LEGAL RISK MANAGEMENT IN
ERA OF EVOLVING
STEWARDSHIP EXPECTATIONS
Julie Hatcher
Latham & Watkins LLP
© Copyright 2010 Latham & Watkins. All Rights Reserved.
ENVIRONMENTAL LAW INSTITUTE
The Future of Chemical Toxicity Testing in the U.S.:
Creating a Roadmap to Implement the National Research Council’s
Vision and Strategy
June 21, 2010
Latham & Watkins operates as a limited liability partnership worldwide with affiliated limited liability partnerships conducting the practice in the United Kingdom, France and Italy. ©Copyright 2009 Latham & Watkins. All Rights Reserved.
1
2
U.S. LEGAL
CONSIDERATIONS
Latham & Watkins operates as a limited liability partnership worldwide with affiliated limited liability partnerships conducting the practice in the United Kingdom, France and Italy. ©Copyright 2009 Latham & Watkins. All Rights Reserved.
REGULATORY COMPLIANCE
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INDUSTRIAL
TSCA § 5 Inventory/PMN
TSCA § 12/13 Import/Export
TSCA § 8(a)
TSCA § 8(c)
TSCA § 8(d)
TSCA § 8(e)
TSCA “Bans” (e.g., PFOS)
Other “Bans” (e.g., SNAP under Title VI
of Clean Air Act)
OSHA Hazard Communication
OSH Act “General Duty”
OSHA Process Safety
Drug Diversion Registration (if one of 40
listed chemicals)
Emergency Release (e.g., EPCRA 304)
Community Notification (e.g., EPCRA
311/312)
Prop 65
DOT Placarding and Labeling
Waste Handling under RCRA and state
laws
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CONSUMER
FHSA Labeling
CPSIA Compliance
Poison Prevention Act
State Registration
Toxics in Packaging
“Little” FTC
State VOC Limits
State VOC Labeling
4
Tort Liability
DUTY TO AVOID SELLING A DEFECTIVE PRODUCT
Duty to Test
Duty to Warn
Duty of Care
Intrinsic
Hazards
Exposure Profile
Data And Methods
Does The Chemical Fall Within Any Categories of Concern?
E.g., Cancer; Birth Defects
What Are The Potentially
Exposured Subpopulations?
E.g., "Sensitive" subpopulations; workers
What Is The Extent Of The Current
Data Base As Compared To Scientific Capabilities/Norms?
E.g., Extent of animal data; availability of human data
BIOMONITORING
New paradigms for testing and
risk assessment, e.g.,
molecular screening;
computational toxicology
5
Elasticity of the Law
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Manufacturer held to expert standard
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Duty to warn is triggered by “early warning flags”
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Will proliferation of biomonitoring data effectively change the
standard?
Will new tests to illuminate changes at the molecular level
become expected for certain types of chemicals or uses (e.g., use
with sensitive subpopulation exposures)?
Do biomonitoring or molecular screening results ever constitute
such a trigger?
Adherence to regulations/standards not necessarily
sufficient –
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Do regulations/standards adequately address biomonitoring
data or lag behind?
6
Elasticity of the Law (continued)
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Might plaintiffs argue that the duty to test includes
the duty to perform biomonitoring or molecular
screening assay?
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New toxicology data
Exposure profile
 Widespread exposure
 Worker exposure
 Contamination
Might plaintiffs argue that properties of a chemical,
such as persistence, create greater obligations?
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Duty to Warn due to potential for long residence time/build-up in the
body?
Duty to test extensively as reasonable precaution?
Inherent defect?
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OTHER POTENTIAL CLAIMS
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Medical Monitoring
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Seeks costs of diagnostic testing to detect latent diseases
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Not recognized in all states, but trend is towards increasing recognition (either
as remedy or separate cause of action) based on a “significantly increased risk”
of contracting disease standard
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Available in some states for class of individuals with similar exposures.
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Lump-sum awards allowed in some states
Increased Fear/Increased Risk
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Recognized as separate claims in some states
Fear must be “reasonable, genuine and serious”
“More likely than not” standard may apply absent egregious conduct
amounting to “oppression, fraud, or malice
Chemical “Trespass”/Chemical “Battery”
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Alleged by plaintiffs in recent chemical exposure cases, but not yet established
in law
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LIABILITY RISK MANAGEMENT:
The Basics
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Understand and manage hazards associated with each chemical
being imported, manufactured or used
Maintain a Comprehensive Compliance System (CCS) – i.e., a
system that accounts for all applicable regulatory compliance
obligations
Take reasonable measures to ensure that CCS avoids the
following management system problems:
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Duplication of effort
Gaps in coverage
No clear mechanism for employees to raise issues
No clear lead individual/organization for identifying or resolving issues
Decisions made too low in organization
“Turfing” a common phenomenon
Lack of cooperation/information sharing
Progress often occurs ad hoc through either personal relationships or strength of personality
Compliance equated with risk management, but regulations do not address all risks
Weak-systems for management of risks
EVER-CHANGING RISK ASSESSMENT LANDSCAPE
MANDATES MOVING BEYOND THE BASICS
9
U.S. LEGAL
IMPLICATIONS OF
REACH
More of a Stewardship Driver
Than You Might Think
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Company-Driven Risk Decisions
Currently Being Made Under REACH
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What additional testing is needed to support Registration?
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Traditional Health Studies
Biomonitoring
Exposure Assessment
Nanomaterials
Emerging Science
 E.g., Genomics
 E.g., Low Dose
When is an Article subject to Registration or Notification due to:
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“Intended to be released under normal or reasonably foreseeable conditions of
use” (Registration)
