the new tsca - keller heckman | about keller and heckman reform webinar slides.pdf · the...

Copyright © 2016 | www.khlaw.com Keller and Heckman LLP 1

The New TSCAJune 8, 2016

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Preliminary Word

This presentation provides information aboutthe law. Legal information is not the same aslegal advice, which involves the application oflaw to an individual's specific circumstances.The interpretation and application of the law toan individual’s specific circumstance dependson many factors. This presentation is notintended to provide legal advice.

The information provided in this presentation isdrawn entirely from public information. Theviews expressed in this presentation are theauthors’ alone and not those of the authors’clients.


Speakers

Thomas C. BergerPartner

[email protected]

Herbert EstreicherPartner

[email protected]

Eric P. GottingPartner

[email protected]

Martha E. MarrapesePartner

[email protected]

Adrienne M. TimmelAssociate

[email protected]


Agenda

How Does TSCA Stack Up in the GlobalContext?

TSCA Testing Enters the Modern Era

Existing Chemicals

New Chemicals, Recordkeeping/Reporting, Imports and Exports, andPenalties

Confidential Business Information

Preemption & Judicial Review


How Does TSCA Stack Upin the Global Context?


[email protected]


Main Elements of the New TSCA

Identification of Substances Actively in Commerce.

Preservation of Existing Class II Nomenclature.

No Lock-step Information Requirements. QSARand Alternative Testing to Play a Central Role.

Risk-based Safety Standard Evaluated UnderConditions of Use Not Taking into Account Costsor Other Non-risk Factors but RequiringConsideration of Potentially Exposed orSusceptible Populations.

Prioritization of Active Substances into High andLow Priority.


Agency-driven Process.

Science-based Risk Assessment.

Broad Authority to Regulate But Bans and Phase-Outs Must Offer Alternatives. No Authorization-type Scheme.

Regulatory Pace is Measured.

Preservation of CBI But More Liberal Disclosure.

Industry Pays a Portion of the Cost.

Main Elements of the New TSCA (con’t)


Global Comparison

Identification of Substances Actively in Commercesimilar to EU REACH pre-registration but more closelyaligned with process in other countries.

Preservation of Existing Class II Nomenclature is asharp and positive departure from EU REACH.

Absence of Lock Step Data Requirements is morealigned with Canadian and Australian Approaches.

More Limited Scope – TSCA does not include cosmeticingredients, food contact substances, monomers inpolymers.


Global Comparison (con’t)

Agency-driven Process Follows the Approachin Other Countries although the EU has aBifurcated Scheme.

Measured Pace and Science-based RiskAssessment and Decision-making maybecome the Major Contribution of the NewTSCA to the Global Debate.

More Modest Cost and Burden on IndustryRelative to the EU.


Some Statistics EU: Registration of 13,441 unique substances from 51,920 Dossiers

to-date with the largest number of substances still to be registered bymid-2018; 1130 compliance checks; 270 substances on theCommunity Rolling Action Plan (CoRAP) list; 168 substances on theCandidate List of Substances of Very High Concern (SVHCs); 31substances on the Annex XIV authorization list with 11 additionalsubstances recommended for authorization; and 105 Restrictions.400+ ECHA staff and 200 MM € budget plus 28 member states plusEU Commission.

CANADA: 2,740 screening assessments under its ChemicalManagement Plan (CMP 1 and 2); 276 final risk managementinstruments covering 325 substances or groups of substances havebeen developed; and 363 substances (or groups) have beenassessed as toxic.

KOREA: 510 substances subject to registration by 2018 withadditional 500 by 2021, and 500-600 by 2024.


In Sum

New TSCA envisions a much more hands on role forthe Agency than EU REACH but process is mostsimilar to Substance Evaluation under REACH.

No Authorization type-process and therefore differentfrom EU and Korea REACH.

Decision-making based on risk rather than hazard.

QSAR is likely to play a central role in the prioritizationsimilar to Australian and Canadian approaches.

Far lower through-put than in the other countries.


TSCA Testing Enters theModern Era


[email protected]


Greater Authority to Require Testing

EPA can proceed by rule, order or consentagreement. If EPA decides to issue a testing order, itmust justify the use.

