disclosure of secrets: reach and tsca - steptoe & johnson...disclosure of secrets in the eu and...
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Disclosure of Secrets:
REACH and TSCA Seth Goldberg
Darren Abrahams
Giorgio Rizzello
Rachel Tennis
www.steptoe.com
17 July 2012
© Copyright 2012 Steptoe & Johnson LLP
Presenter: Seth Goldberg
Partner in Steptoe’s Washington office
More than 30 years of experience in a broad range
of issues centered on chemical regulation
In the US, practice focuses on FIFRA and TSCA; in
Europe, on biocides, pesticides, and REACH
Devotes substantial time to direct advocacy before
regulatory agencies
Heavily involved in organization and management
of data generation consortia, data compensation,
and advocacy on scientific issues
Clients often call on him to represent them in
complex matters before administrative agencies
and judicial challenges to agency decisions
2 www.steptoe.com
Presenter: Darren Abrahams
Barrister and Partner in Steptoe’s Brussels office
Focuses on EU regulatory requirements and related
commercial issues in the environment, chemicals,
and life sciences area
Advocacy and representation before the Court of
Justice of the European Union, EU Institutions and
Agencies, and before the national authorities of EU
Member States
Pre-market authorizations for biocides, PPPs,
GMOs, and REACH substances
Due Diligence aspects of international transactions
and the structuring compliance programs
Consistently recommended by Legal 500 EMEA,
Chambers & Partners Europe, and PLC Which
Lawyer? Yearbook
3 www.steptoe.com
Presenter: Giorgio Rizzello
Associate in Steptoe's Brussels office
Italian qualified lawyer (Avvocato)
Focuses on EU regulatory and related commercial
issues in the areas of environment, chemicals, and
life sciences
Assists multinational companies and trade
associations in developing effective and cost efficient
compliance strategies to meet the strict requirements
of EU and national legal regimes
Represents clients in litigation before the EU courts
Spent six months working in the legal unit of the
European Commission’s DG Environment, dealing
with infringement proceedings for non-compliance by
Member States with EU environmental law
4 www.steptoe.com
Presenter: Rachel Tennis
Associate in Steptoe’s Washington office
Focuses on environmental regulation and
commercial litigation
Prior to joining Steptoe, Ms. Tennis worked as a
legal intern in the US Attorney’s Office, District of
Connecticut
She also served as a law clerk in the US
Department of Justice, Environment and Natural
Resources Division, Environmental Crimes Section
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Introduction
Disclosure of secrets in the EU and US under chemicals law:
1. REACH dissemination policy
2. EU Access to Documents regime & REACH
3. US EPA’s declassification of CBI
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1. REACH Dissemination Policy
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Dissemination and Access to Documents
Overview
Different regimes with separate procedures and thresholds
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Dissemination Access To Documents
Purpose General publication on ECHA’s website of
information that ECHA holds on registered
substances
Disclosure to an applicant(s) in response to a
request, of (i) information contained in
documents and (ii) environmental information
held by ECHA
Legal basis • Art. 119 REACH
• Art. 10(a)(xi)
• Art. 118 REACH
• ATD Reg. (EC) No 1049/2001
• Aarhus Implementing Reg. (EC)
1367/2006)
Exception
Art. 119(2) REACH
Confidentiality accepted as valid only if
can demonstrate that “potentially harmful
to the commercial interest of the registrant
or another party concerned”
Art. 4 ATD Reg. exceptions, including where
“would undermine the protection of
commercial interests of a natural or legal
person including IP”
Art. 118(2) list of what is normally deemed to
“undermine the protection of commercial
interests of the concerned person”
Dissemination Under REACH
Art. 119(1): Information that must be disseminated (no exception)
– This information has already been disseminated
Art. 119(2): Information ultimately disseminated unless confidentiality
claim is submitted and accepted as valid (Article 10(a)(xi))
– Disseminated if no conf. claim or not accepted
– A rolling program of dissemination (SDS information is the latest)
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Dissemination: What Has Been Done and Will Be
Done
Information that has already
been disseminated
Art. 119(1)
Information disseminated
except where valid conf. claim
Art. 119(2)
SDS Information will be
ultimately disseminated except
where valid conf. claim
Art. 119(2)(d)
Substance name
(in IUPAC and EINECS) Substance trade name Registration number
C&L Identity of hazardous impurities Registrant name
Result of toxicological and
ecotoxicological studies Total tonnage band (June 2012)
Life cycle description (formerly
“uses”) and uses advised against
Physiochemical data concerning
pathways and environmental fate
Study summaries or robust study
summaries of physchem. and tox.
