Magnesium Sulfate; Exemption From the Requirement of a Tolerance, 43702-43706 [2020-14401]
Download as PDF
<![CDATA[
43702
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Rules and Regulations
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 tolerances 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).
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.
VerDate Sep<11>2014
17:30 Jul 17, 2020
Jkt 250001
Dated: June 12, 2020.
Michael Goodis,
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—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.463 amend paragraph (a)(1)
by designating the table and revising in
newly designated Table 1 to paragraph
(a)(1) the entries for ‘‘Rice, bran’’ and
‘‘Rice, grain’’ to read as follows:
■
§ 180.463180.463
for residues.
Quinclorac; tolerances
(a)(1) * * *
TABLE 1 TO PARAGRAPH (a)(1)
Parts per
million
Commodity
*
*
*
Rice, bran .............................
Rice, grain ............................
*
*
*
*
*
*
*
*
*
30
10
*
*
*
[FR Doc. 2020–14395 Filed 7–17–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0571; FRL–10010–64]
Magnesium Sulfate; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
exemptions from the requirement of a
tolerance for residues of magnesium
sulfate anhydrous (CAS Reg. No. 7487–
88–9); magnesium sulfate monohydrate
(CAS Reg. No. 14168–73–1); magnesium
sulfate trihydrate (CAS Reg. No. 15320–
30–6); magnesium sulfate tetrahydrate
(CAS Reg. No. 24378–31–2); magnesium
sulfate pentahydrate (CAS Reg. No.
15553–21–6); magnesium sulfate
hexahydrate (CAS Reg. No. 17830–18–
1); and magnesium sulfate heptahydrate
(CAS Reg. No. 10034–99–8), collectively
referred to as magnesium sulfate, when
used as an inert ingredient in
antimicrobial pesticide formulations
SUMMARY:
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
applied to food-contact surfaces in
public eating places, dairy-processing
equipment, and food-processing
equipment and utensils at an end-use
concentration not to exceed 4400 parts
per million (ppm). Ecolab, Inc.
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting establishment of
exemptions from the requirement of a
tolerance for magnesium sulfate. This
regulation eliminates the need to
establish a maximum permissible level
for residues of magnesium sulfate when
used in accordance with these
exemptions.
DATES: This regulation is effective July
20, 2020. Objections and requests for
hearings must be received on or before
September 18, 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–2019–0571, 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 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 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
E:\FR\FM\20JYR1.SGM
20JYR1
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Rules and Regulations
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/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(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2019–0571 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 18, 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–
2019–0571, 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.
VerDate Sep<11>2014
17:30 Jul 17, 2020
Jkt 250001
• 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 4,
2020 (85 FR 6129) (FRL–10003–17),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–11325) by Ecolab, Inc.,
1 Ecolab Place, St. Paul, MN 55102. The
petition requested that 40 CFR
180.940(a) be amended by establishing
exemptions from the requirement of a
tolerance for residues of magnesium
sulfate when used as an inert ingredient
at an upper limit of 4,400 ppm in
antimicrobial pesticide formulations
applied to food-contact surfaces in
public eating places, dairy-processing
equipment, and food-processing
equipment and utensils. That document
referenced a summary of the petition
prepared by Ecolab, Inc., the petitioner,
which is available in the docket, https://
www.regulations.gov. One comment was
received on the notice of filing. EPA’s
response to this comment is discussed
in Unit V.B.
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.
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
43703
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of the 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 the FFDCA
defines ‘‘safe’’ to mean that EPA has
determined 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 it does not
include occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing an
exemption 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
harm 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 to
magnesium sulfate, including exposure
resulting from the exemptions
established by this action. EPA’s
assessment of exposures and risks
associated with magnesium sulfate
follows.
E:\FR\FM\20JYR1.SGM
20JYR1
43704
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Rules and Regulations
A. Toxicological Profile
Magnesium and sulfate are both
abundant in the natural enviroment and
are necessary for human life.
Magnesium sulfate is commonly found
in food and water, including as a
naturally occuring element or as an
additive. EPA has evaluated the
available toxicity data for magnesium
sulfate 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 magnesium sulfate as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in this unit.