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Contains SVHC and cannot exclude “exposure to humans or the environment
during normal or reasonably foreseeable conditions of use, including disposal”
(Notification)
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Company-Driven Risk Decisions
Currently Being Made Under REACH
(continued)
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Where Chemical Safety Report requirement applies. . .
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When must Chemical Safety Report include Exposure Scenarios
and Risk Characterization because assessment indicates
substance qualifies as:
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Does sufficient information exist for requisite human health and environmental
assessment?
Should one (or more than one) DNEC be calculated and with reference to what
endpoints?
What environmental spheres should PNECs be calculated for?
PBT;
vPvB; or
“(i) with dispersive or diffuse use(s) particularly where such substances are used
in consumer preparations or incorporated into consumer articles and (ii) for
which it is predicted . . . that they are likely to meet the [other Dangerous
Substance] classification criteria for any human health or environmental effects
endpoints under Directive 67/548/EEC”?
When must “safer alternative” to SVHC be identified in
Substitution Plan?
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U.S. Regulatory Requirements Potentially
Triggered by Such Decisions
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TSCA Section 8(e) “substantial risk” notification
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Product-Related Disclosures
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Federal Insecticide, Fungicide and Rodenticide Act
Federal Food, Drug and Cosmetics Act
Federal Hazardous Substance Act
Consumer Products Safety Act
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Securities Disclosures
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State Laws
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E.g., Proposition 65
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TSCA Section 8(e)
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8(e) can be triggered
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“Sliding scale” reporting trigger in EPA’s guidance
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New information
Re-assessment of existing information
Requires qualitative judgments about (1) seriousness of the adverse
effect, and (2) fact or probability of effect’s occurrence
Possibility of such judgments being second-guessed later and in
hindsight by EPA through enforcement action
“Sliding Scale” Examples (see next page)
14
TSCA Section 8(e)
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“Sliding Scale” Examples:
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For substance subject to CSR exposure scenarios requirement as PBT or vPvB,
does potential exist for “widespread exposure” and “non-trivial adverse effect”
For substance subject to CSR exposure scenarios requirement as “likely to
meet” “dangerous substance” criteria for CMRs, does EPA already “know” of
information forming basis for this judgment
For substance subject to CSR exposure scenarios requirement as “likely to
meet” “dangerous substance” criteria for “very toxic to aquatic organisms”,
does evidence indicate “chemical has bioaccumulated to a pronounced degree
. . . or it is or could (based on use patterns) be widespread in environmental
media”
For substance where CSR exposure scenarios indicate potential for exposure in
excess of DNEL, is chemical associated with “non-trivial adverse” effect and
does potential exist for “widespread” or “significant” exposure
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Securities Disclosure:
Regulation 5-K Item 303 (17 C.F.R. §
229.303)
“Describe any known trends or uncertainties that
have had or that the registrant reasonably expects
will have a material favorable or unfavorable impact
on net sales or revenues or income from continuing
operations. If the registrant knows of events that will
cause a material change in the relationship between
costs and revenues (such as known future increases
in costs of labor or materials or price increases or
inventory adjustments), the change in the
relationship shall be disclosed.”
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Securities Disclosure:
Regulation 5-K Item 100 (17 C.F.R. §
229.101
(c) Narrative description of business.
...
(xii) Appropriate disclosure also shall be made as to the
material effects that compliance with Federal, State and local
provisions which have been enacted or adopted regulating the
discharge of materials into the environment, or otherwise
relating to the protection of the environment, may have upon
the capital expenditures, earnings and competitive position of
the registrant and its subsidiaries. The registrant shall disclose
any material estimated capital expenditures for environmental
control facilities for the remainder of its current fiscal year and
its succeeding fiscal year and for such further periods as the
registrant may deem materials.
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Securities Disclosure:
Some Recent Developments
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Some companies have mentioned REACH in
securities filings
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Indicate could restrict ability to market certain products
Shareholder activists increasingly target chemical
risk management issues for disclosure resolutions,
using REACH as one focal point
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E.g., Investor Environmental Health Network “Toxic Stock Syndrome:
How Corporate Financial Reports Fail to Apprise Investors of the Risks
of Product Recalls and Toxic Liabilities”
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Additional Regulatory and
Stewardship Implications
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New Chemicals Review
Risk Assessment
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Changes in paradigms and approaches
Adjustment of health benchmarks by federal and state agencies
Biomonitoring
Corporate EHS Policies and Procedures
Deselection and Manufacturing phase-outs
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E.g., Certain suppliers could discontinue or limit production due to
REACH regulatory burdens/health and safety considerations.
E.g., REACH Authorization required for SVHC to remain in EU
commerce ultimately may lead not only to restrictions in the EU, but to
deselection around the world as other countries -- and even some U.S.
