Pendimethalin; Pesticide Tolerances, 6975-6981 [2018-03277]
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Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Rules and Regulations
rule may take effect, the agency
promulgating the rule must submit a
rule report, which includes a copy of
the rule, to each House of the Congress
and to the Comptroller General of the
United States. Section 804, however,
exempts from section 801 the following
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applicability; rules relating to agency
management or personnel; and rules of
agency organization, procedure, or
practice that do not substantially affect
the rights or obligations of nonagency
parties. 5 U.S.C. 804(3). Because this is
a rule of particular applicability, EPA is
not required to submit a rule report
regarding this action under section 801.
Under section 307(b)(1) of the Clean Air
Act, petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by November 20, 2017. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2)).
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart EE—New Hampshire
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Lead,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
2. In § 52.1520 paragraph (c), amend
the table by:
■ a. Adding four entries for‘‘Env-A 100’’
after the entry ‘‘Env-A 100;
Organizational Rules: Definitions’’;
■ b. Revising the entry ‘‘Env-A 1000’’;
and
■ c. Adding in numerical order an entry
‘‘Env-A 1900’’.
The revision and additions read as
follows:
■
Dated: February 6, 2018.
Alexandra Dapolito Dunn,
Regional Administrator, EPA New England.
For the reasons set forth in the
preamble, 40 CFR part 52 is amended as
follows:
§ 52.1520
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Identification of plan.
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*
(c) * * *
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EPA-APPROVED NEW HAMPSHIRE REGULATIONS
State effective
date
EPA approval date 1
Explanations
State citation
Title/subject
*
Env-A 100 ........................
*
*
Definition of ‘‘Incinerator’’
*
*
04/29/2003 02/16/2018, [Insert Federal Register citation].
Env-A 100 ........................
Definition of ‘‘Wood
Waste Burner’’.
04/29/2003
02/16/2018, [Insert Federal Register citation].
Env-A 100 ........................
Definition of ‘‘Incinerator’’
04/23/2013
Env-A 100 ........................
Definition of ‘‘Wood
Waste Burner’’.
01/14/2005
02/16/2018, [Insert Federal Register citation].
02/16/2018, [Insert Federal Register citation].
*
Env-A 1000 ......................
*
*
Control of Open Burning
*
*
05/01/2011 02/16/2018, [Insert Federal Register citation].
*
*
Approve Part Env–A 1000 ‘‘Prevention,
Abatement and Control of Open
Source Air Pollution.’’
*
Env-A 1900 ......................
*
*
Emission Standards and
Operating Practices for
Incinerators.
*
*
04/23/2013 02/16/2018, [Insert Federal Register citation].
*
*
Approve Part Env–A 1900 ‘‘Incinerators
and Wood Waste Burners.’’
*
*
*
*
*
*
Remove Part Env–A 101.59, definition of
‘‘Incinerator’’ and replace with ‘‘[reserved].’’
Remove Part Env–A 101.95, definition of
‘‘Wood Waste Burner’’ and replace with
‘‘[reserved].’’
Approve Part Env–A 101.104, definition
of ‘‘Incinerator.’’
Approve Part Env–A 101.219, definition
of ‘‘Wood Waste Burner.’’
*
*
*
1 In
order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for the particular provision.
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[FR Doc. 2018–03251 Filed 2–15–18; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
BILLING CODE 6560–50–P
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40 CFR Part 180
[EPA–HQ–OPP–2014–0247; FRL–9973–03]
Pendimethalin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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This regulation amends the
tolerances for residues of pendimethalin
in or on alfalfa, forage and alfalfa, hay.
BASF Corporation requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 16, 2018. Objections and
requests for hearings must be received
on or before April 17, 2018, and must
be filed in accordance with the
instructions provided in 40 CFR part
SUMMARY:
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178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0247, 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 L. Goodis, Director,
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:
ADDRESSES:
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 Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&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
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objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2014–0247 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 17, 2018. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0247, 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.
2-methyl-3,5-dinitrobenzyl alcohol, in
or on alfalfa, forage to 80 parts per
million (ppm) and alfalfa, hay to 150
ppm. That document referenced a
summary of the petition prepared by
BASF Corporation, the registrant, which
is available in the docket EPA–HQ–
OPP–2014–0397 at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 1,
2014 (79 FR 44729) (FRL–9911–67),
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 4F8245) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.361 be
amended by increasing the tolerances
for residues of the herbicide
pendimethalin, [N-(1-ethylpropyl)-3,4dimethyl-2,6-dinitrobenzenamine], and
its metabolite, 4-[(1-ethylpropyl)amino]-
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.
