Chemicals Regulation: A comparison of US and European Approaches. James Searles

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1 Chemicals Regulation: A comparison of US and European Approaches James Searles April 11, April 11, 2011

2 TSCA vs.. REACH - OVERVIEW Both TSCA and REACH aim at gathering scientific information on chemical substances for better protection of human health and the environment. But Substantial differences exist in their approach to obtain the necessary information and supply chain obligations Provisions under REACH address long-standing difficulties experienced under TSCA and previous European chemicals legislation to secure test data and make chemical industry more accountable for ensuring safety of its products; industry responsible for assessment plus its cost REACH requires broader range of data than TSCA and No data, no market 2

3 TSCA vs. REACH 1. General Descriptions USA : Toxic Substances Control Act (TSCA) Provides for reporting, recordkeeping, and testing of chemical substances and mixtures Does not cover food, drugs, cosmetics, pesticides, tobacco, nuclear material, or munitions Provides for restrictions on manufacturing, processing, distribution, or disposal of certain substances Administered by Environmental Protection Agency (EPA, Washington, D.C.) 3

4 TSCA vs. REACH EU: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Requires reporting, recordkeeping, and testing of chemical substances and mixtures Does not cover nuclear material, non-isolated intermediates, waste, substances for defence; some provisions do not apply to medicinal and veterinary products, food and feed additives; some substances considered already registered. REACH covers the manufacture, import ( placing on the market ) and use of chemical substances on their own, in preparation and articles Administered by ECHA (European Chemicals Agency, Helsinki, Finland) 4

5 TSCA vs. REACH key terms 2. Key Terms affecting coverage A. Chemical Substance definition TSCA Any organic or inorganic substance of a particular molecular identity, including - (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and (ii) any element or uncombined radical 5

6 TSCA vs. REACH - key terms (substance definition cont.) REACH A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Special cases: monomers, polymers, intermediates, substances in articles 6

7 TSCA vs. REACH - key terms B. Preparation/Mixture definition TSCA : Mixture With certain exceptions, any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction REACH: Preparation (same as mixture ) Mixture or solution composed of two or more substances. 7

8 TSCA vs. REACH - key terms C. New vs. Existing Substances TSCA Section 8(b): TSCA Inventory New chemical substance : Any chemical substance not included in EPA s TSCA Inventory Existing chemical substances are in the Inventory Includes over 84,000 existing chemical substances List is expanded to included notified new chemicals for manufacture or import 8

9 TSCA vs. REACH - key terms REACH Virtually no distinction between new and existing chemicals (main impact is on registration timing and content) Phase-in substances : substances listed in European Inventory of Existing Commercial Chemical Substances (EINECS) (over 100,000 substances); subject to transitional registration deadlines (2010, 2013, 2018) Non-phase-in substances : go directly to registration Pre-REACH New substances : substances listed in European List of Notified Chemical Substances (ELINCS) (~5,000 substances/~8,000 notifiers); deemed REACH registered (for original notifiers only) 9

10 3. Key Provisions A. Pre-Manufacture Notice / Registration TSCA - Pre-Manufacture Notice (PMN) (Section 5) Required for all new chemical substances 90 days prior to manufacture or import by individual company Exclusions for certain substances, and exemptions for low volume manufacture, low release/low exposure, research and development, and test marketing Allows EPA to act as a gatekeeper for new substances coming on to the US market 10

11 (Pre-Manufacture Notice / Registration cont.) REACH Registration (Title II) Requirement to register substances manufactured or imported in EU above 1 tonne per year (alone, in preparation or if release from articles) Registration deadline and data requirements depend on phase-in status, tonnage band and hazard profile Non-EU manufacturers may appoint an EU Only Representative taking charge of the registration obligations (avoids importer registration) Registration normally joint action of companies placing same substance on the market; sharing of data costs (via LoA), individual registration fee paid to ECHA 11