Available studies on magnesium
sulfate include an oral toxicity study, a
dermal irritation study, a dermal
sensitization study, a combined oral
repeat dose reproduction/
developmental toxicity screening test,
and a 1-year inhalation cancer study in
rats. No adverse effects of treatment
were seen at the highest dose tested in
the repeat dose oral study in rats at the
NOAEL of 450 mg/kg/day. In addition,
there was no evidence of
carcinogenicity or neuropathological
changes or effects reported in any of the
studies. Magnesium sulfate was also
tested for genotoxic and/or mutagenic
effects using bacterial reverse mutation
tests and in vitro mammalian
chromosome aberration tests. The
agency does not believe magnesium
sulfate will be carcinogenic or
neurotoxic.
All studies showed low acute and
repeat dose toxicity and no
reproductive/developmental toxicity.
The primary health effect associated
with magnesium sulfate is an osmotic
laxative effect at high doses. The
laxative effect is transient, and recovery
is rapid and is usually observed only
when following acute exposures to high
concentrations above the limit dose of
1,000 mg/kg/day.
B. Toxicological Points of Departure/
Levels of Concern
No toxicological endpoint of concern
for magnesium sulfate has been
identified in the database.
C. Exposure Assessment
1. Dietary exposure from food, feed
uses, and drinking water. In evaluating
VerDate Sep<11>2014
17:30 Jul 17, 2020
Jkt 250001
dietary exposure to magnesium sulfate,
EPA considered exposure under the
current and proposed exemption from
the requirement of a tolerance.
Magnesium sulfate is currently exempt
from the requirement of a tolerance
under 40 CFR 180.910 for use as an inert
ingredient in pesticide formulations
used pre- and post-harvest. Dietary
exposure to magnesium sulfate may
occur from eating foods treated with
pesticide formulations containing this
inert ingredient and drinking water
containing runoff from soils containing
the treated crops. In addition,
magnesium sulfate is used as a food
additive and a dietary supplement.
However, no toxicological endpoint of
concern was identified for magnesium
sulfate and therefore, a quantitative
assessment of dietary exposure is not
necessary.
2. 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).
Residential exposure to magnesium
sulfate may occur based on its use as an
inert ingredient in pesticide
formulations registered for residential
uses. Additional non-dietary exposure
may occur from use of magnesium
sulfate in pharmaceutical products and
cosmetics. However, no toxicological
endpoint of concern was identified for
magnesium sulfate and therefore a
quantitative residential exposure
assessment for magnesium sulfate 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.’’
EPA has not found magnesium sulfate
to share a common mechanism of
toxicity with any other substances, and
magnesium sulfate does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that magnesium sulfate does
not have a common mechanism of
toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
D. Safety Factor for Infants and
Children
Section 408(b)(2)(C) of the FFDCA
requires EPA to retain an additional
tenfold margin of safety in the case of
threshold effects 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. As noted in Unit
IV.B., there is no indication of threshold
effects being caused by magnesium
sulfate. Therefore, this requirement does
not apply to the present analysis.
Moreover, due to the lack of any
toxicological endpoints of concern, EPA
conducted a qualitative assessment of
magnesium sulfate, which does not use
safety factors for assessing risk, and no
additional safety factor is needed for
assessing risk to infants and children.
E. Aggregate Risks and Determination of
Safety
Taking into consideration all available
information on magnesium sulfate, EPA
has determined that there is a
reasonable certainty that no harm to the
general population or any population
subgroup, including infants and
children, will result from aggregate
exposure to magnesium sulfate residues.
Therefore, the establishment of
exemptions from the requirement of a
tolerance under 40 CFR 180.940(a) for
residues of magnesium sulfate when
used as an inert ingredient in
antimicrobial pesticide formulations
applied to food-contact surfaces in
public eating places, dairy-processing
equipment, and food-processing
equipment and utensils at a maximum
end-use concentration of 4,400 ppm is
safe under FFDCA section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. Response to Comments
One comment was submitted
generally opposing the establishment of
these tolerance exemptions and
chemical use overall. Although the
Agency recognizes that some
individuals believe that chemicals
should be banned, the existing legal
framework provided by section 408 of
the FFDCA authorizes EPA to establish
exemptions from the requirement of a
tolerance when it determines that the
exemption is safe. Upon consideration
of the validity, completeness, and
reliability of the available data as well
E:\FR\FM\20JYR1.SGM
20JYR1
43705
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Rules and Regulations
as other factors the FFDCA requires EPA
to consider, EPA has determined that
this exemption from the requirement of
a tolerance is safe. The commenter
provided no information to support a
conclusion that the exemption was not
safe.
