The New TSCA: What Does It Mean For
Consumer Products Companies?
WWW.TSCAREFORMCENTER.COM
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Speakers
Sheila Millar
Partner
[email protected]
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Martha Marrapese
Partner
[email protected]
Keller and Heckman LLP
Nathan Cardon
Associate
[email protected]
2
Preliminary word
 This presentation provides information about
the law. It is not intended to provide legal
advice.
 Legal information is not the same as legal
advice, which involves the application of law to
an individual's specific circumstances.
 The interpretation and application of the law to
an individual’s specific circumstance depends
on many factors.
 The information provided in this presentation is
drawn entirely from public information.
 The views expressed in this presentation are
the authors’ alone and not those of the authors’
clients.
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Agenda
 New TSCA: Basic Provisions and
Overview of Preemption
 Consumer Product Safety
Statutes and Preemption
 The State of the States
 What To Expect, When to
Participate
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New TSCA: Basic Provisions
and Overview of Preemption
Martha Marrapese
[email protected]
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The Toxic Substances Control Act (TSCA)
• Purpose of Law:
To require the review,
testing, reporting and regulation for new and
existing industrial chemicals.
• First passed into law in 1976 as Public Law
(P.L.) 94-649; Significantly amended June 22,
2016 as P.L. 114-182.
• Originally intended to cover chemicals that
•
were not regulated as pesticides or foods,
food packaging, drugs, cosmetics.
Consumer product ingredients fall in TSCA’s
definition of a chemical substance (15
U.S.C. § 2602(2)).
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Principal Sections of TSCA (for Today)
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Section 3 – Definitions
Section 4 – Testing
Section 5 – PMNs and Significant New Uses
Section 6 – “Existing” Chemicals
Section 8 – Recordkeeping and Reporting
Section 12 – Exports
Section 13 – Imports
Section 14 – Confidential Business Information (CBI)
Sections 15/16 – Penalties
Section 18 – Preemption
Section 26 – Fees, Administration
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Old TSCA Criticisms
•
Difficult and costly for EPA to make findings necessary
to promulgate test rules or negotiate voluntary consent
agreements with industry to test chemicals.
• Testing has been required for less than 300
chemicals.
 New chemical review process was not transparent.
• EPA was not required to publish findings of reviews.
 Safety standard for regulating existing chemicals set
too high a hurdle for EPA to act.
• Harmful chemicals were being left on the market.
• Agency had to select the “less burdensome”
approach to regulate.
• Entire burden on the agency.
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Fast Forward to 2016: Congress’ Response
 Greater Authority to Collect Information and Require
Testing:
• EPA now CAN require testing by order or consent
agreement, and has explicit authority to obtain
exposure information
• To review PMN/SNUN, perform 6(b) risk evaluation,
to implement 5(e), 5(f), or 6(a) requirement, or under
12(a)(2) (export exemption)
• Must identify need for information, explain why order
used
• Expands “serious or widespread harm” testing
authority beyond cancer, gene mutations, and birth
defects
 EPA generally must “tier” test, and reduce vertebrate
testing to the extent practicable
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New Section 5 – New Chemicals
 Premanufacture notification (PMN) under
section 5 is similar • Still submit PMN at least 90 days before
commencing substance or activity
 EPA must determine if the substance is
likely not to present an unreasonable risk
•
•
•
•
Based on conditions of use
No consideration of cost or non-risk factors
Must include risk to susceptible populations
If workplace issues proposed to be regulated,
Agency must first consult with OSHA “to the
extent practicable”
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PMN Actions
 “(A)” determination (“presents”):
• Must use § 5(f) and may issue order
 “(B)” determination (“insufficient,” “may
present,” or exposure-based):
• Must use § 5(e) and must issue order
 “(C)” determination (“not likely”):
• May commence non-exempt production
– Even before review period ends!
 Safeguards (EPA has to return fees) against
undue delays in review process now.
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“Articles”
 Can require Significant New Use Rule
(SNUR) for chemicals in “articles” only if
EPA makes affirmative finding in a rule
that reasonable potential for exposure to
chemical through article (or category of
articles) justifies notification.
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New Section 6 – Existing Chemicals
 “No “unreasonable risk of injury to health or
the environment” criterion is preserved.
 Adds the need to consider –
•
•
•
•
•
Conditions of use.
