Sulfuric Acid; Exemption From the Requirement of a Tolerance, 67291-67293 [2020-22188]
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Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Rules and Regulations
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Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: RDFRNotices@
epa.gov.
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[FR Doc. 2020–22190 Filed 10–21–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
I. General Information
[EPA–HQ–OPP–2019–0169; FRL–10013–16]
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
Sulfuric Acid; 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 sulfuric acid on
hop vines when applied as a desiccant
in the production of hops. J.R. Simplot
Company submitted a petition to EPA
under the Federal Food, Drug and
Cosmetic Act (FFDCA), requesting an
amendment to an existing requirement
of a tolerance. This regulation
eliminates the need to establish a
maximum permissible level for residues
of sulfuric acid.
DATES: This regulation is effective
October 22, 2020. Objections and
requests for hearings must be received
on or before December 21, 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–2019–0169, 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.
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, Acting Director,
Registration Division (7505P), Office of
SUMMARY:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the 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–2019–0169 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
December 21, 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
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67291
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–
2019–0169, 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. Background and Statutory Standard
In the Federal Register of May 8, 2020
(85 FR 27346) (FRL–1008–38), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 9F8742) by J.R.
Simplot Company, P.O. Box 27, Boise,
ID 83707. The petition requested that 40
CFR 180.1019 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of sulfuric acid in or on hop vines. That
document referenced a summary of the
petition prepared by the petitioner J.R.
Simplot Company, which is available in
the docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
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
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Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Rules and Regulations
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. . . .’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. Toxicological Profile
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.
Available data indicate that sulfuric
acid rapidly dissociates to non-toxic
hydrogen ions and sulfate ions in the
human body and the environment. For
further information on sulfuric acid, see
Mineral Acids Interim Decision and
supporting risk assessment in docket ID
number EPA–HQ–OPP–2008–0766.
Due to the lack of toxicity associated
with any residues remaining in or on
food, toxicological endpoints were not
identified for dietary assessment, and a
quantitative risk assessment using safety
factors was not conducted. Based on
reliable data that supports the lack of
threshold effects, EPA has not retained
the additional tenfold children’s safety
factor.
IV. Aggregate Exposures
In examining aggregate exposure,
FFDCA section 408 directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
Based on the rapid dissociation of
sulfuric acid in the environment to
sulfate ion, which is not of toxicological
concern, the Agency has determined
that a quantitative aggregate exposure
and risk assessment is not required for
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sulfuric acid. Sulfuric acid produces
sulfate salts in the environment, many
of which are designated by FDA as
GRAS. So, there is no dietary, dermal or
inhalation exposures of concern when
used per label directions. Also, there are
no conventional residential uses for
sulfuric acid as a desiccant/herbicide
reducing the potential for nonoccupational exposure.
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 sulfuric acid to
share a common mechanism of toxicity
with any other substances, and sulfuric
acid does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that sulfuric acid does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
VI. Determination of Safety for U.S.
Population, Infants and Children
Based on its assessment of sulfuric
acid, EPA concludes that there is a
reasonable certainty of no harm from
aggregate exposure to residues of
sulfuric acid. Accordingly, EPA finds
that an exemption from the requirement
of a tolerance for sulfuric acid when
used as a desiccant in the production of
hops will be safe.
VII. 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.
VIII. Conclusion
Therefore, an exemption is
established for residues of sulfuric acid,
when used as a desiccant in the
production of hop vines.
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IX. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), 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 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
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Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Rules and Regulations
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).
X. 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: September 22, 2020.
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. Amend § 180.1019 by revising
paragraph (a) to read as follows:
■
§ 180.1019 Sulfuric acid; exemption from
the requirement of a tolerance.
(a) Residues of sulfuric acid are
exempted from the requirement of a
tolerance when used in accordance with
good agricultural practice when used as
a herbicide in the production of garlic
and onions, and as a vine desiccant in
the production of potatoes and hops.
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[FR Doc. 2020–22188 Filed 10–21–20; 8:45 am]
BILLING CODE 6560–50–P
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Jkt 253001
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[EPA–R05–RCRA–2018–0376; FRL–10015–
30–Region 5]
Indiana: Final Authorization of State
Hazardous Waste Management
Program Revisions
Environmental Protection
Agency (EPA).
ACTION: Final authorization.
AGENCY:
The Environmental Protection
Agency (EPA) is granting Indiana final
authorization for changes to its
hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). The Agency published a
proposed rule on May 6, 2020, and
provided for public comment. No
comments were received on the
proposed revisions. No further
opportunity for comment will be
provided.
DATES: This final authorization is
effective October 22, 2020.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R05–RCRA–2018–0376. All
documents in the docket are listed on
the https://www.regulations.gov website.
Although listed in the index, some
information is not publicly available,
e.g., 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 electronically through https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jean
Gromnicki, Indiana Regulatory
Specialist, U.S. EPA Region 5, LL–17J,
77 West Jackson Boulevard, Chicago,
Illinois 60604, (312) 886–6162, email
Gromnicki.jean@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
A. What changes to Indiana’s
hazardous waste program is EPA
authorizing with this action?
