Sound Science. Innovative Solutions.
MAY 2010
NEWS

www.thesapphiregroup.com
301.657.8008
                                      
FROM THE PRESIDENT’S DESK:

Science-based Policy or Policy-based Science?

This month, the President’s Cancer Panel (the Panel) released a report which attributed much of the incidence of cancer in this country to environmental risk factors. The Panel urged policymakers "to use the power of your office to remove the carcinogens and other toxins from our food, water, and air that needlessly increase health care costs, cripple our nation's productivity, and devastate American lives."

The report also recommends that Americans: 
  • Remove shoes before entering the home to avoid tracking in chemicals such as pesticides; 
  • Use stainless steel, glass or BPA-free plastic water bottles; 
  • Use ceramic or glass in the microwave instead of plastic containers; and, 
  • Minimize consumption of processed, charred or well-done meats, which may contain heterocyclic amines and polyaromatic hydrocarbons.
The Panel’s work elicited a critical response from other authorities, most notably the American Cancer Society. The ACS took issue with the report’s contention that pollution is the primary factor behind the current cancer rates in this country. ACS estimates that only 6 percent of U.S. cancer cases can be linked to environmental factors, with two thirds of those caused by workplace exposures. ACS epidemiologist Dr. Michael Thun cautioned that an overemphasis on the environment could divert attention and resources away from larger and more easily addressable risk factors. He cited tobacco as the cause of 30 percent of U.S. cancer deaths, adding that poor nutrition, obesity and lack of exercise all exert larger influences than pollution.

The controversy generated by the report illustrates several shortcomings under which U.S. science policy commonly labors. The links between chemicals and health impacts are frequently considered in the abstract, with insufficient attention paid to real-world factors such as routes and frequency of exposure, elective risk behaviors, and the practicality of chemical substitution to reduce resultant risks. An example of this approach to chemical regulation is evident in the 2008 Consumer Product Safety Improvement Act (CPSIA). It is well established that lead is highly toxic, and particularly harmful to the cognitive development of children. However, it was misguided for Congress to require the removal of lead from “children’s products” such as motorcycles and golf clubs that are very unlikely to be swallowed or mouthed. Moreover, the CPSIA established testing requirements which were unattainable at the time. As the article below indicates, Congress is now forced to revisit this overreach.

NEXT MONTH – Revisions to the Toxic Substances Control Act (TSCA)
Will the lessons learned from the CPSIA experience be applied to the Toxic Substances Control Act (TSCA) currently being considered for revision by the House and Senate? TSCA modernization and its implications will be a featured subject of next month’s TSG News.

Richard P. Hubner, President


About Us

The Sapphire Group is an international risk management consulting firm specializing in integrating applied science into decision-making. We provide strategic planning to protect health while advancing business goals & objectives. We do this by utilizing our core expertise in toxicology, risk analysis, exposure assessment, dose-response assessment, epidemiology, industrial hygiene, regulatory negotiation, risk communication, crisis management, litigation support, & product stewardship. In so doing, we are able to excel in providing de novo scientific evaluations & strategies; third-party review of science & its interpretation; intelligence gathering & strategy development; and assistance with science advocacy & regulatory affairs.

LOCATIONS

Corporate Headquarters
3 Bethesda Metro Center Suite 830
Bethesda, MD 20814
T: 301/657-8008
F: 301/657-8558

United Kingdom
89 Heath End Road
Blackwell Heath
Bucks
HP10 9EW, UK
T: 44(0) 1628 520 494
F: 44(0) 1628 520 494


House Panel Weighs Changes to the CPSIA

The House Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection held an April 29 hearing on draft legislation to amend the Consumer Product Safety Improvement Act of 2008 (CPSIA). The subcommittee’s action comes in response to complaints from product manufacturers that the CPSIA over-regulates lead and phthalates in products and components to which children are unlikely to be exposed.

The CPSIA was in large part a reaction to recalls of children’s toys and jewelry that contained excessive lead levels. In several cases, these items had been mouthed or ingested, and lead poisoning resulted. However, Congress applied the tighter content limits and third-party testing requirement to all “children’s products,” a category that by statute includes products marketed to individuals as old as twelve.

