Proposed Actions to Reform TSCA
Confidential Business Information
U.S. Environmental Protection Agency
Office of Prevention, Pesticides, and Toxic Substances
Office of Pollution Prevention and Toxics
May 20, 1993
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Introduction
For the past several years,- the'Office of Pollution 'Prevention-and Toxics has 1C
examined the impact of confidential business information on its ability to perform its duties
set forth in the Toxic Substances Control Act. In this document, the Office provides a
summary of the consideration of the issue and a plan to address confidentiality claims.
I. Background: Going Public
Over the past three years, the Office of Pollution Prevention and Toxics (OPPT) has
engaged in a revitalization effort. This process has entailed the review and integration of
what OPPT has learned in nearly twenty years of toxics management: To further this effort,
OPPT has reorganized to more effectively undertake its work. OPPT's revitalization has
been defined in a Vision Statement which integrates OPPT's activities into four principles:
I. Promote pollution prevention as a principle of first choice to achieve environmental
stewardship throughout society;
n. Promote the design, development and application of safer chemicals, processes and
technologies in the industrial sector of the economy;
HI. Promote risk reduction and responsible risk management practices throughout the
life cycle of major chemicals of concern, and;
IV. Promote the public understanding of the risks of chemicals and public
involvement in environmental decisionmaking through the development and
dissemination of information on toxic chemicals.
Principle IV of the OPPT Vision Statement is the guiding force behind the Toxics
Risk Management "Going Public" effort. The "Going Public" effort has two related goals.
The first goal is to provide for an educated public which is cognizant of chemical risks and
benefits. The first goal will act as a catalyst for the second: a more environmentally and
scientifically literate public which will be an integral part of the regulatory process and help
insure that government sets appropriate priorities and makes the best choices on toxics
control.
OPPT is acutely aware that the goal of securing a scientifically literate populace
through the "Going Public" effort needs to be balanced against the need to protect
legitimately claimed confidential proprietary information. While OPPT recognizes some of
the data directed to
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Proposed Actions to Reform IESCA Confidential (Business Information May 20, 1993
inappropriate CBI claims.1 This CBI reform effort advances OPPT's goal enunciated in
Principal IV of the Vision Statement. Reducing the number of inappropriate claims will have
several favorable effects on OPPT's ability to respond to its mission. The favorable effects
are as follows:
""P, - . -. ' '.;' '
Fkst, toxic chemicals management is a task best undertaken in a public forum with
the participation of all those who might be affected by the decisions, including other federal
government entities, the regulated community, state governments -and the interested public.
OPPT seeks to foster the participation of all these parties in the toxic chemical management
process and, to the extent that such participation is impaired or discouraged by inappropriate
CBI claims, will undertake action tŪ limit CBI claims. -
Second, OPPT has concluded one of its fundamental purposes is to facilitate the
education of the public about the characteristics, including risks, of chemicals in commerce.
This will empower the public to allow it to participate in environmental management
activities. To achieve this end, OPPT will become a clearinghouse of toxics information.
The Office will actively disseminate information products and make information more
accessible to the interested public. Every individual invalid CBI claim is an imposition on
the public's ability to participate effectively in the process.
Third, OPPT must endeavor to operate in a fiscally responsible manner. In an
environment of scarce resources, it is imperative that every program operate as efficiently as
possible. As information is a basic raw material for OPPT's programs, it is necessary that
information with the highest programmatic utility be made available. Because of this it is
appropriate that OPPT limit CBI claims to the extent permitted by law.
The principal of Going Public and encouraging broad participation in toxics
management by the dissemination of TSCA information is consistent with the language and
intent of the statute. TSCA is replete with references to a participatory role of the public in
toxics regulation. Public participation is specifically provided for in the evaluation and
regulation of new chemicals, TSCA § 5, the testing of existing chemicals, TSCA § 4, and
the regulation of hazardous chemical substances, TSCA § 6. Each of these sections provides
for the public's role in toxics control.
