Long Chain Alcohols; Exemption From the Requirement of a Tolerance, 46004-46008 [2020-15743]
Download as PDF
<![CDATA[
46004
Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Rules and Regulations
collections subject to OMB approval
under the Paperwork Reduction Act, 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 action,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (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. As a result,
this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA 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, EPA 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 (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
EPA’s consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act (15
U.S.C. 272 note).
V. 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).
VerDate Sep<11>2014
16:02 Jul 30, 2020
Jkt 250001
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 10, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, the EPA amends 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1378 to subpart D to read
as follows:
■
§ 180.1378 Trichoderma atroviride strain
SC1; exemption from the requirement of a
tolerance.
Residues of Trichoderma atroviride
strain SC1 are exempt from the
requirement of a tolerance in or on all
food commodities when used in
accordance with label directions and
good agricultural practices.
[FR Doc. 2020–15695 Filed 7–30–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0591; FRL–10011–33]
Long Chain Alcohols; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of long chain
alcohols when used as inert ingredients
(carrier/adjuvant and coating agent/
binder) in pesticide products applied to/
on all growing crops and raw
agricultural commodities after harvest,
and to/on animals, and in certain
antimicrobial formulations. Spring
Trading Company on behalf of Sasol
Chemicals (USA) LLC., submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting an establishment of an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of certain
SUMMARY:
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
long chain alcohols when used in
accordance with these exemptions.
DATES: This regulation is effective July
31, 2020. Objections and requests for
hearings must be received on or before
September 29, 2020, 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–2019–0591, 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 is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
Please note that due to the public
health emergency the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; 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).
E:\FR\FM\31JYR1.SGM
31JYR1
Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Rules and Regulations
• 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 Government Publishing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How 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–2019–0591 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 September 29, 2020. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2019–0591, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
VerDate Sep<11>2014
16:02 Jul 30, 2020
Jkt 250001
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of February
11, 2020 (85 FR 7708) (FRL–10005–02),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (IN–11284) by Spring Trading
Company (203 Dogwood Trail,
Magnolia, TX 77354) on behalf of Sasol
Chemicals (USA) LLC (12120
Wickchester Lane, Houston, TX 77224).
The petition requested that 40 CFR be
amended by establishing an exemption
from the requirement of a tolerance for
residues of certain long chain alcohols
(CAS Reg. Nos.: 112–42–5, 112–72–1,
112–92–5, 629–96–9, 661–19–8, 68603–
17–8, 1190630–03–5, 1430895–61–6,
and 1430895–62–7) when used as inert
ingredients (carrier/adjuvant and
coating agent/binder) in pesticide
formulations applied to/on all growing
crops and raw agricultural commodities
after harvest under 40 CFR 180.910, to/
on animals under 180.930, and in
certain antimicrobial formulations
under 180.940(a). That document
referenced a summary of the petition
prepared by Spring Trading Company
on behalf of Sasol Chemicals (USA)
LLC, the petitioner, which is available
in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
46005
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 in
residential settings but does not include
occupational exposure. Under FFDCA
section 408(c)(2)(B), EPA must take into
account, among other considerations,
the factors in subparagraphs (C) and (D)
of subsection (b)(2). 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 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 . . . .’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated 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 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(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for certain long
chain alcohols including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with certain long chain
alcohols follows.
E:\FR\FM\31JYR1.SGM
31JYR1
46006
Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Rules and Regulations
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies 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. Specific
information on the studies received and
the nature of the adverse effects caused
by the relevant long chain alcohols as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
Long Chain Alcohols; Human Health
Risk Assessment and Ecological Effects
Assessment to Support Proposed
Exemption from the Requirement of a
Tolerance When Used as an Inert
Ingredient in Pesticide Formulations in
docket ID number EPA–HQ–OPP–2019–
0591.
Toxicological data for several long
chain alcohols (C12–C34) are used as
surrogate data for the proposed long
chain alcohols since long chain alcohols
are structurally similar, differing only in
carbon chain length so toxicity is
expected to be similar.
