2,4-D; Pesticide Tolerances, 9523-9529 [2017-02477]
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Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
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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).
ENVIRONMENTAL PROTECTION
AGENCY
VII. Congressional Review Act
9523
SUMMARY:
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 6, 2017.
Daniel J. Rosenblatt,
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.
2. In § 180.499, revise the entry for
‘‘Potato’’ in the table in paragraph (a) to
read as follows:
■
§ 180.499 Propamocarb; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
*
*
*
*
*
*
*
*
0.30
*
*
[FR Doc. 2017–02479 Filed 2–6–17; 8:45 am]
BILLING CODE 6560–50–P
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[EPA–HQ–OPP–2016–0594; FRL–9958–07]
2,4–D; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of 2,4–D in or on
cotton, gin byproducts and amends the
existing tolerance on cotton, undelinted
seed. Dow AgroSciences requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 7, 2017. Objections and
requests for hearings must be received
on or before April 10, 2017, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0594, 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:
I. General Information
*
Potato ...................................
40 CFR Part 180
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
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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).
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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
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–2016–0594 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 10, 2017. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0594, 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
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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 October 27,
2016 (81 FR 74754) (FRL–9953–98),
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 4F8303) by Dow
AgroSciences, 9330 Zionsville Road,
Indianapolis, IN 46268. The petition
requested that 40 CFR 180.142 be
amended by establishing tolerances for
residues of the herbicide, 2,4–D (2,4dichlorophenoxyacetic acid), both free
and conjugated, determined as the acid,
in or on gin byproducts and undelinted
seed of herbicide-tolerant cotton at 1.5
and 0.08 parts per million (ppm)
respectively. That document referenced
a summary of the petition prepared by
DowAgrosciences, the registrant, which
is available in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing.
Responses to these comments are
included in the document titled
Response to Public Comments Received
Regarding the Evaluation of Enlist
Duo TM on Enlist Corn, Cotton, and
Soybeans, which is available in the
docket. This document also includes
several comments and responses to
those comments that are not specifically
relevant to this tolerance action but
were submitted in response to EPA’s
proposed decision under FIFRA on the
pending associated application for
registration of a product containing 2,4–
D. Because of the overlap in some of the
comments, EPA has prepared a single
response to comments document, which
can be found in this docket, which is
also the same docket for the pending
pesticide action.
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
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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 2,4–D, including
exposure resulting from the tolerances
established by this action. EPA’s
assessment of exposures and risks
associated with 2,4–D 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 toxicity
profile shows that 2,4–D is not acutely
toxic via the oral, dermal, and
inhalation routes, is not a dermal
irritant or a dermal sensitizer, but it is
a severe eye irritant. The principal toxic
effects are changes in the kidney
[increased kidney weight,
histopathological lesions], thyroid
[decreased thyroxine, increased thyroid
weight, hyperplasia and hypertrophy of
follicular cells], liver [increased liver
weight, increased ALT and AST,
histopathological lesions, including
hypertrophy], adrenal [increased
adrenal weight, histopathological
lesions], eye [retinal degeneration,
cataract formation, lens opacity], and
ovaries/testes [decreased testes weight
and ovarian weight, atrophy] in the rat
following exposure to 2,4–D via the oral
route at dose levels above the threshold
of saturation of renal clearance. No
systemic toxicity was observed in
rabbits following repeated exposure via
the dermal route at dose levels up to the
limit dose. Neurotoxicity, as evidenced
by the increased incidence of
incoordination and slight gait
abnormalities (forepaw flexing or
knuckling) was observed in the acute
neurotoxicity study in rats at the highest
dose. In an extended 1-generation
reproductive toxicity study in rats,
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reproductive toxicity, developmental
neurotoxicity, and immunotoxicity were
not observed, and the thyroid effects
observed at dose levels up to/
approaching renal saturation were
considered treatment-related, although
not adverse. Neuropathological effects
were not observed in any study.
Maternal and developmental toxicity
were observed at high dose levels
exceeding the threshold of saturation of
renal clearance. There are no residual
uncertainties for pre- and/or postnatal
toxicity. 2,4–D has been classified as a
Category D chemical, ‘‘not classifiable as
to human carcinogenicity’’, based upon
bioassays in rats and mice that showed
no statistically significant tumor
response in either species. The Agency
has determined, based on several
reviews of epidemiological studies, in
addition to the animal studies, that the
existing data do not support a
conclusion that links human cancer to
2,4–D exposure. Specific information on
the studies received and the nature of
the adverse effects caused by 2,4–D as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document, 2,4–
D. Human Health Risk Assessment for a
Proposed Use of 2,4–D Choline on
Herbicide-Tolerant Cotton at pgs. 40–50
in docket ID number EPA–HQ–OPP–
2016–0594.
