Polyvinyl Alcohol (PVA); TSCA Section 21 Petition for Rulemaking; Reasons for Agency Response; Denial of Requested Rulemaking, 25590-25600 [2023-08864]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Proposed Rules]
[Pages 25590-25600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08864]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2022-0923; FRL-10453-01-OCSPP]


Polyvinyl Alcohol (PVA); TSCA Section 21 Petition for Rulemaking; 
Reasons for Agency Response; Denial of Requested Rulemaking

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: On January 26, 2023, EPA received a petition from Blueland, 
Plastic Pollution Coalition, and partners, including Beyond Plastics, 
Plastic Oceans International, The Shaw Institute, Lonely Whale, 5 
Gyres, Global Alliance for Incinerator Alternatives (GAIA), Oceanic 
Global Foundation, The Last Beach Cleanup, Rio Grande International 
Study Center, Inland Ocean Coalition, Occidental Arts and Ecology 
Center, Turtle Island Restoration Network, Friends of the Earth, 
Surfrider, and Made Safe. The petition requests under the Toxic 
Substances Control Act (TSCA) that EPA require manufacturers and 
processors of polyvinyl alcohol (PVA) affiliated with EPA's Safer 
Choice certification program to fund and conduct health and 
environmental safety testing using independent, third-party scientists. 
The petition also requests under the Administrative Procedure Act (APA) 
that EPA update the status of PVA on EPA's Safer Chemical Ingredients 
List (SCIL) from ``green circle'' to ``gray square'' until the testing 
is complete and reviewed by EPA. The Safer Choice program is a 
voluntary EPA program that certifies cleaning and other products made 
with ingredients that meet criteria for human health and the 
environment and manages these safer ingredients on the SCIL. After 
careful consideration, the EPA has denied the TSCA petition and APA 
petition requests for reasons discussed in this document.

DATES: EPA's response to the petition was signed on April 21, 2023.

ADDRESSES: EPA established a docket for this petition under docket 
identification (ID) number EPA-HQ-OPPT-2022-0923 which is available 
online at https://www.regulations.gov. Additional instructions on 
visiting the docket, along with more information about dockets 
generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Brian Barone, Data Gathering and Analysis Division (7406M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-0233; 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. However, this 
action may be of particular interest to those who manufacture 
(including import), distribute in commerce, process, use, or dispose of 
polyvinyl alcohol (PVA). Since other entities may also be interested, 
the Agency has not attempted to describe all of 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 has 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.
    Under the Administrative Procedure Act (APA) section 553(e), any 
person may petition for a rule's issuance, amendment, or repeal. 
Petitions should identify the rule requested to be repealed or provide 
the text of a proposed rule or amendment and include reasons supporting 
the petition. The agency may either grant the petition, undertake 
public rulemaking proceedings, or deny the petition. If an agency 
grants a petition for rulemaking--thereby initiating an action to 
issue, amend, or repeal a rule per request of the petitioner--any 
relevant procedural requirements for rulemaking or other types of 
action would still apply. In the case of the full or partial denial of 
a petition, prompt notice is given to the interested parties. Except in 
affirming a prior denial or when the denial is self-explanatory, the 
notice shall be accompanied by a brief statement of the grounds for 
denial.

C. What criteria apply to the decision on the 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 the provisions under which actions have been requested 
to evaluate this TSCA section 21 petition.
    2. Legal standard regarding TSCA section 4.
    TSCA section 21(a) authorizes any person to petition the Agency to 
``initiate a proceeding'' for the issuance of a rule or an order under 
TSCA section 4. 15 U.S.C. 2620(a). To grant a petition for the testing 
of a chemical substance, EPA must find that the petitioners ``set forth 
the facts which it is claimed establish that it is necessary'' for 
testing under TSCA section 4(a)(1)(A)(i), TSCA section 4(a)(1)(A)(ii), 
or TSCA section 4(a)(1)(B). If the information the petitioner provides 
fails to present such facts, the petition must be denied. Additionally, 
if testing is initiated under TSCA section 21, TSCA section 4(h) 
dictates requirements for limiting testing on vertebrate animals. The 
specific section 4 provisions are provided in the units that follow.

[[Page 25591]]

    a. Legal standard regarding TSCA section 4(a)(1)(A)(i) and TSCA 
section 4(a)(1)(A)(ii).
    Under TSCA section 4(a)(1)(A)(i), in order to initiate a rule or 
order, EPA must find that the manufacture, distribution in commerce, 
processing, use, or disposal of a chemical substance or mixture, or 
that any combination of such activities, may present an unreasonable 
risk of injury to health or the environment; that information and 
experience are insufficient to reasonably determine or predict the 
effects of such activity or activities on health or the environment; 
and that testing of the chemical substance or mixture is necessary to 
develop the missing information. 15 U.S.C. 2603(a)(1)(A)(i).
    Under TSCA section 4(a)(1)(A)(ii), in order to initiate a rule, EPA 
must find that the chemical substance or mixture is or will be produced 
in substantial quantities, and it enters or may reasonably be 
anticipated to enter the environment in substantial quantities or there 
is or may be significant or substantial human exposure to such 
substance or mixture; that information and experience are insufficient 
to reasonably determine or predict the effects of the manufacture, 
distribution in commerce, processing, use, or disposal of the chemical 
substance or mixture on health or the environment; and that testing of 
the chemical substance or mixture is necessary to develop the missing 
information. 15 U.S.C. 2603(a)(1)(A)(ii).
    b. Legal standard regarding TSCA section 4(a)(1)(B) and 
relationship to TSCA section 21(b)(4).
    In the case of a mixture, per TSCA section 4(a)(1)(B), EPA must 
also find that the effects which the mixture's manufacture, 
distribution in commerce, processing, use, or disposal, or any 
combination of such activities, may have on health or the environment 
may not be reasonably and more efficiently determined or predicted by 
testing the chemical substances which comprise the mixture. 15 U.S.C. 
2603(a)(1)(B). In addition, TSCA section 21 establishes standards a 
court must use to decide whether to order EPA to initiate rulemaking in 
the event of a lawsuit filed by the petitioner after denial of a TSCA 
section 21 petition. 15 U.S.C. 2620(b)(4)(B). EPA believes TSCA section 
21(b)(4) does not provide for judicial review of a petition to 
promulgate a test rule for mixtures. TSCA section 21(b)(4)(B)(i) 
specifies that the court's review pertains to application of the TSCA 
section 4 factors to chemical substances. Moreover, TSCA section 
21(b)(4)(B)(i) does not contain the additional finding that TSCA 
section 4 requires for issuing a test rule for mixtures (that the 
effect may not be reasonably and more efficiently determined or 
predicted by testing the chemical components). Congress left the 
complex issues associated with the testing of mixtures to the 
Administrator's discretion.
    c. Legal standard regarding TSCA section 4(h).
    TSCA section 4(h) requires EPA to reduce and replace the use of 
vertebrate animals in the testing of chemical substances or mixtures, 
to the extent practicable, scientifically justified, and consistent 
with the policies of TSCA. 15 U.S.C. 2603(h).
    3. Legal standard regarding TSCA section 26.
    TSCA section 26(h) requires EPA, in carrying out TSCA sections 4, 
5, and 6, to make a decision 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 six considerations, including the 
relevance of information and any uncertainties. TSCA section 26(i) 
requires that decisions under TSCA sections 4, 5, and 6 be ``based on 
the weight of scientific evidence.'' Finally, TSCA section 26(k) 
requires that EPA consider reasonably available information in carrying 
out TSCA sections 4, 5, and 6.

II. Summary of the Section 21 Petition

A. What action was requested under TSCA section 21?

    On January 26, 2023, EPA received a TSCA section 21 petition (Ref. 
1) from Blueland, Plastic Pollution Coalition, and partners Beyond 
Plastics, Plastic Oceans International, The Shaw Institute, Lonely 
Whale, 5 Gyres, GAIA (Global Alliance for Incinerator Alternatives), 
Oceanic Global Foundation, The Last Beach Cleanup, Rio Grande 
International Study Center, Inland Ocean Coalition, Occidental Arts and 
Ecology Center, Turtle Island Restoration Network, Friends of the 
Earth, Surfrider, and Made Safe (petitioners) to initiate a rulemaking 
proceeding or issue an order under the authorities afforded to EPA 
under TSCA section 4(a)(1), compelling health and environmental effects 
tests under the TSCA on PVA and ``ultimately regulate PVA used in 
dishwasher and laundry pods and sheets as a toxic substance, pending 
the results from testing'' (Ref. 1, Pg. 11). This petition specifically 
requests a test order be issued to those manufacturers and processors 
of PVA who ``are part of the EPA Safer Choice Program, have products 
with the EPA Safer Choice certification, and who are seeking an EPA 
Safer Choice certification for pods or sheets products'' (Ref. 1, pg. 
11). The petitioners request that EPA require the test order recipients 
to fund and conduct this testing under the guidance and direction of 
independent, third-party scientists.

