Beveridge & Diamond
 

Bisphenol A Ban Proposals Proliferate

Beveridge & Diamond, P.C., April 17, 2009

Chemical-specific legislative proposals are increasingly common across the country, where states or localities propose to regulate the content of products sold in interstate commerce, effectively regulating those products nationwide.  Products containing mercury, phthalates, brominated flame retardants, and other chemicals of concern have been the subject of many such bills, but products containing bisphenol A (“BPA”) have been attracting the most attention in 2009.

In January 2009, Beveridge & Diamond circulated a client alert, available here, highlighting BPA developments occurring in 2008.  The alert explained that the current BPA controversy, and resulting increased public concern, revolves around results of “low dose” studies indicating that BPA may cause adverse health effects at exposure levels well below the “no observable adverse effect level” obtained through traditional toxicology studies.  The alert further explained that after weighing the evidence, national government regulatory agencies around the world maintain the position that BPA is generally safe at current exposure levels (with the limited exception of Canada, as explained below).  Nevertheless, federal, state, and local legislatures have proposed numerous measures aimed to restrict the use of BPA in children’s products, and in food and beverage containers.

In addition, the marketplace is reacting to public concern about BPA.  Several retailers have committed not to sell certain products containing BPA, and some product manufacturers have committed to reformulate their products to eliminate use of BPA.  Given the unsettled state of the science and the lack of regulatory agency support for BPA restrictions, the current drive to eliminate key uses of BPA is remarkable.

This article summarizes current legislative activity concerning BPA, publicly announced corporate deselection efforts, and the industry’s response to such initiatives.  Attachment A details the proposed bills currently under consideration.

Background

BPA is a monomer used in the production of polycarbonate plastic and epoxy resins, among other uses.  These, in turn, are used in a variety of everyday products across several industries.  Those receiving the most media attention recently include baby bottles, sippy cups, and sports bottles (using polycarbonate); and the inner linings for food and beverage containers (using epoxy resins).  Other uses of such materials include optical media, such as compact discs and DVDs; construction materials; safety equipment; medical equipment; electronics; composites for storage tanks, gas bottles, and windmill blades; adhesives for buildings, construction, and automobiles; and coil coatings for office furniture and household appliances.[1]

In 2008, BPA received public attention after reports from the National Toxicology Program and Health Canada and Environment Canada indicated that there may be cause for concern over the safety of BPA at current exposure levels.  In certain circumstances, traces of BPA can leach out of the polycarbonate plastics or epoxy resins at low concentrations.  As a result, through food and beverage consumption, people may be exposed to the chemical.  The debate surrounding the safety of BPA, therefore, largely concerns what level of consumption is safe for adults, children, and infants. 

The BPA safety debate presents two opposing views, depending on how the “low dose” studies are regarded.  As discussed in our previous client alert, on the one hand, some discount the “low dose” studies and accordingly find current BPA exposure levels to be safe.  For example, the U.S. Food and Drug Administration (“FDA”) recently reiterated its position that:

With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe, and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.[2] 

FDA is continuing to study BPA safety.[3]

Health Canada plans to propose a ban on polycarbonate baby bottles and other actions as a precaution, but it nevertheless maintains that:

Health Canada’s Food Directorate has concluded that the current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and infants.”[4] 

Such views are echoed by Japan’s National Institute of Advanced Industrial Science and Technology, and the European Food Safety Authority (“EFSA”).[5]  The food safety agency for Australia and New Zealand has joined in as well, saying:

FSANZ has assessed the risk to infants from exposure to BPA and concurred with the conclusions reached by the US FDA and the EFSA that the levels of exposure are very low and do not pose a significant health risk.[6]

On the other hand, others consider the “low dose” studies sufficiently reliable to support concern about current exposure levels.  They include, for example, the National Toxicology Program and numerous advocacy groups.

In light of this debate, numerous new laws have been proposed across the country, on the national, state, and local levels, restricting the use of BPA in certain products. 

