[Federal Register Volume 79, Number 14 (Wednesday, January 22, 2014)]
[Rules and Regulations]
[Pages 3512-3518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01183]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0829; FRL-9904-19]


Acetochlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
acetochlor in or on sugar beets and peanuts. Monsanto Company requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective January 22, 2014. Objections and 
requests for hearings must be received on or before March 24, 2014, 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-2012-0829, 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

[[Page 3513]]

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: Lois Rossi, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 305-7090; email address: RDFRNotices@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-2012-0829 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 
March 24, 2014. 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-2012-0829, 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 January 16, 2013 (78 FR 3377) (FRL-9375-
4), 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 
2F8077) by Monsanto Company, 1300 I Street NW., Suite 450 East, 
Washington DC 20005. The petition requested that 40 CFR 180.470 be 
amended by establishing 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, to be 
expressed as acetochlor equivalents, resulting from applications to 
soil or growing crops, in or on the following agricultural commodities: 
Beet, sugar, dried pulp at 0.5 parts per million (ppm); beet, sugar, 
molasses at 1.3 ppm; beet, sugar, roots at 0.3 ppm; beet, sugar, tops 
at 0.8 ppm; peanut at 0.2 ppm; peanut, hay at 6.0 ppm; and peanut, meal 
at 0.5 ppm. The petition also requested that EPA delete from 40 CFR 
180.470(d) tolerances for indirect or inadvertent residues in beet, 
sugar, root at 0.05 ppm; and beet, sugar, tops at 0.05 ppm. That 
document referenced a summary of the petition prepared by Monsanto 
Company, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
increased the proposed tolerances for peanut, hay and decreased the 
proposed tolerances for sugar beet, molasses and tops, and peanut, 
meal. The reason 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 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

[[Page 3514]]

subgroups of consumers, including infants and children.
    Acetochlor has low acute toxicity by the oral, dermal, and 
inhalation routes of exposure and is minimally irritating to the eyes. 
A dermal irritation study indicates that it is a severe 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 (190 milligrams/kilograms/day 
(mg/kg/day) and 300 mg/kg/day); whereas maternal toxicity (body weight 
loss) was seen at 190 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 highest dose tested of 216 mg/kg/day.
    There was evidence of carcinogenicity in studies conducted with 
acetochlor in rats and mice. A 23-month mouse carcinogenicity study 
showed weak evidence for increased benign lung tumors in females, and a 
78-week study showed weak evidence for increased benign lung tumors in 
males. The increases were considered equivocal, based on increases in 
benign tumors only, inconsistent dose-responses between the two 
studies, inconsistencies in the responses of males and females between 
the two studies, lack of pre-neoplastic lung lesions in the 23-month 
study (while the 78-week study showed an increase in bronchiolar 
hyperplasia), and the variable incidence of lung tumors known to occur 
in older mice.
    Two carcinogenicity studies in rats showed an increase in nasal 
epithelial tumors and thyroid follicular cell tumors. Thyroid tumor 
incidence was relatively low, and there was evidence that the tumors 
were due to disruption of thyroid-pituitary homeostasis. 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, margin of exposure (MOE), approach 
for assessment of cancer risk. The data show that, like the related 
compounds, alachlor and butachlor, tumor formation is dependent upon 
local cytotoxicity secondary to oxidative damage by a reactive quinone 
imine intermediate. The mechanistic data on nasal tumorigenesis of 
acetochlor in the rat, when considered together with the mutagenicity 
data on acetochlor and consistent findings in mechanistic and 
mutagenicity studies on the closely related compound alachlor, are 
considered adequate to demonstrate a cytotoxic, non-mutagenic mode of 
tumor induction.
    Because a clear mode of action was demonstrated for the rat tumors, 
EPA based the cancer classification on the data from the mouse. Given 
the weakness of these data (benign lung tumors in male and female mice 
and histiocytic sarcomas in female mice), EPA has classified acetochlor 
as having ``Suggestive Evidence of Carcinogenic Potential'' and 
determined that linear quantification of carcinogenic potential would 
not be appropriate for the mouse tumors. The rat nasal tumors, with a 
point of departure (POD) of 10 mg/kg/day, are the most sensitive effect 
for cancer risk. The chronic population adjusted dose (cPAD), based on 
the no observed adverse effect level (NOAEL) of 2.0 mg/kg/day from the 
chronic dog study, 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 NOAEL and the 
lowest observed adverse effect level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document Acetochlor Human 
Health Risk Assessment for Proposed New Uses of Acetochlor on Sugar 
Beet and Peanut at pages 41-53 in docket ID number EPA-HQ-OPP-2012-
0829.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological 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 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 shown in Table 1. of this unit.

