Public Webinar 1,4 Dioxane Risk Evaluation and Risk Management under Toxic Substances Control Act (TSCA) Section 6 03-Feb-2021


Transcription details:

Date:

Title of Event:

03-Feb-2021

US EPA: Public Webinar 1,4-Dioxane Risk Evaluation and Risk
Management under TSCA Section 6

Transcription results:

[silence]

SI: 01:34

SI: 04:44

S2: 05:23

S2: 06:25

S3: 07:51

The EPA meeting on 1,4-Dioxane risk evaluation will begin in about three minutes,
[silence]

Good day. Welcome to this public webinar presented by the US Environmental
Protection Agency. 1,4-Dioxane Risk Evaluation and Risk Management under TSCA
Section 6. My name is Meredith Fritz, assisted by Vincent Brown, and we are from
Battelle. Battelle is a contractor providing meeting support for today's meeting. This
event is being recorded. The hosts may use Webex chat to share announcements with
all attendees, but attendees will not be able to respond to the chat. I will now
introduce Niva Kramek, the leader of this call for the US EPA. Niva?

Thank you. Good afternoon, everyone, and thank you for joining EPA's Office of
Pollution, Prevention, and Toxics webinar on managing unreasonable risks for 1,4-
Dioxane under the Toxic Substances Control Act. My name is Niva Kramek. I'm a team
lead in the Existing Chemicals Risk Management Division. My role will be to moderate
today's webinar. We have approximately 200 people on the line, including attendees
from across the United States. I'm going to provide an overview of the technical
aspects of the webinar and what to do if you need assistance. First, if you experience
technical difficulties, please email me at kramek.niva@EPA.gov and also Vince Brown
at brownv@battelle.org. For today's webinar, we'll be advancing the slides through
the presentation using Webex. You can also download the slides from the 1,4-Dioxane
Risk Management website. Today's agenda is also on that website.

Today's webinar will start with a presentation from EPA. Then after the presentation,
for those who signed up to make remarks, we'll have a period for public comment.
We're limiting those remarks to five minutes per person. The webinar operator will
introduce the speakers during the public comment period. If you have registered to
make a comment, please be sure you're connected through the Webex so the
operator can unmute you. Again, if there are technical issues, please email me at
kramek.niva@epa.gov, and I'll spell that out, K-R-A-M-E-K dot N-l-V-A at E-P-A dot
gov, and also Vince Brown at brownv@battelle.org. I'll spell that out B-R-O-W-N-V at
B-A-T-T-E-L-L-E dot O-R-G. You can also send a message in the chat regarding any
technical difficulties. The agency will not be answering questions during the webinar.
Please know there are a variety of other forums that will be described during the
presentation if you have questions or if you are interested in further dialog on risk
management. With that, let's start the webinar. Our first speaker this morning is
Tanya Mottley, the director of the Existing Chemicals Risk Management Division.
Thank you, Tanya. Please start your remarks now.

Good afternoon, everyone. My name is Tanya Hodge Mottley, and I'm the director of
the Existing Chemicals Risk Management Division in the Office of Pollution Prevention

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and Toxics. I'm opening today's webinar to emphasize how much we value your input.
This is a useful forum for the agency to obtain public comment on the
implementation of the Toxic Substances Control Act and risk management of 1,4-
dioxane. Today we will discuss the findings of our final risk evaluation and EPA's work
to develop proposed regulations under Section 6 of TSCA. But before I turn it over to
my colleague, Cindy, I want to leave you with a few thoughts. With the amendments
to TSCA that were enacted in 2016, we have been building a new regulatory program
from the ground up. As with many things in life, the way EPA works to ensure
chemical safety and indeed the way Congress directed us to undertake this work is a
process. We've taken some big steps in that process over the past several months by
issuing all of our first 10 risk evaluations for methylene chloride, 1-bromopropane,
HPCD, carbon tetrachloride, trichloroethylene, NMP and more. Today we are focusing
on 1,4-dioxane with a final risk evaluation issued in early January 2021. In each of
these risk evaluations, we identified whether there are unreasonable risks of injury to
health or the environment.

S3: 09:24 For 1,4-Dioxane, we have determined there are unreasonable risks to workers and

occupational non-users. Now we are taking the next step in the process by moving to
the risk management phase. When unreasonable risks are identified, TOSCA requires
the agency to undertake a rulemaking process to address the unreasonable risks. I
want you to be aware of our work and, through meetings like today's, contribute to
the risk management rulemaking under TSCA. The agency wants you involved early in
the process, and I thank you for joining us in today's meeting. Excuse me. We'll be
using this opportunity to bring you up to speed on the key provisions of TSCA as it
relates to the risk management requirements to inform you about the unreasonable
risk findings for 1,4-Dioxane and to outline the next steps in the process. Perhaps,
most importantly, throughout this process, we'll be taking input from you on
potential risk management approaches, their effectiveness, and any impact those
approaches might have on stakeholders. Your feedback is important to us as we
develop regulations that are practical and protective. Today kicks off that process.
Now is a critical juncture for you to be involved. Again, we need and appreciate your
inputs, expertise, and feedback now early in the process to help shape the way we are
going to address the unreasonable risks that we've found. You'll hear from Cindy
more about how you can get in touch and get involved. Thank you again for your
interest in TSCA. On behalf of the Office of Pollution Prevention and Toxics, we look
forward to working with you. Thank you.

S4: 11:11 Thank you, Tanya. Hi, my name is Cindy Wheeler, and I work in the existing chemicals

risk management division at EPA, and I am going to be talking this afternoon about
our 1,4-Dioxane risk evaluation and our risk management activities under TSCA
section 6. Next slide, please. Okay. On slide 2, there's an agenda for my presentation
that I will be talking about. I will be giving you some background on the risk
evaluations, the findings from the risk evaluation for 1,4-Dioxane, general risk
management requirements under TSCA, the types of information that can inform risk
management, our principles for transparency during risk management, and some
additional contact information. Next slide, please. On slide number 3, risk evaluations,
statutory requirements; EPA must evaluate the risks presented by a chemical under
the conditions of use and determine if the chemical presents an unreasonable risk of
injury to health or the environment under the conditions of use. That has to be
without consideration of cost or other non-risk factors, and it must include
unreasonable risks to potentially exposed or susceptible subpopulations determined
to be relevant to the evaluation. And TSCA finally requires the risk evaluation to be

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completed within three to three and a half years. Next slide, please. And I'm going to
turn my video off so we can concentrate on the slides.