In addition, TSCA § 21 provides the public with the right to petition for the issuance,
amendment or repeal of a rule pertaining to testing (TSCA § 4), regulation of hazardous
1 For purposes of this document the term "inappropriate CBI claims" are those made on
information which is not eligible for confidential treatment by the standards established in
TSCA and its implementing regulations, including 40 CFR Part 2.
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Proposed Actions to Reform'TSGA ConfidertSal Business Infonrnfirtion- May 20, 1993
chemical substances (TSCA § 6), or information reporting (TSCA § 8); TSCA § 2-1 also
provides for public petitions relating to an order regulating a; new "chemical pending the
development of data about the health and environmental effects of a new chemical(TSCA §
5(e)), or mandating production quality control measures (TSCA § 6(b)(2)). The
unmistakable purpose behind the participatory opportunities provided in TSCA is to afford
the public the chance to contribute meaningfully to the regulatory process.
EPA has long taken the position that the public's right of participation is directly
related to the availability of information. For example, in the original Premanufacture
Notice rules promulgation, the Agency stated that "[p]ublic participation cannot be effective
unless meaningful information is made available to the interested persons."2 Effective
public participation as envisioned by the statute requires greater dissemination of health and
safety data than that minimally necessary for public participation identified above under
TSCA §§ 4, 5, 6 and 21.
While the statute's general information disclosure provision, TSCA § 14(a), allows
certain proprietary information to be claimed as confidential and not be subject to public
disclosure, the statute's provision concerning health and safety data, TSCA § 14(b), restricts
confidential treatment of health and safety data contained in a health and safety study.
Health and safety data is still entitled to confidential treatment if, and only if, the disclosure
of the data would result in the disclosure of a chemical process, or chemical proportion in a
mixture. This statutory mandate for the broad availability of health and safety data, with its
narrow protection only for the most crucial proprietary information, demonstrates the
overriding statutory policy of information access.
The Legislative History of the Toxic Substances Control Act provides further insight
into the public participation and information dissemination aspects of the statute. Securing
the public understanding of chemical substances in commerce was one purpose underlying
TSCA. Senator Pearson, one of the primary sponsors of TSCA, observed:
I think the essential element of this legislation is that it has attempted to
provide the individual -not only who works, but for the rest of American
society- the right to know what is in store as far as the toxicity of chemicals is
concerned.3
2 48 Fed. Reg. 21737 (May 13, 1983)
3 Legislative History of the Toxic Substances Control Act (1976) Chapter II, S.3149,
Senate debate, page 218.
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Proposed Actions to Reforta TSCA Confidential Business Information May 20, 1993
Senator Hartke, another of the sponsors, provided the following view of the utility of
TSCAdata:
there are thousands and thousands of items at this moment which are going
undetected and unknown by millions of Americans and it is high time we
recognized that they are entitled not alone to the right to know but the right to
have the Administrator of the Environmental Protection Agency to move
effectively and immediately to do what he can to provide a better health and a
cleaner environment for Americans.4
In keeping with the goal of enabling a genuine public understanding of the risks of
chemical substances, the House of Representatives Report to the full House expressly
provided that the term "health and safety study" as used in TSC A § 14 be broadly
interpreted.
Not only is information which arises as a result of a formal disciplined study
included but other information related to the effects of a chemical substance or
mixture on health and the environment is also included. Any data which bears
on the effects of a chemical substance on health or the environment would be
included.5
This interpretation was made to insure that publicly available data on toxic substances
would be informative to the greatest extent possible.
EPA has consistently taken the position that chemical identity is an integral part of
health and safety study. This position has been incorporated into a number of the Agency's
regulations implementing TSCA. For example, with regard to Premanufacture Notices
M[c]hemical identity is always part of a health and safety study." 40 CFR 720.3(k). With
regard to health and safety studies themselves, "[c]hemical identity is part of, or underlying
data to, a health and safety study." 40 CFR 716.3.
Accordingly, EPA believes that chemical identity used in a health and safety study is
generally subject to disclosure under TSCA § 14(b) and may be eligible for confidential
4 Legislative History of the Toxic Substances Control Act (1976) Chapter II, S.3149,
Senate debate page 294.