states (e.g., California) -- look to REACH as a chemical regulatory
model
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Liability Implications of
Company-Driven Risk Decisions
May constitute “admissions” by Company for litigation purposes
May serve as catalyst for litigation
_________________________________
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“Toxic Tort”/Product Liability
 E.g., Certain exposure scenarios raise risk concerns or have other legal
implications
 E.g., Articles with SVHC where “exposure to humans or environment
during normal or reasonably foreseeable conditions of use” cannot be
“excluded”
 E.g., Evolution of industry standard of care
 E.g., Substitution plan process for high risk chemicals identifies “safer
alternatives”
NGO Litigation
 E.g., Petitions/lawsuits around denial of petitions for agency action
 E.g., Citizen’s Suits
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Regulatory Findings Under REACH
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REACH imposes various regulatory review
standards that -- in theory -- could have material
impacts from an evidentiary standpoint in the U.S.
courts.
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These standards, among others, include:
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Regulatory Findings Under REACH
(continued)
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ECHA finding that substance qualifies as a “SVHC”
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Essentially entails finding that “there is scientific evidence of
probable serious effects to human health or the environment”
from the substance
ECHA setting for SVHC of:
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“Derived No-Effect Level” (DNEL)
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“Level of exposure to the substance above which humans should not
be exposed”
“Predicted No-Effect Concentration” (PNEC)
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“Concentration of a substance below which adverse effects in the
environmental sphere of concern are not expected to occur”
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Regulatory Findings Under REACH
(continued)
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EHCA ruling (implemented through a European
Commission directive) that authorisation of each
SVHC should (or should not) occur under one of two
standards:
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(1) "if the risk to human health or the environment from the use of a
substance arising from the intrinsic properties . . . is adequately
controlled . . . taking into account . . . all discharges, emissions and losses,
including risks arising from diffuse or dispersive uses known at the time
of the decision" or
(2) "if it is shown that socio-economic benefits outweigh the risk to
human health or the environment arising from the use of the substance
and if there are not suitable alternative substances or technologies."
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Potential Evidentiary Impacts
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EHCA decisions, being that of foreign agency, would not have
legally preemptive impact, but would be
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Admissible under the “public records” exception to the hearsay rule (Fed. R.
Evid. 803(8)),
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unless “sources of information” or “other circumstances” indicate that
particular decision is “untrustworthy” or “unreliable”
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Even if admissible, evidentiary weight given to ECHA decision
would vary depending upon considerations, such as,
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(i) whether process underlying decision reflects indicia of fairness and scientific
rigor;
(ii) whether decision is interim or final;
(iii) whether decision reflects an industry "standard"; and
(iv) whether decision has been repudiated or superseded by a U.S. federal or
state agency.
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Implications of REACH for
Chemical Stewardship
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REACH may have various impacts, including:
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Targeting articles via SVHC provision
Creating U.S. regulatory disclosure obligations
Generating findings or evidence relevant to litigation (or that even could serve
as a catalyst for litigation)
REACH may fuel U.S. state initiatives in absence of new or
different federal chemical control action, including:
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Highlighting risk issues not well-understood
Altering supply-chain relationships
Chemical bans
State risk levels for drinking water, groundwater and other media
Such initiatives will add to already existing burden and
pressures on industry fueled by public “right to know”/scientific
populism
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WHAT STEPS MIGHT
COMPANIES CONSIDER TO
MANAGE U.S. LEGAL RISK?
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Potential Risk Management Approaches In
Era Of Evolving Stewardship Expectations
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Protect deliberative scientific process
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Qualified discovery privilege recognized by many courts rooted in 1st
Amendment
Generally applies to preliminary discussions among scientists for research
(and non-litigation) purposes maintained as confidential
Document company-driven risk decisions
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Documentation should capture
 Rationale for decision
 Process for decision
 Uncertainties attendant to decision
Documentation helps
 To avoid mischaracterization of decision by others
 To assure clarity and consistency within organization on basis for
decision
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Potential Risk Management
Approaches (continued)
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Build solid regulatory record
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Process concerns
 Sufficient “due process” opportunity
Scientific rigor issues
 Technical “shortcuts”
 Precautionary Principle
Conflict of interest
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Potential Risk Management
Approaches (continued)
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Perform not just a “nuts and bolts”, but also a
strategic, vulnerability assessment
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Benefit v. Risk
 Critical uses
