Legislative and Regulatory Developments With Respect to Chemicals - PowerPoint PPT Presentation

Legislative and Regulatory Developments With Respect to Chemicals & Products Squire Patton Boggs’ Environmental, Safety & Health Practice in Conjunction with the Ohio Chemistry Technology Council August 8, 2014

AGENDA  9 a.m. – Welcome & Introductions Karen A. Winters, Environmental, Safety & Health Practice Group Leader, Squire Patton Boggs (Columbus) Jenn Klein, President, Ohio Chemistry Technology Council  9 a.m. – Congressional Efforts To Reform TSCA The Honorable Bill Johnson, United States House of Representatives (Washington DC)  10 a.m. – Regulatory Developments under TSCA Stephen A. Owens, Squire Patton Boggs (Phoenix & Washington DC)  10:45 a.m. – Break  11 a.m. – A Review of REACH Enforcement in Europe and Environmental Enforcement Trends in the UK David Gordon, Squire Patton Boggs (Birmingham) Rob Elvin, Squire Patton Boggs (Manchester) squirepattonboggs.com squirepattonboggs.com 2 2

AGENDA  Noon – Luncheon Presentation David Mustine, Senior Managing Director for Energy, Polymers and Chemicals, JobsOhio  1:15 p.m. – Chemical Sector Enforcement Litigation Vincent Atriano, Squire Patton Boggs (Columbus)  2 p.m. – The “Greening” of California’s Green Chemistry Initiative Chris M. Amantea, Squire Patton Boggs (Los Angeles)  2:30 p.m. – Closing Remarks squirepattonboggs.com squirepattonboggs.com 3 3

Congressional Efforts to Reform TSCA The Honorable Bill Johnson United States House of Representatives (Washington DC) squirepattonboggs.com squirepattonboggs.com

Regulatory Developments Under TSCA Stephen A. Owens, Squire Patton Boggs (Phoenix & Washington DC) squirepattonboggs.com squirepattonboggs.com

Some Issues to Consider  Is a chemical substance that is being manufactured, imported or processed regulated by TSCA?  Is the chemical on the TSCA Inventory?  Public portion  Confidential portion  If it is not on the TSCA Inventory, does a Pre-manufacture Notice (PMN) have to be filed with EPA?  Is the chemical substance subject to one of the PMN exemptions?  Is the chemical substance actually a mixture?  Is the chemical substance being imported as part of an article?  Are the uses of the chemical substance limited?  Section 5 consent orders  Significant New Use Rules (SNUR)  Section 6 rules squirepattonboggs.com squirepattonboggs.com 6 6

Current TSCA Reform Legislation  Chemical Safety Improvement Act (S. 1009)  Introduced May 22, 2013 by Senators Frank Lautenberg (D-NJ) & David Vitter (R- LA) with 25 bipartisan cosponsors • April 2013 – Senator Lautenberg had introduced S. 696, the “Safe Chemicals Act of 2013”  Hearing held in Senate EPW Committee on July 31, 2013  Chemicals in Commerce Act (H.R. ____)  Multiple hearings held on TSCA reform issues by the House E&C Subcommittee on Environment & the Economy  U.S. House discussion draft released in February 2014 by Rep. John Shimkus (R- IL) (subcommittee chair) • Revised discussion draft released in April 2014 • Democratic redline edits released in May 2014  Bill not yet introduced squirepattonboggs.com squirepattonboggs.com 7 7

Chemical Safety Improvement Act & Chemicals in Commerce Act  Key aspects of both bills:  Set a safety standard for new and existing chemicals  Require EPA to make a safety determination for existing chemicals in commerce  Require EPA to prioritize existing chemicals (as high or low priority) for evaluation  Require EPA to designate existing chemicals as active or inactive  Require EPA to consider vulnerable subpopulations in evaluating chemicals  Give EPA authority to issue orders to require testing of chemicals  Eliminate the “least burdensome” language for chemical restrictions  Put limits on confidential business information (CBI) claims  Allow EPA to share CBI with states squirepattonboggs.com squirepattonboggs.com 8 8

