[alpha]-D-Glucopyranoside, [beta]-D-Fructofuranosyl, Polymer With Methyloxirane and Oxirane; Tolerance Exemption, 24705-24708 [2023-08584]
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Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, amend table 1 to the
section by adding, in alphabetical order,
the polymer ‘‘Oxirane, 2-methyl-,
■
polymer with oxirane, ether with Dglucitol (6:1), minimum number average
molecular weight (in amu) of 10,000’’ to
the table to read as follows:
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
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TABLE 1 TO § 180.960
Polymer
CAS No.
*
*
*
*
*
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Oxirane, 2-methyl-, polymer with oxirane, ether with D-glucitol (6:1), minimum number average molecular weight (in amu) of
10,000 ..............................................................................................................................................................................................
*
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0711; FRL–10848–01–
OCSPP]
α-D-Glucopyranoside, β-DFructofuranosyl, Polymer With
Methyloxirane and Oxirane; Tolerance
Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of a-Dglucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane with a minimum number
average molecular weight (in amu) of
9,800 (CAS Reg. No. 26301–10–0) when
used as an inert ingredient in a pesticide
chemical formulation. Delta Analytical
Corporation, on behalf of Borchers
Americas, Inc. 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 a-Dglucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane on food or feed commodities
when used in accordance with this
exemption.
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SUMMARY:
This regulation is effective April
24, 2023. Objections and requests for
hearings must be received on or before
June 23, 2023, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0711, 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.
ADDRESSES:
[FR Doc. 2023–08583 Filed 4–21–23; 8:45 am]
DATES:
*
FOR FURTHER INFORMATION CONTACT:
Daniel Rosenblatt, 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.
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).
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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(g), 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–2022–0711 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before June
23, 2023. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b), although the Office of the
Administrative Law Judges, which
houses the Hearing Clerk, encourages
parties to file objections and hearing
requests electronically. See https://
www.epa.gov/sites/default/files/202005/documents/2020-04-10_-_order_
urging_electronic_service_and_
filing.pdf.
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–
2022–0711, by one of the following
methods.
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Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Rules and Regulations
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• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-epa-dockets#express.
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 September
23, 2022 (87 FR 58047) (FRL–9410–05–
OSCPP), EPA issued a document
pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of
a pesticide petition (PP IN–11712) filed
by Delta Analytical Corporation, 12510
Prosperity Drive, Suite 160, Silver
Spring, MD 20904 on behalf of Borchers
Americas, Inc., 811 Sharon Drive,
Westlake, OH 44145. The petition
requested that 40 CFR 180.960 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of a-D-glucopyranoside, b-Dfructofuranosyl, polymer with
methyloxirane and oxirane with a
minimum number average molecular
weight (in amu) of 9,800 (CAS Reg. No.
26301–10–0). 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 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
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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. In order 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). a-D-Glucopyranoside, b-Dfructofuranosyl, polymer with
methyloxirane and oxirane 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,
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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. An available
biodegradation study supports that a-Dglucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane is not readily biodegradable
(MRID 52074101).
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 minimum number
average MW of 9,800 Daltons is greater
than 1,000 and less than 10,000 Daltons.
The polymer contains less than 10%
oligomeric material below MW 500 and
less than 25% oligomeric material
below MW 1,000, and the polymer does
not contain any reactive functional
groups.
Thus, a-D-Glucopyranoside, b-Dfructofuranosyl, polymer with
methyloxirane and oxirane 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 a-DGlucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that a-DGlucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane could be present in all raw and
processed agricultural commodities and
drinking water, and that nonoccupational non-dietary exposure was
possible. The minimum number average
MW of a-D-Glucopyranoside, b-Dfructofuranosyl, polymer with
methyloxirane and oxirane is 9,800
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Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Rules and Regulations
Daltons. Generally, a polymer of this
size would be poorly absorbed through
the intact gastrointestinal tract or
through intact human skin. Since a-DGlucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane 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 a-DGlucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane to share a common mechanism
of toxicity with any other substances,
and a-D-Glucopyranoside, b-Dfructofuranosyl, polymer with
methyloxirane and oxirane does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance exemption,
therefore, EPA has assumed that a-DGlucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane 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 (10X) margin of safety
for infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act (FQPA)
Safety Factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
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additional safety factor when reliable
data available to EPA support the choice
of a different factor. Due to the expected
low toxicity of a-D-glucopyranoside, bD-fructofuranosyl, polymer with
methyloxirane and oxirane, EPA has not
used a safety factor analysis to assess
the risk. For the same reasons no
additional safety factor is needed for
assessing risk to infants and children.
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 a-D-glucopyranoside, b-Dfructofuranosyl, polymer with
methyloxirane and oxirane.
