Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities for June 2019, 37818-37821 [2019-16389]
Download as PDF
37818
Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Proposed Rules
C. EPA Recommendations To Further
Improve the Rule
The TSD includes recommendations
for the next time the local agency
modifies the rule.
D. Public Comment and Proposed
Action
As authorized in section 110(k)(3) of
the Act, the EPA proposes to fully
approve the submitted rule because it
fulfills all relevant requirements. We
will accept comments from the public
on this proposal until September 3,
2019. If we take final action to approve
the submitted rule, our final action will
incorporate this rule into the federally
enforceable SIP.
jbell on DSK3GLQ082PROD with PROPOSALS
III. Incorporation by Reference
In this rule, the EPA is proposing to
include in a final EPA rule regulatory
text that includes incorporation by
reference. In accordance with
requirements of 1 CFR 51.5, the EPA is
proposing to incorporate by reference
the VCAPCD rule described in Table 1
of this preamble. The EPA has made,
and will continue to make, these
materials available through https://
www.regulations.gov and at the EPA
Region IX Office (please contact the
person identified in the FOR FURTHER
INFORMATION CONTACT section of this
preamble for more information).
IV. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to approve a
SIP submission that complies with the
provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP
submissions, the EPA’s role is to
approve state choices, provided that
they meet the criteria of the Clean Air
Act. Accordingly, this proposed action
merely proposes to approve state law as
meeting federal requirements and does
not impose additional requirements
beyond those imposed by state law. For
that reason, this proposed action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866;
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
VerDate Sep<11>2014
17:36 Aug 01, 2019
Jkt 247001
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide the EPA with the
discretionary authority to address
disproportionate human health or
environmental effects with practical,
appropriate, and legally permissible
methods under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where the EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the proposed rule does
not have tribal implications and will not
impose substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements.
Authority: 42 U.S.C. 7401 et seq.
Dated: July 23, 2019.
Michael Stoker,
Regional Administrator, Region IX.
[FR Doc. 2019–16576 Filed 8–1–19; 8:45 am]
BILLING CODE 6560–50–P
PO 00000
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 174 and 180
[EPA–HQ–OPP–2019–0041; FRL–9996–78]
Receipt of a Pesticide Petition Filed for
Residues of Pesticide Chemicals in or
on Various Commodities for June 2019
Environmental Protection
Agency (EPA).
AGENCY:
Notice of filing of petition and
request for comment.
ACTION:
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.
SUMMARY:
Comments must be received on
or before September 3, 2019.
DATES:
Submit your comments,
identified by docket identification (ID)
number by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(RD) (7505P), main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov. 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:
Frm 00025
Fmt 4702
Sfmt 4702
E:\FR\FM\02AUP1.SGM
02AUP1
Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Proposed Rules
I. General Information
II. What action is the Agency taking?
A. Does this action apply to me?
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 https://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.
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).
jbell on DSK3GLQ082PROD with PROPOSALS
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
https://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.
VerDate Sep<11>2014
17:36 Aug 01, 2019
Jkt 247001
Amended Tolerance Exemptions for
Inerts (Except PIPS)
PP IN–11271. (EPA–HQ–OPP–2019–
0279). Spring Trading Company (203
Dogwood Trail Magnolia, TX 77354–
5201) on behalf of BASF Corporation
(100 Campus Drive, Florham Park NJ
07932), requests to amend an exemption
from the requirement of a tolerance for
residues of propanamide, 2-hydroxy-N,
N-dimethyl- (CAS Reg. No. 35123–06–9)
by increasing the limitation from 20%
by weight to 50% by weight when used
as a pesticide inert ingredient (solvent/
co-solvent) in pesticide formulations
applied in or on raw agricultural
commodities and to growing crops
under 40 CFR 180.910 and applied in/
on animals under 40 CFR 180.930. The
petitioner believes no analytical method
is needed because it is not required for
PO 00000
Frm 00026
Fmt 4702
Sfmt 4702
37819
an exemption from the requirement of a
tolerance. Contact: RD.