The target organ for pendimethalin is
the thyroid. Thyroid toxicity in chronic
and subchronic rat and mouse studies
was manifested as alterations in thyroid
hormones (decreased total T4 and T3,
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III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for pendimethalin
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with pendimethalin follows.
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increased percent of free T4 and T3),
increased thyroid weight, and
microscopic thyroid lesions (including
increased thyroid follicular cell height,
follicular cell hyperplasia, as well as
follicular cell adenomas). Due to these
effects, the Agency required that a
developmental thyroid assay be
conducted to evaluate the impact of
pendimethalin on thyroid hormones,
structure, and/or thyroid hormone
homeostasis during development. A
developmental thyroid study was
submitted and demonstrated that there
is no potential thyroid toxicity
following pre- and/or post-natal
exposure to pendimethalin.
There is no evidence that
pendimethalin is a developmental,
reproductive, neurotoxic, or
immunotoxic chemical. There is no
evidence of increased qualitative or
quantitative susceptibility in the young.
EPA classified pendimethalin as a
‘‘Group C’’, possible human carcinogen
based on a statistically significant
increased trend and pair-wise
comparison between the high-dose
group and controls for thyroid follicular
cell adenomas in male and female rats.
A non-quantitative approach (i.e., non-
linear, reference dose (RfD) approach)
was used to assess cancer risk since
mode-of-action studies are available to
demonstrate that the thyroid tumors are
due to a thyroid-pituitary imbalance,
and also since pendimethalin was
shown to be non-mutagenic in
mammalian somatic cells and germ
cells.
Specific information on the studies
received and the nature of the adverse
effects caused by pendimethalin as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in the
final rule published in the Federal
Register of December 21, 2015 (80 FR
79267) (FRL–9937–18).
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
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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 pendimethalin used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PENDIMETHALIN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (General population including infants and
children).
Chronic dietary (All populations)
Incidental oral short-term (1 to
30 days).
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Dermal short-term (1 to 30
days).
Dermal intermediate-term (1 to
6 months).
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Point of departure
and
uncertainty/safety
factors
NOAEL = 100 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 10 mg/kg/
day.
UFA = 3x
UFH = 10x
FQPA SF = 1x
NOAEL= 10 mg/kg/
day.
UFA = 3x
UFH = 10x
FQPA SF = 1x
Dermal (or oral)
study NOAEL = 10
mg/kg/day (dermal
absorption rate =
3%.
UFA = 3x
UFH = 10x
FQPA SF = 1x
Dermal (or oral)
study NOAEL = 10
mg/kg/day (dermal
absorption rate =
3%.
UFA = 3x
UFH = 10x
FQPA SF = 1x
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RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute RfD = 1 mg/
kg/day.
aPAD = 1 mg/kg/day
Acute neurotoxicity study.
LOAEL = 300 mg/kg/day based on reduced motor activity for
males and females on Day 0.
Chronic RfD = 0.3
mg/kg/day.
cPAD = 0.3 mg/kg/
day
92-Day thyroid function study in rats; 56-day thyroid study in
rats; 14-day intra thyroid metabolism study in rats.
LOAEL = 31 mg/kg/day based on hormonal and
histopathological changes in the thyroid.
LOC for MOE = 30 ..
92-Day thyroid function study in rats; 56-day thyroid study in
rats; 14-day intra thyroid metabolism study in rats.
LOAEL = 31 mg/kg/day based on hormonal and
histopathological changes in the thyroid.
LOC for MOE = 30 ..
92-Day thyroid function study in rats; 56-day thyroid study in
rats; 14-day intra thyroid metabolism study in rats.
LOAEL = 31 mg/kg/day based on hormonal and
histopathological changes in the thyroid.
LOC for MOE = 30 ..
92-Day thyroid function study in rats; 56-day thyroid study in
rats; 14-day intra thyroid metabolism study in rats.
LOAEL = 31 mg/kg/day based on hormonal and
histopathological changes in the thyroid.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PENDIMETHALIN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Inhalation short-term (1 to 30
days).