Volumes and exposure.
Consideration of susceptible populations.
Proximity to significant sources of drinking water.
Persistence and bioaccumulation.
 No consideration of costs or other non-risk factors
in prioritization or safety determinations.
 Least burdensome” restriction requirement for
risk management of existing chemicals is gone.
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Inventory “Reset”
 Within 1 year EPA must issue rule
requiring producers (and “may” require
processors) to notify EPA within 180 days
of each existing substance produced
within 10 years prior to enactment.
• Reported substances = “active”
• Non-reported = “inactive”
– EPA cannot delist, or require PMN for inactive upon
change to active
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Existing Chemicals Mandate
 EPA must make 20 low priority substance
designations within 3.5 years.
 EPA also must be conducting risk evaluations
on 20 high priority substances.
• Only 50 percent of chemicals in risk evaluation have
to be 2014 TSCA Work Plan chemicals.
 System designed to encourage voluntary
nominations for risk evaluation.
• At least 25 percent (and no more than 50 percent)
of the risk evaluations must consist of voluntary
requests.
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Statutory Priorities – Existing Chemicals
 Preferred High Priority: § 6(b)(2)(D). (1) score 3 for
persistence and bioaccumulation; (2) known human
carcinogen; and (3) high acute and chronic toxicity.
• Cadmium and cadmium compounds
• Chromium and chromium compounds
 Mercury compounds: § 8(b)(10).
• No later than April 2017 and every three years thereafter,
EPA must publish in FR inventory of Hg supply, use, and
trade.
• Must recommend actions to further reduce use, EPA has
two years to develop reporting rule.
• Hg export ban beginning 1/1/2020 for:
• Hg(I) chloride, Hg(II) oxide, Hg(II) sulfate, Hg(II)
nitrate, Cinnabar, or Hg sulphide
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Statutory Priorities – Existing Chemicals (con’t)
 PBTs Scoring High/moderate: § 6(h)(1). EPA must conduct
exposure and use assessment but not a risk evaluation. Possible
candidates:
• Pigment Yellow 83 (Butanamide, 2,2'-[(3,3'- dichloro[1,1'- biphenyl]4,4'-diyl)bis(azo)]bis[N- (4-chloro-2,5 - dimethoxyphenyl)-3-oxo-)
(CASRN 5567-15-7)
• Decabromodiphenyl ethers (DecaBDE) (CASRN 1163-19-5)
• Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,5,5- tetramethyl-2naphthalenyl)- (CASRN 54464-59-4)
• Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,8,8- tetramethyl-2naphthalenyl)- (CASRN 54464-57-2)
• 4-tert-Octylphenol (4-(1,1,3,3- Tetramethylbutyl)- phenol) (CASRN
140-66-9)
• Pentachlorothio-phenol (CASRN 133-49-3)
• Phenol, isopropylated, phosphate (3:1) (iPTPP) (CASRN 68937-41-7)
• 2,4,6-Tris(-tert- butyl)phenol (CASRN 732-26-3)
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New Section 14 - Confidential Information
 New §14 completely replaces old §14
 CBI preserved but with more
exceptions for disclosure
 Establishes more detailed
requirements, procedures, timelines
 Substantiation required for protecting
chemical identity and claims have to
be renewed every 10 years.
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Higher Penalties and Fees
 Civil: Maximum penalty $25,000  $37,500
 Criminal: Maximum penalty $25,000  $50,000
• Persons that know that violation places individual in
imminent danger of death or serious bodily injury subject
to fine of $250,000, imprisonment not more than 15
years, or both
• Organizations – also subject to fine not more than $1
million
 Fees to defray 25% of costs (or $25 million,
whichever lower) of administering §§4,5,6 and
CBI under §14.
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Other Changes
 In carrying out §§ 4, 5, and 6, EPA must use
“best available science” and make decisions
based on “weight of the scientific evidence”
 Within 2 years EPA must develop policies,
procedures and guidance needed to carry out
Act and must review adequacy at least every 5
years
 Must establish Science Advisory Committee
within 1 year
 Prior TSCA actions preserved. Pending ones?
 If EPA has published completed risk assessment
before enactment, can proceed and regulate
under new §6
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What has NOT Changed?