VI. Conclusions
Therefore, exemptions from the
requirement of a tolerance are
established under 40 CFR 180.940(a) for
residues of magnesium sulfate
anhydrous (CAS Reg. No. 7487–88–9);
magnesium sulfate monohydrate (CAS
Reg. No. 14168–73–1); magnesium
sulfate trihydrate (CAS Reg. No. 15320–
30–6); magnesium sulfate tetrahydrate
(CAS Reg. No. 24378–31–2); magnesium
sulfate pentahydrate (CAS Reg. No.
15553–21–6); magnesium sulfate
hexahydrate (CAS Reg. No. 17830–18–
1); and magnesium sulfate heptahydrate
(CAS Reg. No. 10034–99–8) when used
as an inert ingredient in antimicrobial
pesticide formulations applied to foodcontact surfaces in public eating places,
dairy-processing equipment, and foodprocessing equipment and utensils at an
end-use concentration not to exceed
4,400 ppm.
VII. Statutory and Executive Order
Reviews
This action establishes tolerance
exemptions 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
Pesticide chemical
*
Magnesium
Magnesium
Magnesium
Magnesium
Magnesium
Magnesium
Magnesium
sulfate
sulfate
sulfate
sulfate
sulfate
sulfate
sulfate
VerDate Sep<11>2014
CAS Reg. No.
*
anhydrous ..................
heptahydrate ..............
hexahydrate ...............
monohydrate ..............
pentahydrate ..............
tetrahydrate ................
trihydrate ....................
*
‘‘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 exemptions 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
*
7487–88–9
10034–99–8
7830–18–1
14168–73–1
5553–21–6
24378–31–2
15320–30–6
*
17:30 Jul 17, 2020
PO 00000
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 22, 2020.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore for the reasons stated in the
preamble, 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 the table in
paragraph (a) by adding, in alphabetical
order, ‘‘Magnesium sulfate anhydrous’’,
‘‘Magnesium sulfate heptahydrate’’,
‘‘Magnesium sulfate hexahydrate’’,
‘‘Magnesium sulfate monohydrate’’,
‘‘Magnesium sulfate pentahydrate’’,
‘‘Magnesium sulfate tetrahydrate’’, and
‘‘Magnesium sulfate trihydrate’’ to read
as follows:
■
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
*
*
Limits
When
When
When
When
When
When
When
*
ready
ready
ready
ready
ready
ready
ready
*
Jkt 250001
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
for
for
for
for
for
for
for
use,
use,
use,
use,
use,
use,
use,
*
Frm 00025
Fmt 4700
the
the
the
the
the
the
the
*
end-use
end-use
end-use
end-use
end-use
end-use
end-use
concentration
concentration
concentration
concentration
concentration
concentration
concentration
is
is
is
is
is
is
is
*
Sfmt 4700
E:\FR\FM\20JYR1.SGM
*
not
not
not
not
not
not
not
*
20JYR1
to
to
to
to
to
to
to
exceed
exceed
exceed
exceed
exceed
exceed
exceed
4400
4400
4400
4400
4400
4400
4400
*
ppm.
ppm.
ppm.
ppm.
ppm.
ppm.
ppm.
*
43706
*
*
Federal Register / Vol. 85, No. 139 / Monday, July 20, 2020 / Rules and Regulations
*
*
*
[FR Doc. 2020–14401 Filed 7–17–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–2010–0636; FRL–10011–
18–Region 2]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List: Deletion
of the Hormigas Ground Water Plume
Superfund Site
Environmental Protection
Agency.
ACTION: Direct final rule.
AGENCY:
The Environmental Protection
Agency (EPA) Region 2 is publishing a
direct final Notice of Deletion of the
Hormigas Ground Water Plume
Superfund Site (Site), located in Caguas,
Puerto Rico, from the National Priorities
List (NPL). The NPL, promulgated
pursuant to section 105 of the
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) of 1980, as amended, is
an appendix of the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP). The EPA, with
the concurrence of the Commonwealth
of Puerto Rico (Commonwealth),
through the Department of Natural and
Environmental Resources (DNER), has
determined that all appropriate
response actions under CERCLA have
been completed. However, this deletion
does not preclude future actions under
Superfund.