12 B. Updating TSCA (Section 5: Significant New Use) EPA may issue a Significant New Use Rule (SNUR) 90-day Significant New Use Notice (SNUN) required for such use REACH (Registration dossier updates) Update of the registration dossier mandatory if significant change, such as: production volumes, uses, substance composition, new knowledge on risks, classification and labelling, chemical safety report 12

13 C. Risk Assessment TSCA New and existing chemicals: no risk assessment required from manufacturer Existing chemicals: mandatory to inform EPA in case of new unpublished information reasonably supporting a conclusion of substantial risk Currently many chemicals are never evaluated by EPA (information deficit to be remedied by TSCA reform?) 13

14 (Risk Assessment cont.) REACH (Art 14) Mandatory risk assessment ( Chemical Safety Report ) if placing on market 10 tonnes per year Physicochemical hazard, health & environment hazard, PBT and vpvb assessment If dangerous, exposure assessment (scenarios) and risk characterisation, for all known uses/exposures Identification of Risk Management Measures (also inclusion of RMM in esdss) 14

15 D. Testing TSCA (Section 4) Does not require companies to develop new data for either new or existing chemicals unless EPA, by rule (case-by-case) requires testing, e.g. if it finds insufficient data and that manufacture, distribution, processing, use, or disposal of a chemical may i) present an unreasonable risk of injury to health or the environment, or ii) is or will be produced in significant quantities and is or may be substantial exposure to humans or environment Available hazard information must be submitted with PMN for new chemicals 15

16 (Testing cont.) REACH (Art 30) Data-sharing in general strongly encouraged, and is mandatory for existing vertebrate animal studies New studies on vertebrate animals as last resort and only after proposal to and ECHA approval All other data must be generated through new studies to be agreed amongst intending registrants (SIEF members) and carried out in time for registration dossier Testing will be necessary/more extensive for coming, lower tonnage registrations for 2013/2018 (whereas many high volume substances registered 2010 had much existing data) Cost-sharing: fair, proportionate and non-discriminatory 16

17 Tests: comparison of number of end-points TSCA REACH** New chemicals* ( 100 tonnes) Existing chemicals Substances 100 tonnes Substances 1,000 tonnes Physical/ chemical Human health Environment * Tests not required for PMN but companies normally provide on request or per EPA order ** Mandatory data 17

18 E. Disclosure of production quantities TSCA New chemicals: 3 rd year estimate Existing chemicals: 5-year reports for chemicals 25,000 pounds REACH Registration dossier includes annual tonnage information Update of the registration dossier in case of significant change of tonnages (plus additional data per new tonnage band) 18

19 F. Downstream users TSCA REACH No specific requirement relating to downstream users Right, to make use(s) known to registrant Required to report information and apply RMM Required to prepare Chemical Safety Report for any DU use falling outside registered exposure scenarios or re use advised against by supplier Required to keep available information related to REACH duties for a period of 10 years (plus successor responsibility) 19

20 G. Recordkeeping and Reporting TSCA (Section 8) 8(a): EPA may by rule require reports of manufacturers/importers and processors (e.g., Inventory Update Rule) 8(c): Manufacturers/importers and processors must keep records for certain chemicals with significant adverse health or environmental effects 8(d): EPA may by rule require submission of health and safety studies Distributors and retailers that do not manufacture, import, or process are exempt 8(e): Manufacturers/importers and processors that obtain information that reasonably supports the conclusion that a chemical substance presents a substantial risk of injury to health or the environment must immediately inform EPA 20

21 (Recordkeeping and Reporting cont.) REACH All actors in the supply chain required to assemble and keep available information related to their REACH duties for a period of 10 years after the substance or preparation has been manufactured/imported/supplied/used Record-keeping essential in light of expected effective enforcement actions by national authorities 21

