The New TSCA: What Does It Mean For Consumer Products … New TSCA and CPC... · 2016. 7. 14. ·...

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The New TSCA: What Does It Mean ForConsumer Products Companies?

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Speakers

Sheila MillarPartner

[email protected]

Martha MarrapesePartner

[email protected]

Nathan CardonAssociate

[email protected]


Preliminary word

This presentation provides information aboutthe law. It is not intended to provide legaladvice.

Legal information is not the same as legaladvice, which involves the application of law toan individual's specific circumstances.

The interpretation and application of the law toan individual’s specific circumstance dependson many factors.

The information provided in this presentation isdrawn entirely from public information.

The views expressed in this presentation arethe authors’ alone and not those of the authors’clients.


Agenda

New TSCA: Basic Provisions andOverview of Preemption

Consumer Product SafetyStatutes and Preemption

The State of the States

What To Expect, When toParticipate


New TSCA: Basic Provisionsand Overview of Preemption

Martha [email protected]


The Toxic Substances Control Act (TSCA)

• Purpose of Law: To require the review,testing, reporting and regulation for new andexisting 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 thatwere not regulated as pesticides or foods,food packaging, drugs, cosmetics.

• Consumer product ingredients fall in TSCA’sdefinition of a chemical substance (15U.S.C. § 2602(2)).


Principal Sections of TSCA (for Today)

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


Old TSCA Criticisms

• Difficult and costly for EPA to make findings necessaryto promulgate test rules or negotiate voluntary consentagreements 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.


Fast Forward to 2016: Congress’ Response

Greater Authority to Collect Information and RequireTesting:• EPA now CAN require testing by order or consent

agreement, and has explicit authority to obtainexposure information

• To review PMN/SNUN, perform 6(b) risk evaluation,to implement 5(e), 5(f), or 6(a) requirement, or under12(a)(2) (export exemption)

• Must identify need for information, explain why orderused

• Expands “serious or widespread harm” testingauthority beyond cancer, gene mutations, and birthdefects

EPA generally must “tier” test, and reduce vertebratetesting to the extent practicable


New Section 5 – New Chemicals

Premanufacture notification (PMN) undersection 5 is similar -• Still submit PMN at least 90 days before

commencing substance or activity

EPA must determine if the substance islikely 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 theextent practicable”


PMN Actions

“(A)” determination (“presents”):

• Must use § 5(f) and may issue order

“(B)” determination (“insufficient,” “maypresent,” 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) againstundue delays in review process now.


“Articles”

Can require Significant New Use Rule(SNUR) for chemicals in “articles” only ifEPA makes affirmative finding in a rulethat reasonable potential for exposure tochemical through article (or category ofarticles) justifies notification.


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 factorsin prioritization or safety determinations.

Least burdensome” restriction requirement forrisk management of existing chemicals is gone.


Inventory “Reset”

Within 1 year EPA must issue rulerequiring producers (and “may” requireprocessors) to notify EPA within 180 daysof each existing substance producedwithin 10 years prior to enactment.

• Reported substances = “active”

• Non-reported = “inactive”– EPA cannot delist, or require PMN for inactive upon

change to active


Existing Chemicals Mandate

EPA must make 20 low priority substancedesignations within 3.5 years.

EPA also must be conducting risk evaluationson 20 high priority substances.

• Only 50 percent of chemicals in risk evaluation haveto be 2014 TSCA Work Plan chemicals.

System designed to encourage voluntarynominations for risk evaluation.

• At least 25 percent (and no more than 50 percent)of the risk evaluations must consist of voluntaryrequests.


Statutory Priorities – Existing Chemicals

Preferred High Priority: § 6(b)(2)(D). (1) score 3 forpersistence and bioaccumulation; (2) known humancarcinogen; 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, andtrade.

