Rule2021-17192
Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-2,5-dihydro-; Exemption From the Requirement of a Tolerance
Primary source
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Published
August 13, 2021
Effective
August 13, 2021
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 154 (Friday, August 13, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#36647270647859425f5553457653465718515940"><span class="__cf_email__" data-cfemail="f3a1b7b5a1bd9c879a909680b3968392dd949c85">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl">http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="http://www.epa.gov/dockets/contacts.html">http://www.epa.gov/dockets/contacts.html</a>. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
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, <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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
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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 <a href="http://www.epa.gov/pesticides/cumulative">http://www.epa.gov/pesticides/cumulative</a>.
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
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Inert ingredients Limits Uses
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* * * * * * *
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
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