82_FR_9547 82 FR 9523 - 2,4-D; Pesticide Tolerances

82 FR 9523 - 2,4-D; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 24 (February 7, 2017)

Page Range9523-9529
FR Document2017-02477

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).

Federal Register, Volume 82 Issue 24 (Tuesday, February 7, 2017)
[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Rules and Regulations]
[Pages 9523-9529]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                  Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations                                                  9523

                                                VI. Statutory and Executive Order                       described under Title II of the Unfunded                      ENVIRONMENTAL PROTECTION
                                                Reviews                                                 Mandates Reform Act (UMRA) (2 U.S.C.                          AGENCY
                                                   This action establishes a tolerance                  1501 et seq.).
                                                under FFDCA section 408(d) in                                                                                         40 CFR Part 180
                                                                                                          This action does not involve any
                                                response to a petition submitted to the                 technical standards that would require                        [EPA–HQ–OPP–2016–0594; FRL–9958–07]
                                                Agency. The Office of Management and                    Agency consideration of voluntary
                                                Budget (OMB) has exempted these types                   consensus standards pursuant to section                       2,4–D; Pesticide Tolerances
                                                of actions from review under Executive                  12(d) of the National Technology                              AGENCY:  Environmental Protection
                                                Order 12866, entitled ‘‘Regulatory                      Transfer and Advancement Act                                  Agency (EPA).
                                                Planning and Review’’ (58 FR 51735,                     (NTTAA) (15 U.S.C. 272 note).                                 ACTION: Final rule.
                                                October 4, 1993). Because this action
                                                has been exempted from review under                     VII. Congressional Review Act                                 SUMMARY:   This regulation establishes a
                                                Executive Order 12866, this action is                                                                                 tolerance for residues of 2,4–D in or on
                                                not subject to Executive Order 13211,                     Pursuant to the Congressional Review
                                                                                                                                                                      cotton, gin byproducts and amends the
                                                entitled ‘‘Actions Concerning                           Act (5 U.S.C. 801 et seq.), EPA will                          existing tolerance on cotton, undelinted
                                                Regulations That Significantly Affect                   submit a report containing this rule and                      seed. Dow AgroSciences requested these
                                                Energy Supply, Distribution, or Use’’ (66               other required information to the U.S.                        tolerances under the Federal Food,
                                                FR 28355, May 22, 2001) or Executive                    Senate, the U.S. House of                                     Drug, and Cosmetic Act (FFDCA).
                                                Order 13045, entitled ‘‘Protection of                   Representatives, and the Comptroller                          DATES: This regulation is effective
                                                Children from Environmental Health                      General of the United States prior to                         February 7, 2017. Objections and
                                                Risks and Safety Risks’’ (62 FR 19885,                  publication of the rule in the Federal                        requests for hearings must be received
                                                April 23, 1997). This action does not                   Register. This action is not a ‘‘major                        on or before April 10, 2017, and must
                                                contain any information collections                     rule’’ as defined by 5 U.S.C. 804(2).                         be filed in accordance with the
                                                subject to OMB approval under the                                                                                     instructions provided in 40 CFR part
                                                                                                        List of Subjects in 40 CFR Part 180
                                                Paperwork Reduction Act (PRA) (44                                                                                     178 (see also Unit I.C. of the
                                                U.S.C. 3501 et seq.), nor does it require                 Environmental protection,                                   SUPPLEMENTARY INFORMATION).
                                                any special considerations under                        Administrative practice and procedure,                        ADDRESSES: The docket for this action,
                                                Executive Order 12898, entitled                         Agricultural commodities, Pesticides                          identified by docket identification (ID)
                                                ‘‘Federal Actions to Address                            and pests, Reporting and recordkeeping                        number EPA–HQ–OPP–2016–0594, is
                                                Environmental Justice in Minority                       requirements.                                                 available at http://www.regulations.gov
                                                Populations and Low-Income                                                                                            or at the Office of Pesticide Programs
                                                Populations’’ (59 FR 7629, February 16,                    Dated: January 6, 2017.
                                                                                                                                                                      Regulatory Public Docket (OPP Docket)
                                                1994).                                                  Daniel J. Rosenblatt,                                         in the Environmental Protection Agency
                                                   Since tolerances and exemptions that                 Acting Director, Registration Division, Office                Docket Center (EPA/DC), West William
                                                are established on the basis of a petition              of Pesticide Programs.                                        Jefferson Clinton Bldg., Rm. 3334, 1301
                                                under FFDCA section 408(d), such as                                                                                   Constitution Ave. NW., Washington, DC
                                                the tolerance in this final rule, do not                  Therefore, 40 CFR chapter I is
                                                                                                                                                                      20460–0001. The Public Reading Room
                                                require the issuance of a proposed rule,                amended as follows:
                                                                                                                                                                      is open from 8:30 a.m. to 4:30 p.m.,
                                                the requirements of the Regulatory                                                                                    Monday through Friday, excluding legal
                                                Flexibility Act (RFA) (5 U.S.C. 601 et                  PART 180—[AMENDED]
                                                                                                                                                                      holidays. The telephone number for the
                                                seq.), do not apply.                                                                                                  Public Reading Room is (202) 566–1744,
                                                   This action directly regulates growers,              ■ 1. The authority citation for part 180
                                                                                                                                                                      and the telephone number for the OPP
                                                food processors, food handlers, and food                continues to read as follows:
                                                                                                                                                                      Docket is (703) 305–5805. Please review
                                                retailers, not States or tribes, nor does                   Authority: 21 U.S.C. 321(q), 346a and 371.                the visitor instructions and additional
                                                this action alter the relationships or                                                                                information about the docket available
                                                distribution of power and                               ■  2. In § 180.499, revise the entry for                      at http://www.epa.gov/dockets.
                                                responsibilities established by Congress                ‘‘Potato’’ in the table in paragraph (a) to
                                                                                                                                                                      FOR FURTHER INFORMATION CONTACT:
                                                in the preemption provisions of FFDCA                   read as follows:
                                                section 408(n)(4). As such, the Agency                                                                                Michael Goodis, Registration Division
                                                has determined that this action will not                § 180.499 Propamocarb; tolerances for                         (7505P), Office of Pesticide Programs,
                                                have a substantial direct effect on States              residues.                                                     Environmental Protection Agency, 1200
                                                or tribal governments, on the                                                                                         Pennsylvania Ave. NW., Washington,
                                                                                                            (a) * * *                                                 DC 20460–0001; main telephone
                                                relationship between the national
                                                government and the States or tribal                                                                                   number: (703) 305–7090; email address:
                                                                                                                                                       Parts per      RDFRNotices@epa.gov.
                                                governments, or on the distribution of                              Commodity                           million
                                                power and responsibilities among the                                                                                  SUPPLEMENTARY INFORMATION:
                                                various levels of government or between                                                                               I. General Information
                                                the Federal Government and Indian                       *            *             *             *         *
                                                tribes. Thus, the Agency has determined                                                                               A. Does this action apply to me?
                                                that Executive Order 13132, entitled                    Potato ...................................             0.30      You may be potentially affected by
                                                ‘‘Federalism’’ (64 FR 43255, August 10,                                                                               this action if you are an agricultural
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                                                1999) and Executive Order 13175,                        *            *             *             *         *          producer, food manufacturer, or
                                                entitled ‘‘Consultation and Coordination                                                                              pesticide manufacturer. The following
                                                with Indian Tribal Governments’’ (65 FR                                                                               list of North American Industrial
                                                67249, November 9, 2000) do not apply                   *       *        *         *        *                         Classification System (NAICS) codes is
                                                                                                        [FR Doc. 2017–02479 Filed 2–6–17; 8:45 am]
                                                to this action. In addition, this action                                                                              not intended to be exhaustive, but rather
                                                                                                        BILLING CODE 6560–50–P
                                                does not impose any enforceable duty or                                                                               provides a guide to help readers
                                                contain any unfunded mandate as                                                                                       determine whether this document