However, EPA must proceed in a tiered fashionunless it can justify that more advanced testing isrequired.

EPA is given express authority to require exposureinformation.

EPA can require development of new information toimplement a Section 5(e) or 5(f) or 6(a) requirement(Does this mean monitoring?)

Other Federal Agencies can request EPA to requiretoxicity/exposure testing to support other Federalprograms.


Authority to Require Testing is Limited in the Contextof Prioritization

EPA is expected to prioritize based onexisting data and screening techniques.

Can require development of newinformation but only upon a showing ofneed, the testing must be tailored toprioritization, and must completeprioritization decision within 90 days ofreceiving the information.


Use of Alternatives to Animal Testing

Significant Focus on Three R’s(Replacement, Reduction andRefinement) in order to avoidunnecessary animal testing: Use Existing Info where available

Use QSAR and Biometrics

Use High-throughput Screening Methods

Test with Reduced Animal Numbers

Use Grouping and Read-across

Encourage Joint Testing through Consortia


Within 2 Years of Enactment EPA is toDevelop a Strategic Plan for AlternativeTesting including a list of ScientificallySound Alternative Methods (to be updated).

Public to be given Notice and Opportunity toComment.

Report to Congress Every 5-years onProgress.

Industry Encouraged to Use AlternativeTesting When Voluntarily Developing TSCAData.

More on Three R’s


Existing Chemicals


[email protected]


Schedule – Risk Evaluation

1. Starting vehicles: Work plan evaluations already underway, otherWork Plan Chemicals, and “active” substances on the TSCAInventory.

2. Chemicals will be designated as high/low priority. High prioritysubstances will proceed to risk evaluation

– Designation process 9 months – 1 year.

– Scope of risk evaluation issued 6 months after that.

– Risk evaluations have to be finished in 3 years.

3. Risk management proposed within 1 year/ finalized within 2 yearsof completing risk evaluation. Extension of up to 2 years possible.

4. Management measures to become effective from “as soon aspracticable” up to 5 years.

5. Future rulemakings and best science provisions in section 26underlay process.


Schedule, cont. Within 6 months, EPA needs to be conducting

risk evaluations (and publish the list) for atleast 10 chemical substances drawn fromthe 2014 TSCA Work Plan § 6(b)(2)(A)

Other section 6 priorities –• Preferred High Priority Chemicals § 6(b)(2)(D)

Criteria: (1) score 3 for persistence andbioaccumulation; (2) known human carcinogen;and (3) high acute and chronic toxicity

• PBTs Scoring High/moderate: § 6(h)(1)– Proposed rulemaking to regulate within 3 years– EPA must conduct exposure and use

assessment but not a risk evaluation.


Schedule, cont.

50 percent of chemicals in risk evaluation inthe first 3.5 years have to be 2014 Work Planchemicals.

At least 25 percent of the risk evaluations mustconsist of voluntary requests. These cannotbe comprise > 50 percent of the ongoingevaluations in total at any one time.

Within 3.5 years, EPA must be in the processof conducting risk evaluations on 20 highpriority substances and must have designated20 low priority substances.


Schedule - General RulemakingsDeadline EPA Must -

Within 1 year • Promulgate a rule setting risk basedscreening process for prioritization

• Promulgate a rule setting risk evaluationprocess

Within 2 years • Issue program guidance on preparing riskevaluations, other aspects.

Within 3 years • Propose risk management rules for PBTsubstances that are scored moderate to highwhich are not otherwise under review, to befinalized in 18 months.

Within 3.5 years • Be in the process of publishing prioritydeterminations, risk evaluations, and riskmanagement measures for approximately 40chemicals (20 low priority/20 high priority).


Safety Standard “Least burdensome” restriction requirement for

risk management of existing chemicals is gone.

Preserves no “unreasonable risk of injury tohealth or the environment” criterion.

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.


Safety Standard

High Priority Chemical – A substance thatEPA concludes without consideration ofcosts or other non-risk factors, may presentan unreasonable risk of injury to health orthe environment because of a potentialhazard and a potential route of exposureunder the conditions of use, including anunreasonable risk to a potentially exposedor susceptible subpopulation identified asrelevant by [EPA].

