[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Rules and Regulations]
[Pages 9353-9360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03910]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-0489; FRL-9941-87]


Triclopyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerances for residues of 
triclopyr in milk and livestock commodities which are identified and 
discussed later in this document, and amends the tolerance expressions 
to include triclopyr choline salt. Dow AgroSciences, LLC requested 
these tolerance changes under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective February 25, 2016. Objections and 
requests for hearings must be received on or before April 25, 2016, 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 dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-
0489, are available at http://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) in the 
Environmental Protection Agency Docket Center (EPA/DC), West William 
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805. Please review 
the visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

[[Page 9354]]

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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

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 
by docket ID numbers EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-0489 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 25, 2016. 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 numbers EPA-HQ-OPP-2014-0314 and EPA-
HQ-OPP-2014-0489, 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 Wednesday, November 25, 2015 (80 FR 
73695) (FRL-9937-14), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a revised 
pesticide petition (PP 4F8249) by Dow AgroSciences, LLC, 9330 
Zionsville Rd., Indianapolis, IN 46268-1054. The revised petition 
requested that 40 CFR part 180.417(a)(1) be amended by establishing a 
tolerance for residues of the herbicide triclopyr, [(3,5,6-trichloro-2-
pyridinyl)oxy] acetic acid, in or on the raw agricultural commodity 
milk, fat at 0.7 parts per million (ppm); and increasing the tolerance 
in or on milk from 0.01 ppm to 0.6 ppm. The petition also requested 
that 40 CFR part 180.417(a)(2) be amended by establishing tolerances 
for residues of triclopyr, [(3,5,6-trichloro-2-pyridinyl)oxy] acetic 
acid and its metabolite 3,5,6-trichloro-2-pyridinol (TCP), calculated 
as the stoichiometric equivalent of triclopyr, in or on the raw 
agricultural commodities of cattle, goat, hog, horse, and sheep meat 
byproducts at 0.7 ppm; by increasing tolerances in cattle, goat, hog, 
horse, and sheep fat from 0.05 ppm to 0.09 ppm; and increasing 
tolerances in cattle, goat, hog, horse, and sheep meat from 0.05 ppm to 
0.08 ppm.
    In the Federal Register of Friday, September 5, 2014 (79 FR 53009) 
(FRL-9914-98), 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 4F8279) by Dow AgroSciences, LLC, 9330 Zionsville Rd., 
Indianapolis, IN 46268-1054. The petition requested that 40 CFR part 
180.417(a)(1) and 180.417(a)(2) be amended to include residues of the 
herbicide triclopyr choline salt as triclopyr, [(3,5,6-trichloro-2-
pyridinyl)oxy] acetic acid, including its metabolites and degradates, 
in or on the raw agricultural commodities listed.
    The documents referenced summaries of the petitions prepared by Dow 
AgroSciences, LLC, the registrant, which are available in the dockets 
at http://www.regulations.gov. The petition summary for PP 4F8249 is 
located in docket number EPA-HQ-OPP-2014-0314, and the petition summary 
for PP 4F8279 is located in docket number EPA-HQ-OPP-2014-0489. Several 
comments were received on the notices of filing. EPA's response to 
those comments are discussed in Unit IV.D.
    Based upon review of the data supporting the petitions, EPA has (1) 
determined that a tolerance for milk fat is not required; (2) increased 
the proposed tolerances for the fat and meat of cattle, goat, hog, 
horse, and sheep; (3) decreased the proposed tolerances for the meat 
byproducts of cattle, goat, hog, horse, and sheep; and (4) determined 
that the current tolerances for kidney, liver, and meat byproducts 
except kidney and liver of cattle, goat, hog, horse, and sheep are not 
required.
    EPA is also revising the tolerance expressions to correct the 
nomenclature of the chemical name, clarify the chemical moieties that 
are covered by the tolerances, and specify how compliance will be 
measured. The reasons for these changes are explained in Unit IV.C.

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

[[Page 9355]]