The acute oral, dermal, and inhalation
toxicities are low in rats treated with
long chain alcohols. They are mildly to
non-irritating to the rabbit eye and
moderately to non-irritating to rabbit
skin. Long chain alcohols are not skin
sensitizers.
No toxicity is observed in repeated
dose studies conducted with long chain
alcohols administered via diet and
gavage to rats, mice, dogs and rabbits.
Mutagenicity is not expected with
long chain alcohols since negative
results are observed in mutagenicity
studies.
Neurotoxicity and immunotoxicity
studies are not available for review.
However, no evidence of neurotoxicity
or immunotoxicity is observed in any of
the available studies on long chain
alcohols.
B. Toxicological Points of Departure/
Levels of Concern
The available toxicity studies indicate
that long chain alcohols have very low
overall toxicity. Acute oral toxicity
studies show LD50s above 2,000 mg/kg
in rats. Repeated dose studies show no
toxicity at doses as high as 2,000 mg/kg/
day, twice the limit dose of 1,000 mg/
kg/day. Since no toxicity is observed, an
endpoint of concern for risk assessment
purposes was not identified. EPA
VerDate Sep<11>2014
16:02 Jul 30, 2020
Jkt 250001
assessed dietary and other nonoccupational exposures qualitatively.
C. Exposure Assessment
1. Dietary exposure from drinking
water, food and feed uses. In evaluating
dietary exposure to long chain alcohols,
EPA considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from long
chain alcohols in food as follows:
Dietary exposure (food and drinking
water) to long chain alcohols may occur
following ingestion of foods with
residues from their use in accordance
with this exemption. Dietary exposure
may also occur from direct and indirect
food contact uses under the Food and
Drug Administration Code of Federal
Regulations Title 21. However, a
quantitative dietary exposure
assessment was not conducted since a
toxicological endpoint for risk
assessment was not identified.
2. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Long chain alcohols may be used in
pesticide products and non-pesticide
products that may be used in and
around the home. Based on the
discussion above regarding the toxicity
of the long chain alcohols, a quantitative
residential exposure assessment for long
chain alcohols was not conducted.
3. 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.’’
Based on the available data, long
chain alcohols do not have a toxic
mechanism; therefore, section
408(b)(2)(D)(v) does not apply.
D. Safety Factor for Infants and
Children
Based on the lack of threshold effects,
EPA has not identified any toxicological
endpoints of concern and is conducting
a qualitative assessment of long chain
alcohols. The qualitative assessment
does not use safety factors for assessing
risk, and no additional safety factor is
needed for assessing risk to infants and
children. Based on an assessment of
long chain alcohols, EPA has concluded
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
that there are no toxicological endpoints
of concern for the U.S. population,
including infants and children.
E. Aggregate Risks and Determination of
Safety
Because no toxicological endpoints of
concern were identified, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to long chain
alcohols residues.
V. 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.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
for residues of long chain alcohols: 1undecanol (CAS Reg. No. 112–42–5), 1tetradecanol (CAS Reg. No. 112–72–1),
1-octadecanol (CAS Reg. No. 112–92–5),
1-eicosanol (CAS Reg. No. 629–96–9), 1docosanol (CAS Reg. No. 661–19–8),
alcohols, C16–18, distn. residues (CAS
Reg. No. 68603–17–8 & CAS Reg. No.
1190630–03–5), alkenes, C18–22, mixed
with polyethylene, oxidized,
hydrolyzed, distn. residues from C16–18
alcs. manuf. (CAS Reg. No. 1430895–
61–6), alkenes, C18–22, mixed with
polyethylene, oxidized, hydrolyzed,
distn. residues from C20–22 alcs. manuf.
(CAS Reg. No. 1430895–62–7) when
used as inert ingredients (carrier/
adjuvant and coating agent/binder) in
pesticide formulations applied to/on all
growing crops and raw agricultural
commodities after harvest under 40 CFR
180.910, to/on animals under 180.930,
and in certain antimicrobial
formulations under 180.940(a).