Inhalation (1 to 6 months) .........
Cancer (Oral, dermal, inhalation).
Point of departure
and
uncertainty/safety
factors
Inhalation (or oral)
study NOAEL= 10
mg/kg/day (inhalation absorption
rate = 100%).
UFA = 3x
UFH = 10x
FQPA SF = 1x
Inhalation (or oral)
study NOAEL= 10
mg/kg/day (inhalation absorption
rate = 100%).
UFA = 3x
UFH = 10x
FQPA SF = 1x
Group C, possible
human carcinogen
based on a statistically significant
increased trend
and pair-wise comparison between
the high dose
group and controls
for thyroid follicular
cell adenomas in
male and female
rats. The chronic
RfD will be protective of cancer effects.
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
LOC for MOE = 30 ..
92-Day thyroid function study in rats; 56-day thyroid study in
rats; 14-day intra thyroid metabolism study in rats.
LOAEL = 31 mg/kg/day based on hormonal and
histopathological changes in the thyroid.
LOC for MOE = 30 ..
92-Day thyroid function study in rats; 56-day thyroid study in
rats; 14-day intra thyroid metabolism study in rats.
LOAEL = 31 mg/kg/day based on hormonal and
histopathological changes in the thyroid.
FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. LOAEL = lowest 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). UFDB = to account for the
absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL =
use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pendimethalin, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing pendimethalin tolerances in 40
CFR 180.361. EPA assessed dietary
exposures from pendimethalin 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
pendimethalin. In estimating acute
dietary exposure, EPA Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM–FCID) Version 3.16. This
software uses 2003–2008 food
consumption data from the U.S.
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Department of Agriculture’s (USDA’s)
National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). As to
residue levels in food, EPA used
tolerance-level residues, and 100
percent crop treated (PCT) for all
commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEM–FCID, Version 3.16
software with 2003–2008 food
consumption data from the USDA’s
NHANES/WWEIA. As to residue levels
in food, EPA used tolerance-level
residues, and 100 PCT for all
commodities.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to pendimethalin. Cancer
risk was assessed using the same
exposure estimates as discussed in Unit
III.C.1.ii., chronic exposure.
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iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for pendimethalin. Tolerance-level
residues and 100 PCT were assumed for
all food commodities.
2. Dietary exposure from drinking
water. In drinking water, the residue of
concern is pendimethalin, parent only.
The Agency used screening-level water
exposure models in the dietary exposure
analysis and risk assessment for
pendimethalin in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of
pendimethalin. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www2.epa.gov/
pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide.
Based on the Pesticide Root Zone
Model Ground Water (PRZM GW) and
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Surface Water Concentration Calculator
(SWCC) models, the estimated drinking
water concentrations (EDWCs) of
pendimethalin for acute exposures are
estimated to be 96.4 parts per billion
(ppb) for surface water and 4.38 ×
10 9 ppb for ground water. For
chronic exposures for non-cancer
assessments, they are estimated to be
9.73 ppb for surface water.
For acute dietary risk assessment, the
water concentration value of 96.4 ppb
was used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 9.73 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Pendimethalin is currently registered
for the following uses that could result
in residential exposures: Turf, home
gardens, and ornamentals. EPA assessed
residential exposure using the following
assumptions:
• For handlers, it is assumed that
residential use will result in short-term
(1 to 30 days) duration dermal and
inhalation exposures.
• Residential post-application
exposure is also assumed to be shortterm (1–30 days) in duration, resulting
from the following exposure scenarios:
• Gardening: Adults (dermal) and
children 6 < 11 years old (dermal);
• Physical activities on turf: Adults
(dermal) and children 1–2 years old
(dermal and incidental oral);
• Mowing turf: Adults (dermal) and
children 11 < 16 years old (dermal); and
• Exposure to golf courses during
golfing: Adults (dermal), children 11 <
16 years old (dermal), and children 6 <
11 years old (dermal).
