[Federal Register Volume 74, Number 242 (Friday, December 18, 2009)]
[Rules and Regulations]
[Pages 67129-67132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30053]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0385; FRL-8408-1]


Glyphosate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a new tolerance for a plant 
commodity, and revises other tolerances for glyphosate and its 
metabolite N-acetyl-glyphosate and revises one tolerance for glyphosate 
per se. These changes are detailed in Unit II. of this document. E.I. 
DuPont de Nemours and Company 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-2008-0385. 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: Dan Kenny, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7546; 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 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-2008-0385 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

[[Page 67130]]

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-2008-0385, 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 June 13, 2008 (73 FR 33817) (FRL-8367-
3), 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 
7F7307) by E.I. DuPont de Nemours and Company, DuPont Crop Protection, 
Laurel Run Plaza, P. O. Box 80038, Wilmington, DE 19880-0038. The 
petition requested that 40 CFR 180.364 be amended by establishing 
tolerances for combined residues of the herbicide, glyphosate, N-
(phosphonomethyl)glycine and its metabolite N-acetylglyphosate (N-
acetyl-N-(phosphonomthyl)glycine) resulting from the application of 
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine 
salt of glyphosate, the ammonium salt of glyphosate, and the potassium 
salt of glyphosate to Optimum\TM\ GAT\TM\ field corn, in or on the food 
commodities field, corn, grain; field, corn, forage, aspirated grain 
fractions at levels already established alone. That notice referenced a 
summary of the petition prepared by E.I. DuPont de Nemours and Company. 
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. DuPont has 
requested a Section 3 registration under Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) for the preplant application of 
the herbicides glyphosate and pyrithiobac sodium to glyphosate tolerant 
field corn. The petitioner is also working to commercialize a 
genetically modified field corn designated as Optimum\TM\ GAT\TM\ corn. 
N-acetyl glyphosate is produced when glyphosate is applied to Optimum 
GAT corn. As a result the petitioner is requesting that the currently 
established tolerances on field corn commodities be modified 
accordingly.
    Based upon review of the data supporting the petition, EPA has 
reassigned the currently established tolerances for corn, field, grain 
at 5.0 parts per million (ppm) and corn, field, forage at 6.0 ppm in 
paragraph 40 CFR 180.364 (a)(1) to paragraph 40 CFR 180.364 (a)(2). The 
tolerance expression for paragraph (a)(2) reads ``Tolerances are 
established for the combined residues of glyphosate, N-
(phosophonomethyl)glycine and its metabolite N-acetyl-glyphosate 
(expressed as glyphosate) 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 on the food 
commodities:''. The Agency is also establishing a tolerance for corn, 
field, stover at 100 ppm and assigning it to paragraph (a)(2). The 
Agency is also changing the current commodity definition for the 
currently established grain, cereal, forage, fodder and straw, group 
16, except field corn, forage in paragraph (a)(1) to read: Grain, 
cereal, forage, fodder, and straw, group 16, except field corn, forage 
and field corn, stover. The currently established tolerance for grain, 
aspirated fractions at 310 ppm in paragraph (a)(2) will remain 
unchanged. The reasons 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 combined residues of glyphosate, N-
(phosophonomethyl)glycine and its metabolite N-acetyl-glyphosate 
(expressed as glyphosate) 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 on the food 
commodities: corn, field, forage at 6.0 ppm; corn, field, grain at 5.0 
ppm; corn, field , stover at 100 ppm; and for the combined residues 
glyphosate, phosophonomethyl)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 on the food 
commodity grain, cereal, forage, fodder, and straw, group 16, except 
field corn, forage and field corn, stover at 100 ppm. EPA's assessment 
of exposures and risks associated with establishing tolerances follows.

Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by glyphosate per se and glyphosate and 
its metabolite N-acetyl-glyphosate as well as no-observed-effect-level 
(NOEL) and the lowest-observed-adverse-effect-level (LOAEL) from the 
toxicity studies can be found in the documents in this unit.
    The toxicological profile of glyphosate per se can be found in the 
risk

[[Page 67131]]

assessments referenced in the final rule published in the Federal 
Register of December 3, 2008 (73 FR 73586) (FRL-8385-7) which 
establishes tolerances for glyphosate and its metabolite N-acetyl-
glyphosate in or on cattle, meat byproducts and various other 
commodities and in the risk assessment referred to 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 noni at 0.20 ppm and various other commodities. The toxicological 
profile for the metabolite N-acetyl-glyphosate and N-acetyl 
amionomethylphosphonic acid (N-acetyl-AMPA), one of the metabolites 
formed following oral administration of N-acetyl-glyphosate can be 
found in the same rule making documents.
    Amendment of the glyphosate corn tolerances to include N-acetyl-
glyphosate in the tolerance expression does not result in changes in 
the exposure or risk estimates reported in the previous risk 
assessments for the reasons listed in this unit and discussed in the 
Agency review entitled Glyphosate and Pyrithiobac Sodium. Amended 
Section 3 Registration to Permit the Rotation to Glyphosate-Tolerant 
Field Corn and Glyphosate-Tolerant Soybean following Application to 
Glyphosate-Tolerant Cotton and Revison of the Field Corn Tolerance 
Expression. Summary of Analytical Chemistry and Residue Data., 
available at www.regulations.gov in Docket ID number EPA-HQ-OPP-2008-
0385 and identified as document EPA-HQ-OPP-2008-0385-005.
    1. The Agency has determined that N-acetyl-glyphosate has no 
greater toxicity than glyphosate and probably is of lower toxicity.
    2. The numerical value of the currently-established tolerances for 
field corn commodities, livestock and poultry commodities, and feed 
commodities will remain unchanged.
    3. The most recent dietary analysis assumed tolerance level 
residues and 100 percent crop treated.
    4. The estimate of glyphosate in drinking water is based on a 
glyphosate use involving direct application to water at 3.75 pounds 
active ingredient per acre. Use of glyphosate on glyphosate-resistant 
corn will not result in higher levels in drinking water.
    Accordingly, based on the risk assessments and findings discussed 
in the notices referenced in this unit, EPA concludes that no harm will 
result to the general population and to infants and children from 
aggregate exposure to the combined residues of glyphosate and its 
metabolite N-acetyl-glyphosate (expressed as glyphosate).

