An Editorial by Richard A. Becker, director of the California EPA's Office of Environmental Health Hazard Assessment.
Nearly 10 years ago, voters in California passed a unique
right-to-know initiative that changed how businesses inform their
customers, employees, and neighbors about potentially harmful
chemicals.
The Safe Drinking Water and Toxic Enforcement Act of 1986, more commonly known as Proposition 65, is premised on the notion that the people of California have a right to be warned about exposures to chemicals known to the state to cause cancer, birth defects, or other reproductive harm. The proposition requires that the governor of California publish a list of these substances. It mandates that a "clear and reasonable warning" be provided prior to exposing anyone to a chemical on the list, and it prohibits the discharge of listed chemicals to any source of drinking water. The governor, by executive order, gave lead agency responsibility for overseeing the implementation of Proposition 65 to the Office of Environmental Health Hazard Assessment (OEHHA), a department in the California Environmental Protection Agency (Cal/EPA).
Proposition 65 has a number of important features. First and most fundamentally, Proposition 65 shifts the burden of proof from the regulatory agency to the business. Warning is required and discharge to a source of drinking water is prohibited unless the business can show that the exposure in question does not result in a "significant risk." Thus businesses have an incentive to seek clarity with regard to hazards and risks posed by chemicals -- an incentive not provided under typical regulatory approaches. OEHHA has worked diligently to adopt "no significant risk" exposure levels for listed chemicals.
Second, in many respects Proposition 65 is a market-oriented approach. Rather than relying on command and control, Proposition 65 uses disclosure of information and assignment of labeling as risk management tools. The market, rather than any administrative agency of the government, is the risk manager. The public has a greater awareness of the potential risks posed by different products and compounds, and as a result, the incentive to change product formulation comes from the market -- not from a government agency.
Finally, Proposition 65 is intended to be self-enforcing, in that notice of violations of the proposition can be filed by private parties if the attorney general or other designated enforcement officials choose not to take the case. Though rare, such private party suits can result in private parties recovering attorney fees and a portion of any fines and penalties.
Much has happened these past 10 years. Nearly 580 chemicals have been listed, 25 of those chemicals being listed since February 1995, when I joined OEHHA. These accomplishments are admirable. However, our office is working hard to make this program the best it can be as we enter a second decade.
Observers and participants will be able to count on several firm, reliable rules as we move forward:
The changes initiated since 1995 are evidence that Cal/EPA and OEHHA have, first of all, worked hard to ensure that placement of a chemical on the list is done in accordance with rigorous science and an open public process, and second, attempted to minimize any unnecessary regulatory burdens.
As each of these reforms wind their way from proposal through public comment and refinement, I hope I can count on continued support by those with valuable insight and scientific studies regarding the compounds proposed for listing. I am confident that the success of these reforms will come from a partnership built on the free exchange of ideas and information.
Tangible improvements completed or underway include a prioritization mechanism to assess which chemicals pose the greatest hazard and evaluate those first; obtaining more complete information and public comment on chemicals that are deemed to be eligible for listing based on one of the proposition's administrative listing mechanisms; creating a "delisting" procedure; clarifying information that must be contained in a "60-day notice" of intent to sue under the proposition; and ensuring that our evaluations are based on sound, up-to-date science. I would like to discuss each of these in more detail.
Prioritization. Common sense tells us to focus and move quickly on chemicals with the greatest potential public health hazard. Using the application of sound science, this process will ensure that the compounds that pose the highest threat of cancer, birth defects, or other reproductive harm be considered first. The prioritization process has been under development and refinement for approximately two years, and has evolved and been improved by open public discussion and comment on OEHHA's draft proposals and refinements.
At its July 1996 meeting, the Cancer Identification Committee -- one of two subcommittees of the Science Advisory Board charged with identifying chemicals that have been clearly shown to cause cancer or reproductive toxicity -- indicated its desire to concentrate its scientific efforts not on low hazard chemicals, but on the ones posing the greatest cancer or reproductive toxicity threat to Californians. In response, OEHHA conducted a workshop on November 15 to discuss some refinements and the draft prioritization status of various chemicals. At appropriate points, we request public comment to enter into this process.
There are two important refinements we should emphasize. First we perform a "triage" and review to make sure chemicals posing the highest hazard to humans to cause cancer or reproductive harm are the highest priority candidates for committee review.
Second, we ensure a fully open process. We solicit scientific data, we release a draft proposal for public review and comment, and then OEHHA conducts a workshop to discuss scientific issues.
I cannot stress this second step enough. OEHHA does not have a monopoly on sound, objective science. OEHHA must diligently request, obtain, and use the latest scientific findings from leading thinkers and researchers irrespective of affiliation. Whether the source is academia, government, industry, or a chemical company -- good science is good science! We have an obligation to take a hard look at each scientific study, so that our analysis is complete. This open exchange of data and analysis is the cornerstone of the scientific process and is a core value of our vision for OEHHA as an impartial, completely objective risk assessment organization built upon open scientific processes, peer involvement, and peer review.
Administrative Listings. We have also worked to open up the process to obtain information and initiate dialog on important and evolving scientific findings pertaining to the administrative listing mechanisms provided under Proposition 65. We have an open door policy and encourage all interested individuals or organizations to talk with us if there are any concerns. As the administrative processes existed before, in practical terms outside parties had little time to comment, or even learn very much in advance of any actions we were considering with respect to listing.
