Sinus (Samar:

WASHINGTON, DC 20510

June 20, 2019

The Honorable Andrew Wheeler
Administrator

US. Environmental Protection Agency
1200 Ave., NW.
Washington, DC. 20460

Dear Mr. Administrator:

Nearly three years ago, major reforms to the Toxic Substances Control Act (TSCA) were enacted
by a strong bipartisan majority of both Houses of Congress, in the form of the Frank R.
Lautenberg Chemical Safety for the 215? Century Act. Those reforms were intended to address
longstanding structural problems with the original 1976 law that were broadly agreed to have
stymied the Environmental Protection Agency?s (EPA) authority to ensure that chemicals in and
entering commerce are safe for human health and the environment.

These problems included debilitating constraints on ability to obtain and require the
development of suf?cient information on chemicals; the lack of a mandate for EPA to review
and make af?rmative risk ?ndings on new chemicals prior to allowing them onto the market; the
limited authority and mandate TSCA gave EPA to review the safety of chemicals already in
commerce and regulate those that present unreasonable risk; and inability to share much
of the chemical information it obtains with the public, or in the case of information deemed
con?dential, to share such information with other levels of government and health and
environmental professionals.

The Lautenberg Act made improvements to address each of these problems. Among the many
changes:

0 Section 4: enhanced information authorities by allowing EPA to issue orders to
obtain information and removing the original law?s requirement that EPA ?rst show
potential risk in order to require a company to test a chemical;

0 Section 5: required EPA to make af?rmative safety ?ndings for each new chemical,
taking into account reasonably foreseen as well as intended uses of the chemical and
requiring EPA to issue binding orders on any new chemical that ?may present an
unreasonable risk? or lacked suf?cient information for EPA to conduct a reasoned
evaluation;

0 Section 6: required EPA to establish a continuous ?pipeline? process to prioritize
existing chemicals in commerce; subject those deemed high-priority to robust risk
evaluations that account for: the full lifecycle of the chemical; its intended, known and
reasonably foreseen conditions of use; and its potential risks to all ?potentially exposed or
susceptible subpopulations? (including children and workers); and impose regulatory

restrictions on any chemical found to ?present an unreasonable risk? that are sufficient to
mitigate those risks; and

0 Section 14: required companies to substantiate and EPA to review many claims for
protection from disclosure of con?dential business information (C131) and where
approved to provide that such protection generally expires after 10 years unless a claim is
reasseited and reapproved; reiterated that health and safety studies and related
information are not eligible for CBI protection, subject to two narrow exceptions; and
expanded authorized access to CBI to other levels of government and certain health and
environmental professionals.

Sadly, the implementation of the. Lautenberg Act has deviated dramatically from Congress?
intent and the new law?s requirements. This letter describes some of the many serious problems
with the actions taken by this Administration since January of 2017 actions that have rendered
the law?s implementation weaker than even before the 2016 reforms.

For each of several major sections of TSCA as amended by the Lautenberg Act, we describe
What was intended under the law, and provide some examples of how implementation has
fallen short of or deviated from that intent. For each area of concern, we request prompt
responses to the questions identi?ed.

Section 4: El?A?s failure to use its enhanced information authOrities under TSCA

One of the areas of greatest bipartisan consensus in TSCA reform was the need to improve
ability to readily obtain more robust information on chemicals, including data on
exposure pathways and extent of exposure. It is impossible to ensure the safety of chemicals and
protect human health and the environment without having solid information about a chemical?s
risks. That?s just common sense.

Under the 2016 reforms to TSCA, EPA can now readily acquire information where needed to
review new chemicals Or to priOritize 0r review the risks of a chemical already on the market.
The law also makes clear that EPA can require the development of real-world exposure
information.

Yet in the nearly 3 years since passage of TSCA reform, EPA has not once used thesenew
authorities, and seems to be avoiding using them at all costs even where there are critical
information gaps. For extrinple, in a recent draft risk evaluation for Pigment Violet 29, EPA
relied exclusively on an unsupported guesstiinate from a company representative for the level of
workplace exposure to a chemical, rather than using its authority to require actual workplace
monitoring.

1. Why has EPA failed to use its information authorities?

2. Is there a policy at the agency that discourages use of such authorities?

3. Is there a policy for determining when such authorities are to be used?
4. Please share any existing policies with the committee by the end of June 2019.

