Cellulose, Ethyl Ether; Exemption From the Requirement of a Tolerance, 30206-30210 [2021-11840]
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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Rules and Regulations
PART 81—DESIGNATION OF AREAS
FOR AIR QUALITY PLANNING
PURPOSES
1. The authority citation for part 81
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart C—Section 107 Attainment
Status Designations
NAAQS [Primary and Secondary]’’ is
amended by revising the entry for ‘‘Kern
County (Eastern Kern), CA’’ to read as
follows:
§ 81.305
2. In § 81.305, the table entitled
‘‘California—2008 8-Hour Ozone
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California.
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CALIFORNIA–2008 8-HOUR OZONE NAAQS
[Primary and secondary]
Designation
Classification
Designated area
Date 1
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Kern County (Eastern Kern), CA: 2
Kern County (part):
That portion of Kern County (with the exception of that portion in Hydrologic Unit Number 18090205—the Indian
Wells Valley) east and south of a line described as follows: Beginning at the Kern-Los Angeles County boundary and running north and east along the northwest
boundary of the Rancho La Liebre Land Grant to the
point of intersection with the range line common to
Range 16 West and Range 17 West, San Bernardino
Base and Meridian; north along the range line to the
point of intersection with the Rancho El Tejon Land Grant
boundary; then southeast, northeast, and northwest along
the boundary of the Rancho El Tejon Grant to the northwest corner of Section 3, Township 11 North, Range 17
West; then west 1.2 miles; then north to the Rancho El
Tejon Land Grant boundary; then northwest along the
Rancho El Tejon line to the southeast corner of Section
34, Township 32 South, Range 30 East, Mount Diablo
Base and Meridian; then north to the northwest corner of
Section 35, Township 31 South, Range 30 East; then
northeast along the boundary of the Rancho El Tejon
Land Grant to the southwest corner of Section 18, Township 31 South, Range 31 East; then east to the southeast
corner of Section 13, Township 31 South, Range 31
East; then north along the range line common to Range
31 East and Range 32 East, Mount Diablo Base and Meridian, to the northwest corner of Section 6, Township 29
South, Range 32 East; then east to the southwest corner
of Section 31, Township 28 South, Range 32 East; then
north along the range line common to Range 31 East and
Range 32 East to the northwest corner of Section 6,
Township 28 South, Range 32 East, then west to the
southeast corner of Section 36, Township 27 South,
Range 31 East, then north along the range line common
to Range 31 East and Range 32 East to the Kern-Tulare
County boundary.
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Nonattainment .. July 7, 2021 ......
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Severe-15.
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date is July 20, 2012, unless otherwise noted.
Indian country located in each area, unless otherwise noted.
2 Excludes
[FR Doc. 2021–11704 Filed 6–4–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Part 180
[EPA–HQ–OPP–2021–0138; FRL–10023–34]
Cellulose, Ethyl Ether; Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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This regulation establishes an
exemption from the requirement of a
tolerance for residues of cellulose, ethyl
ether; number average molecular weight
13,000 Daltons when used as an inert
ingredient in a pesticide chemical
formulation. Exponent, Inc. on behalf of
Nutrition & Biosciences USA 1, LLC,
formerly DDP Specialty Electronic
Materials US, Inc. submitted a petition
to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting
an exemption from the requirement of a
SUMMARY:
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tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of
cellulose, ethyl ether on food or feed
commodities.
This regulation is effective June
7, 2021. Objections and requests for
hearings must be received on or before
August 6, 2021, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2021–0138. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm.
S–4400, One Potomac Yard (South
Bldg.), 2777 S Crystal Dr., Arlington,
VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The
Docket Facility telephone number is
(703) 305–5805.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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ADDRESSES:
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. Potentially
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affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
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 Government Publishing
Office’s e-CFR site at https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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–2021–0138 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
August 6, 2021. 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 that does not
contain any 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 a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2021–0138, by one of
the following methods.
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• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of March 22,
2021 (86 FR 15162) (FRL–10021–44),
EPA issued a notification pursuant to
section 408 of FFDCA, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–11484) filed by
Exponent, Inc., 1150 Connecticut Ave.
NW, Suite 1100, Washington, DC 20036
on behalf of Nutrition & Biosciences
USA 1, LLC, 3490 Winton Place,
Rochester, NY 14623 formerly DDP
Specialty Electronic Materials US, Inc.,
400 Arcola Road, Collegeville, PA
19426. The petition requested that 40
CFR 180.960 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of cellulose, ethyl ether; CAS Reg. No.
