Green Chemistry Update: Maine Releases BPA Alternatives Assessment Report
The State of Maine recently took another significant step in implementing its Green Chemistry statute, known as the Toxic Chemicals in Children's Products law.[1] On December 11, 2012, Maine's Department of Environmental Protection (DEP) published its alternatives assessment (AA) for bisphenol A (BPA). The AA report, which was commissioned by DEP and completed on the state's behalf by an outside consultant, focuses specifically on BPA used in infant formula cans and baby food jar lids, and examines potential alternatives to BPA for use in such products. The report concludes that, while there are presently no readily available alternatives to BPA for use in infant food packaging, polyethylene (PE) appears to be the most promising replacement candidate based on a number of factors when compared to other non-BPA options.
Although the full implications of the report are not yet known, it certainly has the potential to have lasting effects in a number of areas involving BPA and Green Chemistry initiatives generally. As we discuss below, not only might the AA prompt Maine to expand its existing ban on certain products containing BPA,[2] it could also impact the likelihood of product liability litigation targeting the chemical, as well as influence how other states proceed with their own AA programs.
Background
In January 2011, Maine designated BPA as a "priority chemical" pursuant to its Green Chemistry statute and regulations.[3] Under this framework, if a priority chemical has been intentionally added to a children's product, then the manufacturer must report its presence in the product at levels above a practical quantitation threshold. Priority chemicals that are present in a product only as contaminants must be reported if they are in amounts above 100 ppm unless the company can demonstrate to DEP's satisfaction that a system of manufacturing controls is in place to minimize the contamination. Initial reports from the manufacturers were due in October 2011.
As part of this process, Maine required manufacturers of children's products, including infant formula and baby food packaging that contain intentionally-added BPA, to report on the presence, quantity, and function of BPA in their products. In addition, Maine required these manufacturers to assess the feasibility of using potential BPA alternatives and submit these findings to the state.[4] Manufacturers filed their reports with DEP between October 2011 and May 2012. In June 2012, however, environmental groups submitted a petition requesting that the state expand the scope of its BPA ban and demanding that Maine conduct its own AA, taking the position that the manufacturers' assessments were "inadequate." In response, DEP commissioned its own report.
The AA Report
The AA report begins by summarizing scientific studies regarding BPA, finding that the literature does not conclusively support a determination that low levels of human exposure to BPA are harmful. Specifically, it states that "there is lack of consensus about impacts to human health, even at very low-dose exposure."[5] The AA report continues by noting that "[s]tudies employing standardized toxicity tests used globally for regulatory decision making thus far have supported the safety of current low levels of human exposure to BPA….Overall, the current literature cannot yet be fully interpreted for biological or experimental consistency or for relevance to human health."[6]
Nevertheless, the report catalogs scientific literature purportedly linking BPA exposure to a host of adverse health effects. Although most of the studies regarding health risks focus on BPA's impact on estrogenic activity, the report also cites studies associating BPA exposure with abnormal behaviors in children (e.g., hyperactivity, aggression), premature births, infant immune suppression, sexual dysfunction, heart disease, metabolic disruption, and reproductive developmental effects.
The report then discusses ten possible alternatives to BPA for use in infant food packaging. These include: polypropylene (PP); polyethylene (PE); polylactic acid (PLA); polystyrene (PS); Tritan CopolyesterTM; glass jars with polyester coated lids; cans lined with resins, such as oleoresin; isosorbide diglycidyl ether coatings; aseptic cartons (e.g., Tetra Pak); and laminated pouches (e.g., Cheer Pak).[7] The report analyzes their viability from a number of perspectives, discussing their chemical, functional, and toxicological properties, as well as their environmental impact. Further, the AA describes advantages and disadvantages of each material, taking into account factors such as cost, barriers to market entry, rigidity/flexibility, durability, weight, shelf life, reactivity, and recyclability.
In the final analysis, the AA does not identify a readily available chemical alternative to replace BPA in infant food packaging. Among the considered alternatives, however, PE emerged as the preferred choice to replace containers that incorporate a BPA-based lining. PE is favored because it is already widely used, unreactive, stable, inexpensive, and recyclable. Further, the report states that no health implications are associated with the use of PE in food packaging. The reliance on "recyclability" of PE as a key determinative factor is particularly odd since linings are not separated from containers for recycling purposes.
