[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Rules and Regulations]
[Pages 44620-44623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17192]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0450; FRL-8672-01-OCSPP]


Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-2,5-
dihydro-; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-
bis(4-chlorophenyl)-2,5-dihydro- when used as an inert ingredient (dye, 
coloring agent) in pesticide formulations applied to growing crops or 
to raw agricultural commodities after harvest. BASF Corporation 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting establishment of an exemption from the 
requirement of a tolerance for pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-
bis(4-chlorophenyl)-2,5-dihydro-. This regulation eliminates the need 
to establish a maximum permissible level for residues of pyrrolo[3,4-
c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-2,5-dihydro- when used in 
accordance with this exemption.

DATES: This regulation is effective August 13, 2021. Objections and 
requests for hearings must be received on or before October 12, 2021, 
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-2020-0450, 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

[[Page 44621]]

Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
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-2020-0450 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 
October 12, 2021. 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-2020-0450, 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 December 21, 2020 (85 FR 82998) (FRL-
10016-93), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11384) by Spring Regulatory Sciences, on behalf of BASF Corporation, 
100 Park Avenue, Florham Park, New Jersey 07932. The petition requested 
that 40 CFR 180.910 be amended by establishing an exemption from the 
requirement of a tolerance for residues of pyrrolo[3,4-c]pyrrole-1,4-
dione, 3,6-bis(4-chlorophenyl)-2,5-dihydro- (CAS Reg. No. 84632-65-5) 
when used as an inert ingredient (dye, coloring agent) in pesticide 
formulations applied pre- and post-harvest. That document referenced a 
summary of the petition prepared by BASF Corporation, 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

[[Page 44622]]

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 pyrrolo[3,4-c]pyrrole-1,4-dione, 
3,6-bis(4-chlorophenyl)-2,5-dihydro- including exposure resulting from 
the exemption established by this action. EPA's assessment of exposures 
and risks associated with pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-
chlorophenyl)-2,5-dihydro- follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data 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 pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-
bis(4-chlorophenyl)-2,5-dihydro- (also referred to as Pigment Red 254) 
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 acute toxicity studies on Pigment Red 254 show low oral, 
dermal, and inhalation toxicity. An eye irritation, a dermal 
irritation, and a dermal sensitization study were also available and 
showed no effect of treatment. No adverse effects of treatment were 
seen in rats in either a 28-day oral toxicity study or a reproduction/
developmental toxicity study at the highest dose tested (1,000 mg/kg/
day). Therefore, the NOAEL for the 28-day study and the parental, 
reproductive, and developmental NOAELs are (1,000 mg/kg/day).
    There was no evidence of carcinogenicity or neuropathological 
changes or effects reported in any of the studies. There were no in 
vivo or in vitro mutagenic effects in mutagenicity testing with Pigment 
Red 254. The agency does not believe Pigment Red 254 will be 
carcinogenic or neurotoxic.

B. Toxicological Points of Departure/Levels of Concern

    No toxicological endpoint of concern for Pigment Red 254 has been 
identified in the database.

C. Exposure Assessment

    1. Dietary exposure from food, feed uses, and drinking water. In 
evaluating dietary exposure to Pigment Red 254, EPA considered exposure 
under the current and proposed uses of Pigment Red 254. Dietary 
exposure to Pigment Red 254 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, Pigment Red 254 is used as an indirect food additive. 
However, no toxicological endpoint of concern was identified for 
Pigment Red 254, 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 Pigment Red 254 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 
Pigment Red 254 in consumer products. However, no toxicological 
endpoint of concern was identified for Pigment Red 254, and therefore, 
a quantitative residential exposure assessment for Pigment Red 254 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 or 
exemption, 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 Pigment Red 254 to share a common mechanism of 
toxicity with any other substances, and Pigment Red 254 does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has assumed that Pigment Red 
254 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 Pigment Red 254. 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 Pigment Red 254, 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 Pigment Red 
254, 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 Pigment 
Red 254 residues. Therefore, the establishment of exemptions from the 
requirement of a tolerance under 40 CFR 180.910 for residues of Pigment 
Red 254 when used as an inert ingredient in pesticide formulations pre- 
and post- harvest 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 received which asserted that Pigment Red 254 
contains chlorine gas and opposed its use; however, chlorine gas is not 
a constituent nor a metabolite/degradate of Pigment Red 254 and is 
therefore not relevant to the assessment of this chemical.

[[Page 44623]]

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for pyrrolo[3,4-c]pyrrole-1,4-dione, 
3,6-bis(4-chlorophenyl)-2,5-dihydro- (CAS Reg. No. 84632-65-5) when 
used as an inert ingredient (dye, coloring agent) in pesticide 
formulations applied pre- and post-harvest.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). 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 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and 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: July 23, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is amended 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.  180.910, amend the table by adding in alphabetical order 
the inert ingredient ``Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-
chlorophenyl)-2,5-dihydro- (CAS Reg. No. 84632-65-5)'' to the table to 
read as follows:


Sec.  180.910   Inert ingredients used pre- and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Pyrrolo[3,4-c]pyrrole-1,4-dione,    ..............  Dye, coloring agent.
 3,6-bis(4-chlorophenyl)-2,5-
 dihydro- (CAS Reg. No. 84632-65-
 5).
 
                              * * * * * * *
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[FR Doc. 2021-17192 Filed 8-12-21; 8:45 am]
BILLING CODE 6560-50-P