TSCA Reform - Amazon Web...

© Intertek 2016. All rights reserved.

June 22, 2016

Pratik Ichhaporia, Ph.D.

Director – Technical Services,

Intertek

TSCA Reform

Quin Dodd

Principal, Law Offices of Quin

D. Dodd, LLC

2 © Intertek 2016. All rights reserved.

Agenda

Overview & Timeline

Definitions

Key Requirements

Confidential Business Information

Preemption

Practical Considerations & Key Takeaways

01

02

03

04

05

06


Overview

01


What is TSCA?

Toxic Substances Control Act

• Passed in 1976 by Congress and

signed by President Gerald Ford in

to law

• Regulates chemicals in commerce,

existing and new, to protect human

health and the environment

• Regulates the use of any

chemical(s) that present “an

unreasonable risk of injury to human

health or environment”


Why TSCA Reform?

TSCA Shortcomings:

• 60,000+ chemicals grandfathered in

• Development of information on

existing chemicals

• Restrict/ban chemical(s) believed to

pose risk to human health or

environment

o Asbestos case

• State legislative activity

• Australia, Asia, Canada & EU –

chemical management


HR2576: Overview and Timeline

Frank R. Lautenberg Chemical Safety for the 21st Century Act

Complexity to balance State, industry and public advocacy group interests.

Effective date

TSCA Reform vs. EU REACH


Definitions

02


Definitions

Chemical substance: any organic or inorganic

substance of a particular molecular identity,

including:

i. any combination of such substances occurring

in whole or in part as a result of a chemical

reaction or occurring in nature, and

ii. any element or uncombined radical

Exceptions:

a) Mixture

b) Pesticide per Federal Insecticide, Fungicide,

and Rodenticide Act (FIFRA)

c) Tobacco or tobacco products

d) Nuclear material or byproduct per Atomic

Energy Act (AEA)

e) Firearms, shells & cartridges

f) Food, food additive, drug, cosmetic, or device

per Food, Drug and Cosmetic Act (FD&C)


Definitions

“Mixture” means any combination of two or more chemical substances if the

combination does not occur in nature and is not, in whole or in part, the result of a

chemical reaction; except that such term does include any combination which

occurs, in whole or in part, as a result of a chemical reaction if none of the chemical

substances comprising the combination is a new chemical substance and if the

combination could have been manufactured for commercial purposes without a

chemical reaction at the time the chemical substances comprising the combination

were combined.

“Conditions of use” means the circumstances, as determined by the Administrator,

under which a chemical substance is intended, known, or reasonably foreseen to be

manufactured, processed, distributed in commerce, used, or disposed of.

“Potentially exposed or susceptible subpopulation” means a group of individuals

within the general population identified by the Administrator who, due to either

greater susceptibility or greater exposure, may be at greater risk than the general

population of adverse health effects from exposure to a chemical substance or

mixture, such as infants, children, pregnant women, workers, or the elderly.


Key

Requirements

03


Chemical Substance – Evaluation Process


Inventory Reset (Sec. 8)

Final rule requiring manufacturer to submit information on chemicals used

during past 10 years – 1 year from date of enactment

• Information to be submitted by manufacturer within 180 days from

final rule publication date

EPA to publish active list (w/o confidential portion) based on information

received above, and inactive list of chemicals

• Must notify before use of inactive chemicals

Confidential Business Information (CBI) claim review plan: establish within

1 year

• CBI to be substantiated and expires after 10 years

• Review all claims within 5 years, which may be extended by 2

additional years if justified

Latest Chemical Data Reporting reported chemicals serves as interim

active list of substances


New Chemicals or Significant New Uses (Sec. 5)

Manufacturer must submit premanufacture notice (PMN) or significant new

use notice (SNUN) 90 days prior to commencing activity

EPA has to make an affirmative determination: ‘presents’ / ‘may present’ /

‘not likely’ to present unreasonable risk of injury

• No consideration of cost or non-risk factors

• Fee refunded if EPA fails to make determination by end of review

period. Even though fee is refunded, EPA still has to make the

determination

Article: Notification required only if affirmative finding that “reasonable

potential for exposure to the chemical substance through the article or

category of articles subject to the rule justifies notification”

