[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8433-8441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02038]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0784; FRL-10004-12]


Acetamiprid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
acetamiprid in or on multiple commodities that are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

[[Page 8434]]


DATES: This regulation is effective February 14, 2020. Objections and 
requests for hearings must be received on or before April 14, 2020, 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-2018-0784, 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 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: 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 
Publishing 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-2018-0784 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
April 14, 2020. 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-2018-0784, 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.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 April 19, 2019 (84 FR 16430) (FRL-9991-
14), 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 
8E8715) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201W, Princeton, 
NJ 08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of acetamiprid, (1E)-N-[(6-chloro-
3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide, including its 
metabolites and degradates in or on the following raw agricultural 
commodities: Tropical and subtropical, medium to large fruit, smooth, 
inedible peel, subgroup 24B at 0.50 parts per million (ppm); leafy 
greens subgroup 4-16A at 3.0 ppm; leaf petiole vegetable subgroup 22B 
at 3.0 ppm; celtuce at 3.0 ppm; Florence fennel at 3.0 ppm; Brassica, 
leafy greens, subgroup 4-16B at 15 ppm; Vegetable, Brassica, head and 
stem, group 5-16 at 1.2 ppm; kohlrabi at 1.2 ppm; fruit, stone, group 
12-12 at 1.5 ppm; nut, tree, group 14-12 at 0.10 ppm; rapeseed subgroup 
20A at 0.01 ppm; and cottonseed subgroup 20C at 0.70 ppm.
    Additionally, the petition requested to amend 40 CFR 180.578 by 
removing the established tolerances for residues of acetamiprid in or 
on the following raw agricultural commodities: Vegetable, leafy, except 
Brassica, group 4 at 3.00 ppm; Brassica, leafy greens, subgroup 5B at 
15 ppm; turnip, greens at 15 ppm; Brassica, head and stem, subgroup 5A 
at 1.20 ppm; fruit, stone, group 12, except plum, prune at 1.20 ppm; 
plum, prune, fresh at 0.20 ppm; nut, tree, group 14 at 0.10 ppm; 
pistachio at 0.10 ppm; canola, seed at 0.010 ppm; mustard, seed at 
0.010 ppm; and cotton, undelinted seed at 0.60 ppm.
    That document referenced a summary of the petition prepared by 
Nippon Soda Co., Ltd. c/o Nisso America Inc, the registrant, which is 
available in the docket, http://www.regulations.gov. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.
    Pursuant to its authority in FFDCA section 408(d)(4)(A)(i), EPA is 
establishing tolerances that vary slightly from what the petitioner 
requested. The reasons for these changes are 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

[[Page 8435]]

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 concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    In all species tested, generalized nonspecific toxicity was 
observed as decreases in body weight/body weight gain, food 
consumption, and food efficiency. Hepatocellular hypertrophy was 
observed in both mice and rats, and hepatocellular vacuolation in the 
rat, but these liver effects alone are considered adaptive and not 
indicative of an adverse effect. Other effects observed in the oral 
studies include amyloidosis of multiple organs in the mouse 
carcinogenicity study, tremors in high dose females in the mouse 
subchronic study, and micro-concretions in the kidney papilla and 
mammary hyperplasia in the rat chronic/carcinogenicity study.
    Acetamiprid is rapidly absorbed, metabolized, and eliminated. The 
metabolism study in rats indicates 96-99% absorption following an oral 
administration. Peak blood concentrations in the rat occur within 1-2 
hours at the low dose (1 mg/kg), 3-6 hours post-dosing at the high dose 
(50 mg/kg), and the main route of excretion is through the urine, which 
is nearly complete by 48 hours for all doses. Metabolites of 
acetamiprid account for 79-86% of the administered radioactivity, with 
6-Chloronicotinic (IC-O) acid being the most abundant metabolite. There 
were no significant sex differences noted in the ADME profile in rats.
    No effects were observed in the 21-day dermal study in the rabbit 
and no inhalation studies were conducted. EPA has used a refined value 
of 10% as a dermal absorption factor based on the rat dermal absorption 
study and weight of evidence.
    Evidence of qualitative susceptibility was observed in the 2-
generation reproductive study, with the offspring effects (significant 
reductions in pup weights, reduction in litter size and viability, 
significant delays in weaning indices and the age to attain vaginal 
opening and preputial separation) considered more severe than the 
decrease in parental body weights. Qualitative susceptibility was also 
seen in the developmental neurotoxicity study (DNT) with offspring 
effects (decreased body weight, pre-weaning survival, and startle 
response) occurring in the presence of marginal parental body weight 
decreases.
    Evidence of neurotoxicity was observed in the rat acute 
neurotoxicity study (decrease in locomotor activity, and at higher 
doses: Tremors, difficulty in handling, walking on toes, dilated 
pupils, chewing, coldness to the touch, abnormal gaits and/or posture, 
decreased forelimb grip strength, and hind limb foot splay), subchronic 
toxicity study in mice (tremors), the DNT (decreased startle response), 
and comparative metabolism study (decreased alertness, reactivity, 
spontaneous activity, locomotor activity, rearing, muscle tone, and 
grip strength; as well as tremors, staggering, and depressed reflexes 
in the rat, mouse, and/or rabbit). Subchronic immunotoxicity studies 
were performed in both sexes in rats and mice, with no effects on the 
immune system observed up to the highest dose tested. Acetamiprid and 
its metabolites IC-0, IM-1-2, IM-1-4, IM-2-1, and IM-0 tested negative 
for mutagenicity. With no treatment-related tumors seen in rats or 
mice, the Agency has classified acetamiprid as not likely to be 
carcinogenic to humans.
    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 the document titled ``Acetamiprid. Human Health 
Risk Assessment for Proposed Use on Tropical and Subtropical, Medium to 
Large Fruit, Smooth, Inedible Peel Subgroup 24B; Greenhouse-grown 
Peppers; and Crop Group Conversions and Expansions'' on pages 38-43 in 
docket ID number EPA-HQ-OPP-2018-0784.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for acetamiprid used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 8436]]