[[Page 3515]]



  Table 1--Summary of Toxicological Doses and Endpoints for Acetochlor for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, for risk    Study and toxicological effects
                                      safety factors          assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  NOAEL = 150 mg/kg/    Acute RfD = 1.5 mg/  Acute oral neurotoxicity in rats
                                    day.                  kg/day.              (MRID 45357501)
                                   UFA = 10x...........  aPAD = 1.5 mg/kg/    LOAEL = 500 mg/kg/day based on
                                   UFH = 10x...........   day.                 decreased motor activity in
                                   FQPA SF = 1x........                        females.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 2.0 mg/kg/day  Chronic RfD = 0.02   Chronic oral toxicity in beagle
                                   UFA = 10x...........   mg/kg/day.           dogs (MRID 41565118)
                                   UFH = 10x...........  cPAD = 0.02 mg/kg/   LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 increased salivation and
                                                                               histopathology in the testes,
                                                                               kidney, and liver.
----------------------------------------------------------------------------------------------------------------
Cancer (all routes)..............  ``Suggestive Evidence of Carcinogenic Potential''. The cRfD of 0.02 mg/kg/day
                                              will be protective of both non-cancer and cancer effects
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. mg/kg/day =
  milligram/kilogram/day. NOAEL= no observed adverse effect level. PAD = population adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

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 U.S. Department of Agriculture's 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA assumed 
tolerance level residues and 100 percent crop treated (PCT) for all 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture's NHANES/WWEIA. As to residue levels in food, EPA 
assumed anticipated residues from field trial data and 100 PCT for all 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A.; based on 
the results of carcinogenicity studies in rats and mice, EPA classified 
acetochlor as having ``Suggestive Evidence of Carcinogenic Potential'' 
but determined that the chronic risk assessment will be protective of 
both non-cancer and cancer effects. Therefore, a separate exposure 
assessment to evaluate cancer risk is unnecessary.
    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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of acetochlor 
for acute exposures are estimated to be 74.9 parts per billion (ppb) 
for surface water and 129.0 ppb for ground water. EDWCs of acetochlor 
for chronic exposures for non-cancer assessments are estimated to be 
4.84 ppb for surface water and 82.6 ppb for ground 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 129.0 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 82.6 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 Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific 
Advisory Panel (SAP) as a related group of chemicals for this purpose. 
Acetochlor is included in a Cumulative Assessment Group of 
chloroacetanilide pesticides. 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 
U.S. The group was selected based on common endpoints of:
    i. Nasal turbinate tumors in rats, and a known mechanism of 
toxicity for development of these tumors.
    ii. 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. Thyroid effects were not included in the final

[[Page 3516]]

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 
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 cumulative assessment group (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 adding the use on sugar 
beets and peanuts will only have a minor impact on acetochlor exposure 
since only low residues occurred on sugar beet and peanut food 
commodities.

