[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Rules and Regulations]
[Pages 9523-9529]
[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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document

applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at 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,

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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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.
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 FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. HEC = Human
  Equivalent Concentration (mg/L). HED = Human Equivalent Dose (mg/kg/day).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 2,4-D, EPA considered exposure under the petitioned-for
tolerances as well as all existing 2,4-D tolerances in 40 CFR 180.142.
EPA assessed dietary exposures from 2,4-D in food as follows:
    i. Acute and chronic exposure. In estimating acute and chronic
dietary exposure, EPA used 2003-2008 food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, EPA assumed that 100% of all crops had been
treated and conservative default processing factors were used for all
relevant processed commodities. EPA also assumed tolerance-level
residues for all commodities excluding transgenic soybean and cotton
commodities. For transgenic soybean, the combined 2,4-D and 2,4-DCP
residues were used for the acute and chronic dietary analyses as the
combined residues found in tolerant soybean were greater than the
tolerance of parent only for soybean. Since residue levels of parent
2,4-D in/on tolerant soybean were non-detectable, estimated 2,4-D
residues (at \1/2\ the level of detection of 0.003 ppm, or 0.0015 ppm)
were added to the 2,4-DCP highest average field trial residue (HAFT is
0.047 ppm) to be used in the acute and chronic dietary analyses. For
the proposed new use on transgenic cotton, a combined 2,4-D and 2,4-DCP
residue value of 0.15 ppm was used in 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

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

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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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

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


19755 Federal Register / Vol. 65, No. 71 / Wednesday, April 12, 2000 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OPP   00621A; FRL   6552   1]

Pesticides; Data Submitter Rights for Data Submitted in Support of Tolerance Actions; Notice of Availability; Reopening of Comment Period AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: On January 19, 2000 ( 65 FR 2947) ( FRL   6385   7), EPA announced the availability for comment of a paper discussing options to enable the Agency to appropriately implement the new provisions contained in section 408( i) of the Federal Food, Drug, and Cosmetic Act ( FFDCA) to address exclusive use and compensation rights for data submitted to EPA in support of tolerance and tolerance exemption actions. The comment period closed on March 20, 2000. However, the Agency received requests to extend the comment period. This notice announces the reopening of the comment period for an additional 30 days. DATES: Comments, identified by docket control number OPP   00621A must be received on or before May 12, 2000. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP   00621A in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Cameo G. Smoot, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305   5454; fax number: ( 703) 305   5884; e mail address: smoot. cameo@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to you if you submit data to EPA in support of establishing or maintaining tolerances for pesticides, or are a pesticide registrant or a person applying for pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). You may also be interested in commenting if you submit data to EPA in support of an exemption from a tolerance. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations'' and then look up the entry for this document under the `` Federal Register   Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. You may obtain a copy of the options paper described in this notice by accessing this Federal Register notice using the Federal Register Environmental Documents cite on EPA's Internet and selecting `` Related Documents.'' Hard copies of the options paper are available by consulting with the person listed under FOR FURTHER INFORMATION CONTACT.

2. In person. The Agency has established an official record for this action under docket control number OPP   00621A. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305   5805. C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP   00621A in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305   5805. 3. Electronically. You may submit your comments electronically by e mail to: `` opp docket@ epa. gov,'' or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP   00621A. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior VerDate 20< MAR> 2000 17: 44 Apr 11, 2000 Jkt 190000 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 12APN1. SGM pfrm01 PsN: 12APN1 19756 Federal Register / Vol. 65, No. 71 / Wednesday, April 12, 2000 / Notices notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA is reopening the comment period for an additional 30 days and will continue to make available for comment an options paper on exclusive use and data compensation rights for data submitted to the Agency in support of tolerance and tolerance exemption actions. As part of the Food Quality Protection Act of 1996, Congress amended section 408( i) of the FFDCA addressing such rights. The Agency is currently evaluating how to implement this new provision and is seeking public comment. The options paper briefly discusses the new section 408( i) of the FFDCA and the Agency's practices regarding data compensation and exclusive use; the current compensation and exclusive use process the Agency implements under section 3 of FIFRA; and presents three options for implementing the new provision. The options represent different interpretations focusing on who the data submitters may be. However, the Agency also seeks comments on other interpretations of section 408( i) and suggested procedures for implementing whatever option the commenter prefers. EPA will consider the comments received and develop a detailed proposal for implementing data rights under section 408( i) of FFDCA. List of Subjects Environmental protection, Pesticide tolerances, Data compensation.