B. What support did the petitioners offer for the TSCA section 21 
request?

    By referencing TSCA section 4(a)(1) the petitioners assert that EPA 
can direct manufacturers and/or processors to test a chemical substance 
or mixture if all three of the following findings are made:
     The manufacture, distribution in commerce, processing, 
use, or disposal of a chemical substance or mixture, or that any 
combination of such activities, may present an unreasonable risk of 
injury to health or the environment or is produced in substantial 
quantities and it enters or may reasonably be anticipated to enter the 
environment in substantial quantities or there is or may be significant 
or substantial human exposure to such substance or mixture;
     There is insufficient information and experience upon 
which the effects of such manufacture, distribution in commerce, 
processing, use, or disposal of such substance or mixture or of any 
combination of such activities on health or the environment can 
reasonably be determined or predicted; and
     Testing of such substance or mixture with respect to such 
effects is necessary to develop such information.
    The petitioners assert that ``Given the potential for PVA to 
persist in the environment as a harmful plastic pollutant, this 
petition requests that the EPA require health and environmental safety 
tests under the Toxic Substances Control Act'' (Ref. 1, pg. 11). 
Although not explicitly stated, EPA interprets this assertion as 
indicating that the petitioners believe PVA may present an 
``unreasonable risk of injury to health or the environment.'' 
Similarly, the petitioners provide estimates of the use of PVA-wrapped 
laundry pods in the United States (Ref. 1, pg. 3), which EPA interprets 
as an assertion that PVA is ``produced in substantial quantities.'' The 
evidence the petitioners provide for each assertion is detailed in the 
units that follow.
    1. May present an unreasonable risk of injury to health or the 
environment or produced in substantial quantities.
    a. May present an unreasonable risk of injury to health or the 
environment.
    In support of the belief that PVA may present an unreasonable risk 
of injury to

[[Page 25592]]

health or the environment, the petitioners provide some references 
which specifically discuss PVA, while others focus generally on 
microplastics (Ref. 1, pg. 5-6). Based on the references provided, the 
petitioners conclude that ~75% of PVA from dishwasher and laundry pods 
persist through conventional wastewater treatment, passing into 
waterways and ecosystems beyond (Ref. 1, pg. 4 and 6). Petitioners 
claim that PVA could bioaccumulate and potentially absorb dangerous 
contaminants and move those contaminants up the food chain (Ref. 1, pg. 
3 and 6). Although it is not explicitly stated, from these claims the 
Agency infers that the petitioners believe that PVA may present an 
``unreasonable risk of injury to health or the environment.''
    b. May be produced in substantial quantities.
    The petitioners do not directly provide a statement indicating that 
they believe PVA is produced in ``substantial quantities'' as discussed 
in TSCA section 4(a)(1). Typically, substantial quantities are defined 
by EPA as any production in excess of one million pounds per year (Ref. 
2, pg. 6). The petition states that ``. . . over 20 billion PVA wrapped 
laundry and dishwasher pods are used every year in the United States 
alone'' (Ref. 1, pg. 3). The petition also cites a study by Rolsky and 
Kelkar, which estimates that ``17,200  5000 metric ton 
units per year (mtu/yr) of PVA are used . . . [in laundry detergent 
pods] in the United States'' (Ref. 3, pg. 1; see also Ref. 1, pg. 6). 
Although it is not explicitly stated, the Agency infers through the 
discussion of volumes of PVA used and the discussed widespread consumer 
uses of soluble PVA that the petitioners believe that the soluble PVA 
films used in detergent pods are produced in ``substantial quantities'' 
and ``there is or may be significant or substantial human exposure to 
such substance.''
    2. Insufficiency of information and experience.
    The petitioners assert, ``Further research is needed to determine 
the potential hazards that polluted PVA can pose to ecosystems and 
human health'' (Ref. 1, pg. 14). To support their assertion, the 
petitioners did not provide evidence of a literature search or data gap 
analysis. However, a literature review was conducted as part of the 
study by Rolsky and Kelkar (Ref. 3, pg. 3) related to the fate of PVA 
in wastewater treatment plants. The objective of this study was to 
estimate the US nationwide emissions of PVA resulting from domestic use 
of laundry and dish detergent pods corroborated by a nationwide, online 
consumer survey and a literature review of its fate within conventional 
wastewater treatment plants (WWTPs) (Ref. 3, pg. 1). As evidence of 
insufficient information and experience related to the effects of PVA 
on health and the environment, the petitioners reference the testing 
methods commonly used to establish biodegradability, including 
Organization for Economic Cooperation and Development (OECD) 301 and 
OECD 310 tests for Ready Biodegradability (Ref. 1, pg. 9). The 
petitioners believe that these testing procedures are insufficient to 
evaluate biodegradation in wastewater treatment plants and assert that 
there are ``critical gaps between the OECD tests and real-world WWTP 
conditions'' (Ref. 1, pg. 10). The petitioners assert that the 
established OECD testing methodologies are inadequate for the 
evaluation of the biodegradation of PVA due to the testing conditions 
differing from those present in a wastewater treatment plant (Ref. 1, 
pg. 9-10). The petitioners also assert that the elapsed time required 
for PVA to degrade in these tests is not being evaluated appropriately 
(Ref. 1, pg. 10).
    3. Need for testing.
    The petitioners claim that PVA poses unknown dangers to the 
environment, and further research is needed to understand PVA's ability 
to absorb and bioaccumulate dangerous contaminants up the food chain 
(Ref. 1, pg. 6). Additionally, the petitioners claim that the 
established OECD tests for inherent biodegradation are insufficient to 
determine if PVA poses a risk to human health and the environment (Ref. 
1, pg. 10-12).

C. What additional information did EPA receive regarding the TSCA 
section 21 request?

    As a result of this petition, Proctor and Gamble has made available 
to EPA previously unreleased tests related to the biodegradability and 
toxicity of the forms of PVA used in detergent pods and sheets. EPA has 
posted this information in the petition docket, which is available to 
the public for review online at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#polyvinyl.

III. Disposition of Section 21 Response

A. What was EPA's response?

    After careful consideration, EPA has denied the section 21 portion 
of this petition. A copy of the Agency's response, which consists of 
the letter to the petitioners and this document, is posted on the EPA 
petition website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#reporting. The response, the 
petition (Ref. 1), and other information is available in the docket for 
this TSCA section 21 petition (see ADDRESSES).

B. What was EPA's reason for this response?

    In considering the petition within the statutory 90-day petition 
review period, EPA evaluated the information presented or referenced in 
the petition and considered that information in the context of the 
applicable authorities and requirements contained in TSCA sections 4, 
21, and 26, as previously described in Unit I.C. of this document. 
Also, notwithstanding that the burden is on the petitioners 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 
evaluated relevant information that was reasonably available to the 
Agency during the 90-day petition review period.
    EPA finds the petitioners have not provided the facts necessary for 
the Agency to determine that existing information and experience are 
insufficient and that testing of such substance or mixture with respect 
to such effects is necessary to develop such information. These 
deficiencies, among other findings, are detailed in this document.
    1. May present unreasonable risk of injury to health or the 
environment or produced in substantial quantities.
    EPA is not opining on the sufficiency of the information presented 
for purposes of determining whether PVA may present unreasonable risk 
because the Agency finds that petitioners have not provided the facts 
necessary for the Agency to determine that existing information and 
experience are insufficient and that testing with respect to such 
effects is necessary to develop such information, as described in more 
detail later in this document. However, EPA agrees that PVA is or will 
be produced in substantial quantities and that there is or may be 
significant or substantial human exposure due to its common use in 
agriculture, foodstuffs, cleaning, and personal-care products. 15 
U.S.C. 2603(a)(1)(A)(ii)(I).
    2. Insufficiency of information in the petition.
    The petition does not set forth the facts necessary to demonstrate 
that there is ``insufficient information and experience'' on which the 
effects of PVA can reasonably be determined or predicted, as TSCA 
section 4(a)(1) requires.
    Although the petitioners point to some evidence that there is 
insufficient