- Section 6(b)(1)(B)(i)


Safety Standard

Risk Management – chemical substancepresents an unreasonable risk of injury tohealth or the environment, withoutconsideration of costs or other non-riskfactors, including an unreasonable risk toa potentially exposed or susceptiblesubpopulation identified as relevant tothe risk evaluation by [EPA].

- Section 6(b)(4)


Stewardship (Risk Management) By rule (or in certain cases by order) EPA can require

testing and impose limits on process and use conditions.

By rule, EPA can impose bans/phase outs, and regulatearticles. To do so, EPA must consider:

• Effects on human health, environment and magnitude ofexposure

• The benefits of the substance/mixture for various uses

• Reasonably ascertainable economic consequences onnational economy, small business, innovation,environment, public health, costs/benefits, and costeffectiveness of the proposed rule and alternative

• Availability of alternatives

Agency may request and defer to action under anotherstatute unless the contacted agency/office declines to act.


Risk Management

Replacement parts for designated complex durable goodsand complex consumer goods exempt.

Other conditional exemptions may be granted, subject tonotice and comment, for which time limits and otherconditions may apply:

• Critical or essential uses with no feasible saferalternative.

• Disruption to national economy, security, or criticalinfrastructure.

• A condition of use that compared to alternatives providesa substantial benefit to health, environment or publicsafety.


Funding

New fees are contemplated, Congress must maintain 2014authorization level for new fees to be assessed.

Consultation process anticipated prior to rulemaking onsetting fees - no deadlines. To be adjusted every 3 years.

Lower fees for small businesses in consultation with SBA.

Fees to defray 25% of program costs (or $25 million, iflower) of administering sections 4, 5, 6 and CBI protectionunder section 14 –

• Voluntary risk evaluation requests must be fully fundedby requesters, and up to 50% for work plan chemicals.

• Balancing of costs among manufacturers, processors,consortia is contemplated.


New Chemicals,Recordkeeping/Reporting,Imports and Exports, and

Penalties

Thomas C. BergerPartner

[email protected]


The “Core” of “Old” TSCA

Section 5 – New Chemicals and SNURs

Section 8 – Recordkeeping/Reporting

Section 12 – Exports

Section 13 – Imports

Section 15/16 – Penalties/Enforcement


Section 5

Overall process similar but a number of keychanges.

Submit PMN or SNUN at least 90 daysbefore commencing activity.

EPA must review notice, and make5(a)(3)(A), (B), or (C) determination:• 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”


Section 5(a)(3) Determinations

“(A)” Determination• Substance/SNU presents unreasonable risk

“(B)” Determination• (i) information insufficient to permit reasoned evaluation

of substance/SNU; or• (ii(I)) in absence of sufficient information and evaluation

substance may present unreasonable risk; or• (ii(II)) substance is/will be substantial quantities, and

enters or may enter environment in substantialquantities or is/may be significant or substantial humanexposure

“(C)” Determination• Substance/SNU is not likely to present an

unreasonable risk


Section 5 Actions Required

“(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!


Failure to Make Determination

If EPA fails to make determination by endof review period, then EPA “shall” refundfiling fee.

• No refund if EPA certifies that submitter hasnot provided all 5(b) information, or has“otherwise unduly delayed the process.”

• EPA, however, “shall not be relieved of anyrequirement to make such determination.”


Articles

Can require SNUR for chemicals in“articles” only if EPA makes affirmativefinding in a rule that reasonable potentialfor exposure to chemical through article (orcategory of articles) justifies notification.

• Recall: Under section 6 EPA can restrict orprohibit chemicals in articles, but only to extentnecessary to address identified risks fromexposure so chemical does not presentunreasonable risk.


Section 8

8(a) – PAIR/Chemical Data Reporting(CDR)

8(b) – Inventory

8(c) – Allegations of significant adversereactions (no changes)

8(d) – Unpublished health and safetystudies (no changes)

8(e) – Substantial risk reporting (nochanges)


8(a) - General

2016 CDR unchanged

• Deadline = 9/30/2016

EPA must conduct negotiated rulemakingand publish within three years ofenactment proposed rule providing forlimiting 8(a) reporting for manufacturersof any “inorganic byproducts” that aresubsequently recycled, reused, orreprocessed


Section 8(b)

EPA must:

• Maintain use of Class 2 nomenclature

• Maintain use of SDA nomenclature

• Treat individual members of categoriesidentified as statutory mixtures as being on theInventory

Upon demonstrating to EPA that substanceappears multiple times on Inventory undermultiple CASRNs, EPA “may” recognizemultiple listings as single substance.