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
9525
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm. A summary of the
toxicological endpoints for 2,4–D used
for human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 2,4–D FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of
departure and
uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Developmental
NOAEL = 25 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL = 67 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 21 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.25
mg/kg/day.
aPAD = .025 mg/kg/
day.
Developmental Toxicity Study—rat.
Developmental LOAEL = 75 mg/kg/day based on fetal skeletal
abnormalities (14th rudimentary ribs).
Acute RfD = 0.67
mg/kg/day.
aPAD = 0.67 mg/kg/
day.
Acute Neurotoxicity Study—rat.
LOAEL = 227 mg/kg/day based on slight gait abnormalities
(forepaw flexing and knuckling) and increased incidence of
incoordination.
Chronic RfD = 0.21
mg/kg/day.
cPAD = 0.21 mg/kg/
day.
Incidental oral short- and intermediate term (1 to 30 days
and 1–6 months).
NOAEL = 21 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Extended 1-generation Reproduction—rat.
Parental LOAEL = 55.6 mg/kg/day (males) and 46.7 mg/kg/day
(females) based on kidney toxicity manifested as increased
kidney weights and increased incidence of degeneration of
the proximal convoluted tubules and for offspring based on
decreased body weight observed throughout lactation.
Extended 1-generation Reproduction—rat.
Parental LOAEL = 55.6 mg/kg/day (males) and 46.7 mg/kg/day
(females) based on kidney toxicity manifested as increased
kidney weights and increased incidence of degeneration of
the proximal convoluted tubules and for offspring based on
decreased body weight observed throughout lactation.
Dermal (all durations) ...............
No potential hazard via the dermal route, based on the lack of systemic effects following repeat dermal exposure of rabbits at dose levels up to 1000 mg/kg/day. Although developmental toxicity was not assessed in
the dermal study, clear NOAELs (dermal equivalent doses of 250 and 300 mg/kg/day) were determined;
the developmental effects occurred at dose levels that exceed renal clearance mechanism (dermal equivalent doses of 750 and 900 mg/kg/day); dose levels required to exceed the renal clearance mechanism
would not be attained following dermal exposure to humans.
Exposure/scenario
Acute dietary (Females 13–50
years of age).
Acute dietary (General population including infants and
children).
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Chronic dietary (All populations)
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 2,4–D FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Inhalation (all durations) ...........
Point of
departure and
uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Inhalation study
LOAEL = 0.05 mg/L/
day.
HEC = 0.013 mg/L/
day (bystander).
HED = 1.76 mg/kg/
day (residential
handler)
UFA = 3x
UFH = 10x
UFL = 10x
Cancer (Oral, dermal, inhalation).
Study and toxicological effects
LOC for MOE = 300
Subchronic inhalation toxicity study—rat.
LOAEL = 0.05 mg/L/day based on portal-of-entry effects (squamous metaplasia and epithelial hyperplasia with increased
mixed inflammatory cells within the larynx); not totally resolved following a 4-week recovery period.
Classification: Group D—not classifiable as to human carcinogenicity.
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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). UFL = use of a LOAEL to extrapolate a NOAEL. HEC = Human Equivalent
Concentration (mg/L). HED = Human Equivalent Dose (mg/kg/day).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to 2,4–D, EPA considered
exposure under the petitioned-for
tolerances as well as all existing 2,4–D
tolerances in 40 CFR 180.142. EPA
assessed dietary exposures from 2,4–D
in food as follows:
i. Acute and chronic exposure. In
estimating acute and chronic dietary
exposure, EPA used 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 assumed
that 100% of all crops had been treated
and conservative default processing
factors were used for all relevant
processed commodities. EPA also
assumed tolerance-level residues for all
commodities excluding transgenic
soybean and cotton commodities. For
transgenic soybean, the combined 2,4–D
and 2,4–DCP residues were used for the
acute and chronic dietary analyses as
the combined residues found in tolerant
soybean were greater than the tolerance
of parent only for soybean. Since
residue levels of parent 2,4–D in/on
tolerant soybean were non-detectable,
estimated 2,4–D residues (at 1⁄2 the level
of detection of 0.003 ppm, or 0.0015
ppm) were added to the 2,4–DCP
highest average field trial residue
(HAFT is 0.047 ppm) to be used in the
acute and chronic dietary analyses. For
the proposed new use on transgenic
cotton, a combined 2,4–D and 2,4–DCP
residue value of 0.15 ppm was used in
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the acute and chronic dietary
assessment for cotton seed oil. For 2,4–
D, it was not possible to calculate a
processing factor for refined oil because
residues were non-detectable in both the
RAC and the oil in the processing study.