5. EPA received public comments on the ?rst 10 chemicals it is reviewing under TSCA that
identi?ed serious information gaps. Yet EPA has already stated publicly that it does not
intend to use these authorities for any of the ?rst 10 chemicals. Please explain this
decision.

a. I-las EPA documented the basis for its decision not to rely on these authorities
with respect to the ?rst 10 chemicals?

b. If so, please provide documents related to this decision.

6. Has EPA considered using any of these information authorities when assessing a new
chemical since passage of the Lautenberg Act?

a. If so, please provide any documentation related to those decisions.

b. If not, why EPA has not considered using its infomiation authorities when
assessing any of the approximately 2,500 new chemical submissions it has
reviewed over this time period?

c. Has EPA requested or required??and received?any vertebrate animal or
non/vertebrate or non-animal toxicity information?

The law?s vertebrate animal testing provisions in no way limit testing authorities; they
simply call for EPA to rely on methods not involving vertebrate animals where such methods can
provide information of equivalent or better scienti?c quality and relevance than vertebrate
animal tests.

7. Does EPA consider that the law in any manner constrains authority to request or
require testing if the needed test is an animal test? if so, please indicate where such a
constraint is stated in the law.

8. Has EPA requested or required the use of any tests, whether involving vertebrate animals
or not, using its section 4 authorities since passage of the Lautenberg Act?

9. In order for the public to understand how use of its information authorities affects
the information that EPA receives, when and how will EPA make publicly available any:

a. voluntary exposure and toxicity information it receives for new or existing
chemicals,

b. any requests or requirements EPA issues regarding new or existing chemicals, and

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0. exposure or toxicity information it receives as a result of such requests or
requirements?

10. EPA has stated that the agency intends to rely principally or entirely on voluntary
submissions of information.

a. Please describe any steps that the EPA has taken to that it obtains all reasonably
available information through voluntary submissions.

b. Please describe any steps that the EPA has taken to ensure that all companies with
relevant information choose to provide information.

0. Please describe any steps that the EPA has taken to ensure that companies do not
choose not to provide infonnati on that is unfavorable to their chemicals Or that
they for some other reason do not wish to provide EPA or have be made public.

1 1. Does EPA have a written policy or procedure to prevent receiving only incomplete or
biased information when relying solely on voluntary submissions? If so, please provide
them.

Section 5, part 1: failure to protect workers when reviewing new chemicals under
TSCA

Congress gave EPA authority to regulate chemicals that may present risks to workers when
TSCA was ?rst enacted in 1976. Bipartisan TSCA reform in 2016 strengthened this authority by
explicitly naming workers as a ?potentiain exposed or susceptible subpopulation? and requiring
that EPA consider and address potential risks to workers when assessing new or existing
chemicals.

Every year, industry submits 1,000 or so new chemical notices that EPA must review before the
chemicals can enter the market. As part of this review, Congress told EPA to determine whether
any of these chemicals ?may present an unreasonable risk? to workers, using TS health
standard, which is much more stringent than the Occupational Safety and Health
Administration?s (OSHA) workplace standards. Where potential risks to workers are identi?ed
under TSCA, EPA must mitigate or eliminate those risks

Unfortunately, EPA is failing to carry out the law and is putting the health of American workers
injeopardy. Even where EPA ?nds a new chemical does or may present serious risks to
workers, the agency is allowing that chemical onto the market without imposing any conditions
to protect the workers. only justi?cation for this is that it simply ?expects? that workers
will protect themselves from harmful workplace exposures by wearing personal protective
equipment (PPE) that the company is not required to provide or train workers to use properly. in

doing this, EPA is deferring to OSHA regulatiOns that allow workers to be exposed to chemical
risks that are a thousand or more times higher than are acceptable under 

12. Why is EPA failing to carry out its duty to ensure workers are protected under TSCA,
and is instead deferring to the much weaker health standards and regulations of 

13. On what legal basis is EPA allowing, without any conditions or restrictions, new
chemicals onto the market that may present risk to workers, when the law clearly requires
EPA to regulate such chemicals?

a. Whatactual evidence does the agency have that American workers will be
sufficiently protected once these chemicals are On the market?

14. Please provide us with your new chemicals decision?making policies that set
ferth the legal basis for your decisions regarding worker safety, along with any evidence
that workers are being suf?ciently protected under your approach. If y0u lack any such
Written policies or evidence, please explain why EPA has consistently applied this
approach to so many of its recent new chemicals decisions?

