20101117 GMAFINAL MaineBPADesignationAlternativesAnalyses

							Ms Andrea Lani
November 17, 2010




November 17, 2010

Andrea Lani
Maine Department of Environmental Protection
17 State House Station
Augusta, ME 04333

Fax: 207-287-7826

       Re: GMA Comments on REVISED Chapter 8821, Designation of Bisphenol A as a
    Priority Chemical and Regulation of Bisphenol A in Children’s Products, “For inclusion
                             in the Chapter 882 public record.”

Dear Ms. Lani:

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 Maine’s Chemicals Management
initiative, and submits this letter in response to Maine’s Department of Environmental
Protection (DEP) recently revised Chp 882 regulations, “Designation of Bisphenol A as a
Priority Chemical and Regulation of Bisphenol A in Children’s Products (October 26,
2010)”. Unfortunately, BPA’s designation as priority chemical does not achieve the
objective of the broader framework to create a deliberate and focused program to drive
real and efficient public health and environmental improvements. Instead, it will have
questionable value in improving the safety of consumer products in Maine all the while
wasting precious limited resources.

GMA continues to advocate for key elements in establishing authority to identify,
assess, and manage high priority chemicals. GMA is a strong supporter of a risk-based

1
    http://www.maine.gov/dep/oc/safechem/ch882draftproposedrevisedd.pdf


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Ms Andrea Lani
November 17, 2010


prioritization and qualitative “weight-of-evidence” approach to help in the priority-
setting process. GMA has been notably active in Maine’s effort on chemicals
management since it began in 2008 with the passage of its Act to Protect Children’s
Health and the Environment from Toxic Chemicals in Children’s Products (LD 2048 –
Pingree under P.L. c. 643). Together with our partners at the Maine Impacted
Stakeholder Coalition and the Food Packaging Coalition, GMA has provided substantive
and constructive comments and suggestions at every step of the process - through
participation at public workshops, testimony at Public Hearings, comment submissions
during the drafting of Maine’s Chemical Use in Children’s Products Regulations, and
comment submissions as Maine’s regulatory proposal on BPA continues to be vetted.2
GMA has listened closely and carefully to DEP and to the public’s questions and
concerns. GMA has contributed a significant number of creative solutions to address
those. GMA incorporates by reference our formal submissions to this process (please
see footnote 2 for links).

GMA continues to assert that:
  (i) Designation of BPA as priority chemical is improper;
  (ii) A robust federal regulatory framework currently exists for food contact
           substances; and,
  (iii) Furthermore, infant formula (and baby food) manufacturers, by themselves, are
           in no position to submit alternatives analyses work plans for potential
           alternatives to BPA in epoxy-lined cans, as they rely on their packaging
           suppliers to provide them with these materials. The baby food/infant
           formula manufacturers’ expertise is with manufacturing of baby food/infant
           formula, not with the packaging that contains them.

GMA appreciates the opportunity to provide below further feedback on Maine DEP’s
REVISED Draft Rule.




2
 Maine’s Department of Environmental Protection’s (DEP) Chemical Use in Children’s Products Regulatory Proposal (Chp
880/881)
» 1st Set of GMA Comments on Maine's Toxic Chemicals in Children's Products Proposed Regulations (3/4/09) (Word)
» 2nd Set of GMA Comments on Maine's Toxic Chemicals in Children's Products Proposed Regulations (4/27/09) (Word)
» 3rd Set of GMA Comments on Maine's Toxic Chemicals in Children's Products Proposed Regulations (12/16/09) (PDF)
» 4th Set of GMA Comments on Maine's Toxic Chemicals in Children's Products Proposed Regulations (1/11/10) (PDF)
» 1st Set of Maine Impacted Stakeholder Coalition Cover Letter and Comments (12/15/09) (PDF)
» Maine Impacted Stakeholderd Coalition Regulatory Proposal (12/15/09) (PDF)
» 2nd Set of Main Impacted Stakeholder Coalition Comments (1/11/10) (PDF)
» Maine Food Packaging Coalition Cover Letter (12/16/09) (PDF)
» Maine Food Packaging Coalition Comments (12/16/09) (PDF)
» Bill Greggs Testimony Regarding Maine BEP (12/1/09) (PDF)
Maine’s Department of Environmental Protection’s (DEP) Chemical Specific Regulatory Proposals
» GMA Comments on DEP’s Designation of BPA as Priority Chemical – Chp 882 (8/30/10) (Word)


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Ms Andrea Lani
November 17, 2010


     I. BPA Designation as Priority Chemical

As previously noted in GMA’s August 30 comments, the designation of BPA by Maine
DEP as priority chemical is flawed. The prerequisites for designation of BPA as priority
chemical have NOT been met, and do not adhere to the mandates of the statute 3. “[A]
chemical may be included on the list only if it has been identified by an authoritative
governmental entity on the basis of credible scientific evidence as being known as… a
carcinogen, a reproductive or developmental toxicant or an endocrine disruptor …”
(emphasis added) The known hazard criterion has not been met. BPA is NOT KNOWN
to be a reproductive/developmental toxicant nor an Endocrine Disruptor.

At a recent international expert meeting, the World Health Organization4 reiterated that
“initiation of public health measures would be premature…”

     II. FDA Regulation of Food Contact Substances

In terms of Food Contact Substances generally, FDA has established a comprehensive
regulatory framework for food-contact material. GMA incorporates by reference the
Food Packaging Coalition comments dated December 16, 2009. The scope of FDA’s
regulations leaves no room for Maine DEP to regulate food-contact material. Maine
DEP’s intent to regulate BPA used in the epoxy-lining of canned baby foods and infant
formula unduly interferes with the well-established federal regulatory scheme.