22 H. Treatment of Exports and Imports TSCA (Sections 12-13) Export notification required if chemical substances are subject to submission of test data or certain EPA rules or orders Import certification Customs requires importers of chemical substances or mixtures to certify that: o Chemical substances in the shipment comply with all applicable rules or orders under TSCA; or o All chemicals in the shipment are not subject to TSCA Chemical substances, mixtures, and articles may be refused entry if they violate EPA rules or orders Articles containing chemicals do not require certification 22

23 Treatment of Exports and Imports (cont.) REACH Export: Production in EU for export same as production for EU market (for purposes of calculating registration tonnage) Imports = placing on the [EU] market, same as production within EU; Importer subject to same registration & other requirements as manufacturer Importer responsibilities may be substituted by qualified EU Only Representative (appointed by non-eu producer, for all or only certain substances exported to the EU) 23

24 I. Authorisation/Restrictions TSCA REACH TSCA generally requires EPA to demonstrate that chemicals will cause unreasonable risk and that they should have limits placed on their production or use. REACH requires chemical companies to ensure no adverse effect. Title VII Authorisation assures that risk from Substances of Very High Concern are properly controlled (substances listed in the Candidate List ): An authorisation is required for producing/importing/using substances listed in Annex XIV. Requires the risk to be adequately controlled, no suitable alternative and socio-economic benefits outweigh the risk. Title VIII Restrictions list the substances where only certain uses are allowed 24

25 J. Enforcement TSCA EPA is in charge of monitoring compliance REACH EU Member States in charge of monitoring compliance Administrative and/or criminal penalties, depending on specific Member State in question some discretion But REACH requires effective, proportionate and dissuasive penalties 25

26 K. Protection of Confidential Business Information (CBI) TSCA REACH Possibility to make confidentiality claims on nearly all information provided to EPA Possibility to make confidentiality claims but, depending on which information is claimed confidential, restrictions and even additional fees may apply General rule is disclosure except where competition or other commercial interests clearly affected by disclosure; must be justified by party concerned 26

27 TSCA Reform Similar House and Senate bills introduced in 2010 Both proposed overhaul of TSCA Toxic Chemicals Safety Act of 2010 House bill introduced in July 2010 Safe Chemicals Act of 2010 Senate bill introduced in April 2010 May be re-introduced in next months (2011) with emphasis on protection of children Substantive action not anticipated until

28 TSCA Reform What reform might look like: Higher safety standard Current: unreasonable risk to health or the environment Proposed: reasonable certainty of no harm Increased burden on manufacturers Current: notified chemicals placed in Inventory and regulated only if EPA identifies a risk Proposed: prohibition on manufacture or import of chemicals until EPA determines they meet safety standards Increased burden on processors Current: TSCA requires PMN of manufacturers, not processors, and EPA regulations often focus on manufacturers Proposed: PMN requirements for processors, and greater manufacturer reliance on processors for detailed information (supply chain information) 28

29 TSCA Reform What reform might finally look like: TSCA could look more like REACH Minimum data sets proposed for new chemicals, priority list chemicals, and eventually most all chemicals; currently many chemicals are never evaluated by EPA Chief obstacles to reform Protection of confidential business information Degree of testing for new and existing chemicals Safety standard to be met State pre-emption of federal law EPA authority to regulate articles for the first time 29

30 REACH Review REACH will be reviewed in June 2012 Unlikely to result in legal changes (heavy legislative process) Focus on evaluating and assessing the implementation of REACH New administrative improvements might be proposed Guidance rather than legislative amendments Watch out concerning polymers (potential registration as such) and nano materials. 30

31 TSCA vs. REACH - Conclusions Both TSCA and REACH aim at gathering scientific information on chemical substances for better protection of human health and the environment But substantial differences exist currently in their regulatory approach (substances covered, responsibility of industry to generate data, extent of data needed, cost of registration, ability to market without data/registration) Reform in US faces obstacles but will move in direction of REACH REACH will likely be world standard for chemicals regulation for the future Chinese industry should gear itself to REACH to ensure access to global chemicals market. 31

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