Section 5, part 2: failure to adequately identify and review ?reasonably foreseen?-
condi?tions of use when reviewing new chemicals under TSCA

When reviewing a new chemical, EPA is directed by statute to examine the chemical under its
?conditions of use,? de?ned in TSCA as ?the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be
mamufactured, processed, distributed in commerce, used, or disposed of.? In the context of new
chemicals, Congress?s inclusion of a requirement for EPA to examine ?reasonably foreseen?
activities is particularly noteworthy. Where EPA determines that a new chemical ?is notlikely
to present an unreasonable risk? and the notifying company commences manufacture, that
chemical is then placed on the TSCA Inventory and other companies can make or use that
chemical at will without any noti?cation to or review by EPA. Such a chemical may be
produced or used in amounts or in ways that the original company did not intend at the time it
?rst noti?ed EPA of the new chemical. The risks of these additional activities, in combination
with those from the-ori ginal 1y intended activities, could well increase to a point where EPA
would ?nd that the chemical ?presents? or ?may present? an unreasonable risk. Hence it is vital
that EPA consider both intended and reasonably foreseen activities in its initial review.

Unfortunately, EPA has attempted to skirt this requirement for an integrated assessment of both
intended and reasonably foreseen conditions of use in. several ways that are contrary to what
TSCA requires:

 

1 According to an analysis conducted by the Environmental Defense Fund, since EPA embarked on its
dangerous new approach, EPA has given a green light to more than 80% of new chemicals it has
reviewed letting them onto the market with no conditions whatsoever. For 70% of these new
chemicals, EPA clearly identified potential risks to workers but imposed no restrictions.

 For most new chemicals EPA has reviewed in recent months, it simply asserts there are
no such reasonably foreseen uses.

0 For most of the small subset of such new chemicals where EPA does identify a
reasonably foreseen use, it merely states without providing any analysis that it expects
that use to present no greater risk than the intended use. By doing this, EPA not only
fails to demonstrate that the reasonably foreseen use is not likely to present an
unreasonable risk; it also fails to consider that the combination of use could present such
a risk.

0 For the remaining few new chemicals where EPA does identify a reasonably foreseen use
and identi?es some potential concern with that use, EPA has separately promulgated a
Signi?cant New Use Rule (SNUR) that requires a company to notify EPA prior to
engaging in that reasonably foreseen use. However, in these SNURs, EPA has not made
clear that it would assess the potential exposure and risks from that use in combination
with the already approved intended uses as part of its review of any such notice.

None of these recent policy changes to examination of new chemicals? conditions of use
has been. made public or subject to apublic comment opportunity. While certain aspects of the
third case outlined above appear to mirror aspects ofEPA?s November 2017 ?decision?making
framework? that was subject to public comment, EPA has never responded to those public
comments, and when a lawsuit challenged that earlier framework, EPA did not apply the
framework until the lawsuit was dismissed, apparently to evade judicial review of the
framework.

15. Why has EPA implemented these new ?reasonably foreseen? policies for months now
without publicly describing them and allowing the public an opportunity to comment on
them?

16. We expect that EPA has put its new policies and procedures in writing for internal use.
Please provide us with copies. If written cepies are not available, please explain how
EPA is making decisions concerning new chemicals without such written policies.

17. What are plans to publish and take public comment on its current decision?making
framework, including the legal and scientific justi?cations for it?

18. On what statutory basis does EPA believe it has authority to separate its consideration of
potential risks arising from intended vs. reasbnably foreseen conditions of use of a new
chemical, given clear mandate that they be assessed together?

Section 6: failure to assess even known conditions of use and pathways of exposure
in conducting risk evaluations of existing chemicals under TSCA

The 2016 reforms to TSCA strengthened authority and mandate to conduct
comprehensive, robust evaluations of potential risks posed by chemicals in commerce. As

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mentioned above, EPA is required to determine whether a chemical substance, as a whole,
presents an unreasonable risk under its conditions of use. To do so, EPA must evaluate potential
risks arising from activities across the entire lifecycle of a chemical, and it must consider all
?known? and ?reasonably foreseen? circumstances, not just those ?intended? by a company
making 01' using a chemical.