Amended Tolerances for Non-Inerts
1. PP 9E8739. (EPA–HQ–OPP–2017–
0694). The Interregional Research
Project Number 4 (IR–4), Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201 W,
Princeton, NJ 08540, proposes upon
establishment of the tolerance
referenced above under ‘‘New
Tolerances’’ to remove the existing
tolerance in 40 CFR part 180.672 for
residues of the insecticide
cyantraniliprole, 3-bromo-1-(3-chloro-2pyridinyl)-N-[4-cyano-2-methyl-6[((methylamino)carbonyl]phenyl]-1Hpyrazole-5-carboxamide, including its
metabolites and degradates in or on
Strawberry at 1.0 ppm. Contact: RD.
2. PP 9E8743. (EPA–HQ–OPP–2019–
0250). IR–4, Rutgers, The State
University of New Jersey, 500 College
Road East, Suite 201 W, Princeton, New
Jersey 08540, proposes to amend 40 CFR
part 180.613(a) for residues of the
insecticide flonicamid, including its
metabolites and degradates, to be
determined by measuring only the sum
of flonicamid, N-(cyanomethyl)-4(trifluoromethyl)-3pyridinecarboxamide, and its
metabolites, TFNA (4trifluoromethylnicotinic acid), TFNAAM (4-trifluoromethylnicotinamide),
and TFNG, N-(4trifluoromethylnicotinoyl)glycine,
calculated as the stoichiometric
equivalent of flonicamid, in or on Leafy
greens subgroup 4–16A, except spinach
by increasing the existing tolerance from
4.0 ppm to 8.0 ppm. Upon
establishment of the amended tolerance
above, the petitioner requests removal of
the existing tolerance for flonicamid on
Leafy greens subgroup 4–16A, except
spinach at 4.0 ppm. The analytical
method used to quantitate above
designated flonicamid residues in plants
incorporates a liquid chromatograph
(LC) equipped with a reverse phase
column and a triple quadruple mass
spectrometer (MS/MS). Contact: RD.
3. PP 9E8755. (EPA–HQ–OPP–2019–
0128). IR–4, Rutgers, The State
University of New Jersey, 500 College
Road East, Suite 201W, Princeton, NJ
08540, proposes upon establishment of
tolerances referenced in this document
under ‘‘New Tolerances (for PP
9E6755)’’ to remove the existing
tolerances in 40 CFR part 180.685 for
residues of the fungicide
oxathiapiprolin, 1-[4-[4-[5-(2,6difluorophenyl)-4,5-dihydro-3isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on the
E:\FR\FM\02AUP1.SGM
02AUP1
37820
Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Proposed Rules
following commodities: Pea, ediblepodded at 1.0 ppm and Pea, succulent
shelled at 0.05 ppm. Contact: RD.
jbell on DSK3GLQ082PROD with PROPOSALS
New Tolerance Exemptions for Inerts
(Except PIPS)
PP IN–11264. (EPA–HQ–OPP- 2019–
0327). Spring Trading Company (203
Dogwood Trail Magnolia, TX 77354–
5201) on behalf of Stoller Enterprises,
Inc. (9090 Katy Freeway, Suite 400
Houston, TX 77024), requests to
establish an exemption from the
requirement of a tolerance for residues
of formic acid (CAS Reg. No. 64–18–6)
when used as a pesticide inert
ingredient (pH adjuster) in pesticide
formulations applied in or on raw
agricultural commodities and to
growing crops under 40 CFR 180.910
and applied in/on animals under 40
CFR 180.930. The petitioner believes no
analytical method is needed because it
is not required for an exemption from
the requirement of a tolerance. Contact:
RD.
New Tolerance Exemptions for NonInerts (Except PIPS)
1. PP 8F8713. (EPA–HQ–OPP–2019–
0368). Acqua Concepts, Inc. (d/b/a Ag
Water Chemical), 2665 S. Chestnut,
Fresno, CA 93725, requests to establish
an exemption from the requirement of a
tolerance in 40 CFR part 180 for
residues of the gopher repellent methyl
mercaptan in or on all food
commodities that use irrigation lines
treated with methyl mercaptan. The
analytical method ‘‘ASTM D 5504–12
using a gas chromatograph equipped
with a sulfur chemiluminescence
detector (SCD)’’ is available to EPA for
the detection and measurement of the
pesticide residues. Contact: BPPD.