9004–57–3. That notification 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
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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). cellulose, ethyl ether
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
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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.
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.
Additionally, the polymer also meets
as required the following exemption
criteria specified in 40 CFR 723.250(e).
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 MW is
greater than or equal to 10,000 daltons.
The polymer contains less than 2%
oligomeric material below MW 500 and
less than 5% oligomeric material below
MW 1,000.
Thus, cellulose, ethyl ether 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 cellulose, ethyl
ether.
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 cellulose, ethyl ether to share a
common mechanism of toxicity with
any other substances, and cellulose,
ethyl ether does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that cellulose, ethyl ether 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/pesticides/cumulative.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that
cellulose, ethyl ether could be present
in all raw and processed agricultural
commodities and drinking water, and
that non-occupational non-dietary
exposure was possible. The number
average MW of cellulose, ethyl ether is
13,000 daltons. Generally, a polymer of
this size would be poorly absorbed
through the intact gastrointestinal tract
or through intact human skin. Since
cellulose, ethyl ether conform 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.
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 cellulose, ethyl ether.
V. Cumulative Effects From Substances
With a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
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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 cellulose, ethyl ether, EPA
has not used a safety factor analysis to
assess the risk. For the same reasons the
additional tenfold safety factor is
unnecessary.
VIII. Other Considerations
A. 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.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
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required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL
for cellulose, ethyl ether.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of cellulose, ethyl
ether from the requirement of a
tolerance will be safe.
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these rules
from review under Executive Order
12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule 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 final rule 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 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 of 1995 (NTTAA),
Public Law 104–113, section 12(d) (15
U.S.C. 272 note).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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,
or otherwise have any unique impacts
on local governments. 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 final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4).
Although this action does not 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), EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. As such, to the
extent that information is publicly
available or was submitted in comments
to EPA, the Agency considered whether
groups or segments of the population, as
a result of their location, cultural
practices, or other factors, may have
atypical or disproportionately high and
adverse human health impacts or
environmental effects from exposure to
the pesticide discussed in this
document, compared to the general
population.
XI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. 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 this rule in the Federal
Register. This rule 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: May 28, 2021.
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:
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. In § 180.960, amend the table by
adding in alphabetical order the
polymer ‘‘Cellulose, ethyl ether,
minimum number average molecular
weight (in amu), insert 13,000 Daltons’’
to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
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Polymer
CAS No.
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[FR Doc. 2021–11840 Filed 6–4–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2020–0302; FRL–10022–
76]
RIN 2070–AB27
Modification of Significant New Uses
of Certain Chemical Substances (20–
2.M)
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is amending significant
new use rules (SNURs) issued under the
Toxic Substances Control Act (TSCA)
for certain chemical substances
identified herein, which were the
subject of premanufacture notices
(PMNs) and significant new use notices
(SNUNs). This action would amend the
SNURs to allow certain new uses
reported in the SNUNs without
additional notification requirements and
modify the significant new use
notification requirements based on the
actions and determinations for the
SNUN submissions. EPA is issuing
these amendments based on review of
new and existing data for the chemical
substances.
DATES: This rule is effective on August
6, 2021. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on June 21, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
William Wysong, New Chemicals
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–4163;
email address: wysong.william@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this rule. The following list
of North American Industrial
Classification System (NAICS) codes is
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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:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA, which would
include the SNUR requirements.
Chemical importers are subject to the
TSCA section 13 (15 U.S.C. 2612)
import provisions. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20,
any persons who export or intend to
export a chemical substance that is the
subject of this rule are subject to the
export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)), and
must comply with the export
notification requirements in 40 CFR part
707, subpart D.
B. How can I access the docket?
The docket includes information
considered by the Agency in developing
the proposed and final rules. The docket
for this action, identified by docket
identification (ID) number EPA–HQ–
OPPT–2020–0302, is available at
https://www.regulations.gov or at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
Due to the public health emergency,
the EPA Docket Center (EPA/DC) and
Reading Room is closed to visitors with
limited exceptions. The staff continues
to provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
II. Background
A. What action is the Agency taking?
EPA is issuing amendments to the
SNURs for certain chemical substances
in 40 CFR part 721 subpart E.
Previously, in the Federal Register of
November 18, 2020 (85 FR 73439) (FRL–
10013–54), EPA proposed amendments
to the SNURs for these chemical
substances and established the record
for these SNUR amendments in the
docket under docket ID number EPA–
HQ–OPPT–2020–0302. That docket
includes information considered by the
Agency in developing the proposed and
final rules, including public comments.