EPA did not combine exposure
resulting from adult handler and postapplication exposure resulting from
treated gardens, lawns, and/or golfing
because the conservative assumptions
and inputs within each estimated
exposure scenario would result in an
overestimate of adult exposure. EPA
selected the most conservative adult
residential scenario (adult dermal postapplication exposure from gardening) as
the contributing source of residential
exposure to be combined with the
dietary exposure for the aggregate
assessment. The children’s oral
exposure is based on post-application
hand-to-mouth exposures. To include
exposure from object-to-mouth and soil
ingestion in addition to hand-to-mouth
would overestimate the potential for
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oral exposure. However, there is the
potential for co-occurrence of dermal
and oral exposure, since the
toxicological effects from the dermal
and oral routes of exposure are the
same. As a result, the children’s
aggregate assessment combines postapplication dermal and oral exposure
along with dietary exposure from food
and water. Further information
regarding EPA standard assumptions
and generic inputs for residential
exposures may be found at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide.
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 pendimethalin to
share a common mechanism of toxicity
with any other substances, and
pendimethalin does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that pendimethalin 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.
There was no indication of pre- and/or
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Fmt 4700
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6979
post-natal qualitative or quantitative
increased susceptibility in the
developmental studies in rats and
rabbits or the 2-generation reproduction
studies in rats. A developmental thyroid
toxicity study demonstrated that there is
no potential thyroid toxicity following
pre- and/or post-natal exposure to
pendimethalin.
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
pendimethalin is complete. Although a
subchronic inhalation study was not
available in the database, EPA
determined that one is not needed at
this time based on a weight-of-evidence
analysis, considering the following: (1)
All relevant hazard and exposure
information, which indicates its low
acute inhalation toxicity; (2) its
physical/chemical properties, which
indicate its low volatility; and (3) the
use of an oral POD that results in a
residential inhalation margin of
exposure (MOE) more than 10X the
level of concern (in the case of
pendimethalin MOE = 30 based on
thyroid POD).
ii. There is no indication that
pendimethalin is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
pendimethalin results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study. In addition, a
developmental thyroid toxicity study
demonstrated that there is no potential
thyroid toxicity following pre- and/or
post-natal exposure to pendimethalin.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
pendimethalin 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 pendimethalin.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
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6980
Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Rules and Regulations
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
pendimethalin will occupy 2% of the
aPAD for all infants less than 1 year 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 pendimethalin
from food and water will utilize 2.4% of
the cPAD for children one to two years
old the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
pendimethalin is not expected.
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).
Pendimethalin 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 pendimethalin.
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 130 for adults and 92 for
children 1–2 years old, the two
population subgroups receiving the
greatest combined dietary and nondietary exposure. Because EPA’s level of
concern for pendimethalin is a MOE of
30 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; however, pendimethalin
is not registered for any use patterns
that would result in intermediate-term
residential exposure. Intermediate-term
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17:46 Feb 15, 2018
Jkt 244001
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
pendimethalin.
5. Aggregate cancer risk for U.S.
population. As discussed in Unit III.A.,
EPA has determined that an RfD
approach based on the chronic point of
departure is appropriate for evaluating
cancer risk. As there are not chronic
aggregate risks of concern, there are no
cancer aggregate risk concerns.
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
pendimethalin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
gas chromatography with electron
capture detection (GC/ECD), is available
to enforce the tolerance expression.
The method 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.
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Fmt 4700
Sfmt 4700
There are currently no established
Codex MRLs for the residues of
pendimethalin on alfalfa hay, although
Codex has established an MRL for
residues of pendimethalin in alfalfa
fodder (which is equivalent to the US
commodity of alfalfa forage) at 4 ppm.
Harmonization is not possible because
use of the Codex MRL would result in
residues of pendimethalin exceeding
tolerances in the U.S. as a result of use
in accordance with the approved label.
V. Conclusion
Therefore, tolerances are established
for plant residues by measuring only the
sum of pendimethalin, [N-(1ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine], and its metabolite,
4-[(1-ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol calculated as the
stoichiometric equivalent of
pendimethalin, in or on alfalfa, forage at
80 ppm and alfalfa, hay at 150 ppm. In
addition, the Agency is revising the
tolerance expression for paragraph (a)(1)
to clarify that the residues of the parent
compound are to be summed with the
residues of the metabolite in order to
determine compliance with the
tolerance. This revision does not
substantively change the existing
language; the current language already
requires measurement of both residues.
The insertion of the words ‘‘the sum’’
just provides a small clarification for
measuring residues to determine
compliance with the tolerance.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001); Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997); or 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
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Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / 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 tolerances in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
daltland on DSKBBV9HB2PROD with RULES
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
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17:46 Feb 15, 2018
Jkt 244001
and pests, Reporting and recordkeeping
requirements.