Chemical of concern list: EPA may, by rule, compile and update list of

chemicals that EPA has found presents or may present an unreasonable

risk of injury to health or the environment

Workplace exposure – consult with OSHA


Existing Substances – Prioritization (Sec. 6)

Removes the “least burdensome” requirement

Prioritization: risk based screening without consideration of cost

• High priority substance: may present an unreasonable risk of injury

due to potential hazard and a potential route of exposure

• Low priority substance: Does not meet high priority substance criteria

above

High priority substance designation triggers risk evaluation (RE)

Priority designation process – promulgate rule establishing process

between 9 months to 1 year. Process shall include:

• Opportunity to submit relevant information by interested parties. 90

days for comment, which may be extended by another 3 months

• Publish proposed priority designation for 90 day public comments


Existing Substances – Risk Evaluation (Sec. 6)

To determine if chemical presents an unreasonable risk of injury

• Not based on cost or other non-risk factor

• Takes in to account susceptible subpopulation under conditions of use

RE process: EPA required to establish it within 1 year

Deadlines:

• Within 180 days – 10 RE being conducted on chemicals drawn from TSCA

Work Plan

• Within 3.5 years – 20 RE being conducted on high priority substances (at least

50% of RE from TSCA Work Plan), and 20 chemicals designated as low

priority

Manufacturer requested RE:

• Between 25% to 50%

• Full cost paid by manufacturer (50% if on TSCA Work Plan)

• No preemption pause


Existing Substances – Risk Evaluation (Sec. 6)

Publish RE Scope – Within 6 months of initiation of RE

• For high priority chemicals: within 12 months from initiation of

prioritization process

• For RE of first 10 chemicals on TSCA Work Plan chemicals – within 3

months from initiation process

RE completed within 3 year from initiation of RE

• May be extended by 6 months

If RE outcome is that chemical presents unreasonable risk:

a) Within 1 year – propose rule for risk management

b) Within 2 years – Publish final rule

c) Deadlines in a) and b) can be extended up to 2 more years, under

certain circumstances


Existing Substances – Risk Management (Sec. 6)

If RE outcome is that chemical presents unreasonable risk:

a) Within 1 year – propose rule for risk management (RM)

b) Within 2 years – publish final rule

c) Deadlines in a) and b) can be extended up to 2 more years, under

certain circumstances

Compliance requirement under the rule should become effective as soon

as practicable, but not later than 5 years from date of rule promulgation

PBT chemicals on TSCA Work Plan, which meet 1 & 2 below – propose

rules within 3 years; final rule within 18 months after proposing a rule

1. For chemical (not a metal/metal compound) that is toxic and with

respect to persistence and bioaccumulation score high for one and

high or moderate for other

2. Exposure under conditions of use is likely


Existing Substances – Risk Management (Sec. 6)

Requirements for rule:

• Effect on health and environment and magnitude of exposure

• Benefits of substance

• Cost benefit of proposed/final regulatory action and 1 or more alternative

regulatory action(s) considered by EPA

• Consideration of alternatives

• Articles / Category of articles: prohibition/restriction to be applied only to

address identified risk from exposure to chemical from the article so that

substance does not pose unreasonable risk of injury

• Replacement parts: “complex durable goods” and “complex consumer

goods” replacement parts manufactured prior to effective date of rule

exempt, unless EPA find they contribute significantly to the identified risk

• Exemptions: national economy, national security, or critical infrastructure;

no technically or economically feasible safer alternative


Testing (Sec. 4)

More flexibility as testing by rule, order or consent agreement, if needed

Tiered testing

Other Federal agencies can request EPA to require toxicity/exposure data

Priority list:

• Developed by 10 government agency members committee

• Within 9 months publish in the federal register; every 6 months after

publication, the list to be reviewed and revised

• Within 12 months of a chemical being added to this list, EPA to issue

rule/order/consent agreement for testing requirements

Animal testing

• Reduce, refine and replace, to extent practicable

• Alternative testing methods

• Industry encouraged to use alternative testing for voluntary submissions


Penalties (Sec. 16)

Civil:

• Increased from not more than $25K to not more than $37.5K per violation

Criminal:

General – for knowing or willful violation; in addition to or in lieu of Civil

penalty

• Increased from not more than $25K to not more than $50K for each day

of violation,

AND/OR

• Not more than 1 year imprisonment

Imminent danger of death of serious bodily injury

• Person: Not more than $250K AND/OR not more than 15 years

imprisonment

• Organization: Not more than $ 1 million for each violation; this is

notwithstanding the Civil penalty that may be levied


Fees (Sec. 26)

Establish “TSCA Service Fee Fund”

Lower fees for small businesses

Fees

• Up to 25% of the cost for carrying out Sec 4, 5, and 6, but capped at $25

million

• Risk evaluation under 6(b) per request by manufacturer – full cost

o If substance on TSCA Work Plan – 50% of cost

Review and adjust fees beginning w/ FY 3 years after date of enactment and

every 3 years thereafter

Fee authority terminates after 10 years, unless reauthorized by Congress


Notifications and Guidance (Sec. 26)

Notify Environment & Public Works (EPW) and Energy & Commerce (E&C)

committees, within 6 months from date of enactment:

1) Estimate of RE EPA can conduct and resources required

2) Capacity to promulgate rules based on RE

3) Resources for 1 & 2

4) Review and resubmit plan at least every 5 years

Annual Plan: publish at beginning of each calendar year

• Inform public regarding RE expected to be initiated or in progress

• Status of each RE that was initiated but not complete

• Change, if any, in RE timeline

Establish science advisory committee of chemicals within 1 year; meet once at least

every 2 years

Policies, procedures and guidance: Develop within 2 years for implementation, review

and revise at least every 5 years

Guidance to develop and submit draft RE – within 1 year after enactment


Confidential

Business

Information

04


TSCA Reform: Confidential Business Information (CBI)

CBI (including trade secrets) currently generally protected indefinitely under

TSCA

Reform limits somewhat and requires substantiation and reassertion for some

types:

• Companies may assert protection from public disclosure of CBI based on various

criteria – MUST be substantiated up front (not merely asserted)

• No substantiation required for obviously exempt information/data

• Resubstantiation required at least every 10 years (or protection expires)

Within 5 years after Active Inventory compiled, existing CBI claims (including of

chemical identity) must be reviewed by EPA of all “active” substances – upwards

of 20,000


TSCA Reform: CBI

Not Protected from 3rd Party

Disclosure

• General Manufacturing and Use Info

• Banned/phased-out Chemicals

• Health and Safety Data

o Info to health providers to diagnose/treat

condition

o First responders

Protected From Disclosure Upon

Designation and (where required)

Substantiation

• Chemical Identity

• Chemical Structure/Formula

• Chemical Specification Process Info

• Mixtures

• Customer Lists

• Mixed CBI/Non-CBI


Preemption

05


TSCA Reform: State Law Preemption

General

Grandfathered State Laws and Actions

EPA Preemption of Non-Grandfathered State Laws/Actions

State Preemption Waivers

Practical Considerations for Consumer Products


State Law Preemption: General

Constitution Supremacy Clause: Article IV, Clause 2:

“This Constitution, and the Laws of the United States which shall be made in Pursuance

thereof; and all Treaties made, or which shall be made, under the Authority of the United

States, shall be the supreme Law of the Land; and the Judges in every State shall be

bound thereby, any Thing in the Constitution or Laws of any State to the Contrary

notwithstanding.”