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                                                9524              Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations

                                                applies to them. Potentially affected                   follow the instructions at http://                    residential settings, but does not include
                                                entities may include:                                   www.epa.gov/dockets/contacts.html.                    occupational exposure. Section
                                                  • Crop production (NAICS code 111).                     Additional instructions on                          408(b)(2)(C) of FFDCA requires EPA to
                                                  • Animal production (NAICS code                       commenting or visiting the docket,                    give special consideration to exposure
                                                112).                                                   along with more information about                     of infants and children to the pesticide
                                                  • Food manufacturing (NAICS code                      dockets generally, is available at http://            chemical residue in establishing a
                                                311).                                                   www.epa.gov/dockets.                                  tolerance and to ‘‘ensure that there is a
                                                  • Pesticide manufacturing (NAICS                                                                            reasonable certainty that no harm will
                                                code 32532).                                            II. Summary of Petitioned-For
                                                                                                        Tolerance                                             result to infants and children from
                                                B. How can I get electronic access to                                                                         aggregate exposure to the pesticide
                                                                                                           In the Federal Register of October 27,             chemical residue . . . .’’
                                                other related information?                              2016 (81 FR 74754) (FRL–9953–98),                       Consistent with FFDCA section
                                                   You may access a frequently updated                  EPA issued a document pursuant to                     408(b)(2)(D), and the factors specified in
                                                electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.                    FFDCA section 408(b)(2)(D), EPA has
                                                regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                reviewed the available scientific data
                                                the Government Printing Office’s e-CFR                  pesticide petition (PP 4F8303) by Dow                 and other relevant information in
                                                site at http://www.ecfr.gov/cgi-bin/text-               AgroSciences, 9330 Zionsville Road,                   support of this action. EPA has
                                                idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Indianapolis, IN 46268. The petition                  sufficient data to assess the hazards of
                                                40tab_02.tpl.                                           requested that 40 CFR 180.142 be                      and to make a determination on
                                                                                                        amended by establishing tolerances for                aggregate exposure for 2,4–D, including
                                                C. How can I file an objection or hearing
                                                                                                        residues of the herbicide, 2,4–D (2,4-                exposure resulting from the tolerances
                                                request?                                                dichlorophenoxyacetic acid), both free                established by this action. EPA’s
                                                  Under FFDCA section 408(g), 21                        and conjugated, determined as the acid,               assessment of exposures and risks
                                                U.S.C. 346a, any person may file an                     in or on gin byproducts and undelinted                associated with 2,4–D follows.
                                                objection to any aspect of this regulation              seed of herbicide-tolerant cotton at 1.5
                                                and may also request a hearing on those                 and 0.08 parts per million (ppm)                      A. Toxicological Profile
                                                objections. You must file your objection                respectively. That document referenced                   EPA has evaluated the available
                                                or request a hearing on this regulation                 a summary of the petition prepared by                 toxicity data and considered its validity,
                                                in accordance with the instructions                     DowAgrosciences, the registrant, which                completeness, and reliability as well as
                                                provided in 40 CFR part 178. To ensure                  is available in the docket, http://                   the relationship of the results of the
                                                proper receipt by EPA, you must                         www.regulations.gov. Comments were                    studies to human risk. EPA has also
                                                identify docket ID number EPA–HQ–                       received on the notice of filing.                     considered available information
                                                OPP–2016–0594 in the subject line on                    Responses to these comments are                       concerning the variability of the
                                                the first page of your submission. All                  included in the document titled                       sensitivities of major identifiable
                                                objections and requests for a hearing                   Response to Public Comments Received                  subgroups of consumers, including
                                                must be in writing, and must be                         Regarding the Evaluation of Enlist                    infants and children. The toxicity
                                                received by the Hearing Clerk on or                     Duo TM on Enlist Corn, Cotton, and                    profile shows that 2,4–D is not acutely
                                                before April 10, 2017. Addresses for                    Soybeans, which is available in the                   toxic via the oral, dermal, and
                                                mail and hand delivery of objections                    docket. This document also includes                   inhalation routes, is not a dermal
                                                and hearing requests are provided in 40                 several comments and responses to                     irritant or a dermal sensitizer, but it is
                                                CFR 178.25(b).                                          those comments that are not specifically              a severe eye irritant. The principal toxic
                                                  In addition to filing an objection or                 relevant to this tolerance action but                 effects are changes in the kidney
                                                hearing request with the Hearing Clerk                  were submitted in response to EPA’s                   [increased kidney weight,
                                                as described in 40 CFR part 178, please                 proposed decision under FIFRA on the                  histopathological lesions], thyroid
                                                submit a copy of the filing (excluding                  pending associated application for                    [decreased thyroxine, increased thyroid
                                                any Confidential Business Information                   registration of a product containing 2,4–             weight, hyperplasia and hypertrophy of
                                                (CBI)) for inclusion in the public docket.              D. Because of the overlap in some of the              follicular cells], liver [increased liver
                                                Information not marked confidential                     comments, EPA has prepared a single                   weight, increased ALT and AST,
                                                pursuant to 40 CFR part 2 may be                        response to comments document, which                  histopathological lesions, including
                                                disclosed publicly by EPA without prior                 can be found in this docket, which is                 hypertrophy], adrenal [increased
                                                notice. Submit the non-CBI copy of your                 also the same docket for the pending                  adrenal weight, histopathological
                                                objection or hearing request, identified                pesticide action.                                     lesions], eye [retinal degeneration,
                                                by docket ID number EPA–HQ–OPP–                                                                               cataract formation, lens opacity], and
                                                                                                        III. Aggregate Risk Assessment and                    ovaries/testes [decreased testes weight
                                                2016–0594, by one of the following
                                                                                                        Determination of Safety                               and ovarian weight, atrophy] in the rat
                                                methods:
                                                  • Federal eRulemaking Portal: http://                    Section 408(b)(2)(A)(i) of FFDCA                   following exposure to 2,4–D via the oral
                                                www.regulations.gov. Follow the online                  allows EPA to establish a tolerance (the              route at dose levels above the threshold
                                                instructions for submitting comments.                   legal limit for a pesticide chemical                  of saturation of renal clearance. No
                                                Do not submit electronically any                        residue in or on a food) only if EPA                  systemic toxicity was observed in
                                                information you consider to be CBI or                   determines that the tolerance is ‘‘safe.’’            rabbits following repeated exposure via
                                                other information whose disclosure is                   Section 408(b)(2)(A)(ii) of FFDCA                     the dermal route at dose levels up to the
                                                restricted by statute.                                  defines ‘‘safe’’ to mean that ‘‘there is a            limit dose. Neurotoxicity, as evidenced
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                                                  • Mail: OPP Docket, Environmental                     reasonable certainty that no harm will                by the increased incidence of
                                                Protection Agency Docket Center (EPA/                   result from aggregate exposure to the                 incoordination and slight gait
                                                DC), (28221T), 1200 Pennsylvania Ave.                   pesticide chemical residue, including                 abnormalities (forepaw flexing or
                                                NW., Washington, DC 20460–0001.                         all anticipated dietary exposures and all             knuckling) was observed in the acute
                                                  • Hand Delivery: To make special                      other exposures for which there is                    neurotoxicity study in rats at the highest
                                                arrangements for hand delivery or                       reliable information.’’ This includes                 dose. In an extended 1-generation
                                                delivery of boxed information, please                   exposure through drinking water and in                reproductive toxicity study in rats,