DATES: This direct final deletion is
effective September 18, 2020 unless the
EPA receives adverse comments by
August 19, 2020. If adverse comments
are received, the EPA will publish a
timely withdrawal of the direct final
deletion in the Federal Register
informing the public that the deletion
will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID no. EPA–HQ–
SFUND–2010–0636, by one of the
following methods:
• https://www.regulations.gov.
Follow on-line instructions for
submitting comments. Once submitted,
comments cannot be edited or removed
from Regulations.gov. The EPA may
publish any comment received to its
public docket. Do not submit
electronically any information you
consider to be confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
SUMMARY:
VerDate Sep<11>2014
17:30 Jul 17, 2020
Jkt 250001
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. The EPA will
generally not consider comments or
comment contents located outside of the
primary submission (i.e., on the web,
cloud, or other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
• Email: bosque.adalberto@epa.gov.
• Phone: Public comment by phone
may be made by calling (787) 977–5819
and following the directions provided
for public comment.
• Written comments submitted by
mail are temporarily suspended and no
hand deliveries will be accepted. We
encourage the public to submit
comments via https://
www.regulations.gov.
Instructions: Direct your comments to
Docket ID no. EPA–HQ–SFUND–2010–
0636. The EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be CBI or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or email. The
https://www.regulations.gov website is
an ‘‘anonymous access’’ system, which
means the EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an email
comment directly to the EPA without
going through https://
www.regulations.gov, your email
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the internet. If you
submit an electronic comment, the EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If the EPA
cannot read your comment because of
technical difficulties and cannot contact
you for clarification, the EPA may not
be able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. 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,
will be publicly available only in the
hard copy. Publicly available docket
materials are available electronically in
https://www.regulations.gov.
The EPA is temporarily suspending
its Docket Center and Regional Records
Centers for public visitors to reduce the
risk of transmitting COVID–19. In
addition, many site information
repositories are closed and information
in these repositories, including the
deletion docket, has not been updated
with hardcopy or electronic media. For
further information and updates on the
EPA Docket Center services, please visit
us online at https://www.epa.gov/
dockets.
The EPA continues to carefully and
continuously monitor information from
the Centers for Disease Control and
Prevention (CDC), local area health
departments, and our federal partners so
that we can respond rapidly as
conditions change regarding COVID.
FOR FURTHER INFORMATION CONTACT: Dr.
Adalberto Bosque Remedial Project
Manager, U.S. Environmental Protection
Agency, Region 2, U.S. Environmental
Protection Agency, City View Plaza II—
Suite 7000, 48 RD, 165 Km. 1.2,
Guaynabo, PR 00968–8069, (787) 977–
5825, email: bosque.adalberto@epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Site Deletion
V. Deletion Action
I. Introduction
The EPA Region 2 is publishing this
direct final Notice of Deletion of the
Hormigas Ground Water Plume
Superfund Site, from the National
Priorities List (NPL). The NPL
constitutes appendix B of 40 CFR part
300, which is the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP), which the EPA
promulgated pursuant to section 105 of
the Comprehensive Environmental
Response, Compensation and Liability
Act (CERCLA) of 1980, as amended. The
EPA maintains the NPL as the list of
sites that appear to present a significant
risk to public health, welfare, or the
environment. Sites on the NPL may be
the subject of remedial actions financed
by the Hazardous Substance Superfund
E:\FR\FM\20JYR1.SGM
20JYR1
]]>Agencies
[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Rules and Regulations]
[Pages 43702-43706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14401]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0571; FRL-10010-64]
Magnesium Sulfate; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of magnesium sulfate anhydrous (CAS Reg. No.
7487-88-9); magnesium sulfate monohydrate (CAS Reg. No. 14168-73-1);
magnesium sulfate trihydrate (CAS Reg. No. 15320-30-6); magnesium
sulfate tetrahydrate (CAS Reg. No. 24378-31-2); magnesium sulfate
pentahydrate (CAS Reg. No. 15553-21-6); magnesium sulfate hexahydrate
(CAS Reg. No. 17830-18-1); and magnesium sulfate heptahydrate (CAS Reg.
