Document ID: EPA-HQ-OPP-2015-0215-0018
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Tioxazafen
Posted Date: 2017-05-01T04:00Z

[Federal Register Volume 82, Number 82 (Monday, May 1, 2017)]
[Rules and Regulations]
[Pages 20279-20284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08538]

[[Page 20279]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0215; FRL-9955-97]

Tioxazafen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tioxazafen in or on corn, field, forage; corn, field, grain; corn, 
field, stover; cotton, gin byproducts; cotton, undelinted seed; 
soybean, forage; soybean, hay; soybean, meal; soybean, seed. Monsanto 
Company requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective May 1, 2017. Objections and 
requests for hearings must be received on or before June 30, 2017, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0215, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0215 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 
June 30, 2017. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0215, 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 20, 2015 (80 FR 28925) (FRL-9927-
39), 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 
4F8339) by Monsanto Company, 1300 I Street NW., Suite 450 East, 
Washington, DC 20005. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the nematicide 
tioxazafen, in or on cattle, fat at 0.01 parts per million (ppm); 
cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm; corn, 
field, forage at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, field, 
stover at 0.02 ppm; cotton, gin byproducts at 0.02 ppm; cotton, 
undelinted seed at 0.01 ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 
ppm; goat, meat byproducts at 0.01ppm; horse, fat at 0.01 ppm; horse, 
meat at 0.01 ppm; horse, meat byproducts at 0.01 ppm; milk at 0.01 ppm; 
sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts 
at 0.01 ppm; soybean, forage at 0.15 ppm; soybean, hay at 0.30 ppm; 
soybean, meal at 0.05 ppm; and soybean, seed at 0.04 ppm. That document 
referenced a summary of the petition prepared by Monsanto Company, the 
registrant, which is available in the docket, http://www.regulations.gov. One comment was received in response to the notice 
of filing. The Agency's response to that comment is contained in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerance levels for corn, field, forage; corn, field, 
grain; and cotton, undelinted seed that differ from what the petitioner 
requested. In addition, the Agency determined tolerances were not 
necessary on cattle, fat; cattle, meat; cattle, meat byproducts; goat, 
fat; goat, meat; goat, meat byproducts; horse, fat; horse, meat; horse, 
meat byproducts, milk; sheep, fat; sheep, meat; and sheep, meat 
byproducts because of no expectation of

[[Page 20280]]

residues. The reasons 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 tioxazafen including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tioxazafen 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.
    Tioxazafen has low acute toxicity by the oral, dermal and 
inhalation routes of exposure. It is a mild eye irritant, nonirritating 
to the skin, and is not a dermal sensitizer.
    The adrenal gland in male and female rats was the primary target 
organ in subchronic and chronic oral toxicity studies. These effects 
were also observed in the dermal and inhalation (28- and 90-day) 
toxicity studies. In male rats, adrenal effects included increased 
adrenal weights and adrenal vacuolation. Although female rats exhibited 
decreased rather than increased adrenal weights, there were no 
corresponding histological effects in adrenals of females in the 2-
generation reproductive study or the chronic toxicity study to indicate 
adversity of the finding. The available studies suggest that the male 
rat may be more sensitive than females to the adrenal effects of 
tioxazafen.
    Evidence of neurotoxicity (i.e., decreased locomotor activity) was 
observed in the acute neurotoxicity study in the rat. Decreased 
hindlimb splay observed in the rat subchronic neurotoxicity study was 
not considered adverse, and there was no evidence of neurotoxicity in 
the rest of the database and no corroborating neuropathology.
    Tioxazafen did not result in developmental effects in either rats 
or rabbits, and therefore, there is no quantitative or qualitative 
susceptibility. In rats, the only maternal effects were decreased 
adrenal weights, and decreased food consumption. No histology was 
performed on the adrenal to assess potential functional effects. There 
were no maternal effects in the rabbit of toxicological significance. 
No offspring toxicity was noted up to 60 milligram/kilogram/day (mg/kg/
day) (highest dose tested (HDT)) in the 2-generation reproductive 
toxicity study.
    In an immunotoxicity rat study, decreased serum IgM response (not 
statistically significant) was noted at the high dose and decreasing 
median values exhibited a clear dose-response. These findings provide 
an indication of perturbation/dis-regulation of the immunologic 
response.
    Long-term dietary exposure to high doses of tioxazafen was 
associated with the development of malignant thoracic hibernomas in 
female rats, hepatocellular tumors in male and female mice, and 
hemangiosarcomas in male mice. Based on the observation of tumors in 2 
species and both sexes without an adequate mode of action, EPA 
classified tioxazafen as ``likely to be carcinogenic to humans'' with a 
linear cancer slope factor (Q1*) of 9.63 x 10-\3\ (mg/kg/
day)-\1\. Tioxazafen is not considered to be a mutagen.
    Specific information on the studies received and the nature of the 
adverse effects caused by tioxazafen 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, ``Tioxazafen. Human Health Risk 
Assessment for the First Food Uses on Corn, Cotton, and Soybean Seeds'' 
(K. Rickard, 10/06/2016) in docket ID number EPA-HQ-OPP-2015-0215.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological Point of Departures (PODs) 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 the NOAEL and the LOAEL are identified. 
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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for tioxazafen used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 20281]]

