Document ID: EPA-HQ-OPP-2015-0559-0011
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Penflufen
Posted Date: 2016-10-19T04:00Z

[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Rules and Regulations]
[Pages 72002-72007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25293]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0559; FRL-9952-22]

Penflufen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
penflufen in or on vegetable, bulb, group 3-07; beet, sugar, roots; and 
beet, sugar, tops. Interregional Research Project Number 4 (IR-4) 
requested the tolerance associated with pesticide petition number (PP#) 
5E8382, and Bayer CropScience requested the tolerances associated with 
PP# 5F8379, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 19, 2016. Objections and 
requests for hearings must be received on or before December 19, 2016, 
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-2015-0559, 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-2015-0559 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 
December 19, 2016. 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-2015-0559, 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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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# 
5E8382) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Princeton, NJ 08540. The petition requested that 40 CFR 
180.664 be amended by establishing tolerances for residues of the 
fungicide penflufen, (1H-Pyrazole-4-carboxamide, N-[2-(1,3-
dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-), in or on onion, bulb, 3-
07A at 0.01 parts per million (ppm); and onion, green, 3-07B at 0.015 
ppm. That document referenced a summary of the petition prepared by 
Bayer CropScience, the registrant, which is available in the docket 
EPA-HQ-OPP-2015-0559-0002 at http://www.regulations.gov.
    In the Federal Register of July 20, 2016 (81 FR 47150) (FRL-9948-
45), EPA issued a document pursuant to

[[Page 72003]]

FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of 
a pesticide petition (PP# 5F8379) by Bayer CropScience, 2 T.W. 
Alexander Drive, Research Triangle Park, NC 27709. The petition 
requested that 40 CFR 180.664 be amended by establishing tolerances for 
residues of the fungicide penflufen, (1H-Pyrazole-4-carboxamide, N-[2-
(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-), in or on beet, 
sugar, roots at 0.01 ppm and beet, sugar, tops at 0.01 ppm. That 
document referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available in the docket EPA-HQ-
OPP-2015-0559-0006 at http://www.regulations.gov.
    Five comments were received in response to the notices of filing. 
EPA's responses to these comments are discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the petitioned-for tolerances for subgroups 3-07A and 3-07B 
since the Agency has determined that a crop group tolerance for 
vegetable, bulb, group 3-07 is more appropriate. The reason for these 
changes are explained in Unit IV.D.

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 penflufen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with penflufen 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 liver and thyroid are target organs for penflufen. No evidence 
of quantitative or qualitative susceptibility was seen in developmental 
toxicity studies (rats and rabbits). Developmental toxicity was not 
observed in the rat or rabbit studies, although the studies did not 
test up to the limit dose. However, new studies are not expected to 
identify developmental endpoints with points of departure (PODs) lower 
than those determined in the current studies. In the reproductive 
study, decreased pup weight, delayed vaginal patency, and decreased 
brain, spleen, and thymus weights were seen in the presence of limited 
maternal effects (body weight changes), suggesting qualitative 
sensitivity. However, concern for the sensitivity is low since the 
effects are well characterized, and there is a clear NOAEL for the 
effects seen. Decreased motor and locomotor activity were observed in 
both sexes of rats following acute oral exposure and in female rats 
following subchronic oral exposure; neuropathological lesions were not 
observed in either study.
    Penflufen is classified as having ``suggestive evidence of 
carcinogenicity.'' A statistically significant increase in histiocytic 
sarcomas with a positive trend in male rats only (but in the absence of 
a dose response and lack of pre-neoplastic lesions) was seen. A 
marginal increase in brain astrocytomas was also observed in males at 
the high dose; however, this effect was not dose-related, did not reach 
statistical significance, and there was no overall trend. In addition, 
there were no pre-neoplastic lesions, such as glial proliferations, 
which are a good indicator of chemical tumor induction (i.e., there 
will be changes in the cells prior to transformation to a neoplasm). 
The ovarian adenomas observed at the high dose also showed no dose 
response, no pair-wise significance, no decrease in latency, and there 
were no pre-neoplastic lesions such as hyperplasia of the epithelial 
cells of the endometrium. Additionally, there was no evidence of 
carcinogenicity in male or female mice (at doses that were judged to be 
adequate to assess the carcinogenic potential), no concern for 
mutagenicity (in vivo or in vitro) for the parent molecule or the two 
metabolites, and there were no other lines of evidence of 
carcinogenicity (such as structure-activity relationship). Although 
these three tumors were considered treatment-related, they provided 
weak evidence of carcinogenicity due to the marginal nature of the 
tumor responses and the other factors mentioned above. Given the weak 
evidence indicating any potential for carcinogenicity, EPA has 
determined that quantification of risk using a non-linear approach 
(i.e., RfD) will adequately account for all chronic toxicity, including 
carcinogenicity, which could result from exposure to penflufen. The 
NOAEL (38 mg/kg/day) used for establishing the chronic RfD is 
approximately 10-fold lower than the dose (approximately 300 mg/kg/day) 
that induced a marginal tumor response. The EPA has determined that the 
chronic population adjusted dose is protective of all long-term 
effects, including potential carcinogenicity, based on limited evidence 
for carcinogenicity (histiocytic sarcomas) in male rats. There is no 
mutagenicity concern for penflufen. The risk assessments conducted for 
penflufen are based on the most sensitive endpoints in the toxicity 
database and are protective of all effects observed in the toxicology 
database.
    Specific information on the studies received and the nature of the 
adverse effects caused by penflufen as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document ``Penflufen. 
Human Health Risk Assessment to Support New Uses on Bulb Vegetables 
(Crop Group 3-07) and Sugar Beets.'' in pages 8-12 in docket ID number 
EPA-HQ-OPP-2015-0559.