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                                                                   Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations                                            9525

                                                reproductive toxicity, developmental                       the adverse effects caused by 2,4–D as                toxicological study to determine the
                                                neurotoxicity, and immunotoxicity were                     well as the no-observed-adverse-effect-               dose at which no adverse effects are
                                                not observed, and the thyroid effects                      level (NOAEL) and the lowest-observed-                observed (the NOAEL) and the lowest
                                                observed at dose levels up to/                             adverse-effect-level (LOAEL) from the                 dose at which adverse effects of concern
                                                approaching renal saturation were                          toxicity studies can be found at http://              are identified (the LOAEL). Uncertainty/
                                                considered treatment-related, although                     www.regulations.gov in document, 2,4–                 safety factors are used in conjunction
                                                not adverse. Neuropathological effects                     D. Human Health Risk Assessment for a                 with the POD to calculate a safe
                                                were not observed in any study.                            Proposed Use of 2,4–D Choline on                      exposure level—generally referred to as
                                                Maternal and developmental toxicity                        Herbicide-Tolerant Cotton at pgs. 40–50               a population-adjusted dose (PAD) or a
                                                were observed at high dose levels                          in docket ID number EPA–HQ–OPP–                       reference dose (RfD)—and a safe margin
                                                exceeding the threshold of saturation of                   2016–0594.                                            of exposure (MOE). For non-threshold
                                                renal clearance. There are no residual                                                                           risks, the Agency assumes that any
                                                                                                           B. Toxicological Points of Departure/
                                                uncertainties for pre- and/or postnatal                                                                          amount of exposure will lead to some
                                                                                                           Levels of Concern
                                                toxicity. 2,4–D has been classified as a                                                                         degree of risk. Thus, the Agency
                                                Category D chemical, ‘‘not classifiable as                    Once a pesticide’s toxicological                   estimates risk in terms of the probability
                                                to human carcinogenicity’’, based upon                     profile is determined, EPA identifies                 of an occurrence of the adverse effect
                                                bioassays in rats and mice that showed                     toxicological points of departure (POD)               expected in a lifetime. For more
                                                no statistically significant tumor                         and levels of concern to use in                       information on the general principles
                                                response in either species. The Agency                     evaluating the risk posed by human                    EPA uses in risk characterization and a
                                                has determined, based on several                           exposure to the pesticide. For hazards                complete description of the risk
                                                reviews of epidemiological studies, in                     that have a threshold below which there               assessment process, see http://
                                                addition to the animal studies, that the                   is no appreciable risk, the toxicological             www.epa.gov/pesticides/factsheets/
                                                existing data do not support a                             POD is used as the basis for derivation               riskassess.htm. A summary of the
                                                conclusion that links human cancer to                      of reference values for risk assessment.              toxicological endpoints for 2,4–D used
                                                2,4–D exposure. Specific information on                    PODs are developed based on a careful                 for human risk assessment is shown in
                                                the studies received and the nature of                     analysis of the doses in each                         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           RfD, PAD, LOC for
                                                        Exposure/scenario                                                                                        Study and toxicological effects
                                                                                               uncertainty/            risk assessment
                                                                                              safety factors