[[Page 25593]]

information on soluble versions of PVA commonly used in detergent pods 
and sheets, the information supplied by petitioners is only a sample of 
the information available on the health and environmental risks 
potentially associated with PVA. The petitioners primarily rely on a 
study that models the potential extent of biodegradation of soluble 
versions of PVA at wastewater treatment plants, and a limited number of 
additional studies related to PVA and microplastics. The petitioners 
also assert that, ``[m]any of the tests used to determine PVA's 
biodegradability rely on OECD standards for biodegradability. While 
OECD biodegradability standards can be an important tool to determine a 
material's end of life implications, in the case of PVA and current 
conditions within WWTPs, these tests are insufficient'' (Ref. 1, pg. 
14). Petitioners rely on this assertion to claim that there is a data 
need for biodegradability of PVA in real world scenarios to inform 
EPA's understanding of health and environmental effects from PVA. 
However, as explained in further detail in the Unit V.B.1, the OECD 
biodegradation test conditions are more conservative than real world 
conditions in WWTPs and are appropriate tools for predicting 
biodegradation of PVA. The petitioners have not provided the facts to 
show that ``there is insufficient information and experience'' per TSCA 
section 4(a)(1)(A)(i)(II).
    Furthermore, the petitioners failed to acknowledge the nature and 
extent of existing data and articulate why these data are insufficient. 
While the petitioners point to a single study that models the potential 
extent of biodegradation of soluble versions of PVA at wastewater 
treatment plants, and a limited number of additional studies related to 
PVA and microplastics, they do not refer to or provide an assessment of 
other reasonably available health and environmental effects studies 
completed on the soluble versions of PVA commonly used in detergent 
pods and sheets. EPA performed a cursory search of publicly available 
databases on the endpoints raised by the petition request (i.e., 
biodegradation, toxicity, and bioaccumulation potential of PVA) and has 
found that there is, at a minimum, one study assessing the 
biodegradation of PVA using non-OECD test guidelines, as well as 
multiple studies--which were not identified or considered by the 
petitioner--on the toxicity and bioaccumulation potential of PVA 
available in the public domain. These studies include, but are not 
limited to, materials related to the approval of PVA as a food 
additive, approval for use in pharmaceutical products, and approval for 
use in medical appliances and devices, some of which are as follows:
     ``Review of the oral toxicity of polyvinyl alcohol (PVA)'' 
(Ref. 4) was published in the journal Food and Chemical Toxicology in 
March 2003. The study investigated the toxicity of PVA in association 
with its use as an indirect food additive and coating agent for 
pharmaceutical and dietary supplement products. The study concluded 
that orally administered PVA has low oral toxicity, is poorly absorbed 
from the gastrointestinal tract, does not bioaccumulate when 
administered orally, and is not mutagenic or clastogenic.
     ``Assessment of Toxicity and Biodegradability of 
Poly(vinyl alcohol) Based Materials in Marine Water'' (Ref. 5) was 
published in the journal Polymers in September 2021. This study 
characterizes the biodegradation and ecotoxicity of PVA polymers in 
marine environments. The results support the limited biodegradability 
of PVA materials under conditions representative of a natural marine 
environment but also concluded that none of the tested polymers pose a 
relevant risk to the model marine organism used in the studies.
     ``Final Report on the Safety Assessment of Polyvinyl 
Alcohol'' (Ref. 6) was published in The International Journal of 
Toxicity in 2003. In this study, PVA was evaluated by the Cosmetic 
Ingredient Review Expert Panel. The study included an assessment of 
general biology, toxicology, mutagenicity, carcinogenicity, and a 
clinical assessment of the safety of PVA. The CIR Expert Panel 
concluded that Polyvinyl Alcohol is safe for use in cosmetic 
formulations.
     The European Food Safety Authority (EFSA) released its 
``Opinion of the Scientific Panel on Food Additives, Flavourings, 
Processing Aids and Materials in Contact with Food (AFC) related to the 
use of polyvinyl alcohol as a coating agent for food supplements'' in 
2006. (Ref. 7). In this report, EFSA provides an evaluation of PVA as a 
food additive. The report included an assessment of an analysis of 
toxicological data, the reaction and fate of PVA in food, and exposure 
levels to PVA through ingestion in order to assess its safety for use 
in food supplements. The panel concluded that the consumption of the 
PVA through the use as a coating agent for food supplement tablets and/
or capsules at its intended use level is not a safety concern.
    Specific to the petitioner's claim that there is a data gap 
regarding the biodegradation endpoint because OECD guidelines fail to 
inform real world scenarios at WWTPs, the petitioners do not provide an 
inventory of other biodegradation data on PVA that could potentially 
address the purported data need. In addition to not identifying 
existing studies, the petitioners have not provided facts to show why 
such studies or other existing resources are insufficient to inform the 
characterization of biodegradation of PVA in the real world at WWTPs. 
Because EPA, upon a cursory review, has been able to easily identify 
existing, reasonably available information on PVA's biodegradation and 
toxicity potential not mentioned in the petition, the petitioners have 
failed in carrying their burden of setting forth facts which are 
necessary to demonstrate that there is insufficient information, 
thereby necessitating the requested action. The petitioners do not 
provide evidence that a literature search of publicly available 
information has been completed, have not included an analysis and 
characterization of the results of such a literature search, and have 
not provided an inventory of knowledge they claim is missing from the 
public domain, specifically the ``health and environmental safety 
tests'' they claim are needed because ``there is insufficient 
information and experience upon which the effects of such manufacture, 
distribution in commerce, processing, use, or disposal of such 
substance or mixture or of any combination of such activities on health 
or the environment can reasonably be determined or predicted'' per TSCA 
section 4(a)(1)(A)(i)(II).
    EPA finds the petitioners have not incorporated available existing 
information related to their request, or adequately indicated that gaps 
were located for data needed in order for EPA to make a decision using 
the best available science. Such an evaluation is necessary for EPA to 
carry out TSCA section 4, as provided under TSCA section 26(h).
    3. Testing of such substance or mixture with respect to such 
effects is necessary to develop such information.
    No evidence of toxicity or bioaccumulation potential for the 
soluble form of PVA used in detergent pods and sheets has been 
presented in the petition to the extent necessary to warrant EPA 
initiating a TSCA section 4 action. The petitioners provide no further 
information identifying specific gaps in the data already available to 
the public, or why additional testing in lieu of other data generation 
methods, such

[[Page 25594]]

as modeling or using existing analog data as read across, is necessary 
under TSCA section 4(a)(1)(A). The petitioners' request for ``full 
environmental and human health tests on both untreated and treated 
PVA'' also lacks specificity. For example, the petitioner did not 
specify the relevant PVA Chemical Abstracts Service Registry Number 
(CASRN) or polymer structure required for testing. EPA notes that the 
PVA used in consumer products and industry varies based on polymer 
size, degree of hydrolysis, solubility, and other physical and chemical 
characteristics (Ref. 4, pg. 144). These PVA structures are represented 
by several different CASRNs. Therefore, any requested testing should 
provide detail on which specific chemical substance, or category of 
chemical substances, testing should be conducted. In addition, the 
petitioners could have presented information about the types of tests 
that could be conducted, including some analysis of the methods that 
could be used to identify the data or information submitted or used, 
hazard thresholds recommended, and exposure estimates. The need for 
more specificity regarding testing requirements and a failure to 
identify the PVA forms that may require additional testing and studies 
disallows sufficient evaluation of associated data necessary to 
determine the need for new testing.
    EPA finds the petitioners have not explained why the testing 
requested, as compared to other testing or other data generation 
methods, would provide the quality of data being sought in order for 
EPA to make a decision using the best available science. Such an 
evaluation is necessary for EPA to carry out TSCA section 4, as 
provided under TSCA section 26(h).
    4. Request for oversight by a third party.
    Regarding the petitioners' request that testing be conducted only 
under the guidance and direction of independent third-party scientists, 
EPA finds that such an oversight arrangement is not in keeping with the 
authority provided under TSCA section 21. See Ctr. for Envtl. Health, 
et al. v. EPA, No. 7:22-CV-00073-M, slip op. at 25-26 (E.D.N.C. March 
30, 2023). Additionally, the petition has not demonstrated a need for 
additional measures ensuring the reliability of studies required under 
TSCA section 4 beyond that already provided in the Good Laboratory 
Practice Standards in 40 CFR part 792, and the petitioners provide no 
legal, administrative, or organizational procedures for the 
implementation of such oversight. Therefore, the Agency has no 
obligation to grant or deny this request. All test orders must be 
planned and completed in a manner consistent with the best available 
science per TSCA section 26(h). To that end, EPA conducts reviews of 
all testing plans, reports, and test data to ensure the validity of 
results. When reviewing data in response to a TSCA section 4 test 
order, EPA is required to consider the extent to which information, 
procedures, measures, protocols, and methodologies or models employed 
are ``reasonable for and consistent with the intended use of the 
information.'' EPA also must consider, per TSCA section 26(i), the 
extent of independent verification and peer review and ``shall make 
decisions under sections 4, 5, and 6 based on the weight of the 
scientific evidence.''

C. What were EPA's conclusions under TSCA section 21?

    EPA is denying the request to initiate a rule or issue an order 
under TSCA section 4 because the TSCA section 21 petition does not set 
forth the facts necessary for the Agency to determine that existing 
information and experience are insufficient and testing of such 
substances or mixture with respect to such effects is necessary to 
develop such information. Therefore, the petitioners have yet to 
demonstrate that the rule or order they requested is necessary.
    Additionally, because the authorities provided to EPA under TSCA 
section 4 specifically relate to test rules, enforceable consent 
agreements, or orders issued directly to manufacturers and/or 
processors of a chemical substance, any requests made under section 4 
that extend beyond those statutory authorities cannot be granted. 
Therefore, the petitioners' request for the EPA to require third-party 
oversight of PVA testing, paid for by manufacturers and/or processors 
is outside of the authorities provided in TSCA section 4.

