[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Rules and Regulations]
[Pages 13548-13552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04524]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0061; FRL-10004-86]


Penoxsulam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
penoxsulam in or on globe artichoke. Interregional Research Project 
Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 9, 2020. Objections and 
requests for hearings must be received on or before May 8, 2020, 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-2019-0061, 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 
Publishing 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-2019-0061 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 
May 8, 2020. 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 13549]]

2019-0061, 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 May 9, 2019 (84 FR 20320) (FRL-9992-36), 
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 8E8727) 
by IR-4, Rutgers, The State University of New Jersey, 500 College Road 
East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.605 be amended by establishing a tolerance for residues of the 
herbicide penoxsulam, including its metabolites and degradates, in or 
on artichoke, globe at 0.01 parts per million (ppm). That document 
referenced a summary of the petition prepared by Dow AgroSciences, the 
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed 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 penoxsulam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with penoxsulam 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 kidney was the major target organ for penoxsulam in the rat and 
dog following subchronic and chronic dietary exposure. There are no 
mechanistic studies characterizing the mode of action for renal 
toxicity of penoxsulam or other triazolopyrimidine herbicides, but the 
presence of crystals in the urinary tract and lack of tissue 
bioaccumulation suggest that cellular inflammation and damage may occur 
secondary to their presence. Hyperplasia (rat and dog) and inflammation 
(rat) of the renal pelvic epithelium were observed by week 4 in dietary 
dose range-finding studies. The dog was the more sensitive species in 
studies of all durations. The rat, but not the dog, showed progression 
of the severity of kidney toxicity with prolonged exposure. In dogs, 
renal toxicity in the subchronic and chronic studies occurred at 
comparable dose levels and measurable effects on renal function were 
not observed. In the rat, effects on renal function (increased blood 
urea nitrogen in both sexes, urinary bladder mucosal hyperplasia, and 
increased severity of chronic glomerulonephropathy in males) were 
observed only following chronic exposure, although the doses at which 
kidney toxicity occurred were comparable to doses tested in the 
subchronic study. A consistent pattern that identified a greater 
sensitivity of either sex was not observed.
    Other effects in the rat included decreased red blood cell 
parameters and decreased body weight and/or weight gain. Liver effects 
were observed at the higher dose levels in the dog 4-week feeding study 
but not in other studies in the database. The findings of liver and/or 
kidney effects are consistent with effects observed for other 
triazolopyrimidine herbicides.
    No effects of toxicological significance were observed in the 
mouse. Penoxsulam showed no evidence of neurotoxicity or immunotoxicity 
in the rodent, and no effects were seen in rats following dermal 
exposure. The Agency waived the requirement for inhalation data based 
on high inhalation margins of exposure using an oral endpoint, lack of 
observed irritation effects, and low vapor pressure.
    There was no evidence of increased pre- and/or post-natal 
susceptibility. No developmental effects were observed in the rat or 
rabbit. Maternal effects in the rat included decreased body weight gain 
and food consumption and increased kidney weights. In the rabbit, 
maternal effects included mortality, clinical signs of toxicity, and 
decreased body weight gain and food consumption. In the rat 2-
generation reproductive toxicity study, delayed preputial separation 
and lactation body weights were observed in F1 offspring at a dose that 
caused kidney lesions in parental females.
    Although there is evidence of an increased incidence of mononuclear 
cell leukemia (MNCL) in Fisher 344 rats from exposure to penoxsulam, 
EPA has concluded that a quantitative assessment of cancer is not 
necessary and that the chronic reference dose (cRfD) is considered 
protective of possible cancer effects.
    Specific information on the studies received and the nature of the 
adverse effects caused by penoxsulam 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 ``Penoxsulam: Human Health 
Risk Assessment for the Proposed Use on Globe Artichoke'' (Penoxsulam 
HHRA) on pages 32-37 in docket ID number EPA-HQ-OPP-2019-0061. For 
further discussion of the Agency's rationale for its cancer conclusion, 
see page 16 of the Penoxsulam HHRA.

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

[[Page 13550]]