VII. 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,
E:\FR\FM\31JYR1.SGM
31JYR1
46007
Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Rules and Regulations
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997),
nor is it considered a regulatory action
under Executive Order 13771, entitled
‘‘Reducing Regulations and Controlling
Regulatory Costs’’ (82 FR 9339, February
3, 2017). 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).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 26, 2020.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, for the reasons stated in the
preamble, the EPA amends 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 § 180.910, amend Table 1 by
adding ‘‘1-undecanol (CAS Reg. No.
112–42–5), 1-tetradecanol (CAS Reg. No.
112–72–1), 1-octadecanol (CAS Reg. No.
112–92–5), 1-eicosanol (CAS Reg. No.
629–96–9), 1-docosanol (CAS Reg. No.
661–19–8), alcohols, C16–18, distn.
residues (CAS Reg. No. 68603–17–8 &
CAS Reg. No. 1190630–03–5), alkenes,
C18–22, mixed with polyethylene,
oxidized, hydrolyzed, distn. residues
from C16–18 alcs. manuf. (CAS Reg. No.
1430895–61–6), alkenes, C18–22, mixed
with polyethylene, oxidized,
hydrolyzed, distn. residues from C20–22
alcs. manuf. (CAS Reg. No. 1430895–
62–7)’’ in alphabetical order to read as
follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.910
Inert ingredients
Limits
*
*
*
*
1-undecanol (CAS Reg. No. 112–42–5), 1-tetradecanol (CAS Reg. No. 112–
72–1), 1-octadecanol (CAS Reg. No. 112–92–5), 1-eicosanol (CAS Reg. No.
629–96–9), 1-docosanol (CAS Reg. No. 661–19–8), alcohols, C16–18, distn.
residues (CAS Reg. No. 68603–17–8 & CAS Reg. No. 1190630–03–5),
alkenes, C18–22, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from C16–18 alcs. manuf. (CAS Reg. No. 1430895–61–6), alkenes,
C18–22, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from
C20–22 alcs. manuf. (CAS Reg. No. 1430895–62–7).
*
........................
*
*
*
3. In § 180.930;
a. Designate the table as Table 1 to
180.930; and
■ b. Amend newly designated Table 1
by adding, in alphabetical order, an
entry for ‘‘1-undecanol (CAS Reg. No.
112–42–5), 1-tetradecanol (CAS Reg. No.
112–72–1), 1-octadecanol (CAS Reg. No.
112–92–5), 1-eicosanol (CAS Reg. No.
■
VerDate Sep<11>2014
16:02 Jul 30, 2020
Jkt 250001
*
Uses
*
629–96–9), 1-docosanol (CAS Reg. No.
661–19–8), alcohols, C16–18, distn.
residues (CAS Reg. No. 68603–17–8 &
CAS Reg. No. 1190630–03–5), alkenes,
C18–22, mixed with polyethylene,
oxidized, hydrolyzed, distn. residues
from C16–18 alcs. manuf. (CAS Reg. No.
1430895–61–6), alkenes, C18–22, mixed
with polyethylene, oxidized,
PO 00000
Frm 00041
Fmt 4700
*
*
Carrier/Adjuvant and Coating Agent/Binder.
Sfmt 4700
*
*
hydrolyzed, distn. residues from C20–22
alcs. manuf. (CAS Reg. No. 1430895–
62–7)’’.
The additions read as follows:
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
*
E:\FR\FM\31JYR1.SGM
*
*
31JYR1
*
*
46008
Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Rules and Regulations
TABLE 1 TO 180.930
Inert ingredients
Limits
*
*
*
*
1-undecanol (CAS Reg. No. 112–42–5), 1-tetradecanol (CAS Reg. No. 112–
72–1), 1-octadecanol (CAS Reg. No. 112–92–5), 1-eicosanol (CAS Reg. No.
629–96–9), 1-docosanol (CAS Reg. No. 661–19–8), alcohols, C16–18, distn.
residues (CAS Reg. No. 68603–17–8 & CAS Reg. No. 1190630–03–5),
alkenes, C18–22, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from C16–18 alcs. manuf. (CAS Reg. No. 1430895–61–6), alkenes,
C18–22, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from
C20–22 alcs. manuf. (CAS Reg. No. 1430895–62–7).