5 Legislative History of the Toxic Substances Control Act (1976) Chapter IV,
Conference Report, House Report No. 94-1679 page 671.
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Proposed Actions jo Reform* TSC^Cojifid^al.B^siii^Infonnation May 20,1993
treatment only under a limited set of circumstances. It is the Agency's belief that this
position is consistent with the intent of Congress.6
OPPT has committed itself to a mission objective of making toxics data available to
the interested public. This policy choice is consistent with TSCA itself. InappropriateJ'CBI
claims thwart this mission goal., TSCA CBI reform furthers OPPT's objectives by
addressing this problem of inappropriate CBI claims.
H.a. Going Public: CBI Reform
Over the past several years, OPPT has come to recognize that inappropriate
confidentiality claims have impaired the dual goals of public education about chemical
substances and public participation in the toxics control process. Until recently, OPPT has
not focused on the public information dissemination aspects of TSCA.
To address the idea which would eventually become Principle IV of the OPPT Vision
Statement and promote public participation in TSCA, OPPT reviewed the issue of
inappropriate CBI claims included in TSCA submissions. Beginning in August, 1990, the
Office engaged in the following activities to further public information goals:
CBI claims were systematically challenged in health and safety filings. To
date in excess of six hundred claims have been challenged and subsequently
amended by information submitters.
Discussions were held with industry to reduce inappropriate confidentiality
claims.
OPPT initiated some public dissemination of TSCA information. In particular,
states, a critical party in toxics environmental protection, have been apprised
of the types and utility of data maintained by OPPT. Nonconfidential site
specific toxics information collected from 1990 Inventory Update Rule
submissions has been directed to thirteen states.
In the 1992 OPPT reorganization an Information Access Branch was created in
the Information Management Division to facilitate the dissemination of toxics
information collected under TSCA, the Emergency Planning and Community
6 See. Legislative History of the Toxic Substances Control Act (1976) Chapter HI,
House Report No. 94-1341, pages 456-458.
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Proposed Actions to Reform TSCA Confidential Business Information May 20, 1993
Right-To-Know Act and the Pollution Prevention Act. This branch was
designed to further OPPT's goal of empowering its partners and promoting
public understanding through the dissemination of toxics information. The
Information Access Branch has been actively developing new information
products for distribution to the public.
OPPT retained a contractor, Hampshire Research Associates, Inc., to produce
an analysis (the "study") of how EPA has addressed its responsibilities under
TSCA § 14. OPPT was concerned by the success CBI Review and Challenge
Program had in identifying inappropriate CBI claims and by certain trends
perceived by OPPT in assertions of CBI claims. The study was to address
these concerns.
The study was to determine how OPPT policies on CBI have affected the
implementation of TSCA. The study examined the confidentiality claims
made, the validity of the claims, and the impact inappropriate claims had on
the utility of TSCA data to the public. Additionally, the study contained
suggestions on ways to reduce inappropriate claims.
n.b. The Influence of CBI Requirements on TSCA Implementation
In the summer of 1992, OPPT notified other Federal Agencies, states, environmental
groups, labor, the regulated community, and the public that the study was available. The
essential message of the study was that there were inappropriate CBI claims on TSCA data,
in particular health and safety data. These invalid claims restrict the utility of TSCA data to
the public and limit the public understanding of chemical substances, TSCA regulations and
Agency policies.
Among the particulars the study highlighted were:
While many CBI claims are, in fact, appropriate, there are a large number
which are not eligible for confidential treatment.
There is no penalty or cost associated with a submitter making an invalid CBI
claim.
With limited exceptions, health and safety data submitted under TSCA is not
eligible for confidential treatment. Yet, in practice, some of this data come to
the Agency claimed as CBI. For example, in 1990 such important data as
chemical identity provided in Notice of Substantial Risk filings under TSCA §
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Proposed Actions to Reform TSCA Confidential Business Information May 20, 1993
8(e) was claimed as CBI 45% of the time. While some of these claims might
be justified under TSCA 14(b), the perception, reflected in the study, was that
the overwhelming majority of these claims could not.
