[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Proposed Rules]
[Pages 64129-64132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25027]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter I
[EPA-HQ-OPPT-2021-0622; FRL-9100-01-OCSPP]
TSCA Section 21 Petition for Rulemaking Under TSCA Section 6;
Reasons for Agency Response; Denial of Requested Rulemaking
AGENCY: Environmental Protection Agency (EPA).
ACTION: Petition; reasons for Agency response.
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SUMMARY: This action announces the availability of EPA's response to a
petition received on August 16, 2021, from William D. Bush. The
petition requests that EPA determine that the ``chemical mixtures
contained within cosmetics present an unreasonable risk of injury to
health and the environment,'' and issue a rule or order under the Toxic
Substances Control Act (TSCA) to ``eliminate the hazardous chemicals
used in mixtures [in cosmetics].'' After careful consideration, EPA has
denied the petition for the reasons set forth in this document.
DATES: EPA's response to this TSCA section 21 petition was signed
November 10, 2021.
ADDRESSES: The docket for this petition, identified by docket
identification (ID) number EPA-HQ-OPPT-2021-0622, is available at
https://www.regulations.gov or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. 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 OPPT Docket is (202) 566-
0280.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room is by appointment only.
For the latest status information on EPA/DC services and docket access,
visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Amy Shuman, Existing Chemicals
Risk Management Division (7404T), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: (202) 564-2978; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of interest to those persons who manufacture (including
import), distribute in commerce, process, use, or dispose of cosmetics.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action.
B. What is EPA's authority for taking this action?
Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA
to initiate a proceeding for the issuance, amendment, or repeal of a
rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA
sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth
the facts which it is claimed establish that it is necessary to
initiate the action requested. EPA is required to grant or deny the
petition within 90 days of its filing. If EPA grants the petition, the
Agency must promptly commence an appropriate proceeding. If EPA denies
the petition, the Agency must publish its reasons for the denial in the
Federal Register. A petitioner may commence a civil action in a U.S.
district court seeking to compel initiation of the requested proceeding
within 60 days of a denial or, if EPA does not issue a decision, within
60 days of the expiration of the 90-day period.
C. What criteria apply to a decision on this TSCA section 21 petition?
1. Legal Standard Regarding TSCA Section 21 Petitions
TSCA section 21(b)(1) requires that the petition ``set forth the
facts which it is claimed establish that it is necessary'' to initiate
the proceeding requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21
implicitly incorporates the statutory standards that apply to the
requested actions. Accordingly, EPA has relied on the standards in TSCA
section 21 and in
[[Page 64130]]
the provisions under which actions have been requested in evaluating
this TSCA section 21 petition.
2. Legal Standard Regarding TSCA Section 6(a)
In general, to promulgate a rule under TSCA section 6(a), EPA must
first determine ``in accordance with section 6(b)(4)(A) that the
manufacture, processing, distribution in commerce, use, or disposal of
a chemical substance or mixture . . . presents an unreasonable risk.''
15 U.S.C. 2605(a). TSCA section (b)(4)(A) is part of the risk
evaluation process whereby EPA must determine ``whether a chemical
substance presents an unreasonable risk of injury to health or the
environment,'' and thus, whether a rule under TSCA section 6(a) is
necessary. 15 U.S.C. 2605(b)(4)(A). In particular, EPA must conduct
this evaluation ``without consideration of costs or other non-risk
factors, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant to the risk evaluation
by the Administrator, under the conditions of use.'' Id. Unless EPA
establishes an exemption under TSCA section 6(g) (whereby certain
unreasonable risks may be allowed to persist for a limited period) or
EPA is addressing a persistent, bioaccumulative, and toxic substance as
set forth in TSCA section 6(h), the standard for an adequate rule under
TSCA section 6(a) is that it regulates ``so that the chemical substance
or mixture no longer presents'' unreasonable risks under the conditions
of use. 15 U.S.C. 2605(a). EPA may eliminate the unreasonable risk of a
chemical substance or mixture by regulating manufacture, processing,
distribution in commerce, commercial use, or disposal of the chemical
substance in one or more of the manners described in TSCA section 6(a).