                                                Acute dietary (Females 13–50              Developmental              Acute RfD = 0.25           Developmental Toxicity Study—rat.
                                                  years of age).                            NOAEL = 25 mg/             mg/kg/day.               Developmental LOAEL = 75 mg/kg/day based on fetal skeletal
                                                                                            kg/day.                  aPAD = .025 mg/kg/           abnormalities (14th rudimentary ribs).
                                                                                          UFA = 10x                    day.
                                                                                          UFH = 10x
                                                                                          FQPA SF = 1x
                                                Acute dietary (General popu-              NOAEL = 67 mg/kg/          Acute RfD = 0.67           Acute Neurotoxicity Study—rat.
                                                  lation including infants and              day.                       mg/kg/day.               LOAEL = 227 mg/kg/day based on slight gait abnormalities
                                                  children).                              UFA = 10x                  aPAD = 0.67 mg/kg/           (forepaw flexing and knuckling) and increased incidence of
                                                                                          UFH = 10x                    day.                       incoordination.
                                                                                          FQPA SF = 1x
                                                Chronic dietary (All populations)         NOAEL= 21 mg/kg/           Chronic RfD = 0.21         Extended 1-generation Reproduction—rat.
                                                                                           day.                        mg/kg/day.               Parental LOAEL = 55.6 mg/kg/day (males) and 46.7 mg/kg/day
                                                                                          UFA = 10x                  cPAD = 0.21 mg/kg/           (females) based on kidney toxicity manifested as increased
                                                                                          UFH = 10x                    day.                       kidney weights and increased incidence of degeneration of
                                                                                          FQPA SF = 1x                                            the proximal convoluted tubules and for offspring based on
                                                                                                                                                  decreased body weight observed throughout lactation.
                                                Incidental oral short- and inter-         NOAEL = 21 mg/kg/          LOC for MOE = 100          Extended 1-generation Reproduction—rat.
                                                  mediate term (1 to 30 days               day.                                                 Parental LOAEL = 55.6 mg/kg/day (males) and 46.7 mg/kg/day
                                                  and 1–6 months).                        UFA = 10x                                               (females) based on kidney toxicity manifested as increased
                                                                                          UFH = 10x                                               kidney weights and increased incidence of degeneration of
                                                                                          FQPA SF = 1x                                            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 expo-
                                                                                              sure 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 equiv-
                                                                                              alent 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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                                                9526               Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations

                                                       TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 2,4–D FOR USE IN HUMAN HEALTH RISK
                                                                                         ASSESSMENT—Continued
                                                                                                 Point of
                                                                                              departure and           RfD, PAD, LOC for
                                                        Exposure/scenario                                                                                        Study and toxicological effects
                                                                                               uncertainty/            risk assessment
                                                                                              safety factors

                                                Inhalation (all durations) ...........    Inhalation study           LOC for MOE = 300          Subchronic inhalation toxicity study—rat.
                                                                                          LOAEL = 0.05 mg/L/                                    LOAEL = 0.05 mg/L/day based on portal-of-entry effects (squa-
                                                                                            day.                                                  mous metaplasia and epithelial hyperplasia with increased
                                                                                          HEC = 0.013 mg/L/                                       mixed inflammatory cells within the larynx); not totally re-
                                                                                            day (bystander).                                      solved following a 4-week recovery period.
                                                                                          HED = 1.76 mg/kg/
                                                                                            day (residential
                                                                                            handler)
                                                                                          UFA = 3x
                                                                                          UFH = 10x
                                                                                          UFL = 10x

                                                Cancer (Oral, dermal, inhala-                                     Classification: Group D—not classifiable as to human carcinogenicity.
                                                  tion).
                                                  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                                     the acute and chronic dietary                         Further information regarding EPA
                                                   1. Dietary exposure from food and                       assessment for cotton seed oil. For 2,4–              drinking water models used in pesticide
                                                feed uses. In evaluating dietary                           D, it was not possible to calculate a                 exposure assessment can be found at
                                                exposure to 2,4–D, EPA considered                          processing factor for refined oil because             http://www.epa.gov/oppefed1/models/
                                                exposure under the petitioned-for                          residues were non-detectable in both the              water/index.htm.
                                                tolerances as well as all existing 2,4–D                   RAC and the oil in the processing study.                 Modeled estimates of drinking water
                                                tolerances in 40 CFR 180.142. EPA                          Therefore, the Agency used a processing               concentrations based on the Surface
                                                assessed dietary exposures from 2,4–D                      factor of 1.0x, multiplied by the HAFT                Water Concentration Calculator (SWCC)
                                                in food as follows:                                        of undelinted cotton seed (0.07 ppm)                  were directly entered into the dietary
                                                   i. Acute and chronic exposure. In                       from the recently submitted magnitude                 exposure model.
                                                estimating acute and chronic dietary                       of residue study. The 2,4–DCP                            For acute dietary risk assessment, the
                                                exposure, EPA used 2003–2008 food                          processed commodity residue for                       water concentration value of 298 ppb
                                                consumption data from the U.S.                             refined oil (0.08 ppm), was calculated                was used to assess the contribution to
                                                Department of Agriculture’s (USDA’s)                       by multiplying the processing factor of               drinking water. For chronic dietary risk
                                                National Health and Nutrition                              0.4x by the HAFT of undelinted cotton                 assessment, the water concentration of
                                                Examination Survey, What We Eat in                         seed for 2,4–DCP (0.206 ppm). The 2,4–                value 34.5 ppb was used to assess the
                                                America (NHANES/WWEIA). As to                              D residue product (0.07 ppm) was then                 contribution to drinking water.
                                                residue levels in food, EPA assumed                        added with the 2,4–DCP residue                           3. From non-dietary exposure. The
                                                that 100% of all crops had been treated                    product (0.08 ppm) and the sum was                    term ‘‘residential exposure’’ is used in
                                                and conservative default processing                        0.15 ppm.                                             this document to refer to non-
                                                factors were used for all relevant                            ii. Cancer. Based on the data                      occupational, non-dietary exposure
                                                processed commodities. EPA also                            summarized in Unit III.A., EPA has                    (e.g., for lawn and garden pest control,
                                                assumed tolerance-level residues for all                   concluded that 2,4–D does not pose a                  indoor pest control, termiticides, and
                                                commodities excluding transgenic                           cancer risk to humans. Therefore, a                   flea and tick control on pets).
                                                soybean and cotton commodities. For                        dietary exposure assessment for the                      2,4–D is currently registered for the
                                                transgenic soybean, the combined 2,4–D                     purpose of assessing cancer risk is                   following uses that could result in
                                                and 2,4–DCP residues were used for the                     unnecessary.                                          residential exposures: Ornamental turf,
                                                acute and chronic dietary analyses as                         iii. Anticipated residue and percent               including parks, sports fields, and golf
                                                the combined residues found in tolerant                    crop treated (PCT) information. EPA did               courses, as well as aquatic uses. The
                                                soybean were greater than the tolerance                    not use anticipated residue and/or PCT                existing residential uses were
                                                of parent only for soybean. Since                          information in the dietary assessment                 previously assessed in 2013. However,
                                                residue levels of parent 2,4–D in/on                       for 2,4–D. Tolerance level residues and/              since that time there have been changes
                                                tolerant soybean were non-detectable,                      or 100% CT were assumed for all food                  to the policy for calculating inhalation
                                                estimated 2,4–D residues (at 1⁄2 the level                 commodities.                                          HECs and the policy for assessing
                                                of detection of 0.003 ppm, or 0.0015                          2. Dietary exposure from drinking                  aquatic exposure; therefore, the
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                                                ppm) were added to the 2,4–DCP                             water. The Agency used screening level                residential scenarios have been
                                                highest average field trial residue                        water exposure models in the dietary                  reassessed. EPA assumes that residential
                                                (HAFT is 0.047 ppm) to be used in the                      exposure analysis and risk assessment                 handlers complete all elements of an
                                                acute and chronic dietary analyses. For                    for 2,4–D in drinking water. These                    application without use of any
                                                the proposed new use on transgenic                         simulation models take into account                   protective equipment or baseline attire
                                                cotton, a combined 2,4–D and 2,4–DCP                       data on the physical, chemical, and fate/             such as long pants and long-sleeved
                                                residue value of 0.15 ppm was used in                      transport characteristics of 2,4–D.                   shirt. Quantitative short-term inhalation


