[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Rules and Regulations]
[Pages 68909-68911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25014]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0203; FRL-10212-01-OCSPP]


Sulfur Dioxide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of sulfur 
dioxide in or on blueberry. Interregional Research Project Number 4 
(IR-4) requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 17, 2022. Objections and 
requests for hearings must be received on or before January 17, 2023, 
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-2021-0203, 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 and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2021-0203 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
January 17, 2023. 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-2021-0203, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0E8894) by IR-4, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to 
amend 40 CFR part 180 by establishing tolerances for residues of sulfur 
dioxide, including its metabolite and degradates, in or on blueberry at 
9 parts per million (ppm). That document referenced a summary of the 
petition prepared by IR-4, the petitioner, which is available in the 
docket, https://www.regulations.gov. Two comments were received on the 
notice of filing from the United States Department of Agriculture and 
the North American Blueberry Council. Both were in support of the 
action.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
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 a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.. . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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

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aggregate exposure for sulfur dioxide including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with these inorganic sulfites follow.

A. Toxicological Profile

    There is a large volume of published data detailing the toxicity of 
sulfur dioxide and sodium metabisulfite, and consequently the toxicity 
of these pesticides has been well established. Sodium metabisulfite 
pads generate sulfur dioxide gas which then reacts with foods to 
quickly form sulfite. In addition to the use of sodium metabisulfite 
pads, direct application of sulfur dioxide gas is proposed for 
blueberry treatments. For both treatments, sulfite is the residue of 
concern in food and is determined by the analytical enforcement method. 
EPA's Office of Air Quality Planning and Standards (OAQPS) has worked 
extensively on sulfur dioxide, including setting national ambient air 
quality standards (NAAQS) for sulfur dioxide, a gaseous air pollutant. 
The U.S. Food and Drug Administration (FDA) has also performed an 
extensive review of sulfiting agents (including sulfur dioxide, sodium 
metabisulfite, and sodium bisulfite) that have been added to any food 
or to any ingredient in any food. For the dietary assessment, EPA is 
relying on the established FDA regulatory value for sulfite.
    Sulfiting agents are used to add sulfites to foods and include 
sulfur dioxide, sodium metabisulfite, sodium bisulfite, sodium sulfite, 
potassium metabisulfite, and potassium bisulfite. Humans may experience 
sensitivity reactions following exposure to sulfites including, but not 
limited to, diarrhea, headache, difficulty breathing, vomiting and 
nausea, and abdominal pain and cramps. Asthmatics account for many, but 
not necessarily all, of the individuals who have a sensitivity to 
sulfites. Given the known effects to certain individuals within the 
population, the FDA requires that any food that contains a sulfiting 
agent at >= 10 ppm or mg/kg be declared as such on the food label.
    Additional information on the toxicological profile can be found at 
https://www.regulations.gov in the document titled ``Inorganic 
Sulfites. Human Health Risk Assessment in Support of a Section 3 
Registration for Postharvest Fumigation of Blueberry'' (hereinafter 
``Sulfur Dioxide Human Health Risk Assessment'') in docket ID number 
EPA-HQ-OPP-2021-0203.

B. Toxicological Points of Departure/Levels of Concern

    No appropriate toxicological endpoints were selected for sulfur 
dioxide. The Agency is relying on the FDA-established regulatory level 
of up to 10 ppm sulfite residues in foods.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sulfur dioxide, EPA compared exposure from residues on 
blueberries to the FDA-established regulatory level. EPA assessed 
dietary exposures from these inorganic sulfites in food as follows:
    Sulfite is the residue of concern for consumption of treated 
blueberries. A quantitative dietary assessment was not conducted for 
sulfite since no appropriate toxicological endpoints were selected. The 
Agency is relying on the FDA-established regulatory level of up to 10 
ppm sulfite residues in foods. Residues of sulfites in blueberry from 
sulfur dioxide and sodium metabisulfite applications are expected to be 
below the 10 ppm level when applied as tested in the blueberry residue 
trials.
    EPA did not use anticipated residue or PCT information in the 
dietary assessment for sulfur dioxide.
    2. Dietary exposure from drinking water. No residues are expected 
in drinking water based on the current use pattern, which includes 
post-harvest fumigant treatment in a chamber and slow release or dual 
release pads that are placed in the clamshells used to distribute 
blueberries.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    There are no uses of sulfur dioxide or sodium metabisulfite 
resulting in direct residential exposures; therefore, residential 
exposure is not expected.
    4. 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to the inorganic sulfites and 
any other substances and the inorganic sulfites do not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
the inorganic sulfites have a common mechanism of toxicity with other 
substances.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA)(SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has also reviewed the available scientific data and 
other relevant information in support of regulations establishing the 
10 ppm maximum permissible level for residues of sulfur dioxide to 
support a time-limited tolerance of sulfur dioxide residues in or on 
fig (September 14, 2011; 76 FR 56644) (FRL-8887-2). EPA also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including sulfite 
sensitive individuals, infants, and children. EPA has concluded that 
there is sufficient toxicological information for sulfur dioxide to 
address risks to infants and children. In addition, the available 
information indicated that there is no evidence of increased 
quantitative or qualitative susceptibility of the offspring after in 
utero or postnatal exposure. Based on the lack of observed 
susceptibility, and since the current regulatory value for sulfites (10 
ppm) takes into account the potential for sensitive populations, 
including infants and children, these regulatory values are considered 
protective, and no additional FQPA safety factor is required.

E. Aggregate Risks and Determination of Safety

    In accordance with the FQPA, the Agency must consider and aggregate 
pesticide exposures and risks from three

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major sources: food, drinking water, and residential exposures. There 
are no residential uses of sulfur dioxide or sodium metabisulfite, and 
exposures through drinking water are not expected based on the use 
pattern. Dietary exposures resulting from the proposed uses on 
blueberries are expected to be below the 10 ppm FDA-established 
regulatory level; therefore, there are no dietary risks of concern from 
these uses on blueberries.
    Based on these risk assessments, EPA concludes that there is a 
reasonable certainty that no harm will result to the general 
population, or to infants and children from exposure to inorganic 
sulfites resulting from the application of sulfur dioxide and sodium 
metabisulfite.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate liquid chromatography method with tandem mass 
spectrometry detection (LC/MS/MS) method is available for enforcing 
sulfite tolerances in blueberries.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4).
    There are no Codex MRLs for sulfur dioxide in or on blueberry.

V. Conclusion

    Therefore, a tolerance is established for residues of sulfur 
dioxide in or on blueberry at 9 ppm. EPA is also removing the expired 
time-limited tolerance in paragraph (b) and reserving paragraph (b) as 
a housekeeping measure.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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.

    Dated: November 4, 2022.
Jennifer Saunders,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.444:
0
a. Amend paragraph (a) by:
0
i. Designating the table as ``Table 1 to paragraph (a)''.
0
ii. Adding in alphabetical order the entry ``Blueberry''.
0
b. Removing and reserving paragraph (b).
    The addition reads as follows:


Sec.  180.444  Sulfur Dioxide; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Blueberry...............................................               9
 
                                * * * * *
------------------------------------------------------------------------

    (b) [Reserved]
* * * * *
[FR Doc. 2022-25014 Filed 11-16-22; 8:45 am]
BILLING CODE 6560-50-P