*
........................
*
*
*
4. In § 180.940 amend paragraph (a)
by;
■ a. Designating the table as Table 1 to
180.940(a); and
■ b. Amending newly designated Table
1 by adding, in alphabetical order,
entries for ‘‘1-undecanol (CAS Reg. No.
112–42–5)’’, ‘‘1-tetradecanol (CAS Reg.
No. 112–72–1)’’, ‘‘1-octadecanol (CAS
Reg. No. 112–92–5)’’, ‘‘1-eicosanol (CAS
■
*
Uses
*
*
Carrier/Adjuvant and Coating Agent/Binder.
*
Reg. No. 629–96–9)’’, ‘‘1-docosanol
(CAS Reg. No. 661–19–8)’’, ‘‘alcohols,
C16–18, distn. residues (CAS Reg. No.
68603–17–8 & CAS Reg. No. 1190630–
03–5)’’, ‘‘alkenes, C18–22, mixed with
polyethylene, oxidized, hydrolyzed,
distn. residues from C16–18 alcs.
manuf. (CAS Reg. No. 1430895–61–6)’’,
‘‘alkenes, C18–22, mixed with
*
*
polyethylene, oxidized, hydrolyzed,
distn. residues from C20–22 alcs.
manuf. (CAS Reg. No. 1430895–62–7)’’.
The addition reads as follows:
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions)
(a) * * *
TABLE 1 TO 180.940(A)
Inert ingredients
CAS Reg. No.
*
*
*
*
1-undecanol .....................................................................................................
1-tetradecanol .................................................................................................
1-octadecanol ..................................................................................................
1-eicosanol ......................................................................................................
1-docosanol .....................................................................................................
alcohols, C16–18, distn. residues .....................................................................
alkenes, C18–22, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from C16–18 alcs. manuf.
alkenes, C18–22, mixed with polyethylene, oxidized, hydrolyzed, distn. residues from C20–22 alcs. manuf.
*
*
*
*
*
*
*
*
Limits
*
112–42–5
112–72–1
112–92–5
629–96–9
661–19–8
68603–17–8
1190630–03–5
1430895–61–6
1430895–62–7
*
*
DEPARTMENT OF COMMERCE
[FR Doc. 2020–15743 Filed 7–30–20; 8:45 am]
National Oceanic and Atmospheric
Administration
BILLING CODE 6560–50–P
50 CFR Part 679
[Docket No. 200227–0066; RTID 0648–
XA334]
Fisheries of the Exclusive Economic
Zone Off Alaska; Greenland Turbot in
the Aleutian Islands Subarea of the
Bering Sea and Aleutian Islands
Management Area
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
VerDate Sep<11>2014
16:02 Jul 30, 2020
Jkt 250001
PO 00000
Frm 00042
Fmt 4700
*
*
Carrier/Adjuvant and Coating Agent/Binder.
Sfmt 4700
*
*
NMFS is prohibiting retention
of Greenland turbot in the Aleutian
Islands subarea of the Bering Sea and
Aleutian Islands management area
(BSAI). This action is necessary because
the 2020 Greenland turbot total
allowable catch (TAC) in the Aleutian
Islands subarea of the BSAI has been
reached.
SUMMARY:
Effective 1200 hours, Alaska
local time (A.l.t.), July 28, 2020, through
2400 hours, A.l.t., December 31, 2020.
FOR FURTHER INFORMATION CONTACT:
Steve Whitney, 907–586–7228.