3. Legal Standard Regarding TSCA Sections 3(2) and (10)
TSCA section 3(2) excludes from the definition of a ``chemical
substance'' ``any food, food additive, drug, cosmetic, or device (as
such terms are defined in Section 201 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic, or device.'' 15 U.S.C. 2602(2) (emphases added). In addition,
TSCA section 3(10) defines ``mixture'' as ``any combination of two or
more chemical substances if the combination does not occur in nature
and is not, in whole or in part, the result of a chemical reaction;
except that such term does include any combination which occurs, in
whole or in part, as a result of a chemical reaction if none of the
chemical substances comprising the combination is a new chemical
substance and if the combination could have been manufactured for
commercial purposes without a chemical reaction at the time the
chemical substances comprising the combination were combined.'' 15
U.S.C. 2602(10).
4. Legal Standard Regarding TSCA Section 26
TSCA section 26(h) requires EPA, in carrying out TSCA sections 4,
5, and 6, to make science-based decisions using ``scientific
information, technical procedures, measures, methods, protocols,
methodologies, or models, employed in a manner consistent with the best
available science,'' while also taking into account other
considerations, including the relevance of information and any
uncertainties. 15 U.S.C. 2625(h). TSCA section 26(i) requires that
decisions under TSCA sections 4, 5, and 6 be ``based on the weight of
scientific evidence.'' 15 U.S.C. 2625(i). TSCA section 26(k) requires
that EPA consider information that is reasonably available in carrying
out TSCA sections 4, 5, and 6. 15 U.S.C. 2625(k).
II. Summary of the TSCA Section 21 Petition
A. What action was requested?
On August 16, 2021, EPA received a TSCA section 21 petition (Ref.
1) from William D. Bush (the petitioner) that requests EPA take several
actions under TSCA section 6. The petition asks EPA to determine that
the ``chemical mixtures contained within cosmetics present an
unreasonable risk of injury to health and the environment'' and seeks
the issuance of a rule or order to ``eliminate the hazardous chemicals
used in mixtures [in cosmetics].'' The petition also requests ``any
other prudent [methods] of toxic mixture substance control [EPA] may
see due and fit.''
1. Request for Determination That the Chemical Mixtures Contained
Within Cosmetics Present an Unreasonable Risk of Injury to Health and
the Environment
The petition requests that EPA determine that the ``chemical
mixtures contained within cosmetics present an unreasonable risk of
injury to health and the environment.'' With respect to actions under
TSCA section 6, TSCA section 21 provides only for the submission of a
petition seeking the initiation of a proceeding for the issuance,
amendment, or repeal of a rule under TSCA section 6(a). In general,
before promulgating a TSCA section 6(a) rule, EPA must first determine
``in accordance with section 6(b)(4)(A)''--that is, through a TSCA risk
evaluation--whether a chemical substance presents an unreasonable risk
to health or the environment under the conditions of use. To initiate a
TSCA section 6(b) risk evaluation, however, EPA generally must
designate the chemical substance a high priority for risk evaluation.
Prioritization of high priority substances for risk evaluation under
TSCA section 6(b) and risk evaluation under TSCA section 6(b) are
activities distinct from rulemaking under TSCA section 6(a). Because
TSCA section 21 does not provide an avenue for petitioners to request
the initiation of the prioritization process or the risk evaluation
process through which EPA would determine whether ``chemical mixtures
contained within cosmetics'' present an unreasonable risk, this Federal
Register document does not address this specific request.
2. Request for Order by Rule That the Manufacturing Producers of
Cosmetics Eliminate the Hazardous Chemicals Used in Mixtures in
Cosmetics
The petition requests that EPA ``[o]rder by [r]ule that the
manufacturing producers of cosmetics eliminate the hazardous chemicals
used in mixtures [in cosmetics].'' TSCA section 21 provides for the
submission of a petition to initiate a proceeding for the issuance,
amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or to
issue an order under TSCA sections 4, 5(e), or 5(f). As the petitioner
is seeking issuance of a rule under TSCA section 6, this Federal
Register document addresses this request.
