TSCA Compliance Presentation

REACH Conference

September 2019

Sol Bobst

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Overview

• TSCA

• Lautenberg Act Updates

• Practical Considerations for Compliance / Reporting• PMNs

• TSCA 8c / 8e

• Inventory

• Active Inactive Rules (Polymers)

• SNURs (Similar to Canadian SNACs)

• CDR Reporting (Importer of Record)

• Compliance ChecklistToxSci

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TSCA

• The Toxic Substances Control Act (15 U.S.C. 2601 et seq.) authorizes the EPA to screen existing and new chemicals used in manufacturing and commerce to identify potentially dangerous products or uses

• Both naturally occurring and synthetic chemicals are subject to TSCA

• Exceptions: Chemicals regulated by other federal laws concerning food, drugs, cosmetics, firearms, ammunition, pesticides, tobacco, or mixtures

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TSCA

• Three Key Sections: • Section 4: Chemical Testing

• Section 5: New Chemical Review

• Section 6: Permissive authority to regulate chemicals if EPA determines it has a reasonable basis to conclude the chemical may present unreasonable risk to health or the environment

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Why Was TSCA Reformed?

• Limited Enforcement Capabilities….• Grandfathered Chemicals

• CBI

• Non-Mandatory Requirements

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The Lautenberg Act, June 22nd 2016

• Aims to fix the TSCA problems by:

• Broadening the coverage of the Act - applies to all chemicals in commerce or intended for commerce

• Giving EPA the power to act - EPA must conduct risk assessments on all new chemicals and existing high priority chemicals and EPA must take action on chemicals deemed to present an unreasonable risk

• Giving EPA the tools to act - EPA can issue an order or enter into a consent agreement requiring testing and additional information regarding a chemical, instead of going through rulemaking process

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Sections of Lautenberg Act

• Existing Chemicals

• New Chemicals

• Testing and Data

• Confidential Business Information

• Preemption

• Funding

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Existing Chemicals

• Inventory Reset

• Report all Chemicals Manufactured / Imported for past 10 years in 2018.

• Reorganize Active / Inactive

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Prioritization• EPA to establish a rule that sets forth a risk-based process to prioritize chemicals as

either “high” or low”• The process must include a consideration of:

(i) the hazard and exposure potential of a chemical;(ii) the conditions of use;(iii) the volume of the chemical substance manufactured or processed • Rule must require EPA must post notice and request comment• High priority – EPA determines the chemical “may present an unreasonable risk

of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator”

• Low priority – the chemical fails to satisfy standard for high-priority, based upon sufficient information

• Insufficient information - EPA can require testing

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Risk Evaluations

• High priority designations evaluated to determine whether they actually do present “an unreasonable risk of injury to health or the environment” without regard to cost (Companies pay 50% of cost). Companies can request risk evaluations and pay full cost.

• Each evaluation cannot take more than 3 years and draft evaluations will be subject to notice and comment

• Low priority designation does not require further action

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High Priority List (Di/Tri Chloros & Phthalates)Name CAS #p-Dichlorobenzene 106-46-7

1,2-Dichloroethane 107-06-2

trans-1,2- Dichloroethylene 156-60-5

o-Dichlorobenzene 95-50-1

1,1,2-Trichloroethane 79-00-5

1,2-Dichloropropane 78-87-5

1,1-Dichloroethane 75-34-3

Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester)

84-74-2

Butyl benzyl phthalate (BBP) - 1,2-Benzene-dicarboxylic acid, 1- butyl 2(phenylmethyl) ester

85-68-7

Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene-dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)

117-81-7

Di-isobutyl phthalate (DIBP) - (1,2-Benzene-dicarboxylic acid, 1,2- bis-(2methylpropyl) ester)

84-69-5

Dicyclohexyl phthalate 84-61-7

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High Priority List Con’tName CAS #4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)

79-94-7

Tris(2-chloroethyl) phosphate (TCEP) 115-96-8

Phosphoric acid, triphenyl ester (TPP) 115-86-6

Ethylene dibromide 106-93-4

1,3-Butadiene 106-99-0

1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)

1222-05-5

Formaldehyde 50-00-0

Phthalic anhydride 85-44-9

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High Priority Substances

• Your Opportunity to Comment: https://www.federalregister.gov/documents/2019/08/23/2019-18134/proposed-high-priority-substance-designations-under-the-toxic-substances-control-act-tsca-notice-of

