[Federal Register Volume 85, Number 28 (Tuesday, February 11, 2020)]
[Proposed Rules]
[Pages 7708-7712]
[FR Doc No: 2020-02700]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0041; FRL-10005-02]

Receipt of a Pesticide Petition Filed for Residues of Pesticide
Chemicals in or on Various Commodities (October 2019)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petition and request for comment.

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SUMMARY: This document announces the Agency's receipt of an initial
filing of a pesticide petition requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before March 12, 2020.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number 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 Confidential Business
Information (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.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), main telephone number:<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>or Robert McNally, Biopesticides and Pollution
Prevention Division (7511P), main telephone number:<PHONE_NUMBER>,
email address<EMAIL_ADDRESS>The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each pesticide petition summary.

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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing receipt of a pesticide petition filed under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 and/or part 180 for residues of
pesticide chemicals in or on various food commodities. The Agency is
taking public comment on the request before responding to the
petitioner. EPA is not proposing any particular action at this time.
EPA has determined that the pesticide petition described in this
document contains data or information prescribed in FFDCA section
408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
supports granting of the pesticide petition. After considering the
public comments, EPA intends to evaluate whether and what action may be
warranted. Additional data may be needed before EPA can make a final
determination on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition that is the
subject of this document, prepared by the petitioner, is included in a
docket EPA has created for this rulemaking. The docket for this
petition is available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

A. Amended Tolerance Exemptions for Inerts (Except PIPS)

    1. PP IN-11306. (EPA-HQ-OPP-2019-0593). Spring Trading Company (203
Dogwood Trail, Magnolia, TX 77354) on behalf of Stepan Company,
requests to amend an exemption from the requirement of a tolerance in
40 CFR part 180 for residues of N,N-dimethyl 9-decenamide (CAS Reg. No.
1356964-77-6) and N,N-dimethyldodecanamide (CAS Reg. No. 3007-53-2) by
increasing the current limitation from 20% to unlimited when used as a
pesticide inert ingredient (solvent/co-solvent) in pesticide
formulations. The petitioner believes no analytical method is needed
because it is not required for an exemption from the requirement of a
tolerance. Contact: RD.
    2. PP IN-11307. (EPA-HQ-OPP-2019-0601). Ecolab Inc., 1 Ecolab
Place, St. Paul, MN 55102, requests to amend an exemption from the
requirement of a tolerance for residues of 2,6-pyridinedicarboxylic
acid (CAS Reg. No. 499-83-2) by expanding the current exemption to
180.940(a) and increasing the limit to 2 parts per million (ppm) when
used as a pesticide inert ingredient in pesticide formulations applied
to hard, non-porous food-contact surfaces in public eating places,
dairy processing equipment, and food-processing equipment and utensils
and establishing an exemption from the requirement of a tolerance in
180.910, limited 2 ppm when used in pesticide formulations applied to
growing crops. The petitioner believes no analytical method is needed
because it is not required for an exemption from the requirement of a
tolerance. Contact: RD.

B. Amended Tolerances for Inerts

    PP IN-11306. (EPA-HQ-OPP-2019-0593). Spring Trading Company, 203
Dogwood Trail, Magnolia, TX 77354, on behalf of Stepan Company,
requests to amend an exemption from the requirement of a tolerance in
40 CFR part 180 for residues of N,N-dimethyl 9-decenamide (CAS Reg. No.
1356964-77-6) and N,N-dimethyldodecanamide (CAS Reg. No. 3007-53-2) by
increasing the current limitation from 20% to unlimited when used as a
pesticide inert ingredient (solvent/co-solvent) in pesticide
formulations. The petitioner believes no analytical method is needed
because it is not required for an exemption from the requirement of a
tolerance. Contact: RD.

C. Amended Tolerances for Non-Inerts

    1. PP 9E8766. (EPA-HQ-OPP-2019-0162). IR-4, IR-4 Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to amend 40 CFR
180.566 by removing the established tolerances for residues of
fenpyroximate plus its Z-isomer, determined by measuring the sum of
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate and its Z-isomer, (Z)-
1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, calculated as the
stoichiometric equivalent of fenpyroximate, in or on the raw
agricultural commodities of: Avocado at 0.15 ppm; canistel at 0.15 ppm;
mango at 0.15 ppm; papaya at 0.15 ppm; sapote, black at 0.15 ppm; and
star apple at 0.15 ppm. Contact: RD.
    2. PP 9E8771. (EPA-HQ-OPP-2019-0460). IR-4, Rutgers, The State
University of New Jersey, 500 College

Road East, Suite 201 W, Princeton, NJ 08540, proposes upon
establishment of tolerances referenced in this document under ``New
Tolerances'' for PP# 9E8771, to remove existing tolerances in 40 CFR
180.679 for residues of the insecticide flupyradifurone, 4-[[(6-chloro-
3-pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5H)-furanone, including
its metabolites and degradates in or on Brassica, head and stem
subgroup 5A at 6.0 ppm, Brassica, leafy greens subgroup 5B at 40 ppm;
cactus, fruit at 0.30 ppm; cilantro, fresh leaves at 30 ppm; coffee,
green bean (import tolerance) at 1.5 ppm; leaf petioles, subgroup 4B at
9.0 ppm; leafy greens, subgroup 4A at 30 ppm; pitaya at 0.30 ppm; and
turnip greens at 40 ppm. Contact: RD.
    3. PP 9E8778. (EPA-HQ-OPP-2019-0526). IR-4, IR-4 Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to amend 40 CFR
180.635 by removing the following spinetoram tolerances: Brassica, head
and stem, subgroup 5A at 2.0 ppm; brassica, leafy greens, subgroup 5B
at 10 ppm; vegetable, leafy, except brassica, group 4 at 8 ppm; and
cranberry at 0.04 ppm. Contact: RD.
    4. PP 9E8779. (EPA-HQ-OPP-2019-0525). IR-4, IR-4 Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to amend 40 CFR
180.495 by removing the following spinosad tolerances: Brassica, head
and stem, subgroup 5A at 2.0 ppm; brassica, leafy greens, subgroup 5B
at 10 ppm; vegetable, leafy, except brassica, group 4 at 8 ppm; and
cranberry at 0.01 ppm. Contact: RD.