S4: 12:52 This is slide number 4, and it provides a flow-chart illustrating the risk evaluation

process and the timeline. We move from prioritization to high priority chemicals,
manufacture requests. 1,4-Dioxane was one of the first 10 chemicals which sort of got
jump-started by the statute. Risk evaluation involved all of these elements: hazard
assessment, risk exposure assessment, risk characterization. We published a draft risk
evaluation for public and peer-review comment, and we have now published the final
risk evaluation. Next slide, please. On slide number 5, I'm going to give you a little
overview of the risk evaluation for 1,4-Dioxane. The final risk evaluation was
published on January 8th of this year. There were 24 conditions of use evaluated and
the final risk evaluation followed a series of risk evaluation activities, including a
supplemental analysis published in November 2020 for public comment, the draft risk
evaluation published in June 2019 for public comment and peer review, the problem
formulation document published in June 2018, and the scope document published in
June 2017. Public comments and external scientific peer review informed the
following risk evaluation. We received 34 public comments on the draft risk
evaluation. The peer review, the Science Advisory Committee on Chemicals, SACC,
met to review the draft evaluation in July of 2019, and we also received 16 public
comments on the supplemental analysis that was published in November of 2020.
The final risk evaluation and supplemental materials are in this docket, EPA-HQ-OPPT-
2019-0238, and we have some additional materials in another docket, EPA-HQ-OPPT-
2016 -0723. And that's what regulations backed up. Next slide, please.

S4: 15:15 And now I'm on slide 6. This is some general information on 1,4-Dioxane. It is a clear,

volatile liquid used primarily as a solvent. EPA identified conditions of use during
various life cycle stages, such as manufacturing which includes import, processing
distribution and commerce, use, and disposal. 1,4-Dioxane is also found as a by-
product in commercial and consumer cleaning products and other products. 1,4-
Dioxane is used as a catalyst, an intermediate and [inaudible] solvent in the
production of other chemicals including agricultural chemicals and plastic. 1,4-
Dioxane is also used in laboratory applications, functional fluids such as metalworking
fluid, film cement, printing inks and dry film lubricant. The total annual production
volume of 1,4-Dioxane in 2015 was approximately one million pounds. Next slide,
please. Slide 7: determinations of no unreasonable risk. EPA determined that 1,4-
Dioxane does not present an unreasonable risk to the environment and to the general
population under the conditions of use. EPA further determined that 11 of the 24
conditions of use of 1,4-Dioxane do not present an unreasonable risk of injury to
health or the environment. There is no unreasonable risk to terminations or
considered final agency actions, and they are issued by order pursuant to TSCA
Section 6(i)(l). Next slide, please.

S4: 16:49 Slide number 8:the determinations of no unreasonable risk. Distribution and

commerce, industrial and commercial use in functional fluids and spray polyurethane
foam, and eight consumer uses. Used in textile dye, antifreeze, surface cleaner, dish
soap, dishwasher detergent, laundry detergent, paint and floor lacquer, and spray
polyurethane foam. Next slide, please. This is slide number 9: the unreasonable risk
determination. EPA determined that 13 of the 24 conditions of use of 1,4-Dioxane
presents an unreasonable risk of injury to health. EPA's determinations are based on
unreasonable risk of injury to workers during occupational exposures. EPA's risk
evaluation identified unreasonable risk for liver toxicity from acute inhalation and
dermal exposures and olfactory epithelium effects and increased risk of cancer from

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chronic inhalation and dermal exposures to 1,4-Dioxane. Next slide, please. Slide 10
lists the conditions of use for which EPA has found unreasonable risk. Here we have
manufacture. That includes domestic manufacture and import/repackaging. We have
four processing conditions of use: repackaging, recycling, processing as non-
incorporative use, and as a reactant. And then we have some industrial and
commercial use. Used as an intermediate, as a processing aid in laboratory chemicals,
in adhesives or sealants, in printing and printing compositions, in dry film lubricant,
and in disposal. Next slide, please.

S4: 18:49 This is slide 11, the basis for the unreasonable risk determination for workers. The

unreasonable risk determination for workers are based on the following health
hazards during occupational exposures, liver toxicity from acute inhalation and
dermal exposure and olfactory epithelium effects and increased risk of cancer from
chronic inhalation and dermal exposures. With respect to personal protective
equipment, the OSHA permissive exposure limit or PEL for 1,4-Dioxane, which was
established in 1971, is 100 parts per million. Many conditions of use presented an
unreasonable risk to workers even with the use of gloves with a protection factor of
20. No unreasonable risk to workers due to acute and chronic exposure, but that
assumes the use of respirators with an APF of 50 in industrial and commercial
settings. EPA does not assume that occupational non-users use personal protective
equipment because they do not handle the chemical. Next slide, please. Now, moving
on to risk management requirements on slide 12. Under TSCA, EPA is required to take
action to address chemicals that present unreasonable risk to human health or the
environment. EPA must issue a Section 6(a) rule following risk evaluation to address
all identified unreasonable risk within two years. The proposed rule must be issued
one year after the risk evaluation, and the final rule must be issued two years after
the risk evaluation. There are specific requirements on the consideration of
alternatives, selecting among options, and the required statement effects that apply
to the risk management rule. An input from stakeholders is critical to this process.

Next slide, please.

S4: 20:50 Slide 13, that's half the Section 6(a) regulatory options. This is our toolbox for

addressing unreasonable risk under TSCA Section 6. EPA may prohibit, limit, or
otherwise restrict manufacture, processing, or distribution and commerce. We may
prohibit, limit, or otherwise restrict manufacture processing, distribution, and
commerce for a particular use or for use above a set concentration. EPA may require
minimum warnings and instructions with respect to use, distribution, and/or disposal.
EPA may require record-keeping, monitoring, or testing. EPA may prohibit or regulate
the manner or method of commercial use and the manner or method of disposal by
certain persons. EPA may direct manufacturers processersto give notice of the
unreasonable risk determination to distributors, users, and the public and replace or
repurchase. Next slide, please. Slide number 14, continuing with the regulatory
options, TSCA provides the authority to regulate entities, including distributors,
manufacturers, and processors, for example, formulators, commercial users,
workplaces, and workers, and entities disposing of chemicals for commercial
purposes. Next slide, please. Slide number 15. This is TSCA section 6(c). This is the
statement of effects that EPA must consider and publish with any rulemaking under
TSCA Section 6(a). So we must consider and publish based on recently available
information the effects and magnitude of exposure to human health, the effects and
magnitude of exposure to the environment, the effects of the chemical for various
uses, and the reasonably ascertainable economic consequences of the rule, including
consideration of the likely effect on the national economy, small business,
technological innovation, the environment, and public health. The costs and benefits

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of the proposed final regulatory action and one or more primary regulatory
alternatives and the cost-effectiveness of the proposed regulatory action and one or
more primary regulatory alternatives. Next slide, please.