CBI claims in TSCA filings have been reviewed and, when appropriate
challenged, by OPPT regularly since August, 1990. Given the large number
of CBI claims asserted, only a small portion could be reviewed. By
September of 1992, over 600 claims had been voluntarily amended and
reduced by submitters after inquiry by OPPT. This stood as anecdotal
evidence that inappropriate CBI claims were being filed.
Information publicly available through other sources was being represented to
EPA as CBI. For example, newspaper articles and corporate annual reports
had been submitted as CBI. The study suggests that some publicly available
information on the Toxics Release Inventory was claimed as CBI when
submitted under TSCA.
According to the language of TSCA, EPA could not provide CBI to states
irrespective of the level of security those states provided. This limitation
prevented states from fully benefitting from TSCA data collection efforts.
Inappropriate CBI claims on health and safety data restrict EPA's ability to
convey chemical risks and explain the rationale for particular regulatory
activity.
Interest in the data by states and environmental and other public interest
groups has been stymied by CBI claims- many of them invalid.
No effective regulatory scheme exists to declassify old CBI claims in data
filings directed to the Agency.
The study suggests that there are broad, systemic problems with the current TSCA
CBI procedures and administration.
n.c. The Continuing Public Dialogue: Summary of Comments
After the study was released the OPPT Director invited all interested parties to engage
in an open dialogue with the Agency to consider the points raised in the study, and to
improve EPA's existing TSCA CBI policies. The goal of the dialogue was to educate the
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Proposed Actions to Reform TSCA Confidential Business Information May 20, 1993
states, environmental groups, labor, the regulated community and the public about the
problems and then devise solutions.
The first public meeting was held on October 14, 1992 in Washington, DC. Forty six
representatives from other Federal Agencies, states, environmental groups, labor, the
regulated community and the public attended the meeting. Seven persons from outside the
Federal government provided public comments. Three persons ;submitted written comments.
Since October, more meetings have been held .among a! variety -of states,
environmental groups and the regulated community. EPA has received seventeen additional
comments from environmental groups, labor and the regulated community. These comments
as well as the transcript of the October 14 meeting have been incorporated into a public
docket.
Chemical Industry Comments
The Agency received twelve comments on the study and on general CBI issues from
the chemical industry. As one writer noted, "protection of confidential (or trade secret)
business information strikes at the lifeblood of the American economy and the
competitiveness of American industry."7
The twelve chemical industry commentators were uniform in their skepticism of the
points and conclusions raised in the study. One commentator, representative of the group,
dismissed the Report as essentially biased and partial. Industry commentators were
particularly skeptical about the basic assertions raised in the study that there was in fact an
information dissemination aspect of TSCA. Industry commentators asserted that the primary
articulated purpose of the information collected under TSCA was to provide EPA with a
factual basis for chemical regulation.
Industry commentators expressed acute concern about the protection of confidentiality
claims for new chemicals which were submitted for the TSCA § 5, "New Chemicals" review
process. One commentator observed that requiring disclosure of identity for these chemical
substances could provide a company's competitors with critical information on research
direction, timing and developmental progress of new products. That critical information
could, in turn, affect future marketability of the chemical products. It was the
commentator's opinion that the acute sensitivity of such information, combined with the
Kraska, page 1
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May 2Q. 1993
minimal exposure to the public by suqh neyvr chemicals, made forced disclosure of new :
chemical identities in health-and. j$afety studies an unreasonable proposition.8
Yet while the chemical industry was largely critical of the report, most commentators
accepted that there were improper CBI claims made by industry and that these improper
claims needed to be addressed. As noted by one commentator "frivolous or unnecessary CBI
claims should be discouraged, as they undercut both the credibility and the effectiveness of
the efforts made by EPA to protect the information and documents covered by legitimate CBI
claims not even to mention depriving those with a legitimate interest of their ability to gain
access to needed data."9
The industry commentators believed the issues of TSCA CBI policy could best be
addressed through a voluntary education process. Workshops, newsletters, question and
answer bulletins and other memoranda were potential vehicles suggested by industry to insure
compliance with the regulations.