D. New Tolerance Exemptions for Inerts (Except PIPs)

    1. PP IN-11284. (EPA-HQ-OPP-2019-0591). Spring Trading Company (203
Dogwood Trail, Magnolia, TX 77354) on behalf of Sasol Chemicals (USA)
LLC (Sasol) (12120 Wickchester Lane, Houston, TX 77224) requests to
establish an exemption from the requirement of a tolerance for residues
of 1-undecanol (CAS No. 112-42-5), 1-tetradecanol (CAS No. 112-72-1),
1-octadecanol (CAS No. 112-92-5), 1-eicosanol (CAS No. 629-96-0), 1-
docosanol (CAS No. 661-19-8), Alcohols, C16-18, distn. Residues (CAS
No. 68603-17-8 & CAS No. 1190630-03-5), Alkenes, C18-22, mixed with
polyethylene, oxidized, hydrolyzed, distn. Residues from C16-18 alcs.
Manuf. (CAS No. 1430895-61-6), Alkenes, C18-22, mixed with
polyethylene, oxidized, hydrolyzed, distn. Residues from C20-22 alcs.
Manuf. (CAS No. 1430895-62-7) when used as inert ingredients (carriers/
adjuvants and as coating agents/binders) in pesticide formulations
applied to growing crops pre- and post-harvest under 40 CFR 180.910,
growing crops pre-harvest under 40 CFR 180.920, in/on animals under
180.930, and in antimicrobial formulations under 40 CFR 180.940(a). The
petitioner believes no analytical method is needed because it is not
required for an exemption from the requirement of a tolerance. Contact:
RD.
    2. PP IN-11316. (EPA-HQ-OPP-2019-0594). Verto Solutions, ``VS'',
1101 17th Street, NW Suite 700, Washington, DC 20036, requests to
establish an exemption from the requirement of a tolerance in 40 CFR
part 180.940(a) for residues of various fragrances (CAS Nos. multiple)
when used as a pesticide inert ingredient in antimicrobial pesticide
formulations for use on food contact surfaces in public eating places,
dairy processing equipment, and food processing equipment and utensils
at end-use concentrations not to exceed 100 ppm. The petitioner
believes no analytical method is needed because it is not required for
an exemption from the requirement of a tolerance. Contact: RD.
    3. PP IN-11339. (EPA-HQ-OPP-2019-0610). Lamberti USA, Incorporated,
P.O. Box 1000, Hungerford TX 77448, requests to establish an exemption
from the requirement of a tolerance in 40 CFR part 180.960 for residues
of 2-Propenoic acid, homopolymer, ester with [alpha]-methyl-[omega]-
hydroxypoly(oxy-1,2-ethanediyl) and [alpha]-[2,4,6-tris(1-
phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2-ethanediyl), graft,
sodium salt (CAS Reg. No. 2221936-17-8) when used as a pesticide inert
ingredient in pesticide formulations as dispersants, emulsifiers,
surfactants and related adjuvants of surfactants. The petitioner
believes no analytical method is needed because it is not required for
an exemption from the requirement of a tolerance. Contact: RD.
    4. PP IN-11344. (EPA-HQ-OPP-2019-0602). Solvay USA Inc., c/o
SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192, requests to
establish an exemption from the requirement of a tolerance in 40 CFR
part 180.960 for residues of Poly(oxy-1,2-ethanediyl), [alpha]-sulfo-
[omega]-hydroxy-, C10- 16-alkyl ethers, sodium salts (where average
number of moles of oxyethylene = 30) (CAS Reg. No. 68585-34-2) when
used as a pesticide inert ingredient in pesticide formulations. The
petitioner believes no analytical method is needed because it is not
required for an exemption from the requirement of a tolerance. Contact:
RD.
    5. PP IN-11359. (EPA-HQ-OPP-2019-0607). Milliken Chemical, 920
Milliken Road, Spartanburg, SC 29303, requests to establish an
exemption from the requirement of a tolerance in 40 CFR part 180.920
for residues of Poly(oxy-1,2-ethanediyl), alpha, alpha'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[omega-hydroxy-
, monosodium salt (CAS Reg. No. not available) when used as a pesticide
inert ingredient in pesticide formulations applied pre-harvest and not
to exceed 20% wt/wt (weight/weight). The petitioner believes no
analytical method is needed because it is not required for an exemption
from the requirement of a tolerance. Contact: RD.

E. New Tolerances for Non-Inerts

    1. PP 8F8704. (EPA-HQ-OPP-2019-0560). FMC Corporation, 2929 Walnut
Street, Philadelphia, PA 19104, requests to establish a tolerance in 40
CFR part 180 for residues of the insecticide bifenthrin, in or on
sunflower (crop subgroup 20B) at 0.01 ppm. The Gas Chromatography with
Electron Capture Detection (GC/ECD) method is used to measure and
evaluate the chemical bifenthrin residues. Contact: RD.
    2. PP 8F8710. (EPA-HQ-OPP-2019-0074). SePRO Corporation, 11550
North Meridian Street, Suite 600, Carmel, IN 46032, requests to
establish a tolerance in 40 CFR part 180 for residues of the herbicide
fluridone in or on avocados, mandarins, pomegranates, pistachios, and
the stone fruit group (crop group 12) at 0.1 ppm. The enzyme-linked
immunosorbant assay (ELISA), high performance liquid chromatography
with ultraviolet detection (HLPC/UV), and liquid chromatography with
tandem mass spectroscopy (LC-MSMS) and QuEChERS are used to measure and
evaluate the chemical fluridone. Contact: RD.
    3. PP 9E8757. (EPA-HQ-OPP-2019-0492). Nissan Chemical Corporation;
5-1, Nihonbashi 2-Chome Chuo-Ku; Tokyo 101-6119 Japan c/o Lewis and
Harrison; 2461 South Clark Street, Suite 710, Arlington, VA 22202
requests to establish a tolerance in 40 CFR part 180 for residues of
the insecticide, fluxametamide, in or on tea at 5 ppm. An independent
laboratory validation (ILV) was performed for the methods used to
determine residues in crude green tea leaves using a quantification ion
transition methodology. Contact: RD.
    4. PP 9E8762. (EPA-HQ-OPP-2019-0389). IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ

