[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Rules and Regulations]
[Pages 24731-24735]
[FR Doc No: 2021-09911]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0607; FRL-10022-79]

Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt; 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 Poly(oxy-1,2-ethanediyl), [alpha],
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt when used as an
inert ingredient (colorant) in pesticide formulations applied to seed
treatment slurries for raw agricultural commodities and not to exceed
20% weight/weight (wt/wt). Milliken Chemical 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. This
regulation eliminates the need to establish a maximum permissible level
for residues of Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt.

DATES: This regulation is effective May 10, 2021. Objections and
requests for hearings must be received on or before July 9, 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-2019-0607, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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-2019-0607 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
July 9, 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-2019-0607, 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 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11359) by Milliken Chemical, 920 Milliken Rd., M-209 Spartanburg, SC
29303. The petition requested that 40 CFR 180.920 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt (CAS Reg. No. N/A) when used as an inert
ingredient (colorant) in pesticide formulations applied to seed
treatment slurries for raw agricultural commodities not to exceed 20%
(wt/wt). That document referenced a summary of the petition prepared by
Milliken Chemical, the petitioner, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.

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 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 tolerance is ``safe.'' Section 408(c)(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) and (c)(2)(B) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
or 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 appreciable risks 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 finite 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 for Poly(oxy-1,2-ethanediyl),
[alpha], [alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with Poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-

ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt 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 Poly(oxy-1,2-ethanediyl), [alpha],
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt 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.
    In acute studies, exposure to Poly(oxy-1,2-ethanediyl), [alpha],
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt resulted in no
observable or minimal toxicity. The acute oral median lethal dose
(LD50) in rats is >2,000 mg/kg. Minimal dermal irritation
was observed in an acute dermal study with rabbits. No indications of
sensitization have been observed in local lymph node assay.
    Two reverse mutation assays (OECD 471), a mouse lymphoma assay
(OECD 476) and an in vitro micronucleus test (OECD 487) found Poly(oxy-
1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt to not be mutagenic.
    In a combined repeat dose developmental/reproduction study (OECD
422), there were no adverse effects from oral administration of
Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt up to 1000 mg/kg/day on any parameter
measured, including gonadal function, mating performance, conception,
development of the conceptus or parturition. The NOAEL for these
parameters was 1000 mg/kg/day for males and females. The NOAEL for
reproductive performance and fetal/developmental toxicity was also
considered to be 1,000 mg/kg/day.

B. Toxicological Points of Departure/Levels of Concern

    Based on available studies provided for Poly(oxy-1,2-ethanediyl),
[alpha], [alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt, no
toxicological endpoint of concern was identified, and a quantitative
risk assessment is not required for this compound.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt in food as follows:
    Dietary exposure (food and drinking water) to Poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt is not expected to occur due to its intended
use as a colorant for seed treatment. Seed treatment formulas
containing Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt will be applied directly to seeds and if
released into the environment, the colorant would not be taken up by
the germinating seedling and translocated within the plant vascular
system to result in crop residues and dietary exposures.
    2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted.
    3. From 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).
    Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt may be used in pesticide products and non-
pesticide products used in and around the home that would have
residential exposures. However, because no toxicological endpoint of
concern was identified, a quantitative residential exposure assessment
for Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt was not conducted.
    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 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 Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt to share a common mechanism of toxicity with
any other substances, and Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-
{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this action, therefore, EPA has assumed that poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt 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

    Based on the lack of threshold effects, EPA has not identified any
toxicological endpoints of concern and is conducting a qualitative
assessment of poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt. That qualitative assessment does not use
safety factors for assessing risk, and no additional safety factor is
needed for assessing risk to infants and children. Based on an
assessment of poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt, EPA has concluded that there are no
toxicological endpoints of concern for the U.S. population, including
infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on poly(oxy-
1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt when used as an inert

ingredient (colorant) in pesticide formulations applied to seed
treatment slurries for raw agricultural commodities and not to exceed
20% (wt/wt), 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
poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt. Therefore, the establishment of an exemption
from tolerance under 40 CFR 180.920 for residues of poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt when used as an inert ingredient (colorant)
in pesticide formulations applied to seed treatment slurries for raw
agricultural commodities and not to exceed 20% (wt/wt), 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. 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). Codex is a joint United Nation Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level.
    The Codex has not established a MRL for poly(oxy-1,2-ethanediyl),
[alpha], [alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for poly(oxy-1,2-ethanediyl), [alpha],
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt (CAS Reg. No. N/
A) when used as an inert ingredient (colorant) in pesticide
formulations applied to seed treatment slurries for raw agricultural
commodities and not to exceed 20% (wt/wt).

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 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: May 4, 2021.
Marietta Echeverria,
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.  180.920, amend the table by adding in alphabetical order
the inert ingredient ``Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-
{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt'' to read as
follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert ingredients               Limits                Uses
------------------------------------------------------------------------

                              * * * * * * *
Poly(oxy-1,2-ethanediyl),        Not to exceed 20%   Colorant.
 [alpha], [alpha]'-{[[4-[(3-      by weight of
 sulfophenyl)azo]phenyl]imino]d   pesticide
 i-2,1-ethanediyl{time}           formulation.
 bis[[omega]-hydroxy-,
 monosodium salt.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2021-09911 Filed 5-7-21; 8:45 am]
BILLING CODE 6560-50-P