    Table 1--Summary of Toxicological Doses and Endpoints for Acetamiprid for Use in FFDCA Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                   Point of departure
        Exposure/scenario           and uncertainty/      RfD, PAD, LOC for     Study and toxicological effects
                                     safety factors        risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations).  NOAEL = 10 mg/kg/day  Acute RfD = 0.1 mg/   Co-critical studies.
                                  UFA = 10X              kg/day               Developmental Neurotoxicity in
                                  UFH = 10X             aPAD = 0.1 mg/kg/day   rat.
                                  FQPA SF = 1X                                LOAEL = 45 mg/kg/day based on
                                                                               decreased early pup survival on
                                                                               PND 0-1, and decreased startle
                                                                               response on PND 20/60 in males.
                                                                              Acute Neurotoxicity Study in rat.
                                                                              LOAEL = 30 mg/kg/day based on
                                                                               decreased locomotor activity.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All              NOAEL= 7.1 mg/kg/day  Chronic RfD = 0.071   Chronic Toxicity/Carcinogenicity
 populations).                    UFA = 10X              mg/kg/day             Study in rats.
                                  UFH = 10X             cPAD = 0.071 mg/kg/   LOAEL = 17.5 mg/kg/day based on
                                  FQPA SF = 1X           day                   decreased body weight and body
                                                                               weight gains in females and
                                                                               hepatocellular vacuolation in
                                                                               males.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to  NOAEL= 10 mg/kg/day   LOC for MOE = 100     Developmental Neurotoxicity in
 30 days).                        UFA = 10X                                    rat.
                                  UFH = 10X                                   LOAEL = 45 mg/kg/day based on
                                  FQPA SF = 1X                                 decreased body weight and body
                                                                               weight gains in offspring,
                                                                               decreased early pup survival on
                                                                               PND 0-1, and decreased startle
                                                                               response on PND 20/60 in males.
----------------------------------------------------------------------------------------------------------------
Incidental oral long-term         NOAEL= 7.1 mg/kg/day  LOC for MOE = 100     Chronic Toxicity/Carcinogenicity
 (greater than 6 months).         UFA= 10X                                     Study in rats.
                                  UFH= 10X                                    LOAEL = 17.5 mg/kg/day based on
                                  FQPA SF = 1X                                 decreased body weight and body
                                                                               weight gains in females and
                                                                               hepatocellular vacuolation in
                                                                               males.
----------------------------------------------------------------------------------------------------------------
Dermal short- and intermediate-   Oral study NOAEL =    LOC for MOE = 100     Developmental Neurotoxicity in
 term (1 to 30 days; 1 to 6        10 mg/kg/day                                rat.
 months).                         UFA = 10X                                   LOAEL = 45 mg/kg/day based on
                                  UFH = 10X                                    decreased body weight and body
                                  DAF = 10%                                    weight gains in offspring,
                                  FQPA SF = 1X                                 decreased early pup survival on
                                                                               PND 0-1, and decreased startle
                                                                               response on PND 20/60 in males.
----------------------------------------------------------------------------------------------------------------
Dermal long-term (greater than 6  Dermal (or oral)      LOC for MOE = 100     Chronic Toxicity/Carcinogenicity
 months).                          study NOAEL = 7.1                           Study in rats.
                                   mg/kg/day                                  LOAEL = 17.5 mg/kg/day based on
                                  UFA = 10X                                    decreased body weight and body
                                  UFH = 10X                                    weight gains in females and
                                  DAF = 10%                                    hepatocellular vacuolation in
                                  FQPA SF = 1X                                 males.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30    Oral study NOAEL =    LOC for MOE = 100     Developmental Neurotoxicity in
 days).                            10 mg/kg/day                                rat.
                                   Inhalation toxicity                        LOAEL = 45 mg/kg/day based on
                                   assumed to be                               decreased body weight and body
                                   equivalent to oral                          weight gains in offspring,
                                   toxicity                                    decreased early pup survival on
                                  UFA = 10X                                    PND 0-1, and decreased startle
                                  UFH = 10X                                    response on PND 20/60 in males.
                                  FQPA SF = 1X
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal,                      Classification: ``Not likely to be carcinogenic to humans''.
 inhalation).
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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). DAF = Dermal Absorption Factor.