IV. Administrative Procedure Act Petition

A. What action was requested under Administrative Procedures Act?

    The petitioners also asked EPA to change the geometric color code 
indicating the status of PVA on the Safer Chemical Ingredients List 
(SCIL) from a green circle to a gray square until the health and 
environmental safety testing requested in the TSCA section 21 portion 
of the petition is complete (Ref. 1, pg. 13-14). EPA is responding to 
this portion of the petition under the APA.

B. What support and rationale do the petitioners offer for the APA 
request?

    The petitioners define PVA as ``a synthetic, petroleum-derived 
polymer'' with many applications and commonly ``used as a plastic film 
in all dishwasher and laundry pods and sheets'' (Ref. 1, pg. 3). The 
petitioners state that PVA ``can contribute to plastic pollution in 
oceans, waterways and soil . . . and may negatively impact ecosystems 
and the food and water supply'' (Ref. 1, pg. 3), citing Rolsky and 
Kelkar (Ref. 3). The petitioners also suggest that PVA meets EPA's 
definition of a persistent, bioaccumulative, and toxic (PBT) substance 
(Ref. 1, pg. 13-14).
    In support of their claims, the petitioners provide information on 
the persistence and bioaccumulation potential of PVA. The petitioners 
also address marketing claims by companies regarding the use of PVA in 
products. The petitioners' arguments on these topics are summarized in 
the units that follow.
    1. Persistence of PVA.
    The petitioners cite research that models PVA as it travels through 
a wastewater treatment plant. This modeling estimates that 77 percent 
of PVA remains intact after passing through conventional wastewater 
treatment (Ref. 3; see also Ref. 1, pg. 7-8). Based on these results, 
the authors suggest that the incomplete degradation of PVA results in 
the release of PVA into the aquatic environment through WWTPs effluent 
and the terrestrial environment through the application of biosolids 
(Ref. 3).
    2. Bioaccumulation of PVA.
    The petitioners posit that PVA has the potential to bioaccumulate 
(Ref. 1, pg. 13-14). The petitioners argue that PVA has the ability to 
carry toxic chemicals and carcinogens up the food chain and may be 
present in human breast milk (Ref. 1, pg. 6). EPA notes that the source 
materials in the references cited by the petitioners are specific to 
microplastics and not relevant to the types of PVA used in Safer 
Choice-certified products (Ref. 3; Ref. 8; Ref. 9).
    3. Marketing claims of PVA.
    The petitioners also describe marketing claims made in relation to 
use of PVA in products. The petitioners state that many brands market 
products containing PVA as `` `100% biodegradable' and or `100% 
plastic-free' . . . [which] can mislead consumers to think these 
products are better for the environment than they are'' (Ref. 1, pg. 
14). The petitioners further request ``that the EPA Safer Choice 
program review claims about PVA through the lens of truth in

[[Page 25595]]

advertising to ensure that consumers have accurate information about 
PVA and its potential environmental impacts'' (Ref. 1, pg. 14).

C. What is EPA's Safer Choice program?

    Safer Choice is a voluntary EPA program that certifies cleaning and 
other products made with ingredients that are safer for human health 
and the environment. Importantly, the Safer Choice program identifies 
safer ingredients by functional use within a product formulation and 
does not describe any chemicals, ingredients, or products as ``safe.'' 
EPA reviews every chemical within a product, regardless of use level, 
against the Safer Choice Standard and its applicable functional class 
criteria. Under the Safer Choice Standard, the Safer Choice criteria 
define data requirements and toxicity thresholds for a chemical to be 
considered low concern or best in class for a given functional use. 
Chemicals that meet EPA's Safer Choice criteria are eligible for 
listing on SCIL. The Safer Choice Standard also contains requirements 
(e.g., use limits) for the chemical's use in a product or formulation.
    EPA lists chemicals on the SCIL by CASRN. The CASRN-level listing 
of ingredients on SCIL is one tool that can help manufacturers as they 
formulate products with safer chemicals that may be eligible for Safer 
Choice certification. Manufacturers may not use chemicals from SCIL in 
Safer Choice-certified products unless those SCIL chemicals also meet 
the requirements of the Safer Choice Standard.
    In some cases, a single CASRN may cover a broad range of chemical 
structures. For example, for a given polymer listing, a CASRN might 
cover a range of structures and chain lengths. Similarly, for a given 
surfactant listing, a single CASRN might cover varying degrees of 
ethoxylation and propoxylation. When considering a product for Safer 
Choice certification, EPA requires complete disclosure of the name(s), 
CASRN(s), and concentration(s) of all chemicals in a formulation. If a 
proposed formulation includes a SCIL chemical with a CASRN that covers 
a broad range of chemical structures, EPA also requires disclosure of 
the structure(s) under the CASRN associated with that chemical. EPA 
evaluates data associated with these specific structures and allows use 
of only chemicals with structures that meet both the Safer Choice 
Standard and criteria to be used in Safer Choice-certified products.
    1. PVA applicability in the Safer Choice program.
    The structure and function of PVA can vary depending on how the 
chemical is synthesized. PVA is generated by hydrolyzing polyvinyl 
acetate--converting acetates to alcohols--resulting in either partially 
hydrolyzed or fully hydrolyzed PVA. The extent of hydrolysis, polymer 
size, and monomer arrangement impart physical-chemical properties that 
impact the polymer's functionality, water solubility, degradation 
potential, and other characteristics.
    Optimum solubility in cold water is typically observed in PVA with 
a degree of hydrolysis between 87 to 89 mole percent and molecular 
weights between 25,000 and 100,000 Daltons. In contrast, fully 
hydrolyzed, high-molecular-weight PVA is highly crystalline and 
insoluble in cold water (Ref. 10). Manufacturers choose the grade of 
PVA for a given product based on function and other properties. To 
facilitate this choice, manufacturers usually characterize PVA using 
properties linked to structure, such as degree of hydrolysis and 
viscosity.
    The petitioners do not specify PVA by CASRN, structure, grade, or 
specification in the petition. The petitioners do state, however, that 
their request is targeted at ``PVA used in laundry and dishwasher 
detergent pods and sheets as these are product categories relevant to 
the EPA Safer Choice program'' (Ref. 1, pg. 1). Based on this 
description of the type of PVA of interest to the petitioners, EPA 
understands that the request to mark PVA with a grey square on the SCIL 
is specific to two relevant CASRNs listed on SCIL that cover chemicals 
used in Safer Choice-certified products. EPA relies on this 
understanding throughout the remainder of the response. On SCIL, the 
PVA polymeric structures of interest to the petitioners are represented 
under CASRN 25213-24-5 (preferred Chemical Abstract Index Name: Acetic 
acid ethenyl ester, polymer with ethenol) and CASRN 9002-89-5 
(preferred Chemical Abstract Index Name: Ethenol, homopolymer). The PVA 
structures allowed in Safer Choice-certified products, and which 
support the CASRN listings on SCIL range from 87 to 89 mole percent 
hydrolyzed with an average molecular weight ranging from 70,000 to 
215,000 Daltons. The Safer Choice program allows use of only the PVA 
structures represented under CASRN 25213-24-5 and CASRN 9002-89-5 that 
are also associated with data demonstrating the chemical(s) meet(s) the 
Safer Choice Standard and criteria.
    2. Safer Choice Program criteria for polymers.
    The Safer Choice Master- and Functional-Class Criteria, available 
at https://www.epa.gov/saferchoice/safer-choice-standard, documents 
allowable toxicity thresholds for ingredients that are acceptable for 
use in Safer Choice-certified products. Within ``functional classes,'' 
many ingredients share similar toxicological and environmental fate 
characteristics. Recognizing this similarity, the Safer Choice program 
was able to focus its criteria--and its ingredient review--on the 
environmental and health characteristics of concern within a functional 
class. This approach allows EPA to distinguish the safest chemicals in 
each functional class and allows manufacturers to use ingredients with 
lower hazard profiles while formulating high-performing products.
    The criteria for polymers are listed in EPA's Safer Choice Criteria 
for Colorants, Polymers, Preservatives, and Related Chemicals, 
available at https://www.epa.gov/saferchoice/safer-choice-criteria-colorants-polymers-preservatives-and-related-chemicals, and includes 
toxicological thresholds and data requirements polymers must meet to be 
eligible for use in Safer Choice-certified products. The following 
requirements in the criteria for environmental toxicity and fate 
endpoints are relevant to the petitioners' request:
     Limitation on Persistent, Bioaccumulative and Toxic 
chemicals: Acceptable chemicals must not be persistent (half-life >60 
days), bioaccumulative (BCF/BAF >=1,000), and aquatically toxic (LC/
EC50 <=10 mg/L or NOEC/LOEC <=1 mg/L);
     Limitation on very Persistent and very Bioaccumulative 
chemicals: Acceptable chemicals must not be very persistent (half-life 
>180 days or recalcitrant) and very bioaccumulative (>5,000); and
     Limitation on very Persistent and very Toxic chemicals: 
Acceptable chemicals must not be very persistent (half-life >180 days 
or recalcitrant) and very aquatically toxic (LC/EC50 <1.0 mg/L or NOEC/
LOEC <0.1 mg/L).
    The Safer Choice criteria also requires polymers to be screened 
against authoritative lists (specified in EPA's Safer Choice Master 
Criteria, available at https://www.epa.gov/saferchoice/safer-choice-master-criteria-safer-chemical-ingredients) for acute mammalian 
toxicity, repeated dose toxicity, carcinogenicity, genetic toxicity, 
reproductive and developmental toxicity, neurotoxicity, respiratory 
sensitization, and skin sensitization. Acceptable polymers must have 
low concern characteristics. See EPA's Safer