ACTION:
6981
Final rule.
The Environmental Protection
Agency (EPA) Region 1 announces the
deletion of the Hatheway & Patterson
Superfund Site (Site) located in
Mansfield and Foxborough,
Massachusetts, from the National
Therefore, 40 CFR chapter I is
Priorities List (NPL). The NPL,
amended as follows:
promulgated pursuant to section 105 of
PART 180—[AMENDED]
the Comprehensive Environmental
Response, Compensation, and Liability
■ 1. The authority citation for part 180
Act (CERCLA) of 1980, as amended, is
continues to read as follows:
an appendix of the National Oil and
Hazardous Substances Pollution
Authority: 21 U.S.C. 321(q), 346a and 371.
Contingency Plan (NCP). The EPA and
■ 2. In § 180.361:
the Commonwealth of Massachusetts,
■ a. Revise the introductory text of
through the Massachusetts Department
paragraph (a)(1).
of Environmental Protection (MassDEP),
■ b. Revise the entries for ‘‘Alfalfa,
have determined that all appropriate
forage’’; and ‘‘Alfalfa, hay’’ in the table
response actions under CERCLA, other
in paragraph (a)(1).
than operation and maintenance,
The revisions read as follows:
monitoring, and five-year reviews, have
been completed. However, this deletion
§ 180.361 Pendimethalin; tolerances for
residues.
does not preclude future actions under
Superfund.
(a)(1) General. Tolerances are
established for residues of the herbicide DATES: This action is effective February
pendimethalin, including its
16, 2018.
metabolites and degradates, in or on the ADDRESSES: Docket: EPA has established
commodities. Compliance with the
a docket for this action under Docket
tolerance levels specified in the
Identification No. EPA–HQ–SFUND–
following table below is to be
2002–0001. All documents in the docket
determined by measuring only the sum
are listed on the https://
of pendimethalin, [N-(1-ethylpropyl)www.regulations.gov website. Although
3,4-dimethyl-2,6-dinitrobenzenamine]
listed in the index, some information is
and its metabolite, 4-[(1not publicly available, i.e., Confidential
ethylpropyl)amino]-2-methyl-3,5Business Information or other
dinitrobenzyl alcohol, calculated as the
information whose disclosure is
stoichiometric equivalent of
restricted by statute. Certain other
pendimethalin, in or on the commodity. material, such as copyrighted material,
is not placed on the internet and will be
Parts
publicly available only in hard copy
Commodity
per
form. Publicly available docket
million
materials are available either
Alfalfa, forage ...........................
80 electronically through https://
Alfalfa, hay ................................
150 www.regulations.gov or in hard copy at
the site information repositories.
*
*
*
*
*
Locations, contacts, phone numbers and
viewing hours are:
*
*
*
*
*
U.S. EPA Region 1, Superfund
[FR Doc. 2018–03277 Filed 2–15–18; 8:45 am]
Records Center, 5 Post Office Square,
BILLING CODE 6560–50–P
Suite 100, Boston, MA 02109, Phone:
617–918–1440, Monday–Friday: 9:00
a.m.–5:00 p.m., Saturday and Sunday—
ENVIRONMENTAL PROTECTION
Closed.
AGENCY
FOR FURTHER INFORMATION CONTACT:
Kimberly White, Remedial Project
40 CFR Part 300
Manager, U.S. Environmental Protection
[EPA–HQ–SFUND–2002–0001; FRL–9974–
Agency, Region 1, OSRR07–1, Boston,
43—Region 1]
MA 02109–3912, (617) 918–1752, email:
white.kimberly@epa.gov.
National Oil and Hazardous
SUPPLEMENTARY INFORMATION: The site to
Substances Pollution Contingency
be deleted from the NPL is: Hatheway
Plan; National Priorities List: Deletion
& Patterson Superfund Site, Mansfield
of the Hatheway & Patterson
and Foxborough, Massachusetts. A
Superfund Site
notification of deletion for this Site was
AGENCY: Environmental Protection
published in the Federal Register (82
Agency.
FR 56939) on December 1, 2017.
