[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)]
[Rules and Regulations]
[Pages 26599-26603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11928]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0036; FRL-9961-29]
Triclopyr; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of triclopyr in or on sugarcane. This action is in response to
EPA's granting of an emergency exemption under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on sugarcane. This regulation establishes a maximum permissible level
for residues of triclopyr in or on this commodity. The time-limited
tolerance will expire on December 31, 2020.
DATES: This regulation is effective June 8, 2017. Objections and
requests for hearings must be received on or before August 7, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0036 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
[emsp14]Crop production (NAICS code 111).
[emsp14]Animal production (NAICS code 112).
[emsp14]Food manufacturing (NAICS code 311).
[emsp14]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 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this
document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2017-0036 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 August 7, 2017. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0036, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing a time-limited tolerance for residues of triclopyr (2-
[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid), including its
metabolites and degradates in or on sugarcane, cane at 40 parts per
million (ppm). This time-limited tolerance will expire on December 31,
2020.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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
[[Page 26600]]
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue . . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Triclopyr on Sugarcane and FFDCA
Tolerances
The Louisiana Department of Agriculture and Forestry (LDAF)
requested a quarantine emergency exemption for the use of triclopyr on
sugarcane to control Merrill's nightshade (Solanum merrillianum Liou).
Merrill's nightshade is a non-native plant that was introduced into the
United States sometime before its discovery in 1976, where it has
become a pest of importance in sugarcane in Louisiana. According to
LDAF, Merrill's nightshade has been confirmed in 17 of the 24 sugarcane
producing parishes. Substantial economic damage is occurring and has
been documented at 39% reduction of tonnage and 49% reduction of
recoverable sugar losses per acre.
After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption are met. EPA has authorized a
quarantine exemption under FIFRA section 18 for the use of triclopyr on
sugarcane for control of Merrill's nightshade in Louisiana.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of triclopyr in
or on sugarcane. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerances
under FFDCA section 408(l)(6) would be consistent with the safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent, non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment as provided in FFDCA section 408(l)(6). Although
these time-limited tolerances expire on December 31, 2020, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on sugarcane after
that date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
triclopyr meets FIFRA's registration requirements for use on sugarcane
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of triclopyr by a
State for special local needs under FIFRA section 24(c), nor does this
tolerance by itself serve as the authority for persons in any State
other than Louisiana to use this pesticide on the applicable crop under
FIFRA section 18, absent the issuance of an emergency exemption
applicable within that State. For additional information regarding the
emergency exemption for triclopyr, contact the Agency's Registration
Division at the address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
Consistent with 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 expected as a result of this emergency exemption request and
the time-limited tolerances for residues of triclopyr, including its
metabolites and degradates on sugarcane, cane at 40 ppm. EPA's
assessment of exposures and risks associated with establishing time-
limited tolerances follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for triclopyr used for
human risk assessment is discussed in Table 1 of the final rule
published in the Federal Register of February 25, 2016, (81 FR 9353,
9355-56) (FRL-9941-87).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to triclopyr, EPA considered
[[Page 26601]]
exposure under the time-limited tolerances established by this action
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. Acute 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) and the Dietary Exposure Evaluation Model-
Food Commodity Intake Database (DEEM-FCID), version 3.16. As to residue
levels in food, EPA performed the acute analysis using DEEM-FCID to
estimate the dietary exposure of the general U.S. population and
various population subgroups. The acute assessment was unrefined,
assuming that triclopyr residues are present in all commodities at
tolerance levels and that 100% of all crops are treated (100% CT). DEEM
version 7.81 default processing factors were used to estimate residues
in all processed commodities. Drinking water was incorporated directly
into the dietary assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA) and the Dietary Exposure Evaluation Model-Food
Commodity Intake Database (DEEM-FCID), version 3.16. As to residue
levels in food, EPA performed the chronic analysis using DEEM-FCID to
estimate the dietary exposure of the general U.S. population and
various population subgroups. The chronic assessment was slightly
refined, assuming that triclopyr residues are present in all
commodities at tolerance levels (100% CT) except milk. An anticipated
residue calculated from a recently submitted livestock feeding study
was used for milk.
iii. Cancer. For the reasons discussed in a previous triclopyr
tolerance rule February 25, 2016 (81 FR 9353, 9356) (FRL-9941-87), EPA
has concluded that quantification of risk using a non-linear approach
will adequately account for all chronic toxicity, including potential
carcinogenicity that could result from exposure to triclopyr.
Therefore, a separate dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
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 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.
For this time-limited tolerance rule, the Agency assumed 100% crop
treated for all crops.
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.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 400 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 400 ppb was used to assess
the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
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: Residential
exposure is not anticipated from the proposed Section 18 emergency use
for sugarcane. However, residential exposures are anticipated from
currently registered uses of triclopyr. Exposures are expected for
adults who apply triclopyr-containing products and for adults and
children from post-application exposure in residential areas previously
treated with triclopyr. These uses have all been previously assessed
and have resulted in no risk estimates of concern for both handler and
post-application exposures (L. Venkateshwara; 04-AUG-2015; D426070).
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 LOC
are still valid since the tolerances changes will not have a noticeable
effect on dietary exposures to TCP. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is evidence of
increased qualitative susceptibility to offspring from triclopyr
exposure in the rat two-generation reproduction study based on
increased incidence of rare pup
[[Page 26602]]
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.
3. Conclusion. EPA has determined that reliable data show that 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 FQPA SF
consideration. 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 evidence of neurotoxicity from triclopyr exposure.
iii. Selected endpoints are protective of any observed pre- or
post-natal offspring susceptibility.
iv. The exposure databases are sufficient and unlikely to
underestimate exposure. These assessments will not underestimate the
exposure and risks posed by triclopyr.
D. 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 54% of the aPAD for females 13-49 years old
and 8% of the aPAD for all infants less than one year old (<1 year
old), the population subgroups 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 47% of the cPAD for all
infants less than one year old (<1 year old), the population group
receiving the greatest exposure. Based on the explanation in the unit
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 aggregate MOEs of 120 for children
one year old to less than two years old (1 to <2 years old) (dietary
exposures with potential post-application incidental oral exposure
resulting from the registered turf use). Because EPA's level of concern
for triclopyr is a MOE of 100 or below, these MOEs are 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 non-dietary, non-occupational
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, the Agency has
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
exposures. For these reasons, the short-term aggregate is protective of
the longer-term exposures.
5. Aggregate cancer risk for U.S. population. A cancer aggregate
risk assessment was not performed because a separate cancer assessment
was not warranted (see Section B.1.iii).
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.
V. 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. 1, Appendix 1) indicates
triclopyr is completely recovered greater than 80% (>80%) using multi-
residue method PAM Vol. 1 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 method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that
[[Page 26603]]
EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for residues of triclopyr.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
triclopyr, (2-[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid), including
its metabolites and degradates in or on sugarcane, cane at 40 ppm. This
tolerance will expire on December 31, 2020.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), 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).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA has submitted 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: May 10, 2017.
Michael Goodis,
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 (b) to read as follows:
Sec. 180.417 Triclopyr; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
triclopyr (2-[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid), including
its metabolites and degradates in or on the specified agricultural
commodities, resulting from use of the pesticide pursuant to FIFRA
section 18 emergency exemptions. The tolerances expire on the date
specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Sugarcane, cane............................. 40 12/31/2020
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-11928 Filed 6-7-17; 8:45 am]
BILLING CODE 6560-50-P