Grocery Manufacturers Association

Comments—Safer Consumer Product Alternative Proposed Regulation

November 1, 2010

Mr. Jeff Woled, Regulations Coordinator

Department of Toxic Substances Control

P.O. Box 806

Sacramento, CA 95812-0806

Re: Comments on Proposed Regulation - Safer Consumer Product Alternatives

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 September 13, 2010 Proposed Regulation for Safer Consumer Product Alternatives. We recognize the extensive DTSC staff efforts that have gone into developing this proposal.

GMA supports California’s Green Chemistry Initiative (GCI) and advocated for 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.

However, the Proposed Regulation unnecessarily goes well beyond this straightforward task. It does not achieve the objective of the statutes to create a deliberate and focused program to drive real and efficient public health and environmental improvements. Instead, it would create an unworkable and overly bureaucratic program that will require a huge staff at DTSC; will dramatically increase the already high cost of doing business in California; will promote needless and excessively bureaucratic paperwork requirements for virtually every product change on every item in California commerce, thereby hindering rather than promoting green innovation. Most unfortunately of all, it will have questionable value in improving the safety of consumer products in California.

The proposal applies last century’s command and control regulatory approaches to 21st century challenges; invents unique to California scientific approaches, ignoring the statute’s mandate to use available information from federal and international sources; envisions a system that will require virtually unlimited government and business resources in a resource constrained world; envisions extensive, unnecessary data call-ins; structures responsibility for alternatives analysis in such a way that every entity in the supply chain is responsible, ensuring that this will be slow, over-burdensome and costly at best and completely unmanageable at worst; describes punitive regulatory responses with no sense of proportion indicated for their application; and acts as if proprietary confidential information is owned not by its developers but by society as a whole and thus should be assumed to be public information to be shared with domestic and international competitors.

This regulation should create a straightforward, timely, transparent, stepwise and risk-based process in which the state can: 1) identify the highest priority chemicals as chemicals of concern; 2) identify those products containing the chemicals of concern that may pose a safety concern considering product use and exposure; 3) identify for those products whether there are suitable alternatives; 4) make final determinations on regulatory risk management choices as identified in AB 1879.

GMA asserts that the Proposed Regulation does not accomplish these straightforward goals, but unnecessarily and needlessly goes well beyond to create an inefficient, bureaucratic and ultimately sclerotic system that will freeze innovation on every physical item in commerce from paper clips to jet planes. It will be unworkable, and as a result will not have the intended result of improving public health and the environment for Californians.

This outcome is extremely disappointing to GMA. In addition to supporting the passage of AB1879 and SB509, we have been notably active in the Green Chemistry initiative since it’s inception in 2007. Together with our partners at the Green Chemistry Alliance (GCA) and the Food Packaging Coalition, we have provided substantive and constructive comments and suggestions at every step of the program—in Phase 1 with Principles and to the blogs;on DTSC Questions and drafts of AB1879/SB509 in Phase 2; in Phase 3 on the Wiki, on the Toxics Information Clearinghouse,througha detailed proposal by GCA for a Draft Regulation, on the Straw Proposal, on the Draft Regulation Outline,on the 6/2010 Draft Regulation and OEHHA’s pre-draft Regulation proposal. We have made public presentations and participated atnumerous DTSC and OEHHA workshops, webcasts, symposia, and other public meetings as well as in meetings with the Department. We have listened closely and carefully to DTSC and public questions and concerns and have contributed a significant numberof creative solutions to address those. GMAincorporates by reference our formal submissions to this process—they are listed in the Appendix to these comments and attached. Some of this input has been incorporated, establishingimportant provisions in the Proposed Regulation.

However, in analyzing the Proposed Regulation, many of the most important ideas and approaches have not been incorporated, or have been included in ways that will not drive innovation to promoteimprovements in public health and the environment for Californians. There are numerous concerns detailed in GMA’s attached comments. The most notable and egregious, identified below are not necessary, go beyond the authority provided in the statute, are not clear to the regulated community and/or are inconsistent. They will make this program slow, unworkable and counterproductive to the goals of Green Chemistry. Many of these also ignore the statute’s mandate to look to the chemical management approaches taken in other national and international jurisdictions to improve the efficiency and effectiveness of California’s program. The regulation proposes:

  • Unnecessary expansion of the definition of Chemicals of Concern
  • Unnecessary, unauthorized and unworkably burdensome Chemical/Product Removal Notifications and Tier 1 AA Notifications/Reports that create a tremendous paperwork burden and establish a de facto pre-market registration requirement
  • Regulatory duplication provisions that exceed statutory authority and are unnecessarily expansive
  • An appropriate de minimis default, but references to other regulations that must be modified based onthe extent of exposure in order to be rational in the context of exposure from consumer products; the concept of a “0” de minimis that is unnecessary and scientifically not supportable; the notification process for seeking exemptions from the regulation that is unnecessary, unauthorized and bureaucratically burdensome
  • A new“unintentionally added” concept and associated provisions that are unnecessary, overly restrictive, unclear and render the concept of intentionally added meaningless within the regulation
  • An unnecessarily restrictive approach of “…no exposure pathway…” for exemption of chemicals and products rather than an approach based on “reasonable and foreseeable use and exposure” that is the basis for federal and international product safety regulations
  • The inclusion of intermediate manufacturing processes and materials in the regulation that is unnecessary and goes beyond statutory authority.
  • An unauthorized and unnecessarily extensive request for data from manufacturers.
  • California unique definitions for reliable information, hazard traits, bioaccumulation, persistence, chemical, chemical substance and nanomaterials that do not follow nationally and internationally accepted approaches
  • An inconsistent standard for evaluating comparative product performance in the Tier II AA that should be solely focused on “maintaining and enhancing” product performance.
  • Unnecessarily breaking the Tier II AA into two parts (separating hazard/exposure analysis fromperformance, cost, feasibility and lifecycle analysis), ignoring the real world product development paradigm used in every company small and large that evaluates all of these factors simultaneously and at successively more detailed levels in coming to final decisions
  • An unnecessary and burdensome system of triple redundancy on AA resulting from the requirements of lead assessors, 3rd party certification and DTSC review in preparing and reviewing AA’s
  • An unnecessarily broad definition for responsible entity which, rather than making clear who is responsible for Alternatives Analysis and regulatory action, makes the responsibility unclear and will create an inefficient and unworkably slow compliance process.
  • No clarity that Regulatory Responses must be proportional to the degree of risk
  • Unnecessarily complex and unclear confidential business information/trade secret provisions and information collection provisions that go beyond the authority of the statute.

California deserves a credible, workable, and successful program that can achieve this part of the Green Chemistry Initiative’s objectives and work together with the other five planks of the program. GMA is a member of the GCA and supports the Alliance’s 11/1/10 detailed input on the Proposed Regulation. In addition, GMA is a member of the Food Packaging Coalition (FPC) and supports the Coalition’s 11/1/10 comments on excluding food contact substances from the regulation. As can be seen from GMA’s attached detailed comments and fromthose submitted by GCA and the FPC, we have many significant and substantial concerns with the Proposed Regulation.

The Grocery Manufacturers Association remains committed to assisting the Department in developing and implementing a Green Chemistry program that will not only achieve the Green Chemistry Initiative’s objectives, but that will also be a model for the U.S. and elsewhere. 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.

Sincerely,

Caroline Silveira

Director, State Affairs

Grocery Manufacturers Association

1350 I St NW, Suite 300,

Washington, D.C.,

20005

cc: Linda Adams, California EPA

Maziar Movassaghi, DTSC

Jeff Wong, DTSC

Odette Madriago, DTSC

John Moffatt, Office of the Governor

1

Grocery Manufacturers Association

Comments—Safer Consumer Product Alternative Proposed Regulation

SCOPE

These eight provisions, taken together have the potential to draw virtually every product in California into the scope of the regulation

  1. Unnecessary expansion of the definition of Chemicals of Concern

In 69302, the Proposed Regulation on Chemical Prioritization Process, the original concept recommended by GCA (6/24/09, 11/6/09, 5/27/10, 7/19/10, 7/22/10), incorporated by reference—using a stepwise process to identify Chemicals Under Consideration, and after public notice and comment, further focusing that into a set of identified Chemicals of Concern—has been discarded. Instead, two separate ongoing lists would be developed “Chemicals Under Consideration” and “Priority Chemicals” and all chemicals on both of these lists would be identified as Chemicals of Concern. This is a perversion of the prioritization process and, together with other provisions and requirements, leads to the potential for a massive regulatory burden on every physical item in California commerce.

The statute mandates that DTSC identify and prioritize chemicals of concern and prioritize the uses of the chemicals of concern in products that should then become the subject of an Alternatives Assessment. Given the thousands of chemicals in California and the hundreds of thousands of different products and millions of components in products in California, there has been broad agreement since the very first stakeholder workshop that a step-wise approach to this prioritization was the only sensible way to screen and identify those chemical and product combinations that pose the greatest public health and environmental threats as a result of exposure to the chemical at levels that can result in human or environmental harm. In previous submissions incorporated by reference (3/10/09, 6/24/09, 11/6/09, 5/27/10, 7/19/10, 7/22/10), GMA and GCA have consistently supported this concept. For instance, we recommended that DTSC should take an initial step in chemical prioritization to identify “Chemicals Under Consideration” based on information available to the department and publish those with the reasoning that led the department to it’s conclusions. We also recommended that the department conduct public notice and comment, allowing stakeholders to provide additional information to allow the department to move forward to the next step of Identifying Chemicals of Concern.

