Lorin Alusic
Director, State Affairs
Northeastern Region
141 Tremont St., Sixth Floor
Boston, MA 02111
ph 617-556-2929
fx 617-556-9944
[email protected]
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 beyond the required minimum;
(v) Green Chemistry; and
(vi) Stakeholder process and timeline.
Maine PL 643 establishes the authority 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.
GROCERY MANUFACTURERS ASSOCIATION
1350 I Street, NW :: Suite 300 :: Washington, DC 20005 :: ph 202-639-5900 :: fx 202-639-5932 :: www.gmaonline.org
Maine Chemical Management Comments
4/27/2009
Page 2 of 4
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
Maine Chemical Management Comments
4/27/2009
Page 3 of 4
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-andComment 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 for elaborate 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)
involved receiving 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 (Main Framework, Key Elements, Science
Advisory Panel), hosting numerous workshops, webinars, and receiving input from interested
stakeholders. Phase III (January 2009 - present) consists of drafting the implementing
regulations for the two green chemistry legislative bills again by hosting workshops and receiving
input by various means. Chemicals management is a complex issue that requires time (i.e.,
years), and an open and iterative process for stakeholder engagement so that concerns can 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
balanced scientific panel to review and comment on DEP 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.
Maine Chemical Management Comments
4/27/2009
Page 4 of 4
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 Community Development