Proposed Rule2021-23569
TSCA Section 21 Petition for Rulemaking Under TSCA Section 6; Reasons for Agency Response; Denial of Requested Rulemaking
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Published
October 29, 2021
Issuing agencies
Environmental Protection Agency
Abstract
This action announces the availability of EPA's response to a petition received on August 2, 2021, from William D. Bush. The petition requests that EPA determine "that the chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment." The petitioner also seeks issuance of a rule or order to "eliminate the hazardous chemicals used in a mixture with tobacco," and to "develop material techniques of biodegradation to counter or reduce" environmental risk from current disposal methods of cigarettes under section 6(a) of the Toxic Substances Control Act (TSCA). After careful consideration, EPA has denied the TSCA section 21 petition for the reasons set forth in this document.
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<title>Federal Register, Volume 86 Issue 207 (Friday, October 29, 2021)</title>
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[Federal Register Volume 86, Number 207 (Friday, October 29, 2021)]
[Proposed Rules]
[Pages 59931-59934]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23569]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter I
[EPA-HQ-OPPT-2021-0599; FRL-8949-01-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 2, 2021, from William D. Bush. The petition
requests that EPA determine ``that the chemical mixtures contained
within cigarettes present an unreasonable risk of injury to health and
the environment.'' The petitioner also seeks issuance of a rule or
order to ``eliminate the hazardous chemicals used in a mixture with
tobacco,'' and to ``develop material techniques of biodegradation to
counter or reduce'' environmental risk from current disposal methods of
cigarettes under section 6(a) of the Toxic Substances Control Act
(TSCA). After careful consideration, EPA has denied the TSCA section 21
petition for the reasons set forth in this document.
DATES: EPA's response to this TSCA section 21 petition was signed
October 25, 2021.
ADDRESSES: The docket for this TSCA section 21 petition, identified by
docket identification (ID) number EPA-HQ-OPPT-2021-0599, is available
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#512239243c303f7f303c28113421307f363e27"><span class="__cf_email__" data-cfemail="e09388958d818ece818d99a0859081ce878f96">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#bfebecfcfe92f7d0cbd3d6d1daffdacfde91d8d0c9"><span class="__cf_email__" data-cfemail="bce8effffd91f4d3c8d0d5d2d9fcd9ccdd92dbd3ca">[email protected]</span></a>.
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
cigarettes. 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,
[[Page 59932]]
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 the provisions under which actions have been
requested in evaluating this TSCA section 21 petition.
2. Legal Standard Regarding TSCA Section 6(a)
Under TSCA section 6(a), EPA must determine if a chemical substance
or mixture in manufacturing, processing, distribution in commerce, use,
disposal, or any combination of these activities presents an
unreasonable risk of injury to health or the environment. If
unreasonable risk to health or the environment is determined, EPA has
the authority and obligation to issue a rulemaking placing one or more
requirements to the extent necessary so that the chemical substance or
mixture no longer presents an unreasonable risk. 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, including by prohibiting, limiting
volume, limiting a particular use, restricting concentration, requiring
warning and instruction labeling, requiring record-keeping of
exposures, notification of end-users, and/or replacement or repurchase
by issuance of rulemaking to manufacturers, processors, distributors in
commerce, users, and disposers.
3. Legal Standard Regarding TSCA Sections 3(2) and (10)
TSCA section 3(2) excludes from the definition of a ``chemical
substance'' ``any mixture,'' ``tobacco or any tobacco product,'' as
well as ``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). 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.''
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 2, 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 cigarettes 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 a mixture with tobacco; including and not limited to the toxic
substance inclusions resulting from tobacco growing or handling
techniques,'' and to ``develop material techniques of biodegradation to
counter or reduce'' environmental risk from current disposal methods of
cigarettes. 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 Cigarettes Present an Unreasonable Risk of Injury to Health and
the Environment
The petition requests that EPA determine that ``chemical mixtures
contained within cigarettes 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). The purpose of
a TSCA section 6 risk evaluation is to determine whether a chemical
substance or mixture presents an unreasonable risk to health or the
environment under the conditions of use. To initiate a TSCA section 6
risk evaluation, however, the chemical substance or mixture must be
designated a high priority for risk evaluation. Prioritization of high
priority substances for risk evaluation under TSCA section 6(b) is an
activity 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 for ``chemical mixtures
contained within cigarettes,'' this Federal Register document does not
address this specific request.
