[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Rules and Regulations]
[Pages 12516-12520]
[FR Doc No: 2019-06334]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0616; FRL-9987-14]

Metrafenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
metrafenone in or on mushroom. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 2, 2019. Objections and
requests for hearings must be received on or before June 3, 2019 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-2017-0616, 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 protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0616 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 3, 2019. 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-2017-0616,
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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), 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
7F8624) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR
180.624 be amended by establishing a tolerance for residues of the
fungicide metrafenone, (3-bromo-6-methoxy-2-methylphenyl) (2,3,4-
trimethoxy-6-methylphenyl)methanone, in or on mushroom at 0.5 parts per
million (ppm). That document referenced a summary of the petition
prepared by BASF Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA is
establishing the tolerance for residues of metrafenone at 0.50 ppm to
be consistent with EPA rounding class practices. Additionally, the
tolerance is established for the commodity ``White button mushroom'' to
reflect the mushroom variety tested in the supporting crop field trial
studies.

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 metrafenone including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with metrafenone 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 is the primary target organ for metrafenone in mice,
rabbits and rats. Effects on the liver were seen in multiple studies
throughout the database, including subchronic rat studies, the rabbit
developmental toxicity study, and chronic studies in mice and rats.
Liver effects observed in subchronic studies included increased liver
weights, periportal cytoplasmic vacuolation, increased cholesterol, and
hepatocellular hypertrophy. Liver effects observed in chronic studies
included those from the subchronic studies as well as increased serum
gamma glutamyl transferase, eosinophilic alterations, necrosis,
polyploid hepatocytes, bile duct hyperplasia, liver masses, and
hepatocellular adenomas. The additional effects in the chronic studies
indicate a progression of toxicity with time. The effects on the liver
are consistent with the results of the absorption, distribution,
metabolism, and excretion (ADME) studies indicating that the highest
tissue concentrations of metrafenone were found in the liver and
gastrointestinal tract and that bile is the primary route of excretion.
    Additionally, nephrotoxicity was observed following chronic
exposure to metrafenone in mice and rats. The kidney effects observed
in the chronic studies included subacute/chronic interstitial
inflammation and chronic/progressive nephropathy, cysts, brown pigment
in renal cells, increased urinary volume, and increased urinary
protein.
    In a 28-day dermal toxicity study in rats, there were no dermal or
systemic effects observed up to the highest dose tested of 1,000 mg/kg/
day, the limit dose. In a 28-day immunotoxicity study in female rats,
no effect on the immune system was observed up to the highest dose
tested of 1,000 mg/kg/day, the limit dose. This is consistent with the
rest of the database where no effects on the immune system were
observed in any study.
    There was no evidence of qualitative or quantitative susceptibility
in the developmental and reproduction toxicity studies. In the
developmental rat study, no effects were observed in dams or fetuses up
to the limit dose of 1,000 mg/kg/day. In the rabbit study, liver
toxicity (increased liver weights, hypertrophy, and hepatocyte
vacuolation) was observed in the dams but no developmental effects were
observed up to the limit dose of 1,000 mg/kg/day.
    In the rat reproduction toxicity study, there was no evidence of
reproductive toxicity. Effects in the offspring (decreased pup weight)
occurred at doses similar to those that cause toxicity in the parental
animals (decreased body weight).
    The required battery of mutagenicity studies was submitted,
including bacterial reverse mutation assay, mammalian cell mutation
(CHO cells), in vitro chromosome aberration (CHO cells), micronucleus
assay and unscheduled DNA synthesis in mammalian cells in culture.
There is no evidence that metrafenone is genotoxic.
    In the mouse carcinogenicity study, liver tumors (increased
incidence of hepatocellular adenomas and adenomas plus carcinomas) were
observed in male