08540, requests to establish a tolerance in 40 CFR part 180.614 for
residues of kasugamycin, (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-
2,3,4,6-tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol),
in or on almond at 0.04 ppm, almond, hulls at 0.4 ppm, apricot at 0.6
ppm, and peach subgroup 12-12B at 0.4 ppm. The analytical method #
Meth-146, Revision #4 is used to measure and evaluate the chemical.
Contact: RD.
    5. PP 9E8766. (EPA-HQ-OPP-2019-0386). IR-4, IR-4 Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to establish
tolerances for residues of fenpyroximate plus its Z-isomer, determined
by measuring the sum of fenpyroximate, (E)-1,1-dimethylethyl 4-
[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate, calculated as the
stoichiometric equivalent of fenpyroximate in or on the raw
agricultural commodities of peanut at 0.04 ppm; peanut, hay at 30 ppm;
and tropical and subtropical, medium to large fruit, smooth, inedible
peel, subgroup 24B, except banana at 0.6 ppm. An enforcement method has
been developed which involves extraction of fenpyroximate and the M-1
Metabolite from crops with ethyl acetate in the presence of anhydrous
sodium sulfate, dilution with methanol, and then analysis by high
performance liquid chromatography using tandem mass spectrometric
detection (LC/MS/MS). The method has undergone independent laboratory
validation as required by PR Notice 88-5 and 96-1. Contact: RD.
    6. PP 9E8771. (EPA-HQ-OPP-2019-0460). IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part
180.679 for residues of the insecticide flupyradifurone, 4-[[(6-chloro-
3-pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5H)-furanone, including
its metabolites and degradates in or on brassica, leafy greens,
subgroup 4-16B at 40 ppm, celtuce at 9 ppm, coffee, green bean at 1.5
ppm, fennel, florence, fresh leaves and stalk at 9 ppm, kohlrabi at 6
ppm, leaf petiole vegetable subgroup 22B at 9 ppm, leafy greens
subgroup 4-16A at 30 ppm, pineapple at 0.3 ppm, tropical and
subtropical, inedible peel, cactus, subgroup 24D at 0.3 ppm, tropical
and subtropical, palm fruit, edible peel, subgroup 23C at 8 ppm,
sesame, seed at 3 ppm, stalk and stem vegetable subgroup 22A, except
prickly pear, pads, and prickly pear, Texas, pads at 0.01 ppm,
sunflower subgroup 20B at 0.7 ppm, and vegetable, brassica, head and
stem, group 5-16 at 6 ppm. Additionally, (c) a tolerance with a
regional restriction is being proposed for residues of the insecticide
flupyradifurone, 4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]- 2(5H)-furanone, including its metabolites and
degradates in or on the raw agricultural commodity: Grass, forage,
fodder and hay, group 17 at 15 ppm. The high-performance liquid
chromatography-electrospray ionization/tandem mass spectrometry (HPLC/
MS/MS) is used to measure and evaluate the chemical. Contact: RD.
    7. PP 9E8778. (EPA-HQ-OPP-2019-0526). IR-4, IR-4 Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to establish
tolerances for residues of the insecticide spinetoram, including its
metabolites and degradates in or on the raw agricultural commodities
dragon fruit at 1.5 ppm; vegetable, brassica, head and stem, group 5-16
at 2.0 ppm; kohlrabi at 2.0 ppm; brassica, leafy greens, subgroup 4-16B
at 10 ppm; leafy greens subgroup 4-16A at 8.0 ppm; leaf petiole
vegetable subgroup 22B at 8.0 ppm; celtuce at 8.0 ppm; fennel,
Florence, fresh leaves and stalk at 8.0 ppm; and berry, low growing,
except strawberry, subgroup 13-07H at 0.04 ppm. Adequate analytical
methods are available for enforcement purposes for spinetoram in plant
and animal matrices. Contact: RD.
    8. PP 9E8779. (EPA-HQ-OPP-2019-0525). IR-4, IR-4 Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, requests to establish
tolerances for residues of the insecticide spinosad, including its
metabolites and degradates in or on the raw agricultural commodities
dragon fruit at 1.5 ppm; vegetable, brassica, head and stem, group 5-16
at 2.0 ppm; kohlrabi at 2.0 ppm; vegetable, leafy, group 4-16 at 10.0
ppm; celtuce at 10.0 ppm; fennel, Florence, fresh leaves and stalk at
10.0 ppm; leaf petiole vegetable Subgroup 22B at 10.0 ppm; and berry,
low growing, except strawberry, subgroup 13-07H at 0.01 ppm. Adequate
analytical methods are available for enforcement purposes for spinosad
in plant, ruminant, poultry, fish, and shellfish. Contact: RD.
    9. PP 9F8734. (EPA-HQ-OPP-2016-0416). BASF Corporation, 26 Davis
Drive, P.O. Box 13528, Research Triangle Park, North Carolina 27709-
3528, requests to establish a tolerance for residues of the insecticide
afidopyropen in or on the following raw agricultural commodities:
Alfalfa seed at 0.30 ppm; animal feed, nongrass, group 18, forage at
4.0 ppm; animal feed, nongrass, group 18, hay at 9.0 ppm; animal feed,
nongrass, group 18, straw at 5.0 ppm; egg at 0.02 ppm; grain, aspirated
fractions at 20 ppm; grass, forage, fodder and hay, group 17 at 10.0
ppm; poultry, meat byproducts at 0.02 ppm; sorghum, grain, grain at
0.20 ppm; sorghum, grain, forage at 0.30 ppm; sorghum, grain, stover at
0.30 ppm; sorghum, sweet, grain at 0.20 ppm; sorghum, sweet, forage at
0.30 ppm; sorghum, sweet, stalk at 0.30 ppm; sorghum, sweet, stover at
0.30 ppm; soybean, forage at 0.15 ppm; and soybean, hay at 0.40 ppm,
and on the following animal commodities: Cattle, meat at 0.25 ppm;
cattle, meat byproducts at 0.15 ppm; goat, meat at 0.25 ppm; goat, meat
byproducts at 0.15 ppm; hog, meat at 0.02 ppm; hog, meat byproducts at
0.06 ppm; horse, meat at 0.25 ppm; horse, meat byproducts at 0.15 ppm;
milk at 0.04 ppm; sheep, meat at 0.25 ppm; and sheep, meat byproducts
at 0.15 ppm. BASF Corporation is also proposing to raise the existing
tolerance for almond, hulls to 0.30 ppm. Suitable tolerance enforcement
methods for plants and livestock using LC-MS/MS analyses were submitted
for the analysis of afidopyropen. The reported limit of quantitation
(LOQ) of each method is 0.01 ppm for afidopyropen. Contact: RD.
    10. PP 9F8737. (EPA-HQ-OPP-2017-0155). Gowan Company, LLC, P.O. Box
556 Yuma, AZ 85366, requests to establish a tolerance for residues of
the insecticide hexythiazox and its metabolites in or on the following
raw agricultural commodities: Date, dried fruit at 3 ppm and caneberry
crop subgroup 13-07A at 3 ppm. The basic analytical method was
previously reviewed by the Agency in association with the establishment
of the current tolerances with registrations of multiple commodities.
The analytical methods used in a new date raw agricultural commodities
study and a new raspberry raw agricultural commodities study are
described fully in the study report, which is submitted concurrently
with this petition. Contact: RD.
    11. PP 9F8774. (EPA-HQ-OPP-20119-0384). FMC Corporation, 2929
Walnut Street, Philadelphia, PA 19104, requests to establish a
tolerance for residues of the insecticide indoxacarb in or on the
following raw agricultural commodities: Nut, tree, group 14-12 at 0.07
ppm and nut, almond, hulls at 9 ppm. The plant residue enforcement

method detects and quantitates indoxacarb in various matrices including
tree nuts, field corn, sweet corn, lettuce, tomato, broccoli, apple,
grape, cottonseed, peanut and soybean commodity samples by LC-MS/MS.
The limit of quantification in the method (0.010 ppm) allows monitoring
of crops with KN128/KN127 residues at or above the levels proposed in
these tolerances. Contact: RD.