Therefore, the Agency used a processing
factor of 1.0x, multiplied by the HAFT
of undelinted cotton seed (0.07 ppm)
from the recently submitted magnitude
of residue study. The 2,4–DCP
processed commodity residue for
refined oil (0.08 ppm), was calculated
by multiplying the processing factor of
0.4x by the HAFT of undelinted cotton
seed for 2,4–DCP (0.206 ppm). The 2,4–
D residue product (0.07 ppm) was then
added with the 2,4–DCP residue
product (0.08 ppm) and the sum was
0.15 ppm.
ii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that 2,4–D does not pose a
cancer risk to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iii. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for 2,4–D. Tolerance level residues and/
or 100% CT were assumed for all food
commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for 2,4–D in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of 2,4–D.
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Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Modeled estimates of drinking water
concentrations based on the Surface
Water Concentration Calculator (SWCC)
were directly entered into the dietary
exposure model.
For acute dietary risk assessment, the
water concentration value of 298 ppb
was used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 34.5 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).
2,4–D is currently registered for the
following uses that could result in
residential exposures: Ornamental turf,
including parks, sports fields, and golf
courses, as well as aquatic uses. The
existing residential uses were
previously assessed in 2013. However,
since that time there have been changes
to the policy for calculating inhalation
HECs and the policy for assessing
aquatic exposure; therefore, the
residential scenarios have been
reassessed. EPA assumes that residential
handlers complete all elements of an
application without use of any
protective equipment or baseline attire
such as long pants and long-sleeved
shirt. Quantitative short-term inhalation
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exposure estimates for adult residential
handlers are based on the scenarios of
mixing, loading, and application of 2,4–
D to lawns and turf at maximum rates
using hose-end sprayers, manuallypressurized hand wands, and backpack
sprayers with liquid and ready-to-use
forms, as well as belly grinders and
push-type spreaders. Intermediate-term
exposures are not likely and were not
estimated because of the intermittent
nature of applications by homeowners.
Dermal exposures were also not
estimated due to the lack of dermal
hazard.
In addition to residential handler
exposure, the following post-application
exposure scenarios were estimated for
short-term duration to protect adults
and children that might be playing in
treated turf areas or swimming in
treated aquatic areas after applications
of 2,4–D have been made at the
maximum rates:
• Incidental ingestion (i.e., hand-tomouth, object-to-mouth, soil ingestion
exposure) from contact with treated turf
(children 1 <2 years old only)
• Episodic granular ingestion on
treated turf (children 1 <2 years old
only)
• Incidental ingestion of water during
recreational swimming (both adults and
children 3 <6 years old).
None of the above exposure scenarios
resulted in handler or post-application
risk estimates that exceed EPA’s level of
concern. Further information regarding
EPA standard assumptions and generic
inputs for residential exposures may be
found at https://www.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 2,4–D to share a common
mechanism of toxicity with any other
substances, and 2,4–D does not appear
to produce a toxic metabolite produced
by other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that 2,4–D does not have a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
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18:06 Feb 06, 2017
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www.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 is evidence of increased
susceptibility following in utero
exposure to 2,4–D in the rat
developmental toxicity study and
following in utero and/or pre-/post-natal
exposure in the rat 2-generation
reproduction study. There is no
evidence of increased susceptibility
following in utero exposure to 2,4–D in
the rabbit developmental toxicity study
or following in utero and/or pre-/postnatal exposure in the rat extended 1generation reproduction toxicity study.
2,4–D has been evaluated for potential
developmental effects in the rat and
rabbit. Maternal toxicity included
decreased body weight gains in the rat
study at the same dose level where
developmental effects (occurrence of
skeletal malformations) were observed.
Kidney effects would have been
expected in the maternal animal had
examination of the kidney been
performed, and the findings are not
considered evidence of susceptibility.
Maternal toxicity in the rabbit
included decreased body weight gain,
clinical signs of toxicity (decreased
motor activity, ataxia, loss of righting
reflex, extremities cold to the touch),
and abortions, the latter being indicative
of developmental toxicity. Decreased
maternal body weight gains were
observed in the rat 2-generation
reproduction study at a dose that
exceeded renal saturation and resulted
in reduced viability of the F1 pups.
Although decreased maternal body
weight gain is a conservative endpoint,
points of departure used in the risk
assessment are below where these
findings occur and are protective. There
are clearly established NOAELs and
LOAELs for the population of concern,
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9527
there are no data gaps in the toxicology
database, and the points of departure
(POD) are protective of susceptibility.
The exposure assessment will not
underestimate children’s exposure to
2,4–D.