Dated: January 30, 2018.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
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SUMMARY:
E:\FR\FM\16FER1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Rules and Regulations]
[Pages 6975-6981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03277]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0247; FRL-9973-03]
Pendimethalin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the tolerances for residues of
pendimethalin in or on alfalfa, forage and alfalfa, hay. BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 16, 2018. Objections and
requests for hearings must be received on or before April 17, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part
[[Page 6976]]
178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0247, 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 L. Goodis, Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at 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-2014-0247 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 17, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0247, 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 August 1, 2014 (79 FR 44729) (FRL-9911-
67), 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
4F8245) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.361 be amended by
increasing the tolerances for residues of the herbicide pendimethalin,
[N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its
metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl
alcohol, in or on alfalfa, forage to 80 parts per million (ppm) and
alfalfa, hay to 150 ppm. That document referenced a summary of the
petition prepared by BASF Corporation, the registrant, which is
available in the docket EPA-HQ-OPP-2014-0397 at https://www.regulations.gov. There were no comments received in response to the
notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pendimethalin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pendimethalin
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.
The target organ for pendimethalin is the thyroid. Thyroid toxicity
in chronic and subchronic rat and mouse studies was manifested as
alterations in thyroid hormones (decreased total T4 and T3,
[[Page 6977]]
increased percent of free T4 and T3), increased thyroid weight, and
microscopic thyroid lesions (including increased thyroid follicular
cell height, follicular cell hyperplasia, as well as follicular cell
adenomas). Due to these effects, the Agency required that a
developmental thyroid assay be conducted to evaluate the impact of
pendimethalin on thyroid hormones, structure, and/or thyroid hormone
homeostasis during development. A developmental thyroid study was
submitted and demonstrated that there is no potential thyroid toxicity
following pre- and/or post-natal exposure to pendimethalin.
There is no evidence that pendimethalin is a developmental,
reproductive, neurotoxic, or immunotoxic chemical. There is no evidence
of increased qualitative or quantitative susceptibility in the young.
EPA classified pendimethalin as a ``Group C'', possible human
carcinogen based on a statistically significant increased trend and
pair-wise comparison between the high-dose group and controls for
thyroid follicular cell adenomas in male and female rats. A non-
quantitative approach (i.e., non-linear, reference dose (RfD) approach)
was used to assess cancer risk since mode-of-action studies are
available to demonstrate that the thyroid tumors are due to a thyroid-
pituitary imbalance, and also since pendimethalin was shown to be non-
mutagenic in mammalian somatic cells and germ cells.
Specific information on the studies received and the nature of the
adverse effects caused by pendimethalin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of December 21, 2015 (80 FR 79267)
(FRL-9937-18).
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 pendimethalin used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Pendimethalin for Use in 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 (General population NOAEL = 100 mg/kg/ Acute RfD = 1 mg/kg/ Acute neurotoxicity study.
including infants and children). day. day. LOAEL = 300 mg/kg/day based on
UFA = 10x........... aPAD = 1 mg/kg/day. reduced motor activity for males
UFH = 10x........... and females on Day 0.
FQPA SF = 1x........
Chronic dietary (All populations) NOAEL= 10 mg/kg/day. Chronic RfD = 0.3 92-Day thyroid function study in
UFA = 3x............ mg/kg/day. rats; 56-day thyroid study in
UFH = 10x........... cPAD = 0.3 mg/kg/ rats; 14-day intra thyroid
FQPA SF = 1x........ day. metabolism study in rats.
LOAEL = 31 mg/kg/day based on
hormonal and histopathological
changes in the thyroid.
Incidental oral short-term (1 to NOAEL= 10 mg/kg/day. LOC for MOE = 30... 92-Day thyroid function study in
30 days). UFA = 3x............ rats; 56-day thyroid study in
UFH = 10x........... rats; 14-day intra thyroid
FQPA SF = 1x........ metabolism study in rats.
LOAEL = 31 mg/kg/day based on
hormonal and histopathological
changes in the thyroid.
Dermal short-term (1 to 30 days). Dermal (or oral) LOC for MOE = 30... 92-Day thyroid function study in
study NOAEL = 10 mg/ rats; 56-day thyroid study in
kg/day (dermal rats; 14-day intra thyroid
absorption rate = metabolism study in rats.
3%. LOAEL = 31 mg/kg/day based on
UFA = 3x............ hormonal and histopathological
UFH = 10x........... changes in the thyroid.
FQPA SF = 1x........