    Authority:  21 U.S.C. 346a.

    Dated: February 6, 2020.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2020-02700 Filed 2-10-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Notices]
[Page 34262]
[FR Doc No: 2022-12052]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14861-002]

FFP Project 101, LLC; Notice of Reasonable Period of Time for
Water Quality Certification Application

    On May 24, 2022, Rye Development on behalf of FFP Project 101, LLC
submitted to the Federal Energy Regulatory Commission (Commission)
evidence of its application for a Clean Water Act section 401(a)(1)
water quality certification filed with Washington State Department of
Ecology (Washington Ecology), in conjunction with the above captioned
project. Pursuant to section 401 of the Clean Water Act \1\ and section
4.34(b)(5) of the Commission's regulations,\2\ a state certifying
agency is deemed to have waived its certifying authority if it fails or
refuses to act on a certification request within a reasonable period of
time, which is one year after the date the certification request was
received. Accordingly, we hereby notify Washington Ecology of the
following:
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    \1\ 33 U.S.C. 1341(a)(1).
    \2\ 18 CFR 4.34(b)(5).
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    Date that Washington Ecology Received the Certification Request:
May 23, 2022.
    If Washington Ecology fails or refuses to act on the water quality
certification request on or before May 23, 2023, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: May 31, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-12052 Filed 6-3-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11995-11998]
[FR Doc No: 2015-05046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0299]

Douglas M. Hargrave; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a request
for a hearing submitted by Dr. Douglas M. Hargrave (Dr. Hargrave), and
is issuing an order under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) debarring Dr. Hargrave for 2 years from providing services in
any capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Dr. Hargrave was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. In determining the appropriateness and period of
Dr. Hargrave's debarment, FDA has considered the relevant factors
listed in the FD&C Act. Dr. Hargrave has failed to file with the Agency
information and analyses sufficient to create a basis for a hearing
concerning this action.

DATES: The order is effective March 5, 2015.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nathan Doty, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 11, 2009, in the U.S. District Court for the Northern
District of New York, Dr. Hargrave, a physician, pled guilty to a
misdemeanor under the FD&C Act, namely misbranding a drug in violation
of sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act (21 U.S.C.
331(k), 352(i)(3), 333(a)(1)) and 18 U.S.C. 2. The basis for this
conviction was conduct surrounding his injection of patients seeking
treatment with BOTOX/BOTOX Cosmetic (BOTOX) with a product, TRI-toxin,
distributed by Toxin Research International, Inc. BOTOX is a biological
product derived from Botulinum Toxin Type A that is manufactured by
Allergan, Inc., and was approved by FDA for use on humans for the
treatment of facial wrinkles in 1991. According to the records of the
criminal proceedings, Dr. Hargrave's colleague in the same medical
practice, The Plastic Surgery Group (TPSG), directed a nurse to obtain
31 vials of TRI-toxin, an unapproved drug product, which was
represented by its distributor as ``Botulinum Toxin Type A.'' Dr.
Hargrave then proceeded to inject approximately 25 patients, who
believed they were being injected with BOTOX, with TRI-toxin as a
substitute.
    Dr. Hargrave is subject to debarment based on a finding, under
section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)): (1) That he

was convicted of a misdemeanor under Federal law relating to the
regulation of a drug product under the FD&C Act and (2) that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. By notice to Dr. Hargrave dated November 30, 2010,
FDA's Office of Regulatory Affairs (ORA) proposed to debar him for 4
years from providing services in any capacity to a person having an
approved or pending drug product application.
    In a letter dated December 30, 2010, through counsel, Dr. Hargrave
requested a hearing on the proposal. In his request for a hearing, Dr.
Hargrave acknowledges his conviction under Federal law, as alleged by
FDA. By letter dated January 28, 2011, Dr. Hargrave submitted materials
and arguments in support of his request. Dr. Hargrave acknowledges that
he was convicted of a Federal misdemeanor, as found in the proposal to
debar, but argues that he should not be debarred for reasons related to
the factual basis set forth in the proposal to debar. In particular,
with respect to the considerations for determining the appropriateness
and period of debarment under section 306(c)(3) of the FD&C Act, he
argues that there are genuine and substantial issues of fact for
resolution at a hearing, namely factual issues bearing on whether he
participated in or even knew of certain conduct that resulted in his
violation of the FD&C Act.
    Hearings are granted only if there is a genuine and substantial
issue of fact. Hearings will not be granted on issues of policy or law,
on mere allegations, denials, or general descriptions of positions and
contentions, or on data and information insufficient to justify the
factual determination urged or the action requested (see 21 CFR
12.24(b)).
    The Chief Scientist has considered Dr. Hargrave's arguments, as
well as the proposal to debar itself, and concludes that, although Dr.
Hargrave has failed to raise a genuine and substantial issue of fact
requiring a hearing, the appropriate period of debarment is 2 years.

