Acetamiprid; Pesticide Tolerances, 8433-8441 [2020-02038]
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Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
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 exemptions 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).
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 17, 2020.
Donna Davis,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
2. In § 180.910, revise the inert
ingredient ‘‘Propanamide, 2-hydroxy-N,
N-dimethyl- (CAS Reg. No. 35123–06–
9)’’ in the table to read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.910
Inert ingredients
Limits
*
*
*
Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No.
35123–06–9).
*
*
*
Not to exceed 50% by weight in pesticide formulation ........
*
*
*
3. In § 180.930, revise the inert
ingredient ‘‘Propanamide, 2-hydroxy-N,
■
*
Uses
*
N-dimethyl- (CAS Reg. No. 35123–06–
9)’’ in the table to read as follows:
*
*
*
*
Inert ingredients
Limits
*
*
*
Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No.
35123–06–9).
*
*
*
Not to exceed 50% by weight in pesticide formulation ........
*
*
[FR Doc. 2020–02042 Filed 2–13–20; 8:45 am]
BILLING CODE 6560–50–P
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*
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2018–0784; FRL–10004–12]
Acetamiprid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
AGENCY:
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*
Uses
*
ACTION:
*
Solvent/co-solvent.
*
Final rule.
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).
SUMMARY:
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*
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
*
*
Solvent/co-solvent.
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Federal Register / Vol. 85, No. 31 / Friday, February 14, 2020 / Rules and Regulations
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 https://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 https://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:
DATES:
I. General Information
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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 eCFR site at https://www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
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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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://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,
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Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be
amended by establishing tolerances for
residues of acetamiprid, (1E)-N-[(6chloro-3-pyridinyl)methyl]-N′-cyano-Nmethylethanimidamide, 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, https://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
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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.
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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 microconcretions 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–
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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 21day 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
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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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
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 https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for acetamiprid used for
human risk assessment is shown in
Table 1 of this unit.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACETAMIPRID FOR USE IN FFDCA HUMAN HEALTH
RISK ASSESSMENT
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (All Populations)
NOAEL = 10 mg/kg/
day
UFA = 10X
UFH = 10X
FQPA SF = 1X
Acute RfD = 0.1 mg/
kg/day
aPAD = 0.1 mg/kg/
day
Co-critical studies.
Developmental Neurotoxicity in rat.
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 populations)
NOAEL= 7.1 mg/kg/
day
UFA = 10X
UFH = 10X
FQPA SF = 1X
Chronic RfD = 0.071
mg/kg/day
cPAD = 0.071 mg/
kg/day
Chronic Toxicity/Carcinogenicity Study in rats.
LOAEL = 17.5 mg/kg/day based on decreased body weight
and body weight gains in females and hepatocellular
vacuolation in males.
Incidental oral short-term (1 to
30 days).
NOAEL= 10 mg/kg/
day
UFA = 10X
UFH = 10X
FQPA SF = 1X
LOC for MOE = 100
Developmental Neurotoxicity in rat.
LOAEL = 45 mg/kg/day based on 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 (greater than 6 months).
NOAEL= 7.1 mg/kg/
day
UFA= 10X
UFH= 10X
FQPA SF = 1X
LOC for MOE = 100
Chronic Toxicity/Carcinogenicity Study in rats.
LOAEL = 17.5 mg/kg/day based on decreased body weight
and body weight gains in females and hepatocellular
vacuolation in males.
Dermal short- and intermediateterm (1 to 30 days; 1 to 6
months).
Oral study NOAEL =
10 mg/kg/day
UFA = 10X
UFH = 10X
DAF = 10%
FQPA SF = 1X
LOC for MOE = 100
Developmental Neurotoxicity in rat.
LOAEL = 45 mg/kg/day based on 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.
Dermal long-term (greater than
6 months).
Dermal (or oral)
study NOAEL =
7.1 mg/kg/day
UFA = 10X
UFH = 10X
DAF = 10%
FQPA SF = 1X
LOC for MOE = 100
Chronic Toxicity/Carcinogenicity Study in rats.
LOAEL = 17.5 mg/kg/day based on decreased body weight
and body weight gains in females and hepatocellular
vacuolation in males.
Inhalation short-term (1 to 30
days).
Oral study NOAEL =
10 mg/kg/day Inhalation toxicity
assumed to be
equivalent to oral
toxicity
UFA = 10X
UFH = 10X
FQPA SF = 1X
LOC for MOE = 100
Developmental Neurotoxicity in rat.
LOAEL = 45 mg/kg/day based on 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.
Exposure/scenario
Cancer (Oral, dermal, inhalation).
Classification: ‘‘Not likely to be carcinogenic to humans’’.
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.
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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
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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
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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
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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
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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
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8437
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
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-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 nonoccupational, 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
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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 postapplication exposure for individuals
exposed as a result of being in an
environment that has been treated with
acetamiprid. The quantitative risk
assessment for residential postapplication 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. Postapplication dermal exposures from
foundation, perimeter, and spot
treatments outdoors, along with postapplication inhalation exposure, are
considered negligible and were not
assessed. Acetamiprid is also registered
for use as a termiticide. A quantitative
assessment for potential postapplication 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 postapplication 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, shortand intermediate-term exposures are
expected for the proposed use profile.
Since the same endpoint and POD were
selected for short- and intermediate-
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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 https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-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 https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-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
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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.
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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
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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 intermediateterm 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
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8439
using gas chromatography with electron
capture detection (GC/ECD) analysis for
vegetables and non-citrus fruits, highperformance 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.
