[Federal Register Volume 82, Number 82 (Monday, May 1, 2017)]
[Rules and Regulations]
[Pages 20279-20284]
[FR Doc No: 2017-08538]

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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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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

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.

  Table 1--Summary of Toxicological Doses and Endpoints for Tioxazafen for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      Safety  factors      risk assessment
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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

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

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

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


[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Rules and Regulations]
[Pages 18685-18686]
[FR Doc No: 2012-7532]

=======================================================================
-----------------------------------------------------------------------

HEALTH AND HUMAN SERVICES DEPARTMENT

Food and Drug Administration

21 CFR Part 516

New Animal Drugs for Minor Use and Minor Species

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 500 to 599,
revised as of April 1, 2011, on page 96, in Sec.  516.20, (b)(2) is
revised to read as follows:

Sec.  516.20  Content and format of a request for MUMS-drug
designation.

* * * * *
    (b) * * *
    (2) The name and address of the sponsor; the name of the sponsor's
primary contact person and/or permanent-resident U.S. agent including
title, address, and telephone number; the established name (and
proprietary name, if any) of the active pharmaceutical ingredient of
the drug; and the name and address of the source

of the active pharmaceutical ingredient of the drug.
* * * * *
[FR Doc. 2012-7532 Filed 3-27-12; 8:45 am]
BILLING CODE 1505-01-D


Page 1 of 1 Memorandum From: Tom Born USEPA/ OW/ OST ph: ( 202) 566 1001 born. tom@ epa. gov To: Public Record for the Effluent Guidelines Program Plan for 2004/ 2005 DCN 00777, Section 2.1.4 EPA Docket Number OW 2003 0074 ( www. epa. gov/ edockets/)

Date: March 9, 2004 Re: Typical Pollutant Concentration ( TPC) Documentation for the 303( d) Impaired Waters Analysis The purpose of this memorandum is to place into the 304( m) docket the Typical Pollutant Concentration ( TPC) Documentation for the 303( d) Impaired Waters Analysis. The TPC documents were prepared by the Office of Enforcement and Compliance Assurance in the year 2000.

TPCs  average pollutant concentrations by SIC  were used to assign minor facilities to impaired waters, because minors have little or no permit limit information in PCS. Permit limit information was used, primarily for major facilities, to match facility pollutant discharges to waterbody impairments. Note that over counting may occur when matches are based on TPCs  some facilities might not actually discharge some or all of the TPC assigned pollutants.


NOTE TO DOCKET:

On March 10, 2004 EPA provided a status update on the regional haze program to remedy visibility impairment in federal Class I areas.

The following individuals participated in the call:

Kathy Van Dame   Wasatch Valley Coalition Jenn Choe   National Environmental Trust John Stanton   NET David Bard   Clear the Air Josh Tulkin   Clear the Air Dan Howells   Clear the Air Joy Oakes   National Parks Conservation Association Steve Bozak   NPCA Jill Stevens   NPCA Georgia Murray  Appalachian Mountain Club Ann Weeks   Clean Air Task Force David Marshall   CATF Bob Yunke   Environmental Defense Brian Urbaszewski   American Lung Association Bob Gruenig   National Tribal Environmental Council


Harvey Richmond/RTP/USEPA/US

03/11/2008 04:35 PM

To

<EMAIL_ADDRESS>"Johansson, Robert"<EMAIL_ADDRESS> cc

Lydia Wegman/RTP/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS>Tricia Crabtree/RTP/USEPA/US@EPA, Joseph Pinto/RTP/USEPA/US@EPA

Subject

Fw: Revised O3 NFR preamble and rule

With respect to the comments on the footnote 15 on p. 30 of the draft preamble concerning PRB, attached is a revised footnote with our proposed language for the preamble.

I checked with Dr. Pinto and the CD did not discuss year-to-year variability in PRB.  While we expect the variability to be within the noise of the estimated range, there is nothing specifically in the CD that allows us to address this.

I also checked the CASAC specific comments by Dr. Russell and he was discussing the overall approach in his comments and doesn't mention the 2001 year at all.  Therefore, we don't propose to make any revisions to p.132.  We had already included the phrase "using 2001 meteorology" on pages 129 and 130, in addition to the inclusion of "2001" in footnote 15 on p. 30 in the edits sent yesterday.

Harvey

    Harvey M. Richmond

    Ambient Standards Group

    Health and Environmental Impacts Division

    U.S. EPA

    C504-06

    RTP, NC  27711

    (office)<PHONE_NUMBER>

    (fax)<PHONE_NUMBER>

    (email<EMAIL_ADDRESS> _


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3671-3672]
[FR Doc No: 2015-01078]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 206(3)-2; SEC File No. 270-216, OMB Control No. 3235-0243.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 206(3)-2, (17 CFR 275.206(3)-2) which is entitled ``Agency
Cross Transactions for Advisory Clients,'' permits investment advisers
to comply with section 206(3) of the Investment Advisers Act of 1940
(the ``Act'') (15 U.S.C. 80b-6(3)) by obtaining a client's blanket
consent to enter into agency cross transactions (i.e., a transaction in
which an adviser acts as a broker to both the advisory client and the
opposite party to the transaction), provided that certain disclosures
are made to the client. Rule 206(3)-2 applies to all registered
investment advisers. In relying on the rule, investment advisers must
provide certain disclosures to their clients. Advisory clients can use
the disclosures to monitor agency cross transactions that affect their
advisory account. The Commission also uses the information required by
Rule 206(3)-2 in connection with its investment adviser inspection
program to ensure that advisers are in compliance with the rule.
Without the information collected under the rule, advisory clients
would not have information necessary for monitoring their adviser's
handling of their accounts and the Commission would be less efficient
and effective in its inspection program.

    The information requirements of the rule consist of the following:
(1) Prior to obtaining the client's consent appropriate disclosure must
be made to the client as to the practice of, and the conflicts of
interest involved in, agency cross transactions; (2) at or before the
completion of any such transaction the client must be furnished with a
written confirmation containing specified information and offering to
furnish upon request certain additional information; and (3) at least
annually, the client must be furnished with a written statement or
summary as to the total number of transactions during the period
covered by the consent and the total amount of commissions received by
the adviser or its affiliated broker-dealer attributable to such
transactions.
    The Commission estimates that approximately 464 respondents use the
rule annually, necessitating about 32 responses per respondent each
year, for a total of 14,848 responses. Each response requires an
estimated 0.5 hours, for a total of 7,424 hours. The estimated average
burden hours are made solely for the purposes of the Paperwork
Reduction Act and are not derived from a comprehensive or
representative survey or study of the cost of Commission rules and
forms.
    This collection of information is found at (17 CFR 275.206(3)-2)
and is necessary in order for the investment adviser to obtain the
benefits of Rule 206(3)-2. The collection of information requirements
under the rule is mandatory. Information subject to the disclosure
requirements of Rule 206(3)-2 does not require submission to the
Commission; and, accordingly, the disclosure pursuant to the rule is
not kept confidential. Commission-registered investment advisers are
required to maintain and preserve certain information required under
Rule 206(3)-2 for five (5) years. The long-term retention of these
records is necessary for the Commission's inspection program to
ascertain compliance with the Advisers Act.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within sixty 60 days of this publication.
    Please direct your written comments to Pamela Dyson, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send
an email to<EMAIL_ADDRESS>
    Dated: January 16, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-01078 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P