[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Rules and Regulations]
[Pages 75257-75262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29556]



40 CFR Part 180

[EPA-HQ-OPP-2013-0295; FRL-9902-17]

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

[[Page 75258]]

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 

[[Page 75259]]

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 
processing factors.
    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 
residential exposure.
    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

[[Page 75260]]

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 
scenarios; and
     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

[[Page 75261]]

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.

 V. Conclusion

    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 
recordkeeping requirements.

    Dated: December 2, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 75262]]


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) * * *

                                                             Parts per
                        Commodity                             million
                                * * * * *
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]