 Pre-existing definitions
 §4 data compensation provisions for testing
 TSCA §8(b) Inventory
• Retained, with confidential and “public” portions
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§ 8(a) and (d) reporting rules
§ 8(c) Allegation recording
§ 8(e) Substantial risk notification
§12 Export notification and export-only
exemption
 §13 Import certification requirement
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New TSCA and Consumer Products
 The new safety standard includes conditions of
use and susceptible populations.
 EPA can regulate the use of chemical
substances in consumer products, e.g., labeling
& warnings.
 Ingredients in use now will need to be reported
in near future as active in commerce, and EPA
may issue section 8 information collection
requests similar to prior proposal on cadmium.
 Preemption of state laws presents a complex
landscape for consumer products - and will be
the focus of the remainder of the presentation.
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New TSCA Preemption
 Except As Otherwise Provided, New And Existing
State Laws Cannot –
• Collect information (e.g., testing) already required by
EPA.
• Prohibit/restrict a high priority substance once a final
section 6(a) rule is promulgated.
• Duplicate notification for a use already subject to EPA
notification.
 Grandfathers Existing State Laws
• State laws enacted by April 22, 2016, remain in effect –
but what happens if there is a potential conflict in future
with EPA actions?
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Grandfather Provision § 18(e)
“Nothing in this Act . . . shall be construed to preempt or
otherwise affect the authority of a State or political
subdivision of a State to continue to enforce any action
taken or requirement imposed or requirement
enacted relating to a specific chemical substance before
April 22, 2016, under the authority of a law of the State
that prohibits or otherwise restricts manufacturing,
processing, distribution in commerce, use, or disposal of
a chemical substance . . .(or any action taken pursuant to
a State law that was in effect on August 31, 2003).
(emphasis added).*
* language in parens intended to have same effect as CPSIA
section 231(b), and grandfathers (preserves) Proposition 65.
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New State Laws § 18(b)
 “Preemption Pause” on new state laws so
EPA has time to act –
• Starts when scope of risk evaluation is
defined.
• Ends when risk evaluation is published or
3.5 years passes after risk evaluation is
initiated.
• States have an additional 18 months after
scope of risk evaluation is defined to
propose/finalize new action.
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New State Laws (con’t)
 Also preempted by final EPA action.
• No Unreasonable Risk: When EPA
finds that a high priority chemical
meets the safety standard.
• Unreasonable Risk And Adoption of
6(a) Measures: When EPA enacts a
rule to regulate a chemical that does
not meet the safety standard.
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States May Continue To –
 Regulate substances EPA designates as low
priority (although likelihood assumed to be low
it cannot be discounted).
 Adopt laws authorized by another federal law.
§18(d)(1)(A)(i).
 Impose reporting, monitoring, or “other
information obligation” not otherwise required
by TSCA or another federal law.
§18(d)(1)(A)(ii).
• Implications for labeling, warnings, and use
instructions under other laws.
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And States May Continue To –
 Enact air, water, hazardous waste, and
disposal laws. §18(d)(1)(A)(iii).
• May restrict a chemical.
• But cannot directly conflict with action
taken by EPA under TSCA.
 Enact requirements equivalent to EPA’s
and co-enforce. §18(d)(1)(B).
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State Preemption Waivers § 18(f)
 State Waivers
• Discretionary:
– Applies where EPA has taken final action on chemical.
–
–
–
–
Compelling conditions;
No undue burden on interstate commerce;
Does not cause violation of federal law; and
Based on best available science/weight of scientific
evidence.
• Mandatory:
– Applies during “preemption pause”.
–
–
–
–
No undue burden on interstate commerce;
Does not cause violation of federal law; and
Based on peer-reviewed science OR
State takes action within 18 months of prioritization initiation.
» Enacts statute or proposes/finalizes administrative rule.
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Preemption Provisions of Key
Consumer Product Statutes
Sheila Millar
[email protected]
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CPSIA
 Amended Consumer Product Safety Act (CPSA)
• Enacted August 14, 2008, and imposed many new
obligations and requirements.
 Major Focus on Children’s Products:
• Retailer specifications and requirements.
• Requires third-party testing (mechanical + chemical
safety).
• Development of a standard of care for manufacturing,
testing, traceability.
• Requirements for tracking labels.
