Document ID: EPA-HQ-OPP-2016-0495-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Prometryn
Posted Date: 2017-12-04T05:00Z

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57140-57144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26083]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0495; FRL-9970-01]

Prometryn; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
prometryn in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 4, 2017. Objections and 
requests for hearings must be received on or before February 2, 2018, 
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-2016-0495, 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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     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-2016-0495 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 2, 2018. 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-2016-0495, 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 November 30, 2016 (81 FR 86312) (FRL-
9954-06), 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 
6E8492) by IR-4 Project Headquarters, Rutgers, The State University of 
NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of prometryn in or on the raw agricultural 
commodity lettuce at 0.5 parts per million (ppm); cottonseed subgroup 
20C at 0.25 ppm; fennel, Florence at 0.5 ppm; leaf petiole vegetable 
subgroup 22B at 0.5 ppm;

[[Page 57141]]

sesame, oil at 0.12 ppm; sesame, seed at 0.05 ppm; and Swiss chard at 
0.5 ppm.
    In the Federal Register of April 10, 2017 (82 FR 17175) (FRL-9959-
61), 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 
6E8492) by IR-4 Project Headquarters, Rutgers, The State University of 
NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of prometryn in or on the raw agricultural 
commodity celtuce at 0.5 ppm. This notice of filing corrected the 
November 30, 2016 notice of filing which incorrectly listed the 
commodity as ``lettuce'' not ``celtuce.''
    The documents referenced a summary of the petition prepared by 
Syngenta Crop Protection, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to either notice of filing.
    Based upon review of the data supporting the petition, EPA has 
corrected the number of significant figures used, modified one of the 
commodity definitions, and determined that the sesame oil tolerance was 
not necessary. The reason for these changes are 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 prometryn including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with prometryn 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.
    Following subchronic and chronic oral exposures to rabbits, mice, 
dogs and rats, the most consistent effects observed in the database 
were decreases in body weight and food consumption. Following chronic 
exposure, effects in the dog included degenerative hepatic changes, 
renal tubule degeneration, and bone marrow atrophy. In rats following 
chronic exposure, renal toxicity (mineralized concentrations) was 
observed. No adverse effects were seen in rabbits following dermal 
exposures up to the limit dose.
    There was evidence of increased pre- and post-natal quantitative 
susceptibility for prometryn. While there was no evidence of 
susceptibility in the developmental toxicity studies in rabbits and 
rats, there was evidence of quantitative susceptibility in the two-
generation reproduction study in rats, with offspring effects 
(decreased pup body weight) occurring at lower doses than those that 
resulted in parental effects (decreased absolute bodyweight and food 
consumption).
    There was no evidence of neurotoxicity in the acute or subchronic 
neurotoxicity studies. In an immunotoxicity study in rats, there was a 
decreased humoral immune response using the sheep red blood cell assay, 
but only at a dose above the limit dose (1045 mg/kg/day).
    Prometryn has been classified by EPA as ``Group E:--Evidence of 
non-carcinogenicity for humans'' based on the lack of oncogenic effects 
at any dose in both rats and mice. Prometryn was determined to be non-
mutagenic and non-clastogenic in in vitro and in vivo genotoxicity 
assays.
    Specific information on the studies received and the nature of the 
adverse effects caused by prometryn 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 the document titled ``Prometryn--Preliminary 
Human Health Risk Assessment for Registration Review and the Risk 
Assessment for the Section 3 Registration Request for a New Use on 
Sesame and Crop-Group Conversions'' on pages 46-49 in docket ID number 
EPA-HQ-OPP-2016-0495.

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 no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for prometryn used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 57142]]

                       Table 1--Summary of Toxicological Doses and Endpoints for Prometryn
                                     for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       Endpoint not selected as there are no adverse developmental, offspring or
 years of age).                     reproductive effects seen in the toxicological database which are
                                    attributable to a single dose.
Acute dietary (General population     Endpoint not selected as there are no adverse single dose effects in the
 including infants and children).     database which occur at levels relevant for human health risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 4 mg/kg/day..  Chronic RfD = 0.04   Chronic Toxicity--Dog:
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 37.5 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.04 mg/kg/    degenerative hepatic changes,
                                   FQPA SF = 1x........   day.                 renal tubule degeneration and
                                                                               bone marrow atrophy.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: ``Group E: Evidence of non-carcinogenicity for humans.''
----------------------------------------------------------------------------------------------------------------
 FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prometryn, EPA considered exposure under the petitioned-for 
tolerances as well as all existing prometryn tolerances in 40 CFR 
180.222. EPA assessed dietary exposures from prometryn 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.
    No such effects were identified in the toxicological studies for 
prometryn; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA assumed 100 percent crop treated (PCT) and 
tolerance-level residues.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that prometryn 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 or PCT information in the dietary assessment for 
prometryn. Tolerance level residues and 100 PCT 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 prometryn in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of prometryn. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide in Water Calculator (PWC) and Pesticide Root 
Zone Model Ground Water (PRZM GW) model, the estimated drinking water 
concentrations (EDWCs) of prometryn for chronic exposures are estimated 
to be 127 parts per billion (ppb) for surface water and 433 ppb for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration of value 433 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).
    Prometryn 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.''
    EPA has not found prometryn to share a common mechanism of toxicity 
with any other substances, and prometryn does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that prometryn 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://www2.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 was evidence of 
increased pre- and post-natal quantitative