2. PP 9F8735. (EPA–HQ–OPP–2019–
0324). Biocontrol Technologies, S.L.,
Avgda. Madrid, 215–217, entreso`l A,
08014 Barcelona, Spain (c/o Wagner
Regulatory Associates, Inc., P.O. Box
640, Hockessin, DE 19707), requests to
establish an exemption from the
requirement of a tolerance in 40 CFR
part 180 for residues of the fungicide
and bactericide Trichoderma
asperellum, strain T34 in or on all food
commodities. The petitioner believes no
analytical method is needed because an
exemption from the requirement of a
tolerance is being proposed. Contact:
BPPD.
3. PP 9F8760. (EPA–HQ–OPP–2019–
0367). Valent BioSciences LLC, 870
Technology Way, Libertyville, IL 60048,
requests to establish a temporary
exemption from the requirement of a
tolerance in 40 CFR part 180 for
residues of the biochemical plant
regulator (fruit thinner)
VerDate Sep<11>2014
17:36 Aug 01, 2019
Jkt 247001
1-Aminocyclopropane-1-carboxylic acid
(ACC) in or on apples and stone fruits.
The petitioner believes no analytical
method is needed because of low
toxicity and minimal residues. Contact:
BPPD.
New Tolerances for Non-Inerts
1. PP 8F8708. (EPA–HQ–OPP–2019–
0384). E. I. du Pont de Nemours and
Company, 974 Centre Road,
Wilmington, Delaware 19805, requests
to establish a tolerance for residues of
the insecticide indoxacarb in or on corn,
pop, grain at 0.02 parts per million
(ppm) and corn, pop, stover at 15 ppm.
The plant residue enforcement method
detects and quantitates indoxacarb in
various matrices including sweet corn,
lettuce, tomato, broccoli, apple, grape,
cottonseed, tomato, peanut and soybean
commodity samples by HPLC UV. The
limit of quantitation in the method
allows monitoring of crops with KN128/
KN127 residues at or above the levels
proposed in these tolerances. Contact:
RD.
2. PP 9E8739. (EPA–HQ–OPP–2017–
0694). The Interregional Research
Project Number 4 (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
180.672 for residues of the insecticide
cyantraniliprole, 3-bromo-1-(3-chloro-2pyridinyl)-N-[4-cyano-2-methyl-6[((methylamino)carbonyl]phenyl]-1Hpyrazole-5-carboxamide, including its
metabolites and degradates in or on
Strawberry at 1.5 ppm. The highpressure liquid chromatography with
ESI- MS/MS detection is used to
measure and evaluate cyantraniliprole.
Contact: RD.
3. PP 9E8752. (EPA–HQ–OPP–2019–
0281). IR–4, Rutgers, the State
University of New Jersey. 500 College
Road East, Princeton, NJ 08540, requests
to establish a tolerance in 40 CFR part
180.446 for residues of the insecticide,
clofentezine, 3,6-bis(2-chlorophenyl)1,2,4,5-tetrazine in or on hops, dried
cones at 6 parts per million (ppm). The
high-performance liquid
chromatography (HPLC) is available to
enforce the tolerance expression. The
limit of quantitation (LOQ) and limit of
detection (LOD) were determined to be
0.01 ppm and 0.003 ppm, respectively.
Contact: RD.