Limitations
While the report satisfies Maine's AA requirement for BPA, there are several limitations which must be considered when assessing its broader impact. For instance, the report only addresses alleged exposures to BPA from infant formula cans and baby food jar lids. It does not examine whether there are potential exposures from other BPA-containing products. Further, the report does not focus on the exposures or dose amounts that would be necessary for BPA to pose an actual risk to the consuming public.[8] In fact, the report expressly acknowledges these limitations when it concludes:
Because the focus of the [report] is on infant formula and baby foodstuffs, a targeted human health assessment focused on dose and route of exposure is the more appropriate metric to underpin administrative authority decisions limited to actual or expected health risk for the targeted populations."[9]
Along these same lines, the report itself notes the shortcomings of established AA tools, namely the U.S. Environmental Protection Agency's (EPA) Design for the Environment (DfE) and the Clean Production Action's GreenScreen protocol (which is referenced in Maine's regulations and was used in this case to support the BPA AA).[10] The report states that both tools "fall short of an assessment which considers the amount of constituent (dose) which is absorbed (or administered) over a defined period of exposure, given use of a particular product stream."[11] In this way, the report concedes the pervasive shortcoming in Green Chemistry initiatives more generally, i.e., the inherent limitations of embracing a chemical risk model without regard for the well-established proposition that dose matters.
Indeed, the outside consultant that wrote the AA also openly acknowledged the limitations of the assessment in the cover letter accompanying the report.[12] The consultant compared its report, and the BPA GreenScreen analysis in particular, to a separate report submitted by another consultant, Gradient, on behalf of a packaging company, Crown Holdings, Inc., noting that the Gradient analysis focused on "dose (especially as it pertains to low dose assessment of the target populations of infants and children), for the purposes of recommendations as to level-of-concern."[13] The AA report's authors stated that Gradient's approach helps illustrate the deficiencies inherent in the GreenScreen process and in basing an AA report on GreenScreen results, particularly because the GreenScreen approach "does not entirely consider the actual dose (i.e., exposure) to a given human health receptor."[14] They noted that the "health implications associated with BPA exposure addressed in the [AA report and BPA GreenScreen study] discuss any and all potentially adverse health effects associated with BPA via any investigated and documented route of exposure. The discussion of associated health effects is not limited to a particular dose range, constituent delivery mechanism, or receptor population."[15]
Implications for Industry
It is too early to tell whether environmental groups or other stakeholders will attempt to use the AA report as leverage to expand Maine's existing, albeit limited, ban on BPA in reusable food or beverage containers.[16] Although the report reiterates the lack of conclusive evidence linking low levels of human exposure to BPA and adverse health effects, it nevertheless summarizes data illustrating the controversial nature of this chemical in the scientific literature. The report could, therefore, serve as fodder for continued anti-BPA sentiment.
Furthermore, the report's focus on possible alternatives to BPA could influence the likelihood of product liability litigation involving BPA. On the one hand, the AA report concludes that there are no readily available alternatives to BPA's use in infant food packaging and confirms the lack of consensus in BPA scientific literature regarding the chemical's risks, thus strengthening industry's defense against any design defect or failure to warn claims. On the other hand, the listing and consideration of potentially "safer" materials, as well as the discussion of purported adverse health and environmental effects of BPA, might spur renewed interest in litigation against manufacturers of BPA-containing products, given that such an analysis may, at least according to some, help support various product liability claims, whether filed in Maine or elsewhere.[17]
Before this report was issued, consumer product manufacturers had no clear sense of DEP's expectations in this regard, and previous industry AAs for BPA were simply deemed insufficient. Despite its notable shortcomings, Maine has deemed the AA report discussed in this article to be "adequate" for purposes of its requirements. California's requirements, however, will likely be more difficult to satisfy. California regulators have indicated that no AA tools currently in existence will meet the state's statutory AA requirements. The prospect that consumer product companies will have to develop multiple AA's for different states adds to the ongoing anxiety about the AA process.
As a final note, given that DEP decided to commission its own BPA study after rejecting AA reports submitted by manufacturers, industry should pay attention to whether the state requires manufacturers to pay for the report's costs. Maine has the authority to assess fees to cover the cost of an AA report commissioned by DEP.[18] According to Maine's regulations, the total fees for the assessment will be "divided equitably among manufacturers and distributers [sic] of children's product [sic] that contain the priority chemical," with manufacturers or distributors that submitted "acceptable" AAs being exempt from the fee.[19]
For more information on state Green Chemistry requirements, contact Sheila A. Millar (+1 202.434.4143, millar@khlaw.com), Jean-Cyril Walker (+1 202.434.4181, walker@khlaw.com), Eric Gotting (+1 202.434.4269, gotting@khlaw.com), or Alissa Jijon (+1 202.434.4109, jijon@khlaw.com).
