
[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Rules and Regulations]
[Pages 13264-13268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04532]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0302; FRL-9377-6]


Acetochlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends inadvertent tolerances for residues of 
acetochlor in or on crop groups 15 and 16 for cereal grains by dropping 
the exclusion for rice grain and straw. Monsanto Company requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective February 27, 2013. Objections and 
requests for hearings must be received on or before April 29, 2013 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0302, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

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; email 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2012-0302 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 29, 2013. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0302, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F7996) by Monsanto Company, 1300 I St. NW., Suite 450 East, 
Washington, DC 20005. The petition requested revisions to the current 
tolerances for residues of the herbicide acetochlor, 2-chloro-2'-
methyl-6'-ethyl-N-ethoxymethylacetanilide and its metabolites 
containing either the 2-ethyl-6-methylaniline (EMA) or the 2-(1-
hydroxyethyl)-6-methyl-aniline (HEMA) moiety, at 40 CFR 180.470 for 
grain, cereal, group 15, except corn, grain sorghum, rice, and wheat, 
grain and grain, cereal, forage, fodder and straw, group 16, except 
corn, grain sorghum, rice and wheat, straw.
    Specifically the petition requested that crop groups 15 and 16 be 
amended

[[Page 13265]]

by dropping the exception for rice grain and rice straw, respectively. 
That document referenced a summary of the petition prepared by Monsanto 
Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Tolerance Level

    Monsanto sought the removal of the exception for rice and rice 
straw for the acetochlor tolerances for crop groups 15 and 16 so that 
rice crops could be rotated to fields previously treated with 
acetochlor. EPA determined that this revision to these tolerances was 
appropriate without modifying the tolerance value based upon 
translation of residue data reflecting analysis for residues of 
acetochlor and its metabolites in/on wheat and sorghum commodities 
planted after treatment with acetochlor. Residues in the wheat and 
sorghum grain were non-quantifiable, whereas finite residues that were 
below the existing crop group tolerance were reported in the straw.

IV. 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA 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 acetochlor including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with acetochlor 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.
    Acetochlor has low acute toxicity by the oral, dermal, and 
inhalation routes of exposure and is mildly irritating to the eyes. The 
results of two dermal irritation studies indicate that it is a mild to 
strong skin irritant. Acetochlor is also a strong dermal sensitizer.
    Evidence of neurotoxicity was observed in acute and subchronic 
neurotoxicity screening studies in rats, developmental toxicity studies 
in rats, and subchronic and chronic studies in dogs. In addition to the 
nervous system, the major target organs affected in subchronic and 
chronic studies in rats, dogs, and mice exposed to acetochlor are the 
liver, thyroid (secondary to liver), kidney, testes, and erythrocytes. 
Species-specific target organs include the nasal olfactory epithelium 
in rats and the lungs in mice.
    There is no evidence of increased qualitative or quantitative 
susceptibility of fetuses or offspring to acetochlor exposure in the 
developmental and reproduction toxicity studies in rats and rabbits. In 
two developmental toxicity studies in rats, fetal effects (increased 
early resorptions, post-implantation loss, and decreased fetal weight) 
occurred at doses that also resulted in maternal toxicity (mortality, 
clinical signs of toxicity, and decreased maternal body weight gain). 
In two rabbit developmental toxicity studies there were no adverse 
fetal effects at the highest doses tested (HDT) (190 milligrams/
kilograms/day (mg/kg/day) and 300 mg/kg/day); whereas maternal toxicity 
(body weight loss) was seen at 50 mg/kg/day in one study. In three 
reproduction toxicity studies in rats, offspring effects (decreased pup 
weights in the first two studies; decreased pup weights, decreased F2 
litter size at birth, and focal hyperplasia and polypoid adenomata in 
nasal epithelium of adult F1 offspring at study termination in the 
third study) occurred at the same or higher doses than those resulting 
in parental toxicity (decreased body weight or weight gain in the first 
two studies; focal hyperplasia and polypoid adenomata in nasal 
epithelium of adult F1 offspring at study termination in the third 
study). There was no evidence of reproductive toxicity observed at any 
dose tested in two of the three reproductive toxicity studies in rats. 
The third reproduction study in rats showed a decreased number of 
implantations at the HDT of 1,750 parts per million (ppm).
    EPA has determined that quantification of carcinogenic risk on a 
linear, non-threshold basis is not appropriate for the mouse tumors. 
There are acceptable mode of action data for the rat tumors (nasal 
olfactory epithelial tumors and thyroid follicular cell tumors) which 
are adequate to support a non-linear, threshold approach for assessment 
of cancer risk. The rat nasal tumors are the most sensitive effect for 
cancer risk. However, because rat nasal tumors are not the most 
sensitive chronic effect, EPA has not conducted a separate cancer-only 
risk assessment but performed a single, chronic risk assessment that 
will be protective of both non-cancer and cancer effects, including rat 
nasal tumors, thyroid tumors, and mouse tumors.
    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 Human Health 
Risk Assessment for Proposed New Use of Acetochlor on Cotton and 
Soybeans'' at page 41 in docket ID number EPA-HQ-OPP-2009-0002.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some