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography (HPLC) with tandem mass spectrometery (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: [email protected].

B. International Residue Limits

    There are Codex Maximum Residue Levels (MRLS) established for 
glyphosate (sum of glyphosate and AMPA) on maize at 5 mg/kg and maize 
fodder (dry ) at 150 mg/kg. A Canadian MRL is established for 
glyphosate including the metabolite aminomethylphosphonic acid (AMPA) 
on corn at 3 mg/kg. A Mexican MRL is established for corn at 0.1 mg/kg 
for glyphosate. The glyphosate tolerances EPA is establishing in this 
action differ from the tolerance expression for the CODEX, Canadian, or 
Mexican MRLs, because of the inclusion of N-acetyl-glyphosate in the 
expression. Additionally, the EPA tolerances differ from the CODEX or 
Canadian MRLs in that the EPA tolerances do not include AMPA in the 
tolerance expression. At this time, harmonization between the U.S. 
tolerances and the CODEX, Canadian, or Mexican MRLs can not be achieved 
because the inclusion of N-acetyl-glyphosate in the EPA tolerance 
expression is necessary to support use patterns in the United States 
and because EPA has concluded that AMPA it not toxicologically 
significant and therefore, should not be included in the tolerance 
expression.

C. Response to Comments

    One commenter submitted two comments opposing the use of glyphosate 
and glyphosate resistant plants which have resulted in the increased 
use of glyphosate. The commenter also questions the effect of 
glyphosate on bee colonies. A similar comment concerning effect on bees 
was received previously and addressed in the notice published in the 
Federal Register on December 3, 2008. EPA does not regulate the effect 
of herbicide resistant plants on the environment. That function is 
handled by the United States Department of Agriculture (USDA) Animal 
and Plant Inspection Service (APHIS). The effect of herbicide resistant 
plants on the environment is not relevant to EPAs determination of 
safety of the pesticide glyphosate under section 408 of the FFDCA. The 
Agency's database on the chemical glyphosate indicates that no harm 
will result to the general population and to infants and children from 
aggregate exposure to glyphosate per se or from glyphosate and its 
metabolite N-acetyl-glyphosate as discussed in the final rules and risk 
assessments referenced in this document. The commenter did not submit 
any information to support a revision of Agency conclusions.

D. Revisions to Petitioned-For Tolerances

    Because the tolerance expression for field corn changes as a result 
of the inclusion of the metabolite N-acetyl-glyphosate into the 
expression, the Agency is deleting the currently established tolerances 
for corn, field, grain (5.0 ppm) and corn, field forage (6.0 ppm) from 
40 CFR 180.364 (a)(1) and reestablishing them in 40 CFR 180.364(a)(2) 
and establishing a tolerance for corn, field, stover at 100 ppm and 
assigning it to paragraph (a)(2). Because a separate tolerance for 
corn, field, stover is being established under paragraph (a)(2), the 
commodity definition for the currently-established grain, cereal, 
forage, fodder, and straw, group 16, except field corn, forage in 
paragraph (a)(1) is being changed to read grain, cereal, forage, fodder 
and straw, group 16, except field corn, forage and field corn, stover. 
As discussed in the final rule published in the Federal Register of 
December 3, 2008, this change to the tolerance expression for 
glyphosate as it applies to these field corn commodities will not have 
any impact on these field corn tolerances in terms of how they apply to 
glyphosate applied to non-genetically modified field corn.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
glyphosate, N-(phosophonomethyl)glycine and its metabolite N-acetyl-
glyphosate (expressed as glyphosate) 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 on the food 
commodities: Corn, field, forage at 6.0 ppm; corn, field, grain at 5.0 
ppm; corn, field , stover at 100 ppm; and for the combined residues 
glyphosate, phosophonomethyl)glycine resulting from the application of 
glyphosate, the

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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 on the food commodity grain, 
cereal, forage, fodder, and straw, group 16, except field corn, forage 
and field corn, stover at 100 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, 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]

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 is amended in paragraph (a)(1), in the table, by 
removing the commodities corn, field, forage; corn, field, grain; and 
grain, cereal, forage, fodder and straw, group 16, except field corn, 
forage; and adding the commodity grain, cereal, forage, fodder and 
straw, group 16, except field corn, forage and field corn, stover; and 
in paragraph (a)(2), in the table, by alphabetically adding the 
commodities to read as follows:


Sec.  180.364  Glyphosate; tolerance for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grain, cereal, forage, fodder and straw,                             100
 group 16, except field corn, forage and
 field corn, stover.......................
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Corn, field, forage..................................                6.0
Corn field, grain....................................                5.0
Corn, field, stover..................................                100
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-30053 Filed 12-17-09; 8:45 am]
BILLING CODE 6560-50-S