Document ID: EPA-HQ-OPP-2018-0526-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Sedaxane
Posted Date: 2019-08-27T04:00Z

[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Rules and Regulations]
[Pages 44703-44708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18366]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0526; FRL-9998-22]

Sedaxane; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
sedaxane in or on legume vegetables (dried or succulent), crop group 6. 
Syngenta Crop Protection, LLC requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 27, 2019. Objections and 
requests for hearings must be received on or before October 28, 2019, 
and must

[[Page 44704]]

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-2018-0526, 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.

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-2018-0526 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 
October 28, 2019. 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-2018-0526, 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 February 6, 2019 (84 FR 2115) (FRL-9987-
08), 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 
8F8679) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greenboro, NC 
27419. The petition requested that 40 CFR 180.665 be amended by 
establishing a tolerance for residues resulting from seed treatment 
uses of the fungicide sedaxane, in or on legume vegetables (dried or 
succulent), crop group 6 at 0.01 parts per million (ppm) and to remove 
the existing tolerances for soybean, seed at 0.01 ppm and pea and bean, 
dried shelled, except soybean, subgroup 6C at 0.01 ppm upon 
establishment of the group 6 tolerance. That document referenced a 
summary of the petition prepared by Syngenta, 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 sedaxane including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with sedaxane 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.

[[Page 44705]]

    The main target tissue for sedaxane is the liver. Sedaxane also 
caused thyroid hypertrophy/hyperplasia in male rats. In the acute 
neurotoxicity (ACN) and sub-chronic neurotoxicity (SCN) studies, 
sedaxane caused decreased activity, muscle tone, rearing and grip 
strength; however, no adverse histopathology was observed, and EPA has 
concluded that there is low concern for neurotoxicity.
    In the rat, no adverse effects in fetuses were seen in 
developmental toxicity studies at maternally toxic doses. In the 
rabbit, fetal toxicity was observed at the same doses as the dams. 
Offspring effects in the rat reproduction study occurred at the same 
doses causing parental effects.
    The available data show evidence of liver tumors (in male rats and 
mice), thyroid tumors (in male rats), and uterine tumors (in female 
rats) resulting from exposure to sedaxane. Based on a weight of 
evidence of the available data, a constitutive androstane receptor/
pregnane-X receptor (CAR/PXR)-mediated mitogenic mode-of action (MOA) 
was established for liver tumors in male mice and rats and a liver-
mediated altered thyroid hormone homeostasis MOA was established for 
thyroid tumors in male rats. At this time, a MOA for the uterine tumors 
has not been identified.
    To quantitatively assess the carcinogenic potential of sedaxane, 
EPA has concluded that a non-linear approach (i.e., reference dose 
(RfD)) is appropriate for the following reasons: (1) There is a clear 
understanding of the threshold (non-linear) doses associated with the 
key events in the established MOAs leading to liver and thyroid tumors 
in rodents, the key events occur only at doses that well exceed the 
chronic reference dose (0.11 mg/kg/day); (2) Sedaxane is not mutagenic 
or genotoxic; (3) The dose at which uterine tumors was observed is at 
261 mg/kg/day, which greatly exceeds the chronic reference dose (0.11 
mg/kg/day) being used to assess chronic exposure to sedaxane.
    Sedaxane has low acute toxicity by the oral, dermal, and inhalation 
routes. It is not a dermal sensitizer, causes no skin irritation and 
only slight eye irritation.
    Specific information on the studies received and the nature of the 
adverse effects caused by sedaxane 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 the final rule 
published in the Federal Register of December 8, 2017 (82 FR 57867) 
(FRL-9970-04).

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 NOAEL and 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 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 sedaxane used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of December 8, 2017 (82 FR 57867) 
(FRL-9970-04).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sedaxane, EPA considered exposure under the petitioned-for 
tolerances as well as all existing sedaxane tolerances in 40 CFR 
180.665. EPA assessed dietary exposures from sedaxane 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 sedaxane. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) under the Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and the CDC under the 
National Health and Nutrition Examination Survey What We Eat in America 
(NHANES/WWEIA) 2003-2008. As to residue levels in food, EPA assumed 
tolerance-level residues for all commodities and 100% crop treated. 
Default processing factors were used with the exception of peanut 
butter which uses empirical processing data.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/WEIA 
2003-2008. As to residue levels in food, EPA assumed tolerance-level 
residues for all commodities and 100% crop treated (CT). Default 
processing factors were used with the exception of peanut butter which 
uses empirical processing data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to sedaxane. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for sedaxane. Tolerance-level residues and/or 100% 
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sedaxane in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of sedaxane. 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 First Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of sedaxane for acute exposures 
are estimated to be 4.1 parts per billion (ppb) for surface water and 
15.1 ppb for ground and for chronic exposures for non-cancer 
assessments are estimated to be 1.2 ppb for surface water and 13.0 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 15.1 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 13.0 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