II. Arguments

    In support of his hearing request, Dr. Hargrave first asserts that
he is not subject to debarment under section 306(b)(2)(B)(i)(I) of the
FD&C Act. He contends that he pled guilty to a misdemeanor violation of
the FD&C Act (see section 303(a)(1) of the FD&C Act), which is a strict
liability offense, and that thus there was no demonstration or
admission of criminal intent or knowledge underlying the conviction.
Dr. Hargrave concludes, therefore, that the conduct underlying his
conviction did not undermine the process for the regulation of drugs.
    Section 306(b)(2)(B)(i)(I) of the FD&C Act specifically provides
for the debarment of individuals convicted of Federal misdemeanors
related to the regulation of drug products under the FD&C Act. Given
that misdemeanor violations of the FD&C Act themselves are strict
liability offenses, it stands to reason that criminal intent is not a
critical component to debar an individual under section
306(b)(2)(B)(i)(I). During his criminal proceedings, Dr. Hargrave pled
guilty to misbranding and causing the misbranding of a drug in
violation of sections 301(k), 502(i)(3) and 303(a)(1) of the FD&C Act
by offering an unapproved drug, TRI-toxin, for sale as an approved drug
product, BOTOX. Dr. Hargrave's conduct undermined the process for the
regulation of drugs in that it permitted an unapproved drug to be
substituted for an approved drug without the knowledge of the patient.
As a result, Dr. Hargrave is, in fact, subject to debarment under
section 306(b)(2)(B)(i)(I) of the FD&C Act.
    Dr. Hargrave next challenges the manner in which ORA applied the
considerations under section 306(c)(3) of the FD&C Act in determining
the appropriateness and period of his debarment. In the proposal to
debar Dr. Hargrave, ORA stated that there are four applicable
considerations under section 306(c)(3) of the FD&C Act: (1) The nature
and seriousness of his offense under section 306(c)(3)(A); (2) the
nature and extent of management participation in the offense under
section 306(c)(3)(B); (3) the nature and extent of voluntary steps
taken to mitigate the impact on the public under section 306(c)(3)(C);
and (4) prior convictions involving matters within the jurisdiction of
FDA under section 306(c)(3)(F). ORA found with respect to Dr. Hargrave
that the first two considerations weigh in favor of debarment and noted
that the third and fourth considerations would be treated as favorable
factors for him. In making all of its findings under section 306(c)(3)
FD&C Act, ORA characterized Dr. Hargrave's conduct based on records
from his criminal proceedings.
    Under section 306(c)(3)(A) of the FD&C Act, in determining the
appropriateness and period of debarment, FDA considers ``the nature and
seriousness of the offense involved.'' In the proposal to debar, ORA
relied on the criminal information to which Dr. Hargrave pled guilty to
find that the conduct underlying his convictions:

created a risk of injury to consumers due to the use of an
unapproved drug, undermined [FDA's] oversight of an approved drug
product by representing that [he] used the approved drug while
actually substituting an unapproved drug in its place, and seriously
undermined the integrity of [FDA's] regulation of drug products.

Under section 306(c)(3)(B) of the FD&C Act, ORA also considered the
``nature and extent of [Dr. Hargrave's] management participation in the
offense'' and specifically found that he was a corporate principal who
``pleaded guilty to misbranding TRI-toxin'' and ``participated in the
[TPSG's] unlawful conduct of administering [an] unapproved drug on
multiple occasions to patients.'' ORA concluded, therefore, that the
nature and seriousness of Dr. Hargrave's offenses and the nature and
extent of management participation were unfavorable factors with
respect to him.

    Dr. Hargrave counters ORA's findings with respect to those two
considerations in section 306(c)(3) of the FD&C Act with the following
arguments: (1) That he did not admit any criminal intent or intentional
wrongdoing when he pled guilty to a misdemeanor offense under the FD&C
Act; (2) that, in fact, another physician at TPSG took unilateral
action in ordering the TRI-toxin and directing a nurse to substitute it
for BOTOX; (3) that the TRI-toxin vials that they used for injecting
patients with TRI-toxin were identical to the vials he used for BOTOX
before the substitution; and (4) that since the conviction for the
underlying misdemeanor was of an individual, that there was no
management participation and that, thus, the nature and extent of
management participation is inapplicable as a factor in determining
appropriateness and period of debarment. Dr. Hargrave concedes that he
pled guilty to the misdemeanor offense because he was, in fact, guilty
of offering TRI-toxin for sale to their patients as BOTOX. He argues,
however, that the criminal records do not establish any intent or
knowledge on his part and that thus the conduct underlying his
conviction does not warrant debarment in light of the considerations in
section 306(c)(3) of the FD&C Act.
    As noted previously, ORA relied on the records of Dr. Hargrave's
criminal proceedings for its findings in the proposal to debar. There
is nothing definitive in the criminal records before FDA to contradict
Dr. Hargrave's assertions with respect to the nature of his involvement
in the misdemeanor offense to which he pled guilty. The criminal
information to which Dr.

Hargrave pled guilty alleges that TPSG, as opposed to Dr. Hargrave,
began ordering TRI-toxin for use in the medical practice, and there are
no allegations that Dr. Hargrave took part in the ordering process.
Indeed, the proposal to debar states that, as claimed by Dr. Hargrave,
another physician in the practice, William F. DeLuca, Jr., was
responsible for authorizing a nurse to substitute TRI-toxin for BOTOX,
not Dr. Hargrave. At Dr. Hargrave's sentencing hearing, at which six
other codefendants, including DeLuca, were also sentenced, the
presiding judge also made clear that he believed DeLuca was the
physician responsible for making the ``mistake'' that led to the other
physician's offenses. In addressing DeLuca, the court stated:

    And we're here because of your actions and inactions. As I said,
your mistakes were different in kind and degree from those of your
colleagues. It was you who brought this drug into the practice, and
it was your conduct and your failure to check out either the company
or the drug that you were ordering, as you should have done, your
negligence in doing that that has brought us here today in the end.

In addressing one of the other three physicians who pled guilty under
circumstances similar to Dr. Hargrave's, the court further stated:
``There have been disputes on how in the past over who knew what and at
what point in time. It is clear from the facts in this case that you
had no knowledge that the substance was anything other than [BOTOX]
until your discovery of it in November of 2004.''

