Maine Chemical Management Comments

Maine Chemical Management Comments

4/27/2009

Page 1 of 4

Re.: Draft Chapter 880 to implement P.L. c. 643 (LD 2048), An Act to Protect Children’s Health and the Environment from Toxic Chemicals and Children’s Products.

The Grocery Manufacturers Association (GMA) represents the world’s leading food, beverage and consumer products companies. The association promotes sound public policy, champions initiatives that increase productivity and growth and helps to protect the safety and security of consumer packaged goods through scientific excellence. The GMA Board of Directors is comprised of chief executive officers from the Association’s member companies. The $2.1 trillion consumer packaged goods industry employs 14 million workers and contributes over $1 trillion in added value to the nation’s economy. GMA appreciates the opportunity to continue to participate in Maine’s development of a Chemical Management program. GMA refers to comments previously submitted on March 4. GMA submits comments in response to issues raised on the Workshop agendas for April 27 and May 4 regarding:

(i) Economic concerns (impacts of inaction, impacts on other than consumers, identifying opportunities to minimize negative costs and maximize benefits to human and environmental health and for sustainable manufacturing and distribution of quality products);

(ii) Confidential Business Information;

(iii) Protocol for designating priority chemicals;

(iv) DEP resources to address additional priority chemicals beyondthe required minimum;

(v) Green Chemistry; and

(vi) Stakeholder process and timeline.

Maine PL 643 establishes theauthority to identify and manage priority chemicals. The regulations should create an integrated, timely, transparent, stepwise and risk-based process in which the state can 1) identify priority chemicals: 2) identify what products containing those chemicals may present concerns for safety; 3) identify whether there are suitable alternatives and 4) make final determinations on regulatory risk management choices.

Green Chemistry: Identification and Prioritization of Chemicals [(iii), (iv), (v) above]

In identifying priority chemicals, the state should use a risk-based prioritization approach in which both hazard and use/exposure information are considered. Focus should be indicators of high potential for hazard, e.g. CMR, PBT and on indicators of high potential for exposure, e.g. US EPA data on production level, found in drinking water, air, used in consumer products, especially those intended for children, emission/discharge data, and CDC biomonitoring information. In implementing the prioritization, the state should create an open and iterative process for involving the expertise and knowledge of stakeholders to contribute to the information used to make decisions. The process should also work to funnel or narrow the universe of chemicals from a large initial set to a final small set to concentrate on “the important few” versus the trivial many. This process will create a workable approach that produces highly evident results.

On alternatives analysis, the product research and development paradigm is an excellent analog. During R&D, improvement objectives are set, alternative approaches for achieving the improvement are identified, and alternatives are evaluated considering a number of factors. Alternatives must:

• Provide an improved profile for health and environmental issues;
• Be technologically feasible and commercially available in sufficient quantity;
• Deliver the same or better value in cost and performance;
• Be accepted by the consumer;
• Account for economic and social considerations; and
• Have potential to result in lasting change.

GMA believes that alternatives analysis must be done from a broad lifecycle perspective to avoid the potential for unintended consequences that can occur from a narrow or hazard-only approach. At the end of the day, it will always be the consumer who finally determines the performance, value and acceptance of a product and its ingredients.

In making final determinations on regulatory risk management choices, an appropriate range of potential responses to be taken after a deliberate and risk-based process with appropriate opportunity for notice-and-comment by stakeholders would be:

• Not requiring any action.
• Imposing requirements to provide additional information needed to assess a priority chemical and its potential alternatives.
• Imposing requirements on the labeling or other type of information.
• Imposing a restriction on the use of the chemical.
• Prohibiting the use of the chemical in specific uses.
• Imposing requirements that control access to or limit exposure to the chemical.
• Imposing requirements to manage the chemical at the end of its useful life, including recycling or responsible disposal.
• Imposing a requirement to fund green chemistry challenge grants where no feasible alternative exists.
• Any other outcome the agency may determine.

As a first step, Maine should work with industry and other stakeholders on voluntary programs and consumer education. This can often prevent many issues and unexpected outcomes. In making the determination, Maine needs to consider other statutes and regulations that apply, e.g. whether the chemical is approved for certain uses by regulation.

The specifics of reformulation response in the case of a restriction or ban should not be mandated, but must be left to manufacturers. Each company should determine appropriate formulation changes for its products.