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 triclopyr including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with triclopyr 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 bioequivalence of the three chemical forms of triclopyr (acid, 
triethylamine salt, and butoxyethyl ester) has been addressed through a 
variety of special studies with the salt and ester forms, including 
data on comparative disposition, plasma half-life, tissue distribution, 
and hydrolytic cleavage. Those studies were found to adequately address 
the issue of bioequivalence amongst these forms of triclopyr. 
Additionally, the currently available information supports the 
bioequivalence of triclopyr and triclopyr choline salt. Therefore, 
studies conducted with any one form of triclopyr have been used to 
support the toxicology database for triclopyr as a whole.
    Triclopyr has been classified as having low acute toxicity via the 
oral, dermal, and inhalation routes. It is minimally-irritating 
(butoxyethyl ester) to corrosive (triethylamine salt) to the eye. It is 
a dermal sensitizer but not a dermal irritant.
    Overall, effects in the triclopyr database were indicative of 
kidney and liver toxicity in rats and dogs, respectively. The primary 
effect observed in rats was degeneration of the proximal tubule of the 
kidney, which was seen at approximately the same dose in the subchronic 
oral and 2-generation reproduction toxicity studies. Body-weight 
decreases in rats were observed in the subchronic neurotoxicity and 
immunotoxicity studies at doses approximately ten times higher than 
doses resulting in kidney effects. In dogs, liver toxicity was 
evidenced by increased liver enzymes, increased liver weights, and 
liver histopathology at a similar dose as kidney effects in the rat. 
Changes in hematological parameters (decreased packed-cell volume, 
decreased hemoglobin, and decreased red blood cell count) were also 
observed in dogs at the same dose.
    There is evidence of increased qualitative susceptibility to 
offspring from triclopyr exposure in the rat 2-generation reproduction 
study, based on increased incidence of rare pup malformations observed 
in the presence of parental toxicity. There is also potential 
qualitative susceptibility in the rat developmental toxicity study; 
however, the evidence was not as conclusive as the reproduction 
toxicity study. Concern is low since effects are well-characterized 
with clearly established no-observed adverse-effect level/lowest-
observed adverse-effect level (NOAEL/LOAEL) values, effects were seen 
in the presence of parental toxicity, and selected endpoints are 
protective of the observed effects.
    Triclopyr has been classified as a ``Group D Chemical--unable to be 
classified as to human carcinogenicity.'' Although there was marginal 
evidence of carcinogenicity in animal studies (adrenal tumors in male 
rats and mammary gland tumors in female rats and mice), EPA has 
determined that the chronic reference dose (cRfD) will adequately 
account for all chronic effects, including carcinogenicity, likely to 
result from exposure to triclopyr. The Agency reached this conclusion 
employing a weight-of-evidence (WOE) approach after considering the 
following factors: (1) A lack of statistical significance at the high 
dose in pair-wise tests for all the tumors of concern; (2) for the 
adrenal tumors, there was a lack of dose-response and any pre-
neoplastic lesions in the adrenal glands, along with evidence that the 
tumors were mainly benign; (3) for the mammary gland tumors, incidence 
in the concurrent control mice was at the low end of the historical 
control range; and (4) the chronic RfD is approximately 700-fold lower 
than the dose that induced the mammary gland tumors in female rats.
    Acceptable subchronic neurotoxicity and immunotoxicity studies have 
been submitted and show no evidence of neurotoxicity or immunotoxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by triclopyr as well as the NOAEL and the LOAEL 
from the toxicity studies can be found at http://www.regulations.gov in 
document, ``Triclopyr. Human Health Risk Assessment for Petition to 
Amend Tolerance Expressions to Include Triclopyr Choline Salt; and 
Petition to Remove Grazing Restrictions for Dairy Cattle'' on pp. 13-15 
in docket ID numbers EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-0489.

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 the NOAEL and the LOAEL are identified. 
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-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for triclopyr used for 
human health risk assessment is shown in Table 1 of this unit.

[[Page 9356]]