Consequently, manufacturers of products such as ATV’s, youth furniture, golf clubs, and other items rarely mouthed by infants and toddlers have faced compliance and testing burdens. The Consumer Product Safety Commission (CPSC) has exempted a number of products from the lead provisions upon a showing that lead components were inaccessible to children. However, industries who have pursued such exemptions call the process cumbersome and expensive.

Likewise, the CPSC has stayed a requirement that children’s products undergo testing by third-party analytical laboratories. But that moratorium expires in February 2011, at which point a shortage of lab capacity is anticipated.

Section 2 of the draft corrections bill establishes criteria to guide CPSC’s exemption of products from the lead specifications. To do so, the CPSC would need to find that (1) removing lead from the item is not practicable or technologically feasible; (2) that the item is unlikely to be mouthed or ingested, even when misused; and, (3) the exemption would have “no measurable adverse effect” on public health.

The draft bill also exempts from the phthalate provisions of the CPSIA components that are not physically exposed to children by reason of being encased, sealed or covered. CPSC is directed to promulgate guidance on what components should be considered inaccessible under this standard.

At the hearing, discussion focused on the CPSIA’s lead provisions. Rep. Joe Barton (R-TX) maintained that lawmakers never intended the CPSIA to cover lead in products such as motor vehicles or sporting goods. Former full panel chair John Dingell (D-MI) blamed these excesses on ill-advised provisions included by the Senate. He noted that the House version of the bill passed the committee and the House almost unanimously.

Regarding the draft bill, Republicans lawmakers and industry witnesses contended that Section 2 terms such as “practicable” and “no measurable adverse effect” were subject to interpretation. They worried that CPSC might use ambiguous language to continue a “zero tolerance” approach to lead. Subcommittee Chairman Bobby Rush (D-IL) said his intent was to rationalize lead enforcement, and offered to develop report language that would more precisely lay out the committee’s understanding of Section 2.

Industry witnesses recommended that a corrections bill specifically authorize CPSC to employ risk assessment in its implementation of CPSIA’s lead provisions. Manufacturers of ATVs, motorcycles, footwear, and educational toys said that the likelihood of exposure and routes of exposure should be considered.

Rachel Weintraub (Consumer Federation) opposed such a change. She said that prior to CPSIA, the agency had the authority to regulate based on risk and misused it to allow dangerous products into commerce. She emphasized the developmental effects of even low levels of lead exposure. Weintraub believed the three-part test of Section 2 strikes an appropriate balance between safety and practicality. 

Rep. Dingell asked if the corrections bill should allow X-ray fluorescence (XRF) testing as a substitute for deconstructive testing of lead in coatings and substrates. All of the industry witnesses felt it should. CPSC has so far encouraged XRF testing as a screening tool, but not for compliance determination.

With its experience in regulatory compliance and laboratory analysis, The Sapphire Group has been helping manufacturers and importers to meet their obligations under the CPSIA. We will work with you to identify safer materials and designs, formulate sampling plans, and manage compliance documentation. We have also reserved capacity at reputable testing labs for the exclusive use of our clients. Please contact us at info@thesapphiregroup.com .

Focus on Key People at The Sapphire Group

Russell B. Batson, Esq., Program Manager of The Sapphire Group™, is a legislative and regulatory counsel who has effectively represented business interests for over two decades. His approach to advocacy emphasizes lifecycle issue management, including early engagement with non-governmental standards organizations whose work can influence government policy; shaping legislative activity and administrative rulemakings with credible science and economics; outreach to journalists and other opinion leaders; and assisting clients to prepare for litigation. Mr. Batson also utilizes coalitions and non-traditional alliances to advance client interests, and strives to harmonize federal and state regulatory requirements.

The integration of Mr. Batson’s public policy expertise with The Sapphire Group’s proven competency in science provides turn-key solutions for our clients’ environmental, health, and regulatory challenges.