S4: 23:20 Slide 16 lists some executive orders that are relevant to TSCA Section 6(a)

rulemakings. I'm not going to read through all of them, but here we have executive
order 12866 which involves regulatory planning and review, executive order 1298
which addresses environmental justice, executive order 13045, protection of children
from environmental health and safety risks. And also federalism, co-ordination with
Indian tribes and other entities. Next slide, please. Slide 17, these are the types of
information that tend to be very useful in informing risk management. So, EPA would
be looking from stakeholders for suggestions on effective methods that we can use to
address the unreasonable risk. We'd look for input on protective regulatory
approaches, information relating to controlling exposures including current work
practices, engineering, and administrative controls. Information on essential uses and
the impact of the chemical were not available. Identification of uses that have been
phased out or can be phased out and thus are no longer needed. Any information on
substitute chemicals that are safe and effective alternatives and suggestions on how
EPA can further improve its regulatory processes or be more transparent. Next slide,
please.

S4: 24:57 Slide number 18, this is EPA's principles for transparency during risk management.

EPA is looking for transparent, corrective, and meaningful engagement from
stakeholders. We are holding one-on-one meetings, public webinars, and the required
consultations with state and local governments, tribes, environmental justice
communities, and small businesses. We believe an extensive dialogue will help people
understand the findings in the risk evaluation, the risk management process required
by TSCA and the options available for managing unreasonable risk. EPA is seeking
input from stakeholders on potential risk management approaches, their
effectiveness, and the impacts those approaches might have on businesses, workers,
and consumers. Stakeholder input can help the agency develop regulations that are
practical and protective. Next slide, please. Slide 19, coordination and engagement. In
developing risk management approaches, EPA consults with stakeholders to learn
about conditions of use, existing engineering controls, personal protection
equipment, available alternatives, or other programs to tailor effective risk
management solutions. EPA conducts site visits as necessary to obtain detailed
information on existing practices in chemical manufacturing, processing, and use. We
have not been doing that recently due to the pandemic, but we are looking forward
to doing that again in the future. EPA also developed an extensive network among
stakeholders to ensure regulatory approaches are fully informed and based on
current conditions. Next slide, please.

S4: 26:47 And this is slide 20, opportunities for engagement. EPA is always happy to meet one-

on-one with stakeholders. We are providing webinars with overviews upon our risk
evaluations and the unreasonable risk determinations, and we are also doing our
consultations which seek targeted feedback with states and local governments, tribes,
small businesses, and environmental justice organizations and communities. Next
slide, please. And this is additional information. These are some websites that may be
of interest to you. The general TSCA, that's a description of how TSCA works and how
certain chemicals are being managed under it. Current Chemical Risk Management
Activities is another website of interest. And we have a 1,4-Dioxane risk management
website, and I am the main contact for the 1,4-Dioxane risk management activity.
That's my name and email and phone number up there. And general risk

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management outreach. And also contact Douglas Parsons one of my coworkers at
parsons.douglas@epa.gov, and he can be reached at 202-564-0341. I'm Cindy
Wheeler again, wheeler.cindy@epa.gov, and my phone number is 202-566-0484.

And I believe that is the last slide. So that concludes my presentation, and I will now
turn it over to Battelle to start calling on the public commenters.

SI: 28:45	Great. Thank you, Cindy. And we will now begin the public comment period. When

you're making your comment, please state your name and affiliation if you have one.
So, at the beginning of your public comment, please do state your name and any
affiliation. I'm going to turn control over to the operator, Vince, who will introduce
the speaker and open their line. We'll then continue this until all the speakers who
have signed up have completed their remarks. Again, please limit your remarks to five
minutes per person, and don't forget to include your name and affiliation.

S5: 29:23	Okay. Thank you. This is Vince Brown from Battelle. I'm the Webex host. And just a

word, if you registered to make a public comment, but you connected by phone only,
I will not be able to find you and unmute you in the attendee roster. If you would care
to make a public comment, please refer to the email of invitation and log in through
Webex. That way, I will see your name and be able to unmute you. What I'll do is call
each name in turn and then unmute your line and introduce you at that time. The
first one on my list is Manuel Gomez. Manuel Gomez, if you can hear me, please go
ahead.

S6: 30:05	Yes. Should I start?

S5: 30:07	Yes, please.

S6: 30:10	I am Dr. Manuel Gomez, a retired veteran of the Occupational Safety and Health

Administration, the US Chemical Safety Board, the EPA, the American Industrial
Hygiene Association, and other health and safety entities. I am here to recommend,
to urge that the EPA assume primary responsibility for developing and issuing
occupational health standards for chemicals that are found to present unacceptable
workplace risk on the TSCA assessment procedures and require timetables instead of
surrendering that primary authority to OSHA. I speak today with a focus on 1,4-
Dioxane because the agency has determined that its occupational risks are the most
severe, but my arguments apply equally to any chemical for which EPA finds a
reasonable risk on the TSCA. Since its founding 50 years ago, OSHA has been unable
to issue occupational health standards in anything even close to a timely manner. And
it has even sometimes been entirely unable to do so, as was the case with the failed
proposed standard to protect workers from ergonomic hazards. While obviously not a
chemical hazard, that experience illustrates how difficult it would be if OSHA were to
attempt the standard for Dioxane or other chemicals under TSCA. It goes without
saying, of course, that OSHA and NIOSH and sometimes other agencies must
participate actively in the process with their expertise. And I understand there's
already an MOU between EPA and OSHA to collaborate for this purpose. But the
regulatory action should come under EPA authority and mandatory TSCA timetables,
so the standards have a chance of becoming reality in a reasonable time frame.