Dated: April 4, 2000. Marcia E. Mulkey, Director, Office of Pesticide Programs. [ FR Doc. 00   9097 Filed 4   11   00; 8: 45 am]

BILLING CODE 6560   50   F ENVIRONMENTAL PROTECTION AGENCY [ PF   934; FRL   6551   8]

Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the amendment of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments identified by docket control number PF   934, must be received on or before May 12, 2000. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the `` SUPPLEMENTARY INFORMATION.'' To ensure proper receipt by EPA, it is imperative that you identify docket control number PF   934 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Mary Waller, fungicide Branch, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308   9354; e mail address: waller. mary@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production Categories NAICS codes Examples of potentially affected entities 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations'' and then look up the entry for this document under the `` Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number PF   934. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m.,

VerDate 20< MAR> 2000 17: 44 Apr 11, 2000 Jkt 190000 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 12APN1. SGM pfrm01 PsN: 12APN1


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
	WASHINGTON, DC 20460

                    OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

	PC Code: 090100
                                       DP Barcode: 410516,412426, 412427, 412479
	Date: November 27, 2013

MEMORANDUM

Subject:	Chlorantraniliprole (E2Y45): Ecological Risk Assessment to Support New Use on Peanut, Subgroup Additions to Previously Assessed Crop Groups, and Evaluation of Multiple Crop Seasons for Numerous Previously Assessed Uses

To:		Venus Eagle, Product Manager 01
            Jennifer Urbanski, Risk Manager Reviewer
		Registration Division (7505P)

From:		Michael B. Lowit, Ph.D., Ecologist
		Christopher M. Koper, Chemist
		Monica Wait, Acting RAPL
      Sujatha Sankula, Ph.D., Branch Chief
      Environmental Risk Branch I
      Environmental Fate and Effects Division (7507P)
		Office of Pesticide Programs

This memorandum summarizes the ecological risks associated with proposed new uses of the insecticide chlorantraniliprole.  In addition, the Coragen(R) label now includes annual limits for certain crops that reflect multiple crop seasons; risk associated with multiple crop seasons was considered due to the persistence of chlorantraniliprole.  The risk assessment considers three products: Altacor[(R)] (Reg. # 352-730), Coragen[(R)] (Reg. # 352-729), and Prevathon(TM) (Reg. # 352-844).

Foliar applications (ground or aerial spray and overhead chemigation) are proposed up to 0.065 - 0.067 lb ai/A for peanut use depending on the product (Coragen[(R)] or Prevathon(TM)); the minimum application interval is three days and the annual limit is 0.2 lb ai/A of chlorantraniliprole containing products.

The following label changes were proposed:  update stone fruit crops to group 12-12 and tree nut crops to group to 14-2 (commodities added, no rate change); add green onion subgroup 3-07B to the bulb vegetable group (no rate change); increase the tolerance for spice subgroup 19B; and add a last application day before harvest (10 days) for papaya and passionfruit (tropical fruit group).  These changes do not affect the risk conclusions from previous assessments and are not considered further.
Numerous crops were previously assessed assuming that the annual maximum application rate was equivalent to the seasonal application rate (0.2 lb ai/A).  The Coragen[(R)] label now provides an annual limit for many crops that reflect multiple crop seasons (0.4 lb ai/A - 0.8 lb ai/A).  The single application rates, application intervals, and seasonal rates have not changed.
1.	Risk Summary

Risk concerns for the proposed use on peanut and for multiple crop seasons of previously assessed uses (see Table 2) are the same as previous assessments (i.e., the same taxonomic groups); however the RQs for multiple crop seasons are higher than single crop seasons.  There is a risk concern for direct effects on listed and non-listed aquatic invertebrates (acute and chronic).   Risk to terrestrial invertebrates is a concern considering the application rates, the submitted toxicity data, and the mode of action of chlorantraniliprole as an insecticide.  Finally, potential risks to listed terrestrial plants cannot be precluded at this time because a definitive NOEC or EC05 has not been established for dicots.  Risk of direct effects to other aquatic and terrestrial organisms is below the Agency screening levels of concern (LOC).  A summary of risk concerns is presented in Table 1.

Table 1.  Summary of LOC Exceedences for the Assessed Uses of Chlorantraniliprole
                                    Effect
                                Taxonomic Group

                                     Birds
                                    Mammals
                                  Terrestrial
                                    Plants
                           Terrestrial Invertebrates
                                     Fish
                             Aquatic Invertebrates
                                Aquatic Plants
Direct Effect (LOC Exceedence)
                                      --
                                      --
                                     --[a]
                                    √[b]
                                      --
                                      √
                                      --
Indirect Effect Potential
                                      √
                                      √
                                      √
                                      √
                                      √
                                      √
                                      √
[a]The available data could not preclude potential risk to terrestrial plants: dicots (listed and non-listed species).
[b]RQs were not calculated due to lack of a standard quantification methodology. Therefore, the `LOC exceedance' was based on lines of evidence including application rate, toxicity data, and the mode of action of chlorantraniliprole.
2.	Data Gaps

 Risk quotients (RQs) could not be calculated for listed dicots (terrestrial plants) because a NOEC or EC05 was not established in the available Tier 1 or Tier II seedling emergence studies.   Risk to listed dicots will be assumed until data is made available that defines a NOEC for dicots.

