Triclopyr; Pesticide Tolerances, 9353-9360 [2016-03910]
Download as PDF
<![CDATA[
rmajette on DSK2TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
(7) The panel members to be utilized (see
Section 10.1.3) along with their
qualifications.
(8) An example certificate of successful
course completion.
10.1.1 A trainee must verify completion
of at least 12 hours of field observation prior
to attending the Method 303 certification
course. Trainees shall observe the operation
of a coke oven battery as it pertains to
Method 303, including topside operations,
and shall also practice conducting Method
303 or similar methods. During the field
observations, trainees unfamiliar with coke
battery operations shall receive instruction
from an experienced coke oven observer who
is familiar with Method 303 or similar
methods and with the operation of coke
batteries.
10.1.2 The classroom instruction shall
familiarize the trainees with Method 303
through lecture, written training materials,
and a Method 303 demonstration video.
Successful completion of the classroom
portion of the Method 303 training course
shall be demonstrated by a perfect score on
the initial certification test. Those attending
the course for third-year recertification must
complete one of the recertification tests
selected at random.
10.1.3 All trainees must demonstrate
proficiency in the application of Method 303
to a panel of three certified Method 303
observers, including an ability to differentiate
coke oven emissions from condensing water
vapor and smoldering coal. The panel
members will be EPA, state or local agency
personnel, or industry contractors listed in
59 FR 11960 (March 15, 1994) or qualified as
part of the training provider approval process
of Section 10.1 of this method.
Each panel member shall have at least 120
days experience in reading visible emissions
from coke ovens. The visible emissions
inspections that will satisfy the experience
requirement must be inspections of coke
oven battery fugitive emissions from the
emission points subject to emission
standards under subpart L of this part (i.e.,
coke oven doors, topside port lids, offtake
system(s), and charging operations), using
either Method 303 or predecessor state or
local test methods. A ‘‘day’s experience’’ for
a particular inspection is a day on which one
complete inspection was performed for that
emission point under Method 303 or a
predecessor state or local method. A ‘‘day’s
experience’’ does not mean 8 or 10 hours
performing inspections, or any particular
time expressed in minutes or hours that may
have been spent performing them. Thus, it
would be possible for an individual to
qualify as a Method 303 panel member for
some emission points, but not others (e.g., an
individual might satisfy the experience
requirement for coke oven doors, but not
topside port lids). Until November 15, 1994,
the EPA may waive the certification
requirement (but not the experience
requirement) for panel members. The
composition of the panel shall be approved
by the EPA.
The panel shall observe the trainee in a
series of training runs and a series of
certification runs. There shall be a minimum
of 1 training run for doors, topside port lids,
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
and offtake systems, and a minimum of 5
training runs (i.e., 5 charges) for charging.
During training runs, the panel can advise
the trainee on proper procedures. There shall
be a minimum of 3 certification runs for
doors, topside port lids, and offtake systems,
and a minimum of 15 certification runs for
charging (i.e., 15 charges). The certification
runs shall be unassisted. Following the
certification test runs, the panel shall
approve or disapprove certification based on
the trainee’s performance during the
certification runs. To obtain certification, the
trainee shall demonstrate to the satisfaction
of the panel a high degree of proficiency in
performing Method 303. To aid in evaluating
the trainee’s performance, a checklist,
approved by the EPA, will be used by the
panel members.
10.1.4 Those successfully completing the
initial certification or third-year
recertification requirements shall receive a
certificate showing certification as a Method
303 observer and the beginning and ending
dates of the certification period.
10.1.5 The training provider will submit
to the EPA or its designee the following
information for each trainee successfully
completing initial certification or third-year
recertification training: Name, employer,
address, telephone, cell and/or fax numbers,
email address, beginning and ending dates of
certification, and whether training was for 3year certification or 1-year recertification.
This information must be submitted within
30 days of the course completion.