  Table 1--Summary of Toxicological Doses and Endpoints for Tioxazafen 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 (General population  LOAEL = 250 mg/kg/    Acute RfD = 0.25 mg/ Acute neurotoxicity--Rat LOAEL =
 including infants and children).   day.                  kg/day.              250 mg/kg/day based on decreased
                                   UFA = 10............  aPAD = 0.25 mg/kg/    total motor and ambulatory
                                   UFH = 10............   day.                 activity counts (observed at time
                                   FQPA SF/UFL = 10x...                        of peak).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  Parental NOAEL = 5.0  Chronic RfD = 0.05   Two-Generation Reproductive--Rat
                                    mg/kg/day.            mg/kg/day.           LOAEL = 20 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 0.05 mg/kg/    adrenal effects (increased weight
                                   UFH = 10x...........   day.                 and vacuolation of the adrenal
                                   FQPA SF = 1x........                        gland) in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Likely to be
                                    Carcinogenic to Humans'' based on female
                                    mouse liver combined adenoma and/or
                                    carcinoma tumor rates. A linear low dose
                                    extrapolation model for risk assessment
                                    will be used with a unit risk, Q\1\* =
                                    9.63 x 10-3 (mg/kg/day)-1 for female
                                    mouse liver combined adenoma and/or
                                    carcinoma tumor rates.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tioxazafen, EPA considered exposure under the petitioned-
for tolerances in 40 CFR 180. EPA assessed dietary exposures from 
tioxazafen 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 tioxazafen. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA conducted an unrefined acute dietary 
assessment using tolerance-level residues, 100 PCT assumptions, and 
default processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA conducted an unrefined chronic 
dietary assessment, using tolerance-level residues, 100 PCT 
assumptions, and default processing factors.
    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. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be 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 
concluded that tioxazafen should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk. Unrefined cancer dietary assessments were 
conducted using tolerance-level residues, 100 PCT assumptions, and 
default processing factors.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for tioxazafen. Tolerance level residues and/or 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 tioxazafen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tioxazafen. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide in Water Calculator (PWC v1.52) consisting 
of a graphical user interface shell integrating PRZM v.5.02 and 
VVWMv.1.02.1, the estimated drinking water concentrations (EDWCs) of 
tioxazafen for acute exposures are estimated to be 4.89 parts per 
billion (ppb) for surface water and 0.0756 ppb for ground water. For 
chronic exposures for non-cancer assessments the EDWCs are estimated to 
be 0.61 ppb for surface water and there was no breakthrough for ground 
water. Chronic exposures for cancer assessments are estimated to be 
0.38 ppb for surface water and there was no breakthrough 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 4.89 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.61 ppb was used to 
assess the

[[Page 20282]]

contribution to drinking water. For cancer dietary risk assessment, the 
water concentration of value 0.38 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).
    Tioxazafen 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 tioxazafen to share a common mechanism of 
toxicity with any other substances, and tioxazafen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
tioxazafen does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 Food Quality 
Protection Act Safety Factor (FQPA 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, was 
observed in fetuses as a result of in utero exposure in developmental 
toxicity studies in rats or rabbits, or in offspring as a result of 
potential in utero or postnatal exposure in a reproduction study in 
rats.
    3. Conclusion. EPA is retaining the 10X FQPA SF for acute exposure 
scenarios to account for extrapolation to a NOAEL from a LOAEL. For 
other exposure durations and routes, 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 based on the following 
findings:
    i. The toxicology database for tioxazafen is complete.
    ii. Tioxazafen did not result in developmental effects in either 
rats or rabbits, therefore, there is no evidence of increased 
qualitative or quantitative susceptibility in the developing fetus. No 
offspring toxicity was noted up to 60 mg/kg/day (highest dose tested) 
in the 2-generation reproductive toxicity study.
    iii. There is low concern for neurotoxicity. In the acute 
neurotoxicity study in the rat, decreased locomotor activity was noted 
and decreased hind limb splay was observed in the rat subchronic 
neurotoxicity study at week 3 evaluations; however, this effect was not 
considered adverse since there was no dose response relationship, the 
response was variable, nonpersistent, and not observed in the 90-day 
subchronic rat oral toxicity study, and no additional neurotoxicity 
data are required.
    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 tioxazafen in drinking water. These assessments 
will not underestimate the exposure and risks posed by tioxazafen.