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 2,4–D is
complete.
ii. Although there are indications of
neurotoxicity observed in the acute
neurotoxicity study in rats, as evidenced
by an increase in the incidence of incoordination and slight gait
abnormalities (forepaw flexing or
knuckling) at the high dose in both
sexes, developmental neurotoxicity was
not observed in the developmental
neurotoxicity segment of the extended
1-generation reproductive toxicity study
in rats.
iii. For the reasons stated in Unit
III.D.2., there is no residual uncertainty
concerning the potential susceptibility
of infants and children to effects of 2,4–
D; therefore, there is no need to retain
the 10X FQPA safety factor to protect
infants and children.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% crop
treated and tolerance-level or higher
residues assumptions. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to 2,4–D in
drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children. These
assessments will not underestimate the
exposure and risks posed by 2,4–D.
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 2,4–D
will occupy 23% of the aPAD for
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9528
Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations
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 2,4–D from
food and water will utilize 20% of the
cPAD for children 1 to 2 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 2,4–D 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). 2,4–D 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 2,4–
D. 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 2,000 for adults, 560 for
children ages 3–5 that are exposed to
2,4–D residues via incidental ingestion
of treated water during swimming
activities. The aggregate MOE of 280 is
estimated for children ages 1–2 that
exhibit hand-to-mouth behavior on
treated turf. Because EPA’s level of
concern for 2,4–D 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; however, 2,4–D is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
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
2,4–D.
5. Aggregate cancer risk for U.S.
population. Based on bioassays in rats
and mice that show no statistically
significant tumor response in either
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18:06 Feb 06, 2017
Jkt 241001
species as well as several reviews of
epidemiological studies, in addition to
the animal studies, the Agency has
classified 2,4–D as a Category D
chemical, i.e., not classifiable as to
human carcinogenicity, and 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 2,4–D
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate analytical methods are
available for data collection and the
enforcement of plant commodity
tolerances, including cotton. Task Force
II submitted an adequate GC/ECD
enforcement method for plants
(designated as EN–CAS Method No.
ENC–2/93) which has been
independently validated and
radiovalidated. An enforcement method
was submitted for determination of 2,4–
D in livestock commodities, which has
been adequately radiovalidated. The
methods have been submitted to FDA
for inclusion in PAM II. The 10/1997
edition of FDA PAM Volume I,
Appendix I indicates that 2,4–D is
partially recovered (50–80%) using
Multiresidue Methods Section 402 E1
and 402 E2.
These 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
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Frm 00040
Fmt 4700
Sfmt 4700
EPA explain the reasons for departing
from the Codex level. The Codex has not
established a MRL for 2,4–D on cotton.
V. Conclusion
Therefore, tolerances are established
for residues of 2,4–D (2,4dichlorophenoxyacetic acid) in or on
gin byproducts and undelinted seed of
cotton at 1.5 and 0.08 ppm respectively.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
E:\FR\FM\07FER1.SGM
07FER1
Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations
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 9, 2017.
Michael J. Goodis,
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.
2. In § 180.142:
a. Add alphabetically the
commodities ‘‘Cotton, gin byproducts’’
and ‘‘cotton, undelinted seed’’ to the
table in paragraph (a); and
■ b. Remove the entry for ‘‘cotton,
undelinted seed’’ from the table in
paragraph (d) to read as follows:
■
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■
§ 180.142
2,4–D; tolerances for residues.
(a) * * *
VerDate Sep<11>2014
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9529
and set an effective date of January 29,
2017. November Decision, slip op. at 4;
81 FR 87472. On January 20, 2017, a
Memorandum for the Heads of
*
*
*
*
*
Executive Departments and Agencies
Cotton, gin byproducts .........
1.5
Cotton, undelinted seed .......
0.08 from Reince Priebus, Chief of Staff to
President Trump, was issued.1 Although
the Board is an independent regulatory
*
*
*
*
*
agency, it will stay the January 29, 2017
effective date in Docket No. EP 724
*
*
*
*
*
[FR Doc. 2017–02477 Filed 2–6–17; 8:45 am]
(Sub–No. 4) in accordance with the
BILLING CODE 6560–50–P
Memorandum’s request that the
effective date of rules published in the
Federal Register that had not yet
SURFACE TRANSPORTATION BOARD become effective be postponed for 60
days. 2 As a result, the final rule in
49 CFR Part 1250
Docket No. EP 724 (Sub–No. 4) will now
be stayed until March 21, 2017, and
[Docket No. EP 724 (Sub–No. 4)]
initial reporting will begin March 29,
2017.
United States Rail Service Issues—
Performance Data Reporting
The final rule adopted requirements
for reporting cars in fertilizer service, as
AGENCY: Surface Transportation Board.
defined by 14 Standard Transportation
ACTION: Final rule; stay of regulations.
Commodity Codes (STCCs) that The
Fertilizer Institute (TFI) provided in
SUMMARY: On December 5, 2016, the
comments. November Decision, slip op.