Yet EPA has sought in numerous ways to limit the scope of its risk evaluations and risk
determinations. First, in its ?nal Risk Evaluation Rule,2 EPA reversed course from its proposed
rule and asserted sweeping authority to pick and choose what activities and what exposures it
includes in its risk evaluation of a chemical. EPA claimed it could ignore any exposure to a
chemical that also falls under the authority of another agency, such as OSHA, regardless of
whether that agency has actually taken any action to mitigate the risks of the chemical. EPA also
stated that it will exclude what it called ?legacy? activities associated with a chemical. Even
when a chemical is still being used or disposed of, EPA asserted that it could ignore exposures
from those ?legacy? activities ifa chemical was not being actively manufactured for those uses.
Fer example, EPA will ignore known exposures to: ?ame retardants that have been voluntarily
phased out but are still present in millions of items of furniture still in active use; and to asbestos
in insulation that remains in place in millions of homes, schools and other buildings. EPA will
not only be ignoring exposures that clearly contribute to ongoingrisks, it will do so even where
no law or regulation prevents companies from resuming production of a chemical that has been
voluntarily phased out.

But EPA has not stopped there. It has already begun to. conduct risk evaluations that exclude
most or all pathways of exposure to a chemical that fall under the jurisdiction of another statute
that EPA administers. This means EPA will not account for the human health or environmental
risks of releases and exposures to chemicals in air, surface, ground or drinking water, or wastes,
no matter how they are disposed of. Not only will EPA ignore the contribution to overall
exposure of environmental releases that are actually regulated under another law; it will also do
so when no regulation has been issued at all for a chemical under another law--merely because
EPA could in principle regulate the chemical in the future. The magnitude of the exposures EPA
is zeroing out of its risk evaluations is enormous. For just seven of the ?rst 10 chemicals
undergoing risk evaluations under TSCA, own data indicate that 66 million pounds are
released every year to the air, water and land even a?er accounting for any regulations of these
chemicals in place under another lawi

Finally, while TSCA requires EPA to determine whether a chemical as a whole, not individual
uses of a chemical, poses an unreasonable risk, EPA has asserted that it can make use?by-use
determinations of no unreasonable. risk, without ever considering the combined exposures from
multiple uses of the same chemical.

All of these assertions of authority are contrary to both the letter and the spirit of reformed
TSCA, which was intended to ensure that chemical risk assessments accounted for

 

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chemical expOSures in the real world, where people are exposed to chemicals at work and at
home, and through air, water and food as well as throngh the use of products.

19, How does exclusion of known uses and exposures to chemicals represent use of
the ?best available science,? as required tinder TSCA section 2601)?

20. How is EPA complying with TSCA section requirement that EPA consider all
reasonably available information when EPA ignores known uses and exposures to
chemicals?

21. Please identify the speci?c language in TSCA that authorizes EPA to make risk
determinations on individual uses of a chemical, rather than on the chemical as a whole,
thereby not accounting for the potential for people or the environment to be exposed to a
chemical in multiple ways.

22. Please identify the speci?c language in TS CA that authorizes EPA not to account for
exposures from use 'or disposal of a chemical where that chemical is not currently
manufactured for such a use.

23. How will EPA ensure that it meets its obligation under TSCA to protect against
unreasonable risk, including risk to vulnerable suprpulations, if it defers to other
agencies or EPA?administered statutes that use health standards that differ signi?cantly
from and do not require protection of vulnerable subpopulations?

24. While EPA has announced these policies in its ?nal framework rule and risk evaluation
scopes and problem formulations, EPA has provided relatively little explanation of the
legal basis for these approaches. Does EPA have a more robust legal analysis justifying
these approaches? If so, please provide it/ them.

Section 14: failure to provide timely public access to non-con?dential information
and access bv eligible parties to con?dential business information under TSCA

A key aim of TS CA even as originally enacted in 1976 was to ensure there is adequate
infomiation available on the potential health and environmental effects of chemicals. Congress
clearly identi?ed this aim in the ?rst item articulated in policy section TSCA
also called on EPA to play a central role in providing broad access to such information On
chemicals, while protecting legitimate con?dential business information (CBI). Both roles are
Speci?ed in TSCA section 14.

The 2016 TSCA amendments made major changes to section 14, enhancing requirements for
companies? assertion and substantiation, and review, of claims; for providing public
access to chemical information; and for providing expanded access to 

CB1 claims must be asserted at the time information is submitted to EPA. Except for
certain speci?c types of information, all CBI claims must also be substantiated at that
time.

Health and safety studies and their underlying information are not eligible for C131
protection, subject to two narrow exceptions.

EPA must review ali CB1 claims made to protect a chemical?s identity, and at least 25%
of all other types of CBI claims, except for those speci?cally exempted from
substantiation. EPA must conduct its review and make a determination on each CBI
claim within 90 days of its receipt. Any' claim approved expires after '10 years unless
reasserted and reviewed and approved by EPA.