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 food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 National Health and

[[Page 8437]]

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, the acute dietary exposure assessment was 
unrefined and used tolerance-level residues and 100 percent crop 
treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, the chronic dietary 
exposure assessment was slightly refined using PCT information for some 
commodities. Aside from these commodities, the analyses were based on 
tolerance-level residues and the assumption of 100 PCT. In addition, 
conservative default processing factors were used for many processed 
commodities, while empirical processing factors were used for a limited 
number of processed commodities.
    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. Section 408(b)(2)(F) 
of FFDCA states that the Agency may use data on the actual percent of 
food treated for assessing chronic dietary risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area and the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    In the acute assessment, 100 PCT was assumed for all commodities.
    In the chronic assessment, the PCT estimates used were as follows: 
1% of almonds, 30% of apples, 10% of apricots, 5% of asparagus, 10% of 
blueberries, 5% of broccoli, 10% of cabbage, 5% of caneberries, 15% of 
cantaloupes, 10% of cauliflower, 40% of celery, 5% of cherries, 5% of 
cotton, 2.5% of cucumbers, 2.5% of grapefruit, 2.5% of grapes, 2.5% of 
lemons, 15% of lettuce, 1% of nectarines, 2.5% of onions, 2.5% of 
oranges, 5% of peaches, 35% of pears, 1% of pecans, 5% of peppers, 5% 
of pistachios, 2.5% plums/prunes, 2.5% of potatoes, 5% of pumpkins, 10% 
of spinach, 5% of squash, 30% of strawberries, 1% of sweet corn, 5% of 
tomatoes, 15% of walnuts, and 5% of watermelons.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which acetamiprid may be applied in a particular area.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC) and Provisional 
Cranberry Model, the estimated drinking water concentrations (EDWCs) of 
acetamiprid for acute exposures are estimated to be 88.1 parts per 
billion (ppb) in surface water and 211 ppb in ground water, and for 
chronic exposures are estimated to be 12.7 ppb in surface water and 175 
ppb in ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 211 ppb was used to assess 
the contribution from drinking water. For the chronic dietary risk 
assessment, the water concentration of value 175 ppb was used to assess 
the contribution from 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: Gardens and trees, spot-on pet 
treatment, fly control, indoor crack/crevice, mattresses for bed bug 
control, and animal barns. EPA assessed residential exposure using the 
following assumptions: Residential handler dermal and inhalation 
exposure are expected to occur from the use of the registered 
acetamiprid formulations on ornamentals, vegetables, and fruit trees. 
All residential handler exposures are expected to be short-term in 
duration. Residential handler dermal exposure is expected to occur from 
the registered acetamiprid spot-on product when applied to dogs. 
Inhalation exposure from spot-on products is considered to be 
negligible. Residential handler