Board published a final rule in this
at 15. On December 20, 2016, TFI
docket that established new regulations
petitioned the Board to reconsider the
requiring all Class I railroads and the
final rule to modify the definition of
Chicago Transportation Coordination
fertilizer by adding one STCC to the 14
Office (CTCO), through its Class I
that were previously included in the
members, to report certain service
final rule. The Board will rule on the
performance metrics on a weekly,
petition in a subsequent decision.
semiannual, and occasional basis. The
Board is staying the effective date of the
It is ordered:
final rule.
1. The final rule in the November
DATES: Effective February 7, 2017 and
Decision, which was published in the
applicable on January 27, 2017, the final Federal Register on December 5, 2016,
rule establishing 49 CFR part 1250
will be stayed until March 21, 2017. The
published at 81 FR 87472 on December
initial reporting date will be March 29,
5, 2016, is stayed until March 21, 2017.
2017.
The initial reporting date under the final
2. Notice of the Board’s action will be
rule will be March 29, 2017.
published in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Sarah Fancher at (202) 245–0355.
Decided: January 27, 2017.
Assistance for the hearing impaired is
By the Board, Rachel D. Campbell,
available through the Federal
Director, Office of Proceedings.
Information Relay Service (FIRS) at
Brendetta S. Jones,
(800) 877–8339.
Clearance Clerk.
SUPPLEMENTARY INFORMATION: On
[FR Doc. 2017–02492 Filed 2–6–17; 8:45 am]
November 30, 2016, the Board adopted
BILLING CODE 4915–01–P
a final rule to establish new regulations
requiring all Class I railroads and the
1 Reince Priebus, Memorandum for the Heads of
CTCO, through its Class I members, to
Executive Departments and Agencies
report certain service performance
(Memorandum) (Jan. 20, 2017), https://
metrics on a weekly, semiannual, and
www.whitehouse.gov/briefing-room/presidentialoccasional basis. U.S. Rail Serv. Issues— actions (follow hyperlink to Memorandum for the
Performance Data Reporting (November Heads of Executive Departments and Agencies).
2 The Board’s entire decision, U.S. Rail Serv.
Decision), EP 724 (Sub–No. 4), slip op.
Issues—Data Collection, EP 724 (Sub–No. 3) et al.
at 1 (STB served Nov. 30, 2016). The
(STB served Jan. 27, 2017), is available on the
Board published the final rule in the
Board’s Web site by search at https://www.stb.gov/
Federal Register on December 5, 2016,
home.nsf/enhancedsearch?OpenForm.
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Commodity
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]]>Agencies
[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Rules and Regulations]
[Pages 9523-9529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02477]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0594; FRL-9958-07]
2,4-D; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of 2,4-D
in or on cotton, gin byproducts and amends the existing tolerance on
cotton, undelinted seed. Dow AgroSciences requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 7, 2017. Objections and
requests for hearings must be received on or before April 10, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0594, 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:
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
[[Page 9524]]
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-2016-0594 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 10, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0594, 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 October 27, 2016 (81 FR 74754) (FRL-
9953-98), 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
4F8303) by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN
46268. The petition requested that 40 CFR 180.142 be amended by
establishing tolerances for residues of the herbicide, 2,4-D (2,4-
dichlorophenoxyacetic acid), both free and conjugated, determined as
the acid, in or on gin byproducts and undelinted seed of herbicide-
tolerant cotton at 1.5 and 0.08 parts per million (ppm) respectively.
That document referenced a summary of the petition prepared by
DowAgrosciences, the registrant, which is available in the docket,
https://www.regulations.gov. Comments were received on the notice of
filing. Responses to these comments are included in the document titled
Response to Public Comments Received Regarding the Evaluation of Enlist
Duo \TM\ on Enlist Corn, Cotton, and Soybeans, which is available in
the docket. This document also includes several comments and responses
to those comments that are not specifically relevant to this tolerance
action but were submitted in response to EPA's proposed decision under
FIFRA on the pending associated application for registration of a
product containing 2,4-D. Because of the overlap in some of the
comments, EPA has prepared a single response to comments document,
which can be found in this docket, which is also the same docket for
the pending pesticide action.