mice at the highest dose of 1,109 mg/kg/day. In the rat chronic/
carcinogenicity study, there was an increased incidence in
hepatocellular adenomas in females at the high dose of 1,419 mg/kg/day.
However, the tumors in the rat females were not considered in the
weight-of-evidence finding because they were associated with excessive
toxicity to the females, leading to a reduction of the dose during the
study. The registrant submitted mechanistic studies to support a mode
of action (MOA) for the liver tumors, but the studies were conducted in
rats. Although the MOA was considered plausible, the Agency concluded
the data on rats could not be used to support a MOA finding in mice.
The Agency concluded that quantification of cancer risk using a non-
linear approach would adequately account for all chronic toxicity
(including carcinogenicity) that could result from exposure to
metrafenone. The use of the chronic point of departure is protective
based on the following reasons:
     A treatment-related increase in benign liver tumors was
seen only in male CD-1 mice at doses that were adequate to assess the
carcinogenicity.
     The liver tumors were observed at doses significantly
higher (44x) than those currently used for risk assessment.
     No treatment-related tumors were seen in female mice.
     No treatment-related tumors were seen in male rats and
liver tumors in female rats were seen only at the Limit Dose which was
excessively toxic to females; no tumors were seen at the next dose of
5,000 ppm, which was considered adequate to assess carcinogenicity.
     There is no mutagenicity concern for metrafenone.
    Specific information on the studies received and the nature of the
adverse effects caused by metrafenone 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 document ``Metrafenone. Human Health Risk
Assessment for the Section 3 Registration for Use on Mushrooms'' at
pages 26-36 in docket ID number EPA-HQ-OPP-2017-0616.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for metrafenone used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of October 22, 2014 (79 FR 63047)
(FRL-9917-56).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metrafenone, EPA considered exposure under the petitioned-
for tolerance as well as all existing metrafenone tolerances in 40 CFR
180.624. EPA assessed dietary exposures from metrafenone in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
metrafenone; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA National
Health and Nutrition Examination Survey, What We Eat in America,
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed
100 percent crop treated (PCT), tolerance-level residues (using a 2X
metabolism adjustment factor), and EPA's 2018 default processing
factors (with the exception of chemical-specific processing factors
where available).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that the use of the chronic point of departure is appropriate
for assessing cancer risk to metrafenone. Therefore, a separate dietary
exposure assessment for the purpose of assessing cancer risk is
unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for metrafenone. Tolerance level residues (using a 2X metabolism
adjustment factor), default processing factors (with the exception of
chemical-specific processing factors where available), and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for metrafenone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metrafenone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of metrafenone
total toxic residues for chronic exposures are estimated to be 14.52
ppb for surface water and 12.3 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 14.52 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). Metrafenone 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 metrafenone to share a common mechanism of
toxicity with any other substances, and metrafenone does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
metrafenone 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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-identifying-pesticide-chemicals-and-other.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
qualitative or quantitative susceptibility in the developmental and
reproduction toxicity studies. In the developmental rat study, no
effects were observed in dams or fetuses up to the limit dose of 1,000
mg/kg/day. In the rabbit study, liver toxicity (increased liver
weights, hypertrophy, and hepatocyte vacuolation) was observed in the
dams but no developmental effects were observed up to the limit dose of
1,000 mg/kg/day. In the rat reproduction toxicity study, there was no
evidence of reproductive toxicity. Effects in the offspring (decreased
pup weight) occurred at doses similar to those which cause toxicity in
the parental animals (decreased body weight).
    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 metrafenone is complete.
    ii. There is no indication that metrafenone is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that metrafenone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT, tolerance-level residues (using a 2X metabolism adjustment
factor), and EPA's 2017 default processing factors (with the exception
of chemical-specific processing factors where available). EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to metrafenone in drinking water.
These assessments will not underestimate the exposure and risks posed
by metrafenone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
metrafenone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
metrafenone from food and water will utilize 16% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for metrafenone.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    A short- and intermediate-term adverse effect was identified;
however, metrafenone is not registered for any use patterns that would
result in short- and/or intermediate-term residential exposure. Short-
and intermediate-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short- and/
or intermediate-term residential exposure and chronic dietary exposure
has already been assessed under the appropriately protective cPAD
(which is at least as protective as the POD used to assess short-term
risk), no further assessment of short-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for metrafenone.
    4. Aggregate cancer risk for U.S. population. EPA considers the
chronic aggregate risk assessment to be protective of any 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 metrafenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology ((Method FAMS 105-01)) is
available to enforce the tolerance expression. Additionally, BASF has
proposed the QuEChERS LC-MS/MS method as a new enforcement method for
metrafenone.
    The method for Method FAMS 105-01 may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email
address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture

Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level.
    The Codex has established an MRL for metrafenone in or on mushrooms
at 0.5 ppm. The Codex MRL is for ``Mushrooms'' defined as VF 0450 to
include button mushroom, Rodman's agaricus mushroom and Hime-Matsutake,
edible fungi. This MRL matches the tolerance established for
metrafenone in or on white button mushroom in the United States, with
the exception of the number of significant digits.