4. PP 9E8755. (EPA–HQ–OPP–2019–
0128). IR–4, Rutgers, The State
University of New Jersey, 500 College
Road East, Suite 201W, Princeton, NJ
08540, requests to establish tolerances
in 40 CFR part 180.685 for residues of
the fungicide oxathiapiprolin, 1-[4-[4-[5(2,6-difluorophenyl)-4,5-dihydro-3-
PO 00000
Frm 00027
Fmt 4702
Sfmt 4702
isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2[5-methyl-3-(trifluoromethyl)-1Hpyrazol-1-yl]-ethanone, in or on the
following commodities: Berry, low
growing, subgroup 13–07G, except
cranberry at 0.4 parts per million (ppm);
Hop, dried cones at 5 ppm; and Tropical
and subtropical, medium to large fruit,
smooth, inedible peel, subgroup 24B at
0.1 ppm; individual crops of proposed
crop subgroup 6–18B: Edible podded
pea legume vegetable subgroup
including: Chickpea, edible podded at 1
ppm; Dwarf pea, edible podded at 1
ppm; Edible podded pea at 1 ppm;
Grass-pea, edible podded at 1 ppm;
Green pea, edible podded at 1 ppm;
Lentil, edible podded at 1 ppm; Pigeon
pea, edible podded at 1 ppm; Snap pea,
edible podded at 1 ppm; Snow pea,
edible podded at 1 ppm; and Sugar snap
pea, edible podded at 1 ppm; and
individual crops of proposed crop
subgroup 6–18D: Succulent shelled pea
subgroup including: Chickpea,
succulent shelled at 0.05 ppm; English
pea, succulent shelled at 0.05 ppm;
Garden pea, succulent shelled at 0.05
ppm; Green pea, succulent shelled at
0.05 ppm; Lentil, succulent shelled at
0.05 ppm; and Pigeon pea, succulent
shelled at 0.05 ppm. Adequate
analytical methodology, high-pressure
liquid chromatography with MS/MS
detection, is available to enforce the
oxathiapiprolin tolerance expression.
Contact: RD.
5. PP 9E8763. (EPA–HQ–OPP–2019–
0388). IR–4, Rutgers, The State
University of New Jersey, 500 College
Road East, Suite 201 W, Princeton, New
Jersey 08540, requests to establish
tolerances in 40 CFR part 180.613(a) for
residues of the herbicide saflufenacil,
including its metabolites and
degradates, determined by measuring
only the sum of saflufenacil, 2-chloro-5[3,6-dihydro-3-methyl-2,6-dioxo-4(trifluoromethyl)-1(2H)-pyrimidinyl]-4fluoro-N-[[methyl(1methylethyl)amino]sulfonyl]benzamide,
and its metabolites N-[2-chloro-5-(2,6dioxo-4-(trifluoromethyl)-3,6-dihydro1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N′isopropylsulfamide and N-[4-chloro-2fluoro-5-({ (isopropylamino)sulfonyl
amino}carbonyl)phenyl]urea, calculated
as the stoichiometric equivalent of
saflufenacil, in or on the following raw
agricultural commodities: Caneberry
subgroup 13–07A at 0.03 parts per
million (ppm), Chia, seed at 1 ppm,
Chia, straw at 15 ppm, Fig at 0.03 ppm,
and Fig, dried at 0.05 ppm. Adequate
enforcement analytical methodology
(liquid chromatography/tandem mass
spectrometry (LC/MS/MS) for plant and
livestock commodities is available to
E:\FR\FM\02AUP1.SGM
02AUP1
Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Proposed Rules
enforce the saflufenacil tolerance
expression. Contact RD.
6. PP 9F8747. (EPA–HQ–OPP–2019–
0230). Valent U.S.A. LLC, P.O. Box
8025, Walnut Creek, CA 94596–8025,
requests to establish a tolerance in 40
CFR part 180 for residues of the
fungicide, ethaboxam ((RS)-N-(a-cyano2-thenyl)-4-ethyl-2-(ethylamino)-1,3thiazole-5-carboxamide) in or on beet,
sugar, root at 0.01 parts per million
(ppm). The analytical method uses highperformance liquid chromatography
(HPLC) with tandem mass spectrometry
(LC/MS–MS), with turbo-ion spray
ionization in positive ion mode for
ethaboxam and metabolites EEO, and
negative ion mode for EEHO. A linear
forced-origin calibration curve was used
to quantify ethaboxam in the sample
extracts. Contact: RD.
Authority: 21 U.S.C. 346a.
Dated: July 10, 2019.
Delores Barber,
Director, Information Technology and
Resources Management Division, Office of
Pesticide Programs.
