July 19, 2010

Maziar Movassaghi

Acting Director

Department of Toxic Substances Control

California Environmental Protection Agency

1101 I Street, 25th Floor

Sacramento, CA 95814

Re: Comments on Draft Regulations for Safer Consumer Product Alternatives

Dear Acting Director Movassaghi:

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 has appreciated the opportunity to participate in California’s Green Chemistry Initiative, and submits this letter in response to DTSC’s June 23, 2010 Draft Regulations for Safer Consumer Product Alternatives. We commend DTSC staff for the extensive efforts that have gone into developing this proposed regulation, and in responding to input from earlier Straw Proposals.

However, the Draft Regulations do not achieve the objective of the statutes to create a deliberate and focused program to drive real health and environmental improvements. Instead, they would create an overly bureaucratic program that will require a huge staff at DTSC; will further increase the high cost of doing business in California; will promote needless substitutions that could have unintended negative consequences for public health and the environment; and will have questionable value in improving the safety of consumer products.

GMA supports California’s Green Chemistry Initiative (GCI) and supported the passage of AB1879 and SB509 as key elements in establishing authority to identify, assess, and manage high priority chemicals and to establish a portal for chemical safety information.

Properly implemented, the regulations should create an integrated, timely, transparent, stepwise and risk-based process, focused on high priority chemicals of concern, in which the state can: 1) identify the high priority chemicals; 2) identify those products containing high priority chemicals that may pose a safety concern considering product use and exposure; 3) identify whether there are suitable alternatives; 4) make final determinations on regulatory risk management choices as identified in AB 1879; and, 5) establish a useful portal for chemical safety information.

GMA is a member of the Green Chemistry Alliance (GCA) and supports the Alliance’s detailed input on the Draft Regulations. In addition, GMA is a member of the Food Packaging Coalition and supports the Coalition’s past comments on excluding food contact substances from the regulations. GMA also offers the following overall comments.

GMA commends the Department for several key aspects of the Draft Regulations. The initial focus on carcinogens, mutagens, reproductive toxicants and persistent bioaccumulative and toxic substances together with the two step process in identifying chemicals under consideration then chemicals of concern followed by products under consideration then priority products helps to ensure efforts will be placed on the most important concerns. Setting a deminimis concentration at 0.1% harmonizes with other regulatory systems in the US and globally. The inclusion of a Workplan at the outset of alternatives analysis and the elimination of the Certificate of Compliance will work to support an efficient program.

Nevertheless, GMA has many substantial concerns with the Draft Regulations, most importantly including the following.

Science-based decision standard. The regulations are marked by the absence of a clear, science-based standard to support priority decisions. The regulations target situations that "pose threats to public health and the environment" or that cause "adverse impacts to public health and the environment”. GMA supported AB1879/SB509 as a means to place decisions about product safety in the hands of DTSC scientists. We do not believe that the current language provides workable standards for making such decisions in a scientifically credible and defensible manner.

Regulatory duplication. The regulatory duplication language in the regulations is far narrower than what is provided for in statute. If a product category is regulated by a federal or state agency for the same public health or environmental risk as the concern that is being addressed under DTSC’s proposal, the product category should be automatically exempted from regulation. The state should not waste its limited resources and open itself up to legal challenges on duplicative regulation. For instance, targeting food contact products, would be duplicative and in direct conflict with existing FDA regulation. Food packaging and other food contact materials are important to ensure the safety and quality of food. FDA, under federal law, has established a comprehensive regulatory scheme to ensure the safety of food-contact materials, which provides a large margin of safety. This regulatory scheme is consistent with the goals and purposes of the GCI.

• De minimis. While GMA supports DTSC inclusion of a provision for 0.1% to be the “de minimis” concentration unless the Department specifies a different level, statements made at the July 7th workshop suggest that DTSC’s plan, in situations where they believe a lower level may be appropriate, would be to specify that limit be “0”. This all-or-nothing proposition is not scientifically supportable. “0” is a technically impossible to measure regulatory standard that provides no additional benefit to public health and the environment. In a situation where DTSC scientists believe 0.1% is not appropriate as a de minimis concentration, they should calculate an alternative threshold concentration—either higher or lower. Experience in the European Classification and Labeling system (EC No. 1272/2008) is that for 85% of the over 3300 chemicals with classified hazards the de minimis is 0.1%; for the remaining 15% the EU has determined a different level—sometimes lower and sometimes higher. A related issue is that the "0" is the de minimis limit for any nanomaterial chemicals of concern, presenting the same scientifically inappropriate problem.

Intentional ingredients. Related to concerns on the de minimis provision is the lack of clarity that the regulation’s focus is intentional ingredients. This absence presents huge and expensive administration and compliance difficulties for DTSC and for businesses in California that will result in little improvement for public health and the environment. GCA has proposed language to consider chemicals in products only for those intentionally added above the de minimis threshold.

Exposure Pathway. The requirement that “there are no exposure pathways by which the chemical of concern contained in a priority product might pose a threat to public health or the environment” is radically overreaching. It means that only under the most extreme and unlikely situation imaginable would the exemption apply. DTSC should include the “reasonable and foreseeable use” concept in this provision, which is the approach used in federal and global consumer product safety regulations, i.e., “… there are no reasonable and foreseeable use and exposure pathways by which….”