   Table 1--Summary of Toxicological Doses and Endpoints for Triclopyr for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/Scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 5 mg/kg/day....  Acute RfD = 0.05 mg/kg/  2-Generation Rat
 age).                                 UFA = 10x..............   day.                     Reproduction Study
                                       UFH = 10x..............  aPAD = 0.05 mg/kg/day..   with Triclopyr Acid
                                       FQPA SF = 1x...........                           LOAEL = 25 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of rare
                                                                                          malformations
                                                                                          (exencephaly and
                                                                                          ablepharia).
Acute dietary (General population      NOAEL = 100 mg/kg/day..  Acute RfD = 1.0 mg/kg/   Developmental Rat
 including infants and children).      UFA = 10x..............   day.                     Toxicity Study with
                                       UFH = 10x..............  aPAD = 1.0 mg/kg/day...   Triclopyr BEE
                                       FQPA SF = 1x...........                           LOAEL = 300 mg/kg/day
                                                                                          based on maternal
                                                                                          mortality. Additional
                                                                                          effects seen at this
                                                                                          dose included clinical
                                                                                          signs, necropsy
                                                                                          findings, decreased
                                                                                          food and water
                                                                                          consumption, and
                                                                                          increased kidney and
                                                                                          liver weights.
Chronic dietary (All populations)....  NOAEL= 5 mg/kg/day.....  Chronic RfD = 0.05 mg/   2-Generation Rat
                                       UFA = 10x..............   kg/day.                  Reproduction Study
                                       UFH = 10x..............  cPAD = 0.05 mg/kg/day..   with Triclopyr Acid
                                       FQPA SF = 1x...........                           LOAEL = 25 mg/kg/day
                                                                                          based on degeneration
                                                                                          of the proximal renal
                                                                                          tubules.
Incidental oral short-term (1 to 30    NOAEL= 5 mg/kg/day.....  LOC for MOE = 100......  Subchronic Oral Rat
 days) and intermediate-term (1 to 6   UFA = 10x..............                            Toxicity Study with
 months).                              UFH = 10x..............                            Triclopyr Acid
                                       FQPA SF = 1x...........                           LOAEL = 20 mg/kg/day
                                                                                          based on degeneration
                                                                                          of the proximal renal
                                                                                          tubules.
Inhalation short-term (1 to 30 days)   Inhalation (or oral)     LOC for MOE = 1000.....  Subchronic Oral Rat
 and intermediate-term (1 to 6          study.                                            Toxicity Study with
 months).                              NOAEL= 5 mg/kg/day                                 Triclopyr Acid
                                        (inhalation absorption                           LOAEL = 20 mg/kg/day
                                        rate = 100%).                                     based on degeneration
                                       UFA = 10x..............                            of the proximal renal
                                       UFH = 10x..............                            tubules.
                                       FQPA SF/UFDB = 10x.....
----------------------------------------------------------------------------------------------------------------
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). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to triclopyr, EPA considered exposure under the petitioned-for 
tolerances as well as all existing triclopyr tolerances in 40 CFR 
180.417. EPA assessed dietary exposures from triclopyr in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for triclopyr. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA assumed that triclopyr residues were present at tolerance 
levels in all commodities for which tolerances have been established or 
proposed, and that 100% of those crops were treated with triclopyr.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed that triclopyr 
residues were present at tolerance levels in all commodities for which 
tolerances have been established or proposed except milk, and that 100% 
of those crops were treated with triclopyr. An average anticipated 
residue (AR) calculated from a livestock feeding study was used for all 
milk commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
determined that the chronic RfD will adequately account for all chronic 
effects, including carcinogenicity, that are likely to result from 
triclopyr exposure. Therefore, a dietary exposure assessment for the 
purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use PCT information in the dietary assessment for 
triclopyr. However, EPA did use anticipated residue information for 
milk commodities in the chronic dietary assessment. Tolerance-level 
residues and 100 PCT were assumed for all other food commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section

[[Page 9357]]

408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    2. Dietary exposure from drinking water. EPA calculated and 
required setback distances from the application site to the functional 
potable water intake in order to maintain average drinking water 
concentration levels below 400 parts per billion (ppb). Since potable 
water intakes are required to be turned off until triclopyr 
concentration levels are below 400 ppb, EPA has determined that for 
acute and chronic dietary risk assessments, the water concentration 
value of 400 ppb is appropriate to use 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).
    Triclopyr is currently registered for the following uses that could 
result in residential exposures: Aquatic and turf areas. EPA assessed 
residential exposure using the following assumptions: Handler 
inhalation exposure from spot applications to turf for adults, post-
application inhalation and ingestion exposures of water from swimming 
for children 3 to <6 years old, and post-application incidental oral 
exposure to turf for children 1 to <2 years old. The dermal route of 
exposure is not quantitatively assessed because there is no dermal 
hazard. Short-term residential handler exposure, and short- and 
intermediate-term residential post-application exposures are expected. 
Chronic exposures are not expected. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to triclopyr and any other 
substances.
    3,5,6-trichloro-2-pyridinol, commonly known as TCP, is a metabolite 
of triclopyr, chlorpyrifos, and chlorpyrifos-methyl. Risk assessment of 
TCP was conducted in 2002, and the previous conclusions that the acute 
and chronic dietary aggregate exposure estimates are below EPA's level 
of concern (LOC) are still valid since the tolerances changes will not 
have a noticeable effect on dietary exposures to TCP. 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 http://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 Food Quality 
Protection Act Safety Factor (FQPA 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. As summarized in Unit 
III.A., there is evidence of increased qualitative susceptibility to 
offspring from triclopyr exposure in the 2-generation reproduction 
toxicity study and potential qualitative susceptibility in the rat 
developmental toxicity study. However, the concern is low since effects 
are well-characterized with clearly established NOAEL/LOAEL values, 
effects were seen in the presence of parental toxicity, and selected 
endpoints, which are protective of the effects in adult animals, are 
protective of the observed effects.
    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, with the exception for inhalation exposures 
where the FQPA SF is retained at 10X. These decisions are based on the 
following findings:
    i. The toxicity database for triclopyr is adequate for 
characterizing triclopyr toxicity and quantification of hazard 
exposures. For assessing risks associated with inhalation exposures, 
the FQPA SF is retained at 10X to incorporate the database uncertainty 
factor (UFDB) to account for the lack of a subchronic 
inhalation toxicity study.
    ii. There is no indication that triclopyr is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is evidence of increased qualitative susceptibility to 
offspring from triclopyr exposure. However, the concern is low since 
effects are well-characterized with clearly established NOAEL/LOAEL 
values, effects were seen in the presence of parental toxicity, and 
selected endpoints, which are protective of the effects in adult 
animals, are protective of the observed effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues for all crops except milk 
commodities and drinking water in which anticipated residues were used. 
EPA used conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
triclopyr.