3.	Summary of Proposed Use

Foliar applications (ground or aerial spray and overhead chemigation) are proposed up to 0.065 - 0.067 lb ai/A for peanut use depending on the product (Coragen[(R)] or Prevathon(TM)).  The Coragen label does not permit overhead chemigation for use on peanut.

The following label changes were proposed:  update stone fruit crops to group 12-12 and tree nut crops to group to 14-2 (commodities added, no rate change); add green onion subgroup 3-07B to the bulb vegetables group (no rate change); increase the tolerance for spice subgroup 19B; and add a last application day before harvest (10 days) for papaya and passionfruit (tropical fruit group).

Numerous crops were previously assessed assuming that the annual maximum application rate was equivalent to the seasonal application rate (0.2 lb ai/A).  The Coragen[(R)] label now provides an annual limit for many crops that reflect multiple crop seasons (0.4 lb ai/A - 0.8 lb ai/A).  The single application rates, application intervals, and seasonal rates remain the same as previously assessed with two minor exceptions.  Table 2 summarizes the proposed new use and the previously assessed uses with multiple crop seasons; crop grouping additions on the Altacor[(R)] label (as noted above) are not included because application rates did not change.

Table 2.  Assessed Use Rates for Chlorantraniliprole
                                    Product
                                    Use[1]
                          Single Max Application Rate
                                   (lb ai/A)
                Max Number of Applications (min interval, days)
                               Max Seasonal Rate
                                   (lb ai/A)
                             Max Number of Seasons
                                Max Annual Rate
                                   (lb ai/A)
DuPont Coragen
                               Proposed New Use

Peanut
                                     0.065
                                     3 (3)
                                      0.2
                                       1
                                      0.2

                        Reassessed Uses (Annual Rates)

Brassica, leafy vegetables[2]
                                     0.065

                                     3 (3)

                                      0.2

                                       4
                                      0.8

Bulb vegetables; onion, bulb subgroup, green onion subgroup 3-07B
                                     0.065
                                     3 (7)
                                      0.2
                                       3
                                      0.6

Cucurbit vegetables[2]

                                     0.09

                                     2 (5)

                                      0.2
                                       3
                                      0.6

Fruiting vegetables [2]
                                     0.098
                                     2 (5)
                                      0.2
                                       3
                                      0.6

Herbs
                                     0.065
                                     3 (3)
                                      0.2
                                       4
                                      0.8

Leafy vegetables, non-brassica[2]
                                     0.098
                                     2 (3)
                                      0.2
                                       4
                                      0.8

Legume vegetables [3,5]
                                     0.098
                                     2 (3)
                                      0.2
                                       3
                                      0.6

Legume vegetables (foliage)
                                     0.065
                                     3 (3)
                                      0.2
                                       3
                                      0.6

Spices
                                     0.065
                                     3 (3)
                                      0.2
                                       4
                                      0.8

Strawberry
                                     0.065
                                     3 (7)
                                      0.2
                                       2
                                      0.4

Tuberous and corm vegetables[4,5]
                                     0.065
                                     3 (3)
                                      0.2
                                       4
                                      0.8
Dupont Prevathon
                               Proposed New Use

Peanut
                                     0.067
                                     3 (3)
                                      0.2
                                       1
                                      0.2
[1] Foliar (air and ground) applications unless indicated otherwise.
[2] Soil-at planting and drip chemigation applications are permitted at similar rates (see DP 381819+ for details).
[3] Previously assessed at the foliage of legume rate (above).
[4] Previously assessed using a 5 day interval.
[5] It is unknown if the label changed since the initial assessment or if a typographical error was made at the time of the assessment.

4.	Exposure Summary

4.1.	Aquatic Exposure

The PRZM/EXAMS input parameters are shown in Table 3.  EECs are presented in Table 4. A representative PRZM/EXAM model input is presented in Appendix 1.

Table 3.  PRZM/EXAMS Input Parameters for Chlorantraniliprole
Input Parameter
Value
Comment
Source
Scenarios:
Peanut:
NC Peanut
Onion:
CA, GA Onion
Spice:
CA Lettuce
OR Mint
CA Row Crop
PA Vegetable
Brassica (Cole) Leafy Vegetables:
CA Cole Crop
Cucurbit Vegetables:
FL Cucumber
MI, MO, NJ Melon
Fruiting Vegetables:
CA, FL, PA Tomato
Leafy Vegetables:
CA Lettuce
Legumes:
MI Beans
Leaves of /and Root and Tuber Vegetables:
FL Carrot
ID, ME Potato
MN Sugarbeet
NC Sweet Potato
Strawberry:
FL Strawberry
representative scenarios for each use
N/A
Maximum Single
Application Rate
lb ai/acre (kg ai/ha)
Peanut: 0.067 (0.075)
Onion: 0.067 (0.075)
Spice: 0.067 (0.075)
Brassica (Cole) Leafy Vegs:  0.067 (0.075)
Cucurbit Vegetables:  0.100 (0.112)
Fruiting Vegetables:  0.100 (0.112)
Leafy Vegetables:  0.100 (0.112)
Legumes:  0.100 (0.112)
Leaves of /and Root and Tuber Vegs:  0.067 (0.075)
Strawberry:  0.067 (0.075)
proposed maximum single application rate

modeled single rates were slightly higher than the labeled rates (rate = the seasonal application rate/number of applications per season)
proposed  label
Applications per Year
Peanut:  3