[[Page 8438]]

dermal and inhalation exposures from applications to indoor 
environments was not assessed based on current Agency policy because 
the labels for the products that are used in indoor environments 
require personal protective equipment (PPE). Residential handler 
exposure from the fly bait use was not assessed, as exposures are 
expected to be insignificant due to incorporation of acetamiprid in the 
glue.
    There is the potential for post-application exposure for 
individuals exposed as a result of being in an environment that has 
been treated with acetamiprid. The quantitative risk assessment for 
residential post-application exposures is based on the following 
scenarios: Short-term dermal exposure to gardens (gardens, trees, 
indoor plants); short-, intermediate-, and long-term dermal and 
incidental oral exposure to the dog spot-on treatment; short-term 
dermal, inhalation, and incidental oral exposure from the indoor crack 
and crevice and bed bug mattress uses; and short-term dermal and 
incidental oral exposure from the fly bait granule use. Post-
application dermal exposures from foundation, perimeter, and spot 
treatments outdoors, along with post-application inhalation exposure, 
are considered negligible and were not assessed. Acetamiprid is also 
registered for use as a termiticide. A quantitative assessment for 
potential post-application inhalation and dermal exposure resulting 
from a commercial termiticide application in a residential setting is 
not needed, as all applications are made to the soil/foundation around/
underneath a structure. In this case, exposure to acetamiprid vapors is 
not expected. Additionally, EPA believes that inhalation and dermal 
exposure to acetamiprid from bed bug treatments (applied directly to 
the space where people are living vs. application to the foundation/
structure) would be protective of the termiticide uses of acetamiprid.
    The lifestages selected for each post-application scenario are 
based on the Agency's 2012 Residential SOPs. While not the only 
lifestage potentially exposed for these post-application scenarios, the 
lifestage that is included in the quantitative assessment, (i.e., 
Children (1 < 2 years), children (3 < 6 years), children (6 < 12 
years), adult), is health protective for the exposures and risk 
estimates for any other potentially exposed lifestage.
    Based on the proposed uses, short- and intermediate-term exposures 
are expected for the proposed use profile. Since the same endpoint and 
POD were selected for short- and intermediate-term durations, short-
term exposure and risk estimates are considered protective of potential 
intermediate-term exposure and risk.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. Evidence of qualitative 
susceptibility was observed in the 2-generation reproductive study, 
with the offspring effects (significant reductions in pup weights, 
reduction in litter size and viability, significant delays in weaning 
indices and the age to attain vaginal opening and preputial separation) 
considered more severe than the decrease in parental body weights. 
Qualitative susceptibility was also seen in the DNT with offspring 
effects (decreased body weight, pre-weaning survival, and startle 
response) occurring in the presence of marginal parental body weight 
decreases.
    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 toxicity database for acetamiprid is complete.
    ii. 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.
    iii. No quantitative or qualitative evidence of increased 
susceptibility of fetuses to in utero exposure to acetamiprid was 
observed in the developmental toxicity study in either rats or rabbits. 
Although increased qualitative susceptibility was seen in the 
reproduction toxicity and the DNT study, the degree of concern for the 
effects is low. There are clear NOAELs for the offspring effects and 
regulatory doses were selected to be protective of these effects. No 
other residual uncertainties were identified with respect to 
susceptibility. The endpoints and doses selected for acetamiprid are 
protective of adverse effects in both offspring and adults.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment was performed 
based on 100 PCT and tolerance-level residues, and the chronic dietary 
exposure assessment was slightly refined using PCT information for some 
commodities. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 
acetamiprid in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by acetamiprid.

[[Page 8439]]