[[Page 13266]]

degree of risk. Thus, the Agency estimates risk in terms of the 
probability of an occurrence of the adverse effect expected in a 
lifetime. For more information on the general principles EPA uses in 
risk characterization and a complete 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 is discussed in Unit III.A of the final rule 
published in the Federal Register issue of September 16, 2009 (74 FR 
47445) (FRL-8434-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acetochlor, EPA considered exposure under the petitioned-
for tolerances as well as all existing acetochlor tolerances in 40 CFR 
180.470. EPA assessed dietary exposures from acetochlor in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for acetochlor. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, entitled ``What We Eat in America'' (NHANES/WWEIA). 
This dietary survey was conducted from 2003 to 2008. As to residue 
levels in food, EPA assumed tolerance level residues and 100 percent 
crop treated (PCT) for all commodities. Experimentally derived 
processing factors were used for cereal grain commodities. Default 
processing factors were used for all other commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used anticipated 
residues from field trial data and 100 PCT assumptions for all 
commodities. Experimentally derived processing factors were used for 
cereal grain commodities. Default processing factors were used for all 
other commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or non-linear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used and a cancer RfD is 
calculated based on an earlier non-cancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has concluded that a non-linear RfD approach is appropriate 
for assessing cancer risk to acetochlor. However, cancer-only risk 
assessment was not conducted because the chronic RfD of 0.02 mg/kg/day 
will be protective of both non-cancer and cancer effects. The chronic 
exposure assessment described in Unit IV.C.1.ii. also accurately 
estimates exposure for the purposes of assessing cancer risk.
    iv. Anticipated residue information. EPA used anticipated residues 
derived from the results of field trials in the chronic dietary 
exposure assessment.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for acetochlor in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of acetochlor. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Acetochlor parent residue exposure is generally higher and more 
widespread through surface water sources than ground water, therefore, 
the Agency generated the surface water concentrations using the PRZM 
(Pesticide Root Zone Model) and EXAMS (Exposure Analysis Modeling 
System). The estimated drinking water concentrations (EDWCs) of 
acetochlor for acute exposures are estimated to be 75 parts per billion 
(ppb) for drinking water. For chronic exposures for non-cancer 
assessments are estimated to be 4.8 ppb for drinking water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 75 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 4.8 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Acetochlor is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    The chloroacetanilides have been evaluated by the Agency and the 
Federal Insecticides, Fungicides, and Rodenticides Act (FIFRA) 
Scientific Advisory Panel (SAP) as a related group of chemicals for 
this purpose. Acetochlor is included in a Cumulative Assessment Group 
(CAG) of chloroacetanilide pesticides. Structurally related 
chloroacetanilides include acetochlor, alachlor, butachlor, 
metolachlor, and propachlor. For purposes of a cumulative risk 
assessment, it was determined that the common mechanism of toxicity 
group consists of alachlor, acetochlor, and butachlor. Butachlor is 
excluded from the group for risk assessment purposes at present because 
there are no registered uses or tolerances for this chemical in the 
United States. The group was selected based on common endpoints of:
     Nasal turbinate tumors in rats, and a known mechanism of 
toxicity for development of these tumors.
     Induction of hepatic Uridine Diphosphate-Glucuronosyl 
Transferase (UDPGT), which results in increased incidence of thyroid 
follicular cell tumors secondary to disruption of pituitary-thyroid 
homeostasis.

