Pesticides, Chemical Regulation, and
Right-to-Know Committee Newsletter
Vol. 18, No. 1
FROM THE CHAIR
Keith A. Matthews
The Pesticides, Chemical Regulation, and Rightto-Know Committee (PCRRTK) is pleased to
present this special edition of the Committee’s
Newsletter focusing exclusively on H.R. 2576, the
Frank R. Lautenberg Chemical Safety for the 21st
Century Act. H.R. 2576, which effected significant
changes to the Toxic Substances Control Act
(TSCA), passed the House of Representatives by
a vote of 403–12 on May 24, passed the Senate by
voice vote on June 7, and was signed into law by
President Obama on June 22, 2016.
As we explicate in detail below, new TSCA,
inter alia, (1) grants the U.S. Environmental
Protection Agency (EPA) expanded authority to
order testing of chemicals and requires EPA to
develop procedures for tiered testing, screening,
and alternatives to vertebrate testing; (2) imposes
requirements for evaluation of new chemicals and
prohibits commercialization of a new chemical
prior to EPA making an affirmative determination
that the chemical meets the requisite safety
standard; (3) “resets” the TSCA Inventory to
include chemicals that have been in commercial
use the past ten years; (3) mandates that within
six months of enactment of Lautenberg, EPA
initiate risk evaluations of at least ten chemicals
on the 2014 TSCA Work Plan and that within
three and a half years of enactment of new
TSCA EPA have initiated 20 risk evaluations
of chemicals designated as “high-priority”; (4)
September 2016
mandates that EPA designate 20 “low-priority”
chemicals not requiring review within three and
a half years post-enactment; (5) imposes specific
requirements on actions to restrict, phase out, or
ban chemicals and eliminates the requirement
that EPA adopt the “least burdensome” regulatory
action; (6) establishes new preemption standards
applicable to state and local actions affecting
chemicals evaluated by EPA (this was a highly
debated provision, resulting in a complicated
mixture of mandates, exemptions, suspensory time
periods, and discretionary authority); (7) revamps
the procedures and requirements applicable to
confidential information; (8) authorizes EPA to
promulgate and implement new requirements
regarding fees and requires that fees be established
such that they will cover 25 percent of the cost of
implementing the chemical review and assessment
functions of EPA; and (9) authorizes new
regulatory power concerning articles. This listing is
only a sampling of the many new and substantive
provisions that new TSCA contains and are
discussed in this special edition of the Newsletter.
A legislative product of this magnitude and
complexity does not come about easily. It has been
over ten years since the late Senator Lautenberg
(D-NJ) first introduced a bill to overhaul the longoutdated TSCA. But it was not until the Senator
reached across the aisle and partnered with Senator
David Vitter (R-LA) on a bi-partisan proposal that
actual progress became possible. After Senator
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
Continued on page 3.
1
Pesticide, Chemical Regulation, and
Right-to-Know Committee Newsletter
Vol. 18, No. 1, September 2016
Lynn L. Bergeson, Editor
AMERICAN BAR ASSOCIATION
SECTION OF ENVIRONMENT,
ENERGY, AND RESOURCES
In this issue:
From the Chair
Keith A. Matthews ........................................ 1
From the Editor
Lynn L. Bergeson........................................... 3
New TSCA and EPA’s Enhanced Testing Authority
Ria Rana ........................................................ 5
New Chemicals under New TSCA
Lynn L. Bergeson and Charles M. Auer ...... 6
Is the Section 5 Review Period Fixed or Flexible
in New TSCA?
Charles M. Auer and Lynn L. Bergeson ...... 8
New TSCA—Existing Substances
Lisa M. Campbell, Lisa R. Burchi, and Richard E.
Engler, Ph.D. ................................................ 13
Implementing the 2016 TSCA Amendments
Lawrence E. Culleen and
Camille Heyboer ........................................ 17
2017 “Reset” of New TSCA Inventory Will Affect
All Chemical Users, Not Just Manufacturers
James G. Votaw ........................................ 19
Changes Regarding Confidential Information in
New TSCA
Sara Beth Watson ....................................... 21
CALENDAR OF SECTION EVENTS
CALENDAR OF SECTION EVENTS
September 26, 2016
Landmark White-Collar Crime Trials: Individual
Prosecutions in Wake of Major Disasters
CLE Webinar
October 5-8, 2016
24th Fall Conference
Westin Denver Downtown
Denver, CO
October 26, 2016
Environmental and Workplace Safety Criminal
Enforcement Conference
Westin City Center
Washington, DC
March 28-29, 2017
35th Water Law Conference
Los Angeles, CA
March 29-31, 2017
46th Spring Conference
Los Angeles, CA
For full details, please visit
www.ambar.org/EnvironCalendar
Preemption under New TSCA
Judah Prero ................................................ 23
New Fees Provisions in New TSCA
Keith A. Matthews ...................................... 26
Weight of Evidence in New TSCA
Lorenz R. Rhomberg, Ph.D., ATS................ 27
PBT Actions under New TSCA
Martha Marrapese and
Adrienne Timmel ........................................ 28
New TSCA and “Articles”
Thomas C. Berger ....................................... 30
2
Copyright © 2016. American Bar Association. All
rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, or transmitted
in any form or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without the prior
written permission of the publisher. Send requests to
Manager, Copyrights and Licensing, at the ABA, by way
of www.americanbar.org/reprint.
Any opinions expressed are those of the contributors
and shall not be construed to represent the policies
of the American Bar Association or the Section of
Environment, Energy, and Resources.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
Continued from page 1.
Lautenberg’s death, Senator Tom Udall (D-NM)
took up the mantle of leading the effort on the
Minority side. Nonetheless, the past three years
have been tantamount to excruciating to those of us
in the chemicals regulation bar, as various House
and Senate bills wended tortuous paths toward
a hoped-for passage of compromise legislation.
And then, in late May and early June, it all came
together. Forty years after enactment of the original
TSCA, substantial substantive amendments
that are reflective of the significant advances in
toxicological science that have occurred in those
four decades have finally been enacted.
Regardless of how one may view the current state
of Congress, passage of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, when
coupled with the more recent passage of a statute
requiring rational and coherent disclosure related to
genetically engineered foods, constitute significant
and meaningful advances to the state of chemicals
regulation in the United States.
Global Chemical
Control
Handbook:
A Guide to
Chemical
Management
Programs
Lynn L. Bergeson
List Price: $149.95
Section Member: $119.95
ISBN: 978-1-62722-739-1
Product Code: 5350252
(c) 2014, paperback
Global Chemical Control Handbook keeps practitioners
abreast of these important developments—what they are,
on what segment of the global supply chain they apply,
and when and how these measures impact the business
of chemicals. Providing a broad overview of key chemical
management programs in the United States, Europe,
Asia, and Central and South America, this book describes
the key laws and their regulatory implementation in these
jurisdictions. The authors provide a basic understanding
of each law and help practitioners identify key business
issues of concern.
FROM THE EDITOR
Lynn L. Bergeson
The SEER Committee on Pesticides, Chemical
Regulation, and Right-to Know has been at the
forefront of efforts to reform TSCA for years.
Our Committee has written extensively on TSCA
reform topics, sponsored many substantive
programs and webinars over the years, helped with
educating congressional staff and Members on
TSCA law and practice issues, and contributed to
the scholarship on legal issues central to the TSCA
reform debate. Now that Congress has spoken and
passed comprehensive TSCA reform legislation,
we have decided to devote an entire Newsletter to
this historic achievement.
Following a section-by-section summary of the
Frank R. Lautenberg Chemical Safety for the
21st Century Act, Pub. L. No. 114-182, referred
to as “new TSCA,” this special edition issue of
the Newsletter takes you through an informative
review of new TSCA’s expanded testing authorities
under Section 4, prepared by Committee member
Ria Rana.
TSCA’s new chemical provisions under new
TSCA Section 5 are next outlined by Committee
Vice Chair Lynn L. Bergeson and Charles M.
Auer in a summary overview that focuses on new
TSCA’s requirement that EPA make an affirmative
determination on each new chemical or significant
new use of a chemical subject to TSCA Section 5
notification requirements. Charles M. Auer and
Lynn L. Bergeson next offer a few insights on
new TSCA’s Section 5 review period and offer an
interpretation that seeks to explain congressional
changes to TSCA in this regard.
Committee member Lisa M. Campbell and
her colleagues Lisa R. Burchi and Richard
E. Engler, Ph.D. next summarize new TSCA
Section 6 prioritization, risk evaluation, and riskmanagement provisions and their application to
existing chemical substances. This Section is a
critically important component of TSCA reform
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
3
as it sets in motion a comprehensive prioritization
and risk evaluation of the thousands of existing
chemicals that were largely beyond EPA’s reach
under old TSCA. The risk evaluations are expected
to result in risk-management decisions for some
chemicals and thus will have profound impacts
on the marketing of chemicals globally. EPA has
already convened a public stakeholder meeting on
this subject, as explained by Committee Vice Chair
Lawrence E. Culleen and Camille Heyboer, who
write about EPA’s ongoing implementation of new
TSCA. EPA literally hit the ground running on June
22, 2016, and has been working hard to meet the
many demands on its time under new TSCA.
Following the Section 6 discussion, Committee
member James G. Votaw takes you through a
concise summary of the all-important “Inventory
reset” provisions under TSCA Section 8. This
article helps explain why EPA’s prioritization
burden may not be as heavy as it would appear
given the number of chemical substances listed
on the TSCA Inventory. Also as pointed out in the
Culleen and Heyboer article, EPA has convened a
public stakeholder meeting on this subject and is
working on a proposed rule expected out by the
end of the year.
Concerns about confidentiality information and
the scope of protection from public disclosure
under TSCA Section 14’s confidential business
information (CBI) provisions are next reviewed by
Committee Vice Chair Sara Beth Watson. This
topic was much debated in the run-up to TSCA
reform’s passage, and the impact of the changes to
asserting, substantiating, and renewing CBI claims
will have an important impact on EPA and TSCA
stakeholders.
Section 26—Administration—is a critically
important section of TSCA reform as it expands
EPA’s authority to assess fees, requires EPA to use
“best available science” and “weight of evidence”
approaches, creates a Science Advisory Committee
on Chemicals, and requires EPA to develop
policies, procedures, and guidance—actions that
will keep lawyers and other stakeholders busy
for years. Committee Chair Keith A. Matthews
provides his insights on the all-important new
funding provisions that EPA is grappling with
now (having convened an industry stakeholder
meeting in early August) as EPA attempts to
issue a proposed rule later this year. Lorentz R.
Rhomberg, Ph.D., ATS provides a stimulating
explanation of “weight of evidence” and what
conducting weight of evidence evaluations under
new TSCA may mean for EPA.
Finally, we offer important insights on two topics
significantly impacted by new TSCA—persistent,
bioaccumulative, and toxic (PBT) chemicals
and “articles.” Committee Vice Chair Martha
Marrapese and her colleague Adrienne Timmel
outline exactly how PBT chemicals are addressed
under new TSCA. Committee member Thomas C.
Berger provides a comprehensive analysis of new
TSCA’s treatment of articles in contrast with EPA’s
more traditional approach to articles.
The Section offers much more information at its
dedicated website www.ambar.org/environtsca. We
hope you enjoy this issue of the Newsletter and
urge you to join our Committee as we will continue
to explore the wonderful work of TSCA for years
to come.
Judah Prero next provides an illuminating
overview of the thorny issue of preemption,
plainly one of the most challenging sections TSCA
reform negotiators were required to address. TSCA
reform approaches federal-state relationships in a
completely new and potentially precedent-setting
way, and practitioners need to understand how the
concepts of “pause” preemption and “permanent”
preemption work.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
4
NEW TSCA AND EPA’S ENHANCED TESTING
AUTHORITY
Ria Rana
Of the changes ushered in by the new TSCA, one
amendment of particular importance resides within
Section 4 of the Act. Section 4 sets forth EPA’s
ability to compel testing of a chemical substance or
mixture. The amended Section advances chemical
safety because it makes it easier for EPA to obtain
information on a chemical’s risks and regulate such
risks accordingly. EPA’s testing authority has been
enhanced in several notable ways.
Providing Flexibility and Eliminating the
Catch-22. Under TSCA, for EPA to require a
manufacturer to test its chemicals, the Agency had
to promulgate regulations through an unwieldy,
multi-year rulemaking process. In addition, to
propose rulemaking, EPA was first required to
present evidence that the chemical sought to
be tested posed a risk to human health or the
environment. A Catch-22, this effectively thwarted
EPA’s ability to obtain needed information to
determine if a particular chemical presents an
unreasonable risk.