S6: 32:09	In 2012, GAO report documented that the time to develop standards averaged more

than seven years for OSHA. And in a failed OSHA effort to modernize 300 or so of its
roughly 500 permissible exposure levels for chemicals a few years ago, OSHA reported
that, and I quote, "Most have not been updated since 1971, and many are based on
science dating back to the mid-to-late 1960s," end of quote. Not to mention that
there are tens of thousands of other chemicals in commerce to which workers are

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potentially exposed, all with an enforceable exposure standard or any other means of
enforceable protection. So, and I quote OSHA once again, "Workers are essentially
covered by the same PELs as they were 40-" actually now 50 years ago. "And while
OSHA has been given no new tools to control workplace exposures, it has had to
conduct increasingly resource-intensive analyses that have slowed the PEL rulemaking
process to a crawl. Since 1971, OSHA has been successful in establishing or updating
PELs for only about 30 chemicals," end of quote. And I also want to mention that
OSHA's current PEL for Dioxane is more than 350 times the permissible level under
California's OSHA standards. In addition, there is strong evidence that there are an
estimated 60,000 premature deaths through occupational disease each year
compared to some 10,000 deaths through accidents. While both figures are
unacceptably high for a developed country like ours and preventable, the
occupational disease deaths are typically silent and, thus, often receive less attention.

S6: 34:06 Considering the urgency to address the massive public health impact of occupational

disease, we can at least begin to make a dent if EPA undertakes regulatory action
under TSCA procedures and timetables when a chemical is found to present
occupational risk, as is the case with Dioxane and others. EPA is in a far better
position to issue a standard in a timely manner in collaboration with other agencies,
and it should take the regulatory lead under its authority rather than OSHA.
Occupational health standards issued under EPA TSCA authority and mandate will
certainly face legal and political obstacles that I cannot review in five minutes, but
what is certain is that the new TSCA Act has court-enforceable timeframes which
would, at the very least, exert pressure for more timely protection for workers than
can be obtained under OSHA. Thank you.

S5: 35:12 Okay. Thank you. Wanted to clarify an earlier statement I made. If you've been

watching the slides, and you're a public commenter, then you are already in Webex,
and we will be able to find you. My comment about the calling people was only for
those who use the phone only and not the Webex website. The next speaker is Steve
Risotto. And as soon as I can get him unmuted- Steve, if you're there, please go
ahead.

S7: 35:46 Yes. Good afternoon. Can you hear me?

S5:35:47 Yes.

S7: 35:49 All right. Thank you. Good afternoon. I am Steve Risotto, senior director at the

American Chemistry Council. ACC has followed the development of the 1,4-Dioxane
risk evaluation closely and submitted the results of a 90-day mode of action study to
help inform the agency's consideration of the chemical. The results of that study,
which have now been published in two peer-review journal articles, provide strong
biochemical, histopathological, and toxicogenomic evidence for an early mitogenic
response occurring at doses that exceed the metabolic clearance threshold of the
animals. This non-genotoxic mode of action is acknowledged in EPA's 2005 cancer risk
assessment guidelines and is especially relevant to the liver in sensitive rodent strains
such as the mouse strain under consideration here. These two new studies also
support a lack of any primary genotoxic insult associated with the mouse liver tumors.
We encourage EPA staff to continue to investigate the cancer mode of action for 1,4-
Dioxane as it develops risk management measures for the conditions of use of the
chemical. Despite agreeing that the available data do not suggest the genotoxic mode
of action for cancer, and that substantial evidence exists for a threshold MLA, EPA has
continued to apply its default assumption of a linear low-dose response in evaluating
the potential cancer risk associated with exposure to 1,4-Dioxane.

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S7: 37:20 As we have previously noted, this approach is in direct conflict with that taken by

Health Canada, the World Health Organization, and the European Union. In the draft
risk evaluation released in the summer of 2019, EPA staff excluded data for female
mice, when the study conducted at the Japan Bioassay Research Center as reported
by [inaudible] et al. in a 2009 publication. As a result, the oral cancer slope factor in
the draft evaluation was five times higher than that calculated in the 2013 assessment
conducted for the Integrated Risk Information System, or IRIS. In explaining this
decision, the draft risk evaluation noted that the female mouse data exhibited a low
control group incidence and a 70% response rate at the lowest dose, followed by a
plateau. The draft risk evaluation further explained that the analysis excluded the
female mouse results from [inaudible] et al. because of the modeling gymnastics
required to generate the cancer slope in the IRIS assessment, concluding that the data
were unsuitable for risk model. EPA did not seek comment on its decision to exclude
the female mouse data in the draft from the science advisory committee on chemicals
last fall, nor did the committee offer any comments on this decision. Nevertheless,
EPA staff reached out to the Japanese researchers for individual animal data in order
to conduct the time-to-tumor analysis of the female mouse data that is the basis for
the cancer slope factor in the final risk evaluation. This analysis has not been subject
to peer review or to notice and comment. In fact, the change was not identified as
part of the agency's supplemental analysis for consumer and surface water
exposures, which was issued from an abbreviated comment period in December.

S7: 39:11 In reviewing the data provided in Appendix K of the risk evaluation, however, we note

that only a 50% survival rate in the control group. That result combined with the
background incidents of liver tumors among controls suggests that a time-to-tumor
analysis is not adequate for assessing the female mouse data. While EPA ACC
recognizes that the death risk evaluation for 1,4-Dioxane is now complete, the agency
should continue to refine its analysis as it embarks on the next phase of the process
outlined in TSCA. We believe that the data, collected as part of our 90-day study
provides strong support for mitogenic threshold MOA for cancer and raise additional
questions about the findings reported by [inaudible] et al. that are the basis of the
agency's cancer risk evaluation. Thank you.

[silence]

S5: 40:11 Great. Thank you. Our next public speaker is Shakil Saghir. Shakil, if you can hear me,

please go ahead.

S8: 40:24 I don't have any comments at this time. Thank you.

S5: 40:27 Okay. Thank you. Our next commenter is Claudia Walecka-Hutchinson. Takes me just

a second here. Claudia, if you can hear me, please go ahead.

S9: 40:50 Can you hear me? This is Claudia.

S5: 40:51 Yes. Go ahead.

S9: 40:53 I have no comment at this time. Thank you.