3. Request for Other Methods of Toxic Mixture Substance Control the
Agency Determines To Be Required
The petition requests that EPA exercise ``any other prudent
[methods] of toxic mixture substance control'' that the Agency deems
``due and fit.'' As a regulatory body, EPA cannot deviate from the
statutory remedies established under TSCA section 21. Therefore, a
solicitation for EPA to exercise ``any other prudent [methods]'' that
the Agency deems ``due and fit'' does not adequately identify an
objective that is executable within TSCA section 21. Therefore, this
Federal Register document does not address this specific request.
[[Page 64131]]
B. What support did the petitioner offer?
To support the request for an order by rule that the manufacturing
producers of cosmetics eliminate the hazardous chemicals used in
mixtures in cosmetics, the petitioner offers information relating to
human health impacts as a result of cosmetic application, human health
and environmental impacts affected by cosmetic manufacture and import
volume, and lack of cosmetic regulatory policy (Ref. 1, pp. 1-4). Of 13
points included in that discussion, seven are excerpts from an article
on the toxicity of chemicals and contaminants of cosmetics (Ref. 2);
these points are discussed in detail below. For the remaining six
points, the petitioner paraphrases information from the article (Ref.
2), and references the authority of the U.S. Food and Drug
Administration and regulatory actions taken worldwide as each relates
to human health and environmental impacts from cosmetic chemicals.
Regarding the seven points attributed to the article on the
toxicity of chemicals and contaminants in cosmetics, the petitioner
cites various metrics associated with the manufacture and use of
cosmetic products (Ref. 1, points 5, 10, 11, and 12) and the alleged
environmental and human health effects resulting from exposure thereto
(Ref. 1, points 1, 5, and 10).
Regarding manufacturing metrics, the petitioner highlights
references from the article by stating, ``[s]ince 2009, 595 cosmetic
manufacturers reported using 88 chemicals, in more than 73,000
[cosmetic] products'' (Ref. 1, point 5). The petitioner further states
that ``American women use an average of 12 personal care products that
contain 168 different chemicals'' and that the United States cosmetic
industry since 2010 ``has grown an average of 4.1 percent annually''
with sales from 2016 totaling over $169 billion (Ref. 1, points 10 and
11). Lastly, the petitioner points to increased import of cosmetics
from 181 different countries by highlighting ``[c]osmetic imports from
China increased 79 percent between FY 2011 and FY 2016'' (Ref. 1, point
12).
The associated health affects statements mentioned by the
petitioner include that cosmetic chemicals ``have been linked to
cancer, birth defects, and reproductive harm'' and that ``[m]any of
these products are applied directly to the skin, the body's largest
organ, where ingredients can be absorbed directly into the
bloodstream'' (Ref. 1, points 5 and 10). To expand on this point, the
petitioner states ``[n]ot only are these toxic chemicals entering our
bodies through direct application, but excess product that is washed
down the drain pollutes our waterways and drinking water, and compounds
doses of hazardous chemicals in air, water, food, and other consumer
products'' (Ref. 1, point 1).
In addition, the petitioner includes a summary of the findings and
policy section of the Pollution Prevention Act (42 U.S.C. 13101) (Ref.
1, points 14 and 15), though TSCA section 21 does not provide an avenue
for recourse under such Act. The petitioner cites language from the
Pollution Prevention Act which states that ``pollution should be
prevented or reduced at the source whenever feasible; pollution that
cannot be prevented should be recycled in an environmentally safe
manner, whenever feasible; pollution that cannot be prevented or
recycled should be treated in an environmentally safe manner whenever
feasible; and disposal or other release into the environment should be
employed only as a last resort and should be conducted in an
environmentally safe manner'' and that ``source reduction is
fundamentally different and more desirable than waste management and
pollution control.''