New TSCA now gives EPA more flexibility by
allowing it to require testing of chemicals through
order or consent agreement, two methods that are
more cost and time efficient than the rulemaking
process. If EPA issues an order requiring testing, it
must explain why it chose to use an order instead
of promulgating a rule or entering into a consent
agreement.
The Act also eliminates the Catch-22 by giving
EPA authority to mandate testing where it needs
information to assess whether there could be
“exposure or exposure potential to humans or
the environment.” EPA is required to provide an
explanation when it requests new information on a
chemical substance or mixture.
existing chemicals, and it can use the information
it gains for the purpose of prioritization. EPA
cannot, however, mandate testing as a means
of establishing minimum information sets for
chemicals.
Regarding the method of testing, EPA is required to
use tiered testing approaches by which the results
of screening-level tests or assessments of available
information inform the decision of whether
additional tests are needed. It can, however, skip
tiered testing and go directly to advanced testing as
long as it can justify doing so.
New TSCA also retains the Interagency Testing
Committee (which had been eliminated under
the Senate’s version of the bill) and adds the U.S.
Food and Drug Administration and the Consumer
Product Safety Commission to the designated list
of members.
Animal Testing. Perhaps most notable of the testing amendments is the first-ever federal mandate
to reduce animal testing. New TSCA requires EPA
to reduce and replace vertebrate animal testing
where scientifically reliable alternatives exist that
would generate equivalent or better information.
Additionally, new TSCA requires EPA to fund,
develop, and implement a plan to support alternative test methods that are not based on vertebrate
animals. Examples of alternative methods listed in
the statute include the use of computer modeling or
in vitro studies to test isolated human cells against
chemicals. While new TSCA does not ban chemical testing on animals, the legislation is nevertheless groundbreaking because it recognizes that nonanimal testing can be just as, if not more, effective
in determining the safety of chemicals.
Ria Rana is a civil litigation defense attorney with
Arshack, Hajek & Lehrman, PLLC in New York City.
Other Notable Testing Amendments. EPA’s
expanded testing authority applies to both new and
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
5
required to regulate under Section 5(e)
and, as described above, to also consider
the need for a SNUR/publish reasons for
not taking that step. The language in (B)
also makes clear that an order shall be
issued. The language in (B) is similar to
the provisions in TSCA Section 5(e)(1)
(A) except that in TSCA, the first italicized
“or” is an “and” (also nonrisk factors or
potentially exposed subpopulations are not
discussed). The effect of the change from
“and” to “or” is substantially to broaden
the effect of the new provision and allow
EPA action based merely on insufficient
information.
NEW CHEMICALS UNDER NEW TSCA
Lynn L. Bergeson and Charles M. Auer
New TSCA retains much of TSCA Section 5 with
important changes. Under new TSCA, EPA must
make an affirmative determination regarding the
new chemical or significant new use (SNU) of a
chemical substance and take any required actions.
This change has a significant impact on the
commercialization of new chemicals.
Under new Section 5(a)(3), EPA must make any of
three determinations and take associated actions
on a new chemical or SNU. The focus of the
determination concerns whether the new chemical
or SNU presents or may present “unreasonable
risk to a potentially exposed or susceptible
subpopulation identified as relevant by [EPA]
under the conditions of use.” The determinations,
which are not to consider costs or other nonrisk
factors, are as follows:
•
•
6
(A) That the chemical or SNU presents an
unreasonable risk of injury in which case
EPA shall regulate under Section 5(f) and,
per Section 5(f)(4), is to consider whether
to promulgate a SNU rule (SNUR) or, not
taking that step, to publish a statement
explaining why not. Lautenberg also
simplifies the procedural requirements that
applied in TSCA Section 5(f) by deleting
a provision relating to use of a court
injunction in lieu of an order.
(B) That the information is insufficient
to permit a reasoned evaluation of the
chemical or SNU; or that in the absence of
sufficient information, the chemical may
present an unreasonable risk; or that the
chemical will be produced in substantial
quantities and it either enters or may be
anticipated to enter the environment in
substantial quantities or there is or may be
significant or substantial human exposure.
If determination (B) is satisfied, EPA is
•
(C) That the chemical or SNU is “not likely
to present an unreasonable risk.” In these
cases, per Section 5(g), the notifier can
commence manufacture or processing for
the SNU “notwithstanding any remaining
portion of the applicable review period”
and, in addition, EPA is required to publish
a statement of its finding.
New TSCA Section 5(a)(4) specifies that if EPA
fails to make a determination by the end of the
applicable review period (and the notice has not
been withdrawn) EPA is required to refund all
applicable fees for the notice, subject to certain
limitations. EPA must still meet the requirement
that it review and make a determination and
the notifier cannot commence manufacture or
processing until that happens. The effect of
the changes seems to establish a fixed period
not to exceed 180 days for EPA to complete its
determination, lest the fees be returned.
New TSCA states that EPA may require SNU
notifications for import or processing of a chemical
as part of an article/category of articles if EPA
makes an affirmative finding in the Section 5(a)(2)
SNUR that the reasonable potential for exposure
through the article/category or articles justifies
notification. More on articles is available in the
Berger article in this Newsletter.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
New TSCA revises Section 5(e) to require that
EPA issue an order if the Section 5(a)(3)(B)
determination has been made by EPA. The order
must prohibit or limit manufacture, processing,
and related activities, “to the extent necessary to
protect against an unreasonable risk of injury to
health or the environment, without consideration
of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant” by
EPA. The provision makes clear that the submitter
may commence manufacture or processing,
“including while any required information is being
developed,” only in compliance with the order.
Importantly, Section 5(f) contains a new
subparagraph (5) requiring consultation with
the U.S. Occupational Safety and Health
Administration prior to the imposition of any
restrictions under Sections 5(e) or 5(f) addressing
workplace exposures, a feature that could invite
considerable complications.
Lynn L. Bergeson is Managing Partner of Bergeson
& Campbell, P.C. (B&C®), a Washington, D.C. law
firm focusing on conventional, nanoscale, and
biobased industrial, agricultural, and specialty
chemical product regulation and approval
matters, and chemical product litigation. She is
President of The Acta Group, L.L.C. and Managing
Director of The Acta Group EU, Ltd with offices in
Washington, D.C. and Manchester, UK.
Charles M. Auer retired in January 2009 as the
Director of EPA's Office of Pollution Prevention and
Toxics. Mr. Auer is Senior Regulatory and Policy
Advisor with B&C.
GET PLUGGED
IN TO YOUR
SECTION ON
SOCIAL
MEDIA!
LIKE us on Facebook
for Section news and
announcements on programs,
publications, and activities.
JOIN us on LinkedIn Groups
specific to the Section and your
committees for robust discussion
on environmental, energy, and
resource news topics.
FOLLOW us
on Twitter and
Instagram with
a real-time
newsfeed on
conference
updates,
articles,
and more.
facebook.com/ABAEnvLaw
bitly.com/ABAEnvLaw
twitter.com/ABAEnvLaw
instagram.com/ABAEnvLaw
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
7
IS THE SECTION 5 REVIEW PERIOD FIXED OR
FLEXIBLE IN NEW TSCA?
Charles M. Auer and Lynn L. Bergeson
New TSCA fundamentally changes EPA’s approach
to evaluating and managing industrial chemicals.
The body of changes, the careful balancing of competing needs and interests, and artful drafting yield
a statute that has been greatly strengthened and
addresses virtually all of the deficiencies that have
impeded the effective implementation of TSCA
over the years.
Among its other requirements and authorities,
Section 5 of new TSCA generally requires that
a company timely submit to EPA a notice of its
intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then
required to conduct a review of the Section 5(a)(1)
notice and make a determination on the NC/SNU
and take required additional actions. Questions
have been raised as to whether the review period
is fixed and requires that EPA determinations and
actions be completed within that period, or if the
statute can be read to permit a more flexible review
period along the lines of how it was interpreted
and applied in old TSCA with the use of voluntary
suspensions. This article analyzes that question.
Background
Under old TSCA, when EPA identified concerns
that indicated a possible need for a consent order
under Section 5(e) to allow for needed regulatory
requirements to be applied (e.g., to control exposure
or releases, preclude certain uses, and/or to require
that the notifier conduct needed testing), EPA would
typically obtain the agreement from the notifier
to “voluntarily suspend” the notice period. See 40
C.F.R. Section 720.75(b). This was typically done
around day 80–85 of the review period and was
intended to provide the time needed to allow for the
issues to be sorted out and for EPA and the notifier
to agree on the terms of a negotiated consent order
specifying needed controls or testing requirements.
8
New TSCA Requirements
Section 5(a)(1)(B) specifies that to manufacture
or process a NC/SNU, the person must submit a
notice of its intention to manufacture or process
a NC/SNU to EPA at least 90 days before such
manufacture or processing. Emphasis is added
where relevant. The person must comply with any
applicable requirements under Sections 5(b), (e), or
(f).
Section 5(a)(3) requires that “within the applicable
review period” EPA “shall review such notice” and
make a determination. The available determinations at Section 5(a)(3) are the NC/SNU presents
an unreasonable risk, the “information available is
insufficient to permit a reasoned evaluation of the
health or environmental effects,” or in the absence
of sufficient information to make such an evaluation, the NC/SNU may present an unreasonable
risk, or the NC/SNU has substantial production and
substantial or significant exposure, or the NC/SNU
is not likely to present an unreasonable risk. Under
the first two determinations, EPA is required to
regulate the NC/SNU.
Section 5(c) states that EPA “may for good cause
extend for additional periods (not to exceed in
the aggregate 90 days) the period, prescribed
by subsection (a) or (b).” The section goes on to
require that “such an extension and the reasons
therefor shall be published in the Federal Register
and shall constitute a final agency action subject to
judicial review.”
Section 5(d)(1) states that the notice required by
Section 5(a) shall include certain information
as described in the section. Section 5(d)(3)(A)
requires that EPA, at the beginning of each month,
“shall publish” a list in the Federal Register of the
chemicals for which notice has been received under
Section 5(a) “and for which the applicable review
period has not expired, and (B) each chemical
for which such period has expired since the last
publication.”
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
Section 5(e) is used to implement control actions
on cases found by EPA to satisfy a determination
under Section 5(a)(3)(B). In such cases, per Section 5(e)(1)(A)(i), EPA “shall issue an order, to take
effect on the expiration of the applicable review
period, to prohibit or limit…” Section 5(e)(1)(B)
goes on to state that
[a]n order may not be issued under
subparagraph (A) respecting a chemical
substance – (i) later than 45 days before the
expiration of the applicable review period,
and (ii) unless [EPA] has, on or before the
issuance of the order, notified, in writing each
manufacturer or processor, as the case may be,
of the substance of the determination which
underlies such order.
Section 5(f) describes the regulatory procedure
for cases meeting the Section 5(a)(3)(A)
determination, which, in general, parallels but
differs in specifics from that in Section 5(e),
including that EPA “may” issue an immediately
effective proposed Section 6(a) rule or a Section
5(f) order. The provisions of Section 5(e)(1)(B)
concerning the need to issue the action 45 days
before the expiration of the applicable review
period apply in the case of the order but not for the
proposed rule.
Section 5(g) requires that in the case of a
determination under Section 5(a)(3)(C) that a NC/
SNU is not likely to present an unreasonable risk,
“then notwithstanding any remaining portion of
the applicable review period, the submitter of the
notice may commence manufacture or processing.”
EPA is also required to “make public” a statement
of its finding that “shall be submitted for
publication” in the Federal Register “as soon as
practicable before the expiration of such period.”
Note that publication of the statement “is not a
prerequisite to” manufacture or processing.
Section 5(i) defines applicable review period as
follows:
(3) For purposes of this section, the term
‘applicable review period’ means the period
starting on the date [EPA] receives a notice
under subsection (a)(1) and ending 90 days
after that date, or on such date as is provided
for in subsection (b)(1) or (c).
Analysis and Conclusions
A first observation is that if Congress did not want
to change the current understanding, it could have
retained the language in old TSCA. The fact that
Congress changed the language and defined a new
term applicable review period presumably reflects
congressional intent at a minimum to clarify the
concept that had been described as the “notification
period” in old TSCA. Or, as is our view, Congress’s
intent was to change the interpretation of this
concept regarding the effective operation of the old
TSCA Section 5 review period against the calendar.