8(b)(4)–(5) Inventory “Reset”

Within 1 year EPA must by rule requireproducers (and “may” require processors)to notify EPA within 180 days of eachInventory-listed substance produced within10 years prior to enactment.• Reported substances = “active”; others =

“inactive.”– EPA cannot delist, or require PMN for inactive upon

change to active.

Most recent CDR-reported substances willcomprise candidate list of actives.


Reset, CBI

EPA will maintain public and confidentialInventories.

“Reset” submitter must assert / re-substantiate CBI claims for confidentialInventory substances.

Within one year of active list compilation,EPA must publish rule to establish plan toreview all chemical identity CBI claims.• Can approve, deny, approve in part, etc.• If approved, EPA will protect for 10 years

EPA has five years to complete.


Inactive Substances

Must notify EPA before manufacture,import, or processing.

If CBI status desired must submit/assertCBI claim within 30 days of notice.

EPA will move properly reportedsubstances to “active” list.

• Then subject to review under 6(b)


Mercury – Section 8(b)(10)

Includes Hg, and Hg compounds.

No later than April 2017 and every threeyears thereafter, EPA must publish in FRinventory of Hg supply, use, and trade.

• Must recommend actions to further reduceuse.

Manufacturers and intentional users mustperiodically notify EPA.

• EPA has two years to develop reporting rule.


Section 12 - Exports

12(a) – Export-only exemption

• Unchanged other than conformingamendment

12(b) – Export notification

• Unchanged


Exports (con’t)

12(c) amended to include Hg compounds. Hg export ban beginning 1/1/2020 for:

• Hg(I) chloride• Hg(II) oxide• Hg(II) sulfate• Hg(II) nitrate• Cinnabar or Hg sulphide• Any Hg compound EPA adds to list published

by EPA within 90 days

Can export listed compound to OECDmember country for disposal.


Penalties / Enforcement

No change to prohibited acts, orinspection/subpoena authority.

Penalties:• Civil: Maximum penalty $25,000 $37,500

• Criminal: Maximum penalty $25,000$50,000

– Persons that know that violation places individual inimminent danger of death or serious bodily injurysubject to fine of $250,000, imprisonment not morethan 15 years, or both.

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


Confidential BusinessInformation


[email protected]


Overview and Agenda

Overview

New § 14 completely replaces old § 14

Bill preserves CBI but with more exceptions for disclosure

Establishes more detailed requirements, procedures, andtimelines

Agenda

Information Not Protected from Disclosure

Exceptions to Protection

CBI Substantiation and Duration

EPA Review and Decision Requirements

New Information to be Published by EPA


Information Explicitly NOT Protected Health and safety studies

• Except:

– Process information, explicitly including molecular formulasand structures (NEW)

– The concentrations of individual chemicals in a mixture

General manufacturing, processing and use information

• E.g., Volume aggregates (or ranges if authorized by EPA)

Information related to ban or phase-out chemicals

• Rebuttable presumption

• Limited exceptions (e.g., critical uses)

General Caveat:

Confidential information “mixed” with non-confidentialinformation does not lose its protection.

§14(b)


Exceptions to ProtectionMany of the same exceptions, with the following variations and additions.