[FR Doc. 2019–16389 Filed 8–1–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
RIN 0991–AB16
Withdrawal of Proposed Rule
‘‘Medicare and State Health Care
Programs: Fraud and Abuse; Safe
Harbor Under the Anti-Kickback
Statute for Waiver of Beneficiary
Coinsurance and Deductible Amounts’’
Office of Inspector General
(OIG), Department of Health and Human
Services (HHS).
ACTION: Withdrawal of Proposed Rule.
AGENCY:
This document informs the
public that OIG has determined not to
pursue a proposed rule published in the
Federal Register and, as a result, is
withdrawing it. OIG is taking this action
to avoid any confusion that could be
caused by having this proposal in the
public domain.
DATES: The Proposed Rule described
under SUPPLEMENTARY INFORMATION is
withdrawn as of August 1, 2019.
ADDRESSES: Office of Counsel to the
Inspector General, Cohen Building, 330
Independence Ave. SW, Washington,
DC 20201.
jbell on DSK3GLQ082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
17:36 Aug 01, 2019
Jkt 247001
FOR FURTHER INFORMATION CONTACT:
Aaron Zajic, Supervisory Project
Manager, Office of Counsel to the
Inspector General, Cohen Building, 330
Independence Ave. SW, Washington,
DC 20201, 202–619–0335.
SUPPLEMENTARY INFORMATION:
I. Background
A. OIG’s Review of Proposed Rules
Executive Order 13777, entitled
‘‘Enforcing the Regulatory Reform
Agenda’’ (82 FR 12285), instructs
agencies to review regulations which
should be repealed, replaced, or
modified. As a result of a review
undertaken after the issuance of
Executive Order 13777, OIG identified a
Proposed Rule (described below), which
we do not intend to finalize.
Accordingly, OIG is withdrawing the
Proposed Rule from the Federal
Register.
B. OIG’s Withdrawal of the Proposed
Rule
The Proposed Rule that OIG is
withdrawing was published in 2002.
OIG neither applied nor enforced the
position stated therein, nor does it now
intend to do so. If OIG were to finalize
this proposal, we would require
updated comments from the public, as
reimbursement methods and other
aspects of the healthcare industry have
changed in the interim. As a result, OIG
is withdrawing the following Proposed
Rule to eliminate any confusion that
could result from its presence in the
public domain:
The Proposed Rule, Medicare and
State Health Care Programs: Fraud and
Abuse; Safe Harbor Under the AntiKickback Statute for Waiver of
Beneficiary Coinsurance and Deductible
Amounts (67 FR 60202, September 25,
2002), would have expanded an existing
safe harbor at 42 CFR 1001.952(k) to
include waivers of cost sharing amounts
for Part A and B services for holders of
Medicare SELECT policies (a type of
Medicare supplement (Medigap) plan).
II. Regulatory Impact
We expect minimal regulatory impact
and reaction because of the passage of
time since the Proposed Rule was
published and because, to our
knowledge, the public is not currently
relying on, and may be unaware of, it.
Joanne M. Chiedi,
Acting Inspector General.
Dated: July 25, 2019.
Alex M. Azar II,
Secretary.
[FR Doc. 2019–16346 Filed 8–1–19; 8:45 am]
BILLING CODE 4152–01–P
PO 00000
Frm 00028
Fmt 4702
Sfmt 4702
37821
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1003
RIN 0991–AA45
Withdrawal of Proposed Rule ‘‘Health
Care Programs: Fraud and Abuse; Civil
Money Penalties for Hospital Physician
Incentive Plans’’
Office of Inspector General
(OIG), Department of Health and Human
Services (HHS).
ACTION: Withdrawal of Proposed Rule.
AGENCY:
This document informs the
public that OIG has determined not to
pursue a proposed rule published in the
Federal Register and, as a result, is
withdrawing it. OIG is taking this action
to avoid any confusion that could be
caused by having this proposal in the
public domain.
DATES: The Proposed Rule listed under
SUPPLEMENTARY INFORMATION is
withdrawn as of August 1, 2019.
ADDRESSES: Office of Counsel to the
Inspector General, Cohen Building, 330
Independence Ave. SW, Washington,
DC 20201.