Onion:  9
(3 apps/season x 3 seasons)

Spice: 12
(3 apps/season x 4 seasons)

Brassica (Cole) Leafy Vegs:  12
(3 apps/season x 4 seasons)

Cucurbit Vegetables:  6
(2 apps/season x 3 seasons)

Fruiting Vegetables:  6
(2 apps/season x 3 seasons)

Leafy Vegetables:  8
(2 apps/season x 4 seasons)

Legumes:  6
(2 apps/season x 3 seasons)

Leaves of /and Root and Tuber Vegs:  12
(3 apps/season x 4 seasons)

Strawberry:  6
(3 apps/season x 3 seasons)
label directions.  Application number for maximum single application rate.
proposed label
Application Interval (days)
Peanut:  3
Onion:  7
Spice: 3
Brassica (Cole) Leafy Vegs:  3
Cucurbit Vegetables:  5
Fruiting Vegetables:  5
Leafy Vegetables:  3
Legumes:  3
Leaves of /and Root & Tuber Vegs:  3
Strawberry:  7
proposed application intervals
proposed label
Date of Initial Application
(scenario: day-month)
Peanut:
NC Peanut:  16-05
Onion:
CA Onion:  18-05
GA Onion:  18-05
Spice:
CA Lettuce:  21-04
OR Mint:  11-07
CA Row Crop:  18-03
PA Vegetable:  17-09
Brassica (Cole) Leafy Vegetables:
CA Cole Crop:  08-02
Cucurbit Vegetables:
FL Cucumber:  01-11
MI Melon:  11-06
MO Melon:  17-06
 NJ Melon:  16-06
Fruiting Vegetables:
CA Tomato:  17-06
FL Tomato:  07-04
PA Tomato:  16-06
Leafy Vegetables:
CA Lettuce:  21-04
Legumes:
MI Beans:  13-07
Leaves of /and Root and Tuber Vegetables:
FL Carrot:  01-01
ID Potato:  01-08
ME Potato:  17-09
MN Sugarbeet:  17-09
NC Sweet Potato:  01-09
Strawberry:
FL Strawberry:  27-10
For most crops, to give a representative window of the growing season, the date of initial application (season 1) was selected as two weeks (14 days) before crop maturation from crop scenario data.

When modeling multiple seasons, a 14 day interval was arbitrarily selected to represent the time between the final application of the preceding season and first application of the following season.

An arbitrary date of June 1 was selected for FL Citrus and the date of crop emergence of May 16 was selected for NC Peanut due to inconsistencies within the crop scenario dates for these crops.

For FL Cucumber, November 1 was selected as the initial date of application in order to fit all applications in a given calendar year which is needed to run the model.

Crop Scenarios
Application Method
Foliar:  aerial and ground
label directions.  Aerial only modeled for Brassica, cucurbit, fruiting, leafy, root and tuber vegetables, legumes, and strawberry.
proposed label
CAM Input
2  (foliar: aerial, ground)

(2) linear foliar based on crop canopy
US EPA, 2005
IPSCND Input
Peanut:  1
Onion:  2
Spice: 3
Brassica (Cole) Leafy Vegs:  2
Cucurbit Vegetables:  3
Fruiting Vegetables:  3
Leafy Vegetables:  2
Legumes:  3
Leaves of /and Root & Tuber Vegs:  3
Strawberry:  3
remaining pesticide on foliage is:
 (1) converted to surface application to the top soil layer,
(2) completely removed after harvest
(3) Retained as surface residue and continues to decay.  This input only applies to foliar applications (CAM 2).
US EPA, 2005
Spray Drift Fraction
0.05  (aerial)
0.01  (ground)
--
Input parameter guidance (USEPA, 2009)
Application Efficiency
0.95  (aerial)
0.99  (ground)
--
Input parameter guidance
(USEPA, 2009)
Molecular Mass (g/mol)
483.15
--
--
Vapor Pressure at 25°C (torr)
1.57 x 10[-13]
--
DuPont 16517
Henry's Law Constant
(atm-m[3]/mol)
9.76 x 10[-14]
estimated
calculated from solubility, vapor pressure and molecular weight
Solubility in Water (mg/L)
1.023
--
MRID 46889026
Organic Carbon Partition Coefficient (KOC) (L/kgOC)
330
[1] represents the average KOC from 5 values
MRID 46889123
Aerobic Soil Metabolism Half-life (days)
627
2 , 3, 4 Calculated 90[th] percentile of mean. (mean= 509 days, SD= 253 days, t= 1.40, n= 9)
*Several reported half-lives in MRID 46889124
 were not used because of poor fit with first-order degradation model
MRID 46889014
MRID 46889015
MRID 46889124