• Must recommend actions to further reduce use, EPA hastwo 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


Statutory Priorities – Existing Chemicals (con’t)

PBTs Scoring High/moderate: § 6(h)(1). EPA must conductexposure and use assessment but not a risk evaluation. Possiblecandidates:• 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-2-naphthalenyl)- (CASRN 54464-59-4)

• Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,8,8- tetramethyl-2-naphthalenyl)- (CASRN 54464-57-2)

• 4-tert-Octylphenol (4-(1,1,3,3- Tetramethylbutyl)- phenol) (CASRN140-66-9)

• 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)


New Section 14 - Confidential Information

New §14 completely replaces old §14

CBI preserved but with moreexceptions for disclosure

Establishes more detailedrequirements, procedures, timelines

Substantiation required for protectingchemical identity and claims have tobe renewed every 10 years.


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 subjectto fine of $250,000, imprisonment not more than 15years, or both

• Organizations – also subject to fine not more than $1million

Fees to defray 25% of costs (or $25 million,whichever lower) of administering §§4,5,6 andCBI under §14.


Other Changes

In carrying out §§ 4, 5, and 6, EPA must use“best available science” and make decisionsbased on “weight of the scientific evidence”

Within 2 years EPA must develop policies,procedures and guidance needed to carry outAct and must review adequacy at least every 5years

Must establish Science Advisory Committeewithin 1 year

Prior TSCA actions preserved. Pending ones? If EPA has published completed risk assessment

before enactment, can proceed and regulateunder new §6


What has NOT Changed?

Pre-existing definitions

§4 data compensation provisions for testing

TSCA §8(b) Inventory• Retained, with confidential and “public” portions

§ 8(a) and (d) reporting rules

§ 8(c) Allegation recording

§ 8(e) Substantial risk notification

§12 Export notification and export-onlyexemption

§13 Import certification requirement


New TSCA and Consumer Products

The new safety standard includes conditions ofuse and susceptible populations.

EPA can regulate the use of chemicalsubstances in consumer products, e.g., labeling& warnings.

Ingredients in use now will need to be reportedin near future as active in commerce, and EPAmay issue section 8 information collectionrequests similar to prior proposal on cadmium.

Preemption of state laws presents a complexlandscape for consumer products - and will bethe focus of the remainder of the presentation.


New TSCA Preemption

Except As Otherwise Provided, New And ExistingState Laws Cannot –

• Collect information (e.g., testing) already required byEPA.

• Prohibit/restrict a high priority substance once a finalsection 6(a) rule is promulgated.

• Duplicate notification for a use already subject to EPAnotification.

Grandfathers Existing State Laws

• State laws enacted by April 22, 2016, remain in effect –but what happens if there is a potential conflict in futurewith EPA actions?


Grandfather Provision § 18(e)“Nothing in this Act . . . shall be construed to preempt orotherwise affect the authority of a State or politicalsubdivision of a State to continue to enforce any actiontaken or requirement imposed or requirementenacted relating to a specific chemical substance beforeApril 22, 2016, under the authority of a law of the Statethat prohibits or otherwise restricts manufacturing,processing, distribution in commerce, use, or disposal ofa chemical substance . . .(or any action taken pursuant toa State law that was in effect on August 31, 2003).(emphasis added).*

* language in parens intended to have same effect as CPSIAsection 231(b), and grandfathers (preserves) Proposition 65.


New State Laws § 18(b)

“Preemption Pause” on new state laws soEPA has time to act –

• Starts when scope of risk evaluation isdefined.

• Ends when risk evaluation is published or3.5 years passes after risk evaluation isinitiated.

• States have an additional 18 months afterscope of risk evaluation is defined topropose/finalize new action.


New State Laws (con’t)

Also preempted by final EPA action.

• No Unreasonable Risk: When EPAfinds that a high priority chemicalmeets the safety standard.

• Unreasonable Risk And Adoption of6(a) Measures: When EPA enacts arule to regulate a chemical that doesnot meet the safety standard.