and ecotox. data
Exposure scenario elements
after 2013 registr. deadline
DNEL and PNEC Name in IUPAC for non-phase in
substances (for six years)
Result of PBT and vPvB
assessment
Guidance on safe use
Name in IUPAC for substances with
certain hazard classes used only as
intermediate in scientific R&D
and/or PPORD
Indication of whether a CSA was
performed
Analytic Method IF requested for
detection
Additional field in IUCLID 5.4:
identity of competent person
responsible for SDS
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Example of Information Disseminated on ECHA’s
Portal
ECHA’s dissemination portal:
– http://echa.europa.eu/information-on-chemicals/registered-substances
Substance search: “Ethylene” (total tonnage band may be confidential)
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Information Disseminated on ECHA’s Portal Per
Substance
Substance search: “Ethylene oxide” then “View”
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Recent Dissemination of Total Tonnage Band
Aggregated tonnage data disseminated from June 2012:
– Nothing: If valid conf. claim in all registration dossiers and less than four full registrations
– Lower value: If valid conf. claim in some registration dossiers and less than four full registrations
– Upper and Lower value: In all cases where there are four or more registrants and no conf. claims in full
registrations
See ECHA News Alert of April 18, 2012
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Dissemination of Additional Information
Active Lead Registrant (LR) names
– This information is not part of REACH dissemination policy (Art. 119(1) and 119(2))
– Communicated to ECHA on a voluntary basis via ECHA’s LR Notification Form
– Notification deprives LR from possibility of claiming its identity as a “registrant” confidential
ECHA’s table of active LR
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What is SDS Information?
Art. 119(2)(d): “Information, other than that listed in [Article 119(1)],
contained in the safety data sheet.” ECHA does not hold the SDS
ECHA has determined which information, contained in a registration
dossier, is also typically contained in an SDS. This is SDS information:
– Registration number
– Registrant name
– Life cycle description and uses advised against
– Result of PBT and vPvB assessment (new field in IUCLID 5.4)
– Exposure scenario elements (new field in IUCLID 5.4)
– Indication of whether a CSA was performed
SDS information will be disseminated even for substances not requiring
an SDS (unless conf. claim submitted and accepted)
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Dissemination of SDS Information
SDS information will be disseminated after October 31, 2012
Registrants can review registration dossiers already submitted and claim
confidentiality of SDS information before October 31, 2012 even where
they did not claim confidentiality previously (“re-submission”)
New IUCLID 5.4 and REACH-IT (released on July 11, 2012) can process
SDS information and include new confidentiality claims and flags
Updated dossiers for resubmission must be in new IUCLID 5.4 format
which includes a requirement for new information (also subject to
dissemination). Timing of legal requirement to compete new fields (TCC
in 2014)?
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Confidentiality Claim
Foreseen by Art. 10(a)(xi) REACH
It consists of a:
– Request not publish information on the Internet
– Justification as to why publication could be “potentially harmful” for the
commercial interest
Each confidentiality claim for substances requiring an SDS:
– Must be justified (why are you different)
– Will be invoiced
– Will be assessed (i.e., whether the claim is “valid” or not)
Payment is not required if an SDS is not mandatory. ECHA guidance
only commits itself to assessment when payment is required: “Claims
not invoiced because a substance does not require an SDS are not
assessed.” Back door veto for non-SDS substance registrants?
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Confidentiality Claim Justifications
Justification must explain why dissemination may be “potentially harmful
for the commercial interest of the registrant or any other party
concerned”
Guidance on ECHA’s website is outdated and will be updated very
shortly:
– Data Submission Manual 16 on Confidentiality Claims (including a “likely
rationale” to justify a claim)
– Annex I: Instructions for the Confidentiality Claims Justification Template
– Confidentiality Claim Template
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How to Properly Formulate a Confidentiality Claim
Each claim should be properly justified or it will be rejected. IUCLID 5.4
includes a template and a box for justifying the claim
In particular justification must contain:
1. Declaration that the information is not in the public domain
2. Demonstration of the existence of a commercial interest that needs to be
protected
3. Causal link between dissemination and harm to commercial interest
Arguments supporting a confidentiality claim may be:
– Small number of competitors
– Small markets
– Links between registrants and distributors/downstream users
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Fees for Confidentiality Claims
Each conf. claim for substances requiring an SDS will be invoiced
– Fees calculated based on Commission Fee Regulation No 340/2008
IUCLID fees calculation plug-in helps calculates fees per claim
Standard (single) fee for SDS information is € 3,000. Reduced fees for
medium enterprises, SMEs, and micro enterprises
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Fee Regulation
Confidentiality Claims: Assessment and Review
Decision to partially or fully reject a confidentiality claim can be
challenged through a review procedure by filling a form on ECHA’s
website—within two months from the date of receipt of ECHA’s decision
Request for review has suspensive effect (information will not be
disseminated)
ECHA has two months to respond to the request for review
ECHA’s response can be challenged (with suspensive effect) before
– General Court (asking the annulment of ECHA’s decision)
– European Ombudsman (maladministration by ECHA)
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Confidentiality Claims: Statistics
ECHA does not have a deadline to assess conf. claim (not part of
compliance check)
Priority is given to certain claims (e.g., IUPAC names), not to
chronological order
By the end of 2011 ECHA had received 1,693 confidentiality claims. Of
these, only 38% had been assessed
Most of the claims assessed were “out of scope”
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See ECHA General Report 2011
Points to Consider
Each registrant (including ORs) has an opportunity to review/amend its
registration dossier between July and October 2012
Registrants may want to avoid the dissemination of certain SDS
information, e.g.:
– Registration number: It may reveal who is the manufacturer of a substance
– Registrant name: It may link the registrant to a tonnage band
Registrants may want to avoid the dissemination of information included
in earlier registration dossiers, which was not claimed confidential, e.g.:
– ORs may have not claimed their identity confidential and may have included
their list of suppliers (i.e., customers) in the registration dossier: This list may
be disseminated (and OR will be requested to provide the supplier’s agreement
for dissemination)
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ECHA’s Response to Valid Claims
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2. Access to Documents Regime
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ATD Requests
Dissemination is only one half of the attack on your secrets.