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 89% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
acetamiprid from food and water will utilize 48% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure.
    Long-term aggregate risk assessments were conducted to assess risks 
for adults and children and include exposure through oral (children 
only) and dermal routes. The oral and dermal endpoints for long-term 
exposure durations are the same (decreased body weight and body weight 
gains), and therefore exposures from these pathways are aggregated. In 
accordance with the FQPA, the combined exposure from these pathways is 
added to the background dietary exposure from the chronic dietary 
exposure assessment.
    The Agency selected only the most conservative, or worst case, 
scenarios for each lifestage. For both adults and children, worst-case 
long-term scenarios reflect post-application exposure to pets treated 
with spot-on products. As the LOCs are identical for all routes of 
exposure, and since the POD for all routes of exposure is derived from 
an oral study, the long-term aggregate MOEs were calculated by adding 
the exposures and dividing the POD (7.1 mg/kg) by the sum of the 
exposures.
    EPA has concluded the combined long-term food, water, and 
residential exposures result in aggregate MOEs of 110 for children 1 to 
less than 2 years old and 360 for adults. Because EPA's level of 
concern for acetamiprid is a MOE of 100 or below, these MOEs are not of 
concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Acetamiprid is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to acetamiprid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 180 for adults, 
460 for children 6 to less than 12 years old, 340 for children 3 to 
less than 6 years old, and 130 for children 1 to less than 2 years old. 
Because EPA's level of concern for acetamiprid is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified, and 
intermediate-term exposure is expected; however, since the same 
endpoint and POD were selected for short- and intermediate-term 
durations, short-term exposure and risk estimates are considered 
protective of potential intermediate-term exposure and risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, acetamiprid is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to acetamiprid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Approved tolerance enforcement methods for acetamiprid residues in 
crops are available, including methods using gas chromatography with 
electron capture detection (GC/ECD) analysis for vegetables and non-
citrus fruits, high-performance liquid chromatography with ultraviolet 
detection (HPLC/UV) analysis for citrus fruits only, and HPLC with 
tandem mass spectrometric detection (LC/MS/MS) analysis for vegetables 
and non-citrus fruits. An approved HPLC/UV tolerance enforcement method 
for livestock matrices is available.
    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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). 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 following table summarizes the tolerances being established by 
this document and the corresponding Codex tolerances. The U.S. 
tolerance in Cottonseed subgroup 20C is harmonized with the Codex MRL 
in cotton seed. The U.S. tolerance in Fruit, stone, group 12-12 is 
harmonized with the Codex MRL in cherry, which has the highest MRL of 
the individual group 12-12 commodities with Codex MRLs. EPA is not able 
to harmonize the other tolerances with Codex MRLs because the U.S. 
tolerances are higher. Establishing a U.S. tolerance at a lower level 
to harmonize with Codex would put U.S. growers at risk of having 
violative residues despite legal use of the pesticide according to the 
label.

[[Page 8440]]



----------------------------------------------------------------------------------------------------------------
  U.S. tolerances established in this rulemaking (40 CFR Sec.                         Codex
                           180.578)                            -------------------------------------------------
---------------------------------------------------------------
                                                   Tolerance                Commodity               MRL (mg/kg)
                  Commodity                          (ppm)
----------------------------------------------------------------------------------------------------------------
Brassica, leafy greens, subgroup 4-16B........              15  Chinese broccoli................             0.4
Celtuce.......................................               3  ................................  ..............
Cottonseed subgroup 20C.......................             0.7  Cotton seed.....................             0.7
Florence, fennel, fresh leaves and stalk......               3  ................................  ..............
Fruit, stone, group 12-12.....................             1.5  Cherry..........................             1.5
                                                                Nectarine, peach................             0.7
                                                                Dried prune.....................             0.6
                                                                Plum............................             0.2
Kohlrabi......................................             1.2  ................................  ..............
Leaf petiole vegetable subgroup 22B...........               3  Celery..........................             1.5
Leafy greens subgroup 4-16A...................               3  ................................  ..............
Nut, tree, group 14-12........................             0.1  Tree nuts.......................            0.06
Rapeseed subgroup 20A.........................            0.01  ................................  ..............
Tropical and subtropical, medium to large                  0.5  ................................  ..............
 fruit, smooth, inedible peel, subgroup 24B.
Vegetable, brassica, head and stem, group 5-16             1.2  Broccoli, cauliflower...........             0.4
                                                                Cabbage.........................             0.7
----------------------------------------------------------------------------------------------------------------

C. Response to Comments

    One commenter stated that ``EPA has not fully evaluated the 
sufficiency of the submitted data at this time or whether the data 
support granting of the pesticide petitions.'' The commenter does not 
indicate what additional data might be necessary, why the commenter 
questions the sufficiency of the available data, or what about the 
Agency's findings is unsupported. Contrary to the commenter's position, 
the Agency has in fact fully evaluated all the data submitted on 
acetamiprid and determined that the toxicological and exposure 
databases on acetamiprid are complete, i.e., they do not contain any 
data gaps at this time, and dietary and residential exposure and risk 
have not been underestimated. Taking all that information into 
consideration, EPA has concluded that the tolerances for acetamiprid 
are safe.
    The other comments submitted raised more general concerns about the 
use of pesticides and questioned a separate tolerance exemption. 
Neither raise issues relevant to this tolerance rulemaking.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing some of the tolerances at different levels than 
petitioned for in order to be consistent with the Agency's rounding 
class practice, which is based on the rounding procedures of the 
Organisation for Economic Co-operation and Development. EPA corrected 
the commodity definition for Fennel, Florence, fresh leaves and stalk. 
Finally, EPA is removing the existing tolerance in Plum, prune, dried, 
because it is no longer needed with the establishment of the tolerance 
in Fruit, stone, group 12-12; although not requested in the original 
petition, the need to remove this tolerance was confirmed in subsequent 
correspondence with the petitioner.