S5: 40:54 Okay. Thank you. Our next is Vasilis Vasiliou.

S10: 41:11 Do you hear me? Okay.

S5: 41:12 Yes. Yes. Vasilis, please go ahead.

S10: 41:16 Okay. My name is Vasilis Vasiliou. I'm the chairman of the environmental health

sciences from the Yale School of Public Health. And I listened to all the comments and

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everything. I just have to tell you we have a paper, which is under revision right now,
which we have seen that there is DNA damage by 1,4-Dioxane. Unfortunately, it's not
published yet, but we do have substantial more evidence about the action of 1,4-
Dioxane in males now that it might require more molecular mechanisms. And
unfortunately, it's not published data, but I just want to increase the concern that we
don't have a complete mode of action, at least at the molecular level, of this
chemical. And that's all I have to say. And there are two more papers published in
2020 from other groups that indicate that 1,4-Mioxane has a genotoxic effect. With
that being said, the dogma is that Dioxane may offer two types of action, one is
mutagenic, and the other is genotoxic. But we do have DNA damage detected in our
studies. That's all I have to say. And we hope that our paper will be published very
soon, a series of papers indeed.

S5: 43:04 Okay. Thank you. Our next public comment person is Adrienne Esposito.

Sll: 43:19 Yes. Thank you. Can you hear me?

S5: 43:21 Yes. Adrienne, please go ahead.

Sll: 43:23 Yes. Thank you. My name is Adrienne Esposito. I am the executive director of Citizens

Campaign for the Environment. We are a 120,000-member organization throughout
New York and Connecticut. I just wanted to make two points. One is that I noticed in
your presentation that you only evaluated exposure risk from one personal care
product, which was- excuse me, two, laundry and dish soaps. But you did not seem
to, at least in the presentation, take into consideration dermal exposure or inhalation
from other personal care products including shampoo, bath gels, baby bath products,
all of which have 1,4-Dioxane in them. CCER organization did an independent study
and had a laboratory certified by New York State test 80 different common household
products for adults and for children. The vast majority of those products, 80%, had
some level of 1,4 dioxane in them. Some were quite high, reaching up to 17,000 parts
per billion. So my comment relating to that is that a dermal exposure, if someone
uses a bath gel and then a shampoo and then washes the dishes with the dish soap
and then puts the baby in the bath with the bubble bath, that also has 1,4-Dioxane,
now the dermal exposure levels can be anywhere between 20,000 and 50,000 parts
per billion in one day and every day thereafter. And it doesn't seem to be any
evaluation of those personal care products and human dermal exposure.

Sll: 45:12 My second comment is on the issue of 1,4-Dioxane in drinking water. I am sure being

with the EPA you know that Long Island has a sole-source aquifer for our drinking
water. And we unfortunately had the highest level of 1,4-Dioxane out of all the testing
that the EPA did in the 4,400 supply wells across the country. And we had the highest
levels of 1,4-Dioxane, some ranging as high as 33 ppb, and that drinking water well
was closed. But that leads to the concern of not only a public health risk, obviously,
there's a great deal financial concern with filtration of 1,4-Dioxane and the excessive
cost of that. So I don't see any risk associated with these types of exposures coming
from drinking water, particularly in areas that drink from aquifers. That, of course, is a
direct exposure, it's very concerning, and I'm not sure what the EPA is doing about
that. Maybe it just wasn't in the presentation, but that is an extreme concern and
consideration for populations that drink from aquifer systems. Thank you very much.

S5: 46:39 Great. Thank you. Our next speaker is Douglas Troutman. Douglas, if you can hear me,

please go ahead.

S12: 46:53 I can. Thank you very much. You can hear me?

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S5: 46:56

Yes.

S12: 46:57 Thank you. No further comment at this time. You may move on to the next

commenter.

S5: 47:05 Thank you. Next will be Nicholas Chartres. Nicholas, if you can hear me, please go

ahead.

S13: 47:17 Can you hear me?

S5:47:18 Yes.

S13: 47:20 Thank you. Good afternoon. My name is Dr. Nicholas Chartres, and I'm the director of

science and policy at the Program of Reproductive Health and the Environment at the
University of California, San Francisco. Today my comments will focus on the need for
EPA to incorporate quantitative methods for estimating non-cancer risk that leads to
a level of exposure, the incorrect decision made by EPA regarding the scope of the
risk evaluation and that several pathways of exposure to 1,4-Dioxane could be
excluded from the risk evaluation and how they are critical to risk management and
benefits cost analysis considerations. And finally, that EPA should use its rulemaking
authority to ensure that employers are provided proper and necessary protective
personal equipment needed to protect workers from the health risks of 1,4-Dioxane. I
have no conflicts to disclose. As we have already highlighted in our comments
regarding the risk evaluation and risk management of ethylene chloride and IBP,
exposures experienced by the full population at any exposure level can result in
increased risk of adverse health effects. Pro-health effects which there is some
evidence of a relationship, so suggested, possibly, likely, known, the risk should be
quantified. To not estimate risk would assume zero risk. Human health risk
assessment and risk mitigation can be substantially improved by incorporating
quantitative methods for estimating non-cancer risk. This would increase the scientific
rigor of the risk assessments, increase its utility for risk management, better provide
information to the public for non-cancer risks, and allow for capture of benefits
through environmental policymaking. Without incidence to non-cancer risk
assessment, it is difficult to estimate the health benefit from pollution prevention
which is an important input into the decision-making and a key ingredient in the cost-
benefits analysis.

S13: 49:05 The reference dose for reference concentration does not estimate the probability or

incidence of response to any dose. It implies that exposure just below the reference
dose lack any risk, while those just above the reference dose for concentration confer
substantial risk. This is inconsistent with the new risk examples of dose-response
relationships at and below the point of departure where there's essential non-zero
risk levels for non-cancer effects across a diverse population. Therefore, for the points
of departure evaluating human health hazards from liver toxicity from two exposures
and olfactory epithelium effects, EPA should incorporate probabilistic approaches in
quantifying risk instead of using it in [inaudible] these non-cancer endpoints in
estimating the percent of the population at risk at different exposure scenarios and
calculate the benefits risk management under the unreasonable scenarios. EPA
mistakenly also included its several pathways of exposure to 1,4-Dioxane could be
excluded from the risk evaluation. We urge EPA to revisit this decision regarding the
scope of the risk evaluation. Issues regarding the excluded pathways are also
important to risk management and benefits cost analysis considerations. Several of
the regulatory options that may be considered for 1,4-Dioxane may affect the
exposure pathways are excluded from risk analysis. For example, a ban on a condition

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of use 1,4-Dioxane could be expected to reduce releases to water and, ultimately, to
reduce drinking water exposure to 1,4-Dioxane.