In addition, some industry commentators were amenable to a time expiration of
confidentiality claims as long as there was an opportunity for rectification of those claims.
Other Comments
Other commentators were uniform in their opinion that OPPTs present TSCA CBI
policies and guidelines on information are inadequate if TSCA data is to be useful to the
general public. Perceived failures are of two types: first, too much information is claimed as
CBI and, second, the Agency had not effectively disseminated public TSCA data.
A state commentator from Illinois noted that site specific TSCA toxics information is
not available to states if the information is claimed CBI. This denied states information on
the generation and use of toxics in commerce. In the commentator's view, this denied access
"to important information that we saw as relevant for protection of public health and the
environment in Illinois. How could we hope to ensure chemical safety to citizens in Illinois
if we were not even able to find out what chemicals were in production and use?"
A labor commentator recognized that TSCA CBI provisions are problematic both in
the terms drafted in the statute and implementation by EPA. The result was that TSCA data
did not have the utility it otherwise could have.
8 Street, page 2
9 Hawes, page 2
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Proposed Actions to Reform TSCA Confidential Business Information May 20, 1993
Nine environmental groups submitted joint comments on the study and TSCA CBIin
general. They noted that broad indiscriminate CBI claims in TSCA filings eliminated any
practical utility of the data to .the public. , , ( :r ,- .-. ,
All of these non-chemical industry commentators believe that the Emergency Planning
and Community Right-To-Know Act (EPCRA) model for CBI claims is an appropriate design
for TSCA CBI claims and procedures. Under the EPCRA model, only limited information
may be claimed as CBI. For example, site specific data, including submitter identity and site
address, can never be claimed as confidential. Severe penalties can be imposed for illegal
confidentiality claims. To insure that a submitter's upper management is aware of what is
being claimed as CBI, a high official must sign off on any document reflecting CBI status.
Also, each of these commentators urged the Agency to devise effective information
dissemination vehicles for information collected under TSCA.
H.d. Agency Response to Comments
The rationale for OPPT's TSCA CBI reform program is contained in Section I: Going
Public, above. The goal of the "Going Public" is, in part, to close the American people's
knowledge gap on the nature of toxic chemicals.
OPPT has historically been appreciative of the sensitivity industry has towards the
confidentiality issue. Some of the data submitted under TSCA is business confidential; if
released the information could materially injure the competitive position of the submitter.
OPPT is committed to protecting such information. OPPT appreciates and notes that CMA in
its comments states that it knows of "no instance in which an information submitter was
harmed by the inadvertent disclosure of sensitive CBI by its submitters."10 The Agency is
committed to maintaining this record of security for CBI claims.
OPPT has recognized that certain data in a health and safety study is not "health and
safety data." For example, company identity and site specific data may, on occasion, be
confidential business information. Other information within that study such as process or
proportion of a mixture information may properly be claimed as confidential under TSCA §
OPPT is acutely aware of the sensitivity the regulated community has towards
chemicals going through the new chemicals review process under TSCA § 5. OPPT
10 CMA, page iii
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Proposed Actions to Reform TSCA ConfwJenUah Business Information; May 20,1993
recognizes there are policy .reasons for different treatment of thisidata. For this reason the
focus of the "Going Public" effort has been on those chemicals which have already gone
through the new chemicals review process and may be legally utilized in commerce. OPPT's
goal continues to be on educating the public on the characteristics of those chemical
substances which are legally manufactured, processed or imported in the United States.
m. Proposal
The following is what OPPT believes constitutes a reasonable proposal for the
addressing of the various problems identified in the contractor study and the comments raised
by industry, states, labor and environmental groups. -
For ease of understanding, proposal items have been listed in approximate
chronological order: those items which can reasonably be addressed in the near future are
first, long term items are identified towards the end of the section.; The itemschave been
divided into three categories short term, long term, and other action items. For short term
items, start action dates are within six months of the date of this paper's publication.
Parenthesis with dates reflect expected start action dates on these items. The final group of
items, those listed as other action items, are those either still under consideration or rejected.