SUPPLEMENTARY INFORMATION: NMFS
manages the groundfish fishery in the
BSAI according to the Fishery
Management Plan for Groundfish of the
Bering Sea and Aleutian Islands
Management Area (FMP) prepared by
DATES:
E:\FR\FM\31JYR1.SGM
31JYR1
]]>Agencies
[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Rules and Regulations]
[Pages 46004-46008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15743]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0591; FRL-10011-33]
Long Chain Alcohols; 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 long chain alcohols when used as inert
ingredients (carrier/adjuvant and coating agent/binder) in pesticide
products applied to/on all growing crops and raw agricultural
commodities after harvest, and to/on animals, and in certain
antimicrobial formulations. Spring Trading Company on behalf of Sasol
Chemicals (USA) LLC., submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting an establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of certain long chain alcohols when used in accordance with
these exemptions.
DATES: This regulation is effective July 31, 2020. Objections and
requests for hearings must be received on or before September 29, 2020,
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-2019-0591, 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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
Please note that due to the public health emergency the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main 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.
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).
[[Page 46005]]
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 Government Publishing Office's e-CFR site at
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How 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-2019-0591 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
September 29, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0591, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (IN-11284)
by Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354) on
behalf of Sasol Chemicals (USA) LLC (12120 Wickchester Lane, Houston,
TX 77224). The petition requested that 40 CFR be amended by
establishing an exemption from the requirement of a tolerance for
residues of certain long chain alcohols (CAS Reg. Nos.: 112-42-5, 112-
72-1, 112-92-5, 629-96-9, 661-19-8, 68603-17-8, 1190630-03-5, 1430895-
61-6, and 1430895-62-7) when used as inert ingredients (carrier/
adjuvant and coating agent/binder) in pesticide formulations applied
to/on all growing crops and raw agricultural commodities after harvest
under 40 CFR 180.910, to/on animals under 180.930, and in certain
antimicrobial formulations under 180.940(a). That document referenced a
summary of the petition prepared by Spring Trading Company on behalf of
Sasol Chemicals (USA) LLC, the petitioner, which is available in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
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 in residential settings but does not include
occupational exposure. Under FFDCA section 408(c)(2)(B), EPA must take
into account, among other considerations, the factors in subparagraphs
(C) and (D) of subsection (b)(2). 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 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 . . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated 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 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(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for certain long chain alcohols
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with certain
long chain alcohols follows.
[[Page 46006]]
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused by the relevant long chain alcohols as
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be
found at https://www.regulations.gov in the document Long Chain
Alcohols; Human Health Risk Assessment and Ecological Effects
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as an Inert Ingredient in Pesticide Formulations in
docket ID number EPA-HQ-OPP-2019-0591.
Toxicological data for several long chain alcohols (C12-
C34) are used as surrogate data for the proposed long chain
alcohols since long chain alcohols are structurally similar, differing
only in carbon chain length so toxicity is expected to be similar.
The acute oral, dermal, and inhalation toxicities are low in rats
treated with long chain alcohols. They are mildly to non-irritating to
the rabbit eye and moderately to non-irritating to rabbit skin. Long
chain alcohols are not skin sensitizers.
No toxicity is observed in repeated dose studies conducted with
long chain alcohols administered via diet and gavage to rats, mice,
dogs and rabbits.
Mutagenicity is not expected with long chain alcohols since
negative results are observed in mutagenicity studies.
Neurotoxicity and immunotoxicity studies are not available for
review. However, no evidence of neurotoxicity or immunotoxicity is
observed in any of the available studies on long chain alcohols.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies indicate that long chain alcohols
have very low overall toxicity. Acute oral toxicity studies show
LD50s above 2,000 mg/kg in rats. Repeated dose studies show
no toxicity at doses as high as 2,000 mg/kg/day, twice the limit dose
of 1,000 mg/kg/day. Since no toxicity is observed, an endpoint of
concern for risk assessment purposes was not identified. EPA assessed
dietary and other non-occupational exposures qualitatively.
C. Exposure Assessment
1. Dietary exposure from drinking water, food and feed uses. In
evaluating dietary exposure to long chain alcohols, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from long chain alcohols in
food as follows:
Dietary exposure (food and drinking water) to long chain alcohols
may occur following ingestion of foods with residues from their use in
accordance with this exemption. Dietary exposure may also occur from
direct and indirect food contact uses under the Food and Drug
Administration Code of Federal Regulations Title 21. However, a
quantitative dietary exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Long chain alcohols may be used in pesticide products and non-
pesticide products that may be used in and around the home. Based on
the discussion above regarding the toxicity of the long chain alcohols,
a quantitative residential exposure assessment for long chain alcohols
was not conducted.
