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The Styrene Information & Research Center Styrene Regulatory Update Styrene California Workshop October 28, 2009 Jack Snyder, SIRC Executive Director SIRC.

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Presentation on theme: "The Styrene Information & Research Center Styrene Regulatory Update Styrene California Workshop October 28, 2009 Jack Snyder, SIRC Executive Director SIRC."— Presentation transcript:

1 The Styrene Information & Research Center Styrene Regulatory Update Styrene California Workshop October 28, 2009 Jack Snyder, SIRC Executive Director SIRC

2 NTP Report on Carcinogens SIRC

3 NTP Report on Carcinogens What is the Report on Carcinogens (RoC)? –A Congressionally-mandated report by NIH’s National Toxicology Program (NTP) that is issued periodically; identifies substances that are “reasonably anticipated” or “known” to be a human carcinogen –Anyone may nominate a substance for review for the RoC. Styrene was nominated by a single individual. –Unlike other cancer classification schemes, the RoC does not include substances that have only “suggestive” evidence of carcinogenicity, or that are “not likely” to be carcinogenic This means there is a tendency to try to find any evidence to push a chemical over the threshold for “reasonably anticipated” SIRC

4 NTP Report on Carcinogens The styrene review to date: –Styrene is proposed for listing in the 12 th Report on Carcinogens (RoC) as “reasonably anticipated to be a human carcinogen” –NTP’s Background Document on styrene omits large amounts of data that show styrene could, at most, be characterized as having “suggestive evidence” of carcinogenicity; comments from SIRC and others ignored –NTP’s Styrene Expert Panel was heavily weighted with opinionated scientists and likewise ignored oral comments from stakeholders SIRC

5 NTP Report on Carcinogens The styrene review to date (cont.): –SIRC has communicated these concerns via letters to NTP staff, the NTP Director, and the Director of NIH – without substantive response However, some members of NTP’s Board of Scientific Counselors expressed concerns about NTP’s data assessment & conclusion at a meeting in February –Why is industry concerned? Listing in the RoC would prompt automatic listing under California’s Proposition 65. Federal, state, and foreign regulatory agencies could all reference an NTP listing. Public (mis)perception could be devastating. SIRC

6 NTP Report on Carcinogens Current status: –NTP conducted a much more balanced Expert Panel review for glass wool fibers, but the heavy metals & formaldehyde assessments are proving similar to styrene –NTP has indicated the 12 th RoC will not be finalized until late 2010 –Little media attention around proposed classification to date SIRC

7 NTP Report on Carcinogens SIRC / styrene industry action: –Legal: SIRC will file a formal grievance to NTP outlining the scientific deficiencies of RoC process. –Advocacy: We’re working with composites and boat builders groups to engage Members of Congress (e.g. letters to NIH director, possibly Secretary Sebelius at Department of HHS). –Industry Cooperation: Increased coordination with other RoC affected substance groups to share concerns, leverage pressure on NTP. SIRC

8 NTP Report on Carcinogens Industry communications: –SIRC has developed background documents and standby statements on the NTP issue, and on SIRC’s efforts to address the proposed listing. –We’re working with downstream user groups to help develop communications to workers, communities, local regulators. –We’re developing an aggressive communications response to provide accurate information on the styrene cancer data, if NTP moves to finalize a listing. SIRC

9 Proposition 65 Proposed Listing

10 Proposition 65 Listing California Proposition 65: –The Legislatively mandated “Safe Drinking Water and Toxics Enforcement Act of 1986 –Promotes clean drinking water and to keep toxic substances that are “known to the state” to cause cancer and/or developmental/reproductive effects out of consumer products –Requires consumer product and/or workplace labeling warning of exposure to listed substances (if in excess of a “no significant risk level” SIRC

11 Proposition 65 Listing Background: –A Sierra Club lawsuit decision directed Cal EPA’s OEHHA to list California Labor Code substances under Proposition 65; this includes IARC 2B “possible human carcinogens” –SIRC participated in a California Chamber lawsuit to challenge implementation of Labor Code listings; appeal planned, but likely will progress to Calif. Supreme Court level –OEHHA issued a notice of intent to list Labor Code substances, including styrene SIRC

12 Proposition 65 Listing SIRC Action: –SIRC filed its own lawsuit requesting a Preliminary Injunction to stop OEHHA from finalizing a Prop 65 listing of styrene under Labor Code Mechanism. –Court sided with SIRC and issued a stay against OEHHA listing styrene until suit is resolved. OEHHA will hold off listing any 2B “insufficient evidence” substances until suit resolved. Court supported SIRC’s legal argument that IARC “possible” carcinogens don’t meet Prop 65 statute that substances are “known to the state” to cause cancer. –Attorney General filed an answer to SIRC’s complaint. SIRC

13 Proposition 65 Listing Current / future action: –Sept. 11 : SIRC filed Motion for Judgment on the Pleadings –Sept. 25 : Atty. Gen. filed opposition to motion for judgment on the pleadings –Nov. 9 : Hearing on Motion for Judgment on the Pleadings –Whichever party loses will likely file appeal SIRC

14 Proposition 65 Listing Communications: –Moderate media reporting on OEHHA’s notice of intent to list, which has diminished. –Moderate media reporting when SIRC filed lawsuit, and when court granted stay; also has fallen off. –SIRC has standby materials to address media inquiries and to assist downstream users in communicating with employees, customers and communities. SIRC