Reasons for these items' status are provided in the text.
m.a. Short Term Action Items
1. Education Effort (Spring, 1993)
a. Education Courses
Education is a necessary component of the CBI reform program. There is a
perception that contradictory advice has been directed to the regulated community on CBI
policy. OPPT should work with the regulated community to devise the most effective
vehicles to achieve this goal. Already the Chemical Manufacturers Association (CMA) has
suggested a framework for a day long seminar which it feels will be effective to educate its
membership.
OPPT staff members believe that a summary overview of CBI claims policy and
procedures could be provided in conjunction with previously scheduled industry meetings.
OPPT will support industry in developing education program which effectively apprises its
members of OPPT policy on CBI claims and procedures.
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Proposed Actions to Reform TSGA Confidential Businessdnfornaaiioa y May 20,1999.
However, OPPT-is aware that CMA's.membershipJs but a small paftCof the total
number of chemical manufacturers. OPPT is exploring different ways to leachrthis more
numerous portion of the regulated :community. ,GMA has ^uggestedathat it could make its
education program available to others. The issue of reaching the broad regulated community
remains under active consideration by OPPT. , ,,. .
Another facet of education being considered by OPPT is how to inform the public of
the TSCA information products available fromOPPT. As discussed in subsection c below,
OPPT is seeking to expand this function. Educating the public about the spectrum of
information resources available is the first step to educating the public about toxics.
b. Educational Clarifications of TSCA CBI Policies and Procedures.
Part of the education process is advising the regulated community what may be
claimed as CBI. OPPT should prepare instructional papers clearly identifying what CBI
claims EPA will not accept. These papers should discuss not only the policies and policy
implementations, but the rationale behind these policies. This will provide an opportunity to
insure that the regulated community sees the complete picture behind Agency information
dissemination efforts. Such papers should be available at the Education Programs described
above, but also could be distributed independently.
2. Toxics Information Dissemination. (Spring, 1993)
OPPT has already taken steps to improve dissemination of toxics information. OPPT
has created the Information Access Branch within the Information Management Division to
create and disseminate toxics information products. The Information Access Branch is
presently exploring better ways to distribute and use existing toxics information systems.
Chemical information available includes unpublished test data, data on chemical identity,
production volume, production site location, and whether the chemical substance is site
limited. In addition, OPPT maintains a public docket which contains non-confidential
supporting information for OPPT decisions.
OPPT will continue this effort to disseminate non-confidential TSCA information to
the public.
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Proposed Actions to RefonaTSCA ConlidentM Business, MQCToaiwn, May 20,1993
3. State Programs. (Spring, 1993).. : ;uuoi ^,x ..;uio.: \c ; ,;, o:...u;i ,a>
-:.. ; .' ;.; .:: xj-v.-nn? :,.; ;..-j>.,. .., '.. . *, > ' ;:-:
For several years OPPT. has directed nonGBI TSCA data to .states, primarily those
associated with the EPA sponsored program Forum on .States and Tribal Toxics Action.
(FOSTTA) Yet because of CBI, much of the information has not been as helpful as it could
be. OPPT seeks to empower its partners in toxics management to the maximum extent
possible. jntra - :,v-. -. j, -.- ' .
.:cv ...-.....:
Irrespective of the level of security provided, EP.A may not distribute TSCA CBI to
states. Industry and state commentators recognize and agree that the information EPA
collects through the various TSCA information vehicles is necessary for efficient
administration of state toxics programs. CMA has agreed to participate with the Agency and
FOSTTA members in exploring how to make this information available to states.
4. Regulatory Policy Clarifications. (Spring,' 1993) ;.
> r, - , '
v iŧ. ;
To insure clarity of OPPT's position on CBI filings, regulations and policy statements
should be reviewed and amended if necessary. This would help address recognized problems
and ultimately will serve to insure limited and appropriate CBI claims. For example, OPPT
will advise the regulated community through Federal Register notices that broad
indiscriminate CBI claims in filings effectively claiming health and safety data as CBI, are
inappropriate and will be challenged in accordance with OPPT regulations. To the extent that
it is unclear what exactly is meant by the term "health and safety data" in TSCA § 14(b),
policy statement amendments might be issued clarifying OPPT's position. Additionally, we
should make clear that OPPT considers chemical identity to be an integral part of a health
and safety study, and as such, that it should generally be available to the public.