Aerobic Aquatic Metabolism Half-life (days)
341
2 Calculated 90[th] percentile of mean.  Mean= 178 days, SD= 74.95 days, t= 3.078, n=2
MRID 46889016
Anaerobic Aquatic Metabolism Half-life (days)
624
208 days single half-life
(3 x 208 days  per EFED guidance)
DuPont 14568
Hydrolysis Half-lives (days)
0  (stable)
pH 7
MRID 46889017
Aqueous Photolysis
Half-life (days)
32.8 [5]
Natural sunlight half-life
MRID 46889122
 N/A = Not Applicable
[1] Koc values include 152, 438, 535, 268, 255.
2 tinput=Mean + (t90,n-1*SD) / √N
[3] EFED recalculated first-order half-lives for both benzo- and pyrazole-labeled chlorantraniliprole. The calculated half-lives are based on aerobic soil metabolism data in non-sterile soil at 25[0]C. Half-lives used in the assessment include 578, 537, 375, 41, 247, 228, 889, 924, 396 days.
[4] The 90[th] percentile of the mean half-life for chlorantraniliprole was 600 days for half-lives values presented in the OECD Chlorantraniliprole Volume  3(1): Annex B, Environmental Fate and Behavior. (mean = 491 ( 886, 539, 380, 233, 323, 629, 423, 518 days); SD=203; t90, n-1 =1.417; N=8
5 The natural sunlight half-life value of 32.8 days was modeled because this better half-life characterizes the behavior of chlorantraniliprole in the environment.  MRID 46889018 calculates a half-life of 0.31 days from a xenon arc lamp experiment using continuous irradiation.

Table 3.  Chlorantraniliprole Estimated Environmental Concentrations (EECs) for Surface Water Based on Selected Crop Scenarios
                              Proposed Label Use
                                  PRZM/EXAMS
                                  Scenario[1]
                               (first app date)
                                   Method[2]
                               Application Rate
                        (interval between applications)
                               Peak EEC (ug/L)
                                    21 Day
                                  EEC (ug/L)
                                    60 Day
                                  EEC (ug/L)
Dupont(TM) Coragen[(R)] insect control with RYNAXPYR[(R)]  [EPA Reg. No. 352-729]

Peanuts

NC Peanut
(May 16  -  foliar)
                                       A
                           3 app @ 0.067 lb ai/acre
                               (3-day interval)
                                     3.98
                                     3.84
                                     3.68

                                       G

                                     3.23
                                     3.10
                                     2.90

Bulb vegetables; onion, bulb subgroup, green onion subgroup 3-07B
CA Onion
(May 18  -  foliar)
                                       A
                           3 app @ 0.067 lb ai/acre
                               (7-day interval)
                              [0.2 lb ai/A/crop]
                              [0.6 lb ai/A/year]
                                     6.74
                                     6.46
                                     6.10

                                       G

                                     5.02
                                     4.74
                                     4.57

GA Onion
(May 18  -  foliar)
                                       A

                                     24.46
                                     23.86
                                     22.54

                                       G

                                     23.07
                                     22.48
                                     21.22

Spice
Subgroup 19B/Herb Subgroup 19A
CA Lettuce
(April 21  -  foliar)
                                       A
                           3 app @ 0.067 lb ai/acre
                               (3-day interval)
                              [0.2 lb ai/A/crop]
                              [0.8 lb ai/A/year]
                                     30.93
                                     30.07
                                     29.04

                                       G

                                     28.36
                                     27.43
                                     26.34

OR Mint
(July 11  -  foliar)
                                       A

                                     14.43
                                     14.11
                                     13.69

                                       G

                                     10.03
                                     9.84
                                     9.69

CA Row Crop
(March 18  -  foliar)
                                       A

                                     15.66
                                     15.38
                                     15.31

                                       G

                                     12.42
                                     12.11
                                     11.68

PA Vegetable
(Sept 17  -  foliar)
                                       A

                                     28.81
                                     28.50
                                     27.01

                                       G

                                     25.61
                                     24.99
                                     23.63
Brassica (Cole)
Leafy Vegetables

CA Cole Crop
(February 08 - foliar)
                                       A
                           3 app @ 0.067 lb ai/acre
                               (3-day interval)
                              [0.2 lb ai/A/crop]
                              [0.8 lb ai/A/year]
                                     26.43
                                     26.29
                                     25.86
Cucurbit Vegetables
FL Cucumber
(November 01  -  foliar)
                                       A
                           2 app @ 0.100 lb ai/acre
                               (5-day interval)
                              [0.2 lb ai/A/crop]
                              [0.6 lb ai/A/year]
                                     26.16
                                     25.35
                                     22.97

