Document ID: EPA-HQ-OPP-2019-0571-0004
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Magnesium sulfate
Posted Date: 2020-07-20T04:00Z

[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]

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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.

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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: 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

[[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.
 
                              * * * * * * *
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[FR Doc. 2020-14401 Filed 7-17-20; 8:45 am]
BILLING CODE 6560-50-P