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                                                                  Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations                                         9527

                                                exposure estimates for adult residential                www.epa.gov/pesticide-science-and-                    there are no data gaps in the toxicology
                                                handlers are based on the scenarios of                  assessing-pesticide-risks/cumulative-                 database, and the points of departure
                                                mixing, loading, and application of 2,4–                assessment-risk-pesticides.                           (POD) are protective of susceptibility.
                                                D to lawns and turf at maximum rates                                                                          The exposure assessment will not
                                                                                                        D. Safety Factor for Infants and
                                                using hose-end sprayers, manually-                                                                            underestimate children’s exposure to
                                                                                                        Children
                                                pressurized hand wands, and backpack                                                                          2,4–D.
                                                sprayers with liquid and ready-to-use                      1. In general. Section 408(b)(2)(C) of                3. Conclusion. EPA has determined
                                                forms, as well as belly grinders and                    FFDCA provides that EPA shall apply                   that reliable data show the safety of
                                                push-type spreaders. Intermediate-term                  an additional tenfold (10X) margin of                 infants and children would be
                                                exposures are not likely and were not                   safety for infants and children in the                adequately protected if the FQPA SF
                                                estimated because of the intermittent                   case of threshold effects to account for              were reduced to 1X. That decision is
                                                nature of applications by homeowners.                   prenatal and postnatal toxicity and the               based on the following findings:
                                                Dermal exposures were also not                          completeness of the database on toxicity                 i. The toxicity database for 2,4–D is
                                                estimated due to the lack of dermal                     and exposure unless EPA determines                    complete.
                                                hazard.                                                 based on reliable data that a different                  ii. Although there are indications of
                                                   In addition to residential handler                   margin of safety will be safe for infants             neurotoxicity observed in the acute
                                                exposure, the following post-application                and children. This additional margin of               neurotoxicity study in rats, as evidenced
                                                exposure scenarios were estimated for                   safety is commonly referred to as the                 by an increase in the incidence of in-
                                                short-term duration to protect adults                   FQPA Safety Factor (SF). In applying                  coordination and slight gait
                                                and children that might be playing in                   this provision, EPA either retains the                abnormalities (forepaw flexing or
                                                treated turf areas or swimming in                       default value of 10X, or uses a different             knuckling) at the high dose in both
                                                treated aquatic areas after applications                additional safety factor when reliable                sexes, developmental neurotoxicity was
                                                of 2,4–D have been made at the                          data available to EPA support the choice              not observed in the developmental
                                                maximum rates:                                          of a different factor.                                neurotoxicity segment of the extended
                                                   • Incidental ingestion (i.e., hand-to-                  2. Prenatal and postnatal sensitivity.             1-generation reproductive toxicity study
                                                mouth, object-to-mouth, soil ingestion                  There is evidence of increased                        in rats.
                                                exposure) from contact with treated turf                susceptibility following in utero                        iii. For the reasons stated in Unit
                                                (children 1 <2 years old only)                          exposure to 2,4–D in the rat                          III.D.2., there is no residual uncertainty
                                                   • Episodic granular ingestion on                     developmental toxicity study and                      concerning the potential susceptibility
                                                treated turf (children 1 <2 years old                   following in utero and/or pre-/post-natal             of infants and children to effects of 2,4–
                                                only)                                                   exposure in the rat 2-generation                      D; therefore, there is no need to retain
                                                   • Incidental ingestion of water during               reproduction study. There is no                       the 10X FQPA safety factor to protect
                                                recreational swimming (both adults and                  evidence of increased susceptibility                  infants and children.
                                                children 3 <6 years old).                               following in utero exposure to 2,4–D in                  iv. There are no residual uncertainties
                                                   None of the above exposure scenarios                 the rabbit developmental toxicity study               identified in the exposure databases.
                                                resulted in handler or post-application                 or following in utero and/or pre-/post-               The dietary food exposure assessments
                                                risk estimates that exceed EPA’s level of               natal exposure in the rat extended 1-                 were performed based on 100% crop
                                                concern. Further information regarding                  generation reproduction toxicity study.               treated and tolerance-level or higher
                                                EPA standard assumptions and generic                       2,4–D has been evaluated for potential             residues assumptions. EPA made
                                                inputs for residential exposures may be                 developmental effects in the rat and                  conservative (protective) assumptions in
                                                found at https://www.epa.gov/pesticide-                 rabbit. Maternal toxicity included                    the ground and surface water modeling
                                                science-and-assessing-pesticide-risks/                  decreased body weight gains in the rat                used to assess exposure to 2,4–D in
                                                standard-operating-procedures-                          study at the same dose level where                    drinking water. EPA used similarly
                                                residential-pesticide.                                  developmental effects (occurrence of                  conservative assumptions to assess post-
                                                   4. Cumulative effects from substances                skeletal malformations) were observed.                application exposure of children. These