10.1.6 The training provider will
maintain the following records, to be made
available to EPA or its designee on request
(within 30 days of a request):
(a) A file for each Method 303 observer
containing the signed certification checklists,
certification forms and test results for their
initial certification, and any subsequent
third-year recertifications. Initial certification
records must also include documentation
showing successful completion of the
training prerequisites. Testing results from
any interim recertifications must also be
included, along with any relevant
communications.
(b) A searchable master electronic database
of all persons for whom initial certification,
third-year recertification or interim
recertification has been provided.
Information contained therein must include:
The observer’s name, employer, address,
telephone, cell and fax numbers and email
address, along with the beginning and ending
dates for each successfully completed initial,
third-year and interim recertification.
10.1.7 Failure by the training provider to
submit example training course materials
and/or requested training records to the
Administrator may result in suspension of
the approval of the provider and course.
10.2 Observer Certification/
Recertification. The coke oven observer
certification is valid for 1 year. The observer
shall recertify annually by reviewing the
training material, viewing the training video
and answering all of the questions on the
recertification test correctly. Every 3 years, an
observer shall be required to pass the
proficiency test in Section 10.1.3 in order to
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
9353
be certified. The years between proficiency
tests are referred to as interim years.
*
*
*
*
*
[FR Doc. 2016–03757 Filed 2–24–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0314 and EPA–HQ–
OPP–2014–0489; FRL–9941–87]
Triclopyr; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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).
SUMMARY:
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 https://www.regulations.gov or at the
Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
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:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
E:\FR\FM\25FER1.SGM
25FER1
9354
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
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).
rmajette on DSK2TPTVN1PROD with RULES
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/test-guidelines-pesticidesand-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
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
by docket ID numbers EPA–HQ–OPP–
2014–0314 and EPA–HQ–OPP–2014–
0489, by one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of 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-2pyridinyl)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
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
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-2pyridinyl)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
https://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
E:\FR\FM\25FER1.SGM
25FER1
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
rmajette on DSK2TPTVN1PROD with RULES
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 halflife, 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 2generation reproduction toxicity
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
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 2generation 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 pairwise tests for all the tumors of concern;
(2) for the adrenal tumors, there was a
lack of dose-response and any preneoplastic 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
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
9355
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 https://
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 https://
www.epa.gov/pesticides-science-andassessing-pesticide-risks/assessinghuman-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.
E:\FR\FM\25FER1.SGM
25FER1
9356
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRICLOPYR FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/Scenario
Point of departure and
uncertainty/safety factors
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
Acute dietary (Females 13–49 years of age) ...
NOAEL = 5 mg/kg/day ...........
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.05 mg/kg/day ..
aPAD = 0.05 mg/kg/day .........
Acute dietary (General population including infants and children).
NOAEL = 100 mg/kg/day .......
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 1.0 mg/kg/day ....
aPAD = 1.0 mg/kg/day ...........
Chronic dietary (All populations) ......................
NOAEL= 5 mg/kg/day ............
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.05 mg/kg/day
cPAD = 0.05 mg/kg/day .........
Incidental oral short-term (1 to 30 days) and
intermediate-term (1 to 6 months).
NOAEL= 5 mg/kg/day ............
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100 ...............
Inhalation short-term (1 to 30 days) and intermediate-term (1 to 6 months).
Inhalation (or oral) study ........
NOAEL= 5 mg/kg/day (inhalation absorption rate =
100%)
UFA = 10x
UFH = 10x
FQPA SF/UFDB = 10x
LOC for MOE = 1000 .............
2-Generation Rat Reproduction Study with Triclopyr
Acid
LOAEL = 25 mg/kg/day based
on increased incidence of
rare malformations
(exencephaly and ablepharia).
Developmental Rat Toxicity
Study with Triclopyr BEE
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.
2-Generation Rat Reproduction Study with Triclopyr
Acid
LOAEL = 25 mg/kg/day based
on degeneration of the
proximal renal tubules.