A pubiic ?unique. identifier? must be assigned to any con?dential chemical identity and
used to ?tag" all other information EPA has or receives on that chemical.

Subject to certain conditions, EPA is to provide access to CBI by state, local and tribal
governments, associated health and environmental professionals, medical personnel and
?rst responders.

EPA is to establish a ?request and noti?cation system? to provide ?expedient and swift
access? to CBI by government-associated health and environmental professionals,
medical personnel and ?rst rCSponders.

These provisions of amended TSCA were immediately effective. Yet nearly three years after
enactment, there is little evidence that EPA is effectively implementing these provisions 0r
requiring compliance with them. Foremost among our concerns is failure to provide any
means for the public to know about and have con?dence in the extent of EPA CBI reviews, the
determinations being reached, and the provision of access to information the law requires be
provided. Some speci?c examples are listed below:

0 EPA has provided no public accounting of how many CBI claims it has received and for

what types ofinformation; how many claims it has reviewed and within what timeframe;
or the outcomes of any of the claim reviews it has conducted.

While section 26(j) of TSCA requires EPA to make all of its determinations publicfor even a single (3131 claim determination.

Last December, EPA for the ?rst time published a list of ?unique identi?ers? it had
assigned to chemicals for the identities of which ithad approved CBI claims. The list
contained only 157 entries, and the most recent assignment dated back to August 2017,
more than 18 months ago. Yet EPA has allowed the identities of hundreds of additional
chemicals to be hidden from the public without assigning a unique identi?er. For
example, as of the end ot?January of this year, EPA had failed to assign a unique
identi?er to at least 270 new chemicals that have. commenced manufacture and that are
identi?ed only by a generic name indicating EPA has allowed the speci?c name to be
kept con?dential.

0 EPA appears to have made no progress at all toward establishing the ?request and
noti?cation system? required under TSCA section That system is vital to
ensuring that government-associated health and environmental professionals, medical
personnel and ?rst responders can gain access to con?dential information they need to do
their jobs.

Meanwhile, EPA has withheld health and safety studies or their underlying information from the
public pertaining to the ?rst chemical subject to a risk evaluation under TSCA, called Pigment
Vicilet 29. Initially EPA erroneously asserted that such information was eligible for CBI
protection under TSCA and was being withheld from the public on that basis. When that
argument was rebutted, EPA acknowledged it had erred but then came up with a different legal
theory for withholding information that Congress clearly intended be publicly accessible.

Stakeholders report that when they have raised concerns about many of these issues to EPA staff,
they have repeatedly been told that the agency does not have suf?cient resources to carry out its
duties under section 14, Yet comments received by the agency On its proposed user fee rule
pointed to severe underestimation of its costs for implementing these requirements of
amended TSCA and urged EPA both to provide a fuller accounting of its expenses and to
increase the amount of fees it was to collect to help offset these costs. Despite these concerns
being voiced, EPA made no changes either to its cost estimate or to its fee structure.

25. When can we expect to see real progress in the agency?s meeting its duties under TSCA
section 14? Speci?cally:

a. When will EPA provide a public accounting of how many CBI claims it has
received and for what types of information; how many claims it has reviewed and
within what timeframe; and the outcomes of determinations on) the claim
reviews it has conducted, as required?

b. When will EPA make public a current and complete list of ?unique identifiers?
for chemical identities for which EPA has approved CB1 claims, which are
essential fer the public to identify other information EPA has on those chemicals?

0. When will government-associated health and environmental professionals,
medical personnel and. ?rst responders be able to access the con?dential
information they need to do their jobs through the ?request and noti?cation
system? for access required under 

d. When will EPA make public health and safety studies and associated information
on chemicals, which are not eligible for protection as CBI under 

Each of us contributed a great deal of time and energy into the Congressional reform process of
TS CA with a wide variety of stakeholders from the environmental, health and business sectors.
We all had the goal of restoring public trust in the federal government?s ability to protect the

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public from hazardous chemicals in commerce. Three years later, we are sorely disappointed
with the direction the Administration has taken this landmark bipartisan law. Your response to
these questions in a timely manner would be appreciated so we can begin the process of turning
implementation of the new TSCA in the right direction.

 

 

Respectfully,

057M
Tom Udall Cory A. Booker
US. Senator US. Senator

    

Edward J. Markey Jeffrey A.
US. Senator US. Senator

MM

mm Whitehouse
US. Senator

 

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