Legislative Activity Concerning BPA

Federal Legislation

Congress is currently considering three bills restricting the use of BPA -- a Senate and House bill that would enact the “Ban Poisonous Additives Act of 2009” (S. 593 and H.R. 1523), and a Senate bill that would enact the “BPA-Free Kids Act” (S. 753).  S. 593 and H.R. 1523, identical bills, were introduced by Senators Feinstein (D-CA) and Schumer (D-NY) on March 12, and Representatives Markey (D-MA) and Baldwin (D-WI) on March 16, respectively.[7]  By amending the Federal Food, Drug, and Cosmetic Act (“FFDCA”), the bills would ban BPA in food and beverage containers.  Under current law, one way in which food may be deemed adulterated, and thereby prohibited from entering interstate commerce, is “if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.”[8]  S. 593/H.R. 1523 would categorize a container “that is composed, in whole of in part, of bisphenol A, or that can release bisphenol A into food”  as such a container contemplated in that provision of the FFDCA.  Accordingly, under the bills, food and beverage containers “composed” of BPA, or capable of releasing BPA, would render food adulterated for purposes of the FFDCA and thereby be prohibited from entering interstate commerce.  In addition to treating containers “composed of”, or capable of releasing BPA as adulterating food under the FFDCA, the bills further provide that:

  • the Act would apply to reusable food containers, as well as containers that are packed with food;
  • the Secretary of Health and Human Services would be permitted to grant a waiver to facilities that can demonstrate that it is not technologically feasible to replace BPA in certain containers for certain foods, and can submit a timeline for replacing BPA in such;
  • the Secretary of Health and Human Services would be required to review every five years certain food substances generally recognized as safe by FDA; and
  • states would be permitted to adopt more stringent laws, laws that pertain to a different product or category, or laws that require a BPA warning label.

The bills are pending before the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce, respectively. 

On March 31, 2009, Senator Schumer reintroduced his “BPA-Free Kids Act” (S. 753).[9]   The bill was introduced last year, but gained no traction before the end of the 110th Congress.  S. 753 would prohibit the manufacture and sale of food and beverage containers containing BPA that are intended for children under three years of age.  In addition, the bill would require that:

  • plastics and product manufacturers test plastic resins used to ensure they are BPA-free;
  • the Consumer Product Safety Commission audit the plastic resin data provided to the Commission by suppliers of plastic resins and manufacturers of children’s food and beverage containers;
  • the Commission randomly test children’s food and beverage containers on store shelves to ensure such containers are BPA-free;
  • consumer-friendly labeling is utilized; and 
  • criminal and civil penalties be imposed for violations.[10]

S. 753 is currently pending before the Senate Committee on Commerce, Science, and Transportation.

State & Local Legislation

Legislative restrictions of BPA are also being considered in a variety of state and local jurisdictions.  In just the first quarter of 2009, across 19 states, nearly 40 measures have been proposed concerning the regulation of BPA.  Those states include California, Connecticut, Hawaii, Illinois, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Texas, Vermont, and Washington.  Currently, Connecticut is positioned as a state to watch as House Bill 6572 recently received a favorable committee report.[11]  Approvals by the Legislative Commissioner, the House, the Senate, and the Governor, however, are required before the bill would become law.   A detailed listing of pending BPA legislation is provided in Attachment A, available here.

In April 2009, the first BPA ban in the country was enacted on a local level.[12]  Suffolk County, New York Executive Steve Levy signed a bill that prohibits the sale of young children’s empty beverage containers, e.g., baby bottles and sippy cups, made from BPA.[13]  Media reports indicate that other counties, such as Nassau County, are also considering similar bans.

The scope of affected products varies greatly among the pending legislative restrictions.  Most measures concern baby bottles, sippy cups, and children’s products, but some do concern food and beverage containers generally.  Among those concerning children’s products, the applicable age for the intended use of the products ranges from age three to fourteen.  California Senate Bill 797, for example, proposes to ban BPA from certain products intended primarily for children under the age of three years.[14]   New York Assembly Bill 4602, however, pertains to child care products intended for use by a child under the age of fourteen years.[15]

Corporate Deselection

Some retailers are not waiting for government action.  Instead, they are voluntarily removing BPA from their stores.   Last year, Wal-Mart, the world’s largest retailer, announced plans to stop selling bottles with BPA.[16]  Closely following suit was Toys “R” Us, which indicated that “in light of growing consumer concerns . . . the company has been working with manufacturers to phase out all baby bottles and other baby feeding products containing BPA in its Toys “R” Us  and  Babies “R” Us stores nationwide.”[17] 