                                                with a common mechanism of toxicity.                    Kidney effects would have been                        assessments will not underestimate the
                                                Section 408(b)(2)(D)(v) of FFDCA                        expected in the maternal animal had                   exposure and risks posed by 2,4–D.
                                                requires that, when considering whether                 examination of the kidney been
                                                to establish, modify, or revoke a                       performed, and the findings are not                   E. Aggregate Risks and Determination of
                                                tolerance, the Agency consider                          considered evidence of susceptibility.                Safety
                                                ‘‘available information’’ concerning the                   Maternal toxicity in the rabbit                       EPA determines whether acute and
                                                cumulative effects of a particular                      included decreased body weight gain,                  chronic dietary pesticide exposures are
                                                pesticide’s residues and ‘‘other                        clinical signs of toxicity (decreased                 safe by comparing aggregate exposure
                                                substances that have a common                           motor activity, ataxia, loss of righting              estimates to the acute PAD (aPAD) and
                                                mechanism of toxicity.’’ EPA has not                    reflex, extremities cold to the touch),               chronic PAD (cPAD). For linear cancer
                                                found 2,4–D to share a common                           and abortions, the latter being indicative            risks, EPA calculates the lifetime
                                                mechanism of toxicity with any other                    of developmental toxicity. Decreased                  probability of acquiring cancer given the
                                                substances, and 2,4–D does not appear                   maternal body weight gains were                       estimated aggregate exposure. Short-,
                                                to produce a toxic metabolite produced                  observed in the rat 2-generation                      intermediate-, and chronic-term risks
                                                by other substances. For the purposes of                reproduction study at a dose that                     are evaluated by comparing the
                                                this tolerance action, therefore, EPA has               exceeded renal saturation and resulted                estimated aggregate food, water, and
                                                assumed that 2,4–D does not have a                      in reduced viability of the F1 pups.                  residential exposure to the appropriate
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                                                common mechanism of toxicity with                       Although decreased maternal body                      PODs to ensure that an adequate MOE
                                                other substances. For information                       weight gain is a conservative endpoint,               exists.
                                                regarding EPA’s efforts to determine                    points of departure used in the risk                     1. Acute risk. Using the exposure
                                                which chemicals have a common                           assessment are below where these                      assumptions discussed in this unit for
                                                mechanism of toxicity and to evaluate                   findings occur and are protective. There              acute exposure, the acute dietary
                                                the cumulative effects of such                          are clearly established NOAELs and                    exposure from food and water to 2,4–D
                                                chemicals, see EPA’s Web site at https://               LOAELs for the population of concern,                 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               species as well as several reviews of                 EPA explain the reasons for departing
                                                group receiving the greatest exposure.                  epidemiological studies, in addition to               from the Codex level. The Codex has not
                                                   2. Chronic risk. Using the exposure                  the animal studies, the Agency has                    established a MRL for 2,4–D on cotton.
                                                assumptions described in this unit for                  classified 2,4–D as a Category D
                                                chronic exposure, EPA has concluded                                                                           V. Conclusion
                                                                                                        chemical, i.e., not classifiable as to
                                                that chronic exposure to 2,4–D from                     human carcinogenicity, and is not                       Therefore, tolerances are established
                                                food and water will utilize 20% of the                  expected to pose a cancer risk to                     for residues of 2,4–D (2,4-
                                                cPAD for children 1 to 2 years old the                  humans.                                               dichlorophenoxyacetic acid) in or on
                                                population group receiving the greatest                    6. Determination of safety. Based on               gin byproducts and undelinted seed of
                                                exposure. Based on the explanation in                   these risk assessments, EPA concludes                 cotton at 1.5 and 0.08 ppm respectively.
                                                Unit III.C.3., regarding residential use                that there is a reasonable certainty that             VI. Statutory and Executive Order
                                                patterns, chronic residential exposure to               no harm will result to the general                    Reviews
                                                residues of 2,4–D is not expected.                      population, or to infants and children
                                                   3. Short-term risk. Short-term                       from aggregate exposure to 2,4–D                         This action establishes tolerances
                                                aggregate exposure takes into account                                                                         under FFDCA section 408(d) in
                                                                                                        residues.
                                                short-term residential exposure plus                                                                          response to a petition submitted to the
                                                chronic exposure to food and water                      IV. Other Considerations                              Agency. The Office of Management and
                                                (considered to be a background                                                                                Budget (OMB) has exempted these types
                                                                                                        A. Analytical Enforcement Methodology
                                                exposure level). 2,4–D is currently                                                                           of actions from review under Executive
                                                registered for uses that could result in                   Adequate analytical methods are                    Order 12866, entitled ‘‘Regulatory
                                                short-term residential exposure, and the                available for data collection and the                 Planning and Review’’ (58 FR 51735,
                                                Agency has determined that it is                        enforcement of plant commodity                        October 4, 1993). Because this action
                                                appropriate to aggregate chronic                        tolerances, including cotton. Task Force              has been exempted from review under