[[Page 57143]]

susceptibility for prometryn. While there was no evidence of 
susceptibility in the developmental toxicity studies in rabbits and 
rats, there was evidence of quantitative susceptibility in the two-
generation reproduction study in rats, with offspring effects 
(decreased pup body weight) occurring at lower doses than those that 
resulted in parental effects (decreased absolute bodyweight and food 
consumption).
    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 prometryn is complete.
    ii. There is no indication that prometryn is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There was no evidence of increased quantitative or qualitative 
susceptibility in the developmental toxicity studies in rabbits or 
rats. However, there was evidence of increased quantitative 
susceptibility in the two-generation reproduction study. In the two-
generation reproduction study, the offspring effects (decreased 
absolute pup bodyweight in the F1 generation) were observed 
at doses below parental toxicity (decreases in absolute bodyweight, 
bodyweight gain and food consumption in the F1 generation). 
Concern is low since the effects are characterized by clear NOAEL and 
LOAEL values and the selected endpoints are protective of the observed 
effects.
    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 prometryn in drinking water. These assessments 
will not underestimate the exposure and risks posed by prometryn.

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. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
prometryn is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
prometryn from food and water will utilize 60% of the cPAD for all 
infants less than 1-year old, the population group receiving the 
greatest exposure. There are no residential uses for prometryn.
    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).
    Short- and intermediate-term adverse effects were identified; 
however, prometryn is not registered for any use patterns that would 
result in either short- or intermediate-term residential exposure. 
Short- and intermediate-term risk is assessed based on short-and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short- or 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 short- or intermediate-term risk), no further 
assessment of either short- or intermediate-term risk is necessary, and 
EPA relies on the chronic dietary risk assessment for evaluating short- 
and intermediate-term risk for prometryn.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, prometryn is not expected to pose a cancer risk to humans.
    5. 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 prometryn residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
established and proposed tolerances. Prometryn is completely recovered 
(>80% recovery) using the Food and Drug Administration's (FDA's) 
Multiresidue Section 302. In addition, both Ciba-Geigy Method AG-559 
(gas chromatography (GC)/flame-photometric detector (FPD)/S) and Method 
AG-673 (GC/nitrogen-phosphorous detector (NPD) method) are considered 
adequate for enforcement purposes.
    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 not established any MRLs for prometryn.

C. Revisions To Petitioned-For Tolerances

    EPA modified the tolerance levels to reflect the correct number of 
significant figures and to be consistent with Agency policy. Also, the 
commodity definition for Florence fennel was modified to read ``Fennel, 
Florence, fresh leaves and stalk'' to be consistent with Agency 
nomenclature. Lastly, the petitioner recommended a tolerance for 
residues of prometryn in/on sesame, oil at 0.12 ppm. Residues in oil at 
a 5x application rate were 0.1076 which when extrapolated to 1x would 
be 0.02 ppm. As this value is well below the proposed raw agricultural 
commodity (RAC) tolerance, an oil tolerance is not necessary.

V. Conclusion

    Therefore, tolerances are established for residues of prometryn, 
including its metabolites and degradates, in or on

[[Page 57144]]

celtuce at 0.50 ppm; cottonseed subgroup 20C at 0.25 ppm; fennel, 
Florence, fresh leaves and stalk at 0.50 ppm; leaf petiole vegetable 
subgroup 22B at 0.50 ppm; sesame, seed at 0.05 ppm; and Swiss chard at 
0.50 ppm. Additionally, the existing tolerances for the leaf petioles 
subgroup 4B and cotton, undelinted seed are removed as unnecessary, 
since they are superseded by the new tolerances.

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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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: November 15, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.222:
0
i. Remove the entries from the table in paragraph (a) for ``Cotton, 
undelinted seed'' and ``Leaf petioles subgroup 4B''.
0
ii. Add alphabetically entries to the table in paragraph (a) for 
``Celtuce''; ``Cottonseed subgroup 20C''; ``Fennel, Florence, fresh 
leaves and stalk''; ``Leaf petiole vegetable subgroup 22B''; ``Sesame, 
seed''; and ``Swiss chard''.
    The additions read as follows:

Sec.  180.222  Prometryn; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Celtuce....................................................         0.50
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Cottonseed subgroup 20C....................................         0.25
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Fennel, Florence, fresh leaves and stalk...................         0.50
Leaf petiole vegetable subgroup 22B........................         0.50
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Sesame, seed...............................................         0.05
Swiss chard................................................         0.50
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-26083 Filed 12-1-17; 8:45 am]
 BILLING CODE 6560-50-P