• Makes ASTM F 963 mandatory; requires safety
standards for durable infant and toddler products
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Current CPSC Preemption
 §§ 25 and 26 (a)–(c) of Consumer Product Safety Act
and § 231 of CPSIA
• Identical state requirements allowed:
When a consumer product
safety standard is in effect, no State or political subdivision can establish or continue to
enforce a safety standard or regulation designed to deal with the same risk of injury
unless such requirements are identical to the Federal standard.
• More stringent requirements allowed for products used
by governmental entities: The Federal Government or a State or
political subdivision may establish or continue to enforce a performance requirement
that provides a higher degree of protection from such risk of injury, for products used by
those governments (not for the general public).
• State waiver process:
Upon application of a State or political subdivision,
the Commission may by rule allow a proposed safety standard or regulation that
provides a significantly higher degree of protection and does not unduly burden
interstate commerce.
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CPSIA – Toy Safety Standard
 Consumer Safety Specifications for Toy Safety
(ASTM F963–11): Adopted as the presumptive
consumer product safety standard for toys.
 In relation to toxic substances: CPSC was
required by statute to assess adequacy of ASTM
F 963 for requirements, safety labeling, and test
methods for toxic substances.
 Grandfathering: State or political subdivision
could file with CPSC 90 days after enactment of
CPSIA to preserve their own safety
requirements.
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Current FHSA Preemption
 FHSA § 18:
•
Identical state requirements allowed:
•
More stringent requirements allowed for products used
by governmental entities: The Federal Government or a State or
When a cautionary
labeling/packaging requirement is in effect under §§ 2(p) or 3(b), no State or
political subdivision can establish or continue to enforce a cautionary/labeling
standard or regulation designed to deal with the same risk of illness or injury
unless such requirements are identical to the Federal standard.
political subdivision may establish or continue to enforce a requirement
that provides a higher degree of protection from such risk of illness or injury,
for substances used by those governments (not for the general public).
•
State waiver process:
Upon application of a State or political
subdivision, the Commission may by rule allow a proposed safety standard or
regulation that provides a significantly higher degree of protection and does
not unduly burden interstate commerce.
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Current FFA Preemption
 FFA § 16:
• Identical state requirements allowed:
When a flammability
standard/regulation under the FFA on fabric, related material, or product is
in effect, no State or political subdivision can establish or continue to
standard/regulation designed to deal with the same risk of occurrence of
fire unless such requirements are identical to the Federal standard.
•
More stringent requirements allowed for products
used by governmental entities: The Federal Government or
a State or political subdivision may establish or continue to enforce a
requirement that provides a higher degree of protection from such risk of
fire, for fabrics, related materials, or products used by those governments
(not for the general public).
•
State waiver process:
Upon application of a State or political
subdivision, the Commission may by rule allow a proposed safety standard
or regulation that provides a significantly higher degree of protection and
does not unduly burden interstate commerce.
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Selected State Laws
Nathan Cardon
[email protected]
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Example 1: California
 California Safe Drinking Water and Toxic
Enforcement Act of 1986 (Prop 65)
•
•
•
•
•
Cancer + reproductive effects warning labels
Not preempted by CPSIA
Bounty hunter suits continue
Flame retardant focus now
Governor promised changes, but reform
proposal misguided
– More detailed warnings
– NO meaningful reductions in bounty hunter suits
– DTSC work plan covers chems used in many categories
of consumer goods
• Grandfathered in CPSIA and TSCA Reform
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Example 1: California (con’t)
 California Safer Consumer Products
• Aimed at consumer products, not just
children’s products
• Initial priority products
– Spray Polyurethane Foam (SPF) Systems
containing unreacted diisocyanates
– Children’s Foam Padded Sleeping Products
containing TDCPP
– Paint and Varnish Strippers, and Surface Cleaners
with methylene chloride
• Formal rulemaking to begin late
summer/early fall 2016
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Example 1: California (con’t)
 Under DTSC’s SCP 2015–17 Work Plan, finalized in
April 2015, many categories of products are under
consideration (e.g., beauty/personal care,
building/household products, cleaning, clothing, office
machinery).
• DTSC will use screening criteria and prioritization criteria to
identify product-chemical combinations to be considered for
future SCP regulation.
• More workshops starting this latter half of 2016 to discuss
product categories and potential Priority Products.
 Alternatives assessments required for Priority
Products.