We note in this regard that it can be argued EPA
overinterpreted the flexibility in “notification
period” and the other provisions in old Section 5
that related to the review period. Although the use
of voluntary suspensions has been codified in 40
C.F.R. Section 720.75(b), there is not a provision in
old or new TSCA that speaks to such suspensions.
We note also the use of “prescribed” in old and
new TSCA Section 5(c) and in old TSCA Section 5(d)((3)(A). In the dictionary, “prescribed” is
defined as “to lay down, in writing or otherwise,
as a rule or a course of action to be followed” and,
in addition, “enjoin,” which has a particular legal
denotation, is offered as a synonym. No challenge
was made of the interpretation that allowed voluntary suspensions. The practice was subsequently
codified, and, of course, is now widely used. Thus,
despite the efforts of congressional drafters to, in
our view, change the meaning, the bottom line may
be that someone has to make a legal challenge to
EPA’s interpretation of applicable review period if
it includes voluntary suspensions in its implementation approach going forward under the new law.
We recognize that this is an issue that industry
stakeholders will need to consider carefully. We
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
9
believe, however, that a good argument can be
made that applying the new TSCA Section 5 notice
review process within a defined period brings a
clarity and certainty that perhaps may be beneficial
to all involved. Perhaps recognizing the benefits
of clarity on this issue, Congress may have endeavored to restate the requirements in terms of an
applicable review period to make clearer what was
intended to apply.
While we recognize and understand the desire of
notifiers not to be “the nail that sticks out,” an
unintended consequence of the informal voluntary
suspension in lieu of a “due process” approach under old TSCA Section 5 is that EPA reviewers and
new chemical submitters grew unaccustomed to engaging in the push and pull that characterizes other
environmental issues. Perhaps as a consequence,
they did not have the benefit of constructive, albeit
sometimes adversarial, dialogue as scientific, legal,
and policy peers over the substance and conclusions of EPA’s evaluations and its proposed control
remedies, respectively. We believe such dialogue
is essential and strengthens the process by providing clarity while also producing more broadly and
mutually acceptable outcomes. The U.S. regulatory
system is premised on legal requirements and their
application to specific factual settings. Conflict
over the interpretation or application of legal authorities to specific situations can result in the need
for judicial recourse, and the clarity that judicial
resolution provides can be helpful as an alternative
to accepting what may be an unacceptable status
quo.
The starting point for our analysis is to consider
the definition of applicable review period, provided above. “Date” is defined in the dictionary
as “a particular month, day, and year at which
some event happened or will happen.” The review
period thus starts on a particular day and ends 90
days after that particular day, or on “such date”
provided for under a Section 5(c) extension that
allows EPA for good cause to extend the period for
additional periods, not to exceed an additional 90
days in the aggregate. By our reading, the net effect
is to stipulate that, e.g., a premanufacture notifica10
tion’s 90-day review starts on the day and month
received, ends 90 days after that date but can be
extended in the aggregate to no more than 180 days
after that date of receipt. The use of “date” puts a
peg into the calendar and, it can be argued, affords
no discretion to add “voluntary suspension” days to
the allowed period because in so doing, the resulting period would violate the requirement that the
applicable review period begins on a specific date
(day/month/year) and ends no later than the date
(day/month/year) that is 90 or 180 days later.
While this argument alone may suffice to resolve
the question, there is additional support within new
TSCA Section 5, as follows:
•
The new law uses the phrase “within the
applicable review period” in Section 5(a)
(1)(B)(ii)(II) concerning the requirements
on EPA in reviewing and making
determinations on NC/SNUs and at
Section 5(a)(3) concerning the requirement
that EPA “shall review such notice and
determine.” The relevant provisions read as
follows (emphasis added):
Section 5(a)(1)(B). A person may take the
actions described in subparagraph
(A) if— (i) . . .; and
(ii) the Administrator—
(I) conducts a review of the notice; and
(II) makes a determination under
subparagraph (A), (B), or (C) of paragraph
(3) and takes the actions required in
association with that determination under
such subparagraph within the applicable
review period.
Section 5(a)(3). REVIEW AND
DETERMINATION.—Within the
applicable review period, subject to section
18, the Administrator shall review such
notice and determine—(A). . .;(B). . .; or
(C). . . .
The dictionary definition meaning of
“within” in the context of time is as
follows: “in the course or period of, as in
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
time: within the year.” Other meanings
include: “in the compass or limits of; not
beyond: within view; to live within one’s
income.” Thus, one meaning of the phrase
is that “in the course or period of time of
the applicable review period,” EPA shall,
respectively among the two provisions
cited, take the actions required or shall
review such notice and determine (A), (B),
or (C).
•
•
The “such notice” language at Section
5(a)(3) seems to require that EPA review
what was submitted and could be read to
limit, if not preclude, the ability to amend
informally the notice after its submission.
This question needs more consideration but
in the context of a “fixed review period”
analysis, it may be intended to take away
the flexibility that could contribute to EPA
not being able to complete a timely review.
This could result, for example, from the
need to re-review multiple notice iterations
and account for the changes in revising
the EPA exposure and risk assessments.
Such changes could then set up a ripple
effect altering and further delaying EPA’s
determination and decisions regarding the
need for and nature of the control actions.
The Section 5(d)(3)(A) and (B) requirement
to publish the monthly report on Section
5 notices received, as structured, seems to
add to the perspective that the applicable
review period is fixed. This can be inferred
in the way it requires that EPA report on
the cases for which (A) this period has not
expired and (B) those cases for which the
period has expired. We note that one could
also read the original TSCA Section 5(d)
to have a similar effect, although the use
of the term applicable review period gives
a “date-oriented” emphasis to the meaning
which was less evident in TSCA (redlining
shows changes from old TSCA):
(3) At the beginning of each month EPA
shall publish a list in the Federal Register
of “(A) each chemical substance for which
notice has been received under subsection
(a) and for which the applicable review
notification period [i.e., a certain day/date/
month] prescribed by subsection (a), (b), or
(c) has not expired, and (B) each chemical
substance for which such notification
period has expired” [i.e., the day/date/
month 90 or 180 days later] since the last
publication in the Federal Register of such
list.
•
Section 5(e) and Section 5(f) orders are
required to take effect “on the expiration
of the applicable review period,” i.e., on
the day/date/month that, e.g., after using a
Section 5(c) extension, is 180 days after the
date on which the notice was received.
•
The use in Section 5(g) of “notwithstanding
any remaining portion of the applicable
review period” loses its meaning if EPA can
voluntarily suspend, for example, to allow
it to complete the (C) determination by, as it
were, “pretending” not to go beyond day 90
through the artifice of stopping the review
clock while the calendar days continue
to pass. Admittedly, EPA could achieve
this outcome by issuing a Section 5(c)
extension but it would, nonetheless, have to
provide an explanation of the need for the
extension.
By our reading, new TSCA arguably applies a
fixed review period to the completion by EPA of
its review and determination and needed actions
on a NC/SNU submitted to the Agency. Whether
this reading will apply, however, as was the case
in old TSCA, may turn on whether EPA, in light
of the revised statutory text, takes this view and,
if not, on whether a notifier legally challenges the
use of an informal voluntary suspension approach.
At the same time, we note that submitters could
obtain this outcome, even in the presence of a
voluntary suspension approach, by declining
a request to allow for a voluntary suspension,
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
11
thereby compelling EPA to proceed with issuance
of a Section 5(c) notice to extend the review period
and to otherwise meet the deadlines in new TSCA.
Such an approach would require that EPA issue the
order or explain the substance of its determination
in writing to the notifier by day 135 of the review
period. Having acknowledged this requirement,
however, we see no reason why EPA’s discussions
with the notifier could not continue during some
portion of the additional 90-day period to produce
a negotiated order acceptable to both EPA and the
notifier. See EPA, EPA Actions to Reduce Risk for
New Chemicals under TSCA, available at https://
www.epa.gov/reviewing-new-chemicals-undertoxic-substances-control-act-tsca/epa-actionsreduce-risk-new#section%205 (“Most TSCA
section 5(e) orders issued by EPA are Consent
Orders that are negotiated with the submitter of the
PMN.”). Hard deadlines can be helpful in more
promptly producing clarity and agreement if both
parties bring a demonstrable willingness to find
common ground to the table.
Charles M. Auer retired in January 2009 as the
Director of EPA's Office of Pollution Prevention and
Toxics. Mr. Auer is Senior Regulatory and Policy
Advisor with B&C.
Lynn L. Bergeson is Managing Partner of Bergeson
& Campbell, P.C. (B&C®), a Washington, D.C. law
firm focusing on conventional, nanoscale, and
biobased industrial, agricultural, and specialty
chemical product regulation and approval
matters, and chemical product litigation. She is
President of The Acta Group, L.L.C. and Managing
Director of The Acta Group EU, Ltd with offices in
Washington, D.C. and Manchester, UK.
12
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
NEW TSCA—EXISTING SUBSTANCES
Lisa M. Campbell, Lisa R. Burchi, and
Richard E. Engler, Ph.D.
Since its original enactment in 1976, TSCA has
distinguished between “new” and “existing”
substances. As it has since its enactment, TSCA
Section 3 defines chemical substances that are not
listed on the TSCA Inventory as “new” chemical
substances. Chemical substances that are listed
on the TSCA Inventory are considered “existing”
chemical substances. The distinction between new
and existing substances still exists and remains
as significant under new TSCA as it was before.
While new TSCA includes an Inventory “reset”
that will differentiate between “active” versus
“inactive” chemicals, inactive chemicals remain on
the Inventory and will still be considered existing
substances.
The discussion of how requirements for existing
substances have changed under new TSCA focuses
not on the definitional distinction between new
and existing substances, but on the key changes to
sections of TSCA that affect existing chemicals.
Some of these are discussed below.
Prioritization, Risk Evaluation, and
Regulation of Chemical Substances and
Mixtures
The impact of new TSCA on existing substances
must start with the significant changes to TSCA
Section 6. In fact, many have commented that
the changes made to Section 6 are among the key
changes from old TSCA.
TSCA Section 6 provides EPA with authority to
regulate the manufacture, processing, distribution,
use, or disposal of an existing chemical
substance or mixture that EPA determines poses
an unreasonable risk to human health or the
environment. Under old TSCA, before taking
any action to restrict, limit, or ban an existing
chemical substance, EPA was required to initiate a
rulemaking and make several findings, including
but not limited to determining such a restriction
was necessary “to protect adequately against such
risk using the least burdensome requirements.” The
fact that EPA historically had limited success in
using Section 6 and was unable to use its Section 6
authority to ban a substance in the face of industry
opposition was widely attributed to the riskbenefit balancing standard and “least burdensome”
requirements of Section 6.
New TSCA has not only eliminated the
“least burdensome requirement” language
in TSCA Section 6(a), but also requires EPA
to review existing chemicals in a three-step
process: prioritization, risk evaluation, and risk
management.
Prioritizations. New TSCA includes numeric
goals, certain preferences, and deadlines for
the completion of prioritizations of existing
substances. TSCA Section 6(b)(1)(A) requires
that EPA establish by rule, within one year of
enactment, a risk-based screening process that will
designate existing chemical substances as “highpriority” or “low-priority.” This process must
include considerations such as hazard and exposure
potential, persistence and bioaccumulation, and
storage near significant sources of drinking water,
but may not consider economic or other nonrisk
factors.
Under the process, the designation of high-priority
and low-priority is as follows:
•
High-Priority: EPA must designate
chemicals as high-priority if it concludes,
without consideration of costs or other
nonrisk factors, that the substance may
present an unreasonable risk because
of a potential hazard and a potential
route of exposure under the conditions
of use, including an unreasonable risk
to a potentially exposed or susceptible
subpopulation identified as relevant by
EPA. EPA is required to conduct risk
evaluations on all high-priority chemicals.
The default decision at the end of the 9–12
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
13
month prioritization process, if the available
information is insufficient to support a
low-priority designation, is to designate a
chemical as high-priority.
•
Low-Priority: If EPA concludes, “based
on information sufficient to establish,
without consideration of cost or other
non-risk factors,” that a substance does
not meet the high-priority standard,
the substance is to be designated as
low-priority. There is no required risk
evaluation required for chemicals
designated as low-priority, although such
designations are subject to legal challenge
and can be revisited based on new
information.