S13: 50:33 Reduced drinking water exposures to 1,4-Dioxane resulting from any regulatory

options are potentially an important benefit category that must be quantified and
monetized. It's also important to recognize that removal of 1,4-Dioxane from drinking
water with existing technologies is very difficult, energy-intensive, and expensive.

TSCA regulatory options to prevent pollution of drinking water with hazardous
chemicals may be much more effective and much more cost-effective for reducing
drinking water exposures than treatment of contaminated water, and this should be
part of the consideration in selecting a preferred regulatory option. Finally, the EPA
risk evaluation of 1,4-Dioxane includes expensive assumptions regarding- sorry,
extensive assumptions regarding the worker's use of personal protective equipment
with little or no supporting evidence. For a number of conditions of use, the finding
about no unreasonable risk was dependent on the use of this PPE assumption. EPA
should use its law-making authority to ensure that employees are provided proper
and necessary PPE needed to protect workers from the health risk of 1,4-Dioxane,
including those employees associated with the conditions we're used but were found
not to pose an unreasonable risk. Because of the very significant hazards posed by
1,4-Dioxane, it is critical that EPA put the force of TSCA behind requirements, the PPE
provision, maintenance, kit testing, and training. Thank you very much.

S5: 51:54 Great. Thank you. Our next public commenter is Deidra White. Deidra, if you can hear

us, please go ahead.

S14: 52:11 Can you hear me?

S5:52:12 Yes.

S14: 52:13 Okay. Great. Hi, my name is Deidra White. I'm with the Association of State Drinking

Water Administrators, or ASDWA, and ASDWA is the non-partisan professional
association representing the administrators of the 57 state and territorial drinking
water programs that implement the Safe Drinking Water Act and provide assistance
and funding for public drinking water systems. We are hoping that the Biden
administration's actions will change OCSPP policies that have disregarded
considerations for drinking water and other exposures and specifically re-open the
risk evaluation for 1,4-Dioxane to include them. ASDWA has provided multiple
comments on TSCA actions, where we have urged EPA to use a holistic approach to
consider potential impacts to drinking water, human health, and the environment
from chemicals throughout any part or all of the chemical's life cycle from
manufacturing to processing, distribution, and disposal. I'm going to reiterate some of
our comments on one of the 1,4-Dioxane supplemental analyses that focus on the
impacts to both groundwater and service water sources of drinking water and affect
the actions and decisions of state and state drinking water programs as they need to
consider impacts for ensuring public health protection. Contamination of drinking
water sources from 1,4-Dioxane is extensive. This is shown by the results of the third
unregulated contaminant monitoring rule where 1,4-Dioxane from industrial
wastewater streams, wastewater treatment facilities, produce water, groundwater
discharges, and landfill leachate has contaminated those sources. In our comments,
we've provided information about actions and impacts in the states of New
Hampshire and North Carolina, though many other states have seen significant
impacts and have had to take action without a federal drinking water standard.

S14: 54:10 States have also seen a co-occurrence of 1,4-Dioxane with chlorinated solvents in

groundwater plumes and have experienced issues with oil and gas and hydraulic
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fracturing-produced water, water reuse, and disposal via POTWs or wastewater
treatment plants and underground injection control injections. The determination by
EPA not to include drinking water exposures in the 1,4-Dioxane risk evaluation, we
believe, is fundamentally flawed because the Siward does not adequately assess and
effectively manage these exposures. By not including these exposures, EPA is,
essentially, passing the burden and cost of removing 1,4-Dioxane from drinking water
on to the public water systems and their customers. Removal of 1,4-Dioxane with
conventional water and wastewater treatment processes are generally ineffective.
Advanced oxidation appears to be the best treatment process using a combination of
ozone, hydrogen peroxide, and ultraviolet light but is very expensive to construct and
operate and is not economically feasible for many water systems, especially the small
ones. 1,4-Dioxane also has significant potential regulatory implications for safe
[inaudible] agencies and water systems as this contaminant is on EPA's fourth
contaminant candidate list. And EPA recently announced its decision to continue the
evaluation of 1,4-dioxane without making a preliminary regulatory determination in
order to review the TSCA risk evaluation and consider the upcoming Canadian
guideline technical document. In this regard, as were also requested that EPA explain
why the office of water is relying on the TSCA risk evaluation to make a regulatory
determination for 1,4-Dioxane when OCSPP is excluding drinking water exposures
from its analysis. And I will close with emphasizing that projecting drinking water
sources and preventing contamination is essential for sustaining safe drinking water
supplies, protecting public health and the economy, and the environment. Thank you.

S5: 56:30	Thank you. Our next public speaker is Richard Dennison. Richard, if you can hear me,

please go ahead.

S15: 56:39	Yes. Can you hear me?

S5:56:40	Yes.

S15: 56:42	Great. Thank you. My name is Dr. Richard Dennison. I'm a lead senior scientist at

Environmental Defense Fund. I will provide this comment on three issues today. The
first is that the extreme difficulty of removing 1,4-Dioxane through treatment and the
slow degradation demand risk management measures that eliminate its use or
presence altogether and, at a minimum, eliminate all release. EPA's risk evaluation
acknowledge that very little Dioxane is removed through wastewater treatment and
yet its rate of degradation is, quote, "slow or negligible," end quote. This persistence
means that any releases will remain in the environment and lead to human exposure.
State and local government and, as you just heard from Deidra, water utility and
agency associations have all raised concerns about the limited ability of treatment to
remove 1,4-Dioxane once it is present in water. And they need to address the
problem upstream by restricting its use and presence in products and waste streams.
Advanced treatment technologies are required to achieve any significant removal, yet
these systems are expensive, rarely used, and cost-prohibitive in many cases. For this
reason, it is essential that EPA adopt the risk management measures that, to the
maximum extent possible, eliminate the use or presence of 1,4-Dioxane, instituting
bans rather than relying on measures that seek to reduce its release or exposure after
release.