 Business importance
 Viability of alternatives
Management of legacy
 Product in field/service
 Contamination
 Liability
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Potential Risk Management
Approaches (continued)
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Engage regulators and other key constituencies
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Gauge level of concern
Address risk issues forthrightly
Stay involved with scientific community
Be responsive to information needs
Consider voluntary risk management where appropriate
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Potential Risk Management
Approaches (continued)
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Reassess sufficiency of current management
systems for:
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Tracking publication of health and safety data and other pertinent
developments
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Chemical selection
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Worker health
Recognize importance in this ever-changing
landscape of:
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Interdisciplinary Approach
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State relationships
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Coordination through supply-chain and on a global basis
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Creative thinking
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BACK-UP SLIDES
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CHEMICAL REGULATORY
REFORM IN THE UNITED
STATES
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TSCA “REFORM” DEBATE
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Primary U.S. chemical law – Toxic Substances Control Act
(TSCA) of 1976 – is over 30 years old.
Debate over “TSCA reform” has been active in recent years.
Putting aside merits of debate, criticisms of TSCA are
instructive:
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Insufficient authorities to restrict existing chemicals
Burden of proving safety should fall on manufacturers and not government
Inadequate public “right-to-know” mandates for complete health and safety
data
Fails to extend into value chain
Not designed to address 21st Century risk issues:
 Biomonitoring
 Nanotechnology
 Children’s Health
TSCA chemicals authorities cumbersome in practice
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FEDERAL POLITICAL CLIMATE
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Chemical Regulatory Reform a High Priority of Prominent
Legislators
“Kid-Safe Chemical Act”
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“Safe Chemicals Act of 2010
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Introduced in Senate April 15th; referred to EPW
Toxic Chemicals Safety Act of 2010
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Introduced last term in both House and Senate
Discussion draft released on April 15th
Obama Administration Under Pressure From the Start
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January 2009: GAO added EPA’s chemical regulatory program to list of
government programs at “high risk” for waste, fraud, abuse and
mismanagement
January 2009: Confirmation hearings for EPA Administrator Jackson included
focus on toxic chemicals, with promises made for scientific integrity, right-toknow and protection of children
February 2009: Letter from Environmental Working Group urging support for
TSCA reform and aggressive measures in meantime
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Current TSCA Reform
Proposed Legislation
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Senate: Safe Chemicals Act of 2010, S. 3209
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Sponsor: Sen. Lautenberg (D-NJ), Chair, Superfund, Toxics and
Environmental Health Subcommittee
Referred to Committee on Environment and Public Works
House: Toxic Chemicals Safety Act of 2010
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Released as “discussion draft”
Primary sponsor: Rep. Waxman (D-CA), Chairman, Energy and
Commerce Committee
Co-Sponsor: Rep. Rush (D-IL), Chairman, Subcommittee on
Commerce, Trade, and Consumer Protection
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“Adverse Effect” Definition
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The term ‘adverse effect’ means a biochemical change,
anatomic change, functional impairment, or pathological
lesion, or its known precursor, that—
(A) affects or alters the performance of an anatomic structure of a vital system
of an organism or progeny of an organism;
(B) causes irreversible change in the homeostasis of an organism;
(C) increases the susceptibility of an organism or progeny of an organism to
other chemical or biological stressors or reduces the ability of an organism or
progeny of an organism to respond to additional health or environmental
challenges; or
(D) affects, alters, or harms the environment such that the health of humans or
other organisms is directly or indirectly threatened.
(Senate version; House version is nearly identical)
37
“Aggregate Exposure” Definition
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The term ‘aggregate exposure’ means—
(A) all exposure from the manufacture, processing, distribution, use, and disposal
of—
(i) a chemical substance or mixture; (ii) a substance that is not considered
to be the chemical substance or mixture under clause (i) solely because of
the use of the substance as or in a food, food additive, drug, cosmetic, or
device (as such terms are defined in section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321)); and (iii) any mixture containing a
substance described in clause (i) or clause (ii); and
(B) all exposure from all other sources of a substance described in subparagraph
(A), including—
(i) contamination of food, air, water, soil, house dust, and any other
environmental media from current or prior uses or activity; (ii) accidental
releases; (iii) permitted sources of pollution; (iv) nonpoint sources of
pollution; and (v) documented background levels from natural and
anthropogenic sources.
(House version; Senate version similar)
38
“Cumulative Exposure” Definition
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“Cumulative exposure” means the sum of aggregate
exposure to—
(A) each of the chemical substances that are known or suspected to
contribute appreciably to the risk of the same or similar adverse effect;
and
(B) mixtures containing chemical substances described in
subparagraph (A).
(House and Senate versions identical)
39
TSCA Reform Safety Standard