The petitioner also provides two claims: (1) ``[t]oxic [c]hemicals
added to and included in [c]osmetics are unreasonable;'' and (2)
``[c]osmetic [d]isposal presents a clear unreasonable risk to the
[e]nvironment.'' (Ref. 1, pp. 5-6). To support the former claim, the
petitioner argues that the chemical mixtures contained in cosmetics
provide no benefit to consumers considering said chemicals can ``harm
public welfare and the environment through their use consumption and
disposal,'' but does not cite or provide reference. To support the
latter claim, the petitioner states that ``research studies of toxic
waste entering the environment are clear in identifying cosmetics as a
major hazardous waste emission,'' but does not cite or provide any
reference to such studies.
III. Disposition of TSCA Section 21 Petition
A. What is EPA's response?
After careful consideration, EPA has denied this TSCA section 21
petition. A copy of the Agency's response, which consists of the letter
to the petitioner and this document, is posted on the EPA petition
website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#cosmetics. The response, the petition (Ref. 1),
and other information is available in the docket for this TSCA section
21 petition.
B. What was EPA's reason for this response?
TSCA section 21 does provide for the submission of a petition
seeking the initiation of a proceeding for the issuance of a rule under
TSCA section 6(a). The petition must ``set forth the facts which it is
claimed establish that it is necessary to issue'' the requested rule.
15 U.S.C. 2620(b)(1). When determining whether the petition meets that
burden, EPA will consider whether the manufacture, distribution in
commerce, processing, use, or disposal of a chemical substance or
mixture, or any combination of such activities, may present an
unreasonable risk of injury to health or the environment.
EPA evaluated the information presented in the petition and
considered that information in the context of the applicable
authorities and requirements of TSCA sections 3(2), 6, 21, and 26.
Notwithstanding that the burden is on the petitioner to present ``the
facts which it is claimed establish that it is necessary'' for EPA to
initiate the rule or issue the order sought, EPA nonetheless also
considered relevant information that was reasonably available to the
Agency during the 90-day petition review period. As detailed further in
this Unit, EPA finds that the petitioner has not met its burden to
support the requested actions.
Under TSCA section 6(a), EPA must, by rule, issue regulations
applying one or more of the listed requirements to the extent necessary
so that a chemical substance or mixture found to present unreasonable
risk no longer presents such risk.-TSCA section 3(2)(B), which defines
``chemical substance,'' excludes ``any food, food additive, drug,
cosmetic, or device (as such terms are defined in Section 201 of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device'' (emphases added). According
to section 201(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
``cosmetic'' means ``articles intended to be rubbed, poured, sprinkled,
or sprayed on, introduced into, or otherwise applied to the human body
or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and articles intended for
use as a component of any such articles; except that such term shall
not include soap.'' 21 U.S.C. 321(i). Under TSCA, ``cosmetics'' are not
a ``chemical substance'' when manufactured, processed, or distributed
in commerce for use as a cosmetic. Therefore, EPA cannot issue a rule
pursuant to TSCA
[[Page 64132]]
section 6(a) to apply requirements to such cosmetics. In addition,
while a ``mixture'' can be subject to TSCA section 6(a), because the
requested action is for ``hazardous chemicals used in mixtures [in
cosmetics],'' EPA cannot issue a rule pursuant to TSCA section 6(a) to
apply requirements to cosmetics when manufactured, processed, or
distributed in commerce for use as a cosmetic. To the extent the
petition seeks action on ``cosmetics'' when manufactured, processed, or
distributed in commerce as cosmetics--including direct regulation of
cosmetics through an order by rule that cosmetic manufacturers
eliminate hazardous chemicals used in mixtures in cosmetics or through
an action to address the first claim that ``[t]oxic [c]hemicals added
to and included in [c]osmetics are unreasonable''--the petition does
not request actions that are within EPA's jurisdiction under TSCA.