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 a-Dglucopyranoside, b-D-fructofuranosyl,
polymer with methyloxirane and
oxirane from the requirement of a
tolerance will be safe.
X. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption 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
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24707
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 exemption 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
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.
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Federal Register / Vol. 88, No. 78 / Monday, April 24, 2023 / Rules and Regulations
Dated: April 18, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
the polymer ‘‘a-D-Glucopyranoside, bD-fructofuranosyl, polymer with
methyloxirane and oxirane with a
minimum number average molecular
weight (in amu) of 9,800’’ to the table
to read 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:
■
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, amend table 1 to the
section by adding, in alphabetical order,
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
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*
TABLE 1 TO § 180.960
Polymer
CAS no.
*
*
*
*
*
*
a-D-Glucopyranoside, b-D-fructofuranosyl, polymer with methyloxirane and oxirane with a minimum number average molecular
weight (in amu) of 9,800 ..................................................................................................................................................................
*
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[FR Doc. 2023–08584 Filed 4–21–23; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
[Docket No. PHMSA–2011–0023; Amdt. No.
192–133]
RIN 2137–AF39
Pipeline Safety: Safety of Gas
Transmission Pipelines: Repair
Criteria, Integrity Management
Improvements, Cathodic Protection,
Management of Change, and Other
Related Amendments: Technical
Corrections; Response to Petitions for
Reconsideration
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), Department of Transportation
(DOT).
ACTION: Final rule; technical corrections;
response to petitions for
reconsideration.
AGENCY:
PHMSA is making necessary
technical corrections to ensure
consistency within, and the intended
effect of, a recently issued final rule
titled ‘‘Safety of Gas Transmission
Pipelines: Repair Criteria, Integrity
Management Improvements, Cathodic
Protection, Management of Change, and
Other Related Amendments.’’ PHMSA
also alerts the public to its November
18, 2022, and April 19, 2023, responses
to petitions for reconsideration of this
final rule.
DATES: Effective May 24, 2023.
FOR FURTHER INFORMATION CONTACT:
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Technical questions: Steve Nanney,
Senior Technical Advisor, by telephone
at 713–272–2855.
General information: Robert Jagger,
Senior Transportation Specialist, by
telephone at 202–366–4361.
On August
24, 2022, as the culmination of a
decade-long rulemaking process,
PHMSA published a final rule titled
‘‘Safety of Gas Transmission Pipelines:
Repair Criteria, Integrity Management
Improvements, Cathodic Protection,
Management of Change, and Other
Related Amendments’’ 1 amending the
Pipeline Safety Regulations at 49 CFR
part 192 to improve the safety of
onshore gas transmission pipelines. In
preparing to implement provisions of
the August 2022 Final Rule, as well as
through discussions with stakeholders
(including petitions for reconsideration
of the August 2022 Final Rule), PHMSA
has identified several places in the
amended regulatory text that would
benefit from technical correction to
facilitate timely implementation of the
August 2022 Final Rule consistent with
the function and purposes described in
the administrative record. PHMSA also
alerts the public to the availability in
the rulemaking docket of its November
18, 2022, response to a petition for
reconsideration filed by the American
Gas Association and its April 19, 2022,
response to a petition for
reconsideration jointly filed by the
Interstate Natural Gas Association of
America and the American Petroleum
Institute.
SUPPLEMENTARY INFORMATION:
49 CFR Part 192
SUMMARY:
*
1 87 FR 52224 (Aug. 24, 2022) (‘‘August 2022
Final Rule’’).
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A. Technical Corrections To Ensure
Consistency Between §§ 192.714 and
192.933
Among the August 2022 Final Rule’s
regulatory amendments were the
enhancement of existing repair criteria
and repair schedules for anomalies
discovered in a High Consequence Area
(HCA) and the extension of those repair
criteria and schedules to onshore gas
transmission lines outside an HCA. See
87 FR at 52226 (‘‘The content of the
non-HCA repair criteria being finalized
in this rule is consistent with the
criteria for HCAs’’). This was achieved
by adding similar repair criteria and
scheduling requirements to both 49 CFR
192.714 (applicable to non-HCA lines)
and § 192.933 (applicable to HCA lines).
See 87 FR at 52246. However, PHMSA
has identified three instances in the
amended regulatory text that would
benefit from technical correction to
facilitate timely implementation of the
August 2022 Final Rule consistent with
the function and purposes described in
the administrative record.
First, both §§ 192.714 and 192.933
provide, at respective paragraph (d)(1),
for specific conditions that must be
repaired immediately. These are the
most severe, risk-bearing conditions and
the August 2022 Final Rule set out the
importance for public and
environmental safety of their swift
remediation upon detection. That
detection may come from regularly
scheduled assessments and the
evaluation of anomalies that appear
indicative of a serious condition.