Senate: “REASONABLE CERTAINTY OF NO HARM.—The
term ‘reasonable certainty of no harm’ means, in
establishing whether a chemical substance or mixture
meets the safety standard under this subchapter, that
aggregate exposure and cumulative exposure of the
general population or of any vulnerable population to the
chemical substance or mixture presents a negligible risk of
any adverse effect on the general population or a
vulnerable population.”
House: “SAFETY STANDARD.—The Administrator shall
apply, as a safety standard under this title, a standard
takes into account aggregate and cumulative exposure to a
chemical substance or mixture and that provides a
reasonable certainty of no harm, including to vulnerable
populations, and protects the public welfare from adverse
effects, including effects on the environment.”
40
POLITICAL “FORECAST”


Economy, Health Care, Energy Will Take Priority In This
Congress
Partisanship in Congress Could Sideline Reform



Influential political commentators and stakeholders on both sides have been
pressuring political representatives to take stronger stands
If TSCA reform becomes as partisan as other legislation, prospects for significant
legislative reform in 2010 are low
Key Issues:

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Distinction between new and existing chemicals
Legal standard for regulatory action – i.e., “Unreasonable risk” vs. “Reasonable
certainty of no harm”
Hazard versus Risk
Vulnerable Populations
Use of “Sound Science”
Right-to-Know
International “Harmonization”
41
EPA PURSUING REGULATORY REFORM
INDEPENDENT OF LEGISLATIVE REFORM