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 triclopyr will occupy 53% of the aPAD for females 13-49 years old, 
and 8% of the aPAD for all infants less than 1 year

[[Page 9358]]

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 
triclopyr from food and water will utilize 46% of the cPAD for all 
infants less than 1 year 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 
triclopyr 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). Triclopyr 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 triclopyr.
    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 an aggregate MOE of 120 for 
children 1 to <2 years old (dietary exposure with post-application 
incidental oral exposure from turf use). Because EPA's level of concern 
for triclopyr is a MOE of 100 or below, this MOE is not of concern.
    For adults and children 3 to <6 years old, an aggregate risk index 
(ARI) is used since the POD for the oral and inhalation routes of 
exposure are the same, but the LOC values for oral (MOE<100) and 
inhalation (MOE<1000) exposures are different. The ARIs are 3.6 for 
children 3 to <6 years old (dietary exposure with post-application 
inhalation and ingestion from aquatic use), and 1.4 for adults (dietary 
exposure with handler inhalation exposure from turf use). Since EPA's 
level of concern is an ARI below 1, these ARIs 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). Although triclopyr is currently registered for uses that could 
result in intermediate-term residential exposure, EPA determined that a 
quantified intermediate-term aggregate assessment is unnecessary since 
the short- and intermediate-term PODs are the same and the short-term 
aggregate provides a worst-case estimate of residential exposure and is 
therefore protective of the longer-term exposures.
    5. Aggregate cancer risk for U.S. population. As summarized in Unit 
III.A., EPA has determined that an aggregate exposure risk assessment 
for cancer risk is not required based on WOE conclusions on the 
marginal evidence of carcinogenicity in two adequate rodent 
carcinogenicity studies and the use of the chronic RfD which will 
adequately account for any potential carcinogenic effects.
    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 triclopyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (Methods ACR 77.2 and ACR 77.4, 
using gas chromatography with electron-capture detection (GC/ECD); 
Method GRM 97.02 using gas chromatography with mass-spectrometry 
detection (GC/MS)) are available to enforce the tolerance expression. 
The Food and Drug Administration (FDA) PESTDATA database dated 1/94 
(Pesticide Analytical Manual (PAM) Vol. I, Appendix I) indicates that 
triclopyr is completely recovered (>80%) using multi-residue method PAM 
Vol. I Section 402. Data pertaining to multi-residue methods testing of 
triclopyr and its metabolites through Protocols B, C, D, and E have 
been submitted and forwarded to FDA.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established any MRL for triclopyr.

C. Revisions to Petitioned-for Tolerances

    Based on the available residue chemistry data, EPA has determined 
that a tolerance for milk fat is not required. Also, EPA is increasing 
the proposed tolerances for fat (0.09 ppm) and meat (0.08 ppm) of 
cattle, goat, hog, horse, and sheep to 0.10 ppm, and decreasing the 
proposed tolerances for meat byproducts of cattle, goat, hog, horse, 
and sheep from 0.7 ppm to 0.50 ppm in order to harmonize with 
established Canadian MRLs. The current tolerances for kidney (0.5 ppm), 
liver (0.5 ppm), and meat byproducts except kidney and liver (0.05 ppm) 
of cattle, goat, hog, horse, and sheep are being removed and replaced 
by establishing tolerances for meat byproducts of cattle, goat, hog, 
horse, and sheep at 0.50 ppm.
    EPA is also revising the chemical name of triclopyr in the 
tolerance expressions to reflect the preferred Chemical Abstract 
Service (CAS) nomenclature. Lastly, in accordance with Agency guidance 
on tolerance expressions, the tolerance expressions for triclopyr are 
revised by clarifying that the tolerances cover ``residues of the 
herbicide triclopyr, including its metabolites and degradates as well 
as how residues of triclopyr are to be measured.''