[[Page 13267]]

    Thyroid effects were not included in the final cumulative 
assessment of the chloroacetanilide herbicides because they were 
determined to occur at excessively toxic dose levels, and therefore 
were not considered relevant to human risk assessment. Nasal tumors 
represent the most sensitive endpoint for both compounds.
    An updated cumulative risk assessment of the chloroacetanilide 
(CAG) pesticides acetochlor and alachlor conducted in April 2007 
provides an assessment of existing and new uses of those chemicals to 
date. Based on the most recent chloroacetanilide CAG cumulative risk 
assessment, cumulative risk is not of concern. A revised quantitative 
cumulative assessment was not conducted because the proposed amended 
use would not affect the cumulative risk results. Not only is 
acetochlor a very minor contributor to chloroacetanilide cumulative 
risk when compared to alachlor, but removing the exception for rotation 
to rice will only have a minor impact on acetochlor exposure since 
finite residues on grains, including rice, are unlikely. In the residue 
data cited/translated to support this petition, non-quantifiable 
residues were reported in wheat and sorghum grains.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity database for acetochlor includes two rat and two rabbit 
developmental toxicity studies and three reproduction toxicity studies 
in rats. As discussed in Unit IV.A., there was no evidence of 
qualitative or quantitative susceptibility of fetuses or offspring to 
acetochlor exposure in any of these studies.
    3. Conclusion. EPA has determined that the FQPA SF of 10X may be 
reduced to 1X for the acetochlor acute and chronic dietary risk 
assessment. That decision is based on the following findings:
    i. The toxicity database for acetochlor is now complete. An 
immunotoxicity study has been reviewed and is acceptable/guideline. 
Immunotoxicity was not observed at the highest dose tested. The acute 
neurotoxicity (ACN) and subchronic neurotoxicity (SCN) studies have 
also been upgraded to acceptable/guideline based on acceptable positive 
control data and functional observational battery measures.
    ii. Furthermore, EPA has determined that a developmental 
neurotoxicity study is not required since:
    a. There is no evidence of increased susceptibility in the rat and 
rabbit in the prenatal and 2-generation reproduction postnatal studies.
    b. Developmental effects were observed in the presence of maternal 
effects.
    c. The effects observed in the neurotoxicity studies were only at 
high doses.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues or average residue levels 
derived from reliable field trials. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to acetochlor in drinking water. These assessments will not 
underestimate the exposure and risks posed by acetochlor.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to acetochlor will occupy <1% of the aPAD for infants <1 year old, the 
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
acetochlor from food and water will utilize 6.2% of the cPAD for 
infants <1 year old the population group receiving the greatest 
exposure. There are no residential uses for acetochlor.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Because no short-term adverse effect was identified, acetochlor is 
not expected to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Because no intermediate-term adverse effect was identified, 
acetochlor is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. The chronic RfD of 
0.02 mg/kg/day will be protective of both non-cancer and cancer 
effects, including rat nasal tumors, thyroid tumors, and mouse tumors. 
Chronic dietary risks do not exceed the Agency's level of concern.
    6. Determination of safety. Based on these risk assessments, 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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography (HPLC) method with oxidative coulometric electrochemical 
detection (OCED)) 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; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4).

[[Page 13268]]

The Codex Alimentarius is a joint United Nations Food and Agriculture 
Organization/World Health Organization food standards program, and it 
is recognized as an international food safety standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level.
    The Codex has not established a MRL for acetochlor.

VI. Conclusion

    Therefore, the acetochlor tolerances for crop groups 15 and 16 are 
amended to drop the exception for rice and rice straw, respectively.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: February 15, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.470, revise the entries ``grain, cereal, forage, fodder 
and straw, group 16, except corn, grain sorghum, rice and wheat, 
straw'' and ``grain, cereal, group 15, except corn, grain sorghum, 
rice, and wheat, grain'' in the table in paragraph (d) to read as 
follows:


Sec.  180.470  Acetochlor; tolerances for residues.

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Grain, cereal, forage, fodder and straw, group 16, except           0.3
 corn, grain sorghum, and wheat, straw....................
Grain, cereal, group 15, except corn, grain sorghum, and            0.05
 wheat, grain.............................................
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                                * * * * *
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[FR Doc. 2013-04532 Filed 2-26-13; 8:45 am]
BILLING CODE 6560-50-P