Competitors and Campaigners also use the ATD Regulation (EC)
1049/2001:
– Documents held by ECHA must generally be disclosed following a request
submitted (documents received from third parties and drawn up by ECHA) BUT
conditions under which must only grant (ii) partial disclosure or must (iii) refuse
disclosure
– Document definition open-ended: “Any content whatever its medium (written on
paper or stored in electronic form or as a sound, visual or audiovisual
recording) concerning a matter relating to the policies, activities and decisions”
– No requirement to generate documents in order to respond to ATD requests
(just “raw form”)
– Not designed for fishing exercises: No general requirement on Agency to
extract individual pieces of information from documents and/or to assemble
them in a new document, summarising information from various sources or
explaining it
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ATD Requests
Special rules for “Environmental Information” (from Aarhus Implementing
Regulation (EC) 1367/2006) where extraction is required but not
analysis or explanation. Definition captures:
– Condition of the environment
– Introduction of elements affecting or likely to affect its condition including on
human health
– Action taken in relation to it
No immediacy test. No requirement to explain or extrapolate
“Emissions to the environment”: Emissions to the environment are
information on the release as such
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ATD Requests
Information
Environmental Info.
Emissions to the Environment
Document1 Document
2
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Presumptions of Non-Disclosure
Art. 118(2) REACH creates a strong legislative presumption of non-disclosure
for certain categories of information in documents (see table below):
– Details of the full composition of a mixture
– Precise use
– Function or application of a substance or mixture including information about its
precise use as an intermediate
– Precise tonnage of the substance or mixture manufactured or placed on the market
– Links between a manufacturer or importer and his distributors or downstream users
Presumptions relieve obligation of ECHA to make a “concrete, individual
examination of those documents” to justify non-disclosure. BUT applicants
can still demonstrate a higher public interest justifying disclosure (rebuttable
presumptions)
ECJ has upheld strong legislative presumptions as a basis for non-disclosure (in
State Aid and Merger Control contexts). Pending Case T-245/11 ClientEarth and
International Chemical Secretariat v. ECHA
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*1 Case 64/59 Sweden v. Commission. # Reg. 1367/2006 defines “environmental information” as “any information in written, visual, aural, electronic or any other material form on:
(i) the state of the elements of the environment, such as air and atmosphere, water, soil, land, landscape and natural sites including wetlands, coastal and marine areas,
biological diversity and its components, including genetically modified organisms, and the interaction among these elements;
(ii) factors, such as substances, energy, noise, radiation or waste, including radioactive waste, emissions, discharges and other releases into the environment, affecting or likely to
affect the elements of the environment referred to in point (i)…”
4(1)
Would undetermined the protection of:
4(2) 4(3)
(a) (b)
Public interest Privacy & personal data
Security Defence
&
military
International
relations
Financial,
monetary
policy of EU
or Member
State
Would undetermined the protection of: Would seriously undetermined institution’s decision making process:
*Commercial
interest of a natural
or legal person
including
Intellectual Property
Court
proceedings
and legal
advice
*Purpose of
inspections,
investigations &
audits
Relating to matter where
decision not yet taken by
the institution
Received by
an institution
Drawn up by
an institution
for internal use
Unless overriding public interest
(Deemed to exist for * when info “relates to emissions to the
environment”# under Reg. 1367/2006)
4(4)
If a 3rd party document
institution must consult 3rd party unless clear to disclose or not
Opinions for
internal use as part
of deliberations and
preliminary
consultations within
the institution
After
decision
taken
4(5)
Documents originating from a Member State not disclosed if MS requests and gives reasons
falling under Arts. 4(1) to 4(3) *1
Exceptions to Disclosure in ATD Reg.