Information must be disclosed to:

• Protect health or environment against unreasonable risk – withoutconsideration of costs or other non-risk factors, including to protect apotentially exposed or susceptible subpopulation

• Law enforcement - Upon written request by state/local authorities toadminister/enforce the law – NDA must be in place

• Non-emergency release/exposure - Upon written statement of need byhealth/environmental professional to diagnose, treat or respond tosituation – must agree to sign NDA

• Emergency release/exposure – Upon request by environmentalofficials/professionals/first responders/poison control centers – ifrequested by CBI claimant, they must agree to provide a writtenstatement of need and sign NDA as soon as practicable

• Federal or state judicial proceedings

§ 14(d)


CBI Substantiation and Duration

NO substantiation or time limit for:

• Specific production/import volumes

• Specific processes

• Specific uses

• Percentages of constituents in a mixture

• Marketing and sales information

• Supplier and customer identities

§ 14(c)(2)


CBI Substantiation and Duration (con’t)(Re)substantiation required for everything else, includingchemical identity

When:

• Generally, submit CBI claim concurrent with info. and substantiateper rules EPA “has or may” promulgate

• To maintain confidential Inventory listing, file CBI claim with noticeof active manufacture/processing under § 8(b) (within 1.5 yrs.) andsubstantiate claim at a later date (within 5 yrs.)

• After designation of a high-priority substance• If EPA determines info. is important to § 6 actions or the chemical

presents an unreasonable risk under § 6• If necessary in connection with a FOIA request• If EPA has reasonable basis to believe info. does not qualify for

protection

§§ 14(c), (e) and (f)


How: Certified 4-prong statement

1. Reasonable measures to protect CBI

2. Information not required to be disclosed to public underany other Federal law

3. Disclosure is likely to cause substantial harm tocompetitive position

4. Reasonable basis to believe info. is not readilydiscoverable through reverse engineering

For Chemical Identity: Provide generic name that is asstructurally specific as practicable (EPA to issue guidance)

Duration: 10-years, with opportunity for unlimitednumber of 10-year extensions

§§ 14(c), (e) and (f)

CBI Substantiation and Duration (con’t)


EPA Review and Decision Requirements EPA must review:

• All CBI claims for chemical identity*

• A 25% representative subset of all other CBI claims.

For most claims, EPA must issue decision within 90-daysof receipt.

EPA denial and disclosure:

• Must provide written reasons for denial.

• Must generally provide 30-day written notice prior to disclosure.

– Shorter or no notice for exceptions to protection (e.g., emergency release orsubstantial imminent harm).

• If there is a right to notice, may appeal decision before disclosurein U.S. district court.

– Appeal generally stays disclosure until court issues decision (except toCongress and state/local law enforcement).

*Except if chemical has not been offered for commercial distribution.

§ 14(g)(1) – (2)


New Information to be Published by EPA

“Request and Notification System”

• To be developed with CDC, to allow “expedient and swift” access todisclosed info. regarding emergency and non-emergencyexposures/releases.

List of Unique Identifiers for CBI Substances

• EPA must annually publish an updated list of unique identifiersassociated with chemical identities for which EPA has granted CBIclaims, and the expiration date for each such claim.

• EPA must use the unique identifier to identify the chemical insubmissions with non-confidential information.

• EPA must link the specific chemical identity to the unique identifieronce the CBI claim is withdrawn, denied or expired, to the extentpracticable.

§ 14(g)(3) – (4)


Preemption &Judicial Review


[email protected]


Preemption Under H.R. 2576

Existing State Laws• Grandfather Date (April 22, 2016)

• Final EPA Action (on high priority chemicals)

New State Laws• “Preemption Pause”

• Final EPA Action (on high priority chemicals)

Exceptions and Waivers• Adopted under federal law

• Reporting, monitoring, and information laws

• Air, water, hazardous waste, and disposal laws

• Co-enforcement

• Discretionary and mandatory waivers


Preemption: TSCA vs. H.R. 2576

Final EPA Action

Preemption Pause

Grandfather Date

Bans

Waivers


Judicial Review

Potential Litigation

• Decision-Making Procedures– E.g., prioritization; risk evaluations

• Chemical-Specific Decisions– E.g., unreasonable risk; state waivers; Section 6(a) measures

• Sue-and-Settle– E.g., statutory deadlines

Standard of Review

• Arbitrary and capricious

• Substantial evidence


Questions?

Visit TSCAReformCenter.com to stayupdated on new and developing TSCA

Issues and Regulations


Washington, DC • Brussels • San Francisco • Shanghai • Paris

Keller and Heckman LLP

THANK YOUThomas C. Berger

[email protected]


[email protected]


[email protected]


[email protected]


[email protected]

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