Section 7 of ASME/ANSI B31.8S
provides that examination of these
indications must occur ‘‘within a period
not to exceed 5 days following
determination of the condition,’’ with
‘‘prompt[ ]’’ remediation thereafter of
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]]>Agencies
[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Rules and Regulations]
[Pages 24705-24708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08584]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0711; FRL-10848-01-OCSPP]
[alpha]-D-Glucopyranoside, [beta]-D-Fructofuranosyl, Polymer With
Methyloxirane and Oxirane; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of [alpha]-D-glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane with a minimum
number average molecular weight (in amu) of 9,800 (CAS Reg. No. 26301-
10-0) when used as an inert ingredient in a pesticide chemical
formulation. Delta Analytical Corporation, on behalf of Borchers
Americas, Inc. 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 [alpha]-D-
glucopyranoside, [beta]-D-fructofuranosyl, polymer with methyloxirane
and oxirane on food or feed commodities when used in accordance with
this exemption.
DATES: This regulation is effective April 24, 2023. Objections and
requests for hearings must be received on or before June 23, 2023, 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-2022-0711, 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: Daniel Rosenblatt, 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(g), 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-2022-0711 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
June 23, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although the Office
of the Administrative Law Judges, which houses the Hearing Clerk,
encourages parties to file objections and hearing requests
electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
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-2022-0711, by one of
the following methods.
[[Page 24706]]
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
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 September 23, 2022 (87 FR 58047) (FRL-
9410-05-OSCPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11712) filed by Delta Analytical Corporation, 12510 Prosperity Drive,
Suite 160, Silver Spring, MD 20904 on behalf of Borchers Americas,
Inc., 811 Sharon Drive, Westlake, OH 44145. The petition requested that
40 CFR 180.960 be amended by establishing an exemption from the
requirement of a tolerance for residues of [alpha]-D-glucopyranoside,
[beta]-D-fructofuranosyl, polymer with methyloxirane and oxirane with a
minimum number average molecular weight (in amu) of 9,800 (CAS Reg. No.
26301-10-0). 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 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. In order
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). [alpha]-D-Glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane 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. An
available biodegradation study supports that [alpha]-D-glucopyranoside,
[beta]-D-fructofuranosyl, polymer with methyloxirane and oxirane is not
readily biodegradable (MRID 52074101).
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 minimum number average MW of 9,800 Daltons is greater
than 1,000 and less than 10,000 Daltons. The polymer contains less than
10% oligomeric material below MW 500 and less than 25% oligomeric
material below MW 1,000, and the polymer does not contain any reactive
functional groups.
Thus, [alpha]-D-Glucopyranoside, [beta]-D-fructofuranosyl, polymer
with methyloxirane and oxirane 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 [alpha]-D-Glucopyranoside,
[beta]-D-fructofuranosyl, polymer with methyloxirane and oxirane.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that [alpha]-D-Glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane 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 [alpha]-D-Glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane is 9,800
[[Page 24707]]
Daltons. Generally, a polymer of this size would be poorly absorbed
through the intact gastrointestinal tract or through intact human skin.
Since [alpha]-D-Glucopyranoside, [beta]-D-fructofuranosyl, polymer with
methyloxirane and oxirane 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 [alpha]-D-Glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane to share a
common mechanism of toxicity with any other substances, and [alpha]-D-
Glucopyranoside, [beta]-D-fructofuranosyl, polymer with methyloxirane
and oxirane does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance exemption,
therefore, EPA has assumed that [alpha]-D-Glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane 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 (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor. Due to the expected low toxicity of [alpha]-D-
glucopyranoside, [beta]-D-fructofuranosyl, polymer with methyloxirane
and oxirane, EPA has not used a safety factor analysis to assess the
risk. For the same reasons no additional safety factor is needed for
assessing risk to infants and children.
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 [alpha]-D-glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane.
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 [alpha]-D-
glucopyranoside, [beta]-D-fructofuranosyl, polymer with methyloxirane
and oxirane from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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
exemption 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
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.
[[Page 24708]]
Dated: April 18, 2023.
Daniel Rosenblatt,
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:
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 to the section by adding, in
alphabetical order, the polymer ``[alpha]-D-Glucopyranoside, [beta]-D-
fructofuranosyl, polymer with methyloxirane and oxirane with a minimum
number average molecular weight (in amu) of 9,800'' to the table to
read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
Table 1 to Sec. 180.960
------------------------------------------------------------------------
Polymer CAS no.
------------------------------------------------------------------------
* * * * * * *
[alpha]-D-Glucopyranoside, [beta]-D-fructofuranosyl, 26301-10-0
polymer with methyloxirane and oxirane with a minimum
number average molecular weight (in amu) of 9,800......
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2023-08584 Filed 4-21-23; 8:45 am]
BILLING CODE 6560-50-P
