Dipropylene Glycol and Triethylene Glycol; Exemption From the Requirement of a Tolerance, 69512-69514 [2020-23199]
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Federal Register / Vol. 85, No. 213 / Tuesday, November 3, 2020 / Rules and Regulations
PART 63—NATIONAL EMISSION
STANDARDS FOR HAZARDOUS AIR
POLLUTANTS FOR SOURCE
CATEGORIES
2. In § 63.602, revise paragraph
(a)(2)(ii) to read as follows:
(2) * * *
(ii) You must comply with the
mercury emission limit specified in
Table 1 to this subpart beginning on
November 3, 2020.
*
*
*
*
*
§ 63.602
■
Subpart AA—National Emission
Standards for Hazardous Air Pollutants
for Phosphoric Acid Manufacturing
Plants
■
1. The authority citation for part 63
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Standards and compliance dates.
(a) * * *
3. Revise table 1 to subpart AA of part
63 to read as follows:
TABLE 1 TO SUBPART AA OF PART 63—EXISTING SOURCE EMISSION LIMITS a b
You must meet the emission limits for the specified pollutant . . .
For the following existing sources . . .
Total fluorides
Wet-Process Phosphoric Acid Line .......
Superphosphoric Acid Process Line c ....
Superphosphoric Acid Process Line
with a Submerged Combustion Process.
Phosphate Rock Dryer ...........................
Phosphate Rock Calciner ......................
Total particulate
Mercury
0.020 lb/ton of equivalent P2O5
feed.
0.010 lb/ton of equivalent P2O5
feed.
0.20 lb/ton of equivalent P2O5
feed.
....................................................
9.0E–04 lb/ton of rock feed d .....
0.2150 lb/ton of phosphate rock
feed.
0.181 g/dscm .............................
0.23 mg/dscm corrected to 3percent oxygen e
a The
existing source compliance data is June 10, 2002, except as noted.
periods of startup and shutdown, for emission limits stated in terms of pounds of pollutant per ton of feed, you are subject to the work
practice standards specified in § 63.602(f).
c Beginning on August 19, 2018, you must include oxidation reactors in superphosphoric acid process lines when determining compliance with
the total fluorides limit.
d Compliance date is August 19, 2015.
e Compliance date November 3, 2020.
b During
Fungicide, and Rodenticide Act
(FIFRA).
[FR Doc. 2020–24280 Filed 11–2–20; 8:45 am]
BILLING CODE 6560–50–P
This regulation is effective
November 3, 2020. Objections and
requests for hearings must be received
on or before January 4, 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: The dockets for this action,
identified by docket identification (ID)
numbers EPA–HQ–OPP–2013–0219 and
EPA–HQ–OPP–2013–0218, are 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.
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
DATES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0218 and EPA–HQ–
OPP–2013–0219; FRL–10015–39]
RIN 2070–ZA16
Dipropylene Glycol and Triethylene
Glycol; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is exempting residues of
the antimicrobial pesticide ingredients
dipropylene glycol and triethylene
glycol from the requirement of a
tolerance when used on or applied to
food-contact surfaces in public eating
places, dairy-processing equipment, and
food-processing equipment and utensils.
The Agency is finalizing this rule on its
own initiative under the Federal Food,
Drug, and Cosmetic Act (FFDCA) to
address residues identified as part of the
Agency’s registration review program
under the Federal Insecticide,
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
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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:
Anita Pease, Antimicrobials Division
(7510P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
ADFRNotices@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 a 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),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
E:\FR\FM\03NOR1.SGM
03NOR1
Federal Register / Vol. 85, No. 213 / Tuesday, November 3, 2020 / Rules and Regulations
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
khammond on DSKJM1Z7X2PROD with RULES
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 Printing
Office’s e-CFR site at https://www.ecfr.
gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfr
browse/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 numbers EPA–HQ–
OPP–2013–0218 and EPA–HQ–OPP–
2013–0219 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
January 4, 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 (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 numbers EPA–HQ–OPP–
2013–0218 and EPA–HQ–OPP–2013–
0219, 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
VerDate Sep<11>2014
15:54 Nov 02, 2020
Jkt 253001
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. Summary of Proposed Rule-For
Exemption
In the Federal Register of May 22,
2020 (85 FR 31130) (FRL–10008–87),
EPA proposed to exempt residues of the
antimicrobial pesticide ingredients
dipropylene glycol and triethylene
glycol from the requirement of a
tolerance when used on or applied to
food-contact surfaces in public eating
places, dairy-processing equipment, and
food-processing equipment and utensils.