MI Melon
(June 11  -  foliar)

                                     13.41
                                     13.04
                                     12.58

MO Melon
(June 17  -  foliar)

                                     19.41
                                     18.58
                                     17.29

NJ Melon
(June 16  -  foliar)

                                     19.15
                                     18.61
                                     18.01

Fruiting Vegetables

CA Tomato
(June 17   -  foliar)
                                       A
                           2 app @ 0.100 lb ai/acre
                               (5-day interval)
                              [0.2 lb ai/A/crop]
                              [0.6 lb ai/A/year]
                                     13.34
                                     13.08
                                     12.60

FL Tomato
(April 7   -  foliar)

                                     26.13
                                     25.10
                                     23.74

PA Tomato
(June 16  -  foliar)

                                     23.67
                                     22.93
                                     22.13
Leafy Vegetables
CA Lettuce
(April 21   -  foliar)
                                       A
                           2 app @ 0.100 lb ai/acre
                               (3-day interval)
                              [0.2 lb ai/A/crop]
                              [0.8 lb ai/A/year]
                                     25.95
                                     24.95
                                     24.00
Legumes
MI Beans
(July 13   -  foliar)
                                       A
                           2 app @ 0.100 lb ai/acre
                               (3-day interval)
                              [0.2 lb ai/A/crop]
                              [0.6 lb ai/A/year]
                                     35.07
                                     34.41
                                     33.58
Root and Tuber Vegetables

Leaves of Root and Tuber Vegetables
FL Carrot
(January 01  -  foliar)
                                       A
                           3 app @ 0.067 lb ai/acre
                               (3-day interval)
                              [0.2 lb ai/A/crop]
                              [0.8 lb ai/A/year]
                                     29.64
                                     28.20
                                     27.15

ID Potato
(August 01   -  foliar)

                                     17.32
                                     17.13
                                     16.74

ME Potato
(September 17   -  foliar)

                                     36.13
                                     35.70
                                     35.04

MN Sugarbeet
(September 17   -  foliar)

                                     27.90
                                     27.71
                                     27.16

NC Sweet Potato
(September 01   -  foliar)

                                     30.56
                                     30.17
                                     29.65
Strawberry

FL Strawberry
(October 27   -  foliar)
                                       A
                           3 app @ 0.067 lb ai/acre
                               (7-day interval)
                              [0.2 lb ai/A/crop]
                              [0.4 lb ai/A/year]
                                     9.86
                                     9.57
                                     8.96
Dupont(TM) Prevathon[(R)] insect control with RYNAXPYR[(R)]  [EPA Reg. No. 352-844]

Peanuts

NC Peanut
(May 16   -  foliar)
                                       A
                           3 app @ 0.067 lb ai/acre
                               (3-day interval)
                                     3.98
                                     3.84
                                     3.68

                                       G

                                     3.23
                                     3.10
                                     2.90
Bold numbers denote maximum EEC values.
2  A = aerial application, G = ground application.

4.2.	Terrestrial Exposure

In past assessments there was not a risk concern for mammals or birds even assuming a single application at an annual maximum rate of 0.2 lb ai/A (e.g. DP 397575+).  Therefore, there is not a risk concern for the proposed peanut use given the same annual maximum rate; terrestrial exposure was not estimated.

However, exposure was estimated for uses with multiple crop seasons.  As a screen, two methods and sets of assumptions were used to calculate EECs which are intended solely to capture a range of possible exposure scenarios.  (1) Plants may accumulate chlorantraniliprole residues from season to season to the extent that previously treated plant material remains on or off the field.  As a screen, EECs were calculated in T-REX (v 1.5) for multiple crop seasons making the assumption that the same plant material is treated season after season (for example, see Table 4 for the crop scenario resulting in the highest EECs).  (2) EECs for subsequent crop seasons are expected to increase over the EECs based on a single crop season even if previously treated plant material is completely removed from the field given that chlorantraniliprole is persistent in soil and that the Coragen label indicates that the product is translocated into the above ground portions of plants after soil applications. Carryover residues could come from either past soil or foliar applications.  The Briggs model was used as a conservative screening estimate of exposure due to systemic transport into plant material (details and equations provided in White Paper in Support of the Proposed Risk Assessment Process for Bees, September 11  -  14, 2012).  For this screening analysis, it was assumed that estimated concentrations would occur throughout a plant.  The EEC (0.299 mg/kg plant material) was based on an application rate of 0.6 lb ai/A (a maximum of three crop seasons after the initial crop season), log Kow = 2.77, and Koc = 328 L/kgoc.