V. Conclusion

    Therefore, tolerances are established for residues of acetamiprid 
in or on Brassica, leafy greens, subgroup 4-16B at 15 ppm; Celtuce at 3 
ppm; Cottonseed subgroup 20C at 0.7 ppm; Fennel, Florence, fresh leaves 
and stalk at 3 ppm; Fruit, stone, group 12-12 at 1.5 ppm; Kohlrabi at 
1.2 ppm; Leaf petiole vegetable subgroup 22B at 3 ppm; Leafy greens 
subgroup 4-16A at 3 ppm; Nut, tree, group 14-12 at 0.1 ppm; Rapeseed 
subgroup 20A at 0.01 ppm; Tropical and subtropical, medium to large 
fruit, smooth, inedible peel, subgroup 24B at 0.5 ppm; and Vegetable, 
brassica, head and stem, group 5-16 at 1.2 ppm.
    Additionally, the following existing tolerances are removed as 
unnecessary due to the establishment of the above tolerances: Brassica, 
head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; 
Canola, seed; Cotton, undelinted seed; Fruit, stone, group 12, except 
plum, prune; Mustard, seed; Nut, tree, group 14; Pistachio; Plum, 
prune, dried; Plum, prune, fresh; Turnip greens; and Vegetable, leafy, 
except brassica, group 4.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies 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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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 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

[[Page 8441]]

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).

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 24, 2020.
Michael Goodis,
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, amend the table in paragraph (a)(1) as follows:
0
a. Remove the entries for ``Brassica, head and stem, subgroup 5A'' and 
``Brassica, leafy greens, subgroup 5B'';
0
b. Add alphabetically the entry ``Brassica, leafy greens, subgroup 4-
16B'';
0
c. Remove the entry for ``Canola, seed'';
0
d. Add alphabetically the entries ``Celtuce'' and ``Cottonseed subgroup 
20C'';
0
e. Remove the entry for ``Cotton, undelinted seed'';
0
f. Add alphabetically the entries ``Fennel, florence, fresh leaves and 
stalk'' and ``Fruit, stone, group 12-12'';
0
g. Remove the entry for ``Fruit, stone, group 12, except plum, prune'';
0
h. Add alphabetically the entries ``Kohlrabi''; ``Leaf petiole 
vegetable subgroup 22B''; and ``Leafy greens subgroup 4-16A'';
0
i. Remove the entries for ``Mustard, seed'' and ``Nut, tree, group 
14'';
0
j. Add alphabetically the entry ``Nut, tree, group 14-12'';
0
k. Remove the entries for ``Pistachio''; ``Plum, prune, dried''; and 
``Plum, prune, fresh'';
0
l. Add alphabetically the entries ``Rapeseed subgroup 20A'' and 
``Tropical and subtropical, medium to large fruit, smooth, inedible 
peel, subgroup 24B'';
0
m. Remove the entry for ``Turnip greens'';
0
n. Add alphabetically the entry ``Vegetable, brassica, head and stem, 
group 5-16''; and
0
o. Remove the entry for ``Vegetable, leafy, except brassica, group 4''.
    The revisions and additions read as follows:


Sec.  180.578  Acetamiprid; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B......................          15
 
                                * * * * *
Celtuce.....................................................           3
 
                                * * * * *
Cottonseed subgroup 20C.....................................         0.7
Fennel, florence, fresh leaves and stalk....................           3
 
                                * * * * *
Fruit, stone, group 12-12...................................         1.5
 
                                * * * * *
Kohlrabi....................................................         1.2
Leaf petiole vegetable subgroup 22B.........................           3
Leafy greens subgroup 4-16A.................................           3
Nut, tree, group 14-12......................................         0.1
 
                                * * * * *
Rapeseed subgroup 20A.......................................        0.01
 
                                * * * * *
Tropical and subtropical, medium to large fruit, smooth,             0.5
 inedible peel, subgroup 24B................................
Vegetable, brassica, head and stem, group 5-16..............         1.2
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-02038 Filed 2-13-20; 8:45 am]
 BILLING CODE 6560-50-P