In this concept, the Chemicals Under Consideration list plays several roles. First, is the role in a notice and comment context that allows the department to gain valuable information from the public that may not be available to the Department and help it to better inform it’s Chemical of Concern decisions. Second is its role as a queue for future Chemical of Concern decisions, allowing the department to propose and finalize Chemicals of Concern in concert with available resources. Finally, the appearance of a Chemical in the Consideration list plays the role of sending a signal of potential regulatory action to the market place. Companies making and using a Chemical under Consideration will be aware of this status and can consider its implication as they make product design, manufacturing, and formulation decisions in the normal course of business.

The Proposed Regulation, in including “finalized” Chemicals under Consideration as priority chemicals, dramatically shifts some of those roles. This new Chemicals under Consideration list continues to enable the department to gain additional information for priority setting. However, including finalized Chemicals under Consideration as Chemicals of Concern for the purposes of the regulation will dramatically increase the impact of those decisions, placing any products that “contain” the chemical in immediate regulatory jeopardy. A permanent and ever growing Chemical under Consideration list will emerge that has significant economy wide effects. Any chemicals on that finalized list have major regulatory obligations and burdens throughout the balance of the regulation and will encounter them forever, even though they may never be important enough to be finalized as “Priority Chemicals”. These burdens are placed on chemicals that the Department has not yet established meet the requirements for being Priority Chemicals. This is unnecessary, unauthorized and needlessly burdensome.

GMA objects to this approach in the strongest possible terms and asks the department to go back to the original concept—separating Chemicals under Consideration and Chemicals of Concern. Chemicals under Consideration should be just that—under consideration. The Priority Chemical term should be eliminated and returned to its previous Chemical of Concern name. No regulatory compliance burdens should be imposed on chemicals that are being considered for Chemicals of Concern.

  1. Unnecessary, unauthorized and unworkably burdensome Chemical/Product Removal Notifications and Tier 1 AA Notifications/Reports create a tremendous paperwork burden and establisha defactopre-market registration requirement

In Sections 69301.2, 69305.1, and 69305.3, the Department would require any manufacturer of a consumer product containing a chemical of concern(either a Priority Chemical ora Chemical Under Consideration) to comply with burdensome reporting requirements, including Chemical/Product Removal Notifications or Tier I AA Notifications and Reports, prior to placing redesigned products on the market or removing products from California commerce.The Removal Notifications are doubly burdensome in requiring submission first of an Intent notification and then a Confirmation Notification. This is completely counter to the stated purpose of the Safer Consumer Product Alternatives regulations, namely to bring safer products to the market quickly and efficiently.The purpose of these requirements seems to be solely to educate the Department regarding product design; the Department’s conceptual flow chart shows this as a dead-end—information to be collected and posted. The Initial Statement of Reasons states, “The AA Notification is necessary so that DTSC can keep an eye out for any regrettable substitutions….”.In doing this, the Department puts itself in the position of being the gatekeeper and scorekeeperfor any change to any product coming on the market in California. This establishes a de facto premarket registration system for products in California, a completely unjustified burden that is unnecessary, unauthorized and unworkable. In particular, the Tier I AA notification process in Section 69305.1 discourages companies from reformulating products containing a Chemical of Concern until it is identified by the state as a Priority Product containing Priority Chemicals. This will freeze innovation in California—due to paperwork and market delay burdens, the state will be the last place to see introductions of safe and more sustainable products.

Sections69301.2 and 69305.1 should be amended so that all of these are voluntary submission processes, unrelated to the timing of product introductions into California commerce. The Department should provide incentives for participation so that safer products are brought to the market quickly and will be voluntarily noticed to the Department for recognition programs.The Removal Notification should be a single voluntary submission. If the Department needs to develop its capacity in the arena of product development, it should find a more effective approach. Also, the scope of these provisions should be limited to Chemicals of Concern (Priority Chemicals) in Priority Products. If a manufacturer removes a Chemical of Concern from a Priority Product and does not replace it with a Chemical of Concern, there should be no further regulatory requirements.

  1. Regulatory duplication provisions exceed statutory authority and are unnecessarily expansive

In 69302.1, 69303.1, he regulatory duplication provisions in the regulation are far more expansive than what is provided in statute. Section 25257.1(c) of the statute provides that the department “shall not duplicate or adopt conflicting regulations for product categories already regulated or subject to pending regulation consistent with the purposes of this article.” If a product category is regulated by a federal or state agency for the same public health or environmental threatand exposure pathway 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. GMA supports and incorporates by reference detailed comments on this topic by GCA and FPC (11/1/10).

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. That regulatory scheme is consistent with the goals and purposes of the GCI. GMA supports and incorporates by reference detailed comments on this topic by FPC—the Food Packaging Coalition.