3. 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.''
Based on the available data, long chain alcohols do not have a
toxic mechanism; therefore, section 408(b)(2)(D)(v) does not apply.
D. Safety Factor for Infants and Children
Based on the lack of threshold effects, EPA has not identified any
toxicological endpoints of concern and is conducting a qualitative
assessment of long chain alcohols. The qualitative assessment does not
use safety factors for assessing risk, and no additional safety factor
is needed for assessing risk to infants and children. Based on an
assessment of long chain alcohols, EPA has concluded that there are no
toxicological endpoints of concern for the U.S. population, including
infants and children.
E. Aggregate Risks and Determination of Safety
Because no toxicological endpoints of concern were identified, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to long chain alcohols residues.
V. 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.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of long chain alcohols: 1-undecanol (CAS Reg.
No. 112-42-5), 1-tetradecanol (CAS Reg. No. 112-72-1), 1-octadecanol
(CAS Reg. No. 112-92-5), 1-eicosanol (CAS Reg. No. 629-96-9), 1-
docosanol (CAS Reg. No. 661-19-8), alcohols, C16-18, distn.
residues (CAS Reg. No. 68603-17-8 & CAS Reg. No. 1190630-03-5),
alkenes, C18-22, mixed with polyethylene, oxidized,
hydrolyzed, distn. residues from C16-18 alcs. manuf. (CAS
Reg. No. 1430895-61-6), alkenes, C18-22, mixed with
polyethylene, oxidized, hydrolyzed, distn. residues from
C20-22 alcs. manuf. (CAS Reg. No. 1430895-62-7) when used as
inert ingredients (carrier/adjuvant and coating agent/binder) in
pesticide formulations applied to/on all growing crops and raw
agricultural commodities after harvest under 40 CFR 180.910, to/on
animals under 180.930, and in certain antimicrobial formulations under
180.940(a).
VII. 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,
[[Page 46007]]
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 26, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends
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. 180.910, amend Table 1 by adding ``1-undecanol (CAS Reg.
No. 112-42-5), 1-tetradecanol (CAS Reg. No. 112-72-1), 1-octadecanol
(CAS Reg. No. 112-92-5), 1-eicosanol (CAS Reg. No. 629-96-9), 1-
docosanol (CAS Reg. No. 661-19-8), alcohols, C16-18, distn. residues
(CAS Reg. No. 68603-17-8 & CAS Reg. No. 1190630-03-5), alkenes, C18-22,
mixed with polyethylene, oxidized, hydrolyzed, distn. residues from
C16-18 alcs. manuf. (CAS Reg. No. 1430895-61-6), alkenes, C18-22, mixed
with polyethylene, oxidized, hydrolyzed, distn. residues from C20-22
alcs. manuf. (CAS Reg. No. 1430895-62-7)'' in alphabetical order to
read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest;
exemptions from the requirement of a tolerance.
* * * * *
Table 1 to 180.910
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
1-undecanol (CAS Reg. No. 112-42- .............. Carrier/Adjuvant and
5), 1-tetradecanol (CAS Reg. No. Coating Agent/
112-72-1), 1-octadecanol (CAS Binder.
Reg. No. 112-92-5), 1-eicosanol
(CAS Reg. No. 629-96-9), 1-
docosanol (CAS Reg. No. 661-19-
8), alcohols, C16-18, distn.
residues (CAS Reg. No. 68603-17-8
& CAS Reg. No. 1190630-03-5),
alkenes, C18-22, mixed with
polyethylene, oxidized,
hydrolyzed, distn. residues from
C16-18 alcs. manuf. (CAS Reg. No.
1430895-61-6), alkenes, C18-22,
mixed with polyethylene,
oxidized, hydrolyzed, distn.
residues from C20-22 alcs. manuf.