[[Page 25596]]

Choice Criteria for Colorants, Polymers, Preservatives, and Related 
Chemicals available at https://www.epa.gov/saferchoice/safer-choice-criteria-colorants-polymers-preservatives-and-related-chemicals.
    When necessary, EPA reviews information on chemicals or suitable 
analogs against the criteria using a weight-of-evidence (WOE) approach. 
For this WOE approach, EPA prefers experimental data but also considers 
estimated measures of fate and toxicity from predictive tools that are 
based on a chemical's physical/chemical properties and structural and/
or biological similarity to known chemicals of concern. EPA's Safer 
Choice Master Criteria, available at https://www.epa.gov/saferchoice/safer-choice-criteria-colorants-polymers-preservatives-and-related-chemicals, outlines preferred toxicological test methods for the data 
used in Safer Choice chemical reviews. The preferred test methods 
include OECD Guideline studies, which are accepted internationally by 
professionals in environmental advocacy groups, industry, academia, and 
government as standard methods for characterizing chemicals. These 
Guidelines are updated as needed to ensure they reflect the latest 
science and techniques, in consultation with experts from regulatory 
agencies, academia, industry, and environmental and animal welfare 
organizations, and available at https://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_72d77764-en. 
The preferred test methods also include EPA OPPT Test Guidelines that 
were developed in consideration of the guidelines published by the 
OECD, available at https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances. Standardized methods and guidelines are essential for 
proper comparison of chemical hazard profiles and to identify those 
that are considered safer.

V. Disposition of the APA Portion of the Petition

A. What was EPA's response?

    EPA has considered the evidence presented by petitioners and is 
denying the request to remove PVA from SCIL for two reasons: (1) The 
petition does not demonstrate that PVA fails to meet the Safer Choice 
criteria, and (2) The data cited and explained in this unit indicate 
that the PVA structures allowed for use in Safer Choice-certified 
products under the EPA Safer Choice Standard meet the criteria of the 
program. The petition cites five blogs and eight peer-reviewed journal 
articles. Most of these focus on the environmental impacts of 
microplastics rather than the soluble PVA used in Safer Choice-
certified products. EPA identified additional peer-reviewed literature 
not discussed in the petition that is relevant to the PVA structures 
used in Safer Choice-certified products.

B. What was EPA's reason for this response?

    The petitioners cite a portion of the Safer Choice Criteria for 
Colorants, Polymers, Preservatives, and Related Chemicals and write 
that ``if a polymer does break down into PBTs, it should be excluded 
from the EPA Safer Chemical list [sic]'' (Ref. 1, pg. 13). ``PBT'' in 
this text stands for persistent, bioaccumulative, and toxic chemical 
substances (86 FR 894, January 6, 2021 (FRL-10018-88)). EPA will 
address the persistence, bioaccumulation, and toxicity endpoints 
individually and explain that the PVA used in Safer Choice-certified 
products is not a ``PBT'' in the units that follow.
    1. Persistence of PVA.
    The petitioners state that ``dissolved PVA enters WWTPs but ~75 
percent exits WWTPs intact'' (Ref. 1, pg. 7). The referenced Rolsky 
paper more specifically references the potential for PVA to persist 
within the environment with an estimated 77 percent of PVA (61.2 
percent via biosolid sludge and 15.7 percent via wastewater effluent) 
remaining intact after wastewater treatment (Ref. 3, pg. 10). The 
petitioners also state that ``in conventional WWTPs within the United 
States, specific PVA-adapted bacteria and microbes are needed to aid in 
the near to complete degradation of PVA, though they are not likely 
present'' (Ref. 3, pg. 7; see also Ref. 1, pg. 7).
    The Rolsky and Kelkar study does not use measured data and instead 
estimates or models the WWTPs emission of PVA into the environment. 
Through the following examples, EPA explains why the study has limited 
relevance to the specific PVA polymer structures allowed for use in 
Safer Choice-certified products (Ref. 3).
    A first example is that the model assumes low degradation 
efficiencies in WWTPs, with 20 percent biodegradation in aerobic sludge 
and 10 percent in anaerobic sludge. These values were taken from 
studies on PVA in textile wastewaters and highly crystalline starch and 
PVA blends used in food packaging materials (Ref. 11; Ref. 12). Blends 
such as these behave very differently from the soluble PVA structures 
used in detergent applications and are not used in Safer Choice-
certified products.
    A second example is the assumptions Rolsky and Kelkar (Ref. 3) make 
about microbial communities in WWTPs. The authors include summaries of 
studies with higher biodegradation values in supplementary Table S1, 
but disregard these values based on an assumption that PVA degrading 
bacterial species would only be found in textile wastewaters and would 
not be found in conventional WWTPs (Ref. 3, pg. 7). This is not a valid 
assumption. Recent standard ready biodegradation tests that use 
unacclimated inoculum show degradation of PVA, demonstrating that 
competent organisms are present in conventional WWTPs where the inocula 
are collected (Ref. 13; Ref. 14).
    A third example relates to Rolsky and Kelkar's assumption about 
sorption of PVA to solids. The authors' model assumes a removal 
efficiency of 30 percent in the primary clarifier and 75 percent in the 
secondary clarifier based on sorption to biosolids (Ref. 3 and 15). EPA 
expects less sorption to solids for the specific PVA structures used in 
Safer Choice-certified products based on the physical-chemical 
properties of these water-soluble PVA structures (Ref. 16; Ref. 17).
    In summary, Rolsky and Kelkar did not address a range of factors 
that are critical to the fate of PVA used in detergent films and PVA 
allowed in Safer Choice-certified products. These factors are 
associated with the structure of the chemical and include degree of 
polymerization, degree of hydrolysis, tacticity of the main chain 
(regular or irregular stereochemical configuration), ethylene content, 
and 1,2-glycol content (Refs. 3, 16; and 18).
    The petitioners state that guideline ready biodegradation tests 
(i.e., OECD 301 series and OECD 310) ``evaluate the biodegradability of 
PVA, typically in laboratories, under the most optimal circumstances 
[and] in real world scenarios within conventional WWTPs, neither the 
conditions in the lab nor the amount of time needed for PVA to fully 
biodegrade are likely to be met'' (Ref. 1, pg. 9). Guideline OECD tests 
for ready biodegradation and their EU and EPA equivalent tests are not 
intended to mimic WWTPs. Ready biodegradation tests are designed to be 
conservative screening tests, with conditions that reflect a compromise 
between ``real world'' scenarios and what is practical and economical 
to ensure consistency. Although the OECD 301 series tests were not 
significantly updated since 1992, they have undergone review by OECD, 
both in 1995 and 2006 (Ref. 19; Ref. 20).
    Because ready biodegradation tests are not simulations of WWTPs, 
the test

[[Page 25597]]