Points to Consider
There is a sustained period of ATD requests and related legal
challenges. “Private communications” era is a thing of the past
ATD provides a right to request access without a requirement to provide
a justification or explanation for why the documents are requested
coupled with a right of action to challenge decisions before the Court of
Justice of the EU and/or the Ombudsman. A recipe for litigation
Potential chilling effect on engagement with ECHA—companies going
beyond what is necessary. Consider this at each stage
Think about what might now be in the public domain and is useful to you
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3. EPA’s Declassification of CBI
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US Data Collection Toxic Substances Control Act
Toxic Substances Control Act (TSCA), 1976
– First generation chemical control
• “Unreasonable risk” standard
• Burden on agency
• Problem of application to new technologies
– EPA now trying to use TSCA to require more information
• Declassification of CBI claims
• Chemical Data Reporting Rule
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US Data Collection TSCA—Reporting
Requirements
EPA can require submission of information under §8(a) of TSCA
– Chemical or mixture identity
– Categories of use
– Quantity manufactured or processed
– Byproduct description
– Health and environmental effects information
– Number of individuals exposed
– Methods of disposal
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US Data Collection TSCA—CBI Claims
Data submitters can designate information submitted under TSCA as
confidential business information (CBI)
Baseline requirements—EPA regulations and policy statement
– Must assert confidentiality at time of submission, 40 C.F.R. § 2.203
– Otherwise confidentiality is waived, 43 Fed. Reg. 11113 (Mar. 16, 1976)
– CBI must be clearly marked, 40 C.F.R. § 2.203
– Each page containing confidential information must be stamped with a label
such as confidential, proprietary, or trade secret, 43 Fed. Reg. 11113 (Mar. 16
1976)
– Must submit two versions, 43 Fed. Reg. 11113 (Mar. 16 1976)
• One complete (“sanitized”) copy with confidential information marked as described
above
• One copy with confidential information removed or obscured
– See http://www.epa.gov/oppt/tsca8e/pubs/confidentialbusinessinformation.html
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US Data Collection EPA Declassification of CBI
2009 EPA began actively reviewing old claims
2010 voluntary declassification request
Now posting declassified information online
– To view the declassified health and safety studies, visit the Chemical
Data Access Tool
– http://java.epa.gov/oppt_chemical_search
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http://www.epa.gov/oppt/existingchemicals/pubs/transparency-charts.html
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US Data Collection Chemical Data Reporting Rule
Final rule August 2, 2011 promulgated under §8(a) authority
Amended prior Inventory Update Reporting Rule
Broad application
– Lower reporting thresholds
Increases type and amount of information that must be reported to EPA
– Data must be submitted for each year in reporting period
– “Known or reasonably ascertainable” standard
Up-front substantiation of CBI
– Chemical identity
– Site identity
– Processing and use information
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US Data Collection Chemical Data Reporting Rule
Up-front substantiation entails written answers to questions promulgated
at 40 C.F.R. 711.30, including (among others):
Chemical identity
– Extent of competitive harm to self or supplier
– Whether fact of manufacture or import is publicly known
– Measures taken to prevent disclosure
– Purpose of manufacture
Site Identity
– Whether site has been linked with chemical identity in another reporting
scheme
– Extent of competitive harm
Process and use
– Extent to which information about the chemical is publicly available
– Extent of competitive harm to self or customers
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US Data Collection Chemical Data Reporting Rule
Industry generally supportive of CDR
Many of the comments submitted in response to the proposed rule were
taken into account in the final version
– Phase-in of reporting thresholds
– 2,500 pound de minimis level
– Phase-in of historical data requirements
New reporting standard opposed as potentially confusing
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US Data Collection TSCA Reform
Not the end of the story
Similar House and Senate bills introduced in 2010
Safe Chemicals Act Senate bill re-introduced in 2011 (S. 847)
Very conservative bills favored by NGO’s
Unlikely that a new law will be enacted before the election in November
of 2012
Unclear what an eventual law will contain
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Points to Consider
EPA is now more likely to deny CBI claims
Up-front substantiation is essential
Existing claims are also subject to review and may be triggered by CDR
filings that fail to claim confidentiality
TSCA reform is likely to continue this trend toward broader disclosure
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Thank You for Joining Us
44 www.steptoe.com
Seth Goldberg
Partner
Steptoe, Washington
(202) 429-6213
Darren Abrahams
Partner
Steptoe, Brussels
+32 2 626 0500
Giorgio Rizzello
Associate
Steptoe, Brussels
+32 2 626 0563
Rachel Tennis
Associate
Steptoe, Washington
(202) 429-1371