[Federal Register Volume 80, Number 215 (Friday, November 6, 2015)]
[Rules and Regulations]
[Pages 68772-68778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28356]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0740; FRL-9936-12]


Acetamiprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises existing tolerances with regional 
restrictions for residues of acetamiprid in or on clover, forage and 
clover, hay. Interregional Research Project Number 4 (IR-4) requested 
this tolerance action under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective November 6, 2015. Objections and 
requests for hearings must be received on or before January 5, 2016, 
and must

[[Page 68773]]

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-2014-0740, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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-2014-0740 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 
January 5, 2016. 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-2014-0740, 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, 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.html. 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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 
4E8307) by IR-4, IR-4 Project Headquarters, 500 College Road East, 
Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR 
180.578 be amended by revising (increasing) tolerances for residues of 
the insecticide, acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-
cyano-N-methylethanimidamide, including its metabolites and degradates, 
in or on clover, forage from 0.10 to 0.3 parts per million (ppm) and 
clover, hay from 0.01 to 1.5 ppm. That document referenced a summary of 
the petition prepared by Nisso America Incorporated, 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 this comment is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the tolerance for clover, hay from what was requested. The 
reason for this change is 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 acetamiprid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with acetamiprid 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

[[Page 68774]]

concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children.
    Acetamiprid is moderately toxic in acute lethality studies via the 
oral route of exposure and is minimally toxic via the dermal and 
inhalation routes of exposure. It is not an eye or skin irritant, nor 
is it a dermal sensitizer. Acetamiprid does not appear to have specific 
target organ toxicity. Generalized toxicity was observed as decreases 
in body weight, body weight gain, food consumption and food efficiency 
in all species tested. Generalized liver effects were also observed in 
mice and rats (hepatocellular vacuolation in rats and hepatocellular 
hypertrophy in mice and rats); the effects were considered to be 
adaptive. Other effects observed in the oral studies include 
amyloidosis of multiple organs in the mouse oncogenicity study, tremors 
in high dose females in the mouse subchronic study, and 
microconcretions in the kidney papilla and mammary hyperplasia in the 
rat chronic/oncogenicity study. No effects were observed in a dermal 
toxicity study in rabbits.
    In the rat developmental study, fetal shortening of the 13th rib 
was observed in fetuses at the same dose level that produced maternal 
effects (reduced body weight and body weight gain and increased liver 
weights). In the developmental rabbit study, no developmental effects 
were observed in fetuses at doses that reduced maternal body weight and 
food consumption. In the reproduction study, decreased body weight, 
body weight gain, and food consumption were observed in parental 
animals while significant reductions in pup weights were seen in the 
offspring in both generations. Also observed were reductions in litter 
size, and viability and weaning indices among F2 offspring 
as well as significant delays in the age to attain vaginal opening and 
preputial separation. In the developmental neurotoxicity study, 
parental effects were limited to decreased body weight and body weight 
gains, while the offspring effects noted were decreased body weights 
and body weight gains, decreased pre-weaning survival, and decreased 
maximum auditory startle response. In the acute neurotoxicity study, 
male and female rats displayed decreased motor activity, tremors, 
walking and posture abnormalities, dilated pupils, coldness to the 
touch and decreased grip strength and foot splay at the highest dose 
tested (HDT). There were clinical signs (decreases auditory startle, 
tremors) noted in rats and mice in the developmental neurotoxicity 
(DNT) and subchronic mouse studies. However, no neurotoxic effects were 
seen in the subchronic neurotoxicity study in rats. No neuropathology 
was observed in the toxicology studies.
    In immunotoxicity studies performed in both sexes of rats and mice, 
no effects on the immune system were observed up to the highest dose, 
although significant reductions in body weight and body weight gain 
were noted at that dose.
    Based on acceptable carcinogenicity studies in rats and mice, EPA 
has determined that acetamiprid is ``not likely to be carcinogenic to 
humans.'' The classification is based on (1) the absence of an increase 
in the incidence of tumors in a mouse carcinogenicity study; and (2) in 
a rat chronic/carcinogenicity study, the absence of a dose-response and 
the lack of a statistically significant increase in the mammary 
adenocarcinoma incidence by pair-wise comparison of the mid- and high- 
dose groups with the controls. There was no clear evidence of a 
mutagenic effect. Acetamiprid tested positive as a clastogen in an in 
vitro study but not in an in vivo study.
    Specific information on the studies received and the nature of the 
adverse effects caused by acetamiprid 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 document, ``Subject: Acetamiprid. Human Health 
Risk Assessment. . . . .for Use of the Insecticide on Clover. . . . 
.Interval (Regional Registration)'' dated September 2, 2015 at pp. 42 
in docket ID number EPA-HQ-OPP-2014-0740.

