[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