Subchronic Oral Rat Toxicity
Study with Triclopyr Acid
LOAEL = 20 mg/kg/day based
on degeneration of the
proximal renal tubules.
Subchronic Oral Rat Toxicity
Study with Triclopyr Acid
LOAEL = 20 mg/kg/day based
on degeneration of the
proximal renal tubules.
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).
rmajette on DSK2TPTVN1PROD with RULES
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
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
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
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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
E:\FR\FM\25FER1.SGM
25FER1
rmajette on DSK2TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
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 nonoccupational, 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, postapplication inhalation and ingestion
exposures of water from swimming for
children 3 to <6 years old, and postapplication 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 shortand intermediate-term residential postapplication exposures are expected.
Chronic exposures are not expected.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-pesticide.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
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 chlorpyrifosmethyl. 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
https://www.epa.gov/pesticide-scienceand-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
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
9357
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 wellcharacterized 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
E:\FR\FM\25FER1.SGM
25FER1
rmajette on DSK2TPTVN1PROD with RULES
9358
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
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
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
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 electroncapture 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 multiresidue 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: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
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
E:\FR\FM\25FER1.SGM
25FER1
9359
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
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.
rmajette on DSK2TPTVN1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of triclopyr, 2-[(3,5,6trichloro-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
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
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).
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.417, revise paragraph (a)(1)
introductory text, the commodity
‘‘Milk,’’ in the table in paragraph (a)(1)
and paragraph (a) (2) to read as follows:
■
§ 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-2pyridinyl)oxy]acetic acid.
Parts per
million
Commodity
*
*
*
*
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-trichloro2-pyridinol (TCP), calculated as the
stoichiometric equivalent of triclopyr.
Commodity
Cattle, fat ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
E:\FR\FM\25FER1.SGM
25FER1
Parts per
million
0.10
0.10
0.50
9360
Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Rules and Regulations
Goat, fat ....................................
Goat, meat ................................
Goat, meat byproducts .............
Hog, fat .....................................
Hog, meat .................................
Hog, meat byproducts ..............
Horse, fat ..................................
Horse, meat ..............................
Horse, meat byproducts ...........
Sheep, fat .................................
Sheep, meat .............................
Sheep, meat byproducts ..........
*
*
*
*
comments on the burden estimates
listed below, or how the Commission
can improve the collections and reduce
0.10 any burdens caused thereby, please
0.10 contact Cathy Williams, Federal
0.50
Communications Commission, Room 1–
0.10
0.10 C823, 445 12th Street SW., Washington,
0.50 DC 20554. Please include the OMB
0.10 Control Numbers, 3060–0546 and 3060–
0.10 0980, in your correspondence. The
0.50 Commission will also accept your
0.10 comments via the Internet if you send
0.10 them to PRA@fcc.gov.
0.50
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to fcc504@
fcc.gov or call the Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
Parts per
million
Commodity
*
[FR Doc. 2016–03910 Filed 2–24–16; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 76
[MB Docket No. 15–71; FCC 15–111]
Television Market Modification;
Statutory Implementation
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the
Commission announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years, the
information collection associated with
the Commission’s Report and Order,
Television Market Modification;
Statutory Implementation. This
document is consistent with the Report
and Order, which stated that the
Commission would publish a document
in the Federal Register announcing
OMB approval and the effective date of
the rules.
DATES: The amendments to 47 CFR
76.59(a) and (b), published at 80 FR
59635, October 2, 2015, are effective
February 25, 2016.
FOR FURTHER INFORMATION CONTACT: For
additional information contact Cathy
Williams, Cathy.Williams@fcc.gov, (202)
418–2918.
SUPPLEMENTARY INFORMATION: This
document announces that, on February
18, 2016 and February 19, 2016, OMB
approved the information collection
requirements contained in the
Commission’s Report and Order, FCC
15–111, published at 80 FR 59635,
October 2, 2015. The OMB Control
Numbers are 3060–0546 and 3060–0980.
