Siloxanes and Silicones, di-Me, Me Hydrogen; Tolerance Exemption, 61537-61540 [2022-22145]
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Federal Register / Vol. 87, No. 196 / Wednesday, October 12, 2022 / Rules and Regulations
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: October 5, 2022.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1394 to subpart D to read
as follows:
■
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§ 180.1394 Lysate of Willaertia magna C2c
Maky; Exemption from the Requirement of
a Tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the pesticide, lysate of Willaertia
magna C2c Maky, in or on all food
commodities, when used in accordance
with label directions.
[FR Doc. 2022–22045 Filed 10–11–22; 8:45 am]
BILLING CODE 6560–50–P
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SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
A. Does this action apply to me?
[EPA–HQ–OPP–2022–0507; FRL–10196–01–
OCSPP]
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).
Siloxanes and Silicones, di-Me, Me
Hydrogen; Tolerance Exemption
Environmental Protection
Agency (EPA)
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of siloxanes and
silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated
di-Me siloxanes (CAS Reg. No. 156065–
02–0), when used as an inert ingredient
in a pesticide chemical formulation. The
Dow Chemical Company submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of siloxanes and silicones,
di-Me, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes on food or feed commodities.
DATES: This regulation is effective
October 12, 2022. Objections and
requests for hearings must be received
on or before December 12, 2022, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0507, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
SUMMARY:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
C. Can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2022–0507 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
December 12, 2022. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2022–0507, by one of the following
methods.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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Federal Register / Vol. 87, No. 196 / Wednesday, October 12, 2022 / Rules and Regulations
jspears on DSK121TN23PROD with RULES
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at 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.
II. Background and Statutory Findings
In the Federal Register of July 20,
2022 (87 FR 43232) (FRL–9410–03–
OCSPP), EPA issued a document
pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of
a pesticide petition (PP IN–11697) filed
by Dow Chemical Company, 715 E Main
Street, Midland, MI 48640. The petition
requested that 40 CFR 180.960 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of siloxanes and silicones, diMe, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes (CAS Reg. No. 156065–02–0),
with a minimum number average
molecular weight of 10,600 Daltons.
That document included a summary of
the petition prepared by the petitioner
and solicited comments on the
petitioner’s request. The Agency did not
receive any public comments.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and
use in residential settings but does not
include occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing an
exemption from the requirement of a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
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chemical residue.’’ and specifies factors
EPA is to consider in establishing an
exemption.
III. Risk Assessment and Statutory
Findings
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be shown that the
risks from aggregate exposure to
pesticide chemical residues under
reasonably foreseeable circumstances
will pose no appreciable risks to human
health. To determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(b)(2)(D), EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. In the
case of certain chemical substances that
are defined as polymers, the Agency has
established a set of criteria to identify
categories of polymers expected to
present minimal or no risk. The
definition of a polymer is given in 40
CFR 723.250(b) and the exclusion
criteria for identifying these low-risk
polymers are described in 40 CFR
723.250(d). Siloxanes and silicones, diMe, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes with a minimum number
average molecular weight 10,600
Daltons, conforms to the definition of a
polymer given in 40 CFR 723.250(b) and
meets the following criteria that are
used to identify low-risk polymers.
1. The polymer is not a cationic
polymer nor is it reasonably anticipated
to become a cationic polymer in a
natural aquatic environment.
2. The polymer does contain as an
integral part of its composition at least
two of the atomic elements carbon,
hydrogen, nitrogen, oxygen, silicon, and
sulfur.
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3. The polymer does not contain as an
integral part of its composition, except
as impurities, any element other than
those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed
nor can it be reasonably anticipated to
substantially degrade, decompose, or
depolymerize: Adequate biodegradation
studies (MRID 51816203) were
submitted for siloxanes and silicones,
di-Me, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes, with a minimum number
average molecular weight 10,600
Daltons, showing lack of
biodegradation.
5. The polymer is manufactured or
imported from monomers and/or
reactants that are already included on
the Toxic Substances Control Act
(TSCA) Chemical Substance Inventory
or manufactured under an applicable
TSCA section 5 exemption.
6. The polymer is not a water
absorbing polymer with a number
average molecular weight (MW) greater
than or equal to 10,000 Daltons.
7. The polymer does not contain
certain perfluoroalkyl moieties
consisting of a CF3- or longer chain
length as listed in 40 CFR 723.250(d)(6).
Additionally, the polymer also meets
as required the following exemption
criteria specified in 40 CFR 723.250(e).