These exemptions were proposed on the
Agency’s own initiative under section
408(e) of the FFDCA. 21 U.S.C. 346a(e).
No comments were submitted on the
Agency’s proposal. Therefore, the
Agency is finalizing the exemption from
the requirement of a tolerance for
residues of the antimicrobial pesticide
ingredients dipropylene glycol and
triethylene glycol when used on or
applied to food-contact surfaces in
public eating places, dairy-processing
equipment, and food-processing
equipment and utensils as proposed.
III. 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. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which 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 . . . .’’
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69513
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 dipropylene
glycol and triethylene glycol including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with dipropylene glycol and
triethylene glycol are discussed in the
preamble to the proposed rule.
Based on the toxicological and
exposure data discussed in the proposal
and the supporting registration review
documents, EPA concludes that the
exemption from the requirement of a
tolerance for residues of dipropylene
glycol and triethylene glycol when used
in antimicrobial formulations applied to
food-contact surfaces in public eating
places, dairy-processing equipment, and
food-processing equipment and utensils
will be safe. EPA has determined that
there is a reasonable certainty that no
harm will result to the general
population, or to infants and children,
from aggregate exposure to dipropylene
glycol and triethylene glycol residues.
IV. Analytical Enforcement
Methodology
An analytical method for residue is
not needed. Due to the lack of risk, EPA
is establishing exemptions without
limits for dipropylene glycol and
triethylene glycol; therefore, measuring
residues of dipropylene glycol and
triethylene glycol is not necessary.
V. Conclusion
Therefore, EPA is establishing in 40
CFR 180.940(a) exemptions from the
requirement of a tolerance for residues
of dipropylene glycol and triethylene
glycol when used in antimicrobial
formulations applied to food-contact
surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils.
VI. Statutory and Executive Order
Reviews
This action establishes exemptions
from the requirement of a tolerance
under FFDCA section 408(e). 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
E:\FR\FM\03NOR1.SGM
03NOR1
69514
Federal Register / Vol. 85, No. 213 / Tuesday, November 3, 2020 / Rules and Regulations
‘‘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),
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).
Pursuant to the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq.), the
Agency previously assessed whether
establishment of exemptions from the
requirement of a tolerance might
significantly impact a substantial
number of small entities and concluded
that, as a general matter, these actions
do not impose a significant economic
impact on a substantial number of small
entities. This analysis for tolerance
establishments and modifications was
published in the Federal Register of
May 4, 1981 (46 FR 24950) and was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration. Taking into account
this analysis, and available information
concerning the pesticides listed in this
rule, the Agency hereby certifies that
this proposed rule will not have a
significant negative economic impact on
a substantial number of small entities.
Furthermore, for the pesticides named
in this rule, the Agency knows of no
extraordinary circumstances that exist
as to the present rule that would change
EPA’s previous analysis. No comments
were submitted concerning EPA’s
similar determination in the proposed
rule.
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).
VII. 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.
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. In § 180.940 amend paragraph (a)
by adding to the table, in alphabetical
order, the entries of ‘‘Dipropylene
glycol’’ and ‘‘Triethylene glycol’’ to read
as follows:
■
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
*
*
TABLE 180.940(a)
Pesticide chemical
*
*
*
*
*
Dipropylene glycol ...................................................................................................................................................
*
*
*
*
*
*
Triethylene glycol .....................................................................................................................................................
*
*
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CAS Reg. No.
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2020–23199 Filed 11–2–20; 8:45 am]
BILLING CODE 6560–50–P
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Limits
25265–71–8
*
None.
112–27–6
*
None.