5. CBI Review and Challenge. (Spring, 1993)
OPPT will continue the CBI review and challenge program. Presently the OPPT
reviews Section 8(e) and 8(d) submissions as they are received. Additionally Premanufacture
Notices are routinely reviewed and challenged if they contain blanket or total CBI claims or
if health and safety data portions of the submissions are claimed as confidential.
OPPT is increasingly relying on intraagency referrals as well. Specifically, OPPT is
reviewing CBI claims in order to support specific efforts such as the multi-phase review
process for chemical substances that focuses OPPT resources and develops strategies to
reduce risks through pollution prevention on chemicals that are available in commerce.
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Proposed Actions to Reform TSCA Confidential Business Jnformatinn _ May-20,-1993
Also, CBI challenges are being used to support OPPT's Lead program. OPPT intends to
continue using targeted CBI reviews and challenges to enhance its programs' effectiveness.
6. Voluntary Information Dissemination Actions: Review of Old Submissions by the
Regulated Community. (Summer, 1993)
The active participation of the regulated community is necessary for the success of
CBI Reform. It is also in the regulated community's best interest. As was noted by one
industry commentator, invalid CBI claims lower the credibility of all claims, including valid
ones. The goal of CBI Reform is, in part, creating a public knowledgeable in toxics. This
educated public benefits all parties, including the regulated community. Voluntary actions by
industry can further CBI Reform.
One way the regulated community can help is by institutionalizing a periodic review
of files, to weed out unnecessary expired CBI claims. OPPT should initiate an effort to
encourage the regulated community to engage in this activity.
OPPT is aware that such a voluntary program might have some cost to industry
without an appearance of direct benefit. However, such activities as voluntary reviews of
CBI are consistent with industry backed principles of good product stewardship. Good
product stewardship should be encouraged and recognized. OPPT is considering devices like
those included in EPA's successful 33/50 program to reward participants who voluntary
participate in this endeavor.
m.b. Long Term Action Items
7. Confidentiality Claim Reassertion or Resubstantiation Provisions. (Winter, 1993-94)
Often the need for confidential treatment of information expires over time. The
regulated community as well as OPPT should insure that only information requiring
confidentiality is claimed as CBI. OPPT believes that submitters should justify the
continuing need for protection, by reasserting a claim or substantiating the existing claim at
some specific time after the claims are initially made.
OPPT believes that reassertion or substantiation of CBI claims is a vehicle which
should be considered for TSCA submissions. However, this devise entails a cost to both
industry and the Agency. Therefore to minimize burden on industry and OPPT resources,
care should be taken so that a reassertion is only demanded for data which has a usefulness,
if released, to the interested public. The program should also be developed to minimize the
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Proposed Actions ia&lpjan TSCXConfldfintiabB usiaess JnfPJfinatton May- 20,1993
administrative cosLto industry, and the Agency;; With this condition in mind, certain TSGA
§§ 5 and 8 submissions, including Notices of Commencement under TSCA § 5 and Inventory
Update Rule submissions under TSCA § 8, are appropriate for such a provision.
8. High Level Official signing CBI Substantiations. (Spring, 1994)
An asserted CBI claim in a filing is a representation to the government that the
information claimed as confidential meets the statutory and regulatory requirements.
Confidentiality claims therefore need to be carefully considered prior to being asserted.
There is a widely held perception that such claims have not been carefully considered in the
past. OPPT believes that having a senior corporate official sign off on CBI claims will
increase the likelihood that the claims will be carefully considered before being made.