duration and biodegradation time are not directly analogous to WWTP 
conditions. The test conditions in ready biodegradation tests are less 
optimized to promote biodegradation and therefore more conservative 
than real world conditions in WWTPs. Ready biodegradation test 
inoculum, which per the testing protocol are unacclimated, have 
microorganism cell densities that are up to 10,000 times less 
concentrated than in WWTPs, resulting in a higher food-to-microorganism 
ratio (Ref. 19; Ref. 21). Ready biodegradation tests are run for 14-28 
days to encourage microbial population to acclimate and grow to a 
sufficient level before consumption of test substances (Ref. 20).
    The Safer Choice Master Criteria states that the preferred testing 
methods for screening chemicals for persistence in the Safer Choice 
program are OECD Guideline tests for ready biodegradability. Compounds 
that pass ready biodegradation tests (i.e., meet the designated pass 
levels, such as 70 percent removal of DOC, within the 28-day period of 
the test) are understood to be completely removed within WWTPs (Ref. 
19, pg. 70; Ref. 22 and 23). The Agency acknowledges that degradation 
potential may vary by PVA structure and across different environments 
(e.g., terrestrial vs. aquatic; WWTPs vs. textile and paper mill 
effluents) based on the presence of specific microorganisms. However, 
the claim that PVA ``does not fully biodegrade due to the conditions in 
most wastewater treatment plants'' (Ref. 1, pg. 4) (i.e., lack of 
microorganisms adapted to PVA) is unlikely to be correct because PVA 
biodegradation in activated sludge inoculum is well supported and 
discussed later in this unit. The inoculum allowed in the OECD 
Guideline tests for ready biodegradation may be derived from activated 
sludge, unchlorinated sewage effluents, surface waters and soils, or a 
mixture of these sources, available at https://www.oecd-ilibrary.org/environment/test-no-301-ready-biodegradability_9789264070349-en. The 
OECD Guidelines allow for pre-conditioning of the inoculum to the 
experimental conditions (e.g., aerating activated sludge in mineral 
medium or secondary effluent for 5-7 days at the test temperature), but 
do not allow for inoculum to be pre-adapted to the test substance 
(i.e., PVA) (Ref. 20).
    The Agency identified peer-reviewed literature using OECD Guideline 
studies (Ref. 14) showing PVA chemical structures used in laundry 
detergent packets are readily biodegradable. The study measured the 
persistence of four different PVA structures, with molecular weights 
ranging from 10,000-130,000 Daltons and degrees of hydroxylation of 79 
mole percent and 88 mole percent, using OECD 301B Guidelines to 
determine ready biodegradability of the structures (Ref. 14). The 
inoculum used in the study was activated, non-adapted sludge collected 
from a WWTP receiving greater than 90 percent domestic sewage in 
Fairfield, OH. The results indicated that the four PVA structures 
showed greater than 75 percent CO2 evolution after 28 days 
and greater than 87 percent CO2 evolution after 60 days, 
demonstrating that these four materials met the OECD 301B Guideline 
pass levels and are considered readily biodegradable (Ref. 14). 
Additionally, the study tested the same four PVA structures, using the 
same type of inoculum described previously, following OECD 302B 
Guidelines to determine inherent biodegradability of the structures. 
The results indicated greater than 88 percent CO2 evolution 
after 28 days, showing all four structures are also considered 
inherently biodegradable (Ref. 14). Furthermore, additional studies of 
detergent formulations and films containing PVA suggest ultimate 
biodegradation following OECD Guidelines and have half-lives less than 
60 days (Ref. 13; Ref. 24).
    According to the Safer Choice Criteria for Colorants, Polymers, 
Preservatives, and Related Chemicals, for a chemical to be classified 
as persistent or as very persistent, the half-life must be greater than 
60 days or greater than 180 days, respectively. EPA notes that 
chemicals that pass ready biodegradation tests are projected to have 
half-lives of a few hours in sewage treatment plant sludges and half-
lives of a few days in water (Ref. 25). EPA has reviewed the available 
modeled and experimental data, and EPA believes that the weight of the 
scientific evidence supports EPA's determination that the PVA 
structures used in Safer Choice certified products have a half-life of 
less than 60 days (i.e., does not meet the criterion to be classified 
as persistent or very persistent). Thus, the data supports the 
continued listing of PVA CASRN 25213-24-5 and CASRN 9002-89-5 on SCIL.
    2. Bioaccumulation of PVA.
    Bioaccumulation describes a process by which an organism 
accumulates chemical substances across various routes of exposure. 
Bioaccumulation is typically evaluated using the Bioaccumulation Factor 
(BAF). The Bioconcentration Factor (BCF) can be used as part of a 
weight-of-evidence approach when BAF information is not available. 
EPA's Safer Choice program classifies chemicals with BCF or BAF value 
greater than 1000 as bioaccumulative, as listed on the Safer Choice 
Criteria for Colorants, Polymers, Preservatives, and Related Chemicals 
at https://www.epa.gov/saferchoice/safer-choice-criteria-colorants-polymers-preservatives-and-related-chemicals. Water solubility is 
factored into BAF and BCF calculations. Chemicals with high water 
solubility have an affinity to remain in water versus bioconcentrating 
and bioaccumulating in biota (Ref. 26).
    The petitioners contend that PVA can bioaccumulate, but do not 
provide any evidence on specific PVA structures relevant to the Safer 
Choice program (Ref. 1, pg. 6 and 9). In a Guideline bioaccumulation 
study conducted by Japan's National Institute of Technology and 
Evaluation (NITE), researchers exposed Rice fish (Oryzias latipes) to 
two concentrations of a PVA structure (MW approximately 77,000 Daltons, 
reported to be water soluble, and in the range of PVA types used in 
detergent film applications) dissolved in the test water for 6 weeks 
(Ref. 27). NITE performed the study using guidelines that measured the 
concentration of the PVA substance in test water and in the fish to 
calculate the steady state BCF. The results demonstrate a BCF value 
less than 10 for both concentrations, which provides strong evidence 
that water soluble PVA structures have low concern for bioaccumulation 
and invalidates the petitioners' contention.
    The petitioners submitted two biomonitoring studies identifying 
microplastics in human breast milk and placenta (Ref. 8; and 28). Both 
studies included compositional analyses that classify the types of 
microplastics found in these tissues, and noted the presence of 
primarily polyethylene, polypropylene, polyvinyl chloride, and plastic 
additives such as pigments. Ragusa et al. (Ref. 8) also found that PVA 
accounted for 2 percent of the total microplastic composition and that 
``no films or fibres were identified'' in breast milk. While these 
results demonstrate the presence of insoluble microplastics in human 
tissue, they do not indicate bioaccumulation of water soluble PVA 
structures. As noted in the previous section, the PVA structures used 
in Safer Choice-certified detergent products are highly water-soluble, 
have low potential to bioaccumulate in biota, and do not meet the 
European Chemicals Agency's (ECHA) definition of a microplastic. The 
ECHA describes microplastics as insoluble and nonbiodegradable solid 
particles measuring less than 5 mm (Ref. 29).

[[Page 25598]]

    3. Potential for PVA to mobilize and transport other pollutants.
    The petitioners also state that PVA may act as a vector to adsorb 
heavy metals and other pollutants (Ref. 1, pg. 9). Studies referenced 
in Rolsky and Kelkar report increased sorption of other pollutants in 
degraded solid microplastics (Refs. 3, 30; and 31). The authors state 
degraded microplastics may have a greater affinity for sorption to 
other pollutants, resulting in increased mobility of contaminants. 
Degraded microplastics may sorb other pollutants through various 
mechanisms such as through the formation of surface defects on the 
degraded microplastic particles that can trap other pollutants, or 
through an increase in the number of polar functional groups on the 
particle surfaces, which can enhance interactions with other polar 
pollutants (Ref. 30; Ref. 31). The petitioners' references are specific 
to microplastics and not relevant to soluble PVA structures in the 
Safer Choice program.
    The petitioners argue that PVA also has the potential to ``mobilize 
heavy metals from sediments to water resources'' (Ref. 1, pg. 14). 
Rolsky and Kelkar's statement is based on evidence of PVA-based 
composite hydrogels removing heavy metals from wastewater (Ref. 3 and 
32). Additives used in PVA-based blends, such as PVA-based composite 
hydrogels, can influence the sorption and bioaccumulation potential of 
PVA structures by altering the overall physical-chemical properties of 
the ingredient. EPA's Safer Choice program classifies a PVA-based 
composite hydrogel as an ingredient (made up of multiple chemicals). 
EPA organizes SCIL by CASRNs and does not include ingredients. For 
product certification, the Safer Choice program reviews every chemical 
within an ingredient (e.g., impurities, residuals, stabilizers, etc.), 
regardless of use level, against the Safer Choice Standard, available 
at https://www.epa.gov/saferchoice/safer-choice-standard, and 
applicable functional class criteria. All components of an ingredient 
must meet the Safer Choice Standard and criteria to be used in Safer 
Choice-certified products. PVA-based composite hydrogels have never 
been reviewed for certification by the Safer Choice program and are 
different from and not relevant to the PVA structures and applications 
(e.g., detergent packets) in question for this petition.
    The petitioners' concerns over bioaccumulation and transport of 
other pollutants up the food chain appear to be based on microplastic 
pollution research with the assumption that PVA will degrade into 
microplastics. The PVA structures used in detergent films in Safer 
Choice-certified products do not degrade into microplastics; rather 
they degrade via successive oxidation and cleavage steps, producing 
shorter hydroxy, carboxy, and carbonyl-substituted products that are 
also water soluble (Ref. 13).
    4. Toxicity of PVA.
    The petitioners state that PVA ``can contribute to plastic 
pollution'' and that ``plastic pollution can inflict substantial harm 
to aquatic and marine environments'' (Ref. 1, pg. 3 and 5).
    In addition to persistence and bioaccumulation, the Safer Choice 
Criteria for Colorants, Polymers, Preservatives, and Related Chemicals 
require toxicity data on aquatic organisms and human health to be 
considered for the Safer Choice program. The petitioners argue that the 
requirements in the criteria--i.e., that a polymer must not break down 
into PBT substances--are not met for PVA and therefore should be 
excluded from the SCIL (Ref. 1, pg. 14). While the petitioners do not 
provide environmental and human health toxicity data relevant to the 
endpoints listed in the Safer Choice Criteria for Colorants, Polymers, 
Preservatives, and Related Chemicals in the petition, to substantiate 
these statements, the Agency believes there is sufficient toxicity 
information available on PVA structures used in Safer Choice-certified 
products to meet the program's criteria for low concern.
    a. Aquatic toxicity of PVA.
    The Agency identified toxicity studies measuring the effects on 
aquatic organisms of the subset of PVA structures that are used in 
detergent packets. Meier et al. (Ref. 24) performed aquatic toxicity 
testing using a raw material based on PVA that is a component of a 
liquid laundry detergent formulation. Additional information on the 
structures was not provided in the publication and the Agency is unable 
to confirm the PVA-based material is a film. The results indicated the 
potential for high concern for algal toxicity (EC50 = 1-10 mg/L based 
on an OECD 201 guideline study) and high concern for invertebrate 
toxicity (IC50 = 1-10 mg/L based on an OECD 202 guideline study) (Ref. 
24).
    The Agency has also reviewed aquatic toxicity data from companies 
to support the weight-of-evidence approach for the Safer Choice 
program's evaluation of the PVA structures. Proctor and Gamble (P&G) 
submitted supporting data on PVA structures used in their detergent 
films (molecular weight of 130,000 Daltons with 88 mole percent degree 
of hydrolysis) to EPA after this petition was filed. While the P&G PVA 
films are not Safer Choice-certified, the structures of the PVA in 
these films are relevant to the films used in Safer Choice-certified 
products. The data included an acute fish embryo toxicity study 
following OECD 236 Guidelines, an acute algal inhibition assay 
following OECD 201 Guidelines, and an acute invertebrate study 
following OECD 202 Guidelines on a PVA structure used in P&G detergent 
packets. The 96-hour algal inhibition study demonstrated no effects on 
growth or biomass at concentrations greater than 100 mg/L in 
Raphidocelis subcapitata. The 48-hour invertebrate study demonstrated 
no effects on mortality, resulting in an EC50 >100 mg/L. These results 
suggest low potential for algal and invertebrate aquatic toxicity, 
which differs from the results reported by Meier et al. (2013) (Ref. 
24). The 96-hour Danio rerio fish embryo toxicity study submitted by 
P&G demonstrated an LC50 >100 mg/L.
    Another supplier submitted an acute toxicity test to the Safer 
Choice program. This acute toxicity test on freshwater fish followed 
OECD 203 guidelines and demonstrated low aquatic toxicity for a PVA 
film used in Safer Choice-certified products. Guideline studies are 
available for PVA structures used in detergent film used in both Safer 
Choice certified products and other products across multiple suppliers. 
These studies suggest variable aquatic toxicity for algae and 
invertebrate, and low toxicity for fish. Note that the Meier study 
showing toxicity for PVA does not include details on the specific PVA 
structure tested. We have included consideration of these results to be 
conservative in our weight of the scientific evidence approach.
    b. Human health toxicity of PVA.
    PVA does not carry an EU Hazard or Risk Phrase for any of the human 
health endpoints identified in Safer Choice criteria and is not 
included on authoritative lists as a known or suspected carcinogen, 
mutagen, or reproductive toxicant. Additionally, for applications in 
pesticide formulations used for food animals, including polyvinyl 
acetate-polyvinyl alcohol copolymers with MW >50,000 daltons used in 
water soluble film, EPA established a pesticides tolerance exemption on 
the basis that PVA was poorly absorbed, showed a lack of carcinogenic 
effects, and was cleared as a food additive (59 FR 76, April 20, 1994 
(FRL-4769-6)). While data is limited, human health hazards for PVA 
structures used in Safer Choice certified are not expected based on 
read across to other PVA structures.