No. 10034-99-8), collectively referred to as magnesium sulfate, when
used as an inert ingredient in antimicrobial pesticide formulations
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils at an
end-use concentration not to exceed 4400 parts per million (ppm).
Ecolab, Inc. submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting establishment of exemptions from
the requirement of a tolerance for magnesium sulfate. This regulation
eliminates the need to establish a maximum permissible level for
residues of magnesium sulfate when used in accordance with these
exemptions.
DATES: This regulation is effective July 20, 2020. Objections and
requests for hearings must be received on or before September 18, 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-2019-0571, 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 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 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
[[Page 43703]]
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(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0571 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 18, 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-2019-0571, 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 4, 2020 (85 FR 6129) (FRL-
10003-17), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11325) by Ecolab, Inc., 1 Ecolab Place, St. Paul, MN 55102. The
petition requested that 40 CFR 180.940(a) be amended by establishing
exemptions from the requirement of a tolerance for residues of
magnesium sulfate when used as an inert ingredient at an upper limit of
4,400 ppm in antimicrobial pesticide formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment,
and food-processing equipment and utensils. That document referenced a
summary of the petition prepared by Ecolab, Inc., the petitioner, which
is available in the docket, https://www.regulations.gov. One comment was
received on the notice of filing. EPA's response to this comment is
discussed in Unit V.B.
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 the 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 the FFDCA
defines ``safe'' to mean that EPA has determined 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 it does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing an exemption 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 harm 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
to magnesium sulfate, including exposure resulting from the exemptions
established by this action. EPA's assessment of exposures and risks
associated with magnesium sulfate follows.
[[Page 43704]]
A. Toxicological Profile
Magnesium and sulfate are both abundant in the natural enviroment
and are necessary for human life. Magnesium sulfate is commonly found
in food and water, including as a naturally occuring element or as an
additive. EPA has evaluated the available toxicity data for magnesium
sulfate 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
magnesium sulfate as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies are discussed in this unit.
Available studies on magnesium sulfate include an oral toxicity
study, a dermal irritation study, a dermal sensitization study, a
combined oral repeat dose reproduction/developmental toxicity screening
test, and a 1-year inhalation cancer study in rats. No adverse effects
of treatment were seen at the highest dose tested in the repeat dose
oral study in rats at the NOAEL of 450 mg/kg/day. In addition, there
was no evidence of carcinogenicity or neuropathological changes or
effects reported in any of the studies. Magnesium sulfate was also
tested for genotoxic and/or mutagenic effects using bacterial reverse
mutation tests and in vitro mammalian chromosome aberration tests. The
agency does not believe magnesium sulfate will be carcinogenic or
neurotoxic.
All studies showed low acute and repeat dose toxicity and no
reproductive/developmental toxicity. The primary health effect
associated with magnesium sulfate is an osmotic laxative effect at high
doses. The laxative effect is transient, and recovery is rapid and is
usually observed only when following acute exposures to high
concentrations above the limit dose of 1,000 mg/kg/day.
B. Toxicological Points of Departure/Levels of Concern
No toxicological endpoint of concern for magnesium sulfate has been
identified in the database.
C. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water. In
evaluating dietary exposure to magnesium sulfate, EPA considered
exposure under the current and proposed exemption from the requirement
of a tolerance. Magnesium sulfate is currently exempt from the
requirement of a tolerance under 40 CFR 180.910 for use as an inert
ingredient in pesticide formulations used pre- and post-harvest.
Dietary exposure to magnesium sulfate may occur from eating foods
treated with pesticide formulations containing this inert ingredient
and drinking water containing runoff from soils containing the treated
crops. In addition, magnesium sulfate is used as a food additive and a
dietary supplement. However, no toxicological endpoint of concern was
identified for magnesium sulfate and therefore, a quantitative
assessment of dietary exposure is not necessary.
2. 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). Residential
exposure to magnesium sulfate may occur based on its use as an inert
ingredient in pesticide formulations registered for residential uses.
Additional non-dietary exposure may occur from use of magnesium sulfate
in pharmaceutical products and cosmetics. However, no toxicological
endpoint of concern was identified for magnesium sulfate and therefore
a quantitative residential exposure assessment for magnesium sulfate
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.''