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 the NOAEL and the LOAEL are identified. 
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 acetamiprid used for 
human risk assessment is discussed in Unit III of the final rule 
published in the Federal Register of June 19, 2013 (78 FR 36671) (FRL-
9391-2). However, in this tolerance rule, an additional new use is 
considered spot-on treatments for dogs. This newly proposed spot-on dog 
treatment to control fleas, ticks, and mosquitoes has potential for 
long-term exposure in residential indoor settings; therefore, the 
Agency selected additional endpoints and POD for the following 
exposure/scenarios: (1) Long-term (>6 months) incidental oral (hand-to-
mouth in children) and (2) Long-term (>6 months) dermal. The endpoints/
PODs selected were the same for both scenarios, based on effects 
observed in a rat chronic toxicity/oncogenicity study. In the study, at 
the LOAEL of 17.5 milligram/kilogram/day (mg/kg/day), decreased body 
weight and body weight gains were noted in females and hepatocellular 
vacuolation were noted in males. The NOAEL in the study is 7.1 mg/kg/
day. The level of concern (LOC) is 100, based on an interspecies 
uncertainty factor of 10X, an intra-species uncertainty factor of 10X, 
and an Food Quality Protection Act (FQPA) safety factor of 1X.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acetamiprid, EPA considered exposure under the petitioned-
for tolerances as well as all existing acetamiprid tolerances in 40 CFR 
180.578. EPA assessed dietary exposures from acetamiprid 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 acetamiprid. In estimating acute 
dietary exposure, EPA used the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake

[[Page 68775]]

Database (DEEM-FCID), Version 3.16. This software uses 2003-2008 food 
consumption data from the US Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 
percent crop treated (PCT) and tolerance-level residues in the 
assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used DEEM-FCID, Version 3.16 and food consumption data 
from the 2003-2008 USDA NHANES/WWEIA. As to residue levels in food, EPA 
assumed 100 PCT and tolerance-level residues in the assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that acetamiprid does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for acetamiprid. Tolerance-level residues and 100 PCT were assumed for 
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for acetamiprid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of acetamiprid. 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.
    EPA used the Food Quality Protection Act Index Reservoir Screening 
Tool (FIRST) and the Provisional Cranberry Model to generate surface 
water Estimated Drinking Water Concentrations (EDWCs) for use in the 
human health dietary risk assessment, while the Pesticide Root Zone 
Model for Groundwater (PRZM-GW) was used to generate groundwater EDWCs. 
The EDWCs of acetamiprid for acute exposures are 88.3 parts per billion 
(ppb) for surface water and 49.7 ppb for ground water. For chronic 
exposures for non-cancer assessments are estimated to be 32.2 ppb for 
surface water and 45.0 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 88.3 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 45 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).
    Acetamiprid is currently registered for the following uses that 
could result in residential exposures: Controlling a wide variety of 
indoor and outdoor insect pests using insecticide traps, crack and 
crevice treatments, soil treatments, and sprays. There is also a 
proposal to register acetamiprid for use by homeowners and commercial 
applicators as a monthly topical spot-on product for dogs only (not 
cats) to provide continuous protection against fleas, ticks, and 
mosquitoes. Residential exposure from proposed dog spot-on product is 
anticipated to result in dermal exposures for adult handlers. In 
addition, residential post-application dermal exposures are expected 
for adults and children 1 to 2 years old, and incidental oral exposures 
for children 1 to 2 years old. Inhalation exposure from the use of the 
spot-on product is considered negligible. Therefore, only dermal and 
incidental oral exposure were assessed for the proposed product.
    Residential post-application exposures are expected to be short- (1 
to 30 days), intermediate- (1 to 6 months) for the indoor treatments, 
and long-term (greater than 6 months) in duration from pet spot-on 
products. Residential handler exposure is assumed to be short-term due 
to the intermittent nature of homeowner spot-on applications (once-
monthly treatment).
    EPA assessed all these uses and conducted an aggregate residential 
exposure using the following assumptions:
    Residential handler exposures: The Agency used short-term and 
intermediate-term dermal and inhalation exposure estimates to adult 
applicators from applications to mattresses, cracks and crevices in the 
aggregate risk assessment.
    Post-application exposures: The Agency used short-term and 
intermediate-term dermal and inhalation exposure estimates to adults 
and children 1 to 2 years old from indoor applications (mattress 
treatment and crack and crevice treatments) and long-term dermal 
exposure estimates to adults and children 1 to 2 years old from contact 
with spot-on treated pets. In addition, the Agency used short-term and 
intermediate-term hand-to-mouth exposure estimates to children 1-2 
years old from indoor applications and long-term hand-to-mouth exposure 
estimates from contact with spot-on treated pets.
    EPA combines risk values resulting from separate routes of exposure 
when it is likely they can occur simultaneously based on the use 
pattern and the behavior associated with the exposed population, and if 
the hazard associated with the PODs is similar across routes. 
Residential post-application inhalation exposure is expected to be 
negligible from the proposed spot-on product; therefore, a quantitative 
assessment was not performed.
    For children 1 to 2 years old, post-application dermal and 
incidental oral (hand-to-mouth) exposures were combined for short-, 
intermediate-, and long-term durations.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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.''
    EPA has not found acetamiprid to share a common mechanism of 
toxicity with any other substances, and acetamiprid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
acetamiprid does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