Also, contrary to the Department’s assertions (in response to stakeholder comments
submitted by January 11, 2010) that, “The proposed rule does not conflict with federal
regulations on its face, and as with any regulation, the Department will not apply it in
practice in a manner that conflicts with federal regulations,” Chapter 882 would be in
direct conflict with the federal regulatory scheme. Only FDA has the authority to
approve any alternatives to BPA for food contact applications. Furthermore, FDA is
engaged on this issue, considering alternatives, developing guidance document on
endocrine disruption, developing pharmacokinetic data on BPA, and developing the
Chemical Evaluation Risk Estimation System (CERES) which would evaluate risks from
exposure (to be functional by end of 2010). As a matter of fact, EPA has deferred any
human health determinations for BPA in its Chemical Action Plan to FDA.




3
  MRSA Chapter 16-D: TOXIC CHEMICALS IN CHILDREN'S PRODUCTS - 38 MRSA § 1693, and Chp 880 Adopted Rule
(http://www.mainelegislature.org/legis/Statutes/38/title38sec1693.html)
4
  World Health Organization.Summary of November 2010 Expert Meeting to Review the Toxicological and Health Aspects of
BPA.(http://www.who.int/foodsafety/chem/chemicals/bisphenol_release/en/index.html) “The experts were also able to model
circulating levels of BPA in the human body, which are very low, indicating that BPA is not accumulated in the body and is rapidly
eliminated through urine … The meeting concluded that, at this stage, it is difficult to interpret the relevance of these studies in
the light of current knowledge of this compound. Until these associations can be confirmed, initiation of public health measures
would be premature.” (emphasis added)

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Ms Andrea Lani
November 17, 2010


        III. New Proposed Language for Alternatives Assessment

It is well known that BPA serves a critical function in protecting the integrity of certain
metal packaging components. Epoxy coatings containing BPA have unparalleled
performance across a wide range of critical parameters, including toughness, adhesion,
formability and resistance under high-temperature processing conditions. Because
metal packaging enables a significantly longer shelf-life than other kinds of packaging,
canned goods are the mainstay for providing nutritious, economical food around the
world, and for special programs, e.g., USDA’s Women, Infants and Children (WIC)
assistance program, food pantries, disaster relief, special military rations. Epoxy
coatings have been used safely to protect the world’s food supply for over 30 years.

Specifically, as it pertains to the new proposed language5 in which baby food and infant
formula manufacturers are required to conduct alternatives assessment for containers
(of baby food and infant formula) that contain intentionally-added bisphenol A (or to
incur the costs to have one done)6, it is highly unlikely that within the food packaging
context a baby food/infant formula manufacturer by themselves will possess the
necessary knowledge and expertise to identify appropriate alternatives to BPA and
evaluate their safety, effectiveness, and compatibility within the packaging material
matrix. Additionally, the formulations for food-contact materials are trade secret and
highly confidential.

Nevertheless, the infant formula industry, for example, is partnering with its food
packaging suppliers to identify measures that will help minimize migration of trace
levels of BPA from the packaging into the food it contains. They are also working
together with the packaging industry and FDA to aggressively research and identify
possible alternatives to current packaging.

All major coating and can manufacturers continue to innovate, research, and develop
new coating chemistries for commercial food applications.


5
    The proposed language (Section 4(A)(B)[1]) states:

             “No later than January 1, 2012, the manufacturer of infant formula or baby food that is sold in a plastic
             container, jar or can that contains intentionally-added bisphenol A, shall submit to the department an assessment
             of the availability, cost, feasibility and performance, including potential for harm to human health and the
             environment, of alternatives to bisphenol A, polycarbonate plastic or epoxy resin, and the reason bisphenol A,
             polycarbonate plastic or epoxy resin is used in the manufacture of the infant formula and or baby food
             container, jar or can in lieu of identified alternatives. This assessment must, at a minimum, include all of the
             elements of an acceptable assessment listed in 06-096 CMR* Chapter 880 Regulation of Chemical Use in
             Children’s Products.” *http://www.maine.gov/dep/rwm/rules/pdf/ch880_basis_statement

6
  http://www.maine.gov/dep/oc/safechem/ch882_%20factsheetcomment.pdf “FISCAL IMPACT OF THE RULE: Manufacturers of
infant formula and baby food sold in containers that contain intentionally-added bisphenol A will incur costs in conducting an
alternatives assessment. Alternatives assessments conducted for the department for mercury and brominated flame retardants have
cost $25,000 (mercury added button batteries) to $50,000 (mercury added devices and switches), and $215,700 (dec-BDE in shipping
pallets).”

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Ms Andrea Lani
November 17, 2010


                            *       *     *       *      *

GMA remains committed to assisting the Department in developing a Chemicals
Management program that helps identify priority chemicals of real concern for further
evaluation, which may indeed have the potential to significantly improve children’s
health and the environment.

 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,




Greg Costa
Director, State Affairs
Grocery Manufacturers Association
1350 I St NW, Suite 300,
Washington, D.C. 20005
(518) 584-5098
GCosta@gmaonline.org

Cc:    Ginger Jordan-Hillier, Maine DEP
       Terry Hanson
       Acting Commissioner Beth Nagusky, Esq.
       Karin Tilberg, Governor’s Office
       Governor John E. Baldacci
       John James, Maine’s Bureau of Remediation and Waste Management




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