The polymer’s number average
molecular weight (MW) of 10,600
Daltons is greater than 10,000 Daltons.
However, the polymer contains less
than 2% oligomeric material below MW
500 and less than 5% oligomeric
material below MW 1,000.
Thus, siloxanes and silicones, di-Me,
Me hydrogen, reaction products with
vinyl group-terminated di-Me siloxanes
meets the criteria for a polymer to be
considered low risk under 40 CFR
723.250. Based on its conformance to
the criteria in this unit, no mammalian
toxicity is anticipated from dietary,
inhalation, or dermal exposure to
siloxanes and silicones, di-Me, Me
hydrogen, reaction products with vinyl
group-terminated di-Me siloxanes.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that
Siloxanes and Silicones, di-Me, Me
hydrogen, reaction products with vinyl
group-terminated di-Me siloxanes could
be present in all raw and processed
agricultural commodities and drinking
water, and that non-occupational nondietary exposure was possible. The
minimum number average MW of
siloxanes and silicones, di-Me, Me
hydrogen, reaction products with vinyl
group-terminated di-Me siloxanes is
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10,600 Daltons. Generally, a polymer of
this size would be poorly absorbed
through the intact gastrointestinal tract
or through intact human skin. Since
siloxanes and silicones, di-Me, Me
hydrogen, reaction products with vinyl
group-terminated di-Me siloxanes
conforms to the criteria that identify a
low-risk polymer, there are no concerns
for risks associated with any potential
exposure scenarios that are reasonably
foreseeable. The Agency has determined
that a tolerance is not necessary to
protect the public health.
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V. Cumulative Effects From Substances
With a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found siloxanes and
silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated
di-Me siloxanes to share a common
mechanism of toxicity with any other
substances, and siloxanes and silicones,
di-Me, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that siloxanes and silicones,
di-Me, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes does not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
VI. Additional Safety Factor for the
Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base unless
EPA concludes that a different margin of
safety will be safe for infants and
children. Due to the expected low
toxicity of siloxanes and silicones, diMe, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes, EPA has not used a safety
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factor analysis to assess the risk. For the
same reasons the additional tenfold
safety factor is unnecessary.
VII. Determination of Safety
Based on the conformance to the
criteria used to identify a low-risk
polymer, EPA concludes that there is a
reasonable certainty of no harm to the
U.S. population, including infants and
children, from aggregate exposure to
residues of siloxanes and silicones, diMe, Me hydrogen, reaction products
with vinyl group-terminated di-Me
siloxanes.
VIII. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of siloxanes and
silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated
di-Me siloxanes from the requirement of
a tolerance will be safe.
X. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
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61539
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
XI. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et
seq.), EPA will submit a report
containing this rule and other required
information to the U.S. Senate, the U.S.
House of Representatives, and the
Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: October 4, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
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Federal Register / Vol. 87, No. 196 / Wednesday, October 12, 2022 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
2. In § 180.960, amend table 1 by
adding, in alphabetical order, the
polymer ‘‘Siloxanes and silicones, diMe, Me hydrogen, reaction products
with vinyl group-terminated di-Me
■
1. The authority citation for part 180
continues to read as follows:
■
siloxanes, minimum number average
molecular weight (in amu) 10,600’’ to
read as follows:
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
*
TABLE 1 TO § 180.960
Polymer
CAS No.
*
*
*
*
*
*
Siloxanes and silicones, di-Me, Me hydrogen, reaction products with vinyl group-terminated di-Me siloxanes, minimum number
average molecular weight (in amu) 10,600’’ ....................................................................................................................................
*
*
*
[FR Doc. 2022–22145 Filed 10–11–22; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket Nos. 090206140–91081–03,
120405260–4258–02, 200706–0181, and
200127–0032]
RTID 0648–XC448
Revised Reporting Requirements Due
to Catastrophic Conditions for Federal
Seafood Dealers, Individual Fishing
Quota Dealers, and Charter Vessels
and Headboats in Portions of Florida
and South Carolina
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; determination
of catastrophic conditions.