In designating high-priority substances, new
TSCA requires EPA to give preference to chemical
substances listed in EPA’s TSCA Work Plan that
have either a persistence and bioaccumulation
score of 3 or are known human carcinogens with
high acute and chronic toxicity. Manufacturers,
importers, and processors of existing substances
should be aware of opportunities to provide
information during this process: (1) TSCA Section
6(b)(1)(C)(i) requires EPA to provide interested
persons an opportunity to submit “relevant
information” on a chemical substance for which
EPA has initiated the prioritization process; and
(2) TSCA Section 6(b)(1)(C)(ii) requires EPA
to provide a 90-day comment period once it
publishes each proposed designation as a high- or
low-priority substance.
EPA is currently developing the prioritization
procedural rule, which must be issued by June
2017. EPA has stated its intent to issue a proposed
rule related to Section 6 prioritization by midDecember 2016. EPA held a public meeting on
August 10, 2016, to discuss and obtain input
regarding the development of this proposed rule
and addressed several critical issues related to
this proposed rule, including but not limited to
defining the scope of “potentially exposed and
susceptible subpopulations,” improving exposure
14
methodologies or developing new ones, and
determining compatibility of information obtained
from third parties.
Risk Evaluations. New TSCA requires that
EPA initiate risk evaluations on all existing
chemical substances designated as high-priority
chemicals. The risk evaluation standard set forth
at Section 6(b)(4)(A) is to determine “whether a
chemical presents an unreasonable risk, without
consideration of costs or other nonrisk factors,
including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified
by EPA as relevant to the risk evaluation by the
Administrator, under the conditions of use.”
EPA is required to publish the intended scope of the
risk evaluation within six months after initiation
of the risk evaluation. EPA must then complete
the risk evaluation not later than three and a half
years after its initiation. Opportunities for comment
are required on any draft risk evaluation prior to
publishing a final risk evaluation.
As with prioritizations, new TSCA requires EPA
to focus its initial risk evaluations on chemical
substances drawn from the TSCA Work Plan.
Certain requirements must be met in conducting
risk evaluations pursuant to Section 6(b)(4)(F),
including integrating and assessing the available
hazard and exposure information, describing the
weight of the scientific evidence, and describing
whether aggregate or sentinel exposures to a
chemical were considered and the basis for that
consideration. EPA is currently developing the
risk evaluation procedural rule, which must be
issued by June 2017. EPA has stated its intent
to issue a proposed rule related to Section 6 risk
evaluations by mid-December 2016. EPA held
a public meeting on August 9, 2016, to discuss
and obtain input regarding the development of
this proposed rule. Many of the comments were
similar to those raised during the meeting held
on the prioritization process but also focused
on EPA’s existing risk and exposure assessment
models and potential alternative approaches.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
If EPA determines that a substance “presents an
unreasonable risk,” EPA must proceed to risk
management and impose restrictions “to the extent
necessary so that the chemical substance no longer
presents such risk.”
Risk Management. New TSCA deletes certain
procedural requirements from TSCA Section 6(c).
Some believe these requirements complicated
EPA’s ability to regulate existing chemicals; others
in industry may be concerned that the elimination
of these requirements may prove problematic
when industry and EPA disagree on appropriate
measures. In addition, new TSCA applies a
number of requirements to risk-management
rulemakings, including a requirement that EPA
must propose a Section 6(a) rule within one year
and publish a final rule within one additional year
(extendable in the aggregate for two additional
years) for all chemicals determined to present an
unreasonable risk.
In regulating a chemical, Section 6(c)(2)(A)
requires EPA to consider and publish a statement
concerning various issues, including:
•
The effects on health and the environment
and the magnitude of exposure;
•
The benefits of the chemical for various
uses; and
•
The “reasonably ascertainable economic
consequences of the rule,” including
consideration of: (1) the likely effect of
the rule on the national economy, small
business, technological innovation, the
environment, and public health; and (2) the
costs and benefits and cost effectiveness of
the regulatory action and of one or more
primary alternative regulatory actions
considered by EPA.
Under Section 6(c)(2)(C), EPA is required to
consider whether technically and economically
feasible alternatives will be reasonably available
when EPA’s proposed action substantially
prohibiting or restricting a specific condition of
use takes effect.
New TSCA also requires EPA to ensure that risk
evaluations are being conducted on at least 20
high-priority substances no later than three and a
half years from enactment. EPA must also have
designated 20 low-priority substances by that time.
In summary, new TSCA mandates that EPA
review all existing chemicals using a three-stage
process: prioritization, risk evaluation, and risk
management. There will be opportunities for
public input on all three stages through noticeand-comment. EPA is currently seeking comments
on the prioritization and risk evaluation processes.
Section 8. Reporting and Retention of
Information
TSCA Section 8 covers several requirements
applicable to existing substances. Specifically,
TSCA Section 8 provides EPA with authority to
promulgate rules to require manufacturers and
processors to collect, maintain, and submit data
on certain chemical substances (TSCA Section
8(a)); compile, keep current, and publish a list of
each chemical substance which is manufactured
or processed in the United States (TSCA
Section 8(b)); maintain records of allegations of
significant adverse reactions (TSCA Section 8(c));
submit health and safety data on certain chemical
substances and mixtures (TSCA Section 8(d)); and
report any information that a chemical substance
or mixture presents a substantial risk of injury to
health or the environment (Section 8(e)).
The most significant changes to Section 8 relate
to the Inventory “reset,” which is addressed in
“An Analysis of Section 8 of the New Toxic
Substances Control Act” (http://www.lawbc.
com/uploads/docs/BNA_Insights_An_Analysis_
of_Section_8_of_the_New_Toxic_Substances_
Control_Act_%2800189278%29.PDF) and is
discussed in more detail in the Votaw article.
Other significant changes are set forth in Section
8(a). These include:
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
15
•
Section 8(a)(3)(C) – EPA is required
to consult with the Small Business
Administration on “adequacy” of the small
manufacturer standards. Many TSCA
stakeholders expect the standard to be
updated, at least to include a higher ceiling
for company sales.
•
Section 8(a)(4) – EPA may impose
different reporting/recordkeeping
requirements on manufacturers and
processors.
•
Section 8(a)(5) – EPA is directed to: (1)
avoid unnecessary or duplicative reporting;
(2) minimize the cost of reporting and
compliance for small manufacturers and
processors; and (3) impose reporting
requirements to those entities “likely” to
have relevant information.
•
Section 8(a)(6) – EPA is required to
enter into a “negotiated rulemaking” to
propose a rule to limit Chemical Data
Reporting requirements on manufacturers
of inorganic byproducts, when such
byproducts, whether generated by the
byproduct manufacturer or by any other
person, are subsequently recycled, reused,
or reprocessed.
These changes are fairly specific but can greatly
impact companies that manufacture, import, or
process existing chemical substances to the extent
that a company qualifies as a small business,
processes existing substances, or manufactures
existing inorganic byproducts.
Changes in Section 8(b) are largely related to
the Inventory reset, which mandates that EPA
promulgate a rule within one year of enactment
that requires manufacturers and may require
processors to report substances manufactured,
imported, and processed in the preceding ten
years. Currently, EPA expects to propose the rule
by the end of 2016 to meet its statutory deadline.
16
Section 8(b)(10) requires EPA to establish an
inventory of mercury and mercury compound
supply, use, and trade in the U.S. In a notable
departure from other sections of TSCA, the
definition of mercury and mercury compounds is
not limited to those manufactured for TSCA uses.
There are no statutory changes to TSCA Sections
8(c), 8(d), or 8(e), which means that companies
that manufacture, import, process, or distribute
existing substances should continue to comply
with these requirements as they currently do.
Conceivably, the scope or type of information that
may now be considered to “present a substantial
risk of injury to health or the environment” under
TSCA Section 8(e) could be impacted by certain
actions now required under Section 6 and any
guidance developed related to, for example,
EPA’s prioritizations of substances as high- or
low-priority. The full impact of new TSCA
on reporting under Section 8(e) will likely be
determined over time as implementation of the
new provisions occurs.
Section 12. Exports
Effective as of January 1, 2020, new TSCA
prohibits the export of certain mercury
compounds other than to member countries of
the Organization of Economic Cooperation and
Development for environmentally sound disposal.
New TSCA also amends the Mercury Export
Ban Act of 2008 concerning temporary generator
accumulation of elemental mercury.
Although new TSCA does not modify the general
export notification requirements established by
TSCA Section 12(b), changes to other provisions
of TSCA may have an unintentional impact on
Section 12(b) requirements. Generally, chemical
substances and mixtures subject to TSCA Section
12(b) export notification requirements are those
for which EPA has taken one or more of the
following actions: (1) data have been required
under TSCA Sections 4 or 5(b); (2) an order has
been issued under TSCA Section 5(e); (3) a rule
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
has been proposed or promulgated under TSCA
Sections 5 (i.e., significant new use rule) or 6; or
(4) an action is pending or relief has been granted
under TSCA Sections 5(f) or 7. This language has
not changed under new TSCA.
In recent years, EPA has modified its regulations
implementing TSCA Section 12(b) regarding
export notifications with the intended effect
of minimizing the circumstances when export
notifications are required. EPA, for example,
implemented a de minimus exemption provision
providing that no export notification is “required
for the export of a chemical substance or mixture
for which export notification is otherwise
required, where such chemical substance or
mixture is present in a concentration of less
than 1% (by weight or volume)” with a lower
concentration of less than 0.1 percent (by weight
or volume) for chemicals considered to be a
known or potential human carcinogen. The
triggers for export notifications will seemingly
increase under new TSCA, however, to the extent
that there are expected to be more actions taken by
EPA for new and existing substances, including but
not limited to data required under TSCA Section
4 and rules proposed or promulgated under TSCA
Sections 5 or 6.
Lisa M. Campbell is a Partner with Bergeson &
Campbell, P.C. (B&C) in Washington, D.C. Lisa R.
Burchi is Of Counsel with B&C. Richard E. Engler,
Ph.D. is a Senior Chemist with B&C.
IMPLEMENTING THE 2016 TSCA AMENDMENTS
Lawrence E. Culleen and Camille Heyboer
EPA plans for implementing new TSCA are beginning to take shape. Recently published materials
and statements from EPA, including the scheduling
of a series of public meetings, are among the most
notable signals that Agency staff has begun work
implementing the amended law. Key actions and
events are summarized below.
First-Year Implementation Plan
On June 29, 2016, EPA announced its First Year
Implementation Plan for implementing the amendments, a copy of which is available at https://www.
epa.gov/assessing-and-managing-chemicals-undertsca/frank-r-lautenberg-chemical-safety-21st-century-act-2. The Implementation Plan provides a basic
roadmap of EPA’s major goals for the first year
following enactment of the amendments earlier in
June. The Agency’s near-term goals are divided
into four categories (drawn from the most immediate deadlines in the revised Act): (1) immediate
actions, many of which are expansions or updates
to efforts that were in progress before the amendments took effect; (2) the Framework Actions,
which will establish processes to govern implementation of important new provisions of TSCA;
(3) early mandatory actions to be completed within
the next 12 months; and (4) later mandatory actions
to be completed within two or more years.
Framework Actions
Your benefits are available online!
The Framework Actions will establish rules that
will establish Agency procedures for certain cornerstone features of the law. The Framework
Actions will cover (i) the new Section 6 chemical
prioritization process, (ii) the risk evaluation process also under amended Section 6, and (iii) EPA’s
authorization to collect fees from chemical manufacturers and importers.
Visit www.americanbar.org/environ
for links to current and past issues.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
17
EPA is expected to use the risk prioritization process it will establish through rulemaking to select
chemicals for risk evaluations. Chemicals designated as “high-priority” must become subject to
risk evaluations, whereas EPA is not required to
take any action on “low-priority” chemicals. The
designation of a chemical as low-priority is subject
to change if EPA receives new information.
The risk evaluation process will start before EPA
can even complete its two central framework rulemakings for prioritizing and evaluating substances
because the Agency must identify by mid-December EPA’s initial list of ten Work Plan chemicals
for which EPA must initiate risk evaluation actions
for purposes of determining whether the substances
present an unreasonable risk to human health or the
environment. Eventually, the framework rulemakings will establish more officially the Agency’s
mechanisms and procedures for prioritizing substances for risk evaluation reviews (including
establishing opportunities for public input on prioritizing specific candidate substances for review).
EPA is required under TSCA to have at least 20
ongoing risk evaluations by the end of 2019.