D. Response to Comments

    Several comments were received in both dockets, EPA-HQ-OPP-2014-
0314 and EPA-HQ-OPP-2014-0489, containing general comments disapproving 
of the use and EPA's approval of pesticides, and two similar comments 
stating that triclopyr should be banned due to its toxic effects on 
aquatic animals and its soil half-life. EPA understands these 
commenters' concerns and recognizes that some individuals believe that 
pesticides should be banned on agricultural crops. However, the 
existing legal framework provided by Section 408 of the FFDCA states 
that tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. These comments appear to be directed 
at the underlying statute and not EPA's implementation of it; the 
commenters have made no contention that EPA has acted in violation of 
the statutory framework. In addition, some of the

[[Page 9359]]

comments stated that triclopyr's negative effects are detrimental to 
human health. EPA has concluded that there is a reasonable certainty of 
no harm to humans after considering the toxicological studies and the 
exposure levels of humans to triclopyr.

 V. Conclusion

    Therefore, tolerances are established for residues of triclopyr, 2-
[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid, in or on cattle, meat 
byproducts at 0.50 ppm; goat, meat byproducts at 0.50 ppm; hog, meat 
byproducts at 0.50 ppm; horse, meat byproducts at 0.50 ppm; sheep, meat 
byproducts at 0.50 ppm; amended for milk at 0.60 ppm; cattle, fat at 
0.10 ppm; cattle, meat at 0.10 ppm; goat, fat at 0.10 ppm; goat, meat 
at 0.10 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; horse, fat at 
0.10 ppm; horse, meat at 0.10 ppm; sheep, fat at 0.10 ppm; and sheep, 
meat at 0.10 ppm.
    The following livestock tolerances for ``kidney,'' ``liver,'' and 
``meat byproducts, except kidney and liver'' are removed since these 
commodities will be combined under the ``meat byproducts'' tolerances: 
Cattle, kidney at 0.5 ppm; cattle, liver at 0.5 ppm; cattle, meat 
byproducts, except kidney and liver at 0.05 ppm; goat, kidney at 0.5 
ppm; goat, liver at 0.5 ppm; goat, meat byproducts, except kidney and 
liver at 0.05 ppm; hog, kidney at 0.5 ppm; hog, liver at 0.5 ppm; hog, 
meat byproducts, except kidney and liver at 0.05 ppm; horse, kidney at 
0.5 ppm; horse, liver at 0.5 ppm; horse, meat byproducts, except kidney 
and liver at 0.05 ppm; sheep, kidney at 0.5 ppm; sheep, liver at 0.5 
ppm; and sheep, meat byproducts, except kidney and liver at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This action amends and establishes tolerances under FFDCA section 
408(d) in response to petitions 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 11, 2016.
Susan Lewis,
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.  180.417, revise paragraph (a)(1) introductory text, the 
commodity ``Milk,'' in the table in paragraph (a)(1) and paragraph (a) 
(2) to read as follows:


Sec.  180.417  Triclopyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide triclopyr, including its metabolites and degradates, in or on 
the commodities in the table below resulting from the application of 
the butoxyethyl ester of triclopyr, triethylamine salt of triclopyr, or 
choline salt of triclopyr. Compliance with the tolerance levels 
specified below is to be determined by measuring only triclopyr, 2-
[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Milk.......................................................         0.60
 
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
triclopyr, including its metabolites and degradates, in or on the 
commodities in the table below resulting from the application of the 
butoxyethyl ester of triclopyr, triethylamine salt of triclopyr, or 
choline salt of triclopyr. Compliance with the tolerance levels 
specified below is to be determined by measuring the combined residues 
of triclopyr, 2-[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid, and its 
metabolite 3,5,6-trichloro-2-pyridinol (TCP), calculated as the 
stoichiometric equivalent of triclopyr.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.10
Cattle, meat...............................................         0.10
Cattle, meat byproducts....................................         0.50

[[Page 9360]]

 
Goat, fat..................................................         0.10
Goat, meat.................................................         0.10
Goat, meat byproducts......................................         0.50
Hog, fat...................................................         0.10
Hog, meat..................................................         0.10
Hog, meat byproducts.......................................         0.50
Horse, fat.................................................         0.10
Horse, meat................................................         0.10
Horse, meat byproducts.....................................         0.50
Sheep, fat.................................................         0.10
Sheep, meat................................................         0.10
Sheep, meat byproducts.....................................         0.50
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-03910 Filed 2-24-16; 8:45 am]
 BILLING CODE 6560-50-P