15 Other Issues

16 Green Chemistry Initiative Another new California action on the horizon, with potential to impact styrene Established by CalEPA in April 2007 –Characterized as an effort to reduce the impact of toxic chemicals on public health / environment –Intention is to create a comprehensive list of toxic chemicals made, used and sold in the state –Seeks to replace them, when practical, with “greener” alternatives SIRC

17 Green Chemistry Initiative Mixed reaction from industry –Okay if alternative processes are comparatively better than existing –Some groups support concept of “comprehensive” approach to regulation vs. chemical-by-chemical –But underlying expectation is that it could quickly lead to bans on certain chemicals, materials or processes SIRC

18 Green Chemistry Initiative Initiative is currently going through organizational phases –Phase 1 = Identify broad policy options –Phase 2 = Begin to develop plans to implement key elements identified in Phase 1 report –One likely outcome will be requirement to establish an IRIS- like list of chemicals SIRC is monitoring options for public input to establish policy options –Should view Initiative as potential concern for increased substance-specific bans, likely without balanced analysis SIRC

19 EPA IRIS Review Integrated Risk Information System (IRIS) EPA electronic database listing health effects of chemicals and other substances –Widely referenced by EPA, other federal agencies, states, and other countries Listings include an inhalation reference concentration, an oral (ingestion) reference dose, and a carcinogen classification –For styrene, IRIS lists an RfC and RfD, but hasn’t finalized a cancer classification SIRC

20 EPA IRIS Review Styrene’s review has been in-process for 10+ years…initiated in 1998 Time line continually pushed back –Current target for draft = 3 rd quarter 2010 –Internal review to be completed by end of 2010 –Dates for additional review steps not posted yet No current indication that IRIS office is aggressively working on styrene SIRC

21 EPA IRIS Review EPA issued new review procedures for IRIS assessments that shut out stakeholder input – including ability for other federal agencies to weigh-in on proposed classifications –Some IRIS staff very resistant to industry input –Also resistant to using new science, like mode of action NTP issue management & communications response plans will be a good model for addressing IRIS when the time comes SIRC

22 Styrene Transitional Annex XV Restrictions Dossier U.K. HSE as the assigned Member State Competent Authority (MS CA) has submitted (01/12/08) an Annex XV Transitional Restrictions Dossier to the European Chemicals Agency (EChA) The Dossier confirms Carcinogenicity and Mutagenicity “No Classification”; Reproductive Toxicity still Open – “No Classification”, Category “3” or “2” – closure to be handled under REACh process The Dossier proposes restrictions in the form of stricter exposure limits UK HSE proposes that restrictions only come into force after REACh registration dossier submission Community wide and national occupational exposure measures can be implemented beforehand by EU Commission

23 Applications impacted by restriction proposal (DNEL 4 ppm) - Production of Unsaturated Polyester (UP) Styrene resin - Manufacture of Glass Reinforced Plastic (GRP) - Consumer use of Styrene-containing resins, as both pastes and liquids - Boat-building by non-professionals Estimated UPR/GRP market : Tons Industry sectors currently not working at a 4 ppm level (more like ppm today) : 90 to 95%. Assuming that even some closed mold activities would not meet the 4 ppm level today 800*0,95*40% styrene = Tons of Styrene at risk Transitional Annex XV Restriction Dossier - Market Impact

24 Follow-up to Annex XV transitional dossier submission 1) Industry proceeding with the completion and submission of the REACh registration dossier by December 2010 ensuring the Classification and Labelling of Styrene matches the available scientific information. 2) The Styrene transitional dossier has been processed by EChA & will undergo no further scrutiny by the Agency. Should a Member State wish to take action they would need to submit an official Annex XV dossier (see next slide & subsequent action plan). 3) Developing the required scientific argument to justify an appropriate OEL for all Styrene uses. This includes an expert re-evaluation of the Derived No Effect Level (DNEL) calculations in the transitional dossier & will be included in the registration dossier. 4) Following up proactive engagement of CEFIC and PlasticsEurope with NGO groups such as ChemSec to have substances such as Styrene removed from their priority lists based on scientific argumentation. 5) Requested the removal of Styrene from the European Commission’s “Priority List of Substances for further evaluation” with respect to its possible activity as an endocrine disrupter.

25 Annex XV lays down the general principles for preparing a dossier to propose: 1)The harmonised classification and labelling of a substance as carcinogenic, mutagenic and toxic to reproduction (CMR), as a respiratory sensitiser and other effects - 6 month process from dossier submission to final proposal to EU Com - 45 day Public consultation period via EChA website 2) The identification of a substance as a CMR Cat 1 or Cat 2, PBT, vPvB or a substance of equivalent concern (“substances of very high concern” (SVHC) - 18 month process from dossier submission to final proposal to EU Com - 45 day Public consultation period via EChA website 3) Restrictions on the manufacture, placing on the market or use of a substance within the EU community - 18 months process from dossier submission to final proposal to EU Com - 6 month Public consultation period via EChA website No appeal process currently foreseen under EChA & REACh operating rules Annex XV of REACH Legislation

26 Styrene Regulatory Affairs Action Plan: Annex XV Harmonised Classification & Labelling dossier If an EU Member State Competent Authority (MS CA) submits such a dossier before registration dossier submission: 1) Ensure that the necessary scientific data used to defend Styrene CMR non- classification under the Existing Substance Regulation is up to date and ready for use under the REACh Regulation. 2) Engage with the relevant MS CA and EChA Risk Assessment Committee (RAC) representatives as soon as the dossier public consultation period commences. 3) Submit all relevant data to EChA & the assigned dossier rapporteur SSC/O. Sloan Sept ‘09


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