New TSCA authorizes EPA to collect new and
enhanced fees from chemical manufacturers and
importers to offset EPA’s costs relating to TSCA
implementation. One portion of these fees will likely be generated from new fees that may be imposed
on manufacturers who submit premanufacture
notifications and persons who submit significant
new use notices. Submitters of test data in response
to a Section 4 rule or order also may be required to
support EPA’s cost of data review. A manufacturer
that specifically requests EPA to undertake a risk
evaluation for a substance that is already on the
Work Plan will be expected to support 50 percent
of the cost of the evaluation and 100 percent of the
cost of a manufacturer-requested risk evaluation if
the substance is not on the Work Plan already. EPA
hopes to issue the framework rules in final by June
2017.
18
Public Introduction of Framework Actions
EPA held a series of public meetings during the
week of August 8, 2016, to solicit and receive input
about the Framework Actions from the general
public (inclusive of chemical manufacturers, environmental groups, and other stakeholders). The
first two days of meetings focused on the risk evaluation and chemical prioritization process rules.
The planned meeting to address potential fees was
initially intended to be “invitation only”; eventually EPA opened up the meeting to the public,
apparently after receiving inquiries from the press
and from nonindustry stakeholders. These meetings
were held in Washington, D.C., and interested parties could also participate via an online conference.
EPA officials began each meeting by giving a short
presentation on the background of TSCA and the
proposed Framework Actions. EPA framed these
meetings as “listening sessions” rather than opportunities for the Agency to present its positions
on the Framework Actions, in line with EPA’s
goal to engage partners and ensure transparency
in the implementation of the amended TSCA. EPA
announced it would consider both oral comments
from these meetings and written comments when
drafting the proposed rules. The presentations given by EPA at each of these meetings can be found
at https://www.epa.gov/assessing-and-managingchemicals-under-tsca/meetings-and-webinarsamended-toxic-substances-control. Agency spokespeople indicated that a summary of these meetings
will be made publicly available.
Lawrence E. Culleen is a Partner and Camille
Heyboer is a law student and legal assistant at the
Washington, D.C. offices of Arnold & Porter LLP and
are active in chemical-regulatory matters.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
2017 “RESET” OF NEW TSCA INVENTORY
WILL AFFECT ALL CHEMICAL USERS, NOT
JUST MANUFACTURERS
James G. Votaw
The cornerstone of new TSCA is EPA’s Section
6(b)(4) mandate to review the risk of each
existing chemical in commerce and to regulate
their use where unreasonable risks are found.
With approximately 86,000 different substances
on EPA’s TSCA Inventory, completing these risk
evaluations will require significant effort over
many years. The new screening and risk evaluation
prioritization process required by Section 6(b)
(1) provides one means for EPA to focus its
resources on the chemicals in this pool presenting
the most significant current risks (e.g., identifying
and deferring action indefinitely on particular
“low-priority” chemicals unlikely to present an
unreasonable risk). A second means to keep EPA
concentrated on significant current risks rests in the
new TSCA Inventory “reset” process in Sections
8(b)(4)–(6).
As described further below, the reset will relieve
EPA from the need to prioritize or potentially
evaluate any “inactive” chemical not manufactured,
imported, or processed in the United States in
the past ten years (June 2006). Given that, as of
2012, only approximately 7,700 chemicals from
the TSCA Inventory were reported to be in active
use in quantities greater than 25,000 lbs./year at
any location; there is good reason to believe that
the Inventory reset will dramatically reduce the
number of chemicals to be prioritized. Companies
that in the future wish to manufacture, import, or
process a chemical designated as “inactive” for a
nonexempt commercial purpose, however, will be
required to first notify EPA. This presents potential
new regulatory compliance risks for all chemical
users, which all companies should anticipate and
plan for.
New TSCA implements the Inventory reset by
directing EPA to issue a rule requiring each
chemical manufacturer and importer (and
potentially processors) to notify EPA of each
chemical on the TSCA Inventory that it has
manufactured, imported, or processed in the past
ten years. TSCA Section 8(b)(4)(A). Chemicals
reported in this way will be designated as “Active
Substances.” As a start, EPA will designate all
chemicals reported in the 2012 Chemical Data
Reporting (CDR) period (40 C.F.R. Part 711)
as Active Substances. TSCA Section 8(b)(6).
Chemical substances listed on the TSCA Inventory
but not reported as “active” (manufactured or
processed in the prior ten years) will be deemed
“Inactive Substances” and, once designated, it will
be illegal to manufacture, import, or process them
until after notice is given to EPA. TSCA Section
8(b)(5)(B). Records documenting rule compliance
will be required to be maintained for five years.
EPA is required to promulgate a final rule
implementing the Inventory reset no later than June
2017. The rule will require all Active Substance
notices to be submitted within six months
thereafter (i.e., by approximately December 2017).
EPA will then publish an updated TSCA Inventory
identifying each substance as either “active” or
“inactive.” Submitters will be allowed to claim
that the particular chemical identity of an Active
Substance is confidential business information
(CBI) to prevent public disclosure; however, the
claim will be honored only if the identity is already
confidential on the current TSCA Inventory and if
the CBI claim can be adequately substantiated.
EPA currently plans to issue a proposed Inventory
reset rule for public comment in December 2016.
EPA has the option to include chemical processors
in the mandatory reporting program, but also to
make their participation optional. It is currently
uncertain what measures the proposal may include
to avoid unnecessary or duplicative reporting (e.g.,
coordinated reporting through trade associations or
phased reporting to minimize duplicative protective
submissions) or whether the initial Inventory reset
rule will include provisions addressing procedures
for keeping active/inactive status designations
current into the future as required by TSCA Section
8(b)(5)(A) (e.g., requiring periodic updates).
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
19
It is also unclear whether the initial Inventory reset
rule will include specific procedures for providing
notice to EPA to “reactivate” substances initially
designated inactive. Beyond the general intent to
start manufacturing or processing and any chemical
identity CBI claims, the statute does not require
any particular content for the notices and EPA does
not approve them. Rather, the Agency is required
to update a substance’s status to “active” after a
notice is received. TSCA Section 8(b)(5)(B)(iii).
EPA has broad information collection rulemaking
authority under Section 8, however, and it is
possible that, as part of the “reactivation” process,
EPA might, by rule, seek to require submission
of reasonably ascertainable health and safety
information concerning the Inactive Substance
and its intended use to help the Agency screen
the particular risks of these existing chemicals
reentering the marketplace. If notice information
provides cause for concern, it may be far simpler
and faster for EPA to implement reasonable control
measures for the Inactive Substance at this early
stage, before the new use begins (e.g., proposing a
significant new use rule under TSCA Section 5(a)
(2)(ii)) and perhaps avoid or further defer formal
prioritization or risk evaluation, which are much
more burdensome processes for the Agency.
The Inventory reset is a useful tool to focus EPA
risk evaluation resources on the most significant,
current potential chemical risks; however, the
initial reset process and compliance with notice
obligations prior to manufacturing or processing
chemicals deemed “inactive” present their own
costs and risks. Given the potential due diligence
and reporting burden, all companies should pay
attention to the Inventory reset rulemaking as it
evolves.
entering the currently uncertain “reactivation”
notice process for any overlooked chemical or
inadvertently violating the premanufacture notice
obligation for substances designated “inactive.”
Downstream processors and users should do the
same. Even if they technically are not required
to report, they should take steps to assure all
substances important to their operations are
designated as “active,” either reporting themselves
(if the final rule allows) or assuring their suppliers
have reported the substances. Starting internal
chemical reviews now also will surface any
practical difficulties that can arise in the process
and evaluation of potential solutions and can
provide the basis for targeted, effective, and timely
participation in the Inventory reset rulemaking
proceeding to shape the rule to avoid or minimize
those problems.
This may be a particularly auspicious time to start
an internal “active” chemical identification review
as it coincides with 2016 CDR reporting period
and involves a similar investigation process and
will raise many of the same technical, legal, and
practical issues (e.g., identifying which byproduct
and inadvertently manufactured substances must be
reported, nomenclature uncertainties, and chemical
identity uncertainties in imported mixtures). Given
that EPA will include automatically all 2012 CDR
chemicals on the Active Substance list, the focus
for future Active Substance notifications can be
on those substances manufactured, imported, or
processed in quantities below the applicable CDR
reporting thresholds (25,000 or 2,500 lbs./site) or
subject to other CDR reporting exemptions.
James G. Votaw is a Partner with Manatt, Phelps &
Phillips LLP in Washington, D.C.
Companies should start now to investigate and
inventory their current and past nonexempt
chemical manufacturing and processing. A
complete listing of these substances will assure
compliance with the anticipated reporting
obligation, but also will assure that companies
can continue to manufacture and use all chemical
substances important to their operations without
20
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
CHANGES REGARDING CONFIDENTIAL
INFORMATION IN NEW TSCA
Sara Beth Watson
Section 14 of TSCA regarding confidential
information was substantially revised as part of
new TSCA. Key provisions include:
•
•
•
A ten-year time limit, subject to renewal,
on the protection from disclosure for
confidential information;
New substantiation requirements; and
An EPA review of past assertions of
confidentiality.
These changes became effective immediately
on June 22, 2016, and are applicable to any
premanufacture notice submitted on or after that
date. See EPA’s First Year Implementation Plan,
available at https://www.epa.gov/sites/production/
files/2016-06/documents/tsca21_implementation_
plan_6_28.pdf. EPA’s review of confidentiality
claims for previous submissions will be conducted
pursuant to an EPA rulemaking. EPA has projected
that the final rule will be published three and a
half years from enactment of the new TSCA.
See https://www.epa.gov/sites/production/
files/2016-08/documents/prioritization_public_
meeting_8.10.16_slides_final_v2.pdf.
Type of Information Protected
Section 14 generally prohibits the disclosure
of trade secrets and commercial or financial
information that is privileged or confidential
provided that the statutory provisions for asserting
the claim are met. There are, however, some
types of information that are not protected from
disclosure, including health and safety studies,
certain manufacturing information, and certain
information related to bans and phase-outs of
existing chemicals. In addition, nonconfidential
information that is combined with confidential
information is not protected from disclosure.
Health and Safety Studies
Health and safety studies and information obtained
from such studies for any chemical substance
or mixture that has been offered for commercial
distribution are not subject to the disclosure
protection provisions. Similarly, health and safety
studies for any chemical substance or mixture
for which testing is required under Section 4 or
for which notification is required under Section
5 are not covered by the disclosure protection
provision. These provisions do not require the
disclosure of information, including formulas of a
chemical substance or mixture, that would reveal
processes used in the manufacture or processing
of a chemical substance or mixture. General
information describing manufacturing volumes
expressed as aggregated volumes or ranges are
not protected from disclosure, however. Similarly,
general descriptions of manufacture and processing
and industrial, commercial, or consumer functions
and uses of a chemical substance, mixture, or
article, including information specific to an
industry sector, are not protected from disclosure if
the information would generally be shared with the
public or within an industry sector.
Substances Subject to a Ban or Phase-Out
In addition, if EPA issues a rule under Section
6 to ban or phase-out a chemical substance or
mixture, then there is a presumption that any
protection from disclosure no longer applies. EPA
has the discretion, however, to determine that in
a specific case the public interest in disclosing
such information does not outweigh the public or
proprietary interest in maintaining the protection
for all or a portion of the information. Moreover, if
a specific condition of use of a chemical substance
or mixture is exempted from the ban or phaseout, then information that relates solely to that
exemption is not subject to the presumption in
favor of disclosure of information. Conversely, if
the ban or phase-out is related to a specific use,
then the presumption against protection of the
information only applies to information related to
that specific use.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
21
Assertion of Confidentiality Claims
To assert protection from disclosure for
information submitted under new TSCA, one must
make the assertion concurrent with the submission
of the information. The assertion must include a
statement that the person has met the following
criteria. The person must have:
(i) taken reasonable measures to protect the
confidentiality of the information;
(ii) determined that the information is not
required to be disclosed or otherwise made
available to the public under any other Federal
law;
(iii) [had] a reasonable basis to conclude that
disclosure of the information is likely to cause
substantial harm to the competitive position of
the person; and
(iv) [had] a reasonable basis to believe that the
information is not readily discoverable through
reverse engineering. 7 U.S.C. § 2613(c)(1)(B).
The person submitting the information must
certify that the information is true and correct.
EPA has stated that it is developing rules
regarding confidential business information
(CBI) substantiation under new TSCA and
expects to have them in place in two and a half
years. See https://www.epa.gov/sites/production/
files/2016-08/documents/prioritization_public_
meeting_8.10.16_slides_final_v2.pdf.
For assertion of confidentiality claims regarding
chemical identity information, the claim must
include a structurally descriptive generic name for
the chemical that EPA may disclose to the public.