2. Request for Order by Rule That the Manufacturing Producers of
Cigarettes Eliminate the Hazardous Chemicals Used in a Mixture With
Tobacco
The petition requests that EPA ``[o]rder by [r]ule that the
manufacturing producers of cigarettes eliminate the hazardous chemicals
used in a mixture with tobacco.'' 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
[[Page 59933]]
6, this Federal Register document addresses this request.
3. Request for Order by Rule That Cigarette Manufacturers Develop New
Product Designs That Eliminate or Reduce the Cigarette Butt Disposal
Risks to the Environment
The petition asks EPA to ``[o]rder by [r]ule that [c]igarette
manufacturers develop new product designs which eliminate or reduce the
cigarette `butt' disposal risks to the environment.'' TSCA section 21
provides for the submission of a petition seeking issuance of a rule
under TSCA section 6. However, the requirements listed in TSCA section
6(a) do not allow the Agency to compel a manufacturer to alter existing
or develop new product designs. To the extent that the prohibitions and
restrictions on manufacturing, processing, or distribution in commerce
available in TSCA sections 6(a)(1) and (2) could be interpreted as
affecting the design of a product, such issues are described in Unit
III.B. To the extent that EPA may apply the TSCA section 6(a)(6)
requirement to prohibit or otherwise regulate a manner or method of
disposal of a chemical substance, mixture, or article, such a
requirement would only apply to a ``manufacturer or processor or . . .
any other person who uses, or disposes of, it for commercial purposes''
and not the unspecified ``consumer market disposal methods'' cited in
the petition. Therefore, this Federal Register document does not
address this specific request.
4. 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.
B. What support did the petitioner offer?
To support the request for an order by rule that the manufacturing
producers of cigarettes eliminate the hazardous chemicals used in a
mixture with tobacco, the petitioner offers information relating to the
structure and content of cigarettes, human and environmental health
impacts related to smoking cigarettes, and human and environmental
health impacts to discarding cigarette butts (Ref. 1, pp. 2-4). Of 18
points included in that discussion, eight are attributed to an article
on the toxicity of cigarette butts and their chemical components for
fish (Ref. 2); these points are discussed in detail below. For the
remaining ten points, the petitioner does not provide, and EPA could
not identify, a reference to support the information presented, which
generally applied to the human health and environmental impacts related
to smoking cigarettes.
Regarding the eight points attributed to the article on the
toxicity of cigarette butts, the petitioner points to estimates of the
number of and volume of cigarette butts discarded worldwide (Ref. 1, p.
3, points 9, 10, and 11), as well as the general nature of chemicals in
cigarettes and cigarette filters and how such chemicals enter aquatic
ecosystems and become ``acutely toxic to fish and microorganisms''
(Ref. 1, p. 3-4, points 14, 15, and 17). The petitioner also points to
the use of ``Environmental Protection Agency standard acute fish
bioassays'' in the analysis of ``cigarette butt-derived leachate . . .
for aquatic toxicity'' and that ``[i]n laboratory experimentation, the
chemicals that leached from a single cigarette butt (soaked for 24
hours in a liter of water) released enough toxins to kill 50 percent of
the saltwater and freshwater fish exposed to it for 96 hours'' (Ref. 1,
p. 3-4, points 16 and 18).
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, pp. 4-5), though TSCA section 21 does not provide an avenue for
recourse under such Act. The petitioner states ``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]igarettes are unreasonable;'' and (2)
``[c]igarette [d]isposal presents a clear unreasonable risk to the
[e]nvironment.'' (Ref. 1, pp. 5-6). To support the former claim, the
petitioner makes general references to, but does not cite or provide
for reference United States v. Philip Morris USA Inc., 449 F. Supp. 2d
1 (D.D.C. 2006). To support the latter claim, the petitioner states
that ``research studies of toxic waste entering the environment are
clear in identifying cigarette butts 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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#cigarettes">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#cigarettes</a>. 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 under TSCA
section 6(a). 15 U.S.C. 2605(a).