(CAS Reg. No. 1430895-62-7).
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930;
a. Designate the table as Table 1 to 180.930; and
0
b. Amend newly designated Table 1 by adding, in alphabetical order, an
entry for ``1-undecanol (CAS Reg. No. 112-42-5), 1-tetradecanol (CAS
Reg. No. 112-72-1), 1-octadecanol (CAS Reg. No. 112-92-5), 1-eicosanol
(CAS Reg. No. 629-96-9), 1-docosanol (CAS Reg. No. 661-19-8), alcohols,
C16-18, distn. residues (CAS Reg. No. 68603-17-8 & CAS Reg. No.
1190630-03-5), alkenes, C18-22, mixed with polyethylene, oxidized,
hydrolyzed, distn. residues from C16-18 alcs. manuf. (CAS Reg. No.
1430895-61-6), alkenes, C18-22, mixed with polyethylene, oxidized,
hydrolyzed, distn. residues from C20-22 alcs. manuf. (CAS Reg. No.
1430895-62-7)''.
The additions read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
[[Page 46008]]
Table 1 to 180.930
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
1-undecanol (CAS Reg. No. 112-42- .............. Carrier/Adjuvant and
5), 1-tetradecanol (CAS Reg. No. Coating Agent/
112-72-1), 1-octadecanol (CAS Binder.
Reg. No. 112-92-5), 1-eicosanol
(CAS Reg. No. 629-96-9), 1-
docosanol (CAS Reg. No. 661-19-
8), alcohols, C16-18, distn.
residues (CAS Reg. No. 68603-17-8
& CAS Reg. No. 1190630-03-5),
alkenes, C18-22, mixed with
polyethylene, oxidized,
hydrolyzed, distn. residues from
C16-18 alcs. manuf. (CAS Reg. No.
1430895-61-6), alkenes, C18-22,
mixed with polyethylene,
oxidized, hydrolyzed, distn.
residues from C20-22 alcs. manuf.
(CAS Reg. No. 1430895-62-7).
* * * * * * *
------------------------------------------------------------------------
0
4. In Sec. 180.940 amend paragraph (a) by;
0
a. Designating the table as Table 1 to 180.940(a); and
0
b. Amending newly designated Table 1 by adding, in alphabetical order,
entries for ``1-undecanol (CAS Reg. No. 112-42-5)'', ``1-tetradecanol
(CAS Reg. No. 112-72-1)'', ``1-octadecanol (CAS Reg. No. 112-92-5)'',
``1-eicosanol (CAS Reg. No. 629-96-9)'', ``1-docosanol (CAS Reg. No.
661-19-8)'', ``alcohols, C16-18, distn. residues (CAS Reg. No. 68603-
17-8 & CAS Reg. No. 1190630-03-5)'', ``alkenes, C18-22, mixed with
polyethylene, oxidized, hydrolyzed, distn. residues from C16-18 alcs.
manuf. (CAS Reg. No. 1430895-61-6)'', ``alkenes, C18-22, mixed with
polyethylene, oxidized, hydrolyzed, distn. residues from C20-22 alcs.
manuf. (CAS Reg. No. 1430895-62-7)''.
The addition reads as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions)
(a) * * *
Table 1 to 180.940(a)
------------------------------------------------------------------------
Inert ingredients CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
1-undecanol....................... 112-42-5 Carrier/Adjuvant and
Coating Agent/
Binder.
1-tetradecanol.................... 112-72-1
1-octadecanol..................... 112-92-5
1-eicosanol....................... 629-96-9
1-docosanol....................... 661-19-8
alcohols, C16-18, distn. residues. 68603-17-8
1190630-03-5
alkenes, C18-22, mixed with 1430895-61-6
polyethylene, oxidized,
hydrolyzed, distn. residues from
C16-18 alcs. manuf.
alkenes, C18-22, mixed with 1430895-62-7
polyethylene, oxidized,
hydrolyzed, distn. residues from
C20-22 alcs. manuf.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-15743 Filed 7-30-20; 8:45 am]
BILLING CODE 6560-50-P