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U.S. tolerances established in this rulemaking
(40 CFR § 180.578)
Commodity
Brassica, leafy greens, subgroup 4–16B ..................................................
Celtuce .......................................................................................................
Cottonseed subgroup 20C .........................................................................
Florence, fennel, fresh leaves and stalk ...................................................
Fruit, stone, group 12–12 ..........................................................................
15
3
0.7
3
1.5
Kohlrabi ......................................................................................................
Leaf petiole vegetable subgroup 22B ........................................................
Leafy greens subgroup 4–16A ..................................................................
Nut, tree, group 14–12 ..............................................................................
Rapeseed subgroup 20A ...........................................................................
Tropical and subtropical, medium to large fruit, smooth, inedible peel,
subgroup 24B.
Vegetable, brassica, head and stem, group 5–16 ....................................
1.2
3
3
0.1
0.01
0.5
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
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Commodity
MRL
(mg/kg)
Chinese broccoli ..............................
..........................................................
Cotton seed .....................................
..........................................................
Cherry ..............................................
Nectarine, peach .............................
Dried prune ......................................
Plum ................................................
..........................................................
Celery ..............................................
..........................................................
Tree nuts .........................................
..........................................................
..........................................................
0.4
........................
0.7
........................
1.5
0.7
0.6
0.2
........................
1.5
........................
0.06
........................
........................
Broccoli, cauliflower .........................
Cabbage ..........................................
0.4
0.7
Tolerance
(ppm)
C. Response to Comments
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Codex
1.2
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
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‘‘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
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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]
1. The authority citation for part 180
continues to read as follows:
■
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.578, amend the table in
paragraph (a)(1) as follows:
■ a. Remove the entries for ‘‘Brassica,
head and stem, subgroup 5A’’ and
‘‘Brassica, leafy greens, subgroup 5B’’;
■ b. Add alphabetically the entry
‘‘Brassica, leafy greens, subgroup 4–
16B’’;
■
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c. Remove the entry for ‘‘Canola,
seed’’;
■ d. Add alphabetically the entries
‘‘Celtuce’’ and ‘‘Cottonseed subgroup
20C’’;
■ e. Remove the entry for ‘‘Cotton,
undelinted seed’’;
■ f. Add alphabetically the entries
‘‘Fennel, florence, fresh leaves and
stalk’’ and ‘‘Fruit, stone, group 12–12’’;
■ g. Remove the entry for ‘‘Fruit, stone,
group 12, except plum, prune’’;
■ h. Add alphabetically the entries
‘‘Kohlrabi’’; ‘‘Leaf petiole vegetable
subgroup 22B’’; and ‘‘Leafy greens
subgroup 4–16A’’;
■ i. Remove the entries for ‘‘Mustard,
seed’’ and ‘‘Nut, tree, group 14’’;
■ j. Add alphabetically the entry ‘‘Nut,
tree, group 14–12’’;
■ k. Remove the entries for ‘‘Pistachio’’;
‘‘Plum, prune, dried’’; and ‘‘Plum,
prune, fresh’’;
■ l. Add alphabetically the entries
‘‘Rapeseed subgroup 20A’’ and
‘‘Tropical and subtropical, medium to
large fruit, smooth, inedible peel,
subgroup 24B’’;
■ m. Remove the entry for ‘‘Turnip
greens’’;
■ n. Add alphabetically the entry
‘‘Vegetable, brassica, head and stem,
group 5–16’’; and
■ o. Remove the entry for ‘‘Vegetable,
leafy, except brassica, group 4’’.
The revisions and additions read as
follows:
■
*
*
*
*
Tropical and subtropical, medium
to large fruit, smooth, inedible
peel, subgroup 24B .................
Vegetable, brassica, head and
stem, group 5–16 ....................
*
*
*
[EPA–HQ–OPP–2019–0129; FRL–10002–96]
Ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate];
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
when used as an inert ingredient
(stabilizer) limited to 1% (by weight) in
pesticide formulations applied to
growing crops, and raw agricultural
commodities after harvest. Syngenta
Crop Protection, LLC submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting establishment of an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of
ethylenebis(oxyethylene) bis[3-(5-tertbutyl-4-hydroxy-m-tolyl) propionate]
when used in accordance with the terms
of this exemption.
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–2019–0129, is
available at https://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
SUMMARY:
Parts per
million
*
*
*
*
Celtuce ........................................
*
*
*
*
*
Cottonseed subgroup 20C .........
Fennel, florence, fresh leaves
and stalk ..................................
*
*
*
*
*
Fruit, stone, group 12–12 ...........
*
*
*
*
*
Kohlrabi .......................................
Leaf petiole vegetable subgroup
22B ..........................................
Leafy greens subgroup 4–16A ...
Nut, tree, group 14–12 ...............
*
*
*
*
*
Rapeseed subgroup 20A ............
*
0.01
Sfmt 4700
*
*
40 CFR Part 180
*
Fmt 4700
*
*
1.2
ENVIRONMENTAL PROTECTION
AGENCY
*
*
*
*
Brassica, leafy greens, subgroup
4–16B ......................................
Frm 00069
*
*
0.5
BILLING CODE 6560–50–P
(a) * * *
(1) * * *
PO 00000
*
*
[FR Doc. 2020–02038 Filed 2–13–20; 8:45 am]
§ 180.578 Acetamiprid; tolerances for
residues.
Commodity
Parts per
million
Commodity
15
3
0.7
3
1.5
1.2
3
3
0.1
E:\FR\FM\14FER1.SGM
14FER1
]]>Agencies
[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 https://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 https://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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at https://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: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://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, https://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 https://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 https://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 https://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 https://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 https://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:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The 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