As to compliance with final regulatory determinations, there are many current examples of regulations, restrictions, prohibitions, and expectations for product manufacturers. GMA members obey the law in complying with those requirements, and will continue to do so with future requirements including those from this Chemical Management effort. Many manufacturers currently disclose ingredients in their products and many more are moving to do so. This should eliminate the vast majority of concerns. In the case of a priority chemical being intentionally formulated into a product in which the use is regulated or restricted, non-disclosure could represent mis-branding. Thus, we believe that Maine should avoid any new burdensome and costly bureaucratic processes for compliance and reporting for these regulations.

Stakeholder Process and Timeline [(vi) above]

Maine's stakeholder process and timeline should provide ample opportunity for a Notice-and-Comment approach and multiple stakeholder workshops both before and after the development of regulations to guide the chemical management process. The expansion of the stakeholder process before regulations are in place would allow forelaborate discussions on the various concepts that are necessary to implement a successful chemicals management program as is being considered under the Draft Chapter 880 Rules. The current stakeholder process, four meetings, is not sufficient for a thorough discussion of the numerous chemical management structures that have been theorized or are in place. Additionally, the experts presented by the Maine DEP to guide DEP’s regulation development are not a balanced representation of the chemical management experts in the field. While the process in Maine to develop an iterative and open process is limited by the timeline set in statute, the expansion of the stakeholder process is necessary for the proper vetting of regulations that will have the power to ban products in the state of Maine.

As a comparison, California's Green Chemistry Initiative was conducted in three phases starting from Summer 2007 and not yet completed. Phase I(April 2007 - December 2007) involvedreceiving comments/recommendations from over 600 interested stakeholders regarding four challenge areas (how to move to cradle-to-cradle; green chemistry; toxics in products by design; toxics by accident) AND the Department of Toxic Substances Control (DTSC)hosting numerous seminars. Phase II (January 2008 - December 2008) was dedicated to creating the main framework by having three concurrent tracks (MainFramework, Key Elements, Science Advisory Panel), hosting numerous workshops, webinars,and receiving input from interested stakeholders. Phase III (January 2009 - present)consistsof drafting the implementing regulations for the two green chemistry legislative bills again by hosting workshops and receiving input by various means. Chemicalsmanagement is a complex issuethat requires time (i.e., years), and an open and iterative process for stakeholder engagement so that concernscan be addressed appropriately.

Confidential Business Information/ Economic Concerns [(i), (ii), (iv)above]

Available information from other nations, governments and authoritative bodies should be an important emphasis given limited resources.Maine needs some way to bring in other successful approaches, to evaluate and adapt them for the state’s situation.Maine should create a balancedscientific panel to review and comment onDEP insights from these sources.

To date, Canada has established the most efficient and effective process for doing this despite resource and information limitations. The clear focus of their legislation, single minded approach of the agencies, open and iterative process for involving stakeholders, prompt and timely capability of Canada’s data call-in process and high elected leadership support for the program have contributed to this success. There has been a very high focus to concentrate on “the important few” versus the trivial many and has led to a very workable approach producing highly evident results.

A process that emerged from a Canada/Mexico/US meeting in Montebello, the EPA Chemical Assessment and Management Program (ChAMP) program, holds a lot of promise, given strong support from agency leadership, EPA’s technical capability, more available US information and effective assessment tools. But this has been underway for just a short time, its priority in the new administration is not clear, it is voluntary and is hampered by EPA’s challenges in promptly getting adequate data for decisions.

In the 1990’s, Europe had a prioritization process but it operated very slowly with very few decisions and actions over a decade of effort. Frustration with that led directly to the development for and advocacy on REACH.

Governments developing chemical management regulations, such as Maine, should utilize already established regulations pertaining to confidential business information.Maine's limited resources can be used more efficiently through the use of available information from the federal government, other nations, other states and internationally recognized authoritative bodies.

Formulation testing is an unnecessary, costly and inefficient burden. To eliminate the majority of issues surrounding testing, many manufacturers currently disclose ingredients in their products and many more are moving to do so. In the case of a priority chemical being intentionally formulated into a product in which the use is regulated or restricted, non-disclosure could represent mis-branding or non-compliance.

If you have any questions or comments, please feel free to contact us. We look forward to our continued work together on this important public policy initiative.

Cc:Commissioner Seth H. Bradstreet, III,

Department of Agriculture, Food and Rural Resources

Commissioner John Richardson,

Department of Economic and CommunityDevelopment