[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29556]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Flutriafol; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
flutriafol in or on coffee, bean, green and coffee, instant. Cheminova
A/S, c/o Cheminova Inc. requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 11, 2013. Objections and
requests for hearings must be received on or before February 10, 2014,
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-2013-0295, 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), EPA West 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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: [email protected].
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can i get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0295 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
February 10, 2014. 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-2013-0295, 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
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.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2),
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 2E8074)
by Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700,
Arlington, VA 22209-2510. The petition requested that EPA establish
import tolerances for residues of the fungicide flutriafol, in or on
coffee, bean, green at 0.20 parts per million (ppm) and coffee, instant
at 0.30 ppm. That document referenced a summary of the petition
prepared by Cheminova A/S, c/o Cheminova, Inc., the registrant, which
is available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, tolerances
for coffee, green bean have been revised from 0.20 to 0.15 ppm. The
reason for this change is 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 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 flutriafol including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flutriafol 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
The hazard characterization and toxicity endpoints for risk
assessment remain unchanged from the assessment upon which the final
rule published in the Federal Register on August 8, 2012 (77 FR 47296)
(FRL-9348-8) is based. Specific information on the studies received and
the nature of the adverse effects caused by flutriafol as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
preamble to that final rule and its supporting documents as well as in
the most recent human health risk assessment, Flutriafol: Human-Health
Risk Assessment for Tolerances in/on Imported Coffee, which can be
found in www.regulations.gov, under docket ID number EPA-HQ-OPP-2013-
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD) and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for flutriafol used for
human risk assessment is shown in the table contained in Unit III.B. of
the preamble to the final rule published in the Federal Register issue
of August 8, 2012 (77 FR 47296) (FRL-9348-8).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flutriafol, EPA considered exposure under the petitioned-
for tolerances as well as all existing flutriafol tolerances in 40 CFR
180.629. EPA assessed dietary exposures from flutriafol in food as
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 flutriafol. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture's (USDA) National Health and Nutrition Examination Survey,
What We Eat In America (NHANES/WWEIA) conducted from 2003-2008. As to
residue levels in food, EPA made the following assumptions for the
acute exposure assessment: tolerance-level residues or tolerance-level
residues adjusted to account for the residues of concern for risk
assessment, 100 percent crop treated (PCT), modeled drinking water
estimates, and DEEM\TM\ ver. 7.81 default processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's (NHANES/
WWEIA) conducted from 2003-2008 as well. As to residue levels in food,
EPA made the following assumptions for the chronic exposure assessment:
Tolerance-level residues or tolerance-level residues adjusted to
account for the residues of concern for risk assessment, 100 PCT,
modeled drinking water estimates, and DEEM\TM\ ver. 7.81 default
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flutriafol does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for flutriafol. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The proposed tolerance in
or on imported coffee will not impact residues in the U.S. drinking
water. However, there are registered uses for application of flutriafol
in the U.S.A and the Agency used screening level water exposure models
to estimate residues in drinking water. These estimates were then
incorporated in the dietary exposure analysis and risk assessment for
flutriafol. The simulation models take into account data on the
physical, chemical, and fate/transport characteristics of flutriafol.
Based on the First Index Reservoir Screening Tool (FIRST), and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of flutriafol for acute exposures
are estimated to be 48.8 parts per billion (ppb) for surface water and
310 ppb for ground water.
For chronic exposures for non-cancer assessments the EDWC's are
estimated to be 5.70 ppb for surface water and 202 ppb for ground
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 310 ppb was used to assess
the contribution to drinking water.
For chronic dietary risk assessment, the water concentration of
value 202] ppb was used to assess the contribution to drinking water.
The drinking water models and their descriptions are available at the
EPA internet site: http://www.epa.gov/oppefed1/models/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). Flutriafol is not
registered for any specific use patterns that would result in
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.''
Flutriafol is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of
toxicity and EPA is not following a cumulative risk approach based on a
common mechanism of toxicity for the conazoles. For information
regarding EPA's procedures for cumulating effects from substances found
to have a common mechanism of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and two triazole conjugates triazolylalanine (TA) and
triazolylacetic acid (TAA). To support existing tolerances and to
establish new tolerances for triazole-derivative pesticides, EPA
conducted an initial human-health risk assessment for exposure to T,
TA, and TAA resulting from the use of all current and pending uses of
any triazole-derived fungicide as of September 1, 2005. The risk
assessment was a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high-end estimates of both dietary and
non-dietary exposures). In addition, the Agency retained the additional
10X Food Quality Protection Act (FQPA) safety factor (SF) for the
protection of infants and children. The assessment included evaluations
of risks for various subgroups, including those comprised of infants
and children. The Agency's complete risk assessment can be found in the
propiconazole reregistration docket at http://www.regulations.gov,
Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and an update to
the aggregate human health risk assessment for free triazoles and its
conjugates may be found in this current docket, Docket ID Number EPA-
HQ-OPP-2013-0295 entitled ``Common Triazole Metabolites: Updated
Dietary (Food + Water) Exposure and Risk Assessment to Address the
Revised Tolerance for Residues of Fenbuconazole in Peppers.''