                                                exposure through food and water with                    II submitted an adequate GC/ECD                       Executive Order 12866, this action is
                                                short-term residential exposures to 2,4–                enforcement method for plants                         not subject to Executive Order 13211,
                                                D. Using the exposure assumptions                       (designated as EN–CAS Method No.                      entitled ‘‘Actions Concerning
                                                described in this unit for short-term                   ENC–2/93) which has been                              Regulations That Significantly Affect
                                                exposures, EPA has concluded the                        independently validated and                           Energy Supply, Distribution, or Use’’ (66
                                                combined short-term food, water, and                    radiovalidated. An enforcement method                 FR 28355, May 22, 2001) or Executive
                                                residential exposures result in aggregate               was submitted for determination of 2,4–               Order 13045, entitled ‘‘Protection of
                                                MOEs of 2,000 for adults, 560 for                       D in livestock commodities, which has                 Children from Environmental Health
                                                children ages 3–5 that are exposed to                   been adequately radiovalidated. The                   Risks and Safety Risks’’ (62 FR 19885,
                                                2,4–D residues via incidental ingestion                 methods have been submitted to FDA                    April 23, 1997). This action does not
                                                of treated water during swimming                        for inclusion in PAM II. The 10/1997                  contain any information collections
                                                activities. The aggregate MOE of 280 is                 edition of FDA PAM Volume I,                          subject to OMB approval under the
                                                estimated for children ages 1–2 that                    Appendix I indicates that 2,4–D is                    Paperwork Reduction Act (PRA) (44
                                                exhibit hand-to-mouth behavior on                       partially recovered (50–80%) using                    U.S.C. 3501 et seq.), nor does it require
                                                treated turf. Because EPA’s level of                    Multiresidue Methods Section 402 E1                   any special considerations under
                                                concern for 2,4–D is a MOE of 100 or                    and 402 E2.                                           Executive Order 12898, entitled
                                                below, these MOEs are not of concern.                      These methods may be requested                     ‘‘Federal Actions to Address
                                                   4. Intermediate-term risk.                           from: Chief, Analytical Chemistry                     Environmental Justice in Minority
                                                Intermediate-term aggregate exposure                    Branch, Environmental Science Center,                 Populations and Low-Income
                                                takes into account intermediate-term                    701 Mapes Rd., Ft. Meade, MD 20755–                   Populations’’ (59 FR 7629, February 16,
                                                residential exposure plus chronic                       5350; telephone number: (410) 305–                    1994).
                                                exposure to food and water (considered                  2905; email address: residuemethods@                     Since tolerances and exemptions that
                                                to be a background exposure level). An                  epa.gov.                                              are established on the basis of a petition
                                                intermediate-term adverse effect was                                                                          under FFDCA section 408(d), such as
                                                                                                        B. International Residue Limits
                                                identified; however, 2,4–D is not                                                                             the tolerance in this final rule, do not
                                                registered for any use patterns that                      In making its tolerance decisions, EPA              require the issuance of a proposed rule,
                                                would result in intermediate-term                       seeks to harmonize U.S. tolerances with               the requirements of the Regulatory
                                                residential exposure. Intermediate-term                 international standards whenever                      Flexibility Act (RFA) (5 U.S.C. 601 et
                                                risk is assessed based on intermediate-                 possible, consistent with U.S. food                   seq.), do not apply.
                                                term residential exposure plus chronic                  safety standards and agricultural                        This action directly regulates growers,
                                                dietary exposure. Because there is no                   practices. EPA considers the                          food processors, food handlers, and food
                                                intermediate-term residential exposure                  international maximum residue limits                  retailers, not States or tribes, nor does
                                                and chronic dietary exposure has                        (MRLs) established by the Codex                       this action alter the relationships or
                                                already been assessed under the                         Alimentarius Commission (Codex), as                   distribution of power and
                                                appropriately protective cPAD (which is                 required by FFDCA section 408(b)(4).                  responsibilities established by Congress
                                                at least as protective as the POD used to               The Codex Alimentarius is a joint                     in the preemption provisions of FFDCA
                                                assess intermediate-term risk), no                      United Nations Food and Agriculture                   section 408(n)(4). As such, the Agency
                                                further assessment of intermediate-term                 Organization/World Health                             has determined that this action will not
                                                risk is necessary, and EPA relies on the                Organization food standards program,                  have a substantial direct effect on States
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                                                chronic dietary risk assessment for                     and it is recognized as an international              or tribal governments, on the
                                                evaluating intermediate-term risk for                   food safety standards-setting                         relationship between the national
                                                2,4–D.                                                  organization in trade agreements to                   government and the States or tribal
                                                   5. Aggregate cancer risk for U.S.                    which the United States is a party. EPA               governments, or on the distribution of
                                                population. Based on bioassays in rats                  may establish a tolerance that is                     power and responsibilities among the
                                                and mice that show no statistically                     different from a Codex MRL; however,                  various levels of government or between
                                                significant tumor response in either                    FFDCA section 408(b)(4) requires that                 the Federal Government and Indian


