Wednesday, July 21, 2010
California is on the cusp of approving draft regulations that are proposed for California’s new Green Chemistry Initiative (GCI). Green chemistry, per the initiative, is the process for reducing or eliminating the use of hazardous materials by transitioning away from managing toxic chemicals at the end of the lifecycle, and instead reducing or eliminating their use from the start. In other words green chemistry seeks to provide incentives to remove hazardous ingredients and chemicals from products sold in California.
The statutory basis for the GCI in California was AB 1879 (2008 Cal. Stat. Chapter 599), which provides statutory authority for the California Department of Toxic Substances Control (DTSC) to adopt regulations for identifying and prioritizing “Chemicals of Concern” within consumer products and for evaluating safer alternatives to toxic chemicals. Another bill, SB 509 (2008 Cal. Stat. Chapter 560), establishes an online Toxics Information Clearinghouse to provide information about the toxicity and hazard traits of chemicals used in California. The bills also create mechanisms to provide guidance and oversight through a new Green Ribbon Science Panel of experts and by expanding the role of the Environmental Policy Council, made up of heads of the California Environmental Protection Agency boards and departments.
In March 2010, DTSC made public a conceptual process flowchart that established the framework for the regulatory process. The second step created and made public an outline of the Draft Regulations for Safer Consumer Products. This outline proposed a framework for scientific and systematic prioritization of chemicals and products of concern, preparation of alternatives assessments and development of DTSC’s regulatory responses. The next step was the development and release of the draft regulations that occurred in June.. The draft regulations specify the processes for DTSC to scientifically and systematically identify and prioritize chemicals and consumer products, for manufacturers to conduct alternatives assessments and for DTSC to impose regulatory responses for alternatives selected by manufacturers. To get a feel for the regulations, the conceptual model can be found here. The conceptual model is complex, as are the regulations, which have resulted in comments, both pro and con. Essentially the regulations apply to “all consumer products made available for use in California;” judging by the litigation that has occurred with respect to Proposition 65, this sentence provides coverage beyond the manufacturer-retailer-consumer relationship that is usually the target of this type of regulation.
“Make available for use in California” means that a person sells, offers for sale, distributes, leases, offers to lease, supplies, or otherwise transfers control overthe disposition of a consumer product directly to a California consumer; or to another person without maintaining sufficient control over the distribution, sale, lease, supply, or other transfer of the consumer product by that person to prevent the use of the consumer product by a California consumer.”
“Sell or offer for sale” means any transfer or offer to transfer for consideration of title or the right to use, by lease or sales contract, including, but not limited to, transactions conducted through sales outlets, catalogs, or the Internet, or any other similar electronic means.” CHAPTER 53 OF DIVISION 4.5 OF TITLE 22, CALIFORNIA CODE OF DRAFT REGULATIONS Sec. 69301.2 Definitions.
Products that are identified as violating the initiative cannot be sold in and must be recalled from the California market. Under the sections concerning identifying products of concern, full disclosure of the chemical makeup of the products is required. Several lists of chemicals are to be compiled including Chemicals of Concern and Chemicals under Consideration. To provide an idea of the complexity, without going into detail, the outline for 61 pages of regulations is 21 pages long.
The list of “Chemicals of Concern,” includes carcinogens, mutagens, neurotoxins and compounds that disrupt hormones, persist in the environment or accumulate in human bodies. DTSC would pick priority products that are heavily used by children, pregnant women, the elderly and other sensitive populations.
Manufacturers, suppliers and importers would have to certify to the state and to retailers that their products on the list are free of chemicals before they would be able to sell them in California. In some cases, they would also perform assessments to find safer alternatives.
There are already comments from the industry that the regulatory process is unworkable and from the environmental camp that the initiative should go farther to protect public. Comments have been submitted by various groups. The Administrative Procedures Act process calls for public hearings and a 45-day public comment period. Specific information about the APA process will be announced when the final draft regulation is available for review.
Tuesday, July 20, 2010
According to a story by the Kaiser Daily Global Health Policy Report
[a] microbicide gel containing Gilead's HIV drug tenofovir used by women before and after sex has been shown to reduce their risk of HIV infection by nearly 40%, according to a study unveiled at the International AIDS Conference-AIDS 2010, Reuters reports (Ingham, 7/19).
The Centre for the AIDS Programme of Research in South Africa (CAPRISA) trial showed that the gel "curbed the risk of infection by the human immunodeficiency virus (HIV) by 39 percent overall, but by 54 percent among those women who used it most consistently," Agence France-Presse reports (7/19). "The gel also reduced the risk of contracting genital herpes by 51 percent, a factor which could slow the spread of HIV even further, given that people with genital herpes have double the risk of getting HIV," according to the study, HealthDay News/U.S. News & World Report writes (Gardner, 7/19).
"The clinical trial of the microbicide – a 1% concentration of the drug incorporated into a colorless, odorless gel and distributed in a plastic applicator – was organized by the husband-and-wife team of Dr. Quarraisha Abdool Karim and Dr. Salim S. Abdool Karim of the Center for the AIDS Program of Research in Durban, South Africa," the Los Angeles Times reports.
As detailed in the study, published online Monday in the journal Science, researchers "enrolled 889 sexually active women between the ages of 18 and 40 in the South African province of KwaZulu-Natal; about half received the gel with microbicide and half a placebo. The women were told to use the gel in the 12 hours before they expected to have sex and in the 12 hours afterward. The researchers collected applicators to monitor compliance," according to the newspaper (Maugh, 7/20).
Hat tip to Pharmalot for highlighting a proposed bill to give the FDA mandatory recall powers:
In light of the Johnson & Johnson recall scandal, the House Committee on Oversight & Government Reform has, as promised, introduced a bill to give the FDA mandatory recall powers. The move comes after Ed Towns decried the way J&J’s McNeil Consumer Healthcare unit responded to repeated quality control problems that led to the recall of tens of millions of over-the-counter pediatric meds (back story here, here and here).
Under the legislation, which amends the Federal Food, Drug and Cosmetic Act, the FDA would have the authority to demand a recall when there is an indication that a drug has been adulterated, misbranded, or exposure to a drug may cause serious adverse health consequences or death to humans and animals (here is the bill). The J&J products, which the healthcare giant is scrambling to produce elsewhere while its Fort Washington, Pa., plant is shutdown indefinitely, were found to have a musty smell, metallic flecks or too much active ingredient. Towns accused the McNeil unit of conducting a phantom recall in hopes that regulators and consumers would not be alerted to the problems.