
[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Pages 29966-29969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14581]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0384; FRL-8417-8]


Acetochlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation modifies tolerances for residues of acetochlor 
and its metabolites in or on the commodities corn, field, forage; corn, 
field, stover; and corn, pop, stover. The modifications are detailed in 
Unit II. of this document. Monsanto Company requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 24, 2009. Objections and 
requests for hearings must be received on or before August 24, 2009, 
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-2008-0384. 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: 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).
     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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents 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 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-2008-0384 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 August 24, 2009.
    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-2008-0384 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.

[[Page 29967]]

     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 33814) (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 
7F7306) by Monsanto Company (a member of the Acetochlor Registration 
Partnership (ARP), 1300 I St., NW., Suite 450 East, Washington, DC 
20005. The petition requested that 40 CFR 180.470 be amended by 
establishing tolerances for the herbicide acetochlor, (2-chloro-2'-
methyl-6'-ethyl-N-ethoxymethylacetanilide) and its metabolites 
containing either the 2-ethyl-6-methylniline (EMA) or the 2-(1-
hydroxyethyl-6-methyl-aniline (HEMA) moiety, to be expressed as 
acetochlor in or on the food commodities when present therein as a 
result of the application of acetochlor to growing crops: Corn, field, 
forage at 4.5 parts per million (ppm) and corn, field, stover at 3.0 
ppm. That notice referenced a summary of the petition prepared by 
Monsanto 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.
    Monsanto Company has requested an amendment to its registration for 
acetochlor under Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) which would modify the use pattern for post-emergence 
application by allowing application of acetochlor to corn up to 30 
inches in height. Current products are registered for post-emergence 
application up to 11 inches in height. The petitioner is requesting 
that tolerances be increased to support this use pattern.
    Based upon review of the data supporting the petition, EPA has 
determined that the proposed tolerances in this petition should remain 
in Sec.  180.470 (a) which reads: ``Tolerances are established for 
residues of acetochlor; 2-chloro-2'-methyl-6-ethyl-N-
ethoxymethylacetanilide, and its metabolites containing the ethyl 
methyl aniline (EMA) and the hydroxyethyl methyl aniline (HEMA) moiety, 
to be analyzed as acetochlor and expressed as acetochlor equivalents, 
in or on the following raw agricultural commodities.'' Also, the Agency 
has determined that available data support tolerances of 2.5 ppm for 
corn, field, stover, and that the current tolerance for corn, pop, 
stover must be increased to 2.5 ppm. The proposed numerical value for 
the tolerance on corn, field, forage remains at 4.5 ppm. 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 residues of acetochlor on corn, field, forage at 2.5 
ppm, corn, field, stover at 2.5 ppm, and corn, pop, stover at 2.5 ppm. 
EPA's assessment of exposures and risks associated with establishing 
tolerances follows.

A. 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 acetochlor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document entitled ``Acetochlor- RED Phase 2 
Revised HED Chapter of the TRED'' and is available in docket ID number 
EPA-HQ-OPP-2005-0227 identified as document 0004.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete

[[Page 29968]]

description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for acetochlor used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Acetochlor: Human Health Risk Assessment to Support the 
Proposed Uses on Sorghum and Sweet Corn and Rotational Crops of 
Nongrass Animal Feeds (Group 18), Sugar Beets, Dried Shelled Beans and 
Peas (Subgroup 6C), Sunflowers, Potatoes, Cereal Grains (Group 15), and 
Forage, Fodder, and Straw of Cereal Grains (Group 16),'' page 11 in 
Docket ID number EPA-HQ-OPP-2006-0203.