FOR FURTHER INFORMATION CONTACT:
Aaron Zajic, Supervisory Project
Manager, Office of Counsel to the
Inspector General, Cohen Building, 330
Independence Ave. SW, Washington,
DC 20201, 202–619–0335.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
A. OIG’s Review of Proposed Rules
Executive Order 13777, entitled
‘‘Enforcing the Regulatory Reform
Agenda’’ (82 FR 12285), instructs
agencies to review regulations which
should be repealed, replaced, or
modified. As a result of a review
undertaken after the issuance of
Executive Order 13777, OIG identified a
Proposed Rule (described below), which
we do not intend to finalize.
Accordingly, OIG is withdrawing the
proposed rule from the Federal
Register.
B. OIG’s Withdrawal of the Proposed
Rule
The Proposed Rule that OIG is
withdrawing was published in 1994.
OIG neither applied nor enforced the
positions stated therein, nor does it now
intend to do so. If OIG were to finalize
this proposal, we would require
updated comments from the public, as
reimbursement methods and other
aspects of the healthcare industry have
E:\FR\FM\02AUP1.SGM
02AUP1
Agencies
[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Proposed Rules]
[Pages 37818-37821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16389]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 174 and 180
[EPA-HQ-OPP-2019-0041; FRL-9996-78]
Receipt of a Pesticide Petition Filed for Residues of Pesticide
Chemicals in or on Various Commodities for June 2019
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of filing of petition and request for comment.
-----------------------------------------------------------------------
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 September 3, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number by one of the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(RD) (7505P), main telephone number: (703) 305-7090; email address:
[email protected]. 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:
[[Page 37819]]
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 https://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 https://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.
Amended Tolerance Exemptions for Inerts (Except PIPS)
PP IN-11271. (EPA-HQ-OPP-2019-0279). Spring Trading Company (203
Dogwood Trail Magnolia, TX 77354-5201) on behalf of BASF Corporation
(100 Campus Drive, Florham Park NJ 07932), requests to amend an
exemption from the requirement of a tolerance for residues of
propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123-06-9) by
increasing the limitation from 20% by weight to 50% by weight when used
as a pesticide inert ingredient (solvent/co-solvent) in pesticide
formulations applied in or on raw agricultural commodities and to
growing crops under 40 CFR 180.910 and applied in/on animals under 40
CFR 180.930. The petitioner believes no analytical method is needed
because it is not required for an exemption from the requirement of a
tolerance. Contact: RD.
Amended Tolerances for Non-Inerts
1. PP 9E8739. (EPA-HQ-OPP-2017-0694). The Interregional Research
Project Number 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201 W, Princeton, NJ 08540, proposes upon
establishment of the tolerance referenced above under ``New
Tolerances'' to remove the existing tolerance in 40 CFR part 180.672
for residues of the insecticide cyantraniliprole, 3-bromo-1-(3-chloro-
2-pyridinyl)-N-[4-cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-
pyrazole-5-carboxamide, including its metabolites and degradates in or
on Strawberry at 1.0 ppm. Contact: RD.
2. PP 9E8743. (EPA-HQ-OPP-2019-0250). IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, New Jersey 08540, proposes to amend 40 CFR part 180.613(a)
for residues of the insecticide flonicamid, including its metabolites
and degradates, to be determined by measuring only the sum of
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide,
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on Leafy greens subgroup 4-16A, except
spinach by increasing the existing tolerance from 4.0 ppm to 8.0 ppm.
Upon establishment of the amended tolerance above, the petitioner
requests removal of the existing tolerance for flonicamid on Leafy
greens subgroup 4-16A, except spinach at 4.0 ppm. The analytical method
used to quantitate above designated flonicamid residues in plants
incorporates a liquid chromatograph (LC) equipped with a reverse phase
column and a triple quadruple mass spectrometer (MS/MS). Contact: RD.
3. PP 9E8755. (EPA-HQ-OPP-2019-0128). IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540, proposes upon establishment of tolerances referenced in this
document under ``New Tolerances (for PP 9E6755)'' to remove the
existing tolerances in 40 CFR part 180.685 for residues of the
fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-
3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-
(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on the
[[Page 37820]]
following commodities: Pea, edible-podded at 1.0 ppm and Pea, succulent
shelled at 0.05 ppm. Contact: RD.