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 tioxazafen will occupy <1% of the aPAD for all infants <1-year old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tioxazafen from food and water will utilize <1% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. There are no residential uses for tioxazafen.
    3. Short-term risk. Because there are no residential exposures to 
tioxazafen, a short-term aggregate risk assessment was not conducted.
    4. Intermediate-term risk. Because there are no residential 
exposures to tioxazafen, an intermediate-term aggregate risk assessment 
was not conducted.
    5. Aggregate cancer risk for U.S. population. Using a linear low-
dose extrapolation model (Q1*) was used to estimate cancer 
risk, with a Q1* = 9.63 x 10-3 (mg/kg/
day)-1, the Agency estimates cancer risk to Adults 20-49 
years old to be 5 x 10-7. EPA generally considers cancer 
risks (expressed as the probability of an increased cancer case) in the 
range of 1 in 1 million (or 1 x 10-6) or less to be 
negligible.
    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 tioxazafen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods are available to enforce the proposed 
tolerances for tioxazafen and benzamidine in plant commodities. The 
proposed plant enforcement method, Method 115G8064A, employs a single 
extraction and determinative step for both analytes. This method was 
successfully validated by an independent laboratory.
    Adequate enforcement methodology (electrospray ionization liquid 
chromatography with mass spectrometric detection (ESI LC-MS/MS) in 
positive ion mode) is available to enforce the tolerance expression.

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

[[Page 20283]]

international maximum residue limits (MRLs) established by the Codex 
Alimentarius Commission (Codex), as required by FFDCA section 
408(b)(4). The Codex Alimentarius is a joint United Nations Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for tioxazafen.

C. Response to Comments

    EPA received one comment on the Notice of Filing objecting, without 
any supporting information, to the establishment of these tioxazafen 
tolerances for concerns about the toxicity of chemicals generally. The 
Agency understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned from use on 
agricultural crops. The existing legal framework provided by section 
408 of the FFDCA, however, states that tolerances may be set when 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety stand imposed by that statute. EPA has 
evaluated the available data, assessed the effects of this chemical on 
human health, and determined that aggregate exposure to it will be 
safe. The commenter has not provided any information to support 
altering that safety finding.

D. Revisions to Petitioned-for Tolerances

    Some of the petitioned-for tolerance levels in the Notice of Filing 
differ from those currently being set by the Agency. Specifically, the 
Agency has determined that no livestock tolerances are needed as there 
is no reasonable expectation of finite residues in those commodities. 
Further, for corn and cotton raw agricultural commodities, the 
appropriate tolerance level needs to be the sum of the level of 
quantification of tioxazafen and benzamidine (0.02 ppm) rather than 
0.01 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of tioxazafen, 
in or on corn, field, forage at 0.02 ppm; corn, field, grain at 0.02 
ppm; corn, field, stover at 0.02 ppm; cotton, gin byproducts at 0.02 
ppm; cotton, undelinted seed at 0.02 ppm; soybean, forage at 0.15 ppm; 
Soybean, hay at 0.30 ppm; soybean, meal at 0.05 ppm and soybean, seed 
at 0.04 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).

List of Subjects in 40 CFR Part 180

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

    Dated: April 10, 2017.
Richard P. Keigwin, Jr.,
Acting Director, 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. Add Sec.  180.692 to subpart C to read as follows:

Sec.  180.692   Tioxazafen; tolerances for residues.

    (a) General. Tolerances are established for residues of tioxazafen, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring the combined residues of tioxazafen 
[3-phenyl-5-(2-thienyl)-1,2,4-oxadiazole] and benzamidine, expressed as 
tioxazafen in or on the commodity.

------------------------------------------------------------------------
                                                            Parts  per
                        Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.....................................            0.02
Corn, field, grain......................................            0.02
Corn, field, stover.....................................            0.02
Cotton, gin by-products.................................            0.02
Cotton, undelinted seed.................................            0.02

[[Page 20284]]

 
Soybean, forage.........................................            0.15
Soybean, hay............................................            0.30
Soybean, meal...........................................            0.05
Soybean, seed...........................................            0.04
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2017-08538 Filed 4-28-17; 8:45 am]
 BILLING CODE 6560-50-P