[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 http://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
http://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: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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, http://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 http://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