C. Response to Comments

    Two comments were received in response to the Notice of Filing
associated with this action, requesting that the Agency deny approval
of the product due to impacts on the environment. Because the Agency's
role is to assess the safety of the tolerance, these comments are
outside the scope of this rulemaking.

V. Conclusion

    Therefore, tolerances are established for residues of metrafenone,
(3-bromo-6-methoxy-2-methylphenyl) (2,3,4-trimethoxy-6-methylphenyl)
methanone, in or on white button mushroom at 0.50 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 15, 2019.
Donna Davis,
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.  180.624, add alphabetically the entry ``White button
mushroom'' to the table in paragraph (a) to read as follows:

Sec.  180.624  Metrafenone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
White button mushroom...................................            0.50

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-06334 Filed 4-1-19; 8:45 am]
 BILLING CODE 6560-50-P


DuPont Chemical Solutions Enterprise

Chambers Works

Deepwater, NJ  08023

CERTIFIED MAIL – Return Receipt Requested

July 3, 2008

Document Control Office

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 6428

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Re: 	EPA – HQ – OPPT – 2003 - 0012

	DuPont Chambers Works NJPDES Permit No. NJ0005100

	PFOA Data Submittal – Outfall DSN662 Weekly Grab Samples

	April 2008 Sample Data

Dear Document Control Office:

As per Part IV, Section G.5.a of the NJPDES permit, we are submitting a summary of PFOA analytical results for the weekly grab samples taken at internal outfall DSN662A to NJDEP on a monthly basis. Per your request, we are sending you a paper and electronic copy of the report for samples taken during April 2008. We will continue to send you the reports each month.

If you have any questions, please do not hesitate to call me at (856) 540-3015.

Sincerely,

Karen L. Pinder

SET Environmental Coordinator

DuPont Chambers Works

Enclosures

Copies to:

Director, Chemical Control Division

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 4146

1201 Constitution Avenue, NW

Washington, DC 20004

Ms. Susan Rosenwinkel (cover letter only)

Principal Environmental Engineer

NJDEP Division of Water Quality

Bureau of Point Source Permitting – Region 2

401 E. State Street

P.O. Box 029

Trenton, NJ 08625-0029


[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Notices]
[Pages 79718-79720]
[FR Doc No: 2013-31227]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71181; File No. SR-Topaz-2013-19]

Self-Regulatory Organizations; Topaz Exchange, LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to More
Specifically Address the Number and Size of Contra-parties to a
Qualified Contingent Cross Order

December 24, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 18, 2013, Topaz Exchange, LLC (d/b/a ISE Gemini) (the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to

solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to amend Rule 715 (Types of Orders) to
more specifically address the number and size of contra-parties to a
Qualified Contingent Cross Order (``QCC Order''). The text of the
proposed rule change is available on the Exchange's Internet Web site
at http://www.ise.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposal is to expand the availability of QCC
Orders by permitting multiple contra-parties on a QCC Order. Under the
proposal, multiple contra-parties would be allowed, so long as each
contra-party order consists of an order for at least 1,000 contracts;
provided however, that the originating QCC Order must also be for at
least 1,000 contracts (in addition to meeting the other requirements of
a QCC Order). This is intended to accommodate multiple contra-parties,
as explained further below.
    A QCC Order must be comprised of an order to buy or sell at least
1,000 contracts \3\ that is identified as being part of a qualified
contingent trade,\4\ coupled with a contra-side order to buy or sell an
equal number or contracts. QCC Orders are automatically executed upon
entry provided that the execution (i) is not at the same price as a
Priority Customer Order on the Exchange's limit order book and (ii) is
at or between the NBBO. QCC Orders will be automatically canceled if
they cannot be executed. QCC Orders may only be entered in the regular
trading increments applicable to the options class under Rule 710
(Minimum Trading Increments).
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    \3\ In the case of Mini Options, the minimum size is 10,000
contracts.
    \4\ A ``qualified contingent trade'' is a transaction consisting
of two or more component orders, executed as agent or principal,
where: (a) At least one component is an NMS Stock, as defined in
Rule 600 of Regulation NMS under the Exchange Act; (b) all
components are effected with a product or price contingency that
either has been agreed to by all the respective counterparties or
arranged for by a broker-dealer as principal or agent; (c) the
execution of one component is contingent upon the execution of all
other components at or near the same time; (d) the specific
relationship between the component orders (e.g., the spread between
the prices of the component orders) is determined by the time the
contingent order is placed; (e) the component orders bear a
derivative relationship to one another, represent different classes
of shares of the same issuer, or involve the securities of
participants in mergers or with intentions to merge that have been
announced or cancelled; and (f) the transaction is fully hedged
(without regard to any prior existing position) as a result of other
components of the contingent trade.
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    The QCC Order type was approved for the Exchange in its current
form on February 24, 2011 [sic].\5\ It was always the Exchange's intent
and understanding when drafting the rule text that a QCC Order could
involve multiple contra-parties of the QCC trade when the originating
QCC Order consisted of at least 1,000 contracts. However, the rule
language addressing the contra-side of a QCC Order is drafted from the
perspective of how the QCC Order gets entered into the Exchange system.
Specifically, the contra-side order to a QCC Order will always be
entered as a single order, even if that order consists of multiple
contra-parties who are allocated their portion of the trade in a post-
trade allocation. Notwithstanding the foregoing, the literal wording of
the current QCC Order rule could result in a more limited
interpretation of the rule. Therefore, the Exchange now proposes to
make it clear that a QCC Order must involve a single order for at least
1,000 contracts on the originating side, but that it may consist of
multiple orders on the opposite, contra-side, so long as each of the
contra-side orders is for at least 1,000 contracts.
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    \5\ See Securities Exchange Act Release No. 70050 (July 26,
2013), 78 FR 46622 (August 1, 2013) (File No. 10-209).
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    For instance, a 5,000 contract originating QCC Order to buy could,
under this proposal, be coupled with two contra-side orders to sell
2,500 contracts each. Similarly, a 5,000 contract originating QCC Order
to buy could, under this proposal, be coupled with a [sic] two contra-
side orders to sell, one for 4,000 contracts and one for 1,000
contracts. In the above examples, each sell (contra-side) order needs
to be for a minimum of 1,000 contracts, provided that the total of all
sell (contra-side) orders equals the size of the originating order and
that originating order is at least 1,000 contracts.
    Accordingly, the Exchange is proposing to amend the definition of
QCC Order to clarify that an originating order to buy or sell at least
1,000 contracts coupled with a contra-side order or orders totaling an
equal number of contracts is permitted, so long as each contra-side
order is for at least 1,000 contracts.
2. Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \6\ that an exchange have rules that
are designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism for a free and open market and
a national market system, and, in general, to protect investors and the
public interest by amending the rule text to more clearly defining the
QCC Order. Specifically, because the proposal clarifies that a QCC
Order permits multiple contra-parties, it should therefore provide
members and participants with certainty as to what is allowed and,
therefore, provide more opportunity to participate in QCC trades,
consistent with the key principles behind the QCC Order.
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    \6\ 15 U.S.C. 78f(b)(5).
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    In approving QCC Orders, the Commission has stated that ``. . .
qualified contingent trades are of benefit to the market as a whole and
a contribution to the efficient functioning of the securities markets
and the price discovery process.'' \7\ The Commission ``also has
recognized that contingent trades can be useful trading tools for
investors and other market participants, particularly those who trade
the securities of issuers involved in mergers, different classes of
shares of the same issuer, convertible securities, and equity
derivatives such as options [emphasis added].'' \8\ In light of these
benefits, the Exchange believes that the proposal should improve the
usefulness of the QCC Order without raising novel regulatory issues,
because the proposal does not impact the fundamental aspects of this
order type--it merely