Collapsed Prioritization Decisions. The Draft regulations indicate a stepwise approach to identifying Chemicals Under Consideration and then Chemicals of Concern; similarly Products under Consideration then Priority Products that contain a chemical of concern. At the Workshop on July 7, DTSC indicated that they might “collapse” this process, publishing multiple lists at once. GMA strongly disagrees with such an approach. The step-wise approach has several benefits. First it allows for public input of information to inform the Department’s decision on whether to move a chemical or product forward in the process. Second, it provides a “signal” in the marketplace, enabling businesses to make choices about the chemicals that they produce, purchase, use and sell. A collapsed process eliminates this signal and restricts the available time businesses need to make product changes.

• Data quality. It is critical that scientific information used in making decisions in the Green Chemistry program be of high quality--it must be reliable, relevant and adequate. "Peer reviewed studies", which the draft regulation currently focuses on, is not a sufficient criterion. The Organization for Economic Cooperation and Development (OECD) has developed a globally accepted method for rating the quality and reliability of studies. This methodology is used in US and OECD HPV programs and in the REACH regulation for determining data quality and reliability. It is published as Chapter 3 in the OECD's Manual for Investigation of HPV studies.

Immediate Regulatory Jeopardy. The draft regulation indicates that as soon as a Chemical is published in the "Under Consideration" list, then that chemical and any products using it are encompassed by the regulation, subject to Alternatives Analysis and other requirements of the regulations. This is completely unjustified. First, the point of the initial listing is to offer the opportunity for the public to provide information that will allow the Department to decide whether or not the chemical should move forward in the process. Second is that it defeats the concept of using this process as a signal to the marketplace. If a company removes a Chemical under Consideration from its product and does not replace it with a Chemical of Concern, there should be no further regulatory requirements.

• Intermediates. The focus of these statutes is on chemicals in products sold to consumers and the resultant exposures to consumers and the environment through their use and disposal. Inclusion of intermediates as possible priority products, even as "lower priority" is inappropriate and unnecessary.

Chemical/Product Petition Process. While GMA supports the inclusion of a petition process, we are concerned that the provisions not only fail to clearly provide for requests to remove chemicals/products from priority lists, but also that manufacturers of implicated chemicals/consumer products do not have any opportunity to provide necessary input on any chemical/product being petitioned prior to DTSC making a final “denied/approved”determination. The process must work both ways and be fully open to public comment.

Alternative Assessment (AA) Workplan and Report. GMA has a number of concerns with the AA Workplan and AA Report that are covered in detail in GCA comments. In particular, the scope of the Workplan is overly expansive, requiring information upfront that is more appropriately addressed in the Report. The Executive Summaries of the Workplan and Report include the publication of information that is Confidential, voiding the protection of Trade Secrets provided in the Statute.

Third Party Verification. Third party verification is a costly, time delaying and unnecessary step, particularly where the Chemical of Concern is removed from the Priority Product and it is not replaced with another Chemical of Concern.

Joint and Several Liability. The consumer products business comprises a linear “value-chain” that ends up with a final product that is offered for sale to consumers. Under the federal Fair Packaging and Labeling Act (FPLA) the “responsible company” for a product is printed on each product package (e.g. “manufactured by”, “distributed by”). Federal regulatory agencies as well as the California Air Resources Board use the FPLA responsible company as the focus for management of regulatory issues. DTSC should follow this model.

Confidential Information/Trade secrets. GMA supports the Confidential Business Information process set forth in AB1879 (Feuer, 2008). However, we are concerned that the Draft Regulations go beyond the statute and result in numerous issues (described in detail in the Green Chemistry Alliance comments). The net result is that the Regulation will not protect legitimate trade secrets. In particular, the Draft AA Workplan and Report provisions include requirements for providing a complete listing of ingredients in a Priority Product. There is no justification for including such information—the focus of the AA should be on the Chemical of Concern.

Exemption Provisions. These are overly and unnecessarily bureaucratic. DTSC should not have to make a declarative judgment on each submission, but rather should establish exemption criteria that are readily verifiable.

End of Life Regulatory Response. The draft regulation on end of life management as a regulatory response goes beyond the scope of statute and is overly burdensome in that it mandates take back programs. Additional methodologies for addressing end-of-life concerns must be included.

Product Information to Consumers Regulatory Response. This section requires product labeling or an informational insert in the packaging that informs the consumer that the product contains a COC for which an alternative was not substituted. If a manufacturer clearly demonstrates to DTSC the safety of the product and that substitution of the COC is not required, such labeling gives the consumer no accurate, meaningful or useful information about health or environmental risk and should not be mandated.

As can be seen from these comments and the detailed comments submitted by the GCA, the Grocery Manufacturers Association has significant concerns with the current proposal that we believe will make it unworkable, with the result that it will not have the intended result of improving public health and the environment for Californians.

GMA member companies desire a credible, workable, and successful program that can achieve the Green Chemistry Initiative’s objectives. We remain committed to assisting the Department in developing a credible and workable Green Chemistry program that will not only achieve the Green Chemistry Initiative’s objectives, but can also be a model for the U.S. 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.


Caroline Silveira

Director, State Affairs

Grocery Manufacturers Association

1350 I St NW, Suite 300,

Washington, D.C.,


cc: Linda Adams, California EPA

Jeff Wong, DTSC

Odette Madriago, DTSC

Rick Brausch, DTSC