Document ID: EPA-HQ-OPP-2016-0380-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluxapyroxad
Posted Date: 2016-11-08T05:00Z

[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Rules and Regulations]
[Pages 78509-78513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26966]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0380; FRL-9953-87]

Fluxapyroxad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluxapyroxad in or on banana, coffee green bean, mango, and papaya. 
BASF Corporation requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), to ensure that residues on these 
commodities when imported into the United States would be in compliance 
with the FFDCA.

DATES: This regulation is effective November 8, 2016. Objections and 
requests for hearings must be received on or before January 9, 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-2016-0380, 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 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: RDFRNotices@epa.gov.

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2016-0380 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 
January 9, 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-

[[Page 78510]]

2016-0380, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 29, 2016 (81 FR 59165) (FRL-9950-
22), 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 
5E8366 by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, North Carolina 27709-3528. The petition requested that 
40 CFR 180.666 be amended by establishing tolerances for residues of 
the fungicide fluxapyroxad, in or on banana at 3.0 parts per million 
(ppm); coffee, green bean at 0.2 ppm; mango at 0.7 ppm; and papaya at 
0.6 ppm. That document referenced a summary of the petition prepared by 
BASF Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.

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 fluxapyroxad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluxapyroxad follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The Agency recently published a tolerance rulemaking for 
fluxapyroxad. See Federal Register of May 5, 2016 (81 FR 27019) (FRL-
9945-48). The toxicological profile and endpoints used for human risk 
assessment have not changed since that time. Therefore, the Agency is 
relying on that discussion of the toxicological profile and the 
toxicological endpoints for this rulemaking as well. Please refer to 
Unit III. B of the final rule published in the Federal Register of May 
5, 2016 (81 FR 27019) (FRL-9945-48). In addition, specific information 
on the studies received and the nature of the adverse effects caused by 
fluxapyroxad as well as the no-observed-adverse-effect-level (NOAEL) 
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in document, ``Human 
Health Risk Assessment for Use of Fluxaproxad on Imported Banana, 
Coffee, Mango, and Papaya.'' at pp. 12 in docket ID number EPA-HQ-OPP-
2016-0380.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluxapyroxad tolerances in 40 
CFR 180.666. EPA assessed dietary exposures from fluxapyroxad in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for fluxapyroxad. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 food consumption data 
NHANES/WWEIA. Tolerance level residues adjusted to account for the 
metabolites of concern (M700F008) and 100% crop treated assumptions 
were used for all plant commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
CSFII. As to residue levels in food, EPA conducted a moderately refined 
chronic dietary exposure analysis for the general U.S. population and 
various population subgroups. Average field trial residues for parent 
plus maximum metabolite residue were used for all plant commodities. An 
assumption of 100% crop treated was also used for the chronic dietary 
analysis. DEEM default and empirical processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluxapyroxad 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 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.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluxapyroxad in drinking water.

[[Page 78511]]

These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of fluxapyroxad. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model Ground Water (PRZM/GW), the 
estimated drinking water concentrations (EDWCs) of fluxapyroxad for 
acute exposures are 127 ppb parts per billion (ppb) for surface water 
and 203 ppb for ground water. The EDWCs for chronic exposures for non-
cancer assessments are 127 ppb for surface water and 188 ppb for ground 
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 203 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 188 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).
    There is no residential exposure associated with the proposed uses 
of fluxapyroxad in this action; however, there are existing turf uses 
that were previously assessed for fluxapyroxad. Although the Agency had 
conducted a residential exposure assessment for previous fluxapyroxad 
actions, the Agency completed an updated turf assessment to reflect an 
update in the single maximum application rate from 2.47 lb active 
ingredient (ai)/gallon to 0.005 lb ai/gallon. The present assessment 
assumed the following exposure scenarios:
     Residential handler: The Agency assessed inhalation 
exposures to adults from applications only because fluxapyroxad does 
not pose a dermal risk. Residential handler exposure is expected to be 
short-term in duration. Intermediate-term exposures are not likely 
because of the intermittent nature of applications by homeowners.
     Post-application exposures: Dermal exposures were not 
assessed because there is no identified systemic dermal hazard for 
fluxapyroxad. Post-application inhalation exposure while engaged in 
activities on or around previously treated turf is generally not 
quantitatively assessed. The combination of low vapor pressure for 
chemicals typically used as active ingredients in outdoor residential 
pesticide products and dilution in outdoor air is likely to result in 
minimal inhalation exposure. Incidental oral exposure for children is 
anticipated. The quantitative oral exposure/risk assessment for 
residential post-application exposures is based on the incidental oral 
scenario for children 1 to <2 years old.
    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.
    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.''
    EPA has not found fluxapyroxad to share a common mechanism of 
toxicity with any other substances, and fluxapyroxad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fluxapyroxad does not have a common mechanism of toxicity with other 
substances. 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/pesticides/cumulative.