[[Page 25599]]

    5. EPA's Safer Choice evaluation of persistence, bioaccumulation, 
and toxicity endpoints for polymers.
    To meet the Safer Choice Criteria for Colorants, Polymers, 
Preservatives, and Related Chemicals, a chemical must not be 
``persistent, bioaccumulative and toxic'', ``very persistent and very 
toxic'', or ``very persistent and very bioaccumulative'', available at 
https://www.epa.gov/saferchoice/safer-choice-criteria-colorants-polymers-preservatives-and-related-chemicals. In Unit IV.B., the Agency 
provides evidence that the PVA structures listed on SCIL do not meet 
the criteria to be considered ``persistent'', ``very persistent'', 
``bioaccumulative'', or ``very bioaccumulative.'' Two of the three 
conditions (persistence and bioaccumulation) that must be met for a 
chemical to be characterized as a ``PBT'' are not met by the subset of 
PVA structures used in Safer Choice-certified products. Therefore, 
these structures do not meet the criteria to be classified as an 
``PBT'' chemical. If only the most conservative aquatic toxicity data 
were considered (Meier et al. (2013) (Ref. 24), the PVA structures 
would be classified as ``toxic'' (characterized by an LC/EC50 values 
less than 10 mg/L) to algae and invertebrates, but still meet Safer 
Choice criteria due to the mitigation of aquatic toxicity through rapid 
biodegradation. These aquatic toxicity values do not meet the criteria 
for ``very toxic'' (characterized by an LC/EC50 value less than 1 mg/
L). As a result, the PVA structures that form the basis for listing on 
the SCIL and are used in Safer Choice-certified products also do not 
meet the criteria of ``very persistent and very toxic.'' The weight of 
evidence for environmental toxicity and fate demonstrates that PVA 
meets the Safer Choice Criteria for Colorants, Polymers, Preservatives, 
and Related Chemicals.
    6. Marketing claims of PVA.
    The petition finally requests ``the EPA Safer Choice program review 
claims about PVA through the lens of truth in advertising to ensure 
that consumers have accurate information about PVA and its potential 
environmental impacts'' (Ref. 1, pg. 14). As part of the Safer Choice 
product submission, companies must provide complete ingredient 
disclosures and product labels for review. Safer Choice evaluates 
environmental marketing claims on the proposed product label and 
website, encouraging partners to comply with Federal Trade Commission 
(FTC) Guidelines. Any language or claims made on or associated with 
Safer Choice-certified products are subject to FTC regulations and must 
be supportable. Under the Green Guides, the FTC recognizes that 
marketers make unqualified degradability claims, which are prohibited 
unless they have ``competent and reliable scientific evidence that the 
entire product or package will completely break down and return to 
nature within a reasonably short period of time after customary 
disposal,'' typically one year (Ref. 33). When certifying products, EPA 
does not substantiate label claims unless they are supported by the 
Safer Choice Standard. Examples of claims generally not substantiated 
by the standard include ``environmentally safe,'' ``100 percent 
biodegradable,'' or ``100 percent plastic-free.'' EPA requests that 
partners remove such claims from the product and marketing materials 
before EPA grants a Safer Choice certification.
    Additionally, the petitioner states, ``PVA is currently on the 
Safer Choice Program's Safer Chemicals Ingredients List with a green 
circle, suggesting to consumers that the PVA plastic film encasing 
laundry and dishwasher pods is safe for people and the environment, and 
does not have any adverse impacts on the planet'' (Ref. 1, pg. 4). The 
Safer Choice program uses the Safer Choice Standard and relevant 
criteria to identify ingredients that are safer for their functional 
use within a product formulation and does not use the term ``safe'' to 
describe any chemicals, ingredients, or products.

C. What are the conclusions under the APA portion of the petition?

    EPA evaluated the information presented in the APA portion of this 
petition and identified additional information relevant to the PVA 
structures allowed for use in Safer Choice-certified products and that 
form the basis for listing on SCIL. The clear weight of the evidence 
presented in this Federal Register notice demonstrates that the PVA 
structures allowed in Safer Choice-certified products meet the Safer 
Choice Criteria for Colorants, Polymers, Preservatives, and Related 
Chemicals. Specifically, the PVA structures in Safer Choice-certified 
products that are the subject of this petition are not ``PBT'' 
substances, ``very persistent and very bioaccumulative'' substances, or 
``very persistent and very toxic'' substances, and are expected to be 
of low concern for human health. The Agency therefore denies the 
request in the APA portion of this petition to change the status of PVA 
on the SCIL. The petition did not provide adequate information to 
demonstrate that the PVA structures used in Safer Choice-certified 
products and that form the basis for listing on SCIL do not meet the 
Safer Choice Criteria for Colorants, Polymers, Preservatives, and 
Related Chemicals, in light of the evidence supporting such use and 
listing identified by EPA.
    While EPA is denying the APA portion of this petition, EPA does 
appreciate the petitioners' concerns, especially related to plastic 
pollution and microplastics. Past efforts for transparency relevant to 
the concerns stated by the petitioners are reflected in the Safer 
Chemical Ingredients List. SCIL includes a caveat for polymers as 
follows: ``Note for Polymers: The hazard profile of a polymer varies 
with its structure. Manufacturers using CAS numbers in this functional 
class may need to provide additional information for Safer Choice 
review'', available at https://www.epa.gov/saferchoice/safer-ingredients#searchList.