Technical questions can be directed to Diana G. Graham (+1 415.948.2805, graham@khlaw.com)
[1] 38 MRSA § 1691 et seq. Additional information on this law and Maine's recent listing of various chemicals of high concern is available at: http://www.khlaw.com/showpublication.aspx?Show=5721.
[2] As of January 1, 2012, Maine banned the sale or distribution of reusable food or beverage containers that contain intentionally-added BPA. 06-096 ME. CODE R. ch. 882. While the rule designating BPA as a priority chemical indicates that all food and beverage packaging is exempt from the rule unless it is intentionally marketed or intended for use by children under 3 years of age, the language of the rule further specifies that the term "food and beverage packaging" does not include reusable packaging, i.e., packaging that does not contain any food when sold or purchased. Consequently, all reusable food and beverage containers that are "children's products" and that contain intentionally added BPA are subject to the ban.
[3] 38 MRSA § 1694; 06-096 ME. CODE R. ch. 882.
[4] 06-096 ME. CODE R. ch. 882. Although Maine's Green Chemistry law applies only to children's products, which are defined to exclude food additives, a separate statutory section specifies that food packaging intentionally marketed or intended for use by children under three years of age is subject to the law. 38 MRSA § 1697(8).
[5] AA Report at 6.
[6] Id. at Appendix B-4.
[7] The AA report also briefly addresses, but then dismisses, additional materials as inappropriate for use in infant food packaging due to their unfavorable toxicological properties or their incorporation of BPA as a sub-component. These substances include: thermoplastic nylon (TN); polyethersulfone (PES); polysulfone; and polyphenylsulfone (PPS).
[8] "The discussion of associated health effects is not limited to a particular dose range, constituent delivery mechanism (e.g., inhalation, ingestion…) or receptor population (e.g., fetus, adult)." Id. at 64.
[9] Id.
[10] 06-096 ME. CODE R. ch. 880(3)(B)(3)(e). GreenScreen is a screening tool for comparative chemical assessment. It focuses on potential hazards of a chemical, but without placing any emphasis on actual risk based on anticipated exposures and dose. GreenScreen uses available toxicological data and other information to evaluate a chemical's hazard endpoints (e.g., carcinogenicity, aquatic toxicity) and then characterizes the chemical using benchmarks ranging from Benchmark 1 ("chemical of high concern") to Benchmark 4 ("safer chemical"). The BPA GreenScreen appears at Appendix B of the AA Report, which assigned BPA a Benchmark Score of 1.
[11] AA Report at 1.
[12] The cover letter is available on DEP's website at: http://www.maine.gov/dep/safechem/documents/aareport-coverletter.pdf.
[13] Id. at 2. The Gradient analysis is also available at: http://www.maine.gov/dep/safechem/documents/gradient-risk-based-assessment.pdf.
[14] Id. The Gradient study conducted a modified GreenScreen evaluation that focused on assessing both hazard and risk (based on exposures and dose). It concluded that BPA is generally of low concern and assigned a Benchmark score of 3 (indicating that the chemical may still be used in consumer products). As a courtesy to the Maine DEP, the AA report's authors also include in their cover letter a rough "back of the envelope" calculation to estimate the risks of infant exposure to BPA. Their calculation suggests that the mean overall daily exposure rate is "over an order of magnitude below unity and the standard for concern." Id. at 3. They offer to amend their report if the Maine DEP wishes them to expand the scope of the analysis to include infant exposure considerations and data.
[15] Id. at 2.
[16] On January 3, 2013 – in response to a citizen-initiated rulemaking petition – the Maine Board of Environmental Protection deliberated whether to recommend an extension of the BPA ban to include containers of infant food and baby formula, as well as containers of toddler food. The Maine DEP recommended extension of the ban to packaging used for infant formula, but did not suggest that the chemical be banned from baby and toddler food containers altogether. See Memorandum from George M. MacDonald, Director, Sustainability Division, DEP to Chairman Foley and members of the Board of Environmental Protection and Commissioner Aho (January 3, 2013). The Board is expected to make its recommendation on extending the ban by the end of January. Subsequent legislative action would be needed to extend the ban.
[17] For further discussion of the litigation risks inherent in AAs (and in Green Chemistry initiatives more generally), see http://www.khlaw.com/showpublication.aspx?Show=5794.