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 FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No increase in 
susceptibility was seen in developmental toxicity studies in rats and 
rabbits or in three multi-generation reproductive toxicity studies in 
rats. Toxicity to offspring was observed at dose levels which were the 
same or greater than those causing maternal or parental toxicity. Based 
on the results of developmental and reproductive toxicity studies, 
there is no concern for increased qualitative and/or quantitative 
susceptibility of the young following exposure to acetochlor.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for acute dietary, chronic dietary, and 
dermal. That decision is based on the following findings:
    i. The toxicity database for acetochlor is complete for the purpose 
of evaluating this tolerance petition.
    ii. Evidence of neurotoxicity from exposure to acetochlor was 
observed in several oral studies. However, these effects were typically 
observed at high doses. The points of departure selected for risk 
assessment are protective of the potential neurotoxicity observed in 
the database.
    iii. There is no evidence that acetochlor results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. No increase in susceptibility was seen in developmental toxicity 
studies in rats and rabbits or in three multi-generation reproductive 
toxicity studies in rats. Toxicity to offspring was observed at dose 
levels which were the same or greater than those causing maternal or 
parental toxicity. Based on the results of developmental and 
reproductive toxicity studies, there is no concern for increased 
qualitative and/or quantitative susceptibility following exposure to 
acetochlor.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to acetochlor in 
drinking water. The acute dietary exposure analysis used tolerance 
level residues and 100 PCT. The chronic dietary exposure analysis used 
field trial residues and 100 PCT. 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 
aPAD and cPAD. 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. In examining acute aggregate risk, the only pathway 
of exposure relevant to the acute time frame is dietary exposure. 
Therefore, the acute aggregate risk is comprised of exposures to 
acetochlor residues in food and drinking water and is equivalent to the 
acute dietary risk estimates. Using the exposure assumptions discussed 
in this unit for acute exposure, the acute dietary exposure from food 
and water to acetochlor will occupy 1.6% of the aPAD for all infants (< 
1 year old), the population group receiving the greatest exposure.
    2. Chronic risk. In examining chronic aggregate risk, the only 
pathway of exposure relevant to the chronic time frame is dietary 
exposure. Therefore, the chronic aggregate risk is comprised of 
exposures to acetochlor residues in food and drinking water and is 
equivalent to the chronic dietary 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 26% of 
the cPAD for all infants (< 1 year old), the population group receiving 
the greatest exposure. There are no residential uses for acetochlor.
    3. Short- and intermediate-term aggregate risk. Short-term and 
intermediate-term aggregate exposure take into account short-term or 
intermediate-term residential exposure plus chronic exposure from food 
and water (considered to be a background exposure level). Acetochlor is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term or intermediate-term aggregate risk 
is the sum of the risk from exposure to acetochlor through food and 
water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. The Agency has 
concluded that assessments using a non-linear approach (e.g. a chronic 
RfD-based approach) will adequately protect for all chronic toxicity, 
including carcinogenicity that could result from exposure to 
acetochlor. Chronic aggregate risk estimates are below the Agency's 
level of concern, therefore, cancer risk is also below the Agency's 
level of concern.
    5. 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An Enforcement Analytical Method is available to enforce the 
proposed tolerances. The method is a high performance liquid 
chromatography/oxidative coulometric electrochemical detector (HPLC/
OCED) method and is listed as Method I in the Pesticide

[[Page 3517]]

Analytical Manual (PAM) Vol. II (Sec.  180.470).

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). 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 an MRL for acetochlor.

C. Response to Comments

    EPA received one comment from an anonymous citizen objecting to the 
presence of any pesticide residues on food. The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
pesticides should be banned on agricultural crops. However, the 
existing legal framework provided by section 408 of the FFDCA states 
that tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. This citizen's comment appears to be 
directed at the underlying statute and not EPA's implementation of it; 
the citizen has made no contention that EPA has acted in violation of 
the statutory framework.

D. Revisions to Petitioned-for Tolerances

    The requested tolerance levels for residues of acetochlor on the 
raw agricultural commodities beet, sugar, tops, and peanut, hay were 
changed as a result of the Organisation for Economic Cooperation and 
Development (OECD) Tolerance Calculation Procedures. Tolerance 
proposals for the processed commodities beet, sugar, molasses and 
peanut, meal, were changed as a result of the calculation based on the 
highest average field trial residue multiplied by the average 
processing factor.

V. Conclusion

    Therefore, tolerances are established for residues of acetochlor, 
(2-chloro-2'-methyl-6'-ethyl-N-ethoxymethylacetanilide), including its 
metabolites and degradates, on beet, sugar, dried pulp at 0.50 ppm, 
beet, sugar, molasses at 0.80 ppm, beet, sugar, roots at 0.30 ppm, 
beet, sugar, tops at 0.70 ppm, peanut at 0.20 ppm, peanut, hay at 7.0 
ppm, and peanut, meal at 0.25 ppm; and to delete from 40 CFR 180.470(d) 
tolerances for indirect or inadvertent residues in beet, sugar, root at 
0.05 ppm, and beet, sugar, tops at 0.05 ppm because they will now be 
covered under the sugar beet tolerances from direct application to the 
crop.

VI. 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).

VII. 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: January 10, 2014.
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:
0
a. Add alphabetically the commodities to the table in paragraph (a).
0
b. Remove the following commodities in the table in paragraph (d) 
``Beet, sugar, root'' and ``Beet, sugar, tops.''
    The additions read as follows:

[[Page 3518]]

Sec.  180.470  Acetochlor; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Beet, sugar, dried pulp........................                     0.50
Beet, sugar, molasses..........................                     0.80
Beet, sugar, roots.............................                     0.30
Beet, sugar, tops..............................                     0.70
 
                                * * * * *
Peanut.........................................                     0.20
Peanut, hay....................................                      7.0
Peanut, meal...................................                     0.25
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-01183 Filed 1-21-14; 8:45 am]
BILLING CODE 6560-50-P