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-pesticide.
    A summary of the toxicological endpoints for penoxsulam used for 
human risk assessment is discussed in Unit III.B of the final rule 
published in the Federal Register of March 2, 2016 (81 FR 10771) (FRL-
9940-36).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to penoxsulam, EPA considered exposure under the petitioned-
for tolerance as well as all existing penoxsulam tolerances in 40 CFR 
180.605. EPA assessed dietary exposures from penoxsulam 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 
penoxsulam; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the United States 
Department of Agriculture's (USDA's) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, the chronic dietary exposure assessment 
was unrefined and used tolerance-level residues and 100 percent crop 
treated (PCT).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that the cRfD is protective of potential cancer risk from 
exposure to penoxsulam.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
penoxsulam. Tolerance-level residues and 100 PCT were assumed for all 
food commodities as well as contribution to the 5-OH-penoxsulam 
metabolite in fish.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for penoxsulam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of penoxsulam. 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.
    Penoxsulam is registered for control of aquatic weeds. For that use 
pattern, the maximum application rate is 150 parts per billion (ppb) in 
the water column. For the chronic dietary risk assessment, the water 
concentration value of 150 ppb was used to assess the contribution to 
drinking water. This value is likely to be an overestimate of actual 
residues in 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).
    Penoxsulam is currently registered for the following uses that 
could result in residential exposures: Residential and commercial turf 
(lawns and golf courses) and aquatic use sites. EPA assessed 
residential exposure using the following assumptions: For handlers, it 
is assumed that residential use will result in short-term (1 to 30 
days) dermal and inhalation exposures. Residential post-application 
exposure is also assumed to be short-term (1 to 30 days) in duration, 
resulting from the following exposure scenarios:
    Physical activities on turf: Adults (dermal) and children 1 to 2 
years old (dermal and incidental oral);
    Mowing turf: Adults (dermal) and children 11 to <16 years old 
(dermal);
    Exposure to golf courses during golfing: Adults (dermal), children 
11 to <16 years old (dermal), and children 6 to <11 years old (dermal); 
and
    Exposure during aquatic activities (e.g. swimming): Adults (dermal, 
inhalation, ingestion) and children 3 to <6 years old (dermal, 
inhalation, ingestion).
    Due to the lack of a dermal endpoint, EPA did not quantify exposure 
and risk estimates from dermal exposure scenarios. EPA did not combine 
exposure resulting from adult handler and post-application exposure 
resulting from treated gardens, lawns, golfing, and/or aquatic areas in 
residential settings because of the conservative assumptions and inputs 
within each estimated exposure scenario. The Agency believes that 
combining exposures resulting from handler and post-application 
activities would result in an overestimate of adult exposure. EPA 
selected the most conservative adult residential scenario (adult 
handler inhalation exposure from backpack sprayer applications to 
lawns/turf) as the contributing source of residential exposure to be 
combined with the dietary exposure for the aggregate assessment. The 
exposure for the aggregate assessment for children 3 to <6 years old is 
based on post-application combined inhalation and ingestion exposures 
during aquatic activities. The oral exposure for the aggregate 
assessment for children 1 to <2 years old is based on post-application 
hand-to-mouth exposures from applications to lawns/turf. To include 
exposure from object-to-mouth and soil ingestion in addition to hand-
to-mouth would overestimate the potential for oral exposure. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 penoxsulam and any other 
substances

[[Page 13551]]

and penoxsulam does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this action, therefore, EPA 
has not assumed that penoxsulam has 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 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. No evidence of quantitative 
or qualitative increased susceptibility, as compared to adults, of rat 
fetuses to in utero or postnatal exposure was observed in developmental 
toxicity studies in rats or rabbits or a reproduction study in rats. 
Developmental toxicity was not observed in the rat or rabbit up to 
doses resulting in maternal toxicity. In the rat reproductive toxicity 
study, slightly increased time to preputial separation in F1 males and 
decreased pup weight gain were observed in the presence of parental 
toxicity (kidney lesions in females).
    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 penoxsulam is complete.
    ii. There is no indication that penoxsulam is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors to account for neurotoxicity.
    iii. There is no evidence that penoxsulam results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    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 by using the high-end EDWC of 150 ppb from the 
aquatic weed use pattern to assess exposure to penoxsulam in drinking 
water. EPA used similarly conservative assumptions to assess post-
application exposure of children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by penoxsulam.

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, 
penoxsulam 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 
penoxsulam from food and water will utilize 5.6% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
penoxsulam is not expected.
    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). Penoxsulam 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 penoxsulam.
    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 5,500 for adults, 
1,700 for children 1 to 2 years old, and 4,500 for children 3 to 5 
years old. Because EPA's level of concern for penoxsulam 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, 
penoxsulam 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 
penoxsulam.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has determined that an RfD approach based on the chronic 
point of departure is appropriate for evaluating cancer risk. As there 
are not chronic aggregate risks of concern, there are no cancer 
aggregate risk concerns.
    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 penoxsulam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies using high performance liquid 
chromatography with tandem mass spectroscopy (HPLC-MS/MS) are available 
to enforce the tolerance expression. These methods 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].

[[Page 13552]]

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 penoxsulam on globe 
artichoke.

C. Response to Comments

    Two comments were received in response to the notice of filing. One 
was against the Agency granting the use of penoxsulam and one was 
against the use of pesticides in general. Although the Agency 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops, the existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 
authorizes EPA to establish tolerances when it determines that the 
tolerance is safe. Upon consideration of the validity, completeness, 
and reliability of the available data as well as other factors the 
FFDCA requires EPA to consider, EPA has determined that these 
penoxsulam tolerances are safe. The commenters have provided no 
information to support an Agency conclusion that penoxsulam is not 
safe.

V. Conclusion

    Therefore, tolerances are established for residues of penoxsulam, 
including its metabolites and degradates, in or on artichoke, globe at 
0.01 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), 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: February 6, 2020.
Michael 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.  180.605, add alphabetically the entry ``Artichoke, globe'' 
to the table in paragraph (a) to read as follows:


Sec.  180.605  Penoxsulam; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Artichoke, globe............................................        0.01
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2020-04524 Filed 3-6-20; 8:45 am]
 BILLING CODE 6560-50-P