CHI Opposes Harmful and Costly Chemical Regulation Bill
On Wednesday, June 11, CHI submitted a letter to Assemblywoman Sally Lieber (D-Mountain View) opposing AB 515, legislation that would require California’s Occupational Safety and Health Standards Board to duplicate its rulemaking for hundreds of chemicals that already have permissible exposure limits (PEL) standards. California already has the most stringent workplace chemical exposure limits in the nation. AB 515 would add tremendous costs to the state to implement as well as for industry to research, develop and manufacture life-saving medical technologies. CHI appreciates the author’s attempt to address concerns of the biomedical industry in her latest amendments, however they fail to recognize the complexities involved with the U.S. Food and Drug Administration (FDA) and potential disruption that could occur. CHI will testify at a legislative hearing on Monday, June 16, in the Senate Environmental Quality Committee on the measure.
Industry Participation in Stem Cell Research Threatened
On Tuesday, June 17, CHI will testify at a hearing in the Assembly Health Committee on SB 1565, authored by Senator Sheila Kuehl (D-Santa Monica). The legislation would codify intellectual property (IP) policies at the California Institute for Regenerative Medicine (CIRM) that would establish certain pricing and access requirements as a condition for receiving or licensing grants from the agency. In 2006 and 2007, CHI submitted a series of comments to CIRM outlining our position that the basic goal of IP polices should be to minimize barriers to technology transfer and that the pricing and access provisions, that were accepted by the Independent Citizens Oversight Committee (ICOC), would deter industry collaboration. Despite the inclusion of these requirements, CHI has greater concerns with codifying them into law, as it will deny the ICOC the flexibility it may need to amend such policies in the event they prove to be inadequate.
Senate Democrats Call for Tax Increase
State Senate Democrats put forth their budget proposal on Wednesday, sending a clear message as they called for $11.5 billion in new taxes while rejecting Gov. Schwarzenegger’s proposal to tap the state lottery. While the governor intends to offset his refusal to raise taxes with a plan to borrow against the future profits of the state lottery and a string of spending cuts, Assembly Democrats put forth a plan last week that would utilize the lottery while raising $6.4 billion in new revenues. Neither the Assembly nor Senate plans specify what taxes would be raised. Now that both Democratic proposals are on the table, negotiations will take place to begin reconciling their relatively minor differences. A contentious debate will follow as the governor and legislative leaders tackle the big-ticket issues of major spending cuts and taxes.
Industry Concerned with Proposed Prop. 65 Expansion
The Office of Environmental Health Hazard Assessment (OEHHA) has released a draft regulation that would establish a process for a major expansion of Proposition 65 chemical listings offering little or no opportunity for public input of scientific assessment. Proposition 65 provides that the governor must publish a list of chemicals “known to the state” to cause carcinogenicity or reproductive toxicity. Industry groups are very concerned that the expansion would automatically include listings by various groups including the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP) and the American Conference of Governmental Industrial Hygienists (ACGIH). In addition, hundreds of chemicals already on the Prop. 65 list will no longer be eligible for scientific reconsideration. OEHHA will hold a public workshop for the purpose of gathering input from interested parties concerning the issues raised by this regulatory concept on June 17, from 10:00 a.m. to noon in Room 11, at the Elihu Harris Building, located at 1515 Clay Street in Oakland, Calif. 94612. Stakeholders are encouraged to provide input at this workshop.
Sponsorship Opportunities: California Medical Technology Showcase in Sacramento
CHI is pleased to join with AdvaMed to present the California Medical Technology Showcase: An Exhibition of Technologies Improving Healthcare and Lowering Costs on Tuesday, Aug. 12, at the State Capitol. State legislators are considering legislation with the potential to impact medical technology firms' business practices and patients' access to life-enhancing and life-saving technologies. Medical technology industry leaders must build strong relationships with lawmakers to help them understand the benefits we bring to the California economy and public health. Please join CHI and AdvaMed as sponsors to educate legislators and staff on our industry's latest advancements. The day will start with breakfast for company participants, with a legislator providing an overview of the political environment, and follow with an exhibition from 11:00 a.m. to 2:00 p.m. To sponsor the event or for more information, contact Sandra Pizarro, with CHI (pizarro@chi.org or 916-233-3497) or Tom Tremble with AdvaMed (ttremble@advamed.org or 202-233-3497). ***Sponsorship deadline is Friday, June 20.