 State was supposed to be the big mover in green
chemistry, but rulemaking has been slow, impact much
less than other state laws.
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Example 2: Washington State
 Children’s Safe Products Act (CSPA) focus
is on reporting of listed chemicals in
children’s products. Alternatives
assessments are permitted but not
mandatory.
• No current action or requirement to restrict a
listed chemical taken before April 22, 2016.
• State may use 18-month grace period or waiver
process while EPA deliberates on a high priority
chemical
• If State does choose to act, EPA final action
would preempt such an action or requirement.
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Example 3: Maine
 Under the Act to Protect Children’s Health
and the Environment from Toxic Chemicals
in Toys and Children’s Products, Maine lists
chemicals of high concern and calls on
companies to substitute safer alternatives
when feasible. The intentional inclusion of
certain high priority chemicals (e.g., BPA,
DEHP) requires reporting for certain product
categories. Maine’s law imposes an
alternatives assessment obligation on
affected companies.
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Example 4: Vermont
 Under the state’s green chemistry law, listed chemicals
used children’s products are required to be reported to the
state.
• The law includes a working group to advise on risk.
• The state Department of Health has imposed a $200 per
chemical reporting fee.
• The reporting website was just unveiled, and, after
amendment this past legislative session, reports will first be
due on January 1, 2017, with the next reports due August 31,
2018, and biennially thereafter.
• The law permits the prohibition of sale of children’s products
containing listed chemicals after referral to the working group,
or labeling requirements.
 Alternatives assessment not required initially, but they will
be relevant to future rulemakings on chemical-specific
restrictions.
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Example 5: Oregon
 Oregon has a list of chemicals of high concern
for use in children’s products. Requires
manufactures to report products containing
identified chemicals present at greater than de
minimis levels. After submitting the third
biennial report, manufacturers required to seek
a waiver or remove the substance from the
reported children’s product.
 Current action or requirement to restrict a listed
chemical taken before April 22, 2016?
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Example 6: NY County Bans
 County-level children’s product chemical
content limit
• Albany County, which adopted limits lower
than ASTM, before litigation led by the Safe
to Play Coalition
– A new law brought in most ASTM F 963 toy limits
and deferred to preemptive state or federal
requirements
– Limits in other standards for other products are not
preemptive, so the limits continue to apply outside
of the toy space
– Settlement of lawsuit remains pending
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Example 6: NY County Bans (con’t)
 County-level zero-content bans for children’s
products
• Westchester County’s zero-content limits –stayed
by the county executive pending Albany County
settlement
• Rockland County has adopted a revised version of
its original zero-content ban, instead stating that
covered products must comply with state and
federal law
• Suffolk County adopted limits, but they are lower
than F963 for mercury and antimony (40 ppm
versus 60 ppm), and has recently warned of
enforcement against retailers later this year
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Roundtable Discussion:
What To Expect, When to
Participate
Sheila Millar
Partner
[email protected]
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Martha Marrapese
Partner
[email protected]
Keller and Heckman LLP
Nathan Cardon
Associate
[email protected]
46
State v. EPA v. Other Federal Standards
 When should consumer product safety
industries engage with EPA?
 What is the interplay between EPA
actions and other federal requirements?
 What state requirements are likely to be
preempted?
 How can consumer product safety
standards or rules be used to fight state
limits?
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In Summary
 There is a competing patchwork of state
laws currently sizing up the new federal
program.
 TSCA Reform should slow the pace of
new state laws on chemicals but many
questions about scope of new limits on
chemicals will arise under existing state
measures
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In Summary
 CPSIA preemption is stronger with respect to toy
standards than TSCA because it preempts both
existing and new state laws. FHSA preemption is
strong with respect to chemical hazard labeling
(excluding Prop 65).
 Could CPSIA standards conflict with EPA due to
TSCA requirement to evaluate susceptible
populations?
• Coordination provisions of TSCA, impossibility
to comply with both, deference to more specific
law and more recent law will factor in, as will
underlying science.
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In Summary
 It will take time for TSCA preemption
provisions to have a real impact but the
potential is there, particularly in the case of
final EPA actions having preemptive effect
on new state laws/new actions under
existing laws.
 Proactive and defensive use of all available
federal options should be considered
 Litigation will almost certainly be necessary
to sort out the legal landscape on
preemption.
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