residues of glyphosate in or on 
sunflower; safflower; noni; pea, dry; and vegetable, legume, group 6 
except soybean and pea, dry. Based on the risk assessments discussed in 
the notice above, 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 glyphosate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for analysis of residues 
of glyphosate in or on plant and livestock commodities. These methods 
include

[[Page 24190]]

gas liquid chromatography (GLC) (Method I in Pesticides Analytical 
Manual (PAM II; the limit of detection is 0.05 part per million (ppm)) 
and High Performance Liquid Chromatography (HPLC) with fluorometric 
detection. The HPLC procedure has undergone successful Agency 
validation, and was recommended for inclusion in PAM II. A gas 
chromatography/mass spectrometry (GC/MS) method for glyphosate crops 
has also been validated by EPA's Analytical Chemistry Laboratory (ACL).
    The HPLC and GC/MS methods 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

    Codex and Mexican maximum residue levels (MRLS) are established for 
residues of glyphosate per se and Canadian MRLs are established for the 
combined residues of glyphosate and animomethylphosphonic acid (AMPA) 
on a variety raw agricultural commodities. No international 
harmonization issues are associated with the addition of the 
dimethylamine salt of glyphosate to the tolerance expression.

V. Conclusion

    Therefore, tolerance expression for 40 CFR 180.364 (a) is revised 
to read: ``Tolerances are established for residues of glyphosate N-
(phosphonomethyl)glycine resulting from the application of glyphosate, 
the isoprpylamine salt of glyphosate, the ethanolamine salt of 
glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of 
glyphosate, and the potassium salt of glyphosate, in or on the 
following food commodities.''

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).

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: April 17, 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 180.364, paragraph (a) is amended by revising the 
introductory text to read as follows:

 Sec. 180.364  Glyphosate; tolerances for residues.

    (a) General. Tolerances are established for residues of glyphosate 
N-(phosphonomethyl)glycine resulting from the application of 
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine 
salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium 
salt of glyphosate, and the potassium salt of glyphosate in or on the 
following food commodities:
* * * * *
[FR Doc. E7-8000 Filed 5-1-07; 8:45 am]

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