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                                                                  Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations                                            9529

                                                tribes. Thus, the Agency has determined                                                                  and set an effective date of January 29,
                                                                                                                                                 Parts per
                                                                                                                  Commodity
                                                that Executive Order 13132, entitled                                                              million2017. November Decision, slip op. at 4;
                                                ‘‘Federalism’’ (64 FR 43255, August 10,                                                                  81 FR 87472. On January 20, 2017, a
                                                1999) and Executive Order 13175,                                                                         Memorandum for the Heads of
                                                entitled ‘‘Consultation and Coordination                    *         *         *         *        *
                                                                                                        Cotton, gin byproducts .........             1.5
                                                                                                                                                         Executive Departments and Agencies
                                                with Indian Tribal Governments’’ (65 FR
                                                                                                        Cotton, undelinted seed .......            0.08 from Reince Priebus, Chief of Staff to
                                                67249, November 9, 2000) do not apply                                                                    President Trump, was issued.1 Although
                                                to this action. In addition, this action                    *         *         *         *        *     the Board is an independent regulatory
                                                does not impose any enforceable duty or                                                                  agency, it will stay the January 29, 2017
                                                contain any unfunded mandate as                         *      *     *      *      *                     effective date in Docket No. EP 724
                                                described under Title II of the Unfunded                [FR Doc. 2017–02477 Filed 2–6–17; 8:45 am]       (Sub–No. 4) in accordance with the
                                                Mandates Reform Act (UMRA) (2 U.S.C.                    BILLING CODE 6560–50–P                           Memorandum’s request that the
                                                1501 et seq.).                                                                                           effective date of rules published in the
                                                   This action does not involve any                                                                      Federal Register that had not yet
                                                technical standards that would require
                                                                                                        SURFACE TRANSPORTATION BOARD become effective be postponed for 60
                                                Agency consideration of voluntary                                                                        days. 2 As a result, the final rule in
                                                consensus standards pursuant to section                 49 CFR Part 1250                                 Docket No. EP 724 (Sub–No. 4) will now
                                                12(d) of the National Technology                                                                         be stayed until March 21, 2017, and
                                                Transfer and Advancement Act                            [Docket No. EP 724 (Sub–No. 4)]
                                                                                                                                                         initial reporting will begin March 29,
                                                (NTTAA) (15 U.S.C. 272 note).                                                                            2017.
                                                                                                        United States Rail Service Issues—
                                                VII. Congressional Review Act                           Performance Data Reporting                           The final rule adopted requirements
                                                  Pursuant to the Congressional Review                  AGENCY: Surface Transportation Board.
                                                                                                                                                         for   reporting cars in fertilizer service, as
                                                Act (5 U.S.C. 801 et seq.), EPA will                                                                     defined by 14 Standard Transportation
                                                                                                        ACTION: Final rule; stay of regulations.
                                                submit a report containing this rule and                                                                 Commodity Codes (STCCs) that The
                                                other required information to the U.S.                  SUMMARY: On December 5, 2016, the                Fertilizer Institute (TFI) provided in
                                                Senate, the U.S. House of                               Board published a final rule in this             comments. November Decision, slip op.
                                                Representatives, and the Comptroller                    docket that established new regulations          at 15. On December 20, 2016, TFI
                                                General of the United States prior to                   requiring all Class I railroads and the          petitioned the Board to reconsider the
                                                publication of the rule in the Federal                  Chicago Transportation Coordination              final rule to modify the definition of
                                                Register. This action is not a ‘‘major                  Office (CTCO), through its Class I               fertilizer by adding one STCC to the 14
                                                rule’’ as defined by 5 U.S.C. 804(2).                   members, to report certain service               that were previously included in the
                                                List of Subjects in 40 CFR Part 180                     performance metrics on a weekly,                 final rule. The Board will rule on the
                                                                                                        semiannual, and occasional basis. The            petition in a subsequent decision.
                                                  Environmental protection,                             Board is staying the effective date of the           It is ordered:
                                                Administrative practice and procedure,                  final rule.
                                                Agricultural commodities, Pesticides                                                                         1. The final rule in the November
                                                                                                        DATES: Effective February 7, 2017 and
                                                and pests, Reporting and recordkeeping                                                                   Decision, which was published in the
                                                                                                        applicable on January 27, 2017, the final Federal Register on December 5, 2016,
                                                requirements.
                                                                                                        rule establishing 49 CFR part 1250               will be stayed until March 21, 2017. The
                                                   Dated: January 9, 2017.                              published at 81 FR 87472 on December             initial reporting date will be March 29,
                                                Michael J. Goodis,                                      5, 2016, is stayed until March 21, 2017.
                                                                                                                                                         2017.
                                                Acting Director, Registration Division, Office          The initial reporting date under the final
                                                of Pesticide Programs.                                  rule will be March 29, 2017.                         2. Notice of the Board’s action will be
                                                                                                        FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                         published      in the Federal Register.
                                                  Therefore, 40 CFR chapter I is
                                                amended as follows:                                     Sarah Fancher at (202) 245–0355.                    Decided: January 27, 2017.
                                                                                                        Assistance for the hearing impaired is              By the Board, Rachel D. Campbell,
                                                PART 180—[AMENDED]                                      available through the Federal                    Director, Office of Proceedings.
                                                                                                        Information Relay Service (FIRS) at              Brendetta S. Jones,
                                                ■ 1. The authority citation for part 180                (800) 877–8339.
                                                continues to read as follows:                                                                            Clearance Clerk.
                                                                                                        SUPPLEMENTARY INFORMATION: On
                                                                                                                                                         [FR Doc. 2017–02492 Filed 2–6–17; 8:45 am]
                                                    Authority: 21 U.S.C. 321(q), 346a and 371.          November 30, 2016, the Board adopted
                                                                                                                                                         BILLING CODE 4915–01–P
                                                ■ 2. In § 180.142:                                      a final rule to establish new regulations
                                                ■ a. Add alphabetically the                             requiring all Class I railroads and the             1 Reince Priebus, Memorandum for the Heads of
                                                commodities ‘‘Cotton, gin byproducts’’                  CTCO, through its Class I members, to            Executive Departments and Agencies
                                                and ‘‘cotton, undelinted seed’’ to the                  report certain service performance               (Memorandum) (Jan. 20, 2017), http://
                                                table in paragraph (a); and                             metrics on a weekly, semiannual, and             www.whitehouse.gov/briefing-room/presidential-
                                                ■ b. Remove the entry for ‘‘cotton,                     occasional basis. U.S. Rail Serv. Issues— actions (follow hyperlink to Memorandum for the
                                                undelinted seed’’ from the table in                     Performance Data Reporting (November Heads of Executive Departments and Agencies).
                                                                                                                                                            2 The Board’s entire decision, U.S. Rail Serv.
                                                paragraph (d) to read as follows:                       Decision), EP 724 (Sub–No. 4), slip op.
                                                                                                                                                         Issues—Data Collection, EP 724 (Sub–No. 3) et al.
mstockstill on DSK3G9T082PROD with RULES




                                                                                                        at 1 (STB served Nov. 30, 2016). The             (STB served Jan. 27, 2017), is available on the
                                                § 180.142    2,4–D; tolerances for residues.            Board published the final rule in the            Board’s Web site by search at https://www.stb.gov/
                                                    (a) * * *                                           Federal Register on December 5, 2016,            home.nsf/enhancedsearch?OpenForm.




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Document Created: 2017-02-07 00:27:39
Document Modified: 2017-02-07 00:27:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 9523 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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