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

[[Page 72004]]

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 penflufen used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of May 14, 2012 (77 FR 28278) (FRL-
9341-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to penflufen, EPA considered exposure under the petitioned-for 
tolerances as well as all existing penflufen tolerances in 40 CFR 
180.664. EPA assessed dietary exposures from penflufen 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 penflufen. In estimating acute 
dietary exposure, EPA used the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID) Version 
3.16. This software uses 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 used tolerance-level residues, default 
processing factors, and 100 percent crop treated (PCT) for all 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008 
food consumption data from the USDA's NHANES/WWEIA. As to residue 
levels in food, EPA used tolerance-level residues, default processing 
factors, and 100 PCT for all commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has determined that quantification of risk using a non-
linear approach (i.e., cRfD) will adequately account for all chronic 
toxicity, including carcinogenicity, which could result from exposure 
to penflufen. Cancer risk was assessed using the same exposure 
estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for penflufen. Tolerance level residues and 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water.
    In drinking water, the residue of concern is penflufen parent and 
its degradates, penflufen-hydroxybutyl (Pen-3HB) and penflufen-
pyrazolyl-AAP (AAP). The Agency used screening level water exposure 
models in the dietary exposure analysis and risk assessment for 
penflufen in drinking water. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
penflufen. 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 Surface Water Concentration Calculator (SWCC) and 
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated 
drinking water concentrations (EDWCs) of penflufen for acute exposures 
are estimated to be 5.09 parts per billion (ppb) for surface water and 
123 ppb for ground water. The EDWCs of penflufen for chronic exposures 
for non-cancer assessments are estimated to be 3.95 ppb for surface 
water and 84.8 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 123 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 84.8 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). Penflufen 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 penflufen to share a common mechanism of toxicity 
with any other substances, and penflufen does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that penflufen 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

[[Page 72005]]

data available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of quantitative 
or qualitative susceptibility was seen in developmental toxicity 
studies in rats and rabbits. In the rat and rabbit developmental 
toxicity studies, maternal findings were limited to decreased body 
weight gain at the highest doses tested (HDT). No adverse effects were 
observed in rat or rabbit fetuses. In the rat multi-generation 
reproduction study, a slight decrease in litter size, delayed sexual 
maturation, decreased body weight and weight gain, and decreased brain, 
spleen, and thymus weights were noted in the offspring animals in the 
presence of less pronounced maternal toxicity (decreased body weight 
and weight gain, alteration in food consumption, decreased thymus 
weight, and decreased spleen weights) suggesting qualitative 
susceptibility.
    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 penflufen is complete.
    ii. There is no concern for neurotoxicity and no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity. Although clinical signs were observed in acute and 
subchronic neurotoxicity studies with penflufen, there is a clear NOAEL 
for the effects seen and the endpoints and PODs selected for risk 
assessment are protective. The NOAELs used for risk assessment are 2x 
lower than where clinical signs were observed.
    iii. Although there is some evidence of qualitative sensitivity of 
the young in the reproduction study, the effects are well 
characterized, and there is a clear NOAEL for effects seen. Also, the 
current risk assessments are based on the most sensitive endpoints 
derived from studies with NOAELs 5x lower than the doses at which 
offspring effects were observed in the reproductive toxicity study. 
Thus, the PODs selected for risk assessment are protective of potential 
offspring 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 penflufen in drinking water. These assessments 
will not underestimate the exposure and risks posed by penflufen.