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA 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. The potential impact of in
utero and perinatal flutriafol exposure was investigated in three
developmental toxicity studies (two in rats, one in rabbits) and two
multi-generation reproduction toxicity studies in rats. In the first of
two rat developmental toxicity studies, a quantitative susceptibility
was observed (delayed ossification or non-ossification of the skeleton
in the fetuses) at a lower dose than maternal effects. In the second
rat developmental study, a qualitative susceptibility was noted.
Although developmental toxicity occurred at the same dose level that
elicited maternal toxicity, the developmental effects (external,
visceral, and skeletal malformations; embryo lethality; skeletal
variations; a generalized delay in fetal development; and fewer live
fetuses) were more severe than the decreased food consumption and body-
weight gains observed in the dams. For rabbits, intrauterine deaths
occurred at a dose level that also caused adverse effects in maternal
animals. In the two-generation reproduction studies, a qualitative
susceptibility was also seen. Effects in the offspring (decreased
litter size and percentage of live births, increased pup mortality, and
liver toxicity) can be attributed to the systemic toxicity of the
parental animals (decreased body weight and food consumption and liver
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
i. The toxicity database for flutriafol is complete.
ii. There is no indication that flutriafol is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity. Signs of neurotoxicity
were reported in the acute and subchronic neurotoxicity studies at the
highest dose only; however, these effects were primarily seen in
animals that were agonal (at the point of death) and, thus, are not
indicative of neurotoxicity. In addition, there was no evidence of
neurotoxicity in any additional short-term studies in rats, mice, and
dogs, or in the long-term toxicity studies in rats, mice, and dogs.
iii. There are no concerns or residual uncertainties for prenatal
and/or postnatal toxicity. Although there is evidence for increased
qualitative susceptibility in the prenatal study in rats and rabbits
and the two-generation reproduction study in rats, there are no
concerns for the offspring toxicity observed in the developmental and
reproductive toxicity studies for the following reasons:
Clear NOAELs and LOAELs were established in the fetuses/
offspring for each of these studies;
The dose-response for these effects are well-defined and
Developmental endpoints are used for assessing acute
dietary risks to the most sensitive population (females 13-49 years
old) as well as all other short- and intermediate-term exposure
The chronic reference dose is greater than 300-fold lower
than the dose at which the offspring effects were observed in the two-
generation reproduction studies.
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. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to flutriafol in drinking water. These assessments
will not underestimate the exposure and risks posed by flutriafol.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
flutriafol will occupy 27% of the aPAD for females 13-49 years old, the
population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flutriafol from food and water will utilize 36% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. Because there are no
residential uses for flutriafol, the chronic aggregate risk includes
food and drinking water only.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Since flutriafol is not
registered for any use patterns that would result in residential
exposure, the short- and intermediate-term aggregate risk is the sum of
the risk from exposure to flutriafol through food and water and will
not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, flutriafol is classified as ``not likely to be carcinogenic to
humans''. EPA does not expect flutriafol to pose a cancer risk.
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 flutriafol residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Gas Chromatography/Nitrogen/
Phosphorus detector (GC/NPD) for proposed tolerances) are available to
enforce the tolerance expression. 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 EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for flutriafol in or on coffee,
bean, green at 0.15 ppm. These MRLs are the same as the tolerances
established for flutriafol in the United States.
C. Revisions to Petitioned-For Tolerances
Based on the analysis of the residue field trial data and
application of the Organization for Economic Cooperation and
Development (OECD) tolerance calculator procedure, a green coffee bean
tolerance of 0.15 ppm for residues of flutriafol is appropriate. The
tolerance for coffee, green bean is harmonized with the Codex MRL. The
Agency determined that the tolerance level of 0.15 ppm would be
appropriate so as to harmonize with the MRL.
Therefore, tolerances are established for residues of flutriafol,
1,2,4-triazole-1-ethanol in or on coffee, bean, green at 0.15 ppm and
coffee, instant at 0.30 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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
Dated: December 2, 2013.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.629, in the table in paragraph (a), add alphabetically
entries for ``Coffee, green, bean'' and ``Coffee, instant,'' and revise
footnote 1 to read as follows:
Sec. 180.629 Flutriafol; tolerances for residues.
(a) * * *
* * * * *
Coffee, green, bean \1\................................. 0.15
Coffee, instant \1\..................................... 0.30
* * * * *
\1\ There are no U.S. registrations as of October 22, 2013.
* * * * *
[FR Doc. 2013-29556 Filed 12-10-13; 8:45 am]
BILLING CODE 6560-50-P