[[Page 68776]]

and children. This additional margin of safety is commonly referred to 
as the Food Quality Protection Act Safety Factor (FQPA 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. The pre- and post-natal 
toxicity databases for acetamiprid include developmental toxicity 
studies in the rat and rabbit, developmental neurotoxicity (DNT) study 
in rats and a 2-generation reproduction toxicity study in rats. There 
was no evidence of increased quantitative or qualitative susceptibility 
of rat or rabbit fetuses following in utero exposure to acetamiprid in 
the developmental toxicity studies. In the DNT and 2-generation 
reproduction studies there was no evidence of quantitative increased 
susceptibility observed. However, there was evidence of increased 
qualitative susceptibility of rat pups seen in the studies. In the DNT 
study in rats, although both maternal and offspring effects were seen 
at the same dose level, offspring animals were more severely affected. 
Decreased pre-weaning survival, and decreased maximum auditory startle 
response were observed in the presence of limited maternal toxicity 
(body weight effects). In the 2-generation reproduction study, effects 
observed were a decrease in mean body weight, body weight gain, and 
food consumption in the parental animals, and significant reductions in 
body weights in pups (both generations). Also, reduction in litter size 
and viability and weaning indices were seen among F2 
offspring, as well as significant delays in the age to attain vaginal 
opening and preputial separation. These offspring adverse effects were 
more severe than the parental effects.
    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. That decision is based on the following 
findings:
    i. The toxicology database for acetamiprid is complete.
    ii. Although there was evidence of increased qualitative 
susceptibility of the young in the DNT and 2-generation reproduction 
studies, there are clear NOAELs identified for the effects observed in 
the toxicity studies. Also, there was no evidence of increased 
quantitative or qualitative susceptibility of rat or rabbit fetuses in 
the developmental toxicity studies.
    iii. Acetamiprid produced signs of neurotoxicity in the high dose 
groups in the acute and developmental neurotoxicity studies in rats and 
the subchronic toxicity study in mice. However, no neurotoxic findings 
were reported in the subchronic neurotoxicity study in rats. 
Additionally, there are clear NOAELs identified for the effects 
observed in the toxicity studies. The doses and endpoints selected for 
risk assessment are protective and account for all toxicological 
effects observed in the database, including neurotoxicity.
    iv. EPA has used conservative assumptions in the exposure (food, 
drinking water, and residential) assessment, including the use of 100 
PCT assumptions, tolerance-level residue values, and upper-bound 
estimates of potential exposure through drinking water. In addition, 
the residential exposure assessment was conducted such that residential 
exposure and risk will not be underestimated. The aggregate exposure 
and risk estimates considered are expected to over-estimate the actual 
exposure and risk anticipated, based on the current and proposed use 
patterns; no risk estimates of concern were identified.