Dermal intermediate-term (1 to 6 Dermal (or oral) LOC for MOE = 30... 92-Day thyroid function study in
months). study NOAEL = 10 mg/ rats; 56-day thyroid study in
kg/day (dermal rats; 14-day intra thyroid
absorption rate = metabolism study in rats.
3%. LOAEL = 31 mg/kg/day based on
UFA = 3x............ hormonal and histopathological
UFH = 10x........... changes in the thyroid.
FQPA SF = 1x........
[[Page 6978]]
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 30... 92-Day thyroid function study in
days). study NOAEL= 10 mg/ rats; 56-day thyroid study in
kg/day (inhalation rats; 14-day intra thyroid
absorption rate = metabolism study in rats.
100%). LOAEL = 31 mg/kg/day based on
UFA = 3x............ hormonal and histopathological
UFH = 10x........... changes in the thyroid.
FQPA SF = 1x........
Inhalation (1 to 6 months)....... Inhalation (or oral) LOC for MOE = 30... 92-Day thyroid function study in
study NOAEL= 10 mg/ rats; 56-day thyroid study in
kg/day (inhalation rats; 14-day intra thyroid
absorption rate = metabolism study in rats.
100%). LOAEL = 31 mg/kg/day based on
UFA = 3x............ hormonal and histopathological
UFH = 10x........... changes in the thyroid.
FQPA SF = 1x........
Cancer (Oral, dermal, inhalation) Group C, possible
human carcinogen
based on a
statistically
significant
increased trend and
pair-wise
comparison between
the high dose group
and controls for
thyroid follicular
cell adenomas in
male and female
rats. The chronic
RfD will be
protective of
cancer effects.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern. mg/kg/day = milligram/kilogram/day.
MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. LOAEL = lowest 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). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
risk assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pendimethalin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pendimethalin
tolerances in 40 CFR 180.361. EPA assessed dietary exposures from
pendimethalin 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 pendimethalin. In estimating acute
dietary exposure, EPA Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This
software uses 2003-2008 food consumption data from the U.S. Department
of Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, EPA used tolerance-level residues, and 100 percent crop treated
(PCT) for all commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008
food consumption data from the USDA's NHANES/WWEIA. As to residue
levels in food, EPA used tolerance-level residues, and 100 PCT for all
commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to pendimethalin. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for pendimethalin. Tolerance-level residues and 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. In drinking water, the
residue of concern is pendimethalin, parent only. The Agency used
screening-level water exposure models in the dietary exposure analysis
and risk assessment for pendimethalin in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of pendimethalin. 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 Root Zone Model Ground Water (PRZM GW) and
[[Page 6979]]
Surface Water Concentration Calculator (SWCC) models, the estimated
drinking water concentrations (EDWCs) of pendimethalin for acute
exposures are estimated to be 96.4 parts per billion (ppb) for surface
water and 4.38 x 10\-9\ ppb for ground water. For chronic exposures for
non-cancer assessments, they are estimated to be 9.73 ppb for surface
water.
For acute dietary risk assessment, the water concentration value of
96.4 ppb was used to assess the contribution to drinking water. For
chronic dietary risk assessment, the water concentration of value 9.73
ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Pendimethalin is currently registered for the following uses that
could result in residential exposures: Turf, home gardens, and
ornamentals. EPA assessed residential exposure using the following
assumptions:
For handlers, it is assumed that residential use will
result in short-term (1 to 30 days) duration dermal and inhalation
exposures.
Residential post-application exposure is also assumed to
be short-term (1-30 days) in duration, resulting from the following
exposure scenarios:
Gardening: Adults (dermal) and children 6 < 11 years old
(dermal);
Physical activities on turf: Adults (dermal) and children
1-2 years old (dermal and incidental oral);
Mowing turf: Adults (dermal) and children 11 < 16 years
old (dermal); and
Exposure to golf courses during golfing: Adults (dermal),
children 11 < 16 years old (dermal), and children 6 < 11 years old
(dermal).
EPA did not combine exposure resulting from adult handler and post-
application exposure resulting from treated gardens, lawns, and/or
golfing because the conservative assumptions and inputs within each
estimated exposure scenario would result in an overestimate of adult
exposure. EPA selected the most conservative adult residential scenario
(adult dermal post-application exposure from gardening) as the
contributing source of residential exposure to be combined with the
dietary exposure for the aggregate assessment. The children's oral
exposure is based on post-application hand-to-mouth exposures. To
include exposure from object-to-mouth and soil ingestion in addition to
hand-to-mouth would overestimate the potential for oral exposure.