Chemical Safety Improvement Act & Chemicals in Commerce Act  Comments made by critics about both bills:  Use an “unreasonable risk under intended conditions of use” standard  Have language preempting state regulation of chemicals under various circumstances (and CSIA has language affecting state tort actions)  Do not set deadlines for EPA action  Do not require a minimum data set for chemicals  Do not require quick action on the “worst” chemicals (i.e., PBTs)  Do not adequately protect vulnerable populations  Require a form of cost-benefit analysis for chemical restrictions  Require EPA to develop multiple policies and guidance documents, subject to notice and comment, before taking various actions  Limit EPA’s ability to declassify existing CBI claims  Do not provide a source of increased funding to EPA squirepattonboggs.com squirepattonboggs.com 9 9

Toxic Substances Control Act (TSCA)  Enacted in 1976  Signed into law by President Gerald Ford  Applies to chemical manufacturers, importers and processers  Covers chemical substances and mixtures, but does not regulate:  Substances that are regulated as pesticides under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA)  Drugs, cosmetics and other items regulated under the Federal Food, Drug & Cosmetic Act (FFDCA)  Material regulated under the Atomic Energy Act (AEA)  Tobacco and tobacco products  Articles taxed under § 4181 of the Internal Revenue Code (firearms & ammunition)  Requires EPA to coordinate with, and sometime defer to action by, other federal agencies (e.g., FDA, CPSC) squirepattonboggs.com squirepattonboggs.com 10 10

TSCA Requirements  In general, if a chemical substance is not listed on the TSCA Inventory, it cannot be produced, distributed, sold or imported in the US.  Roughly 85,000 substances are listed on the TSCA Inventory  With certain limited exceptions, any person who “manufacturers for commercial purpose” any “new chemical substance” must file a premanufacture notice (PMN) for that substance with US EPA.  A “new chemical substance” is any substance that is not listed on the TSCA Chemical Substance Inventory (TSCA Inventory)  EPA has 90 days to review a PMN  Exemptions: research and development (R&D); low volume (LVE); test marketing (TME); low environmental release and human exposure (LoREX); certain polymers  Exceptions: mixtures; imported articles squirepattonboggs.com squirepattonboggs.com 11 11

Key TSCA Provisions  Section 5: Manufacturing and Processing Notices  PMNs & SNURs  Section 6: Regulation of Hazardous Chemical Substances and Mixtures  Authorizes EPA to take a range of actions to control a chemical hazard that “presents or will present an unreasonable risk of injury to health or the environment.”  Section 4: Testing of Chemical Substances and Mixtures  Gives EPA limited authority to require development of test data on existing chemicals  Section 8: Reporting and Retention of Information § 8a reporting  § 8d health & safety studies  § 8c records of significant adverse reactions to health or the environment alleged to have been  caused by the substance or mixture § 8e “substantial risk” information   Section 12: Exports  Must give notice to EPA before certain substances can be exported  Section 13: Imports  Must file certification that substance complies with TSCA or is not subject to TSCA squirepattonboggs.com squirepattonboggs.com 12 12

Recent EPA Actions under TSCA  Ten Action Plans issued in 2009 - 2010  Increasing use of Section 5 Significant New Use Rules (SNURs) for both new and existing chemicals  April 2013 GAO report: from 2009 to 2012, EPA issued SNURs affecting 540 chemicals (25% of the 2,180 chemicals subject to SNURs issued since 1976)  New Chemical Data Reporting (CDR) Rule (August 2011)  Priority list of 83 “work plan” chemicals announced for risk assessment and potential risk management (March 2012)  Draft risk assessments on five of the chemicals released for public comment in January 2013: Antimony Trioxide (ATO) (CASRN 1309-64-4); 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,- • hexamethylcyclopenta[g]-2-benzopyran (HHCB) (CASRN 1222-05-5); Methylene Chloride (or dichloromethane (DCM)) (CASRN 75-09-2); Trichloroethylene (TCE) (CASRN 79-01-6); N- Methylpyrrolidone (NMP) (CASRN 872-50-4)  Final risk assessment for TCE issued in June 2014  Group of flame retardants also identified for review and risk assessment  Planned TSCA rulemaking on disclosure of chemicals used in hydraulic fracturing (ANPR issued May 2014) squirepattonboggs.com squirepattonboggs.com 13 13