[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 [www.gpo.gov]
[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 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 
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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#cigarettes. 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. https://doi.org/10.1136/tc.2010.040170.

    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]
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