The generic name must be developed in accordance
with EPA guidance.
Certain types of information are exempt from
the substantiation requirements. These include
(1) specific information describing the processes
used in manufacturing or processing; (2) sales
and marketing information; (3) information
identifying a supplier or customer; (4) details on
22
the complete composition of a mixture, including
the percentages of constituents; (5) specific
information regarding the use, function, or
application in a process, mixture, or article; and
(6) specific production or import volumes for a
manufacturer or processor. In addition, the identity
of a chemical substance prior to the date in which
it is first offered for commercial distribution is
exempted from the substantiation requirement,
if the specific chemical identity was claimed as
confidential at the time of submission to EPA.
Time-Limited Protection
New TSCA places a time limit on the protection
of confidential information. Confidentiality claims
are only valid for a period of ten years from the
date on which the claim was asserted. EPA must,
however, notify the submitter 60 days before the
end of the confidentiality period and the submitter
must respond within 30 days with a request to
extend the claim, including substantiation of
the need for an extension of the confidential
protection. There is no limit on the number of
extensions that may be granted.
Any ten-year time period may be ended before
its conclusion if the person submitting the claim
withdraws it or EPA learns that the information
does not qualify for protection under the statute.
Impact on Assertion of Confidentiality
Claim Made Prior to New TSCA
New TSCA requires EPA to review certain
previous assertions of confidentiality. This will
be a daunting task for EPA. EPA has stated
that it expects to have a plan for the review
of CBI claims for active chemical substances
identities in three and a half years. EPA expects
to complete review for all active chemicals
within five years of the June 22, 2016, enactment
date. (See https://www.epa.gov/sites/production/
files/2016-08/documents/prioritization_public_
meeting_8.10.16_slides_final_v2.pdf.)
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
Tips for Preparation
Anyone preparing a submission under new TSCA
should carefully review the confidentiality claims
and clearly define the information to substantiate
the claim. Those who have previously submitted
confidentiality claims should begin to identify
what claims have been submitted and review the
substantiations in terms of both new TSCA and the
current factual situation.
Sara Beth Watson is Of Counsel with Steptoe &
Johnson LLP in Washington, D.C.
save the date
46th spring conference
loews hollywood hotel
los angeles
march 29-31, 2017
PREEMPTION UNDER NEW TSCA
Judah Prero
On June 7, 2016, the Senate debated the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act’s amendments to TSCA. Practically every
Senator that addressed the legislation on the floor
of the Senate spoke of the notable achievement of
advancing a bipartisan bill and spoke of the careful
balance and compromise it reflected. In particular,
the carefully crafted preemption provision was
applauded. Senator Kirsten Gillibrand (D-NY),
however, was not convinced.
Senator Gillibrand stated: “So many parts of this
bill strengthen the standards and review process
for chemicals, and I am pleased that we will finally
be able to effectively regulate chemicals on a
Federal level. However, there is one part of the
bill that still concerns me: the preemption of State
laws. Right now, a number of States, including New
York, have taken the lead in chemical safety and
have set standards for their own citizens that are
higher than the standards set by the EPA.
These State actions have brought the chemical
companies to the table to finally create a strong
Federal system for reviewing chemicals for safety.
But this bill would significantly limit the rights of
individual States to set their own chemical safety
standards from this day forward. It would prevent
a State from regulating or enforcing regulations on
a chemical if the EPA is studying but has not yet
ruled on the safety of that chemical.
So despite all the hard work of my colleagues and
the progress that has been made, I cannot vote
to undermine my State’s ability to protect our
constituents…”
Details coming soon!
Despite Senator Gillibrand’s convictions, the bill
passed the Senate and was signed by President
Obama into law. Now that new TSCA is the law
of the land, are the citizens of the United States,
or even just New York, truly in peril because of a
restrictive preemption provision?
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
23
New TSCA: A Balanced Federal-State
Relationship
Looking at new TSCA, one will see that TSCA
Section 18, which contains the preemption
provisions, has been substantively changed, and
those changes definitely add to the complexity of
the provisions. The general principle underlying
the preemption provision is that once EPA takes
a regulatory action, states are precluded from
regulating differently. Furthermore, preemption is
only effective on a chemical-by-chemical basis,
limited by the scope of the risk evaluation and
regulatory action for the subject chemical. EPA
regulation taken prior to new TSCA preempts
pursuant to the “old” TSCA preemption provision;
going forward, the new provision governs. There
are, however, a multitude of exceptions to the
general principle:
•
•
•
•
•
State laws in effect prior to April 22, 2016
(Earth Day) will never be preempted.
State laws enacted pursuant to federal
statutes will not be preempted.
State laws imposing a monitoring
or reporting requirement will not be
preempted.
State laws relating to air, waste, or water,
as long as they do not impose a TSCAtype risk-management restriction, will not
be preempted.
State laws that are identical to federal laws
will not be preempted. Both states and/
or the federal government can enforce
identical provisions (although the penalty
assessed can never exceed the federally
authorized maximum).
These are significant exceptions, and provide
states with considerable discretion over
controlling air pollution, water pollution, and
waste management, three areas of environmental
protection that impact the citizens of any given state.
New TSCA Preemption
In truth, the aspects of the preemption provision
described above were not what troubled Senator
24
Gillibrand. New TSCA contains a unique form of
preemption that has been dubbed the “preemptive
pause.” Simply put, from the time EPA publishes
the scope of a risk evaluation for a chemical
that EPA has designated a high-priority, until
the evaluation is completed or the deadline for
completion arrives, states cannot take action to
regulate that chemical. The pause does not apply
to chemicals that are undergoing a “requested”
risk evaluation or to the first ten evaluations
of Work Plan chemicals. This pause provision
“encourages” the states to engage with EPA
in the risk evaluation process, by temporarily
limiting their ability to regulate a chemical that
EPA is currently evaluating. In this way, EPA has
the ability to conduct a risk evaluation, secure
information from any interested state, and reach a
conclusion and possibly mandate restrictions that
will be imposed nationwide.
Even with this new, novel preemption—a
preemption caused by an action that is not a final
agency action—there is an exception. For the
“general” preemption, EPA has the discretion
to grant, upon application by a state, a waiver
from the preemptive effect. To grant a waiver,
EPA must find that there are compelling health
or environmental protection conditions; the state
regulation would not unduly burden interstate
commerce; compliance with the state regulation
will not result in a violation of law; and that
the state regulation is based on sound science.
EPA’s waiver decisions are subject to notice and
comment and judicially reviewable. With regards
to the preemptive pause, however, EPA has no
discretion should a state apply for a waiver:
as long as EPA finds that compliance with the
proposed state regulation would not unduly burden
interstate commerce, would not cause a violation
of any applicable federal law, rule, or order, and
the state’s concern about the chemical is based
in peer-reviewed science, EPA must grant the
waiver. In addition, EPA must grant a waiver from
preemption if the subject state law was enacted or
the subject regulation was proposed or finalized
during the 18-month period after EPA initiates the
prioritization process and before EPA publishes
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
the scope of the risk evaluation for the chemical
substance (which cannot be less than 12 months
after EPA initiates the prioritization process). So,
the “pause preemption” by no means closes the
door on a state’s ability to protect its citizens.
In Context
It becomes even more difficult to understand the
objection to new TSCA’s preemption provisions
when one analyzes the chemical management
landscape in the state of New York. The state of
New York has laws that address specifically the
use of the following chemical substances: bisphenol A, chromated copper arsenate, lead, mercury,
cadmium, hexavalent chromium, polybrominated
biphenyls, polybrominated diphenyl ethers, TRIS
flame retardants, creosote, chlorofluorocarbons,
and perhaps a few others. New York State also has
some general reporting and information provision
requirements. Some of the use restrictions under
these laws are not relevant to TSCA, as they concern uses that, on the federal level, would be regulated under other statutes, such as the Federal Food,
Drug, and Cosmetic Act, Consumer Product Safety
Act, or the Resource Conservation and Recovery
Act, for example. Being that risk evaluations are
only conducted on high-priority chemicals, and
it is likely that most high-priority chemicals will
be “grandfathered” chemicals as opposed to those
that underwent the pre-manufacture notice process,
many risk evaluations will be performed on chemicals that have been in commerce for decades. So,
in the 40 years since TSCA’s enactment, the state
of New York has specifically regulated the use of
a tiny percentage of the more than 85,000 chemicals on the TSCA Inventory. It is not clear if any of
these laws were enacted after the state did its own
risk evaluation. Yet, the Senator from the state of
New York is worried about the effect of a “preemptive pause.” To quote Queen Gertrude in Hamlet,
"The lady doth protest too much, methinks.”
balance between the need to have uniform
standards to foster unimpeded interstate commerce
and the police power of states to protect its citizens
needed to be found. New TSCA attempted to strike
that balance. Once a chemical has undergone a
risk evaluation and EPA has determined it poses
no unreasonable risk (whether with or without risk
management), state chemical management action
to restrict or regulate the substance differently is
preempted. This outcome meets the objective of
achieving uniform, risk-based, national chemical
management in a manner that supports healthy
interstate commerce. Yet, states can take action
on any chemical until EPA has taken a series of
steps to evaluate a particular chemical. Even when
EPA announces the chemicals they are considering
for evaluation, states still have up to a year and a
half to take action on these particular chemicals
to avoid the preemptive pause. Lastly, even after
EPA commences an evaluation or announces
its regulation, states have the ability to apply
for a waiver for preemption. These safeguards,
combined with the numerous other exceptions from
preemption, amply provide states with the tools
needed to ensure the protection of the citizens and
environment of the state.
Thankfully, Congress recognized that a balance
had been struck. As EPA implements new TSCA,
we will see to what degree states participate in the
process and whether preemption actually becomes
the significant issue many predicted it will be.
Judah Prero is Counsel with Sidley Austin LLP in
Washington, D.C.
In Sum
The preemption issue was one of the most
contentious in the TSCA reform debate. The
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
25
NEW FEES PROVISIONS IN NEW TSCA
Keith A. Matthews
Committee on Energy and Commerce; and (5) have
the EPA Inspector General conduct an annual audit
of the TSCA fees program.
Section 26(b) of new TSCA substantially revises
EPA’s authority to impose fees that are to be used
to support implementation of specific regulatory
obligations under new TSCA. Specifically, Section
26(b)(1) authorizes EPA to promulgate regulations
requiring payment from persons that are either
(1) required to submit information to the Agency
under Sections 4 or 5 of TSCA, or (2) that are
manufacturers or processors of chemical substances
for which EPA conducts a risk evaluation under
Section 6. The fees established by such regulations
are required to “provide a sustainable source of
funds” that will defray annually no more than
the lower of either 25 percent of EPA’s costs for
implementing TSCA Sections 4, 5, 6, and the
confidential business information provision of
Section 14, or a total of $25 million. EPA may also
impose fees to cover the full amount of the costs
of manufacturer-requested chemical evaluations—
except that EPA may only recover 50 percent of
the costs of evaluating a chemical substance at the
request of a manufacturer if the chemical substance
is on the EPA TSCA Work Plan.
Interestingly, Section 26(b)(5) provides that EPA
may not collect fees under its TSCA fees rule for
any fiscal year that the appropriations for EPA’s
Chemical Risk Review and Reduction program—
excluding the amount of fees funds appropriated
from the TSCA Service Fee Fund—are not equal
to or greater than the Chemical Risk Review and
Reduction program appropriations for fiscal year
2014. This provision is meant to serve as leverage
to ensure that future congressional appropriations
for EPA’s chemical review program are not stinted.
While a laudable goal, this provision, in effect, is
merely hortatory. Any future Congress can, at its
discretion, suspend this provision and prescribe
that fee collections shall continue notwithstanding
the amount of appropriated funds made available to
EPA. This, indeed, has been done in the context of
the Federal Insecticide, Fungicide, and Rodenticide
Act Pesticide Registration Improvement Act fees,
where that statute contains language similar to this.
The hope therefore is that future Congresses shall
always have the good intentions to provide the
necessary appropriated funds that in conjunction
with appropriated fees will enable EPA to meet its
obligations under the amended TSCA.