EPA Administrator Jackson – “Assuring safety of
chemicals” a high priority

Sept. 29, 2009 – Announced new framework for
chemical management program under TSCA



Identify chemicals of concern; quickly evaluate risks and take
appropriate action
Also put forth six “Essential Principles for Reform of Chemical
Management Legislation”
Dec. 30, 2009 – Issued “Existing Chemicals Action
Plans” for 4 groups of existing chemicals (PFCs;
PDBEs; phthalates; and chlorinated paraffins)

Summarize known hazard, use and exposure information; outline risks;
identify steps to mitigate risks
42
STATES WEIGHING IN

On Dec. 2, 2009, a coalition of 13 state regulators
(CA, CT, IL, MA, ME, MD, MI, NH, NJ, NY, OR, VT,
WA) issued a statement of principles for reforming
TSCA:








Require Chemical Data Reporting
Demonstrate Chemicals and Products are Safe
Prioritize Chemicals of Concern
Protect the Most Vulnerable (children)
Promote Safer Chemicals and Products
Address Emerging Contaminants (including nanoscale)
Strengthen Federal Law & Preserve States’ Rights
Fund State Programs
43
CHEMICAL REGULATORY
REFORM IN EUROPE
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IN THE MEANTIME . . .

REGISTRATION, EVALUATION AND
AUTHORIZATION OF CHEMICALS
(REACH) is moving forward in the
European Union
45
REACH BASICS

REACH is the new European Union (EU) law requiring:



(1) Registration of all chemicals, both existing and new, and of
certain articles that either release chemicals under “normal or
reasonably foreseeable conditions of use” or contain very high concern
chemicals where exposure, including from waste disposal, can not be
ruled out;
(2) Authorization of substances of “very high concern” (SVHC) and
of certain articles containing those substances; and
(3) Substitution of highest risk substances and of certain articles
containing those substances.

Shifts responsibility for chemical risk assessment from national
authorities to chemical producers and importers

Will require registration and testing of approximately 30,000
chemicals
46
REACH: TIMELINE
Publication of
REACH in the
Official Journal
PreRegistration
Phase
30 Dec ‘06
2001
1 June to
1 Dec ’08
1 June 2007
EU Commission
White Paper:
“Strategy for a
Future Chemicals
Policy”
REACH
enters
into force
ECHA
publishes
list of SVHC
1 June
’09
Registration deadline for:
 >100 tonne per year (tpy)
substances
31 May 2013
30 Nov 2010
Registration deadline for:
 >1000 tpy substances
 “CMR” substances > 1 tpy
 Substances “very toxic” to aquatic
environments > 10 tpy
31 May 2018
Registration deadline for:
 >1 tpy substances
47
REGISTRATION: SCOPE
Substances
Chemical elements and their
compounds
 Manufactured or imported in
quantities > 1 tpy

Articles

From which substances are “intended to
be released under normal or reasonably
foreseeable conditions of use” if present in
produced or imported articles in excess of
1 tpy
Pre-Registration
1 June 2008 – 1 December 2008
Registration
1 December 2010 – 1 June 2018
Safety Data Sheet
Technical Dossier
Chemical Safety Report
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REGISTRATION REQUIREMENTS:
SAFETY DATA SHEET (SDS)

Already exists in EU for “dangerous” substances

SDS covers a base set of information similar to a
Material Safety Data Sheet in the U.S.