EPA evaluated the information presented in the petition and
considered that information in the context of the applicable
authorities and requirements of TSCA sections 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 as
defined in TSCA sections 6(a) and 21(b)(1) because the petitioner
because cigarettes are not a product that can be regulated under TSCA
section 6(a). These deficiencies, among other findings, are detailed in
this document.
[[Page 59934]]
As previously discussed, TSCA section 6(a) authorizes EPA to
determine if a chemical substance or mixture in manufacturing,
processing, distribution in commerce, use, disposal, or any combination
of these activities presents an unreasonable risk of injury to health
or the environment. If unreasonable risk to health or the environment
is determined, then EPA must, by rule, issue regulations apply one or
more of the following requirements to the extent necessary to that the
chemical substance no longer presents such risk. However, TSCA section
3(2)(B), which defines ``chemical substance,'' excludes ``tobacco or
any tobacco product.'' According to section 201(rr) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), ``tobacco product'' means ``any
product made or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a tobacco
product.'' 21 U.S.C. 321(rr)(1). Section 900(3) of the FFDCA
establishes that a ``cigarette'' is ``a product that . . . is a tobacco
product . . . and . . . includes tobacco, in any form, that is
functional in the product, which, because of its appearance, the type
of tobacco used in the filler, or its packaging and labeling, is likely
to be offered to, or purchased by, consumers as a cigarette or as roll-
your-own tobacco,'' and section 901(b) of the FFDCA makes clear that
FDA has authority over ``all cigarettes, cigarette tobacco, roll-your-
own tobacco, and smokeless tobacco.'' 21 U.S.C. 387(3) and 387a(b).
Finally, cigarette butts are not considered as a separate item from a
cigarette or tobacco product. (See, e.g., FFDCA sections 904(a)(1)
(``the tobacco, paper, filter, or other part of each tobacco product'')
and 907(a)(1)(A) (``a cigarette or any of its component parts
(including the . . . filter, or paper)''). 21 U.S.C. 387d(a)(1) and
387g(a)(1)(A). EPA thus determined that a ``cigarette'' is a ``tobacco
product,'' and, therefore, is not a ``chemical substance.'' Similarly,
EPA determined that ``tobacco'' is not a ``chemical substance.''
Therefore, EPA cannot issue a rule pursuant to TSCA section 6(a) to
apply requirements to tobacco or cigarettes.
TSCA section 3(2)(B) also excludes ``any mixture'' from the
definition of ``chemical substance.'' TSCA section 3(10) defines
``mixture'' generally 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'' (emphasis added).
Because the petition references ``hazardous chemicals used in a mixture
with tobacco'' and the Agency determined that ``tobacco'' is not a
``chemical substance,'' EPA determined that a combination of chemicals
with tobacco is not a mixture as defined by TSCA section 3(10).
Therefore, EPA cannot issue a rule pursuant to TSCA section 6(a) to
apply requirements to ``hazardous chemicals used in a mixture with
tobacco.''
Additionally, 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 of a rule under TSCA section 6(a)
because TSCA section 3(2)(B) excludes from the definition of ``chemical
substance'' ``any mixture'' and ``tobacco or any tobacco product.''
Because the Agency determined a cigarette (including a cigarette butt)
to be a tobacco product, such products are not chemical substances and
cannot be subject to a rule issued under TSCA section 6(a). Because EPA
also determined that a combination of chemicals with tobacco is not a
mixture as defined by TSCA section 3(10), such a combination cannot be
subject to a rule issued under TSCA section 6(a).
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. Received August 2, 2021.
2. Slaughter, E., Gersberg, R.M., Watanabe, K., Rudolph, J.,
Stransky, C., & Novotny, T.E. (2011). Toxicity of cigarette butts,
and their chemical components, to marine and freshwater fish.
Tobacco control, 20 Suppl 1(Suppl_1), i25-i29. <a href="https://doi.org/10.1136/tc.2010.040170">https://doi.org/10.1136/tc.2010.040170</a>.
Authority: 15 U.S.C. 2601 et seq.
Dated: October 25, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-23569 Filed 10-28-21; 8:45 am]
BILLING CODE 6560-50-P
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