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 safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No evidence of quantitative 
susceptibility was observed in a reproductive and developmental 
toxicity study in rats or in developmental toxicity studies in rats and 
rabbits. Developmental toxicity data in rats showed decreased body 
weight and body weight gain in the offspring at the same dose levels 
that caused thyroid follicular hypertrophy/hyperplasia in parental 
animals. Effects in rabbits were limited to paw hyperflexion, a 
malformation that is not considered to result from a single exposure 
and that usually reverses as the animal matures. Developmental effects 
observed in both rats and rabbits occurred at the same doses as those 
that caused adverse effects in maternal animals, indicating no 
quantitative susceptibility. The Agency has low concern for 
developmental toxicity because the observed effects were of low 
severity, were likely secondary to maternal toxicity, and demonstrated 
clear NOAELs. Further, the NOAELs for these effects were at dose levels 
higher than the points of departure selected for risk assessment for 
repeat-exposure scenarios. Therefore, based on the available data and 
the selection of risk assessment endpoints that are protective of 
developmental effects, there are no residual uncertainties with regard 
to pre- and/or postnatal toxicity.
    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 
findings:
    i. The toxicity database for fluxapyroxad is complete.
    ii. There is no indication that fluxapyroxad is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. Although an acute 
neurotoxicity study showed decreased rearing and motor activity, this 
occurred on the day of dosing only in the absence of histopathological 
effects or alterations in brain weights. This indicated that any 
neurotoxic effects of fluxapyroxad are likely to be transient and 
reversible due to alterations in neuropharmacology and not from 
neuronal damage. The Agency has low concern for neurotoxic effects of 
fluxapyroxad at any life stage.
    iii. Based on the developmental and reproductive toxicity studies 
discussed in Unit III.C.2., there are no residual uncertainties with 
regard to prenatal and/or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure 
databases. The residue database is adequate. The dietary risk 
assessment is conservative and will not underestimate dietary exposure 
to fluxapyroxad. There are existing turf uses that were previously 
assessed and approved for fluxapyroxad. The assessment will not 
underestimate residential exposure via

[[Page 78512]]

handler for adults and incidental oral for children. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to fluxapyroxad in drinking water. EPA 
used similarly conservative assumptions to assess post application 
exposure of children as well as incidental oral exposure of toddlers. 
There are residential uses proposed for fluxapyroxad and the assessment 
will not underestimate residential exposure via handler for adults and 
incidental oral for children.

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 fluxapyroxad will occupy 13% of the PAD for children 1 to 2 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 
fluxapyroxad from food and water will utilize 70% of the cPAD for 
infants (<1 year old).
    There are no residential use patterns associated with the proposed 
uses in this action; however, there are residential exposure from 
existing turf uses that were previously assessed for fluxapyroxad. As a 
result, aggregate risk is represented by chronic dietary (food and 
water) and residential exposure. As reflected is these assessments, 
there are no risk concerns.
    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). Fluxapyroxad 
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 fluxapyroxad. 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 1,139 for adults and 431 for 
children. Because EPA's level of concern for fluxapyroxad is a MOE of 
100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
fluxapyroxad is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
fluxapyroxad.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has classified fluxapyroxad as ``Not likely to be 
Carcinogenic to Humans'' based on convincing evidence that carcinogenic 
effects are not likely below a defined dose range. The Agency has 
determined that the quantification of risk using the cPAD for 
fluxapyroxad will adequately account for all chronic toxicity, 
including carcinogenicity that could result from exposure to 
fluxapyroxad. Because the Agency has determined fluxapyroxad will not 
cause a chronic risk, the Agency concludes that fluxapyroxad will not 
pose a cancer risk for the U.S. population.
    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 fluxapyroxad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There is a suitable residue analytical method available for 
enforcement of fluxapyroxad tolerances for plants (BASF Methods L0137/
01) which has been radio validated and has undergone successful 
validation by an independent laboratory. There are liquid 
chromatography with tandem mass spectrometry (LC/MS/MS) method and 
monitors two ion transitions. The Limit of Quantitation (LOQ) for BASF 
method L0137/01 is 0.01 ppm for various matrices.

B. International Residue Limits

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

V. Conclusion

    Therefore, tolerances are established without a U.S. registration 
for residues of fluxapyroxad in or on banana at 3.0 parts per million 
(ppm); coffee green bean at 0.2 ppm; mango at 0.7 ppm; and papaya at 
0.6 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 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

[[Page 78513]]

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: October 24, 2016.
Daniel J. Rosenblatt,
Acting 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.  180.666, add alphabetically the entries ``Banana'', 
``Coffee, green bean'', ``Mango'', and ``Papaya'' to the table in 
paragraph (a), and add footnote 1 to the table to read as follows:

Sec.  180.666   Fluxapyroxad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Banana \1\..................................................         3.0
 
                                * * * * *
Coffee, green bean \1\......................................         0.2
 
                                * * * * *
Mango \1\...................................................         0.7
 
                                * * * * *
Papaya \1\..................................................         0.6
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of November 8,
  2016.

* * * * *
[FR Doc. 2016-26966 Filed 11-7-16; 8:45 am]
 BILLING CODE 6560-50-P