*
]]>Agencies
[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Rules and Regulations]
[Pages 69512-69514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23199]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0218 and EPA-HQ-OPP-2013-0219; FRL-10015-39]
RIN 2070-ZA16
Dipropylene Glycol and Triethylene Glycol; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is exempting
residues of the antimicrobial pesticide ingredients dipropylene glycol
and triethylene glycol from the requirement of a tolerance when used on
or applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils. The
Agency is finalizing this rule on its own initiative under the Federal
Food, Drug, and Cosmetic Act (FFDCA) to address residues identified as
part of the Agency's registration review program under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).
DATES: This regulation is effective November 3, 2020. Objections and
requests for hearings must be received on or before January 4, 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: The dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2013-0219 and EPA-HQ-OPP-2013-
0218, are 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.
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: Anita Pease, Antimicrobials Division
(7510P), 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 a
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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
[[Page 69513]]
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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 Printing 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 numbers EPA-HQ-OPP-2013-0218 and EPA-HQ-OPP-2013-0219 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 January 4, 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 (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 numbers EPA-HQ-OPP-2013-0218 and EPA-
HQ-OPP-2013-0219, 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. Summary of Proposed Rule-For Exemption
In the Federal Register of May 22, 2020 (85 FR 31130) (FRL-10008-
87), EPA proposed to exempt residues of the antimicrobial pesticide
ingredients dipropylene glycol and triethylene glycol from the
requirement of a tolerance when used on or applied to food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. These exemptions were proposed on
the Agency's own initiative under section 408(e) of the FFDCA. 21
U.S.C. 346a(e). No comments were submitted on the Agency's proposal.
Therefore, the Agency is finalizing the exemption from the requirement
of a tolerance for residues of the antimicrobial pesticide ingredients
dipropylene glycol and triethylene glycol when used on or applied to
food-contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment and utensils as proposed.
III. 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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which 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 . .
. .''
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 dipropylene glycol and
triethylene glycol including exposure resulting from the exemption
established by this action. EPA's assessment of exposures and risks
associated with dipropylene glycol and triethylene glycol are discussed
in the preamble to the proposed rule.
Based on the toxicological and exposure data discussed in the
proposal and the supporting registration review documents, EPA
concludes that the exemption from the requirement of a tolerance for
residues of dipropylene glycol and triethylene glycol when used in
antimicrobial formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils will be safe. EPA has determined that there is a
reasonable certainty that no harm will result to the general
population, or to infants and children, from aggregate exposure to
dipropylene glycol and triethylene glycol residues.
IV. Analytical Enforcement Methodology
An analytical method for residue is not needed. Due to the lack of
risk, EPA is establishing exemptions without limits for dipropylene
glycol and triethylene glycol; therefore, measuring residues of
dipropylene glycol and triethylene glycol is not necessary.
V. Conclusion
Therefore, EPA is establishing in 40 CFR 180.940(a) exemptions from
the requirement of a tolerance for residues of dipropylene glycol and
triethylene glycol when used in antimicrobial formulations applied to
food-contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment and utensils.
VI. Statutory and Executive Order Reviews
This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(e). 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
[[Page 69514]]
``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), 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).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether establishment of
exemptions from the requirement of a tolerance might significantly
impact a substantial number of small entities and concluded that, as a
general matter, these actions do not impose a significant economic
impact on a substantial number of small entities. This analysis for
tolerance establishments and modifications was published in the Federal
Register of May 4, 1981 (46 FR 24950) and was provided to the Chief
Counsel for Advocacy of the Small Business Administration. Taking into
account this analysis, and available information concerning the
pesticides listed in this rule, the Agency hereby certifies that this
proposed rule will not have a significant negative economic impact on a
substantial number of small entities. Furthermore, for the pesticides
named in this rule, the Agency knows of no extraordinary circumstances
that exist as to the present rule that would change EPA's previous
analysis. No comments were submitted concerning EPA's similar
determination in the proposed rule.
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).
VII. 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.
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
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. 180.940 amend paragraph (a) by adding to the table, in
alphabetical order, the entries of ``Dipropylene glycol'' and
``Triethylene glycol'' to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
Table 180.940(a)
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
Dipropylene glycol.............. 25265-71-8 None.
* * * * * * *
Triethylene glycol.............. 112-27-6 None.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-23199 Filed 11-2-20; 8:45 am]
BILLING CODE 6560-50-P