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Controls (Post Risk Evaluation) – Major Update of TSCA

• If chemical presents an unreasonable risk, EPA must impose prohibitions or restrictions “to the extent necessary so that the chemical no longer presents an unreasonable risk”

• Rulemaking• includes a consideration of costs

• available alternatives

• EPA must take final risk management action within 2 years (limited extensions)

• If risk is not unreasonable, no action is taken

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Practical Considerations

• If you Export / Work with Importer into TSCA…

• Make Sure someone has looked at Inventory and has checked TSCA compliance of Products

• Make sure someone is responsible for CDR reporting

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Pre-Manufacturing Notice

1) Submit Notice 90 days before Manufacture/Process/Import of New Substance (Includes Reactive Isolated Intermediates, though lower fee / potentially faster tracked process)

2) EPA Can Order Submitter to Provide Additional Data

3) Plan Good Data Strategy• Can Include READ-Across, QSAR, Use of ECHA Data…

4) EPA makes risk decision• Test Orders

5) Controls Set In Place (SNURs), May / May Not be able to proceed.

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TSCA 8c / 8e and other Section 8s…

• 8c If you have any new health allegations…• Need to be reported to EPA

• 8e If you come across any new data….• Need to be reported to EPA within 15 working days…

• Unless Known to Administrator

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TSCA Inventory Rules (Polymer Exemptions)

• Eligibility• Polymers with molecular weight (MW) of 1,000 daltons or greater and less than 10,000

daltons are eligible, with restrictions on low MW species and reactive functional groups;• Polymers with MW of 10,000 daltons or greater, with restrictions on low MW species.

• Exclusions

• Aasdfa

• asdfa

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TSCA Polymer Exclusions

• Polymers which degrade, decompose, or depolymerize are ineligible for the exemption. Also ineligible are several classes of polymers:

• polymers that are prepared from monomers or other reactants that are not on the TSCA (Toxic Substances Control Act) Inventory are ineligible,

• as are water-absorbing polymers with number-average MW equal to or greater than 10,000, and

• polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length.

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TSCA Polymers

• Reporting Requirements

• The manufacturer (which includes import) of any substance for which the polymer exemption is claimed under 40 CFR 723.250 must submit a report of manufacture (which includes import) by mail or courier to EPA by January 31 of the year subsequent to the year in which the substance was manufactured for the first time. This report should be submitted as follows:

• US Postal Service:

• U.S. Environmental Protection Agency (7407M)WJC North Building1200 Pennsylvania Ave, NWWashington, DC 20460Attn: Polymer Exemption

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Significant New Use Rules (SNURs)

• TSCA Section 5(a) Significant New Use Rules (SNURs) can be used to require notice to EPA before chemical substances and mixtures are used in new ways that might create concerns. EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2):• Projected volume of manufacturing and processing of a chemical substance.• Extent to which a use changes the type or form of exposure of humans or the

environment to a chemical substance.• Extent to which a use increases the magnitude and duration of exposure of

humans or the environment to a chemical substance.• Reasonably anticipated manner and methods of manufacturing, processing,

distribution in commerce, and disposal of a chemical substance.

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If a SNUR applies to you, M/I

• You need to file a SNUN• TSCA section 5(a) requires persons to submit a significant new use notice

(SNUN) to EPA at least 90 days before they manufacture (including import), or process the chemical substance for that use.

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Chemical Data Reporting Rule (CDR)

• Next Data Reporting Period Opens June 1st, 2020.

• Get Ready! (Get your Importers Ready)

• https://www.epa.gov/chemical-data-reporting/how-report-under-chemical-data-reporting

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TSCA Section 13 Compliance Checklist for Importers (Exporting Into..)• https://www.epa.gov/sites/production/files/2015-

03/documents/checklist.pdf

• Remember, Always Check TSCA 5,6,7,4,8,12b too…

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References

• https://www.epa.gov/chemicals-under-tsca

• TSCA Compliance Checklist

• https://www.epa.gov/sites/production/files/2015-03/documents/checklist.pdf

• Priority List of Substances• https://www.epa.gov/assessing-and-managing-chemicals-under-

tsca/chemical-substances-undergoing-prioritization

• https://d11m3yrngt251b.cloudfront.net/images/content/8/7/v4/87108/presentation-TSCA-v3-283-29-v1.ppt

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