    In short, consistent with the proposal to debar Dr. Hargrave for 4
years, the records of his criminal proceedings establish that the
misdemeanor convictions for the physicians in TPSG other than DeLuca
were not based on any affirmative involvement in ordering the TRI-toxin
or substituting the TRI-toxin for BOTOX. Furthermore, in proposing to
debar Dr. Hargrave for 4 years, ORA did not rely on any findings with
respect to Dr. Hargrave's intent or knowledge. Rather, citing the
records of Dr. Hargrave's criminal proceedings, the proposal to debar
simply rests on Dr. Hargrave's position of authority within TPSG and
his conduct in misbranding TRI-toxin by administering it to patients
who believed they were receiving BOTOX. As a result, under Sec.
12.24(b), there is no genuine and substantial issue of fact raised by
Dr. Hargrave's arguments for resolution at a hearing.
    As set forth in the proposal to debar and summarized previously,
Dr. Hargrave pled guilty to a misdemeanor under the FD&C Act for his
role in offering a drug under the name of another. Based on the
undisputed record before the Agency, the consideration in section
306(c)(3)(A) of the FD&C Act with respect to the nature and seriousness
of the offense involved is a favorable factor. As reflected in the
records of the criminal proceedings, Dr. Hargrave's offense did not
rest on any intent or knowledge of wrongdoing on his part, nor may such
intent or knowledge be inferred from the circumstances of his offense
or the findings in the proposal to debar. Although, as a practicing
physician, Dr. Hargrave should be expected to take the appropriate
steps to avoid administering an unapproved new drug to patients or
misrepresenting the drug being administered, his failure to do so over
a t10-month period does not warrant considering the nature and
seriousness of his offense as an unfavorable factor, relative to the
range of conduct that might underlie a Federal misdemeanor conviction.
    On the other hand, because of Dr. Hargrave's position of authority
within TPSG and, thus, presumed ability to prevent the series of events
that resulted in the offense underlying his misdemeanor conviction, the
nature and extent of management participation in the offense is an
unfavorable factor, for the purposes of the consideration under
306(c)(3)(B) of the FD&C Act. Dr. Hargrave asserts that there was no
management participation, and that, thus, this factor is inapplicable
because the underlying conviction was of an individual. However, the
criminal information to which Dr. Hargrave pled guilty alleges that
TPSG began ordering TRI-toxin for use in the medical practice. It is
undisputed that Dr. Hargrave is a principal in TPSG, and this is the
basis for considering the nature and extent of management participation
as a factor in determining the appropriateness and period of debarment.
FDA has relied on this factor in other debarment cases where the
underlying conviction was of an individual (see 78 FR 68455 (November
14, 2013), 77 FR 27236-01 (May 9, 2012)).
    The limited scope of his direct actions in committing the
underlying misdemeanor offense does not mitigate the extent of his
management participation, as established during his criminal
proceedings and as set out in the proposal to debar. It is true that
nothing in the criminal proceedings or the proposal to debar reflects
any involvement by him in the decision to order the TRI-toxin and
substitute it for BOTOX, and the proposal to debar specifically finds
that another physician authorized a nurse to place that order. However,
Dr. Hargrave, as a principal of TPSG, was responsible for failing to
ensure that there were controls and procedures in place to prevent
other physicians or a nurse from ordering unapproved drugs for
administration to patients. His own admitted inaction on that front
warrants treating his management participation as an unfavorable
factor.\1\
---------------------------------------------------------------------------

    \1\ See United States v. Park, 421 U.S. 658, 673-74 (1975)
(holding that a high-level manager within a business entity bears a
responsibility to prevent and correct violations of the FD&C Act).
---------------------------------------------------------------------------

    Consistent with the proposal to debar, the record establishes that
the medical practice of which Dr. Hargrave was a part ultimately took
voluntary steps to mitigate the effect on the public health from its
unlawful conduct (see section 306(c)(3)(C) of the FD&C Act).
Furthermore, it is undisputed that Dr. Hargrave had no previous
criminal convictions related to matters within the jurisdiction of FDA
(see section 306(c)(3)(F) of the FD&C Act). Therefore, these will be
treated as favorable factors. In light of the foregoing four
considerations, one of which weighs against Dr. Hargrave, debarment for
2 years is appropriate.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of
the FD&C Act and under authority delegated to him, finds that Dr.
Hargrave has been convicted of a misdemeanor under Federal law for
conduct relating to the development or approval of a drug product or
otherwise relating to the regulation of a drug product under the FD&C
Act and that the conduct underlying the conviction undermines the
regulation of drugs. FDA has considered the relevant factors listed in
section 306(c)(3) of the FD&C Act and determined that a debarment of 2
years is appropriate.
    As a result of the foregoing findings, Dr. Hargrave is debarred for
2 years from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C.
321(dd)). Any person with an approved, or pending, drug product
application, who knowingly uses the services of Dr. Hargrave, in any
capacity during his period of debarment, will be subject to civil money
penalties. If Dr. Hargrave, during his period of debarment, provides
services in any capacity to a

person with an approved or pending drug product application he will be
subject to civil money penalties. In addition, FDA will not accept or
review any abbreviated new drug applications submitted by or with the
assistance of Dr. Hargrave during his period of debarment.
    Any application by Dr. Hargrave for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0299 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j). Publicly available submissions may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to the Internet may obtain
documents in the Docket at http://www.regulations.gov/.

    Dated: February 24, 2015.
Stephen Ostroff,
Director, Office of the Chief Scientist.
[FR Doc. 2015-05046 Filed 3-4-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7720-7721]
[FR Doc No: 2023-02372]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL--10619-01-OA]

Notification of Public Meeting of the Science Advisory Board
BenMAP and Benefits Methods Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office announces a public meeting of the Science
Advisory Board BenMAP and Benefits Methods Panel. The purpose of the
meeting is to discuss responses to charge questions on EPA's new cloud-
based BenMAP model from EPA's Office of Air and Radiation and its
Technical Support Document (TSD): Estimating PM2.5 and Ozone-
Attributable Health Benefits (January 2023).

DATES: The public meeting of the SAB BenMAP and Benefits Methods Panel
will be held on March 2, 2023, from 8:30 a.m. to 5:00 p.m. and on March
3, 2023, from 8:30 a.m. to 12:30 p.m. All Times are in Eastern Standard
Time.

ADDRESSES: The meeting will be held at the Embassy Suites Hotel,
located at 201 Harrison Oaks Boulevard in Cary, North Carolina 27513,
and virtually. Please refer to the SAB website at https://sab.epa.gov
for information on how to attend the meeting.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning this notice may contact Dr. Holly
Stallworth, Designated Federal Officer (DFO), via telephone (202) 564-
2073, or email at [email protected]. General information about
the SAB, as well as any updates concerning the meeting announced in
this notice can be found on the SAB website at https://sab.epa.gov.

SUPPLEMENTARY INFORMATION:
    Background: The SAB was established pursuant to the Environmental
Research, Development, and Demonstration Authorization Act (ERDDAA),
codified at 42 U.S.C. 4365, to provide independent scientific and
technical advice to the EPA Administrator on the scientific and
technical basis for agency positions and