Some product manufacturers are reformulating their products to eliminate reliance on BPA.  Nalgene, a manufacture of plastic sports bottles, announced a phase-out of BPA in its consumer products.[18]  This year, at the request of attorneys general from Connecticut, New Jersey, and Delaware, the six largest baby bottle manufacturers agreed to stop using the chemical in U.S. bottles.  These included Avent, Disney First Years, Gerber, Dr. Brown, Playtex, and Evenflow.[19]  Avent cited decreasing distribution avenues as its rationale, given the recent retailer decisions to ban the sale of such products.[20] 

The Industry Perspective

In response to the increased media attention and proposed restrictive policies, the chemical industry maintains the position that BPA is safe at current exposure levels.  In statements on BPA, the American Chemistry Council (“ACC”) relies on studies supporting the safety of BPA that have been evaluated by national government agencies, such as FDA and others in Europe and Japan.[21]  Most recently, in responding to manufacturers’ decisions to not use BPA in baby bottles, ACC emphasized its commitment to provide products that protect human health and safety, as well as its commitment to “inform credible, transparent scientific assessments of BPA . . . .”[22]

Like the ACC, the North American Metal Packaging Alliance (“NAMPA”) maintains the position that BPA is safe in food contact applications.  The organization advocated against the recently introduced federal bills to ban the chemical from certain products, stating that the legislation “represents a misguided reaction to unfounded fears and demonstrates a complete disregard for the broad consensus among international regulatory authorities regarding the safety of BPA in food-contact applications.”[23] 

The Can Manufacturers Institute agrees, commenting that can coatings result in minimal BPA exposure and pose “no health risk that has been recognized by any governmental authority.”[24]

The International Formula Council also relies on the government-reviewed science concerning the safety of BPA, and recommends “no changes in feeding practices for infants.”[25]

In a 2008 guide on BPA, the Grocery Manufacturers Association concluded that “BPA presents no tangible danger to humans.”[26]  As a result, the group states, neither FDA nor the World Health Organization has deemed it necessary to set any regulatory guidelines on BPA.  The group encourages research initiatives for the purpose of advancing credible knowledge of BPA’s effect in humans.

Conclusion

The use of BPA in certain products continues to receive attention from lawmakers, companies, NGOs, and the general public.  The Obama Administration nominee for FDA Commissioner, Dr. Margaret Hamburg, if confirmed, and Deputy Commissioner Dr. Joshua Sharfstein will have to engage with this issue. 

Beveridge & Diamond continues to monitor BPA developments.

* * * * * *

For more information on this topic, please contact Mark Duvall (mduvall@bdlaw.com) or Rea Harrison (rharrison@bdlaw.com).


[1] For a detailed listing of polycarbonate plastic and epoxy resins usage, see PlasticsEurope: Association of Plastics Manufacturers, Applications
of Bisphenol A
(2007), http://www.bisphenol-a-europe.org/uploads/
BPA%20applications.pdf
.

[2] Press Release, FDA, FDA Statement on Regulatory Meeting with Manufacturers and Users of Bisphenol A-containing Materials (Feb. 9, 2009), http://www.fda.gov/bbs/topics/NEWS/2009/NEW01955.html.

[3] See FDA, slides for Science Board meeting of Feb. 24, 2009, www.fda
.gov/ohrms/dockets/ac/09/slides/2009-4415s1-00-
Index.html
.

[4] Health Canada, Bisphenol A (n.d.), http://www.hc-sc.gc.ca/fn-an/securit/packag-emball/bpa/index-eng.php.

[5] See Japanese National Institute of Advanced Industrial Science and Technology Research Center for Chemical Risk Management;
Bisphenol A Risk Assessment Document, http://unit.aist.go.jp/
riss/crm/mainmenu/e_1-10.html
; European Food Safety Authority,
Statement of EFSA on a Study Associating Bisphenol A with
Medical Disorders
(Oct. 22, 2008), http://www.efsa.europa.eu
/cs/BlobServer/Statement/cef_ej838_statement%20on%20 bpa_
medical%20disorders_statem_en.pdf?ssbinary=true
.

[6] Food Standards Australia New Zealand (FSANZ), Bisphenol A (BPA) and Food Packaging, http://www.foodstandards.gov.au/newsroom/
factsheets/factsheets2009/bisphenolabpaandfood4218.cfm
.

[7] Ban Poisonous Additives Act of 2009, S. 593, 111th Cong. (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s593is.pdf; Ban Poisonous Additives Act of 2009, H.R. 1523, 111th Cong. (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1523ih.pdf. 