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 2,4-D, including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with 2,4-D 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 toxicity profile shows that 2,4-D is not acutely toxic
via the oral, dermal, and inhalation routes, is not a dermal irritant
or a dermal sensitizer, but it is a severe eye irritant. The principal
toxic effects are changes in the kidney [increased kidney weight,
histopathological lesions], thyroid [decreased thyroxine, increased
thyroid weight, hyperplasia and hypertrophy of follicular cells], liver
[increased liver weight, increased ALT and AST, histopathological
lesions, including hypertrophy], adrenal [increased adrenal weight,
histopathological lesions], eye [retinal degeneration, cataract
formation, lens opacity], and ovaries/testes [decreased testes weight
and ovarian weight, atrophy] in the rat following exposure to 2,4-D via
the oral route at dose levels above the threshold of saturation of
renal clearance. No systemic toxicity was observed in rabbits following
repeated exposure via the dermal route at dose levels up to the limit
dose. Neurotoxicity, as evidenced by the increased incidence of
incoordination and slight gait abnormalities (forepaw flexing or
knuckling) was observed in the acute neurotoxicity study in rats at the
highest dose. In an extended 1-generation reproductive toxicity study
in rats,
[[Page 9525]]
reproductive toxicity, developmental neurotoxicity, and immunotoxicity
were not observed, and the thyroid effects observed at dose levels up
to/approaching renal saturation were considered treatment-related,
although not adverse. Neuropathological effects were not observed in
any study. Maternal and developmental toxicity were observed at high
dose levels exceeding the threshold of saturation of renal clearance.
There are no residual uncertainties for pre- and/or postnatal toxicity.
2,4-D has been classified as a Category D chemical, ``not classifiable
as to human carcinogenicity'', based upon bioassays in rats and mice
that showed no statistically significant tumor response in either
species. The Agency has determined, based on several reviews of
epidemiological studies, in addition to the animal studies, that the
existing data do not support a conclusion that links human cancer to
2,4-D exposure. Specific information on the studies received and the
nature of the adverse effects caused by 2,4-D 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 document, 2,4-D. Human Health Risk Assessment
for a Proposed Use of 2,4-D Choline on Herbicide-Tolerant Cotton at
pgs. 40-50 in docket ID number EPA-HQ-OPP-2016-0594.
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://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for 2,4-D used for human risk assessment is shown in Table 1
of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for 2,4-D 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 (Females 13-50 Developmental NOAEL Acute RfD = 0.25 mg/ Developmental Toxicity Study--rat.
years of age). = 25 mg/kg/day. kg/day. Developmental LOAEL = 75 mg/kg/day
UFA = 10x........... aPAD = .025 mg/kg/ based on fetal skeletal
UFH = 10x........... day. abnormalities (14th rudimentary
FQPA SF = 1x........ ribs).
Acute dietary (General population NOAEL = 67 mg/kg/day Acute RfD = 0.67 mg/ Acute Neurotoxicity Study--rat.
including infants and children). UFA = 10x........... kg/day. LOAEL = 227 mg/kg/day based on
UFH = 10x........... aPAD = 0.67 mg/kg/ slight gait abnormalities
FQPA SF = 1x........ day. (forepaw flexing and knuckling)
and increased incidence of
incoordination.
Chronic dietary (All populations) NOAEL= 21 mg/kg/day. Chronic RfD = 0.21 Extended 1-generation
UFA = 10x........... mg/kg/day. Reproduction--rat.
UFH = 10x........... cPAD = 0.21 mg/kg/ Parental LOAEL = 55.6 mg/kg/day
FQPA SF = 1x........ day. (males) and 46.7 mg/kg/day
(females) based on kidney
toxicity manifested as increased
kidney weights and increased
incidence of degeneration of the
proximal convoluted tubules and
for offspring based on decreased
body weight observed throughout
lactation.
Incidental oral short- and NOAEL = 21 mg/kg/day LOC for MOE = 100.. Extended 1-generation
intermediate term (1 to 30 days UFA = 10x........... Reproduction--rat.
and 1-6 months). UFH = 10x........... Parental LOAEL = 55.6 mg/kg/day
FQPA SF = 1x........ (males) and 46.7 mg/kg/day
(females) based on kidney
toxicity manifested as increased
kidney weights and increased
incidence of degeneration of the
proximal convoluted tubules and
for offspring based on decreased
body weight observed throughout
lactation.
------------------------------------------------------------------------------
Dermal (all durations)........... No potential hazard via the dermal route, based on the lack of systemic
effects following repeat dermal exposure of rabbits at dose levels up to
1000 mg/kg/day. Although developmental toxicity was not assessed in the
dermal study, clear NOAELs (dermal equivalent doses of 250 and 300 mg/kg/
day) were determined; the developmental effects occurred at dose levels that
exceed renal clearance mechanism (dermal equivalent doses of 750 and 900 mg/
kg/day); dose levels required to exceed the renal clearance mechanism would
not be attained following dermal exposure to humans.
------------------------------------------------------------------------------
[[Page 9526]]
Inhalation (all durations)....... Inhalation study LOC for MOE = 300.. Subchronic inhalation toxicity
LOAEL = 0.05 mg/L/ study--rat.
day. LOAEL = 0.05 mg/L/day based on
HEC = 0.013 mg/L/day portal-of-entry effects (squamous
(bystander). metaplasia and epithelial
HED = 1.76 mg/kg/day hyperplasia with increased mixed
(residential inflammatory cells within the
handler). larynx); not totally resolved
UFA = 3x............ following a 4-week recovery
UFH = 10x........... period.