regulations. The SAB is a Federal Advisory Committee chartered under
the Federal Advisory Committee Act (FACA), 5 U.S.C. app. 2. The SAB
will comply with the provisions of FACA and all appropriate SAB Staff
Office procedural policies. Pursuant to FACA and EPA policy, notice is
hereby given that the Science Advisory Board BenMAP and Benefits
Methods Panel will hold a public meeting to discuss charge questions
related to the BenMAP model and TSD.
    Availability of Meeting Materials: All meeting materials, including
the agenda will be available on the SAB web page at https://sab.epa.gov.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office. Federal advisory committees and panels, including
scientific advisory committees, provide independent advice to the EPA.
Members of the public can submit relevant comments pertaining to the
committee's charge or meeting materials. Input from the public to the
SAB will have the most impact if it provides specific scientific or
technical information or analysis for the SAB to consider or if it
relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should follow the
instructions below to submit comments.
    Oral Statements: In general, individuals or groups requesting an
oral presentation at a meeting will be limited to three minutes. Each
person making an oral statement should consider providing written
comments as well as their oral statement so that the points presented
orally can be expanded upon in writing. Persons interested in providing
oral statements should contact the DFO, in writing (preferably via
email) at the contact information noted above by February 22, 2023, to
be placed on the list of registered speakers.
    Written Statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by SAB members,
statements should be submitted to the DFO by February 22, 2023, for
consideration at the March 2-3, 2023 meeting. Written statements should
be supplied to the DFO at the contact information above. It is the SAB
Staff Office general policy to post written comments on the web page
for the meeting. Submitters are requested to provide an unsigned
version of each document because the SAB Staff Office does not publish
documents with signatures on its websites.
    Members of the public should be aware that their personal contact
information, if included in any written comments, may be posted to the
SAB website. Copyrighted material will not be posted without explicit
permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Holly Stallworth, at
202.564.2073 or [email protected], preferably at least ten days
prior to the meeting, to give the EPA as much time as possible to
process your request.

V Khanna Johnston,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2023-02372 Filed 2-3-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48159-48161]
[FR Doc No: 2013-19074]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2010-0824; FRL--9678-5]
RIN 2040-ZA18

Preliminary 2012 Effluent Guidelines Program Plan and 2011 Annual
Effluent Guidelines Review Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This notice announces the availability of the Preliminary 2012
Effluent Guidelines Program Plan (``Preliminary 2012 Plan'') and EPA's
2011 Annual Effluent Guidelines Review Report, and solicits public
comment on both. Clean Water Act (CWA) section 304(m), 33 U.S.C.
1314(m), requires EPA to biennially publish a plan for new and revised
effluent guidelines, after public notice and comment, which identifies
any new or existing industrial categories selected for effluent
guidelines rulemaking and provides a schedule for such rulemaking. EPA
works to publish a preliminary plan in the odd numbered years and a
final plan in the even numbered years. The findings from the 2011
Annual Reviews were used in developing the Preliminary 2012 Plan and
will be used in developing the Final 2012 Plan.

DATES: Submit comments on or before October 7, 2013.

ADDRESSES: Submit your comments on the 2011 Annual Reviews and
Preliminary 2012 Plan identified by Docket ID No. EPA-HQ-OW-2010-0824,
by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-
OW-2010-0824.
     Fax:<PHONE_NUMBER>
     Mail: Water Docket, Environmental Protection Agency,
Mailcode: 2822T, Attention Docket ID No. EPA-HQ-OW-2010-0824, 1200
Pennsylvania Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, EPA West, Room 3334,
1301 Constitution Avenue NW., Washington, DC, Attention Docket ID No.
EPA-HQ-OW-2010-0824. Such deliveries are accepted only during the
Docket Center's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments on the 2011 Annual Reviews and
Preliminary 2012 Plan to Docket ID No. EPA-HQ-OW-2010-0824. EPA's
policy is that all comments received will be included in the public
docket without change and could be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means that EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment because of technical difficulties and cannot contact you for
clarification, EPA might not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm. For additional
instructions on submitting comments, go to the SUPPLEMENTARY
INFORMATION section of this document.

Submitting Confidential Business Information

    Do not submit confidential business information (CBI) to EPA
through www.regulations.gov or email. Any CBI you wish to submit should
be sent via a trackable physical method, such as Federal Express or
United Parcel Service, to Mr. M. Ahmar Siddiqui, Document Control
Officer, Engineering

and Analysis Division (4303T), Room 6231S EPA West, U.S. EPA, 1200
Pennsylvania Ave. NW., Washington, DC 20460. A CBI package should be
double-wrapped, so that the CBI is in one package, which is itself
inside another package. Clearly mark the part or all of the information
that you claim to be CBI. For CBI information on a disk or CD ROM that
you mail to EPA, mark the outside of the disk or CD ROM as CBI and then
identify electronically within the disk or CD ROM the specific
information that is claimed as CBI. In addition to one complete copy of
the material that includes information claimed as CBI, a copy of the
material that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information marked as CBI
will not be disclosed except in accordance with procedures set forth in
40 CFR Part 2.
    Docket: All documents in the docket are listed in the index at
www.regulations.gov. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically at www.regulations.gov or in hard copy
at the Water Docket in the EPA Docket Center, EPA/DC, EPA West, Room
3334, 1301 Constitution Ave. NW., Washington, DC. 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 Water Docket
is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. William F. Swietlik, Engineering
and Analysis Division, Office of Water, 4303T, U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC.,
20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Supporting Documents

    Key documents providing additional information about EPA's 2011
Annual Reviews and the Preliminary 2012 Plan include the 2011 Annual
Effluent Guidelines Review Report and the Preliminary 2012 Effluent
Guidelines Program Plan.

B. How can I get copies of these documents and other related
information?

    1. Docket. EPA has established official public dockets for these
actions under Docket ID No. EPA-HQ-OW-2010-0824. The official public
docket is the collection of materials that is available for public
viewing at the Water Docket in the EPA Docket Center, (EPA/DC) EPA
West, Room 3334, 1301Constitution Ave. NW., Washington, DC 20460.
    2. Electronic Access. You may access this Federal Register document
electronically through the United States government online source for
Federal regulations at http://www.regulations.gov.
    3. Internet access. Copies of the supporting documents are
available at http://water.epa.gov/lawsregs/lawsguidance/cwa/304m/index.cfm.

C. What should I consider as I prepare my comments for EPA?

    Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency might ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible.
     Make sure to submit your comments by the comment period
deadline identified.

II. How is this document organized?

    The outline of this notice follows.
A. Legal Authority.
B. Summary Findings of the 2011 Annual Reviews.
C. Summary of the Preliminary 2012 Effluent Guidelines Program Plan.
D. Public Comments.
E. Summary of the Planned Process for 2012 Annual Reviews.
F. Requests for Comment and Information.

A. Legal Authority

    This notice is published under the authority of the CWA, 33 U.S.C.
1251, et seq., and in particular sections 301(d), 304(b), 304(g),
304(m), 306, 307(b), 308, 33 U.S.C. 1311(d), 1314(b), 1314(g), 1314(m),
1316, 1317(b), and 1318.