permits multiple contra-parties, while preserving the 1,000 contract
minimum.
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    \7\ QCC Approval Order at text accompanying footnote 115.
    \8\ QCC Approval Order at Section III.A. citing Securities
Exchange Act Release No. 54389 (August 31, 2006), 71 FR 52829
(September 7, 2006) (Original QCT Exemption).
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    Consistent with Section 6(b)(8) of the Act, the Exchange seeks to
compete with other options exchanges for QCC Orders involving multiple
parties, including where there are multiple contra-parties. The
Exchange believes that this will be beneficial to participants because
allowing multiple contra-parties of at least 1,000 contracts should
foster competition for filling one side of a QCC Order and thereby
result in potentially better prices, as opposed to only allowing one
contra-party and, thereby requiring that contra-party to do a larger
size order which could result in a worse price for the trade.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. In fact, the proposal is
intended to relieve a burden on competition, which results from
different exchanges interpreting their rules differently. Among the
options exchanges, the Exchange believes that the proposal to allow
multiple contra-parties of at least 1,000 contracts should foster
competition for filling the contra-side of a QCC order and thereby
result in potentially better prices for such orders.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) \9\ of the Act and Rule 19b-
4(f)(6) \10\ thereunder. The Exchange provided the Commission with
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of filing the proposed rule
change.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR. 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml ); or
     Send an Email to<EMAIL_ADDRESS>Please include
File No. SR-Topaz-2013-19 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-Topaz-2013-19. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commissions Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-Topaz-2013-19 and should be
submitted by January 21, 2014.
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    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-31227 Filed 12-30-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 152 (Wednesday, August 9, 2017)]
[Notices]
[Page 37212]
[FR Doc No: 2017-16817]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9965-94-Region 6]

Public Water System Supervision Program Revision for the State of
Louisiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of tentative approval.

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SUMMARY: Notice is hereby given that the State of Louisiana is revising
its approved Public Water System Supervision (PWSS) program. Louisiana
has adopted the Revised Total Coliform Rule (RTCR) and Groundwater Rule
(GWR) by reference under LAC Title 51 Part XII--Water Supplies of the
Louisiana State Sanitary Code. EPA has determined that the RTCR and GWR
primacy applications submitted by Louisiana is no less stringent than
the corresponding federal regulations. Therefore, EPA intends to
approve this PWSS program revision package.

DATES: All interested parties may request a public hearing. A request
for a public hearing must be submitted by September 8, 2017 to the
Regional Administrator at the EPA Region 6 address shown below.
Frivolous or insubstantial requests for a hearing may be denied by the
Regional Administrator. However, if a substantial request for a public
hearing is made by September 8, 2017, a public hearing will be held. If
no timely and appropriate request for a hearing is received and the
Regional Administrator does not elect to hold a hearing on his own
motion, this determination shall become final and effective on
September 8, 2017. Any request for a public hearing shall include the
following information: The name, address, and telephone number of the
individual, organization, or other entity requesting a hearing; a brief
statement of the requesting person's interest in the Regional
Administrator's determination and a brief statement of the information
that the requesting person intends to submit at such hearing; and the
signature of the individual making the request, or, if the request is
made on behalf of an organization or other entity, the signature of a
responsible official of the organization or other entity.

ADDRESSES: All documents relating to this determination are available
for inspection between the hours of 8:00 a.m. and 4:30 p.m., Monday
through Friday, at the following offices: Louisiana Department of
Health, Engineering Services, Bienville Building, 628 N. 4th Street,
Baton Rouge, LA 70821-3214; and United States Environmental Protection
Agency, Region 6, Drinking Water Section (6WQ-SD), 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202. Copies of the documents which explain
the rule can also be obtained at EPA's Web site at https://www.federalregister.gov/articles/2013/02/13/2012-31205/national-primary-drinking-water-regulations-revisions-to-the-total-coliform-rule, https://www.federalregister.gov/articles/2014/02/26/2014-04173/national-primary-drinking-water-regulations-minor-corrections-to-the-revisions-to-the-total-coliform, and https://www.federalregister.gov/documents/2006/11/08/06-8763/national-primary-drinking-water-regulations-ground-water-rule or by writing or calling Ms. Evelyn
Rosborough at the address below.

FOR FURTHER INFORMATION CONTACT: For further information contact Evelyn
Rosborough, Environmental Protection Specialist, Water Quality
Protection Division, U.S. Environmental Protection Agency Region 6,
1445 Ross Ave., Dallas, TX 75202-2733, telephone<PHONE_NUMBER>,
facsimile<PHONE_NUMBER>, or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Authority: Section 1413 of the Safe Drinking Water Act, as amended
(1996), and 40 CFR part 142 of the National Primary Drinking Water
Regulations.

    Dated: July 27, 2017.
Samuel J. Coleman,
Acting Regional Administrator, Region 6.
[FR Doc. 2017-16817 Filed 8-8-17; 8:45 am]
 BILLING CODE 6560-50-P