In establishing these implementation fees, EPA
must (1) consult with the Administrator of the
Small Business Administration and provide for
lower fees for “small business concerns”; (2) prior
to promulgating a fee rule, “consult and meet”
with persons that may be subject to the fees (as
discussed in the Culleen and Heyboer article, EPA
held such a consultation meeting with stakeholders
on August 11, 2016); (3) beginning in 2019, and
every three years thereafter, adjust the fees to
account for inflation and ensure that collected
fees defray 25 percent of the applicable costs of
the program (this adjustment, of course, must be
effectuated by rulemaking, so that the adjustment
schedule is likely to be on a five-year or more
schedule, and the adjusted fees are likely to be
outdated upon promulgation); (4) submit biennial
accounting reports to the Senate Committee on
Environment and Public Works and the House
EPA has indicated that it intends to promulgate a
TSCA fees rule expeditiously, with a proposed rule
published before the end of calendar year 2016
and a final rule promulgated by the end of the third
quarter of fiscal year 2017.
Keith A. Matthews is Counsel with Sidley Austin LLP
in Washington, D.C.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
26
WEIGHT OF EVIDENCE IN NEW TSCA
Lorenz R. Rhomberg, Ph.D., ATS
Section 26(i) of the new Toxic Substances Control
Act (TSCA) gives a clear and unqualified mandate:
“The Administrator shall make decisions under
sections 4, 5, and 6 based on the weight of the
scientific evidence.”
This is reiterated in the requirements for existing
chemical risk evaluations, for preemption, and
for evaluation of cancer clusters. At Section 26(h)
on Scientific Standards, it states: “In carrying out
sections 4, 5, and 6 … the Administrator shall
use scientific information, technical procedures,
measures, methods, protocols, methodologies, or
models, employed in a manner consistent with
the best available science” while attending to
relevance, clarity, completeness, quality, variability,
uncertainty, and the extent of independent
verification and peer review.
In short, findings under TSCA that identify
hazards and risks that may be posed by chemical
exposures are clearly to be based on the most
scientifically supportable interpretation of the
available information (rather than, say, worstcase interpretations). This entails considering the
alternative interpretations of the available data and
using the one among these that is most in accord
with the available evidence and documenting the
reasoning used.
That is, more than in earlier statutes, new TSCA
recognizes that, even when presented with wellconducted studies, it is not always possible to
have an unquestionably definitive scientific
demonstration of the existence of particular toxic
effects from chemicals and the exposures needed
to produce them. In the face of extrapolations,
inconsistent study results, natural and experimental
variability, and incomplete understanding of
toxicity-generating biological processes, alternative
scientific interpretations—with different risk
consequences—are possible. We must make
integrative judgments about what interpretations
are most scientifically justified and what these
mean for the identification of potential toxicities
of concern. The weight-of-evidence mandate
in new TSCA makes this process central to risk
assessments conducted under the Act.
The question of how to conduct a systematic,
objective, and transparent review of pertinent
data—and how to integrate the information
reviewed into scientifically supported judgments
about toxicity—is much under review and
development in recent years. Some key critiques
of existing practices have been leveled, notably in
a 2011 review by a panel of the National Research
Council of an EPA assessment of formaldehyde
carcinogenicity, which called for the basis and
reasoning behind judgments to be more explicitly
and fully explicated. The interpretation of how
such weight-of-evidence evaluations are to be
conducted under new TSCA will need to be
constructed in the context of this larger discussion
going on in the risk-assessment field.
There has been much progress in setting up
procedures for identifying relevant studies,
extracting their data, and evaluating study strengths
and shortcomings (at the National Toxicology
Program, at EPA, and in the European Union). The
question of how to specify a rigorous and specific
process by which one can integrate interpretation
across such an array of study results, and how
to resolve contradictions, inform data gaps, and
justify the scientific soundness of conclusions has,
however, been more difficult. (See Rhomberg et
al., 2013, Crit. Rev. Toxicol. 43:753 for a survey of
approaches.)
The phrase “weight of evidence” makes it
clear that the issue is that there are contending
alternative interpretations; the task is to identify the
alternative with the greatest “weight” of support. A
critical part of the process is not only articulating
why a specific alternative is supported, but also
explaining why those data that are inconsistent
with that interpretation do not in fact necessarily
refute it.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
27
Again, the intent of the weight-of-evidence
mandate is clear, and much is accomplished if the
basis for judgments is explained and the viability
of alternatives is also evaluated and transparently
presented. As with all judgments, the challenge for
a codified process is how to be sufficiently specific
in the rules of interpretation that one can be held to
having forthrightly executed the process, but also
to avoid being too rigid in imposing interpretation
rules that might oversimplify the subtleties of
reasoning that are needed.
PBT ACTIONS UNDER NEW TSCA
Martha Marrapese and Adrienne Timmel
The rub is that a careful consideration and
articulation of the full suite of plausible alternatives
is complex and time consuming. Recent weightof-evidence evaluations in the context of chemical
regulatory programs (e.g., the Integrated Risk
Information System program) have highlighted
the challenges involved in reaching consensus on
an interpretation of toxicity and risk and in some
cases has resulted in an inability to arrive at a
final regulatory determination in a timely manner.
Given the multitude of risk evaluations that will be
needed under the amended law, one of EPA’s key
challenges will be to conduct weight-of-evidence
evaluations in an efficient manner that protects
public health while not discouraging innovation of
new chemicals and new uses for existing chemicals
because of the complexities and amount of time
needed to conduct and fully document robust, wellreasoned analyses.
Most significant, however, is new TSCA’s mandate
that EPA take expedited action to regulate certain
PBTs that are listed in the 2014 TSCA Work Plan
and meet other criteria specified in the new Section
6(h)(1) of TSCA. For such chemicals, EPA must
promulgate risk-management rules under Section
6(a) that reduce exposure to the maximum extent
practicable, with proposals due by June 22, 2019,
and final rules due by December 22, 2019. This
fast-track process is possible because EPA is not
required to conduct a risk evaluation for the PBTs
meeting the criteria. Thus, the focus of these
rulemakings will be on use and exposure, data on
which EPA may be able to gather largely from
industry submissions under the 2016 Chemical
Data Reporting rule.
Lorenz R. Rhomberg, Ph.D., ATS is a Principal with
Gradient Corporation.
Persistent, bioaccumulative, and toxic chemicals
(PBT) are a central concern in new TSCA. In
general, EPA must consider persistence and
bioaccumulation in prioritizing existing chemicals
for risk evaluation. The Agency must also give
preference to those chemicals that scored high for
persistence and bioaccumulation in the 2014 TSCA
Work Plan in designating high-priority chemicals.
The TSCA Work Plan program, introduced in 2012,
provides the basic framework for EPA action on
PBTs. In ranking persistence and bioaccumulation
under this program, the Agency relied on criteria
drawn from several sources, including both EPA
regulatory programs and international agreements.
With respect to persistence, EPA ranked individual
chemicals or chemical categories based on their
potential half-lives in air, water, soil, and sediment,
while considering their expected partitioning
characteristics and potential removal pathways. In
ranking bioaccumulation potential, EPA relied on
the bioaccumulation factor (BAF) of a chemical
or chemical category and, when that was not
available, on its bioconcentration factor (BCF).
In the absence of test data, EPA used its EPI Suite
modeling program to derive a ranking. Individual
persistence and bioaccumulation scores were then
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
28
summed and normalized for an overall persistence
and bioaccumulation score. Finally, the Agency
added the overall persistence and bioaccumulation
score to the overall hazard and exposure score for
each chemical/chemical category and developed
a list of 90 Work Plan Chemicals from the highscoring chemicals. The goal of this program,
initiated a few years before the Lautenberg Act,
was to prioritize chemicals for risk evaluation in
the absence of a statutorily mandated framework.
Expedited action under Section 6(h)(1) will apply
to any chemical that meets the following criteria:
(a) is a 2014 Work Plan Chemical;
(b) is toxic (grounded on a reasonable basis);
(c) scores high for persistence and at least
moderate for bioaccumulation, or vice versa
(pursuant to the 2012 Work Plan Chemicals
Methods Document or successor scoring
system);
(d) is not a metal/metal compound;
(e) was not, prior to enactment, the subject of a
completed Work Plan Problem Formulation,
an initiated Section 5 review, or a Section 4
consent agreement; and
(f) to which exposure is likely to the
general population, a potentially exposed
or susceptible subpopulation, or the
environment under the conditions of use.
Based on a review of these criteria, the possible
candidate list for expedited action includes at least
one pigment, certain flame retardant chemicals, and
several phenolic compounds:
•
•
•
•
•
•
•
Pigment Yellow 83 (CASRN 5567-15-7);
Decabromodiphenyl ethers (DecaBDE) (CASRN
1163-19-5);
Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,5,5tetramethyl-2- naphthalenyl)- (CASRN 54464-59-4);
Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,8,8tetramethyl-2- naphthalenyl)- (CASRN 5446457-2);
4-tert-Octylphenol (4-(1,1,3,3Tetramethylbutyl)- phenol) (CASRN 140-66-9);
Pentachlorothio-phenol (CASRN 133-49-3);
Phenol, isopropylated, phosphate (3:1)
(iPTPP) (CASRN 68937-41-7); and
•
2,4,6-Tris(-tert- butyl)phenol (CASRN 73226-3).
The only way a chemical that meets these PBT and
other criteria can be excluded from the expedited
rulemaking schedule is if, prior to September 22,
2016, EPA receives a manufacturer request for a
risk evaluation or makes a high-priority designation
for such chemical. Note, however, that industry
requests for risk evaluation cannot comprise more
than 50 percent of the chemicals evaluated by
EPA. Assuming EPA conducts risk evaluations on
20 chemicals in the first three and a half years of
implementation, as statutorily mandated, industry
can request risk evaluations for a total of ten
chemicals in that timeframe. This means industry
must be selective about the chemicals for which it
submits voluntary requests for risk evaluation.
As a final thought, note that while new TSCA
requires EPA to regulate chemicals meeting certain
PBT criteria developed under the TSCA Work
Plan, it never actually defines the underlying terms
persistent, bioaccumulative, or toxic. Moreover,
the expedited action provision explicitly states that
persistence and bioaccumulation scores can be
based on a “successor scoring system.” Under the
TSCA Work Plan, persistent and bioaccumulative
criteria are largely based on environmental
considerations that may or may not be relevant
for human biological systems. Accordingly, there
may be an opportunity for coalition building to
comment on the upcoming rulemaking and to
review or refine the PBT definition during the
upcoming rulemaking process.
The expedited action program is limited to only a
handful of substances, but represents the tip of the
iceberg for regulation of existing PBT chemicals
under the new Section 6 of TSCA. As existing
chemicals are notified for the Inventory reset
and prioritized as low- or high-priority, it can be
expected that consideration of PBT criteria and
chemicals will remain at the forefront of EPA’s
actions under new TSCA.
Martha E. Marrapese is a Partner and Adrienne
Timmel is an Associate at the Washington, D.C.
offices of Keller and Heckman LLP.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
29
NEW TSCA AND “ARTICLES”
Thomas C. Berger
Given recent highly publicized concerns over
risks posed by the presence of toxic chemicals
in industrial and consumer products, particularly
imported consumer products (e.g., lead in
children’s toys), the legal and regulatory treatment
of “articles” under TSCA, the principal federal
industrial chemical control law in the United States
enacted in 1976, was a focus issue during TSCA
legislative “reform” efforts over the past several
years and has been a critical and longstanding issue
for the regulated community.
Articles have largely been exempt from TSCA’s
reporting requirements, but amendments to TSCA
provide EPA with explicit statutory authority to
regulate articles under TSCA Section 5 (“new”
chemicals and uses) and TSCA Section 6
(“existing” chemicals). This authority, however, is
not as broad or as easily implemented as might first
appear.
“Article” Definition
For purposes of TSCA Chemical Substance
Inventory (Inventory) and TSCA premanufacture
notification (PMN) requirements, an “article” is
defined as a manufactured item that
1. is formed to a specific shape or design
during manufacture;
2. has end-use function(s) dependent in whole
or in part upon its shape or design during
end use; and
3. either has no change of chemical
composition during its end use or only
those changes of composition which have
no commercial purpose separate from
that of the article and that may occur as
described at 40 C.F.R. Section 720.30(h)(5).
Fluids and particles are not considered articles
regardless of their shape or design.
Traditional EPA Approach to Articles
While EPA asserts authority over and “has a long
history of regulating chemical substances as part
of articles under TSCA,” articles have been and
continue to be administratively exempt from TSCA
Section 5 PMN requirements appearing at 40
C.F.R. Part 720. 79 Fed. Reg. 77,891, 77,896 (Dec.
29, 2014). For example, a substance imported into
the United States as part of an article is exempt
from PMN reporting requirements, and, therefore,
is not required to appear on the TSCA Inventory
to properly be placed in U.S. commerce under
TSCA. 40 C.F.R. Section 720.22(b)(1). Further, a
substance formed during manufacture of an article
destined for the U.S. commerce without certain
further chemical changes is exempt from TSCA
Section 5 PMN reporting requirements. 40 C.F.R.
