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ASC 2017 Spring Convention New TSCA: Status Report and Survival Guide Jamie Conrad Conrad Law & Policy Counsel April 4, 2017
ASC2017 Spring Convention
New TSCA: Status Report and Survival Guide
Jamie ConradConrad Law & Policy Counsel
April 4, 2017
Overview
• How we got here • New TSCA from 30,000 feet• Top implementation issues – status,
future prospects and business impacts:–New chemicals–Existing chemicals–CBI–Fees
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How We Got Here
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How We Got Here
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How We Got Here
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New TSCA from 30,000’
• Unreasonable risk from reasonably foreseeable uses, incl. potentially exposed subpopulations
• Affirmative determinations on premanufacturenotices (PMNs)
• Reset of Inventory into active/inactive• Prioritization of existing chemicals (low/high)• Risk evaluation of high priority chemicals
– 3.5 yrs tops per evaluation– At least 20 ongoing after 3.5 years
• EPA to use best available science & weight of evidence; reduce & replace animal test methods
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New TSCA from 30,000’
• Restrictions to eliminate unreasonable risks; costs, substitutes only a consideration
• Substantiation required for confidential business information (CBI) claims– Chem ID can still be CBI– EPA to review 25%, incl. all claims of chem ID
• EPA authorized to charge fees for submitters under §§ 4, 5 & 6– Up to $25 million or 25% of TSCA program costs– Lower fees for small business concerns
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New Chemicals• PMN backlog!
• No minimum data set, but provide data on potential human or eco toxicity and exposures
• Justify analogs8
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Jun 2015 - Jan 2016 Jun 2016 - Jan 2017
New Chemical Determinations
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New Chemicals• Check the P2 box? P2 Recognition Project;
Safer Chemicals Ingredients List• Fees TBD• Exemptions all preserved
– E.g., low volume, R&D, polymers– No no new rulemaking required– Some fees possible
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New Chemicals
• Expect to see more consent orders (COs) & significant new use rules (SNURs)– Possibility of CO with every SNUR– Watch out for conditions and notification
requirements associated with proposed or final SNURs --hard to identify chemicals subject to them
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Inventory Reset• Comments on proposed rule closed last month; final
by next June• Then 180 days to notify EPA re any chemicals you
manufactured in 10 years before 6/22/16– Unless chemical reported on 2012 or 2016 CDR– “One and done”?– Nail down nomenclature issues?– Then 180 more days for optional processor reporting
• No fees authorized for these reports• Notice (not PMN) required to “reactivate” inactive
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Existing Chemicals• Proposed rules on prioritization and risk evaluation
– Comment periods closed last month– “Pre-prioritization” key; needs structure– Agency ducking science mandates
• Manufacturers will need to understand downstream uses of their products. Expect to get more questions about uses and exposures arising from your (and your customers’) uses of their chemicals– Esp. if you don’t have to report them under
Chemical Data Reporting (CDR) Rule– CDR reports need to complete and correct
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Existing Chemicals
• Expect more restrictions on chemicals.
• Expect arguments over “reasonably foreseeable" conditions of use
• Expect greater focus on occupational exposure scenarios:– E.g., TCE in spot dry cleaning– OSHA encouragement
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First ten chemicals sel-ected for risk evaluationunder amended TSCA:− 1,4-Dioxane− 1-Bromopropane− Asbestos− Carbon Tetrachloride− Cyclic aliphatic
bromide cluster− Methylene chloride− N-methylpyrrolidone− Pigment Violet 29− Trichloroethylene− Tetrachloroethylene
CBI
• List of information presumed to CBI – no substantiation required (mfg. process, uses)
• Otherwise, must substantiate. Esp. chemical ID (upon commencement of manufacture).
• 10 years protection; renewable w/o limit if still valid
• EPA will be reviewing ≥25% of claims, 100% of chem ID claims
• Hopefully no or only minimal fees for CBI claims
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Fees
• Proposed rule soon; final sometime in 2017• EPA costs, plus overhead, likely to be huge
($3.7M per risk evaluation)• Fights likely over:
– What costs EPA can recover for years 1-3– Share of costs borne by:
• Testing submitters• PMN & exemption notice submitters• Manufacturers of chemicals undergoing risk evaluations
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Fees
• Lower fees for “small businesses concerns”– Currently, $100 (vs. $2,500) for PMNs from businesses
w/ consolidated annual sales of <$40 million– Will EPA retain 25x differential?– $40M inflated by Producer Price Index = ~$91M– Small Business Administration involved
• Related determination due any day re rulemaking to change threshold for “small manufacturer or processor” exempt from CDR and similar rules
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Nobody wants this
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