AGENCY:
In accordance with the
regulations implementing the individual
fishing quota (IFQ), Federal dealer
reporting, and Federal charter vessel
and headboat (for-hire vessel) reporting
programs specific to the reef fish fishery
in the Gulf of Mexico (Gulf) and the
coastal migratory pelagic (CMP)
fisheries in the Gulf and Atlantic, the
snapper-grouper fishery in the South
Atlantic, and the dolphin and wahoo
fishery in the Atlantic, the Regional
Administrator (RA), Southeast Region,
NMFS, has determined that Hurricane
Ian has caused catastrophic conditions
in certain Florida and South Carolina
counties. This temporary rule authorizes
any dealer in the affected area described
in this temporary rule who does not
have access to electronic reporting to
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SUMMARY:
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*
*
delay reporting of trip tickets to NMFS
and authorizes IFQ participants within
the affected area to use paper-based
forms, if necessary, for basic required
administrative functions, e.g., landing
transactions. This rule also authorizes
any Federal for-hire owner or operator
in the affected area described in this
temporary rule who does not have
access to electronic reporting to delay
reporting of logbook and South Atlantic
‘‘Did Not Fish’’ records to NMFS. This
temporary rule is intended to facilitate
continuation of IFQ, dealer, and Federal
for-hire reporting operations during the
period of catastrophic conditions.
DATES: The RA is authorizing Federal
dealers, IFQ participants, and Federal
for-hire operators in the affected areas to
use revised reporting methods from
October 6, 2022, through November 7,
2022.
FOR FURTHER INFORMATION CONTACT: IFQ
Customer Service, telephone: 866–425–
7627, email: nmfs.ser.catchshare@
noaa.gov. For Federal dealer reporting,
Fisheries Monitoring Branch, telephone:
305–361–4581. For Federal for-hire
reporting, Southeast For-Hire Integrated
Electronic Reporting program,
telephone: 833–707–1632, email:
ser.electronicreporting@noaa.gov.
SUPPLEMENTARY INFORMATION: The reef
fish fishery of the Gulf is managed
under the Fishery Management Plan
(FMP) for Reef Fish Resources of the
Gulf of Mexico (Reef Fish FMP),
prepared by the Gulf of Mexico Fishery
Management Council (Gulf Council).
The CMP fishery is managed under the
FMP for CMP Resources in the Gulf of
Mexico and Atlantic Region (CMP
FMP), prepared by the Gulf Council and
South Atlantic Fishery Management
Council (South Atlantic Council). The
snapper-grouper fishery in the South
Atlantic is managed under the FMP for
the Snapper-Grouper Fishery of the
South Atlantic Region, prepared by the
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*
*
156065–02–0
*
South Atlantic Council. The dolphin
and wahoo fishery in the Atlantic is
managed under the FMP for the Dolphin
and Wahoo Fishery of the Atlantic,
prepared by the South Atlantic Council.
These FMPs are implemented through
regulations at 50 CFR part 622 under the
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act (Magnuson-Stevens Act).
Amendment 26 to the Reef Fish FMP
established an IFQ program for the
commercial red snapper component of
the Gulf reef fish fishery (71 FR 67447,
November 22, 2006). Amendment 29 to
the Reef Fish FMP established an IFQ
program for the commercial grouper and
tilefish components of the Gulf reef fish
fishery (74 FR 44732, August 31, 2009).
Regulations implementing these IFQ
programs (50 CFR 622.21 and 622.22)
require that IFQ participants have
access to a computer and the internet
and that they conduct administrative
functions associated with the IFQ
program, e.g., landing transactions,
online. However, these regulations also
specify that during catastrophic
conditions, as determined by the RA,
the RA may authorize IFQ participants
to use paper-based forms to complete
administrative functions for the
duration of the catastrophic conditions.
The RA must determine that
catastrophic conditions exist, specify
the duration of the catastrophic
conditions, and specify which
participants or geographic areas are
deemed affected.
The Generic Dealer Amendment
established Federal dealer reporting
requirements for federally permitted
dealers in the Gulf and South Atlantic
(79 FR 19490, April 9, 2014). The Gulf
For-Hire Reporting Amendment
implemented reporting requirements for
Gulf reef fish and CMP owners and
operators of Gulf for-hire vessels (85 FR
44005, July 21, 2020). The South
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]]>Agencies
[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Rules and Regulations]
[Pages 61537-61540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22145]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0507; FRL-10196-01-OCSPP]
Siloxanes and Silicones, di-Me, Me Hydrogen; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA)
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of siloxanes and silicones, di-Me, Me
hydrogen, reaction products with vinyl group-terminated di-Me siloxanes
(CAS Reg. No. 156065-02-0), when used as an inert ingredient in a
pesticide chemical formulation. The Dow Chemical Company submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of siloxanes and silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated di-Me siloxanes on food or feed
commodities.