States May Continue To –

Regulate substances EPA designates as lowpriority (although likelihood assumed to be lowit cannot be discounted).

Adopt laws authorized by another federal law.§18(d)(1)(A)(i).

Impose reporting, monitoring, or “otherinformation obligation” not otherwise requiredby TSCA or another federal law.§18(d)(1)(A)(ii).

• Implications for labeling, warnings, and useinstructions under other laws.


And States May Continue To –

Enact air, water, hazardous waste, anddisposal laws. §18(d)(1)(A)(iii).

• May restrict a chemical.

• But cannot directly conflict with actiontaken by EPA under TSCA.

Enact requirements equivalent to EPA’sand co-enforce. §18(d)(1)(B).


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 scientificevidence.

• 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.


Preemption Provisions of KeyConsumer Product Statutes

Sheila [email protected]


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 + chemicalsafety).

• Development of a standard of care for manufacturing,testing, traceability.

• Requirements for tracking labels.

• Makes ASTM F 963 mandatory; requires safetystandards for durable infant and toddler products


Current CPSC Preemption

§§ 25 and 26 (a)–(c) of Consumer Product Safety Actand § 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 toenforce a safety standard or regulation designed to deal with the same risk of injuryunless such requirements are identical to the Federal standard.

• More stringent requirements allowed for products usedby governmental entities: The Federal Government or a State or

political subdivision may establish or continue to enforce a performance requirementthat provides a higher degree of protection from such risk of injury, for products used bythose 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 thatprovides a significantly higher degree of protection and does not unduly burdeninterstate commerce.


CPSIA – Toy Safety Standard

Consumer Safety Specifications for Toy Safety(ASTM F963–11): Adopted as the presumptiveconsumer product safety standard for toys.

In relation to toxic substances: CPSC wasrequired by statute to assess adequacy of ASTMF 963 for requirements, safety labeling, and testmethods for toxic substances.

Grandfathering: State or political subdivisioncould file with CPSC 90 days after enactment ofCPSIA to preserve their own safetyrequirements.


Current FHSA Preemption

FHSA § 18:• Identical state requirements allowed: When a cautionary

labeling/packaging requirement is in effect under §§ 2(p) or 3(b), no State orpolitical subdivision can establish or continue to enforce a cautionary/labelingstandard or regulation designed to deal with the same risk of illness or injuryunless such requirements are identical to the Federal standard.

• More stringent requirements allowed for products usedby governmental entities: The Federal Government or a State or

political subdivision may establish or continue to enforce a requirementthat 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 orregulation that provides a significantly higher degree of protection and doesnot unduly burden interstate commerce.


Current FFA Preemption

FFA § 16:

• Identical state requirements allowed: When a flammability

standard/regulation under the FFA on fabric, related material, or product isin effect, no State or political subdivision can establish or continue tostandard/regulation designed to deal with the same risk of occurrence offire unless such requirements are identical to the Federal standard.

• More stringent requirements allowed for productsused by governmental entities: The Federal Government or

a State or political subdivision may establish or continue to enforce arequirement that provides a higher degree of protection from such risk offire, 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 standardor regulation that provides a significantly higher degree of protection anddoes not unduly burden interstate commerce.


Selected State Laws

Nathan Cardon

[email protected]


Example 1: California

California Safe Drinking Water and ToxicEnforcement 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


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 Productscontaining TDCPP

– Paint and Varnish Strippers, and Surface Cleanerswith methylene chloride

• Formal rulemaking to begin latesummer/early fall 2016


Example 1: California (con’t)

Under DTSC’s SCP 2015–17 Work Plan, finalized inApril 2015, many categories of products are underconsideration (e.g., beauty/personal care,building/household products, cleaning, clothing, officemachinery).• DTSC will use screening criteria and prioritization criteria to

identify product-chemical combinations to be considered forfuture SCP regulation.

• More workshops starting this latter half of 2016 to discussproduct categories and potential Priority Products.