9. Up Front Substantiation of CBI Claims. (Spring, 1994)
Certain TSCA §§ 5 and 8 filings require CBI claims to be substantiated at the time of
submission. It is appropriate to expand this requirement to other filings as well. For
example, there is presently no up front substantiation requirement for CBI claims asserted for
TSCA § 8(e) filings. Considering the number of these CBI claims, particularly for chemicals
on the TSCA Inventory, some form of up front substantiation is appropriate. Currently up
front substantiation requirements exist for a number of TSCA submissions including
Inventory Update Rule and Comprehensive Assessment Information Rule filings under TSCA
§ 8(a) and Notice of Commencement filings under TSCA § 5.
^' < . - -
Up front substantiation requirements should not be all inclusive. Where filings
generally assert few CBI claims, where OPPT chooses not to allocate its resources to review
CBI claims or the utility in disseminating the information is low, up front substantiation is an
inappropriate burden on the regulated community and OPPT. For instance, OPPT considers
it inappropriate to impose up front substantiation requirements for Premanufacture Notice
submissions. -
m.c. Other Action Items Considered.
OPPT has considered the application of fees to CBI claims carefully. There is an
appeal to the use of this device. Fees might make submitters take a hard look at the claim
asserted before they file. OPPTs experience with fees in TSCA § 5 Premanufacture Notice
filings reflected that fewer submissions were made when there was a fee associated with the
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Proposed Actions to Reform TSCA Confidential Business Information May 20, 1993
filing. There is no indication that this imposition ;of a modest fee'nlechanism'has
substantively injured industry-or retarded chemical development; ;-" -; ;
It may be that a fee associated with CBI claims would likewise reduce the number of
CBI claims asserted. However, there is a administrative burden associated with fees. At this
time it may be that this burden would outweigh the possible benefits of fees. In addition,
OPPT observes that TSCA § 26(b) limits the imposition of fees to submissions under TSCA
§§4 and 5. We continue to consider the utility of fees.
OPPT has considered theiull use of the Emergency Planning Community Right to
Know Act (EPCRA) standard for CBI claims. However, OPPT notes that there may be a
problem with the application of the EPCRA model to TSCA filings in that the EPCRA CBI
procedures were statutorily prescribed. EPCRA explicitly limits CBI claims. Under TSCA,
submitters have considerably more flexibility to make claims. OPPT believes that the
differences in the two statutory schemes make it impossible to adopt the entire EPCRA
model for TSCA CBI.
OPPT agrees that, as noted in the proposals above, certain EPCRA devices such as
up front substantiation and having a senior official sign CBI claims are appropriate for TSCA
filings.
OPPT has considered using report cards which rate or characterize submitter CBI
activities. OPPT does not find report cards as described in the study to be a particularly
helpful device. Certain companies, because of the characteristics of the particular market
segment might be more likely to make confidentiality claims than others. For example,
specialty chemical companies are more likely to make CBI claims than commodity chemical
companies given the particularly keen competition in the specialty chemical market. Claims
of confidentiality for company name may also be more likely in the specialty chemical arena.
Moreover, OPPT does not believe there is necessarily a correlation between a company's
frequency of making CBI claims and the appropriateness of those claims.
However, there may be some utility in comparing CBI claims for specific filings.
This could include examining a particular type of submission for a wide range of chemicals,
for example, TSCA § 8(e) filings, or all filings for some specific chemical. With this
information OPPT could notify such companies of the pattern of CBI claims and request a
reevaluation of policies if they are inconsistent with those of others in the market segment.
Therefore, report cards, in a limited sense, remain under
consideration.
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IV. Conclusion
This document represents OPPT's thinking on the CBI issue to date. Our need to
address this issue arises from the Office's commitment to promote the public understanding
of the risks of chemicals and public involvement in environmental decisionmaking through
the development and dissemination of information on toxic chemicals.
The process of reform has been open. This openness has provided the opportunity for
a productive dialogue on the issues and concerns of all the interested parties. In the next
several months OPPT will be soliciting comments from the interested public on the draft
proposals. Our commitment to the open process continues.
The end product, the final proposal, will fully reflect the opportunity for participation
by the interested public. Our aim is that this final proposal adequately address the concerns
of all parties while serving as a vehicle to implement the mission objective to go public with
the Agency toxic chemicals management efforts.
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