EPA has not found magnesium sulfate to share a common mechanism of
toxicity with any other substances, and magnesium sulfate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
magnesium sulfate does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of the FFDCA requires EPA to retain an
additional tenfold margin of safety in the case of threshold effects 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. As noted in Unit IV.B., there is no indication of threshold
effects being caused by magnesium sulfate. Therefore, this requirement
does not apply to the present analysis. Moreover, due to the lack of
any toxicological endpoints of concern, EPA conducted a qualitative
assessment of magnesium sulfate, which does not use safety factors for
assessing risk, and no additional safety factor is needed for assessing
risk to infants and children.
E. Aggregate Risks and Determination of Safety
Taking into consideration all available information on magnesium
sulfate, EPA has determined that there is a reasonable certainty that
no harm to the general population or any population subgroup, including
infants and children, will result from aggregate exposure to magnesium
sulfate residues. Therefore, the establishment of exemptions from the
requirement of a tolerance under 40 CFR 180.940(a) for residues of
magnesium sulfate when used as an inert ingredient in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils at a maximum end-use concentration of 4,400 ppm
is safe under FFDCA section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Response to Comments
One comment was submitted generally opposing the establishment of
these tolerance exemptions and chemical use overall. Although the
Agency recognizes that some individuals believe that chemicals should
be banned, the existing legal framework provided by section 408 of the
FFDCA authorizes EPA to establish exemptions from the requirement of a
tolerance when it determines that the exemption is safe. Upon
consideration of the validity, completeness, and reliability of the
available data as well
[[Page 43705]]
as other factors the FFDCA requires EPA to consider, EPA has determined
that this exemption from the requirement of a tolerance is safe. The
commenter provided no information to support a conclusion that the
exemption was not safe.
VI. Conclusions
Therefore, exemptions from the requirement of a tolerance are
established under 40 CFR 180.940(a) for residues of magnesium sulfate
anhydrous (CAS Reg. No. 7487-88-9); magnesium sulfate monohydrate (CAS
Reg. No. 14168-73-1); magnesium sulfate trihydrate (CAS Reg. No. 15320-
30-6); magnesium sulfate tetrahydrate (CAS Reg. No. 24378-31-2);
magnesium sulfate pentahydrate (CAS Reg. No. 15553-21-6); magnesium
sulfate hexahydrate (CAS Reg. No. 17830-18-1); and magnesium sulfate
heptahydrate (CAS Reg. No. 10034-99-8) when used as an inert ingredient
in antimicrobial pesticide formulations applied to food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils at an end-use concentration not to
exceed 4,400 ppm.
VII. Statutory and Executive Order Reviews
This action establishes tolerance exemptions 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 exemptions 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 22, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore for the reasons stated in the preamble, 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 the table in paragraph (a) by adding, in
alphabetical order, ``Magnesium sulfate anhydrous'', ``Magnesium
sulfate heptahydrate'', ``Magnesium sulfate hexahydrate'', ``Magnesium
sulfate monohydrate'', ``Magnesium sulfate pentahydrate'', ``Magnesium
sulfate tetrahydrate'', and ``Magnesium sulfate trihydrate'' 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) * * *
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
Magnesium sulfate anhydrous.... 7487-88-9 When ready for use, the
end-use concentration
is not to exceed 4400
ppm.
Magnesium sulfate heptahydrate. 10034-99-8 When ready for use, the
end-use concentration
is not to exceed 4400
ppm.
Magnesium sulfate hexahydrate.. 7830-18-1 When ready for use, the
end-use concentration
is not to exceed 4400
ppm.
Magnesium sulfate monohydrate.. 14168-73-1 When ready for use, the
end-use concentration
is not to exceed 4400
ppm.
Magnesium sulfate pentahydrate. 5553-21-6 When ready for use, the
end-use concentration
is not to exceed 4400
ppm.
Magnesium sulfate tetrahydrate. 24378-31-2 When ready for use, the
end-use concentration
is not to exceed 4400
ppm.
Magnesium sulfate trihydrate... 15320-30-6 When ready for use, the
end-use concentration
is not to exceed 4400
ppm.
* * * * * * *
------------------------------------------------------------------------
[[Page 43706]]
* * * * *
[FR Doc. 2020-14401 Filed 7-17-20; 8:45 am]
BILLING CODE 6560-50-P
