[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]


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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.

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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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [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

[[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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of 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, 
http://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 http://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 http://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
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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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.
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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.
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[[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...........
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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 
http://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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The 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