[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17146-17151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07131]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0005; FRL-9959-90]


Acetamiprid; Pesticide Tolerances for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of acetamiprid in or on sugarcane, cane and sugarcane, 
molasses. This action is associated with the issuance of a crisis 
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on sugarcane. This regulation 
establishes maximum permissible levels for residues of acetamiprid in 
or on sugarcane, cane and sugarcane, molasses. The time-limited 
tolerances expire on December 31, 2019.

DATES: This regulation is effective April 10, 2017. Objections and 
requests for hearings must be received on or before June 9, 2017, 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-2017-0005, 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: Michael L. Goodis, 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 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
You must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2017-0005 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 June 9, 2017. 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-

[[Page 17147]]

2017-0005, 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/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is 
establishing time-limited tolerances for residues of acetamiprid, (1E)-
N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, in or 
on sugarcane, cane at 45 parts per million (ppm) and sugarcane, 
molasses at 600 ppm. These time-limited tolerances expire on December 
31, 2019.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption issued under FIFRA section 18. 
Such tolerances can be established without providing notice or period 
for public comment. EPA does not intend for its actions on FIFRA 
section 18 related time-limited tolerances to set binding precedents 
for the application of FFDCA section 408 and the safety standard to 
other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Acetamiprid on Sugarcane and FFDCA 
Tolerances

    With EPA's concurrence, the Louisiana Department of Agriculture and 
Forestry (LDAF) declared a crisis on June 17, 2016 necessitating the 
use of acetamiprid to control the West Indian canefly on sugarcane. At 
that time, LDAF stated that substantial yield losses had likely already 
occurred in sugarcane, and the West Indian canefly populations were 
moving into other crops nearby, posing significant risk to these crops 
as well.
    The state agency asserted that an emergency condition exists in 
accordance with the criteria for approval of an emergency exemption, 
and issued a crisis exemption under FIFRA section 18 to allow the use 
of acetamiprid on sugarcane for control of West Indian canefly in 
Louisiana. After having reviewed the submission, EPA concurred that an 
emergency condition exists.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of acetamiprid 
in or on sugarcane cane and sugarcane molasses. In doing so, EPA 
considered the safety standard in FFDCA section 408(b)(2), and EPA 
decided that the necessary tolerance under FFDCA section 408(l)(6) 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in FFDCA 
section 408(l)(6). Although these time-limited tolerances expire on 
December 31, 2019, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerances 
remaining in or on sugarcane cane and sugarcane molasses after that 
date will not be unlawful, provided the pesticide was applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
acetamiprid meets FIFRA' s registration requirements for use on 
sugarcane, or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
acetamiprid by a State for special local needs under FIFRA section 
24(c). Nor do these tolerances by themselves serve as the authority for 
persons in any State other than Louisiana to use this pesticide on the 
applicable crops under FIFRA section 18 absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for acetamiprid, contact 
the Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for residues of acetamiprid on sugarcane, 
cane at 45 ppm and sugarcane, molasses at 600 ppm. EPA's assessment of 
exposures and risks associated with establishing time-limited 
tolerances follows.

A. 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

[[Page 17148]]

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    The complete human health risk assessment for this action may be 
found at http://www.regulations.gov in the document ``Acetamiprid. 
Aggregate Human Health Risk Assessment for the Proposed FIFRA Section 
18 Specific Exemption Use of the Insecticide on Sugarcane in 
Louisiana'' in the docket for ID number EPA-HQ-OPP-2017-0005. 
Additionally, 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 November 6, 2015 (80 FR 
68772) (FRL-9936-12).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acetamiprid, EPA considered exposure under the time-limited 
tolerances established by this action 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. Acute effects were identified for acetamiprid. 
In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
2003-2008 National Health and Nutrition Examination Survey; What We Eat 
in America (NHANES/WWEIA). As to residue levels in food, EPA assumed 
one hundred percent crop treated (PCT), and established and proposed 
tolerance level residues except as follows for sugarcane molasses. No 
residue data were available for sugarcane molasses, and residue data 
from sweet corn stover were used as a surrogate. The Agency determined 
it appropriate to translate corn stover data to sugarcane, and the use 
patterns and maximum application rates for sweet corn and sugarcane are 
similar. The residue level of 240 ppm acetamiprid in sugarcane molasses 
and sugarcane molasses baby food was used for dietary risk assessment, 
which is less than the recommended tolerance of 600 parts per million 
(ppm). The 240 ppm level is based on the highest average field trial 
acetamiprid residue level of 20 ppm in sweet corn stover, multiplied by 
the average molasses processing factor of 12X. The average processing 
factor was derived from molasses processing data for 9 other 
pesticides, and results in a residue estimate that is more 
representative of potential levels which could occur in these 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA again used the food consumption data from the USDA's 
2003-2008 NHANES/WWEIA. Residue levels in food were included as 
explained in Unit IV.B.1.i. of this document at tolerance-level 
residues for established and proposed tolerances and 240 ppm for 
sugarcane molasses and sugarcane molasses baby food. Additionally, 100 
PCT was assumed.
    iii. Cancer. Based on the data referenced in Unit IV.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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for acetamiprid. As detailed in the previous 
section, residues were estimated for sugarcane molasses and sugarcane 
molasses baby food based upon data for sweet corn and incorporating an 
appropriate processing factor derived from processing data for 9 other 
pesticides in sugarcane. Tolerance level residues were used for the 
remainder of the commodities 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    EPA used the Food Quality Protection Act Index Reservoir Screening 
Tool and the Provisional Cranberry Model to generate 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 was used to generate groundwater EDWCs. The 
EDWCs of acetamiprid for acute exposures were estimated at 88.3 parts 
per billion (ppb) for surface water and 49.7 ppb for ground water. For 
chronic exposures (non-cancer assessment) the EDWCs were estimated at 
32.2 ppb for surface water and 45.0 ppb for ground water. To assess 
dietary exposure contribution from drinking water, the higher acute 
EDWC of 88.3 ppb was used for acute assessment and for chronic 
exposures, the higher EDWC of 45 ppb was used. These modeled EDWCs were 
directly entered into the dietary exposure model.
    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).
    Residential exposures to acetamiprid could result from the 
currently registered uses of spot-on dog treatments, application to 
mattresses, and as crack and crevice treatments. For the dog spot-on 
products, EPA determined that short- and intermediate-term residential 
exposures may occur for residential (non-professional) applicators 
through dermal and inhalation routes; and short- intermediate- and 
long-term exposures may occur post-application for adults and children 
through dermal exposures, and also through incidental oral ingestion 
for children 1-2 years old. For the mattress, crack, and crevice 
treatments, short- and intermediate-term residential handler exposure 
may occur through dermal and inhalation routes; and short- and 
intermediate-term exposures may occur post application for adults and 
children through dermal and inhalation routes, and also through 
incidental oral ingestion for children 1-2 years old. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at: https://www.epa.gov/pesticide-
science-and-assessing-pesticide-risks/standard-