Types of Preemption:

• Express: (“no state may enact or enforce any law to . . . “) – TSCA reform explicitly

does NOT preempt existing or many new state laws/regulations

• Implied:

o Conflict (enforcement of state law would be in conflict, or impossible, with enforcement of

federal law) – This could be key issue with states under new TSCA

o Field (federal law is so pervasive that its presumed states can’t act) – Not likely to come into

play here but could


TSCA Preemption of State/Local Laws/Actions

Under TSCA, EPA actions (rules or orders) generally only preempt state laws

that either:

• Cover the same scope of chemical and use of the chemical (in a non-identical way); or

• Are otherwise in conflict with the EPA action (difficult or impossible to comply with both)

NO preemption for state reporting requirements (e.g., WA, OR, ME, VT) (unless

duplicative or in conflict with EPA order/rule to provide or produce

information/data – WA and similar existing/new state reporting laws fully in force)

NO preemption for state laws to restrict chemicals to address water or air quality

or hazardous waste use/disposal laws (so long as no direct conflict with EPA) –

Could be BIG window for states to act

NO preemption of any state tort/contract causes of action (trial lawyers can still

sue for personal injury due to chemical exposure) – still possible that conflict

preemption trumps this and likely to be litigated

NO preemption for state laws/regs identical to those of EPA (and can co-enforce)

NO preemption for low priority chemicals (although doubtful states will act)

NO preemption for state laws enforcing other federal laws (e.g., OSHA)


State Law Preemption: Grandfathered Laws/Action

Does not preempt state laws or actions based on those laws (e.g., regulations

or enforcement) enacted prior to September 1, 2003

• CA Prop 65 grandfathered

• Expressed congressional intent is to grandfather CA Green Chemistry, but does it?

Does not preempt state laws (framework statutes) enacted prior to April 22, 2016

• “States” includes political subdivisions of states (e.g., NY counties)

Big question is what happens if there is a direct conflict between new EPA

rules/orders and grandfathered state laws/actions under those laws?

• Legal uncertainty as to whether Congress can waive entirely the Supremacy Clause

(as Sen. Boxer and others have claimed occurred here)


State Law Preemption: Non-Grandfathered Laws/Actions

Preemption “pause” (temporary preemption) for a specific chemical substance

begins when EPA establishes scope of risk evaluation and ends when RE is

finalized or 3.5 years from initial EPA action, whichever is sooner

• Scope doc will cover uses and risks and de facto defines limits of state preemption,

so pause is really only effective at stopping state action for broadly scoped EPA risk

evaluations

• Note that after risk evaluation is finalized and before risk management action is

taken by EPA, states may also act (even if only for that two-year or so period)

Permanent preemption (according to scope) once EPA issues final:

• Order (banning or restricting)

• Rule

o Includes testing rules and significant new use notification rules (except low priority and Prop

65)

Consent Agreement

• Determination of no unreasonable risk

• Determination that regulated chemical meets EPA safety standard

KEY here is scope of EPA risk evaluation and eventual risk management action!


State Law Preemption: State Waivers

Discretionary (EPA may grant) if:

• Compelling state interest/”conditions”

o Unclear what this means: state-specific?

• No undue burden on interstate commerce

• Do direct conflict with EPA (final) action/other federal law

• Best available science/weight of scientific evidence – burden on state to

demonstrate so may discourage “ban it because we don’t like it” petitions to EPA

Mandatory (EPA must grant DURING PREEMPTION PAUSE):

• State law/action w/in 18 months of initiation of chemical being listed as high priority

OR

• No direct conflict with existing federal law/regulations

• No undue burden on interstate commerce

• Some science-based rationale for state law/regulation (lower than for discretionary)


TSCA Reform: Judicial Review

Lawsuits Possible for Most Key EPA decisions:

- General rules (e.g., prioritization process)

- Chemical-specific determinations (prioritization; scope of risk evaluation;

risk evaluation (e.g., no unreasonable risk); final risk management

action)

Standard of Review:

- Arbitrary and capricious for most EPA final actions

- “Substantial evidence” for discretionary state preemption waivers

Likely to be significant litigation over various aspects of general and chemical-

specific rules and determinations by EPA, owing to fact that both industry and

NGOs have claimed significant victory, including on preemption of state laws


Practical

Considerations

and Key

Takeaways

06


Practical Considerations

Types of EPA Actions Possible:

• Bans of chemicals

• Bans of chemical/product combinations

• Chemical use restrictions

• Chemical use bans

• Use instruction/warning label mandates

• Workplace restrictions on chemicals/exposures/products containing chemicals

o Personal Protective Equipment (PPE) mandates


Practical Considerations

EPA Limitations under TSCA:

• EPA must consider economically feasible alternatives to a ban on a chemical

• EPA generally can’t restrict a chemical if already regulated for that use and risk by

another federal agency (e.g., CPSC regulation of lead in children’s products)

• Some replacement parts exempt (complex and durable products)

• Exemption from EPA regulation for “critical or essential uses” of chemicals

• Exemption for national economy, security or critical infrastructure

• Exemption for use that provides a “substantial benefit to health, environment or

public safety” (compared to alternatives)


TSCA Reform: Key Take-Aways

TSCA Reform mostly about 3 key issues:

1. Elimination of “least burdensome alternative” requirement – Big win for

NGOs

2. Preemption – Win (?) for industry

3. TSCA Inventory Reset – huge undertaking and will reset the basis for

EPA action


TSCA Reform: Key Take-Aways

Key Timeline/Events to Watch:

• All existing state laws will remain in effect (CA, OR, WA, ME, VT, etc).

• First 10 high priority chemicals (and low priority): late this year (6 months)?

• Look especially for “preferred high priority” chemicals (expedited review):

o Persistent, Bioaccumulative and Toxic (PBT)

o Known human carcinogen

o High acute and chronic toxicity

o Specific treatment of mercury (inventory of supply, use and trade; expand export ban; must

reduce overall use)

• Risk evaluation scope for first 10 high priority/risk evaluation rule – this time next

year?

• Completion of risk evaluation for first 10 high priority and subsequent reviewed

chemicals – two years from now?

• Final risk management rules for up to 40 chemical substances – 3+ years and going

forward?

• Enforcement of risk management rules – 5+ years?


TSCA Reform: Key TBDs

• First 10 high priority chemicals – will be taken from existing EPA Work Plan:

https://www.epa.gov/sites/production/files/2015-

01/documents/tsca_work_plan_chemicals_2014_update-final.pdf

o Criteria for prioritization will be key to watch (e.g., endocrine disrupting; carcinogenic;

bioaccumulative; etc.)

o Likely suspects include (relevant to products) phthalates; BPA; formaldehyde; heavy metals;

flame retardants could be wild card

• Inventory reset process

• Risk evaluation criteria/process

o Practical meaning of “unreasonable risk to health or environment”

• Risk management criteria/process/actions

o Degree to which EPA will focus on product-specific chemical restrictions – must find that chem

is significant source of exposure – not always easy: role for CPSC here??

o Degree to which EPA will focus on specific sub-populations (i.e., children’s products

• Public input/litigation potential at various stages of implementation

o Both NGOs and industry have opportunities here

• Degree to which states will avail themselves of automatic (must act within 18

months of scope being issued) or discretionary waiver process

https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf






TSCA Reform: Other Key Unknowns

Regulating “articles” (products) fairly new territory for EPA – Will EPA grant

complete deference to CPSC and other agency regulations?

Degree to which EPA aggressive on data disclosure/production orders TBD

States reaction/preemption litigation by states

Despite rather narrow preemptive effect, TSCA may have dampening effect on

potential new state laws/regulatory actions (e.g., CA Green Chemistry; OR Toxic

Free Kids Act)

Key Recommendation: Follow closely TSCA implementation developments

(especially high priority chemicals) but continue chemical management policies

and processes to comply with other federal, state, local and supply chain

chemical restrictions/reporting/labeling requirements


Pratik Ichhaporia, Ph.D.

Director, Technical Services –

Products, Intertek

P: 847-212-8273

E: [email protected]

Quin Dodd

Principal, Law Offices of Quin D.

Dodd, LLC

E: [email protected]

Contact Information

mailto:[email protected]

mailto:[email protected]

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