UFL = 10x...........
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: Group D--not classifiable as to human carcinogenicity.
----------------------------------------------------------------------------------------------------------------
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). UFL = use of a LOAEL to extrapolate a NOAEL. HEC = Human
Equivalent Concentration (mg/L). HED = Human Equivalent Dose (mg/kg/day).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 2,4-D, EPA considered exposure under the petitioned-for
tolerances as well as all existing 2,4-D tolerances in 40 CFR 180.142.
EPA assessed dietary exposures from 2,4-D in food as follows:
i. Acute and chronic exposure. In estimating acute and chronic
dietary exposure, EPA used 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 assumed that 100% of all crops had been
treated and conservative default processing factors were used for all
relevant processed commodities. EPA also assumed tolerance-level
residues for all commodities excluding transgenic soybean and cotton
commodities. For transgenic soybean, the combined 2,4-D and 2,4-DCP
residues were used for the acute and chronic dietary analyses as the
combined residues found in tolerant soybean were greater than the
tolerance of parent only for soybean. Since residue levels of parent
2,4-D in/on tolerant soybean were non-detectable, estimated 2,4-D
residues (at \1/2\ the level of detection of 0.003 ppm, or 0.0015 ppm)
were added to the 2,4-DCP highest average field trial residue (HAFT is
0.047 ppm) to be used in the acute and chronic dietary analyses. For
the proposed new use on transgenic cotton, a combined 2,4-D and 2,4-DCP
residue value of 0.15 ppm was used in the acute and chronic dietary
assessment for cotton seed oil. For 2,4-D, it was not possible to
calculate a processing factor for refined oil because residues were
non-detectable in both the RAC and the oil in the processing study.
Therefore, the Agency used a processing factor of 1.0x, multiplied by
the HAFT of undelinted cotton seed (0.07 ppm) from the recently
submitted magnitude of residue study. The 2,4-DCP processed commodity
residue for refined oil (0.08 ppm), was calculated by multiplying the
processing factor of 0.4x by the HAFT of undelinted cotton seed for
2,4-DCP (0.206 ppm). The 2,4-D residue product (0.07 ppm) was then
added with the 2,4-DCP residue product (0.08 ppm) and the sum was 0.15
ppm.
ii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that 2,4-D does not pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the purpose of assessing cancer risk
is unnecessary.
iii. Anticipated residue and percent crop treated (PCT)
information. EPA did not use anticipated residue and/or PCT information
in the dietary assessment for 2,4-D. Tolerance level residues and/or
100% CT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for 2,4-D in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of 2,4-D. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
https://www.epa.gov/oppefed1/models/water/index.htm.
Modeled estimates of drinking water concentrations based on the
Surface Water Concentration Calculator (SWCC) were directly entered
into the dietary exposure model.
For acute dietary risk assessment, the water concentration value of
298 ppb was used to assess the contribution to drinking water. For
chronic dietary risk assessment, the water concentration of value 34.5
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).
2,4-D is currently registered for the following uses that could
result in residential exposures: Ornamental turf, including parks,
sports fields, and golf courses, as well as aquatic uses. The existing
residential uses were previously assessed in 2013. However, since that
time there have been changes to the policy for calculating inhalation
HECs and the policy for assessing aquatic exposure; therefore, the
residential scenarios have been reassessed. EPA assumes that
residential handlers complete all elements of an application without
use of any protective equipment or baseline attire such as long pants
and long-sleeved shirt. Quantitative short-term inhalation
[[Page 9527]]
exposure estimates for adult residential handlers are based on the
scenarios of mixing, loading, and application of 2,4-D to lawns and
turf at maximum rates using hose-end sprayers, manually-pressurized
hand wands, and backpack sprayers with liquid and ready-to-use forms,
as well as belly grinders and push-type spreaders. Intermediate-term
exposures are not likely and were not estimated because of the
intermittent nature of applications by homeowners. Dermal exposures
were also not estimated due to the lack of dermal hazard.
In addition to residential handler exposure, the following post-
application exposure scenarios were estimated for short-term duration
to protect adults and children that might be playing in treated turf
areas or swimming in treated aquatic areas after applications of 2,4-D
have been made at the maximum rates:
Incidental ingestion (i.e., hand-to-mouth, object-to-
mouth, soil ingestion exposure) from contact with treated turf
(children 1 <2 years old only)
Episodic granular ingestion on treated turf (children 1 <2
years old only)
Incidental ingestion of water during recreational swimming
(both adults and children 3 <6 years old).