On, January 23, 2020, Indiana
submitted a complete program revision
application seeking authorization of
changes to its hazardous waste program
in accordance with 40 CFR 271.21. EPA
now makes a final decision that
Indiana’s hazardous waste program
revisions that are being authorized are
equivalent to, consistent with, and no
less stringent than the Federal program,
and therefore satisfy all of the
requirements necessary to qualify for
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67293
final authorization. For a list of State
rules being authorized with this final
authorization, please see the proposed
rule published in the May 6, 2020,
Federal Register at 85 FR 26911.
B. What is codification and is EPA
codifying the Indiana’s hazardous
waste program as authorized in this
action?
Codification is the process of placing
citations and references to the State’s
statutes and regulations that comprise
the State’s authorized hazardous waste
program into the Code of Federal
Regulations. EPA does this by adding
those citations and references to the
authorized State rules in 40 CFR part
272. EPA is not codifying the
authorization of Indiana’s revisions at
this time. However, EPA reserves the
ability to amend 40 CFR part 272,
subpart P, for the authorization of
Indiana’s program changes at a later
date.
C. Statutory and Executive Order
Reviews
This final authorization revises
Indiana’s authorized hazardous waste
management program pursuant to
Section 3006 of RCRA and imposes no
requirements other than those currently
imposed by State law. For further
information on how this authorization
complies with applicable Executive
orders and statutory provisions, please
see the proposed rule published in the
May 6, 2020, Federal Register at 85 FR
26911. The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this document 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 in the Federal Register. A
major rule cannot take effect until 60
days after it is published in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2). This
final action will be effective October 22,
2020.
List of Subjects in 40 CFR Part 271
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous waste, Hazardous waste
transportation, Indian lands,
Intergovernmental relations, Penalties,
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[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Rules and Regulations]
[Pages 67291-67293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22188]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0169; FRL-10013-16]
Sulfuric Acid; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sulfuric acid on hop vines when applied
as a desiccant in the production of hops. J.R. Simplot Company
submitted a petition to EPA under the Federal Food, Drug and Cosmetic
Act (FFDCA), requesting an amendment to an existing requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of sulfuric acid.
DATES: This regulation is effective October 22, 2020. Objections and
requests for hearings must be received on or before December 21, 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-2019-0169, 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.
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, Acting Director,
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).
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-2019-0169 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
December 21, 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-2019-0169, 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. Background and Statutory Standard
In the Federal Register of May 8, 2020 (85 FR 27346) (FRL-1008-38),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
9F8742) by J.R. Simplot Company, P.O. Box 27, Boise, ID 83707. The
petition requested that 40 CFR 180.1019 be amended by establishing an
exemption from the requirement of a tolerance for residues of sulfuric
acid in or on hop vines. That document referenced a summary of the
petition prepared by the petitioner J.R. Simplot Company, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
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
[[Page 67292]]
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. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
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.
Available data indicate that sulfuric acid rapidly dissociates to
non-toxic hydrogen ions and sulfate ions in the human body and the
environment. For further information on sulfuric acid, see Mineral
Acids Interim Decision and supporting risk assessment in docket ID
number EPA-HQ-OPP-2008-0766.
Due to the lack of toxicity associated with any residues remaining
in or on food, toxicological endpoints were not identified for dietary
assessment, and a quantitative risk assessment using safety factors was
not conducted. Based on reliable data that supports the lack of
threshold effects, EPA has not retained the additional tenfold
children's safety factor.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
Based on the rapid dissociation of sulfuric acid in the environment
to sulfate ion, which is not of toxicological concern, the Agency has
determined that a quantitative aggregate exposure and risk assessment
is not required for sulfuric acid. Sulfuric acid produces sulfate salts
in the environment, many of which are designated by FDA as GRAS. So,
there is no dietary, dermal or inhalation exposures of concern when
used per label directions. Also, there are no conventional residential
uses for sulfuric acid as a desiccant/herbicide reducing the potential
for non-occupational exposure.
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 sulfuric acid to share a common mechanism of
toxicity with any other substances, and sulfuric acid does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
sulfuric acid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
VI. Determination of Safety for U.S. Population, Infants and Children
Based on its assessment of sulfuric acid, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues of sulfuric acid. Accordingly, EPA finds that an exemption
from the requirement of a tolerance for sulfuric acid when used as a
desiccant in the production of hops will be safe.
VII. 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.
VIII. Conclusion
Therefore, an exemption is established for residues of sulfuric
acid, when used as a desiccant in the production of hop vines.
IX. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), 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 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
[[Page 67293]]
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).
X. 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: September 22, 2020.
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. Amend Sec. 180.1019 by revising paragraph (a) to read as follows:
Sec. 180.1019 Sulfuric acid; exemption from the requirement of a
tolerance.
(a) Residues of sulfuric acid are exempted from the requirement of
a tolerance when used in accordance with good agricultural practice
when used as a herbicide in the production of garlic and onions, and as
a vine desiccant in the production of potatoes and hops.
* * * * *
[FR Doc. 2020-22188 Filed 10-21-20; 8:45 am]
BILLING CODE 6560-50-P