Table 4.  Screening Terrestrial Food-Item Residue Estimates for Mammals and Birds for Multiple Crop Seasons of Foliar Applications of Chlorantraniliprole[1]
                              Size Class
(grams)
                        Dietary and Dose-Based EECs[2]

                                  Short Grass
                                  Tall Grass
                               Broadleaf Plants
                              Fruits/Pods/
Seeds
                                  Arthropods
                                    Mammals
Dose-Based EECs
                                      15
                                    112.74
                                     51.67
                                     63.41
                                     7.05
                                     44.15
                                      35
                                     77.92
                                     35.71
                                     43.83
                                     4.87
                                     30.51
                                     1000
                                     18.07
                                     8.28
                                     10.16
                                     1.13
                                     7.07
Dietary-Based EECs[3]
                                      NA
                                    118.24
                                     54.20
                                     66.51
                                     7.39
                                     46.31
                                     Avian
Dose-Based EECs
                                      20
                                    134.67
                                     61.72
                                     75.75
                                     8.42
                                     52.75
                                      100
                                     76.79
                                     35.20
                                     43.20
                                     4.80
                                     30.08
                                     1000
                                     34.38
                                     15.76
                                     19.34
                                     2.15
                                     13.47
Dietary-Based EECs[3]
                                      NA
                                    118.24
                                     54.20
                                     66.51
                                     7.39
                                     46.31
[1] 0.098 lb ai/A, 2 applications at 3 day intervals per season (4 seasons with 14 days between the last and first application of sequential seasons).  For consistency, application intervals are the same as those used for aquatic modeling
2 Based on default foliar dissipation half-life of 35 days
[3] Size class not used for dietary EECs

EECs for terrestrial plants were determined in past assessments for the proposed application rates (e.g., DP 338512 and DP 397575+).

5.	Fate and Transport and Ecological Effects Summary

Fate and toxicity data used for this risk assessment has not changed since the last assessment (DP 404738+).  A detailed description of fate and transport properties can be found in the comprehensive drinking water assessment (DP 348133) dated 10 January 2008 and a detailed description of toxicity data can be found in the 2007 (DP 338512),  2011 (DP 377697+), and 2012 (DP 397575+) risk assessments.

6.	Incidents

Reviews were conducted of the Ecological Incident Information System (EIIS, version 2.1.1), the Agency's Aggregated Incidents Reports database, and the Avian Incident Monitoring System (AIMS) on November 26, 2013.  No incidents were reported in AIMS.  One incident was reported in EIIS involving foraging bee mortality from direct spray in an orchard (it is not clear if the bees were directly sprayed); the product was not identified and the certainty of causation is unlikely.  One minor wildlife incident was reported for one of the assessed products (Coragen[(R)]) as well as another chlorantraniliprole containing product (Dupont DERMACOR X-100 Insect Control) in the aggregated incident database.  In addition, one "other non-target" species (i.e., not coded as plants or wildlife) incident was reported for Altacor[(R)] (the product with proposed commodity additions to already labeled crop groups) in the aggregated incident database.  Several minor plant incidents were reported in the aggregated incident database for a chlorantraniliprole containing product (Grubex) other than those considered in this assessment and one incident for application of chlorantraniliprole and sulfentrazone (product(s) not identified).  There was also one plant incident involving Grubex in the EIIS database (> 45% effects on plants for a residential application  -  certainty of causation is possible).

7.	Ecological Risk

7.1.	Terrestrial Organisms

There is not a risk concern for birds or mammals for the use on peanut or for the assessed multiple crop season uses.

      Terrestrial Invertebrates

As in past assessments, a risk concern for terrestrial invertebrates cannot be precluded.  The Agency currently does not have a quantitative method to assess risks of pesticides to non-target terrestrial invertebrates. However, it is a reasonable assumption that an insecticide would pose some direct risk to non-target terrestrial invertebrates, including insects.  Second, compared to the proposed application rates (0.065 - 0.099 lb ai/A single maximum rate; 0.2 - 0.8 lb ai/A annual rate), available toxicity data suggest potential direct effects to at least some non-target insects (e.g., LR50 for mortality was < 0.067 lb ai/A for hoverfly).

      Terrestrial Plants

The LOC (1.0) was not exceeded for non-listed or listed monocots located in dry or semi-aquatic locations or from spray drift (RQs < 0.1) in previous assessments of the same application rates.  Toxicity has not been defined for dicots (EC25 undetermined and NOEC < 0.0167 lb/A in the available Tier II seedling emergence study).  At this time, risk cannot be precluded for dicots (listed and non-listed).  There is not a risk concern for monocots from the proposed use on peanut or the assessed multiple crop season uses.

7.2.	Aquatic Organisms

There is not a risk concern for fish (freshwater and marine/estuarine) or aquatic plants (vascular and non-vascular) for the proposed use on peanut or for the assessed multiple crop season uses.