Alternatives assessments required for PriorityProducts.

State was supposed to be the big mover in greenchemistry, but rulemaking has been slow, impact muchless than other state laws.


Example 2: Washington State

Children’s Safe Products Act (CSPA) focusis on reporting of listed chemicals inchildren’s products. Alternativesassessments are permitted but notmandatory.• 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 prioritychemical

• If State does choose to act, EPA final actionwould preempt such an action or requirement.


Example 3: Maine

Under the Act to Protect Children’s Healthand the Environment from Toxic Chemicalsin Toys and Children’s Products, Maine listschemicals of high concern and calls oncompanies to substitute safer alternativeswhen feasible. The intentional inclusion ofcertain high priority chemicals (e.g., BPA,DEHP) requires reporting for certain productcategories. Maine’s law imposes analternatives assessment obligation onaffected companies.


Example 4: Vermont

Under the state’s green chemistry law, listed chemicalsused children’s products are required to be reported to thestate.• 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 bedue 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 productscontaining listed chemicals after referral to the working group,or labeling requirements.

Alternatives assessment not required initially, but they willbe relevant to future rulemakings on chemical-specificrestrictions.


Example 5: Oregon

Oregon has a list of chemicals of high concernfor use in children’s products. Requiresmanufactures to report products containingidentified chemicals present at greater than deminimis levels. After submitting the thirdbiennial report, manufacturers required to seeka waiver or remove the substance from thereported children’s product.

Current action or requirement to restrict a listedchemical taken before April 22, 2016?


Example 6: NY County Bans

County-level children’s product chemicalcontent limit• Albany County, which adopted limits lower

than ASTM, before litigation led by the Safeto Play Coalition

– A new law brought in most ASTM F 963 toy limitsand deferred to preemptive state or federalrequirements

– Limits in other standards for other products are notpreemptive, so the limits continue to apply outsideof the toy space

– Settlement of lawsuit remains pending


Example 6: NY County Bans (con’t)

County-level zero-content bans for children’sproducts• Westchester County’s zero-content limits –stayed

by the county executive pending Albany Countysettlement

• Rockland County has adopted a revised version ofits original zero-content ban, instead stating thatcovered products must comply with state andfederal law

• Suffolk County adopted limits, but they are lowerthan F963 for mercury and antimony (40 ppmversus 60 ppm), and has recently warned ofenforcement against retailers later this year


Roundtable Discussion:What To Expect, When to

Participate

Sheila MillarPartner

[email protected]

Martha MarrapesePartner

[email protected]

Nathan CardonAssociate

[email protected]


State v. EPA v. Other Federal Standards

When should consumer product safetyindustries engage with EPA?

What is the interplay between EPAactions and other federal requirements?

What state requirements are likely to bepreempted?

How can consumer product safetystandards or rules be used to fight statelimits?


In Summary

There is a competing patchwork of statelaws currently sizing up the new federalprogram.

TSCA Reform should slow the pace ofnew state laws on chemicals but manyquestions about scope of new limits onchemicals will arise under existing statemeasures


In Summary CPSIA preemption is stronger with respect to toy

standards than TSCA because it preempts bothexisting and new state laws. FHSA preemption isstrong with respect to chemical hazard labeling(excluding Prop 65).

Could CPSIA standards conflict with EPA due toTSCA requirement to evaluate susceptiblepopulations?

• Coordination provisions of TSCA, impossibilityto comply with both, deference to more specificlaw and more recent law will factor in, as willunderlying science.


In Summary

It will take time for TSCA preemptionprovisions to have a real impact but thepotential is there, particularly in the case offinal EPA actions having preemptive effecton new state laws/new actions underexisting laws.

Proactive and defensive use of all availablefederal options should be considered

Litigation will almost certainly be necessaryto sort out the legal landscape onpreemption.


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The New TSCA: What Does It Mean For Consumer Products … New TSCA and CPC... · 2016. 7. 14. ·...

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