One of the administrative listing mechanisms requires that a chemical be added to the list if an "authoritative body" has formally identified it as causing cancer or reproductive toxicity. By the proposition, the state's qualified experts may select the authoritative bodies. Those that have been identified are organizations recognized as having scientific expertise, such as U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, the International Agency for Research on Cancer, and other established authorities charged with assuring public health. Our process now provides for preliminary identification by staff of chemicals which may meet the listing criteria, and, importantly, outreach and request for relevant and pertinent data. This allows for outside parties to submit additional information that may not be readily available to us, or updated data. This process is conducted openly and the scientific and regulatory issues identified are discussed in an open, public forum. So far, 23 chemicals since January 1995 have been listed through this open process, and this process continues. A workshop was conducted in October to receive input from a data call-in on 10 chemicals that appear to meet the criteria for listing under the labeling or the authoritative bodies provisions.
So far, this effort to shed sunlight on our process has resulted in several important issues and analyses having been brought to our attention, ensuring that the decisions we reach are based on scientifically sound and the most up-to-date data.
Delisting. At the outset, the proposal to implement a delisting mechanism to remove chemicals from the list -- if new scientific knowledge indicates that it is appropriate to do so -- may appear somewhat controversial. On closer examination, I believe reasonable minds will agree this proposal is consistent with sound scientific methods.
Our proposal is quite simple. Based on the opinion of the state's qualified experts on the OEHHA Science Advisory Board committees, if new scientific knowledge indicates that it is appropriate to remove from the Proposition 65 list a chemical that was placed on the list by action of the committee, then a mechanism should be available to do so. If science can show that a compound does not pose the risk that we once thought it did, this body should be able to remove it from the list.
This proposal has also been up for review and discussed at several public forums. An additional opportunity for public comment and discussion will occur at our December 4, 1996, DART meeting. Science is not static, but a discipline in constant evolution. This is particularly true for the fields of toxicology and risk assessment. It is important, as new knowledge is obtained and we understand more about how chemicals cause toxic effects, that a mechanism be available to translate this new understanding, if warranted, to action by providing the state's expert committees the ability to remove a chemical from the Proposition 65 list.
60-Day Notice. Because of the unique nature of this proposition, we face many challenges in bringing common sense and sound science to the forefront. However, we recognize that refinement is widely endorsed. For example, I think it has been clear to many people for some time that there needed to be clarification of the information that must be contained in a 60-day notice of intent to sue under the proposition. Along these lines, our office has conducted two public hearings on proposed regulatory changes to the requirements for 60-day notice of intent to sue. We can expect to see these changes in place by early 1997.
I think reasonable people, familiar with the contentious, apprehensive history of the Proposition 65 process with regard to these 60-day notices, will see the following proposed requirements are a vast improvement over the previous lack of direction. These proposed requirements are not burdensome but will provide important and needed clarification.
Scientific Practices. Turning now to the broader issue of advancing our scientific practices, a distinguished panel of outside scientists are concluding a comprehensive, year-long, review of Cal/EPA risk assessment policies, practices, and guidelines. This statutorily mandated committee, (SB 1082, State Senator Charles Calderon) known as the Risk Assessment Advisory Committee, is making more than 100 specific recommendations aimed at ensuring that Cal/EPA's risk assessments are based on sound, up-to-date science, objectively and consistently applied.
Importantly, the committee found that our risk assessments, in general, are of good quality both from the perspective of scientific credibility and professional practice. Nevertheless, the committee's report indicates that chemical risk assessment is a young and still evolving area in environmental health sciences and, as such, needs to undergo continuous improvement to reflect the latest scientific thinking and methodologies.
With respect to Proposition 65, the committee noted that the hazard listing process by the State's qualified experts has evolved into an effective structure. However, the committee noted and highlighted one area of Proposition 65 -- the language in the proposition that in effect requires dividing the no observed effect level for birth defects or other reproductive harm by 1,000 -- as a practice that is at variance with risk assessment practices at the federal level, different from regular approaches for all other forms of toxicity assessments outside of cancer, and "is contrary to a strong Committee belief that the risk assessment process must foster the consideration of new scientific knowledge."
In addition, the committee suggested that Cal/EPA convene a process that provides review of its practices and procedures in the area of Proposition 65 authoritative body listing processes. The committee suggested as topics to be considered:
OEHHA is already implementing several key projects that will assure more consistency and use of up-to-date scientific methods in its policies, practices and procedures of risk assessment. Translating the committee's recommendations into action will improve Proposition 65.
Conclusion. All these efforts -- reforming, improving, making the Proposition 65 process more open than ever -- work toward a common end: that sound, objective science be consistently applied in Proposition 65 implementation. We strive to get all relevant data and scientific analysis to the table early on, so that when the information reaches the Science Advisory Board, it has a complete and objective picture of the potential hazard posed by a chemical.
Taken together, these initiatives represent OEHHA's contribution to Cal/EPA's overriding environmental goals -- to provide clarity and openness to our processes, to use sound science as the foundation for regulatory actions, and to maintain the high environmental standards that California citizens enjoy.
As the above activities indicate, the implementation of Proposition 65 continues to evolve to accommodate sound science and active public participation. The noted changes are intended to inspire renewed confidence and shed additional light upon Proposition 65 implementation.
As a unique component in the state's ongoing effort to
sustain the health and safety standards that residents of
California enjoy, Proposition 65 appears ready to enter a second
decade protecting the rights of California residents to know
about potentially harmful chemicals and compounds in their
environment.
Editorial posted on November 19, 1996.
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