      Aquatic Invertebrates

The acute listed species LOC (0.05) was exceeded for freshwater (RQ = 0.34) and marine/estuarine invertebrates (RQ = 0.09) for use on peanut.  For all crops with multiple crop seasons, the acute listed species LOC was exceeded for freshwater (RQ = 0.85-3.1) and marine/estuarine invertebrates (RQ = 0.25-0.91).  There is also an acute risk concern for non-listed aquatic invertebrate species (LOC = 0.5) for all multiple crop season uses except strawberry (non-listed acute LOC was not exceeded for marine/estuarine invertebrates).

There is not a chronic risk concern for aquatic invertebrates for use on peanut.  However, the chronic LOC (1.0) was exceeded for use on crops with multiple crop seasons: freshwater invertebrate chronic RQ = 2.2 - 8.1[4] and marine/estuarine chronic RQ = 0.4 - 1.5[4].   There is a chronic risk concern for aquatic invertebrates for all multiple crop season uses except strawberry (chronic LOC was not exceeded for marine/estuarine invertebrates).

8.	Endangered and Threatened Species

Table 5 summarizes potential concerns for direct and indirect effects to federally-listed threatened and endangered species (i.e., listed species).

Table 5.  Potential Effects to Federally Listed Taxa
Listed Taxa
                                Direct Effects
                               Indirect Effects
Terrestrial and semi-aquatic plants - monocots
                                      No
                                    Yes[2]
Terrestrial and semi-aquatic plants - dicots
                                    Yes[1]
                                    Yes[2]
Terrestrial invertebrates
                                      Yes
                                   Yes[2,5]
Birds
                                      No
                                 Yes[2,3,4,5]
Terrestrial-phase amphibians
                                      No
                                 Yes[2,3,4,5]
Reptiles
                                      No
                                 Yes[2,3,4,5]
Mammals
                                      No
                                 Yes[2,3,4,5]
Aquatic vascular plants
                                      No
                                 Yes[2,3,4,5]
Freshwater fish
                                      No
                                   Yes[3,5]
Aquatic-phase amphibians
                                      No
                                   Yes[3,5]
Freshwater invertebrates
                                      Yes
                                   Yes[3,5]
Marine/estuarine fish
                                      No
                                   Yes[4,5]
Marine/estuarine invertebrates
                                      Yes
                                   Yes[4,5]
[1] insufficient data to preclude risk
2 direct effects on terrestrial invertebrates
3 direct effects on freshwater invertebrates (listed and non-listed)
4 direct effects on estuarine/marine invertebrates (listed and non-listed)
[5]direct effects on terrestrial dicots (listed and non-listed species)

                   Appendix 1.  Representative Model Output


[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Notices]
[Page 11102]
[FR Doc No: 2014-04329]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2013-0579; FRL-9906-98]

Draft Guidelines; Product Environmental Performance Standards and
Ecolabels for Voluntary Use in Federal Procurement; Reopening of
Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: EPA issued a notice in the Federal Register issue of November
27, 2013, concerning public review and comment on draft guidelines with
a potential approach for using non-governmental product environmental
performance standards and ecolabels in Federal purchasing. This
document reopens the comment period for two months, until April 25,
2014. The Agency received several requests to extend the comment period
to allow more time for stakeholder review, collaboration, and response.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2013-0579, must be received on or before April 25, 2014.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of November 27, 2013.

FOR FURTHER INFORMATION CONTACT: Alison Kinn Bennett, Pollution
Prevention Division (7409M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document reopens the public comment
period established in the Federal Register issue of November 27, 2013
(78 FR 70938) (FRL-9394-7). In that document, EPA announced for public
review and comment draft guidelines intended to provide a transparent,
fair, and consistent approach to using nongovernmental product
environmental performance standards and ecolabels in Federal
purchasing, consistent with Federal standards policy and sustainable
acquisition mandates. These draft guidelines have been developed in
response to requests via a wide variety of stakeholder engagement
channels from suppliers, manufacturers, environmental organizations,
Federal purchasers, and other stakeholders over the last several years.
EPA is hereby reopening the comment period to April 25, 2014.
    To submit comments, or access the docket, please follow the
detailed instructions as provided under ADDRESSES in the November 27,
2013 Federal Register document. If you have questions, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Ecolabels, Government procurement,
Guidelines, Standards.

    Dated: February 20, 2014.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2014-04329 Filed 2-26-14; 8:45 am]
BILLING CODE 6560-50-P


MEMORANDUM

DATE:		November 13, 2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	EPA Region 1

SUBJECT:	October 21, 2014, Panel discussion including Proposed Clean Power Plan for Existing Power Plants during the Environmental Law Institute-Miriam Hamilton Keare Policy Forum --------------------------------------------------------------------------------

SUMMARY

      On October 21, 2014, Curt Spalding participated in a panel discussion during the Environmental Law Institute-Miriam Hamilton Keare Policy Forum.  The proposed Clean Power Plan for Existing Power Plants was covered during the forum titled "The Role of State Leadership in Cooperative Federalism."         ATTENDEES: Curt Spalding, EPA

Approximately 100 people attended this conference.  Attendance was not taken by EPA