For substances subject to the Chemical Safety Report
(CSR) requirement, SDS also must incorporate the
Exposure Scenarios covered therein.
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REGISTRATION REQUIREMENTS:
TECHNICAL DOSSIER

Must contain data on the intrinsic properties and
hazards of each substance and the uses of the
substance identified by the producer, importer, or
their customers.
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Must also contain information on the classification of
the substance as well as guidance on safe use.

Dossier content depends upon volume and hazards,
with the greatest information burden imposed for
CMRs, PBTs, and vPvBs, high volume substances
and substances that are potentially dangerous to
health or the environment employed in dispersive
uses.
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REGISTRATION REQUIREMENTS:
CHEMICAL SAFETY REPORT (CSR)

For substances manufactured or imported at ≥ 10
tpy, Registration must include a Chemical Safety
Report



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Must document the hazards and classification of a substance
and the assessment as to whether the substance is PBT or vPvB.
Must describe exposure scenarios for specific uses of substances
that are classified as dangerous or are PBT or vPvB substances.
Must include risk management measures for all “identified
uses” (including uses made known to the manufacturer or
importer by downstream users).
Relevant exposure scenarios must be included in the SDS
supplied to downstream users and distributors.
Note: The Commission must decide within 12 years whether to recommend extending the
CSR requirement to substances produced or imported in amounts of < 10 tpy. For
carcinogenic, mutagenic and reprotoxic substances, this deadline has been shortened to
seven years.
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REGISTRATION:
DOWNSTREAM USERS

A Downstream User may rely on manufacturer or importer to
fulfill the Registration obligations as long as the Downstream
User makes available in writing information on its use(s).


For a substance subject to the Chemical Safety Report or CSR requirements
(i.e., substances manufactured or imported at 10 tpy or more), the
Downstream User also has the obligation to confirm that the Safety Data
Sheet or SDS covers Exposure Scenario(s) associated with its use(s).
A Downstream User may choose to undertake its own
Registration where it wishes to engage in a non-SDS covered
use.

Generally, a Downstream User would go this route for reasons of
confidentiality. In doing so, the Downstream User will also have to
perform its own CSA if its use entails 1 tpy or more of the substance.
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SUBSTANCES OF VERY HIGH
CONCERN (SVHC)

ECHA may designate any of the following as SVHC:


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
CMR (carcinogenic, mutagenic, or reprotoxic) substances
PBT (persistent, bioaccumulative and toxic) substances
vPvBs (very persistent and very bioaccumulative) substances
Other chemicals, such as “endocrine disruptors,” that Member
States or the Commission identify on a case-by-case basis as having
serious and irreversible effects to humans and the environment
equivalent to the other three categories
Authorization required to remain in commerce

Applicant must prepare a substitution plan for “safer” alternatives

May be authorized, possibly subject to restrictions, if risks are
adequately controlled
Disclosure Obligation for “Candidate” SVHC
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SVHCs: Candidate List Disclosure
Obligation As Of October 28, 2009



The first step in Authorization is ECHA’s
creation of a Candidate List Substances
EU suppliers of a Candidate List substance
must provide safety data sheet to customers
EU suppliers of a preparation (i.e., mixture)
must provide safety data sheet, upon request
by any recipient, if contains Candidate List
substance at concentrations of


0.1% (w/w) (non gaseous preparations) or 0.2% by volume
(gaseous preparations)
Applies even if preparation not dangerous under Directive
1999/45/EC
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SVHCs: Candidate List Disclosure
Obligation As Of October 28, 2009


EU suppliers of articles containing Candidate
List substance above 0.1% (w/w) must
provide information sufficient to ensure safe
use of the article:

To their customers, and

upon request to consumers within 45 days of the
receipt of this request.
Inconsistent guidance on how to determine
the 0.1%


Is it gauged based on article as a whole or
Determined for each component of the article
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legal advice from qualified counsel. This presentation is not created nor designed to address the unique facts or
circumstances that may arise in any specific instance. You should not, nor are you authorized to, rely on this content as
a source of legal advice. This seminar material does not create any attorney-client relationship between you and Latham
& Watkins. © Copyright 2010 Latham & Watkins. All Rights Reserved.
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