B. Summary Findings of the 2011 Annual Reviews

    After completing the 2011 Annual Reviews, EPA has determined that
discharges from 17 of the top 20 industrial categories were not a
hazard priority. However, EPA determined that additional information
and analysis is necessary before concluding the review of the three
remaining point source categories: Pulp, Paper and Paperboard (40 CFR
Part 430), Petroleum Refining (40 CFR Part 419), and Meat and Poultry
Products (40 CFR Part 432). Therefore, EPA continued to review these
categories' discharges during the 2012 Annual Reviews and will report
its finding in the Final 2012 Plan.

C. Summary of the Preliminary 2012 Effluent Guidelines Program Plan

    EPA is not identifying any industry category for new or revised
effluent guidelines in the Preliminary 2012 Plan. In addition, for
previously initiated rulemakings, EPA is proposing to delist from the
effluent guidelines plan the rulemaking for the Coalbed Methane
Extraction subcategory based on new information regarding the declining
prevalence and economic viability of this industry, due in large part
to the increased extraction of natural gas from other sources, such as
shale formations. See the supporting documents available at http://water.epa.gov/lawsregs/lawsguidance/cwa/304m/index.cfm for further
explanation. EPA is also proposing to delist the Chlorine and
Chlorinated Hydrocarbon (CCH) manufacturing industry from the Plan and
discontinue its rulemaking.
    Based on a preliminary study that has been completed, EPA has
concluded that an effluent guideline revision is not necessary for
Regenerated Cellulose Manufacturers (previously categorized as Plastics
Molding and Forming (40 CFR Part 463)).

D. Public Comments

    EPA also considered public comments and information submitted by
stakeholders in response to a solicitation for comments on the Final
2010 Effluent Limitations Guidelines (ELG) Program Plan (Final 2010
Plan), published in the Federal Register on October 26, 2011 (76 FR
66286).
    A total of 31 organizations provided comment on the Final 2010
Plan. Most

of the public comment and input submitted focused on expressing
opposition or support for the announced ELGs for Shale Gas Extraction,
Coalbed Methane Extraction and Dental Amalgam. A few comments provided
a small amount of information and ideas on the 304(m) planning process
in general; nanomaterial discharges; the disposal of unused
pharmaceuticals; and on the ore mining and dressing study report.

E. Summary of the Process for 2012 Annual Reviews

    EPA conducted four new targeted review methodologies to better
identify new industries or industry processes at existing industries
that may need new or revised effluent guidelines and standards for the
2012 reviews. These methodologies included:
     Identifying pass-through pollutants in sewage sludge using
the 2009 Targeted National Sewage Sludge Survey (TNSSS).
     Identifying new pollutants and industry discharges using
data and information from EPA's toxic substances control programs.
     Identifying new waste streams generated from new air
pollution controls associated with Clean Air Act rulemakings.
     Identifying new industries through potential TRI expansion
sectors.

These new targeted review methodologies are further described in the
Preliminary 2012 Plan available for review at: http://water.epa.gov/lawsregs/lawsguidance/cwa/304m/index.cfm.
    EPA has modified its annual review process to conduct a toxicity
ranking analysis for industry only during the odd numbered years and
additional targeted reviews of industry during the even numbered years.

F. Request for Comment and Information

    EPA requests comments and information on the Preliminary 2012
Effluent Guidelines Program Plan and on the 2011 Annual Effluent
Guidelines Review Report in the following areas.
1. Data Sources and Methodologies
    EPA solicits comments on whether it used the correct evaluation
factors, criteria, and data sources in conducting its 2011 annual
review and developing this Plan. EPA also solicits comment on other
data sources EPA can use in its annual reviews and biennial planning
process.
2. Methodologies for the 2012 Annual Reviews
    EPA solicits comments on its methods for the 2012 Annual Reviews
and for subsequent even numbered year reviews. EPA used targeted
industrial review methods during 2012, as described above.
Specifically, EPA solicits comment on data and other sources of
available information or approaches that EPA could consider for the
annual reviews in subsequent even years, or comments regarding the
targeted approaches described above and in the Preliminary 20122 Plan.
3. The Preliminary 2012 Effluent Guidelines Program Plan
    EPA solicits comments on its Preliminary 2012 Plan, including the
data and information used to support the findings and conclusions
stated in the Preliminary 2012 Plan. EPA also solicits comments on the
proposed decisions to not identify any industry categories for the
development of new or revised effluent guidelines and to delist the
Coalbed Methane Extraction subcategory and Chlorine and Chlorinated
Hydrocarbon Manufacturing from the effluent guidelines plan.
4. Implementation Issues Related to Existing Effluent Guidelines and
Pretreatment Standards
    As a factor in its decision-making, EPA considers opportunities to
eliminate inefficiencies or impediments to pollution prevention or
technological innovation, or opportunities to promote innovative
approaches such as water quality trading, including within-plant
trading. Consequently, EPA solicits comments on implementation issues
related to existing effluent guidelines and pretreatment standards.
5. Innovation and Technology in the Effluent Guidelines Program
    EPA is requesting public comment and ideas on the subject of
technology innovation. EPA seeks public input and comment on the
following questions and related themes:

--Are there new, innovative pollution control or pollution prevention
technologies that can be used by any of the existing 57 categories of
industry with effluent limitations guidelines?
--Are there innovative manufacturing approaches that can be used by
industries to reduce or prevent their wastewater discharges?
--How can EPA's effluent limitations guidelines program enhance
technology transfer to catalyze and harness innovation to solve
industrial wastewater problems, both now and in the future?
--How can EPA better foster consideration of innovative technologies
through the effluent guidelines planning process?

Nancy K. Stoner,
Acting Assistant Administrator for Water.
[FR Doc. 2013-19074 Filed 8-6-13; 8:45 am]
BILLING CODE 6560-50-P


"Marc Melnick"<EMAIL_ADDRESS> 12/12/2007 03:04 PM

To

David Dickinson/DC/USEPA/US@EPA

cc

"Aron Livingston"<EMAIL_ADDRESS>

Subject

EPA-HQ-OAR-2006-0173

 Consistent with our earlier submissions, I am enclosing Judge Ishii's summary judgment order filed today in Central Valley Chrysler-Jeep, Inc. v. Goldstene (U.S.D.C., E.D. Cal., No. 1:04-CV-06663-AWI-GSA).   As you know, the Central Valley case challenges the same state greenhouse gas emission standards which are involved in this waiver proceeding.  Please place this document in the docket.

Please do not hesitate to contact me if you have any questions.

Thank you.

Marc N. Melnick

Deputy Attorney General

California Attorney General's Office

    1515 Clay Street  , 20th Floor

    P.O. Box  70550

    Oakland ,   CA     94612

510/622-2133

fax 510/622-2270

<EMAIL_ADDRESS>