None of the above exposure scenarios resulted in handler or post-
application risk estimates that exceed EPA's level of concern. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-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 2,4-D to
share a common mechanism of toxicity with any other substances, and
2,4-D does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that 2,4-D does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
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 is evidence of
increased susceptibility following in utero exposure to 2,4-D in the
rat developmental toxicity study and following in utero and/or pre-/
post-natal exposure in the rat 2-generation reproduction study. There
is no evidence of increased susceptibility following in utero exposure
to 2,4-D in the rabbit developmental toxicity study or following in
utero and/or pre-/post-natal exposure in the rat extended 1-generation
reproduction toxicity study.
2,4-D has been evaluated for potential developmental effects in the
rat and rabbit. Maternal toxicity included decreased body weight gains
in the rat study at the same dose level where developmental effects
(occurrence of skeletal malformations) were observed. Kidney effects
would have been expected in the maternal animal had examination of the
kidney been performed, and the findings are not considered evidence of
susceptibility.
Maternal toxicity in the rabbit included decreased body weight
gain, clinical signs of toxicity (decreased motor activity, ataxia,
loss of righting reflex, extremities cold to the touch), and abortions,
the latter being indicative of developmental toxicity. Decreased
maternal body weight gains were observed in the rat 2-generation
reproduction study at a dose that exceeded renal saturation and
resulted in reduced viability of the F1 pups. Although decreased
maternal body weight gain is a conservative endpoint, points of
departure used in the risk assessment are below where these findings
occur and are protective. There are clearly established NOAELs and
LOAELs for the population of concern, there are no data gaps in the
toxicology database, and the points of departure (POD) are protective
of susceptibility. The exposure assessment will not underestimate
children's exposure to 2,4-D.
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 2,4-D is complete.
ii. Although there are indications of neurotoxicity observed in the
acute neurotoxicity study in rats, as evidenced by an increase in the
incidence of in-coordination and slight gait abnormalities (forepaw
flexing or knuckling) at the high dose in both sexes, developmental
neurotoxicity was not observed in the developmental neurotoxicity
segment of the extended 1-generation reproductive toxicity study in
rats.
iii. For the reasons stated in Unit III.D.2., there is no residual
uncertainty concerning the potential susceptibility of infants and
children to effects of 2,4-D; therefore, there is no need to retain the
10X FQPA safety factor to protect infants and children.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated and tolerance-level or higher residues
assumptions. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to 2,4-D in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children. These assessments will not
underestimate the exposure and risks posed by 2,4-D.
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 2,4-D will occupy 23% of the aPAD for
[[Page 9528]]
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
2,4-D from food and water will utilize 20% of the cPAD for children 1
to 2 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 2,4-D 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). 2,4-D 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 2,4-D. 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 2,000 for adults, 560 for
children ages 3-5 that are exposed to 2,4-D residues via incidental
ingestion of treated water during swimming activities. The aggregate
MOE of 280 is estimated for children ages 1-2 that exhibit hand-to-
mouth behavior on treated turf. Because EPA's level of concern for 2,4-
D 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; however,
2,4-D 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 2,4-
D.
5. Aggregate cancer risk for U.S. population. Based on bioassays in
rats and mice that show no statistically significant tumor response in
either species as well as several reviews of epidemiological studies,
in addition to the animal studies, the Agency has classified 2,4-D as a
Category D chemical, i.e., not classifiable as to human
carcinogenicity, and 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 2,4-D residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate analytical methods are available for data collection and
the enforcement of plant commodity tolerances, including cotton. Task
Force II submitted an adequate GC/ECD enforcement method for plants
(designated as EN-CAS Method No. ENC-2/93) which has been independently
validated and radiovalidated. An enforcement method was submitted for
determination of 2,4-D in livestock commodities, which has been
adequately radiovalidated. The methods have been submitted to FDA for
inclusion in PAM II. The 10/1997 edition of FDA PAM Volume I, Appendix
I indicates that 2,4-D is partially recovered (50-80%) using
Multiresidue Methods Section 402 E1 and 402 E2.
These 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 Codex has not
established a MRL for 2,4-D on cotton.
V. Conclusion
Therefore, tolerances are established for residues of 2,4-D (2,4-
dichlorophenoxyacetic acid) in or on gin byproducts and undelinted seed
of cotton at 1.5 and 0.08 ppm respectively.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian
[[Page 9529]]
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 9, 2017.
Michael J. Goodis,
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. 180.142:
0
a. Add alphabetically the commodities ``Cotton, gin byproducts'' and
``cotton, undelinted seed'' to the table in paragraph (a); and
0
b. Remove the entry for ``cotton, undelinted seed'' from the table in
paragraph (d) to read as follows:
Sec. 180.142 2,4-D; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cotton, gin byproducts.................................. 1.5
Cotton, undelinted seed................................. 0.08
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-02477 Filed 2-6-17; 8:45 am]
BILLING CODE 6560-50-P