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 acetamiprid will occupy 67% of the aPAD for children 1-2 years old, 
the population subgroup receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions discussed in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
acetamiprid from food and water will utilize 61% of the cPAD for 
children 1-2 years old, the population subgroup receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., adult aggregate 
exposures reflect background exposure from food and water, plus long-
term post-application dermal exposure from contact with dogs following 
spot-on treatment. For children 1-2 years old, long-term aggregate 
assessment reflects post-application dermal and hand-to-mouth 
(incidental) exposures from contact with spot-on treated dogs. The 
chronic dietary exposure and post-application pet spot-on residential 
exposure were aggregated and compared to the long-term POD. Adult and 
children long-term aggregate MOEs were 570 and 100, respectively, are 
>=100, and indicate that risk estimates are not of concern. The chronic 
dietary exposure estimates are highly conservative, assuming tolerance-
level residues and 100 PCT for all commodities. Therefore, EPA also 
considers the aggregate MOEs to be conservative estimates.
    3. Short- and Intermediate-term risk. Short-term and intermediate 
aggregate exposure take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Acetamiprid is 
currently registered for uses that could result in short- and 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with short- and intermediate- term residential exposures to 
acetamiprid. Toxicological endpoints and POD for assessing short- and 
intermediate-term risks associated with exposure to acetamiprid are 
identical. Therefore, separate assessments are not being conducted for 
these durations. Using the exposure assumptions described in this unit 
for short- and intermediate-term exposures which represent the combined 
short- and intermediate-term food, water, and residential exposures 
aggregate. Additionally, for adults, reflect dermal and inhalation 
exposures from applications to mattresses, cracks and crevices, and for 
children 1-2 years old short- and intermediate- term aggregate 
assessment reflects dermal, inhalation, and hand-to-mouth exposures 
from post-application exposures following indoor applications.
    EPA concluded the combined short- and intermediate-term food, 
water, and residential exposures result in aggregate MOEs of 300 for 
adults and 110 for children. Both short- and intermediate- term 
aggregate MOEs are >=100, and indicate that risks are not of concern. 
The chronic dietary exposure estimates are highly conservative, 
assuming tolerance-level residues and 100 PCT for all commodities. 
Therefore, EPA also considers the aggregate MOEs to be conservative 
estimates.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two

[[Page 68777]]

adequate rodent carcinogenicity studies, acetamiprid is classified as 
``not likely to be carcinogenic to human'' and not expected to pose a 
cancer risk to humans.
    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 acetamiprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression including; (1) gas chromatography with electron 
capture detection (GC/ECD) and (2) high-performance liquid 
chromotography (HPLC) with tandem mass spectrometric detection liquid 
chromotography/mass spectrometry/mass spectrometry (LC/MS/MS).
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 MRLs for acetamiprid in or on clover, 
forage or clover, hay.

C. Response to Comments

    One comment expressed concern generally for pesticide residues 
remaining on harvested food crops and potential human health concerns. 
The commenter further states that ``it is the responsibility of our 
government to protect American consumers for being harmed by the food 
they eat and that this action is a step in the right direction for 
establishing a safer, healthier food system . . . .'' The Agency agrees 
with these comments.

D. Revisions to Petitioned-For Tolerances

    Available and relevant field trial data support a clover tolerance 
of 2.0 ppm, instead of the proposed tolerance of 1.5 ppm, in clover 
hay. The petitioner used residues in clover hay from all field trials 
which included pre-harvest intervals (PHIs) ranging from 27 to 63 days 
to calculate the proposed 1.5 ppm tolerance level. Since the proposed 
labeling stipulates a PHI of 30 days, EPA utilized only those residue 
data for clover hay collected at PHIs of 27-32 days as the input 
dataset for the Organization for Economic Cooperation and Development 
(OECD) tolerance calculation procedure, which yielded a clover hay 
tolerance level at 2.0 ppm.
    In clover forage, the recommended tolerance level includes an 
additional significant figure (0.30 ppm rather than 0.3 ppm). This is 
in order to avoid the situation where rounding of a residue result to 
the level of precision of the tolerance expression would be considered 
non-violative (such as 0.34 ppm being rounded to 0.3 ppm).

V. Conclusion

    Therefore, revised tolerances with regional restrictions are 
established for residues of the insecticide acetamiprid, (1E)-N-[(6-
chloro-3-pyridinyl)methyl]-N--cyano-N-methylethanimidamide, including 
its metabolites and degradates, in or on clover, forage at 0.30 ppm and 
clover, hay at 2.0 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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).

[[Page 68778]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 29, 2015.
Susan Lewis,
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.  180.578, revise the tolerance for commodities in the table 
in paragraph (c) to read as follows:


Sec.  180.578  Acetamiprid; tolerances for residues.

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Clover, forage..........................................            0.30
Clover, hay.............................................             2.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-28356 Filed 11-5-15; 8:45 am]
BILLING CODE 6560-50-P