S15: 58:26	The second point, EPA can and must address risks associated with the conditions of

use and the exposures that the prior administration illegally excluded from its risk
evaluation. EPA's final risk evaluation failed to acknowledge or address the risks of
numerous Dioxane usage and exposures. These include drinking water exposures,
including from legacy sources such as groundwater contamination, that are

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particularly of concern to communities of color and low wealth. The prior
administration falsely asserted it could ignore drinking water exposures based on the
purported coverage by the Office of Water under the Safe Drinking Water Act. This
ignored the fact that one, there was no regulation of 1,4-Dioxane under the Safe
Drinking Water Act. And two, just last March, the Office of Water refused to initiate
the very process that could have eventually led to such a regulation, instead deferring
to the risk evaluation LPPT was conducting which excluded those very exposures by
asserting the Office of Water had addressed them. EPA also ignored down-the-drain
releases from use and disposal of formulated products containing 1,4-Dioxane as a
by-product. Millions of workers using or disposing of such formulated products on the
job were also ignored. These include workers employed in industrial laundries, in
carwashes, in building maintenance, housekeeping, painting, or automotive services,
or as insulation installers or in construction jobs. All of these workers are likely more
highly exposed and chronically exposed than consumers are because they use such
products more frequently, for many more hours a day, and in higher strength
formulations.

S15: 01:00:24 Finally, EPA ignored fence line communities that are exposed to air, water, or waste-

related releases of the chemical. To cite but one example, a recent article from
Chemical and Engineering News identified 1,4-Dioxane as contributing the greatest
risk among those emitted by a chemical facility in the Harrisburg/Manchester
neighborhoods of Houston, Texas. Combined exposures from multiple conditions of
use or sources were also ignored. Just two examples, EPA did not consider a
consumer who used more than one product containing 1,4-Dioxane each day, for
example washing a load of clothes and cleaning a kitchen or bathroom surface. They
also ignored workers that are exposed both at work and also at home as a consumer
through product use. Notably, TSCA section 6(a) explicitly requires EPA to address
combinations of activities that present risk in deciding on appropriate risk
management measures. My last point is that TSCA requires EPA to select risk
management options that entirely eliminate unreasonable risk. Several TSCA
provisions are relevant.

S15: 01:01:43 Section 6(b)(4)(a) states that risk must be determined without regard to costs or

other non-risk factors. In selecting among risk management options that are sufficient
to eliminate all unreasonable risk, Section 6 (c) lists factors that EPA must consider.
These include the effects of the chemical on health and people's exposure to it. EPA
must also consider the benefits as well as the costs of regulatory options selected,
and alternatives considered. Those effects and exposures and benefits may absolutely
include those that go beyond the effects, exposures that were considered in the risk
evaluation. This is especially critical in light of the gross exclusions from the risk
evaluation that I have just described. Finally, sections 6(b)(4)(a) and (c)(1) require EPA
to ensure that its regulation protects all potentially exposed or susceptible
subpopulations. The prior administration's ignoring of risks to those populations is not
a basis for EPA not to ensure that its risk management regulations are sufficient to
address those risks. Thank you.

S5: 01:03:05 Great. Thank you. Our next speaker is Jonathan Kalmuss-Katz.

S16: 01:03:16 Can you hear me?

S5: 01:03:16 Jonathan, please go ahead.

S16: 01:03:20 Thank you. Can everybody hear me?

S5:01:03:22 Yes.

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S16: 01:03:24 Okay. Good Afternoon. I'm Jonathan Kalmuss-Katz Just from Earthjustice. Today I'd

like to focus on just two recent executive orders issued by President Biden and what
they mean for the task or risk management process. On January 21st, one day after
the inauguration, the Biden administration issued a memorandum to all federal
agencies on modernizing regulatory review. The memorandum called for agencies to
take into account the distributional consequences of regulations and to ensure that
rules do not inappropriately burden disadvantaged, vulnerable, or marginalized
communities. Six days later, the president issued another executive order calling on
federal agencies to, quote, "make achieving environmental adjustments as part of
their mission by developing programs, policies, and activities to address the
disproportionately high and adverse human health, environmental, climate-related,
and other cumulative impacts on disadvantaged communities." These orders build on
President Biden's campaign commitments to make environmental justice a focal point
of his administration. They're also directly relevant to EPA's top score and the risk
management process. The only way for EPA to comply with those orders in its risk
management role for 1,4-Dioxane and to meaningfully protect disadvantaged
communities is to consider the risks to communities exposed to the chemical from
their drinking water, air, and soil. Communities of color from east Los Angeles to
Statesville North Carolina face disproportionate exposure too, and that's increased
risks from 1,4-Dioxane. Regrettably, the Trump administration failed to consider those
risks in its 1,4-Dioxane risk evaluation leaving a gap that EPA must fill during risk
management. To satisfy TSCA's mandate to eliminate unreasonable risks to
potentially exposed and susceptible sub-populations and to avoid perpetuating
historic patterns of environmental racism, EPA must evaluate 1,4-Dioxane's risks to
those communities and address those risks in its risk management role.

S16: 01:05:29 President Biden's order on modernizing regulatory review also calls on federal

agencies to fully account for regulatory benefits that are difficult or impossible to
quantify. Fully accounting for such benefits will require EPA to consider populations in
exposure pathways that were excluded from its risk evaluations, such as workers who
use products containing 1,4-Dioxane, people exposed to 1,4-Dioxane in their drinking
water, and people who are exposed from multiple pathways or conditions of use.
Critically, the Biden administration's acknowledgement that certain benefits are
difficult or impossible to quantify reinforces the need for EPA to identify and consider
non-monetized benefits when deciding how to regulate chemicals under TSCA to
pursue risk management approaches that offer the greatest public protection as
opposed to solving the lowest [inaudible]. In sum, TSCA gives EPA broad discretion to
issue health protection risk management roles despite the prior administration's
flawed risk evaluations. President Biden's new executive order should guide EPA's use
of that discretion particularly with regard to the rules environmental justice impacts.
And this may require EPA to conduct additional analyses of chemical exposures and
regulatory benefits during the risk management process. TSCA not only permits but
compels EPA to conduct those analyses and to fully protect workers, consumers, and
the public from 1,4-Dioxane's unreasonable risks. Thank you.