However, there is the potential for co-occurrence of dermal and oral
exposure, since the toxicological effects from the dermal and oral
routes of exposure are the same. As a result, the children's aggregate
assessment combines post-application dermal and oral exposure along
with dietary exposure from food and water. 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 pendimethalin to share a common mechanism of
toxicity with any other substances, and pendimethalin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pendimethalin 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. There was no indication of
pre- and/or post-natal qualitative or quantitative increased
susceptibility in the developmental studies in rats and rabbits or the
2-generation reproduction studies in rats. A developmental thyroid
toxicity study demonstrated that there is no potential thyroid toxicity
following pre- and/or post-natal exposure to pendimethalin.
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 pendimethalin is complete. Although a
subchronic inhalation study was not available in the database, EPA
determined that one is not needed at this time based on a weight-of-
evidence analysis, considering the following: (1) All relevant hazard
and exposure information, which indicates its low acute inhalation
toxicity; (2) its physical/chemical properties, which indicate its low
volatility; and (3) the use of an oral POD that results in a
residential inhalation margin of exposure (MOE) more than 10X the level
of concern (in the case of pendimethalin MOE = 30 based on thyroid
POD).
ii. There is no indication that pendimethalin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that pendimethalin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. In addition, a developmental thyroid toxicity study demonstrated
that there is no potential thyroid toxicity following pre- and/or post-
natal exposure to pendimethalin.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pendimethalin 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
pendimethalin.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are
[[Page 6980]]
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 pendimethalin will occupy 2% of the aPAD for all infants less than 1
year 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
pendimethalin from food and water will utilize 2.4% of the cPAD for
children one to two years old the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
pendimethalin is not expected.
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).
Pendimethalin 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 pendimethalin.
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 130 for adults
and 92 for children 1-2 years old, the two population subgroups
receiving the greatest combined dietary and non-dietary exposure.
Because EPA's level of concern for pendimethalin is a MOE of 30 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; however,
pendimethalin is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
pendimethalin.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has determined that an RfD approach based on the chronic
point of departure is appropriate for evaluating cancer risk. As there
are not chronic aggregate risks of concern, there are no cancer
aggregate risk concerns.
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 pendimethalin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, gas chromatography with electron
capture detection (GC/ECD), is available to enforce the tolerance
expression.
The method 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.
There are currently no established Codex MRLs for the residues of
pendimethalin on alfalfa hay, although Codex has established an MRL for
residues of pendimethalin in alfalfa fodder (which is equivalent to the
US commodity of alfalfa forage) at 4 ppm. Harmonization is not possible
because use of the Codex MRL would result in residues of pendimethalin
exceeding tolerances in the U.S. as a result of use in accordance with
the approved label.
V. Conclusion
Therefore, tolerances are established for plant residues by
measuring only the sum of pendimethalin, [N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(1-
ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol calculated as the
stoichiometric equivalent of pendimethalin, in or on alfalfa, forage at
80 ppm and alfalfa, hay at 150 ppm. In addition, the Agency is revising
the tolerance expression for paragraph (a)(1) to clarify that the
residues of the parent compound are to be summed with the residues of
the metabolite in order to determine compliance with the tolerance.
This revision does not substantively change the existing language; the
current language already requires measurement of both residues. The
insertion of the words ``the sum'' just provides a small clarification
for measuring residues to determine compliance with the tolerance.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or 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
[[Page 6981]]
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 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 30, 2018.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.361:
0
a. Revise the introductory text of paragraph (a)(1).
0
b. Revise the entries for ``Alfalfa, forage''; and ``Alfalfa, hay'' in
the table in paragraph (a)(1).
The revisions read as follows:
Sec. 180.361 Pendimethalin; tolerances for residues.
(a)(1) General. Tolerances are established for residues of the
herbicide pendimethalin, including its metabolites and degradates, in
or on the commodities. Compliance with the tolerance levels specified
in the following table below is to be determined by measuring only the
sum of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric
equivalent of pendimethalin, in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................ 80
Alfalfa, hay............................................... 150
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-03277 Filed 2-15-18; 8:45 am]
BILLING CODE 6560-50-P