Section 720.30(h)(6).
Persons who import or process a substance as part
of an article also typically (discussed below) have
been exempt from TSCA Section 5 significant new
use rule (SNUR) and accompanying significant
new use notification (SNUN) requirements
appearing at 40 C.F.R. Part 721. More specifically,
unless a specific SNUR otherwise specifies, 40
C.F.R. Section 721.45(f) exempts from TSCA
SNUN requirements a person that imports or
processes a SNURed substance as part of an article.
With respect to other sections of TSCA, imported
articles are exempt from TSCA Section 13 import
certification requirements (unless specifically
required in a TSCA rule or order). 19 C.F.R.
Section 12.121(b). Similarly, unless required
in the context of a specific TSCA Section 5, 6,
or 7 action, articles (other than polychlorinated
biphenyl articles) are exempt from the TSCA
Section 12(b) export notification requirement.
40 C.F.R. Section 707.60(b). While in the
majority of cases exempt by rule, articles are both
subject to and exempt from various portions of
TSCA’s Section 8 reporting and recordkeeping
requirements. See, e.g., 40 C.F.R. Section 716.21(a)
(8) (articles subject to TSCA Section 8(d) rule
for consumer products containing lead); 40 C.F.R
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
30
Section 711.10(b) (imported articles exempt from
Section 8(a) Chemical Data Reporting (CDR)
requirements).
Legislative Framework and Amended Language
The terms “chemical substance(s)” and
“mixture(s)” are defined in Section 3 of TSCA
and are used throughout TSCA to describe the
chemicals and the forms of chemicals that are
subject to various requirements of the Act. The
term “article,” however, is not defined in Section 3
and is used only sparsely elsewhere in the Act.
Prior to enactment of H.R. 2576, the term “article”
was meaningfully used only in the definitions of
the terms “distribute in commerce” and “process”
in Section 3; the description of what test data
are required to be included in a Section 5 PMN;
Section 6 (but only when referring to two of the
seven types of restrictions or prohibitions that
may appear in a Section 6(a) rule—labeling and
disposal); Section 7 (rarely if ever used, imminent
hazard provision); Section 12(a) (export-only
exemption); Section 13 (import certification);
and Section 17 (providing federal district courts
specific enforcement and seizure authority).
Significantly, other than in portions of Section
12(a), which itself is an exemption, in no case is
the term “article” used in the context of an article
being excluded from a requirement of TSCA.
Statutory use of the term “article” was unchanged
by H.R. 2576, with two exceptions. First, newlyadded Section 5(a)(5) of TSCA provides EPA with
explicit authority to regulate chemicals in “articles”
under Section 5, by providing that:
The Administrator may require notification
under this section for the import or processing
of a chemical substance as part of an article
or category of articles under paragraph (1)(A)
(ii) if the Administrator makes an affirmative
finding in a rule under paragraph (2) that
the reasonable potential for exposure to the
chemical substance through the article or
category of articles subject to the rule justifies
notification.
Second, under newly added Section 6(c)(2)(E),
EPA is allowed to restrict or prohibit a chemical
in an article in a Section 6 risk-management
action, but only to the extent necessary to address
identified risks so that the chemical does not
present an unreasonable risk, by providing that
In selecting among prohibitions and other
restrictions, the Administrator shall apply such
prohibitions or other restrictions to an article
or category of articles containing the chemical
substance or mixture only to the extent necessary
to address the identified risks from exposure to
the chemical substance or mixture from the article
or category of articles so that the substance or
mixture does not present an unreasonable risk of
injury to health or the environment identified in
the risk evaluation conducted in accordance with
subsection (b)(4)(A).
Section 5
In the context of treatment of articles under Section
5, new TSCA could be viewed as providing EPA
with explicit statutory authority essentially to act as
it has previously in a number of substance-specific
cases. In 1984, when it promulgated the rule initially
establishing SNUR procedural requirements, EPA
indicated that persons would generally be exempt
from SNUR notification requirements when
importing or processing a SNURed substance as
part of an article (or solely for export, or only as
a byproduct used in certain ways). 49 Fed. Reg.
35,011, 35,014 (Sept. 5, 1984). The Agency’s
“minimal” rationale for establishment of this
exemption (now codified at Section 721.45(f)) was
that “people and the environment will generally not
be exposed to substances in articles.” Significantly,
however, the Agency indicated, in relevant part,
that it “may decide to eliminate one or all of these
three exemptions if EPA decides that review under
a SNUR is warranted for specific substances . . . in
articles.” Id.
Consistent with this administrative authority,
imported and processed articles have been
exempted from the notification requirements
of the vast majority of SNURs that have been
promulgated since the inception of TSCA. In a
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
31
handful of proposed and final TSCA SNURs,
however, EPA expressed concerns over exposure
to substances in articles and consequently made
the presumptive 40 C.F.R. Section 721.45(f)
exemption inapplicable. Erionite fiber, 56 Fed.
Reg. 56,472 (Nov. 5, 1991), is an early example.
More recent examples include elemental mercury,
77 Fed. Reg. 31,728 (May 30, 2012); benzidinebased chemical substances, 79 Fed. Reg. 77,891
(Dec. 29, 2014); toluene diisocyanate (TDI),
80 Fed. Reg. 2,068 (Jan. 15, 2015) (proposed
rule); certain perfluorinated substances, 80
Fed. Reg. 2,885 (Jan. 21, 2015) (proposed
rule); and hexabromocyclododecane and
1,2,5,6,9,10-hexabromocyclododecane (HBCD),
80 Fed. Reg. 57,293 (Sept. 23, 2015).
As noted above, while new Section 5(a)(5) provides
EPA with explicit authority to regulate chemicals in
“articles” (effectively rendering Section 721.45(f)
inapplicable), to the extent that such authority
preexisted, such authority could be viewed as being
limited by this statutory provision. New Section
5(a)(5) explicitly requires an affirmative finding in
a rule that the reasonable potential for exposure
justifies notification. Prior to new TSCA, Section
720.45(f) could be rendered inapplicable simply
by EPA deciding that review under a SNUR is
warranted for specific substances.
That being said, it is critical to recognize that
“significant new use” designations under TSCA
are not risk-based, per se. Rather, they are based
on a change in circumstances and by assessing
“all relevant factors,” including production and
processing volume, the extent to which a use
changes the type or form of exposure or increases
the magnitude and duration of exposure, and
the reasonably anticipated manner and methods
of manufacturing, processing, distribution in
commerce, and disposal of the subject substance.
See TSCA Section 5(a)(2).
While the new term “justifies” is not defined,
it seems logical to conclude that EPA would
use the Section 5(a)(2) factors to make this
required affirmative determination. Indeed, EPA
did precisely that in the 2014 benzidine-based
chemical substances SNUR rulemaking discussed
supra. More specifically, while distinguishing its
analysis of making Section 721.47(f) inapplicable
from its initial Section 5(a)(2) factor analysis, EPA
carefully went through each of the 5(a)(2) factors
and found them to be satisfied with respect to the
inapplicability of the article exemption. 79 Fed.
Reg. at 77,899–77,900.
In proceeding in such a fashion, EPA noted that
“EPA’s decision to propose a SNUR for a particular
chemical use and to make the exemption at 40 C.F.R.
721.45(f) inapplicable to that SNUR need not be based
on an extensive evaluation of the hazard, exposure, or
potential risk associated with that use . . . [r]ather, the
Agency is acting because it has reason to anticipate that
such use would raise important new questions related
to the substance’s potential to threaten health or the
environment, and that EPA should have an opportunity
to consider those questions before such use could
occur.” 79 Fed. Reg. at 77,899.
Similarly, in a June 7, 2016 “Additional Views”
document published in conjunction with H.R.
2576, lead Senate Democratic concurring Members
noted that while “[e]xposure is a relevant factor in
identifying other significant new uses of a chemical
substance as well . . . [i]t is not intended to require EPA
to conduct an exposure assessment or provide evidence
that exposure to the substance through the article or
category of articles will in fact occur.” See https://
www.congress.gov/crec/2016/06/07/CREC-2016-0607-pt1-PgS3511.pdf.
It is also critical to recognize that EPA’s SNUR
authority can only restrict or ban “new” uses. EPA
therefore typically uses its SNUR authority shortly
after a substance is added to the Inventory, or, more
recently, after a chemical or use of a chemical is
voluntarily ceased or phased-out such that any
resumption would be considered a significant “new”
use. Thus, demonstrating that an article has been and
continues to be manufactured, imported, or processed
for a “significant new use” (e.g., demonstrating that an
article containing a substance of concern has been
imported) can prevent EPA from restricting that
“use” under even new Section 5.
It is also important to note that new Section 5(a)
(5) refers only to subparagraph 5(a)(1)(A)(ii) and
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
32
not (i). Thus, EPA’s explicit statutory authority
to regulate articles extends only to SNURs,
not PMNs. This means that “new” substances
that are not listed on the TSCA Inventory and
which have not undergone PMN review may be
imported as part of articles under TSCA, even
if a risk is posed due to potential exposure to
chemicals contained in and released from the
article. EPA has discussed its view as to the
bases for and differences between the Section
5 PMN article exemption and the presumptive
Section 5 SNUR article exemption in some
detail. See 79 Fed. Reg. at 77,896–77,901.
From an implementation standpoint, it remains
unclear as to whether new Section 5(a)(5) will
require an administrative amendment to Part 721.
It is equally unclear whether new Section 5(a)
(5) mandates re-proposal of the two above-cited
proposed SNURs for which 40 C.F.R. Section
720.45(f) is proposed to be inapplicable.
Section 6
At the outset, to the extent that new Section 6(c)(2)
(E) can be read to expand EPA’s ability to regulate
articles, such expansion pales in comparison to
EPA’s newly acquired overall ability to use Section
6, particularly after EPA’s attempt to ban certain
forms of asbestos under Section 6 was judicially
eviscerated some 25 years ago. See Corrosion
Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir.
1991). EPA is no longer required to regulate using
the “least burdensome” alternative, and the Section
6 process is now bifurcated into risk assessment
and risk management.
As noted above, prior to enactment of H.R. 2576,
articles were explicitly referenced in Section 6
in only two of the seven types of restrictions or
prohibitions that can become a requirement in a
TSCA Section 6(a) rule. These include: (1) warning
language (“. . . requirement that such substance or
mixture or any article containing such substance or
mixture be marked with or accompanied by clear
and adequate minimum warnings . . .”); and (2)
disposal (“. . . requirement prohibiting or otherwise
regulating any manner or method of disposal
of such substance or mixture, or of any article
containing such substance or mixture . . .”).
These and the other five prohibitions and restrictions
that can become a requirement in a TSCA Section 6(a)
rule were materially unaltered by H.R. 2576. Thus,
the basic substantive Section 6 risk-management
options potentially applicable to substances, mixtures,
and articles are essentially unchanged.
New Section 6(c)(2)(E) establishes EPA’s general
authority to regulate articles under Section 6 in
the context of these seven types of prohibitions
and restrictions, in that articles can be regulated
but only to the extent necessary to address the
identified risks from exposure so that the article
containing the subject substance or mixture “does
not present an unreasonable risk” of injury to
health or the environment. This is to be contrasted
with the nonrisk-based Section 5 “justifies”
standard, discussed above. Given that the Section
6 regulatory mandate is to specify and mandate
risk-management measures such that an identified
chemical “no longer presents” an “unreasonable
risk,” new Section 6(c)(2)(E) can be viewed as
simply preventing EPA from administratively
overreaching as to regulation of “existing”
substances in articles.
On the other hand, under Section 6 (and Section
5), EPA must now take into account risks to a
“potentially exposed or susceptible subpopulation.”
This phrase is defined in Section 3 as “a group of
individuals within the general population identified
by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater
risk than the general population of adverse health
effects from exposure to a chemical substance
or mixture, such as infants, children, pregnant
women, workers, or the elderly.” To the extent
that risks posed by articles have been of concern
to EPA primarily in the consumer (as opposed to
industrial) context, where such types of individuals
are more likely to be exposed, this requirement
may become significant in the future regulation of
articles under new TSCA.
Thomas C. Berger is a Partner in the Washington
D.C. office of Keller and Heckman LLP.
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016
33
34
Pesticides, Chemical Regulation, and Right-to-Know Committee, September 2016