New Tolerance Exemptions for Inerts (Except PIPS)
PP IN-11264. (EPA-HQ-OPP- 2019-0327). Spring Trading Company (203
Dogwood Trail Magnolia, TX 77354-5201) on behalf of Stoller
Enterprises, Inc. (9090 Katy Freeway, Suite 400 Houston, TX 77024),
requests to establish an exemption from the requirement of a tolerance
for residues of formic acid (CAS Reg. No. 64-18-6) when used as a
pesticide inert ingredient (pH adjuster) in pesticide formulations
applied in or on raw agricultural commodities and to growing crops
under 40 CFR 180.910 and applied in/on animals under 40 CFR 180.930.
The petitioner believes no analytical method is needed because it is
not required for an exemption from the requirement of a tolerance.
Contact: RD.
New Tolerance Exemptions for Non-Inerts (Except PIPS)
1. PP 8F8713. (EPA-HQ-OPP-2019-0368). Acqua Concepts, Inc. (d/b/a
Ag Water Chemical), 2665 S. Chestnut, Fresno, CA 93725, requests to
establish an exemption from the requirement of a tolerance in 40 CFR
part 180 for residues of the gopher repellent methyl mercaptan in or on
all food commodities that use irrigation lines treated with methyl
mercaptan. The analytical method ``ASTM D 5504-12 using a gas
chromatograph equipped with a sulfur chemiluminescence detector (SCD)''
is available to EPA for the detection and measurement of the pesticide
residues. Contact: BPPD.
2. PP 9F8735. (EPA-HQ-OPP-2019-0324). Biocontrol Technologies,
S.L., Avgda. Madrid, 215-217, entres[ograve]l A, 08014 Barcelona, Spain
(c/o Wagner Regulatory Associates, Inc., P.O. Box 640, Hockessin, DE
19707), requests to establish an exemption from the requirement of a
tolerance in 40 CFR part 180 for residues of the fungicide and
bactericide Trichoderma asperellum, strain T34 in or on all food
commodities. The petitioner believes no analytical method is needed
because an exemption from the requirement of a tolerance is being
proposed. Contact: BPPD.
3. PP 9F8760. (EPA-HQ-OPP-2019-0367). Valent BioSciences LLC, 870
Technology Way, Libertyville, IL 60048, requests to establish a
temporary exemption from the requirement of a tolerance in 40 CFR part
180 for residues of the biochemical plant regulator (fruit thinner) 1-
Aminocyclopropane-1-carboxylic acid (ACC) in or on apples and stone
fruits. The petitioner believes no analytical method is needed because
of low toxicity and minimal residues. Contact: BPPD.
New Tolerances for Non-Inerts
1. PP 8F8708. (EPA-HQ-OPP-2019-0384). E. I. du Pont de Nemours and
Company, 974 Centre Road, Wilmington, Delaware 19805, requests to
establish a tolerance for residues of the insecticide indoxacarb in or
on corn, pop, grain at 0.02 parts per million (ppm) and corn, pop,
stover at 15 ppm. The plant residue enforcement method detects and
quantitates indoxacarb in various matrices including sweet corn,
lettuce, tomato, broccoli, apple, grape, cottonseed, tomato, peanut and
soybean commodity samples by HPLC UV. The limit of quantitation in the
method allows monitoring of crops with KN128/KN127 residues at or above
the levels proposed in these tolerances. Contact: RD.
2. PP 9E8739. (EPA-HQ-OPP-2017-0694). The Interregional Research
Project Number 4 (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 180.672 for residues of the
insecticide cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-
cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-
carboxamide, including its metabolites and degradates in or on
Strawberry at 1.5 ppm. The high-pressure liquid chromatography with
ESI- MS/MS detection is used to measure and evaluate cyantraniliprole.
Contact: RD.