S5: 01:07:03 Okay. Thank you. Our next public commenter is Roger Rayle. Roger, if you can hear

me, please go ahead.

S17: 01:07:18 Can you hear me?

S5: 01:07:20 Yes. You sound fine. Thank you.

S17: 01:07:23 Okay. Well, my name is Roger Rayle. I am a citizen volunteer of watching over the

[inaudible] government, [Danhouw?] 1,4-Dioxane site in Ann Arbor side township

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Michigan for going over 27 years. I wasn't going to make a public comment, but I
noticed on slide 10 that conditions of uses that present an unreasonable risk under
the industrial commercial included disposal. So disposal of Dioxane is a risk under
industrial commercial settings. It's not clear whether that includes home studies
because as many prior speakers combatted, there are laundry products and other
products that go down the drain, and if you live in an area with wells, like I do, you'd
have septic fields, and your disposal is going to go back into the groundwater, and it's
not going to be- we know from the government site that Dioxane, once it gets
anaerobic in groundwater doesn't breakdown on its own. So this also is a problem
because people are using products with high concentrations of Dioxane, and they may
not know what dioxane is in their products. They would have to do some type of
research on every product they buy. Where it would be behooved, you guys, to
regulate that in the products. Even if you're not getting- you're saying the exposure,
the use of the product might not be- you might not get exposure but over the long
term as you dispose of the stuff into the groundwater through septic fields and even
through water treatment plants, there is exposure there through disposal. It seems
like that route has been ignored. Non-commercial, non-disposable- I encourage you
to correct that and keep the Dioxane out of the products that people use, and maybe
we won't have any more Long Island tanks in the future. Thank you.

S5: 01:09:47	Great. Thank you. I think it's back to Niva Kramek now.

S2: 01:09:52	Yes. Thank you, Vince. This is Niva from EPA. We have a few people who registered to

make a public comment but don't appear to be in the Webex. So if you have
registered to make a public comment, and your name has not been called, we are
looking for the name that you used - is that right? - to register with. So if you are
preregistered and would like to make a public comment, please send a message in the
chat to either All Panelists or Vince Brown or myself. I'm going to take one minute and
check my email and see if anybody has had any issues logging on, or anybody on the
phone has been emailing to say they want to comment. But I do not see any of those.
Vince, have you been contacted by anyone who would like to make a public
comment?

S5:01:10:45	No.

S2: 01:10:52	Okay. So yet again, if you have registered to make a public comment, please send us a

chat right now. This is last call for any preregistered public commenters. There are a
few, and we just want to make sure that everybody has had the opportunity to make
their comment. Okay. And Vince, can you move it to the slide with the contact
information on the end slide. Thank you. If you have not had an opportunity to make
a comment, or you'd like to follow up with us, as Cindy mentioned her contact
information is there along with additional information on TSCA generally, our current
chemical risk management activities, and our point of contact for general risk
management outreach is Doug Parsons, and his information is there. We're very
interested in continuing this engagement with you on 1,4-Dioxane risk management,
and we really want to thank you- yes, Vince?

S5: 01:12:03	Sorry, Niva, didn't mean to interrupt. We have a Yvonne Watson who would like to

make a comment, if that's all right with you?

S2: 01:12:08	Fantastic, yes, thank you.

S5: 01:12:12	Yvonne Watson, if you can hear me, please go ahead.

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S18: 01:12:15 Thank you. I'm Yvonne Martinez Watson. I'm the chair of the Environmental Justice

Committee, Environmental and Social Justice Committee for the Angeles Chapter of
the Sierra Club. I'm very concerned about the lack of consideration of the risk in
groundwater supplies for urban areas and rural areas as well. I happen to live in an
environmental justice community that has been impacted by 1,4-Dioxane, PFOS,

PFOA, and radiation in our groundwater. I live in a home that has been supplied
directly with groundwater that has these contaminants. I also live less than a block
away from a large hospital which I can only assume has also been receiving water
supplies contaminated with these contaminants. I find it very alarming that all these
risk assessments talk about health effects to the outside of the body, but I don't see
anything about what happens if you actually ingest this chemical. And then to hear all
the other speakers talking about how there's all these cumulative effects, that's even
more alarming. And it just seems to me that if you're really concerned about getting
input from environmental justice communities, then that is something that should
have been considered, otherwise it rings pretty hollow to say that you're trying to get
input from us if you haven't even considered what might be happening to people's
health when they're actually drinking this stuff. I hope that you will reconsider this
and keep in mind that there are large populations, especially large Hispanic Latino
populations, black communities, and others that are being affected
disproportionately by COVID, and these types of environmental contaminations make
us a whole lot more susceptible to other things and make us more vulnerable to these
types of damage to our bodies. Thank you very much for the opportunity to
comment.

S5: 01:14:39 Thank you. Niva?

S2: 01:14:46 Yes. Thank you for the comment. And again, anyone else who is registered to make a

public comment, if you haven't had the opportunity or if you have used a different
name for registering through Eventbrite and the Webex, please do send a message to
Vince Brown, the host of the Webex, you can send a message through the chat or to
All Panelists, All Panelists through the chat. I will again look at my email and pause for
a moment to see if anyone has gotten in touch.

S2: 01:15:26 Okay. I haven't received any messages. Vince, do you have anyone else?

S5: 01:15:31 No, nothing here, thank you.

S2: 01:15:34 Okay. Thank you. And again, you can see our website for general TSCA and for risk

management activities under Section 6 plus 1,4-Dioxane specifically are here, also
Cindy Wheeler's contact information - you heard her speak earlier - and our general
risk management outreach contact, Doug Parsons. We really do want to hear more
from you and continue the conversation for the risk management of 1,4-Dioxane. We
appreciate the public comments and your participation in today's webinar, especially
those of you who made comments and also the many of you who were listening. An
audio recording and a transcript of this webinar will be available at the 1,4-Dioxane
risk management website, the same link that is in the chat, and where you can access
the slides right now. We will, as soon as possible, make the transcript and recording
available. I want to emphasize the EPA very much appreciates your participation in
today's webinar, and the team here at the Office of Pollution Prevention and Toxics
looks forward to a continued dialog on risk management. So thank you again, and I'll
turn it back to Vince to close up the call.

S5: 01:16:44 Great. Thank you, Niva. That concludes today's session on 1,4-Dioxane, and I will now

end the Webex.

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