B. What is the Agency’s authority for
taking this action?
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule (i.e., a SNUR)
after considering all relevant factors,
including those listed in TSCA section
5(a)(2). EPA may also amend a SNUR
promulgated under TSCA section
5(a)(2). Procedures and criteria for
modifying or revoking SNUR
requirements appear at 40 CFR 721.185.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a SNUN to EPA at
least 90 days before they manufacture,
import, or process the chemical
substance for that use. Persons who
must report are described in 40 CFR
721.5.
C. Do the SNUR general provisions
apply?
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the final rule, recordkeeping
requirements, exemptions to reporting
requirements, and applicability of the
rule to uses occurring before the
effective date of the final rule.
Provisions relating to user fees appear at
40 CFR part 700. According to 40 CFR
721.1(c), persons subject to these SNURs
must comply with the same notice
requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). In particular,
these requirements include the
information submission requirements of
TSCA sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA
sections 5(h)(1), (h)(2), (h)(3), and (h)(5),
and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA must
either determine that the significant
new use is not likely to present an
unreasonable risk of injury or take such
E:\FR\FM\07JNR1.SGM
07JNR1
]]>Agencies
[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Rules and Regulations]
[Pages 30206-30210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11840]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0138; FRL-10023-34]
Cellulose, Ethyl Ether; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of cellulose, ethyl ether; number average
molecular weight 13,000 Daltons when used as an inert ingredient in a
pesticide chemical formulation. Exponent, Inc. on behalf of Nutrition &
Biosciences USA 1, LLC, formerly DDP Specialty Electronic Materials US,
Inc. submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a
[[Page 30207]]
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of cellulose, ethyl ether on food or
feed commodities.
DATES: This regulation is effective June 7, 2021. Objections and
requests for hearings must be received on or before August 6, 2021, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2021-0138. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (703) 305-7090; 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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
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 Government Publishing Office's e-CFR site at
https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-2021-0138 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
August 6, 2021. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2021-0138, by one of the following methods.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW, Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a notification pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11484) filed by Exponent, Inc., 1150 Connecticut Ave. NW, Suite 1100,
Washington, DC 20036 on behalf of Nutrition & Biosciences USA 1, LLC,
3490 Winton Place, Rochester, NY 14623 formerly DDP Specialty
Electronic Materials US, Inc., 400 Arcola Road, Collegeville, PA 19426.
The petition requested that 40 CFR 180.960 be amended by establishing
an exemption from the requirement of a tolerance for residues of
cellulose, ethyl ether; CAS Reg. No. 9004-57-3. That notification
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
[[Page 30208]]
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). cellulose, ethyl ether 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.
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.
Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
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 MW is greater than or equal to 10,000
daltons. The polymer contains less than 2% oligomeric material below MW
500 and less than 5% oligomeric material below MW 1,000.
Thus, cellulose, ethyl ether 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 cellulose, ethyl ether.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that cellulose, ethyl ether could be present
in all raw and processed agricultural commodities and drinking water,
and that non-occupational non-dietary exposure was possible. The number
average MW of cellulose, ethyl ether is 13,000 daltons. Generally, a
polymer of this size would be poorly absorbed through the intact
gastrointestinal tract or through intact human skin. Since cellulose,
ethyl ether conform 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 cellulose, ethyl
ether to share a common mechanism of toxicity with any other
substances, and cellulose, ethyl ether does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that cellulose, ethyl
ether 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/pesticides/cumulative.
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 cellulose, ethyl ether,
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 cellulose, ethyl ether.
VIII. Other Considerations
A. 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.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as
[[Page 30209]]
required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint
U.N. Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for cellulose, ethyl ether.
IX. Conclusion
Accordingly, EPA finds that exempting residues of cellulose, ethyl
ether from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these rules from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this final rule has been exempted from
review under Executive Order 12866, this final rule 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 final rule 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 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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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, or otherwise have any unique
impacts on local governments. 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 final rule. In addition, this final rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).
Although this action does not 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), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.
XI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this rule in the Federal
Register. This rule 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: May 28, 2021.
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:
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 the table by adding in alphabetical order
the polymer ``Cellulose, ethyl ether, minimum number average molecular
weight (in amu), insert 13,000 Daltons'' to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
Cellulose, ethyl ether, minimum number average molecular 9004-57-3
weight (in amu), insert 13,000 Daltons.................
* * * * * * *
------------------------------------------------------------------------
[[Page 30210]]
[FR Doc. 2021-11840 Filed 6-4-21; 8:45 am]
BILLING CODE 6560-50-P