VI. 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. Yoo, S.J., and Cohen, D. 2023. Petition to Request Health and 
Environmental Testing and Regulation on Polyvinyl Alcohol Under the 
Toxic Substances Control Act and an Update to the Chemical Safety 
Status of Polyvinyl Alcohol on the EPA's Safer Chemical Ingredients 
Lists.
2. EPA. 1993. TSCA Section 4(a)(1)(B) Final Statement of Policy 
Notice (58 FR 28736, May 14, 1993 (FRL-4059-9).
3. Rolsky, C., and Kelkar, V. 2021. Degradation of Polyvinyl Alcohol 
in US Wastewater Treatment Plants and Subsequent Nationwide Emission 
Estimate. Int. J. Environ. Res. Public Health, 18: 6027. https://www.mdpi.com/1660-4601/18/11/6027.
4. DeMerlis C.C., and Schoneker D.R. 2003. Review of the oral 
toxicity of polyvinyl alcohol (PVA). Food Chem Toxicology, 
41(3):319-26. March 2003. https://doi.org/10.1016/s0278-6915(02)00258-2.
5. Alonso-L[oacute]pez, O., L[oacute]pez-Ib[aacute][ntilde]ez, S., 
and Beiras, R. 2021. Assessment of Toxicity and Biodegradability of 
Poly(vinyl alcohol)-Based Materials in Marine Water. Polymers, 13, 
3742. https://www.mdpi.com/2073-4360/13/21/3742.
6. Nair, B. 1998. Final Report on the Safety Assessment of Polyvinyl 
Alcohol. International Journal of Toxicology, 17:5_suppl, 67-92. 
https://doi.org/10.1177/109158189801700505.
7. European Food Safety Authority. 2002. Opinion of the Scientific 
Panel on Food Additives, Flavourings, Processing Aids

[[Page 25600]]

and Materials in Contact with Food (AFC) related to the use of 
polyvinyl alcohol as a coating agent for food supplements. Question 
number EFSA-Q-2005-017. EFSA Journal, 4(2), 294: 1-15. https://doi.org/10.2903/j.efsa.2006.294.
8. Ragusa, A. et al. Raman 2022. Microspectroscopy Detection and 
Characterisation of Microplastics in Human Breastmilk. Polymers, 14 
(13): 2700. https://doi.org/10.3390/polym14132700.
9. Lim, X. 2021. Microplastics Are Everywhere--but Are They Harmful? 
Nature, 593 (7857): 22-25. May 2021. https://www.nature.com/articles/d41586-021-01143-3.
10. Amann M., and Minge, O. 2011. Biodegradability of Polyvinyl 
acetate and Related Polymers. Advances in Polymer Science, 245: 137-
172. https://doi.org/10.1007/12_2011_153.
11. Kumar, K., et al. 2014. Effect of mixed liquor volatile 
suspended solids (MLVSS) and hydraulic retention time (HRT) on the 
performance of activated sludge process during the biotreatment of 
real textile wastewater. Water Resources and Industry, 5, 1-18. 
https://doi.org/10.1016/j.wri.2014.01.001.
12. Russo, M.A., et al. 2009. The anaerobic degradability of 
thermoplastic starch: Polyvinyl alcohol blends: Potential 
biodegradable food packaging materials. Bioresource Technology, 
100(5), 1705-1710. https://doi.org/10.1016/j.biortech.2008.09.026.
13. Byrne, D. et al. 2021. Biodegradability of Polyvinyl Alcohol 
Based Film Used for Liquid Detergent Capsules. Tenside Surfactants 
Detergents, 58(2), 88-96. https://doi.org/10.1515/tsd-2020-2326.
14. Menzies, J. et al. 2023. Water-soluble polymer biodegradation 
evaluation using standard and experimental methods. Science of The 
Total Environment, 858(3). https://doi.org/10.1016/j.scitotenv.2022.160006.
15. West, A.W. 1973. Operational Control of The Return Activated 
Sludge; USEPA: Cincinnati, OH, USA, 1973. Available from: https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=9100LL7T.TXT.
16. Chiellini, E. et al. 2003. Biodegradation of poly (vinyl 
alcohol) based materials. Progress in Polymer Science, 28(6): 963-
1014. https://doi.org/10.1016/s0079-6700(02)00149-1.
17. Schonberger, H. et al. 1997. Study of Microbial Degradation of 
Polyvinyl Alcohol (PVA) In Wastewater Treatment Plants. American 
Dyestuff Reporter, 86(8), 9-18. https://p2infohouse.org/ref/02/01722.pdf.
18. Kawai, F., and Hu, X. 2009. Biochemistry of microbial polyvinyl 
alcohol degradation. Applied Microbiology and Biotechnolology, 84: 
227-237. https://doi.org/10.1007/s00253-009-2113-6.
19. Organization for Economic Cooperation and Development (OECD). 
1995. OECD Series on the Test Guidelines Programme Number 2, 
Detailed Review Paper on Biodegradability Testing, Environment 
Monograph N[deg] 98. Organisation for Economic Co-operation and 
Development. Available from: https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ocde/gd(95)43&doclanguage=en.
20. OECD. 2006. OECD Guidelines for the Testing of Chemicals, 
Revised Introduction to the OECD Guidelines for Testing of 
Chemicals, Section 3, Part 1: Principles and Strategies Related to 
the Testing of Degradation of Organic Chemicals. Available from: 
https://www.oecd-ilibrary.org/environment/revised-introduction-to-the-oecd-guidelines-for-testing-of-chemicals-section-3_9789264030213-en#page1.
21. Davenport R. et al. 2002. Scientific concepts and methods for 
moving persistence assessments into the 21st century. Integrated 
Environmental Assessment and Management, 18(6): 1454-1487. https://doi.org/10.1002/ieam.4575.
22. Struijs, J., and van den Berg, R. 1995. Standardized 
biodegradability tests: Extrapolation to aerobic environments. Water 
Research, 29(1): 255-262. https://doi.org/10.1016/0043-1354(94)00124-p.
23. EPA. 2000. Interim Guidance for Using Ready and Inherent 
Biodegradability Tests to Derive Input Data for Multimedia Models 
and Wastewater Treatment Plants (WWT) Models. Available from: 
https://www.epa.gov/sites/default/files/2015-09/documents/interim_guidance.pdf.
24. Meier, F. et al. 2013. Raw Material Supplier and Detergent 
Manufacturer Cooperate in Environmental Safety Assessment of a New 
Detergent Raw Material-A Case Study. Specialties Case Study, 139(3): 
59-62. Retrieved from: https://www.henkel.com/resource/blob/925932/4a0d6394b9927332913344af8223cbea/data/case-study-environmentalsafetyassessment-en-sofw2013.pdf.
25. EPA. 2022. Interim Guidance for Using Ready and Inherent 
Biodegradability Tests to Derive Input Data for Multimedia Models 
and Wastewater Treatment Plant (WWT) Models. Available from: https://www.epa.gov/tsca-screening-tools/interim-guidance-using-ready-and-inherent-biodegradability-tests-derive-input#wwt.
26. EPA. 2012. Sustainable Futures/Pollution Prevention (P2) 
Framework Manual, OCSPP, EPA-748-B12-001. Available from: https://www.epa.gov/sites/default/files/2015-05/documents/05.pdf.
27. National Institute of Technology and Evaluation (NITE). 2015. 
Chemicals Collaborative Knowledge database (J-CHECK). Available 
from: https://www.nite.go.jp/chem/jcheck/template.action?ano=28743&mno=6-0682&cno=9002-89-5&request_locale=en.
28. Ragusa, A. et al. 2021. Plasticenta: First Evidence of 
Microplastics in Human Placenta. Environment International, 146 
(106274). https://doi.org/10.1016/j.envint.2020.106274.
29. European Chemicals Agency (ECHA). 2020. Opinion on an Annex XV 
dossier proposing restrictions on intentionally-added microplastics. 
Committee for Risk Assessment and Committee for Socio-economic 
Analysis. Available from: https://echa.europa.eu/documents/10162/b56c6c7e-02fb-68a4-da69-0bcbd504212b.
30. Liu, G. et al. 2019. Sorption behavior and mechanism of 
hydrophilic organic chemicals to virgin and aged microplastics in 
freshwater and seawater. Environmental Pollution, 246: 26-33. 
https://doi.org/10.1016/j.envpol.2018.11.100.
31. Wang, F. et al. 2020. Sorption Behavior and Mechanisms of 
Organic Contaminants to Nano and Microplastics. Molecules, 25(8): 
1827. https://doi.org/10.3390/molecules25081827.
32. Chowdhury, N.K. et al. 2015. Polyvinyl alcohol/polysaccharide 
hydrogel graft materials for arsenic and heavy metal removal. New 
Journal of Chemistry, 39(7), 5823-5832. https://doi.org/10.1039/c5nj00509d.
33. Federal Trade Commission 2012. Guides for the Use of 
Environmental Marketing Claims. Available from: https://www.ftc.gov/sites/default/files/documents/federal_register_notices/guides-use-environmental-marketing-claims-green-guides/greenguidesfrn.pdf.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: April 21, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2023-08864 Filed 4-26-23; 8:45 am]
BILLING CODE 6560-50-P