C. Exposure Assessment

    The increased tolerances proposed in this rule do not result in 
changes in the exposures or risk assessments reported in the previous 
risk assessments or in the final rule published in the Federal Register 
of May 16, 2007 (72 FR 27463) (FRL-8126-2). The changed use pattern and 
increased tolerances are only applicable to animal feed commodities and 
not human food. Currently, the available data show that acetochlor 
residues in animal feed are unlikely to result in finite amounts of 
acetochlor in animal commodities for human consumption. This will not 
change with the changed use pattern and increase in tolerance levels. 
EPA has calculated the maximum theoretical dietary burden for livestock 
based on the increased tolerances and compared those with the results 
from livestock feeding studies with acetochlor-impregnated feed. That 
comparison showed that finite residues in animal commodities for human 
consumption remain unlikely. The data supporting this conclusion are 
set forth in the Agency review entitled ``Acetochlor. Petition for 
Increased Tolerances for Field Corn Forage and Stover to Support 
Amended Use on Field Corn, Summary of Analytical Chemistry and Residue 
Data,'' available at www.regulations.gov in Docket ID number EPA-HQ-
OPP-2008-0384 and identified as document EPA-HQ-OPP-2008-0384-0003. 
Further, the changed use pattern for acetochlor will not result in 
higher estimated levels in drinking water because other registered 
acetochlor uses on corn allow greater application amounts.
    Accordingly, based on the risk assessments, and findings made in 
May 16, 2007 final rule for acetochor, 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 
acetochlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate high performance liquid chromatography with oxidative 
coulometric electrochemical detector (HPLC/OCED) method is available 
for enforcement of tolerances for acetochlor and its metabolites in 
plant commodities including corn, field, forage; corn, field, stover, 
and corn, pop, stover. This method is listed as Method I for plants in 
PAM Vol. II.

B. International Residue Limits

    There are no Codex or Canadian Maximum Residue Levels (MRLs) 
established for acetochlor on agricultural Commodities. A Mexican MRL 
is established for residues of acetochlor per se, as ``acetochlor'' in/
on corn (maize) at 0.04 ppm. The acetochlor tolerances EPA is 
establishing in this action differ from the tolerance expression for 
the Mexican MRL, because of the inclusion of the EMA and HEMA 
metabolites in the tolerance expression. At this time harmonization 
between the U.S. tolerances and Mexican MRL can not be achieved because 
of the inclusion of the EMA and HEMA metabolites in the EPA tolerance 
expression are necessary to support use patterns in the United States.

C. Response to Comments

    One commenter submitted a comment stating a general opposition to 
all genetically engineered foods. This comment is non-responsive to the 
proposed action in that Monsanto petitioned for modification of a 
tolerance for pesticide residues and not approval of a genetically 
engineered food.

D. Revisions to Petitioned-For Tolerances

    The tolerance spreadsheet in the Agency's Guidance for Setting 
Tolerances Based on Field Trial Data was utilized in determining 
appropriate tolerance levels for field corn forage and stover. The 
available data supports the proposed tolerance for field corn forage at 
4.5 ppm, but indicates that the proposed tolerance for field corn 
stover of 3.0 ppm is too high. The data support a tolerance of 2.5 ppm 
for field corn stover. The Agency previously concluded that field corn 
trial data would support tolerances on pop corn; therefore, the 
available field trial data will also support a tolerance of 2.5 ppm for 
pop corn stover. Therefore, EPA is revising these tolerances to agree 
with levels the field trial data support.

V. Conclusion

    Therefore, tolerances are established for residues of acetochlor; 
2-chloro-2'-methyl-6-ethyl-N-ethoxymethylacetanilide, and its 
metabolites containing the ethyl methyl aniline (EMA) and the 
hydroxyethyl methyl aniline (HEMA) moiety, to be analyzed as acetochlor 
and expressed as acetochlor equivalents, in or on corn, field, forage 
at 4.5 ppm; corn, field, stover at 2.5 ppm; and corn, pop, stover at 
2.5 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

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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: June 11, 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 180.470 is amended by revising the following entries in the 
table in paragraph (a) to read as follows:


Sec.  180.470  Acetochlor; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
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Corn, field, forage..................................                4.5
                                * * * * *
Corn, field, stover..................................                2.5
                                * * * * *
Corn, pop, stover....................................                2.5
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. E9-14581 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-S