[8] FFDCA § 402(a)(6), 21 U.S.C. § 342(a)(6) (2008) (defining adulterated food); FFDCA § 301, 21 U.S.C. § 331 (2008) (prohibiting adulterated food).

[9] BPA-Free Kids Act, S. 753, 111th Cong. (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s753is.pdf

[10] Id.

[11] H.B. 6572 (Conn. 2009), available at http://www.cga.ct.gov/
asp/cgabillstatus/cgabillstatus.asp?selBillType=Bill&bill_num=6572&which_year=2009
.

[12] In 2006, San Francisco passed an ordinance prohibiting the manufacture, distribution, and sale of toys or child care articles intended
for children under three years of age that contain BPA.  The law was later repealed.  See City of San Francisco Repeals Ban on Bisphenol A in Children’s Products (May 29, 2007), http://www.bisphenol-a.org/whatsNew/20070531SanFranciscoRepeal.html.

[13] Press Release, Suffolk County Government, Suffolk County Executive Steve Levy Signs Legislature Stern’s BPA Ban, http://www.co.suffolk.ny.us/departments/CountyExec/2009%20Press%20Releases/Levy%20Signs%20BPA%20Ban.aspx 

[14] S.B. 797, (Cal. 2009), available at http://www.leginfo.ca.gov/cgi-bin/postquery?bill_number=sb_797&sess=CUR&house=B&author=pavley.

[15] A.B. 4602, Assembly (N.Y. 2009), available at http://assembly.state.
ny.us/leg/?bn=A04602
.

[16] Ylan Q. Mui, Wal-Mart to Pull Bottles Made with Chemical BPA, Washington Post, Apr. 18, 2009, at D01, available at http://www.washing
tonpost.com/wp-dyn/content/article/2008/04/17/AR2008041704205.html

[17] Toys “R” Us, Bisphenol A Questions, https://www2.toysrus.com/safety/safetyFAQs.cfm#baq.

[18] Press Release, Nalgene, Nalgene to Phase Out Production of Consumer Bottles Containing BPA (Apr. 18, 2008), http://www.
nalgene-outdoor.com/PDFs/08NAL_BPA_PR.pdf
.

[19] Press Release, Connecticut Attorney General’s Office, Attorney General Announces Baby Bottle Makers Agree To Stop Using BPA; Calls For Legislative Ban (Mar. 5, 2009), http://www.ct.gov/ag/cwp/view.asp?A=3673 &Q=435360.

[20] Lyndsey Layton, No BPA for Baby Bottles in U.S., Washington Post, Mar. 6, 2009, at A6, available at http://www.washingtonpost.com/wp-dyn/content/article/2009/03/05/AR2009030503285.html.

[21] Press Release, ACC, New Bisphenol A Study has Limited Capability to Assess Human Health Effects, Sept. 16, 2008, http://www.american
chemistry.com/s_acc/bin.asp?CID=206&DID=7967&DOC=FILE.PDF
; Press Release, ACC, ACC Statement on Manufacturers Decision Not to Use Bisphenol A in Baby Bottles, Mar. 6, 2009, http://www.americanchemistry.com/s_acc/bin.asp?CID=206&DID=9237&DOC=FILE.PDF.

[22] Press Release, ACC, ACC Statement on Manufacturers Decision
Not to Use Bisphenol A in Baby Bottles
(Mar. 6, 2009), http://www.americanchemistry.com/s_acc/bin.asp?CID=206&DID=9237&DOC=FILE.PDF.

[23] Press Release, NAMPA, Statement of the North American Metal Packaging Alliance (NAMPA) in Response to Feinstein Legislation/
S. 593
(Mar. 19, 2009), http://www.metal-pack.org/docs/pdf/00043135.PDF,

[24] Can Manufacturers Institute, CMI Statement Regarding BPA (May 17, 2009), http://www.cancentral.com/pdf/CMI_BPA_Statement_2.pdf.

[25] Press Release, International Formula Council, International Formula Council (IFC) Supports Sound Science as Criteria for the Use of
Bisphenol A (BPA)
(Apr. 28, 2008), http://www.infantformula.org
/newsroom_2008-04-28.html
.

[26] Grocery Manufacturers Association, Bisphenol A: A Guide for Consumers, Policymakers, and the Media (2008),  http://www.gmabrands.
com/publications/SciPol_Bisphenol.pdf
.