[[Page 44706]]

flea and tick control on pets). Sedaxane 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.''
    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 sedaxane and any other 
substances, and sedaxane does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that sedaxane 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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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. There is no evidence for 
increased susceptibility following prenatal or post-natal exposures to 
sedaxane based on effects seen in developmental toxicity studies in 
rabbits or rats. In range-finding and definitive developmental toxicity 
studies in rats, neither quantitative nor qualitative evidence of 
increased susceptibility of fetuses to in utero exposure to sedaxane 
was observed. In these studies, there were no single-dose effects. 
There was no evidence of increased susceptibility in a 2-generation 
reproduction study in rats following prenatal or post-natal exposure to 
sedaxane. Clear NOAELs/LOAELs were established for the developmental 
effects seen in rats and rabbits as well as for the offspring effects 
seen in the 2-generation reproduction study. The dose-response 
relationship for the effects of concern is well characterized.
    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 sedaxane is complete.
    ii. Given the available information, there is low concern that 
sedaxane is a neurotoxic chemical and there is no need for a 
developmental neurotoxicity study or additional uncertainty factors 
(UFs) to account for neurotoxicity.
    iii. In the rat, no adverse effects in fetuses were seen in 
developmental toxicity studies at maternally toxic doses. In the 
rabbit, fetal toxicity was observed at the same doses as the dam 
(increased unossified sternebrae and 13th rudimentary ribs, a decrease 
in fetal weights of 9% and increased abortions). In the dam, at the 
same doses, the effects were decreased body weight, reduced food 
consumption, and decreased defecation. In reproduction studies, 
offspring effects occurred at the same doses causing parental effects; 
thus, there was no quantitative or qualitative increase in sensitivity 
in rat pups. The LOAELs and NOAELs for the developmental and 
reproduction studies were clearly defined. The NOAEL used for the acute 
dietary risk assessment (30 mg/kg/day), based on effects observed in 
the ACN study, is protective of the developmental and offspring effects 
seen in rabbits and rats with the NOAELs of 100-200 mg/kg/day. Based on 
these considerations, there are no residual uncertainties for pre-and/
or post-natal susceptibility.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to sedaxane in drinking water. These assessments 
will not underestimate the exposure and risks posed by sedaxane.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to sedaxane will occupy <1% of the aPAD for all infants (<1-year-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 
sedaxane from food and water will utilize <1% of the cPAD for all 
population subgroups the population group receiving the greatest 
exposure. There are no residential uses for sedaxane.
    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). Because there 
are no proposed or registered residential uses of sedaxane a short-term 
risk assessment was not performed. The chronic risk assessment is 
protective for any short-term exposures from food and drinking water.
    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). Because there are no proposed or registered residential uses of 
sedaxane, an intermediate-term risk assessment was not performed. The 
chronic assessment is protective for any intermediate-term exposures 
from food and drinking water.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has concluded that using the nonlinear approach based on 
the chronic RfD will be protective of potential carcinogenicity. 
Because the chronic risk is below the Agency's level of concern, EPA 
concludes there is no aggregate cancer risk from exposure to sedaxane.

[[Page 44707]]

    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 sedaxane residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available to enforce the proposed 
tolerances for sedaxane in plant commodities. A modification of the 
Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) method was 
developed for the determination of residues of sedaxane (as its isomers 
SYN508210 and SYN508211) in/on various crops. The sedaxane isomers 
(SYN508210 and SYN508211) are quantitatively determined by LC/MS/MS. 
The validated limit of quantitation (LOQ) reported in the method is 
0.005 ppm for each sedaxane isomer.
    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: 
residuemethods@epa.gov.

B. International Residue Limits

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

V. Conclusion

    Therefore, tolerances are established for residues of sedaxane in 
or on vegetable, legume, group 6 at 0.01 ppm. In addition, the Agency 
is removing the existing tolerances for pea and bean, dried shelled, 
except soybean, subgroup 6C, and soybean seed as they are unnecessary 
upon the establishment of the group 6 tolerance.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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: August 16, 2019.
Daniel 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.  180.665, amend the table in paragraph (a) as follows:
0
i. Remove the entry for ``Pea and bean, dried shelled, except soybean, 
subgroup 6C''; and
0
ii. Add alphabetically the entry ``Vegetable, legume, group 6''.
    The addition reads as follows:

Sec.  180.665  Sedaxane; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Vegetable, legume, group 6..................................        0.01
------------------------------------------------------------------------

[[Page 44708]]

* * * * *
[FR Doc. 2019-18366 Filed 8-26-19; 8:45 am]
 BILLING CODE 6560-50-P