3. PP 9E8752. (EPA-HQ-OPP-2019-0281). IR-4, Rutgers, the State
University of New Jersey. 500 College Road East, Princeton, NJ 08540,
requests to establish a tolerance in 40 CFR part 180.446 for residues
of the insecticide, clofentezine, 3,6-bis(2-chlorophenyl)-1,2,4,5-
tetrazine in or on hops, dried cones at 6 parts per million (ppm). The
high-performance liquid chromatography (HPLC) is available to enforce
the tolerance expression. The limit of quantitation (LOQ) and limit of
detection (LOD) were determined to be 0.01 ppm and 0.003 ppm,
respectively. Contact: RD.
4. PP 9E8755. (EPA-HQ-OPP-2019-0128). IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540, requests to establish tolerances in 40 CFR part 180.685 for
residues of the fungicide oxathiapiprolin, 1-[4-[4-[5-(2,6-
difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-
2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on the
following commodities: Berry, low growing, subgroup 13-07G, except
cranberry at 0.4 parts per million (ppm); Hop, dried cones at 5 ppm;
and Tropical and subtropical, medium to large fruit, smooth, inedible
peel, subgroup 24B at 0.1 ppm; individual crops of proposed crop
subgroup 6-18B: Edible podded pea legume vegetable subgroup including:
Chickpea, edible podded at 1 ppm; Dwarf pea, edible podded at 1 ppm;
Edible podded pea at 1 ppm; Grass-pea, edible podded at 1 ppm; Green
pea, edible podded at 1 ppm; Lentil, edible podded at 1 ppm; Pigeon
pea, edible podded at 1 ppm; Snap pea, edible podded at 1 ppm; Snow
pea, edible podded at 1 ppm; and Sugar snap pea, edible podded at 1
ppm; and individual crops of proposed crop subgroup 6-18D: Succulent
shelled pea subgroup including: Chickpea, succulent shelled at 0.05
ppm; English pea, succulent shelled at 0.05 ppm; Garden pea, succulent
shelled at 0.05 ppm; Green pea, succulent shelled at 0.05 ppm; Lentil,
succulent shelled at 0.05 ppm; and Pigeon pea, succulent shelled at
0.05 ppm. Adequate analytical methodology, high-pressure liquid
chromatography with MS/MS detection, is available to enforce the
oxathiapiprolin tolerance expression. Contact: RD.
5. PP 9E8763. (EPA-HQ-OPP-2019-0388). IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, New Jersey 08540, requests to establish tolerances in 40 CFR
part 180.613(a) for residues of the herbicide saflufenacil, including
its metabolites and degradates, determined by measuring only the sum of
saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide, and its metabolites N-[2-chloro-
5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-
fluorobenzoyl]-N'-isopropylsulfamide and N-[4-chloro-2-fluoro-5-({
(isopropylamino)sulfonyl amino{time} carbonyl)phenyl]urea, calculated
as the stoichiometric equivalent of saflufenacil, in or on the
following raw agricultural commodities: Caneberry subgroup 13-07A at
0.03 parts per million (ppm), Chia, seed at 1 ppm, Chia, straw at 15
ppm, Fig at 0.03 ppm, and Fig, dried at 0.05 ppm. Adequate enforcement
analytical methodology (liquid chromatography/tandem mass spectrometry
(LC/MS/MS) for plant and livestock commodities is available to
[[Page 37821]]
enforce the saflufenacil tolerance expression. Contact RD.
6. PP 9F8747. (EPA-HQ-OPP-2019-0230). Valent U.S.A. LLC, P.O. Box
8025, Walnut Creek, CA 94596-8025, requests to establish a tolerance in
40 CFR part 180 for residues of the fungicide, ethaboxam ((RS)-N-
([alpha]-cyano-2-thenyl)-4-ethyl-2-(ethylamino)-1,3-thiazole-5-
carboxamide) in or on beet, sugar, root at 0.01 parts per million
(ppm). The analytical method uses high-performance liquid
chromatography (HPLC) with tandem mass spectrometry (LC/MS-MS), with
turbo-ion spray ionization in positive ion mode for ethaboxam and
metabolites EEO, and negative ion mode for EEHO. A linear forced-origin
calibration curve was used to quantify ethaboxam in the sample
extracts. Contact: RD.
Authority: 21 U.S.C. 346a.
Dated: July 10, 2019.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2019-16389 Filed 8-1-19; 8:45 am]
BILLING CODE 6560-50-P