[[Page 17149]]

operating-procedures-residential-pesticide.
    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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. 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 SF 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 the second generation 
of 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 that 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 toxicity 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 in rats, 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. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in exposure 
assessments (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. These assessments will not underestimate the 
exposure and risks posed by acetamiprid.

D. 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 69% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure. Typically, 
EPA does not consider residential exposures when assessing acute 
aggregate risk unless such exposures can be characterized as a series 
of single-day exposures. For acetamiprid, residential exposures are 
assessed as short- and intermediate-term exposures. Therefore, acute 
aggregate risk estimates for acetamiprid are equivalent to the acute 
dietary risk estimates which are not of concern.
    2. Chronic risk. Using the exposure assumptions described in unit 
IV. for chronic exposure, EPA has concluded that chronic exposure to 
acetamiprid from food and water will utilize 62% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Dietary exposure from food and water, considered to be a 
background exposure level, is included in aggregate exposures for all 
population groups. Based on the explanation in Unit IV.B.3., adult 
aggregate chronic exposures also include long-term post-application 
dermal exposure from contact with dogs following spot-on treatment. For 
children 1 to 2 years old, aggregate chronic exposures also include 
long-term post-application dermal and incidental oral 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 390 and 100,

[[Page 17150]]

respectively, and are above the level of concern of an MOE <100, 
indicating that risk estimates are not of concern. The chronic dietary 
exposure estimates are highly conservative, assuming tolerance-level 
residues for registered uses and 100 PCT for all commodities. 
Therefore, EPA also considers the aggregate MOEs to be conservative 
estimates.
    3. Short- and Intermediate-term risk. Acetamiprid is currently 
registered for uses that could result in short/intermediate-term 
residential exposure. Short- (1 to 30 days) and intermediate-term (1-6 
months) aggregate exposures take into account short- and intermediate-
term residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Toxicological endpoints 
and points of departure for assessing short- and intermediate-term 
risks (including oral, dermal, and inhalation routes of exposure) are 
identical for acetamiprid. Therefore, separate assessments were not 
conducted and one risk assessment addresses both of these durations. 
Using the exposure assumptions described in unit IV.B.3. for short/
intermediate-term exposures, EPA has concluded the combined short/
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 290 for adults and 110 for children. Because EPA's 
level of concern for acetamiprid is an MOE of <100, these MOEs do not 
indicate risks of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, acetamiprid is classified as ``not likely to be carcinogenic 
to humans'' and is therefore 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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression, including gas chromatography with electron 
capture detection (GC/ECD) for vegetables and non-citrus fruits, high 
performance liquid chromatography with ultraviolet detection (HPLC/UV) 
for citrus fruits only, and HPLC with tandem mass spectrometric 
detection (LC/MS/MS) for vegetables and non-citrus fruits.
    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 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 acetamiprid on sugarcane.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
acetamiprid, (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, in or on sugarcane, cane at 45 ppm and sugarcane, 
molasses at 600 ppm. These tolerances expire on December 31, 2019.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA submitted 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

[[Page 17151]]

and pests, Reporting and recordkeeping requirements.

    Dated: March 16, 2017.
Daniel J. Rosenblatt,
Acting 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 paragraph (b) to read as follows:


Sec.  [emsp14]180.578   Acetamiprid; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
acetamiprid, (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-
methylethanimidamide, in or on the specified agricultural commodities, 
resulting from use of the pesticide pursuant to FIFRA section 18 
emergency exemptions. Compliance with the tolerance levels specified 
below is to be determined by measuring only acetamiprid. The tolerances 
expire on the date specified in the table.

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date
------------------------------------------------------------------------
Sugarcane, cane...............................           45   12/31/2019
Sugarcane, molasses...........................          600   12/31/2019
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-07131 Filed 4-7-17; 8:45 am]
 BILLING CODE 6560-50-P