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 penflufen will occupy 4.2% 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 
penflufen from food and water will utilize 1.2% of the cPAD for all 
infants (<2 year old) the population group receiving the greatest 
exposure. There are no residential uses for penflufen.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
adverse effects were not identified; however, penflufen is not 
registered for any use patterns that would result in short- or 
intermediate-term residential exposures. Short- and intermediate-term 
risks are assessed based on short- and intermediate-term residential 
exposures plus chronic dietary exposure, respectively. Because there 
are no short- and intermediate-term residential exposures, 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-term risk), no further assessment of short- or 
intermediate-term risks are necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risks for penflufen.
    4. Aggregate cancer risk for U.S. population. EPA assessed cancer 
risk using a non-linear approach (i.e., RfD) since it adequately 
accounts for all chronic toxicity, including carcinogenicity, that 
could result from exposure to penflufen. As the chronic dietary 
endpoint and dose are protective of potential cancer effects, penflufen 
is not expected to pose an aggregate cancer risk.
    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 penflufen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography and triple stage quadrupole mass spectrometry (HPLC/MS/
MS)) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
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 a MRL for penflufen.

C. Response to Comments

    One comment was received in response to the Notice of Filing for 
PP# 5E8382. The commenter was opposing the use and sale of penflufen in 
the United States. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops. However, the existing legal framework 
provided by Section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by

[[Page 72006]]

that statute. EPA has found that there is a reasonable certainty of no 
harm to humans after considering the toxicological studies and the 
exposure levels of humans to penflufen.
    Three comments were received in response to the Notice of Filing 
for PP# 5F8379. One comment was in support of the Proposed Rule, while 
two comments were opposing any tolerance level above 0.00 ppm for any 
pesticides used in the U.S. The Agency understands the commenter's 
concerns and recognizes that some individuals believe that pesticides 
should be banned on agricultural crops. However, the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) states that tolerances may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. In 
addition, both commenters indicated that IR-4 and Rutgers University 
are profiteering. The IR-4 program was created by Congress in 1963 in 
order to assist minor crop growers in the process of obtaining 
pesticide registrations. IR-4 National Coordinating Headquarters is 
located at Rutgers University in New Jersey and receives the majority 
(90%) of its funding from the USDA. It is the only publicly funded 
program that conducts research and submits petitions for tolerances. 
IR-4 operates in collaboration with USDA, the Land Grant University 
System, the agrochemical industry, commodity associations, and EPA. IR-
4 identifies needs, prioritizes accordingly, and conducts research. The 
majority (over 80%) of IR-4's research is conducted on reduced-risk 
chemicals. Under the Pesticide Registration Improvement Act (PRIA), IR-
4 works in cooperation with the registrant to request an exemption for 
the registration services. The exemption may be granted if the 
application is solely associated by simultaneous submission with a 
tolerance petition in connection with IR-4 and if it is in the public 
interest. This fee exemption serves as an incentive to pursue 
registration of minor uses supported by the IR-4 program. In addition 
to the work done in pesticide registration, IR-4 develops risk 
mitigation measures for existing registered products. Therefore, IR-4 
and Rutgers University are not profiteering from registering 
pesticides.
    A comment was submitted by the Environmental Health Program of the 
Center for Biological Diversity and was primarily concerned about 
environmental risks and Agency compliance with any relevant obligations 
under the Endangered Species Act. This comment is not relevant to the 
Agency's evaluation of safety of the penflufen tolerances; section 408 
of the FFDCA focuses on potential harms to human health and does not 
permit consideration of effects on the environment.

D. Revisions to Petitioned-for Tolerances

    Based on review of the data supporting the petitions, EPA has 
revised the petitioned-for tolerance on onion, green, subgroup 3-07B. 
Both representative commodities for crop group 3-07 were submitted for 
the new uses, which included different tolerances proposed for crop 
subgroup 3-07A and 3-07B. Although the petitioner requested separate 
tolerances (based on the Organization for Economic Cooperation and 
Development (OECD) calculation procedure), EPA has decided to establish 
a tolerance for crop group 3-07 at the level of qualification (LOQ) of 
the enforcement method (0.01 ppm), because maximum residues from crop 
subgroup 3-07A and subgroup 3-07B representative commodities were 
within a five-fold difference of each other, and because with residues 
in the field trials all less than the LOQ, the OECD calculation 
procedure stipulates that the LOQ is the appropriate tolerance level. 
Therefore, a single tolerance on the crop group vegetable, bulb, group 
3-07 is appropriate.

V. Conclusion

    Therefore, tolerances are established for residues of penflufen, in 
or on vegetable, bulb, group 3-07 at 0.01 ppm; beet, sugar, roots at 
0.01 ppm; and beet, sugar, tops 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). 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).

[[Page 72007]]

List of Subjects in 40 CFR Part 180

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

    Dated: September 30, 2016.
Michael Goodis,
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.  180.664, alphabetically add entries for ``beet, sugar, 
roots'', ``beet, sugar, tops'', and ``vegetable, bulb, group 3-07'' to 
the table in paragraph (a) to read as follows:

Sec.  180.664  Penflufen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, roots......................................        0.01 ppm
Beet, sugar, tops.......................................        0.01 ppm
 
                                * * * * *
Vegetable, bulb, group 3-07.............................        0.01 ppm
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-25293 Filed 10-18-16; 8:45 am]
 BILLING CODE 6560-50-P