To the extent the petition seeks action on ``chemical substances''
within the TSCA section 3(2) definition of that term--including action
to address the petitioner's second claim that ``[c]osmetic [d]isposal
presents a clear unreasonable risk to the [e]nvironment''--EPA finds
that the petitioner did not set forth facts establishing that it is
necessary to initiate an appropriate proceeding pursuant to TSCA
section 21. In particular, with respect to the second claim, EPA finds
that the petition did not demonstrate facts that could support an EPA
determination of unreasonable risk to the environment. Rather, the
specific chemical substances identified by the petition as examples are
discussed by reference to their potential human health effects when
used in manufactured cosmetic products. In addition, while the petition
cites TSCA and Pollution Prevention Act authorities applicable to
disposal, there are no data or references offered to support the
assertion that ``research studies of toxic waste entering the
environment are clear in identifying cosmetics as a major hazardous
waste emission'' (Ref. 1, p. 6). As explained above, TSCA section
21(b)(1) requires that the petition ``set forth the facts which it is
claimed establish that it is necessary'' to initiate the proceeding
requested. 15 U.S.C. 2620(b)(1). TSCA section 21(b)(4)(B) also provides
the standard for judicial review should EPA deny a request for
rulemaking under TSCA section 6(a): ``If the petitioner demonstrates to
the satisfaction of the court by a preponderance of the evidence that .
. . the chemical substance or mixture to be subject to such rule . . .
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible
subpopulation, under the conditions of use,'' the court shall order the
EPA Administrator to initiate the requested action. 15 U.S.C.
2620(b)(4)(B). Consistent with these provisions, a petition for a TSCA
section 6(a) rulemaking must set forth facts which would enable EPA to
conclude that there is an unreasonable risk for which a TSCA section
6(a) risk management rule is warranted. EPA does not find that the
petition in this case sets forth facts which would enable EPA to
conclude that the disposal of particular chemical substance(s) or
mixture(s) in cosmetics presents unreasonable risk and that an
appropriate proceeding should be initiated. To the extent the petition
seeks other action cognizable under TSCA section 21 to address
``chemical substances'' in cosmetics outside of cosmetic disposal, EPA
similarly finds that the petition does not set forth sufficient facts
to establish the necessity of initiating an appropriate proceeding
under TSCA section 21.
Finally, to the extent that the petition referenced the Pollution
Prevention Act (42 U.S.C. 13101), the Agency reiterates that TSCA
section 21 does not provide an avenue for recourse under such Act.
B. What were EPA's conclusions?
EPA denied the request to issue a rule under TSCA section 6(a).
TSCA section 3(2)(B) excludes ``cosmetic'' from the definition of
``chemical substance'' when manufactured, processed, or distributed in
commerce for use as a cosmetic. Therefore, cosmetics, and any
combination of chemicals contained therein, are not chemical substances
under TSCA when manufactured, processed, or distributed in commerce for
use as a cosmetic. To the extent the petition seeks TSCA section 6
action on ``cosmetics'' when manufactured, processed, or distributed in
commerce as cosmetics, the requested actions are not within EPA's
jurisdiction under TSCA. In addition, to the extent the petition seeks
action on ``chemical substances'' within the TSCA section 3(2)
definition of that term, EPA finds that the petition did not set forth
facts establishing that it is necessary to initiate an appropriate
proceeding pursuant to TSCA section 21. In particular, the petition did
not identify the disposal of any particular chemical substance(s) or
mixture(s) that could support an EPA determination of unreasonable risk
to the environment and, therefore, did not set forth sufficient facts
establishing that it is necessary to issue a TSCA section 6(a) rule
addressing cosmetic disposal.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. Bush, William D. Petition for Issuance of New Rules under Section
15 U.S.C. 2605 re: [COSMETICS]. Received August 16, 2021.
2. Faber, S. (2020). The Toxic Twelve Chemicals and Contaminants in
Cosmetics. Available at https://www.ewg.org/the-toxic-twelve-chemicals-and-contaminants-in-cosmetics.
Authority: 15 U.S.C. 2601 et seq.
Dated: November 10, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-25027 Filed 11-16-21; 8:45 am]
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