DATES: This regulation is effective October 12, 2022. Objections and
requests for hearings must be received on or before December 12, 2022,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0507, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.
C. Can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0507 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
December 12, 2022. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0507, by one of
the following methods.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the
[[Page 61538]]
online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at 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.
II. Background and Statutory Findings
In the Federal Register of July 20, 2022 (87 FR 43232) (FRL-9410-
03-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11697) filed by Dow Chemical Company, 715 E Main Street, Midland, MI
48640. The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of siloxanes and silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated di-Me siloxanes (CAS Reg. No.
156065-02-0), with a minimum number average molecular weight of 10,600
Daltons. That document included a summary of the petition prepared by
the petitioner and solicited comments on the petitioner's request. The
Agency did not receive any public comments.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue.'' and specifies
factors EPA is to consider in establishing an exemption.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. To
determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Siloxanes and silicones, di-Me, Me
hydrogen, reaction products with vinyl group-terminated di-Me siloxanes
with a minimum number average molecular weight 10,600 Daltons, conforms
to the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize:
Adequate biodegradation studies (MRID 51816203) were submitted for
siloxanes and silicones, di-Me, Me hydrogen, reaction products with
vinyl group-terminated di-Me siloxanes, with a minimum number average
molecular weight 10,600 Daltons, showing lack of biodegradation.
5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the Toxic Substances Control Act
(TSCA) Chemical Substance Inventory or manufactured under an applicable
TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 Daltons.
7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40
CFR 723.250(d)(6).
Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
The polymer's number average molecular weight (MW) of 10,600
Daltons is greater than 10,000 Daltons. However, the polymer contains
less than 2% oligomeric material below MW 500 and less than 5%
oligomeric material below MW 1,000.
Thus, siloxanes and silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated di-Me siloxanes meets the criteria
for a polymer to be considered low risk under 40 CFR 723.250. Based on
its conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to siloxanes
and silicones, di-Me, Me hydrogen, reaction products with vinyl group-
terminated di-Me siloxanes.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that Siloxanes and Silicones, di-Me, Me
hydrogen, reaction products with vinyl group-terminated di-Me siloxanes
could be present in all raw and processed agricultural commodities and
drinking water, and that non-occupational non-dietary exposure was
possible. The minimum number average MW of siloxanes and silicones, di-
Me, Me hydrogen, reaction products with vinyl group-terminated di-Me
siloxanes is
[[Page 61539]]
10,600 Daltons. Generally, a polymer of this size would be poorly
absorbed through the intact gastrointestinal tract or through intact
human skin. Since siloxanes and silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated di-Me siloxanes conforms to the
criteria that identify a low-risk polymer, there are no concerns for
risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA has not found siloxanes and silicones, di-Me, Me hydrogen,
reaction products with vinyl group-terminated di-Me siloxanes to share
a common mechanism of toxicity with any other substances, and siloxanes
and silicones, di-Me, Me hydrogen, reaction products with vinyl group-
terminated di-Me siloxanes does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that siloxanes and
silicones, di-Me, Me hydrogen, reaction products with vinyl group-
terminated di-Me siloxanes does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
VI. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of siloxanes and silicones,
di-Me, Me hydrogen, reaction products with vinyl group-terminated di-Me
siloxanes, EPA has not used a safety factor analysis to assess the
risk. For the same reasons the additional tenfold safety factor is
unnecessary.
VII. Determination of Safety
Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of siloxanes and silicones, di-Me, Me
hydrogen, reaction products with vinyl group-terminated di-Me
siloxanes.
VIII. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
IX. Conclusion
Accordingly, EPA finds that exempting residues of siloxanes and
silicones, di-Me, Me hydrogen, reaction products with vinyl group-
terminated di-Me siloxanes from the requirement of a tolerance will be
safe.
X. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
XI. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 4, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
[[Page 61540]]
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.960, amend table 1 by adding, in alphabetical order,
the polymer ``Siloxanes and silicones, di-Me, Me hydrogen, reaction
products with vinyl group-terminated di-Me siloxanes, minimum number
average molecular weight (in amu) 10,600'' to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
Table 1 to Sec. 180.960
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Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
Siloxanes and silicones, di-Me, Me hydrogen, reaction 156065-02-0
products with vinyl group-terminated di-Me siloxanes,
minimum number average molecular weight (in amu)
10,600''...............................................
* * * * * * *
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[FR Doc. 2022-22145 Filed 10-11-22; 8:45 am]
BILLING CODE 6560-50-P