The Commission publishes this notice
as an announcement of the effective
date of the rules. If you have any
rmajette on DSK2TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
13:23 Feb 24, 2016
Jkt 238001
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received OMB approval on February 18,
2016 and February 19, 2016, for the new
information collection requirements
contained in the Commission’s rules at
47 CFR 76.59(a)–(b) and 76.66(d)(6).
Under 5 CFR 1320, an agency may not
conduct or sponsor a collection of
information unless it displays a current,
valid OMB Control Number.
No person shall be subject to any
penalty for failing to comply with a
collection of information subject to the
Paperwork Reduction Act that does not
display a current, valid OMB Control
Number. The OMB Control Numbers are
3060–0546 and 3060–0980.
The foregoing notice is required by
the Paperwork Reduction Act of 1995,
Public Law 104–13, October 1, 1995,
and 44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–0546.
OMB Approval Date: February 18,
2016.
OMB Expiration Date: February 28,
2019.
Title: Section 76.59 Definition of
Markets for Purposes of the Cable
Television Mandatory Television
Broadcast Signal Carriage Rules.
Form Number: N/A.
Type of Review: Revision of a
currently approved collection.
Respondents: Business and other forprofit entities.
Number of Respondents and
Responses: 180 respondents and 200
responses.
Estimated Time per Response: 0.5 to
40 hours.
Frequency of Response: On occasion
reporting requirement; Third party
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
disclosure requirement; Recordkeeping
requirement.
Total Annual Burden: 1,486 hours.
Total Annual Costs: $1,387,950.
Obligation to Respond: Required to
obtain or retain benefits. The statutory
authority for this collection is contained
in 47 U.S.C. 151, 154(i), 303(r), 338 and
534.
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this collection of information.
Privacy Impact Assessment(s): No
impact(s).
Needs and Uses: On September 2,
2015, the Commission released a Report
and Order (Order), FCC 15–111, in MB
Docket No. 15–71, adopting satellite
television market modification rules to
implement Section 102 of the Satellite
Television Extension and Localism Act
(STELA) Reauthorization Act of 2014
(STELAR). The STELAR amended the
Communications Act and the Copyright
Act to give the Commission authority to
modify a commercial television
broadcast station’s local television
market—defined by The Nielsen
Company’s Designated Market Area
(DMA) in which it is located—to
include additional communities or
exclude communities for purposes of
better effectuating satellite carriage
rights. The Commission previously had
the authority to modify a station’s
market only in the cable carriage
context. Market modification allows the
Commission to modify the local
television market of a particular
commercial television broadcast station
to enable commercial television
stations, cable operators and satellite
carriers to better serve the interests of
local communities. Market modification
provides a means to avoid rigid
adherence to DMA designations and to
promote consumer access to in-state and
other relevant television programming.
Section 338(l) of the Communications
Act (the satellite market modification
provision) and Section 614(h)(1)(C) of
the Communications Act (the
corresponding cable provision) permit
the Commission to add communities to
or delete communities from a station’s
local television market following a
written request. Furthermore, the
Commission may determine that
particular communities are part of more
than one television market.
Section 76.59(a) of the Commission’s
Rules authorizes the filing of market
modification petitions and governs who
may file such a petition. With respect to
cable market modification petitions, a
commercial TV broadcast station and
cable system operator may file a market
modification petition to modify the
local television market of a particular
E:\FR\FM\25FER1.SGM
25FER1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov or at the Office of
Pesticide Programs Regulatory Public Docket (OPP Docket) in the
Environmental Protection Agency Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPP Docket is (703) 305-5805. Please review
the visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: 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: RDFRNotices@epa.gov.
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 https://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 https://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: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of 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 https://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 https://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 https://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 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.''
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 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 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:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established 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
