What Does the FDA's BPA Decision Mean for Companies?

Cradle to Cradle

What Does the FDA's BPA Decision Mean for Companies?

On January 15, 2010, The U.S. Food and Drug Administration (FDA) shifted its position on the safety of the chemical Bisphenol A (BPA), expressing for the first time some concern about safety, announcing further research, and providing tips for parents to minimize infants' exposure. As a result, competitive companies will be compelled to shift how they communicate about BPA and their search for innovative options to better align themselves with consumer concerns. Some companies could gain reputational benefits and free media attention from supporting proposed legislation restricting use of BPA.

Major users of BPA in the U.S. and Canada already have exited the market for polycarbonate baby bottles and cups containing BPA and others are pursuing strategies to reduce reliance on BPA for lining food containers. Replacing food can linings is technically tougher, because of the need to satisfy numerous food safety, durability, and other requirements.

BPA was studied as a possible estrogen therapy in the 1930s but was discarded in favor of other methods. In subsequent decades it grew in importance for plastics manufacture. Since the late 1990s a growing body of evidence has linked BPA to a broad array of health effects, particularly due to exposures to low doses of BPA during critical windows of development.

In 2008, two market-shaking events occurred. Health Canada, Canada's overseer of food, drug, and product safety, announced in April that it intended to ban the import, sale and advertising of polycarbonate baby bottles containing BPA because of concerns about the health impact of low dose exposure. In September 2008, the U.S. National Toxicology Program (NTP), headquartered at the National Institute of Environmental Health Sciences (NIEHS) stated in its final report on the developmental effects of BPA exposure that it had "some concern" for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current levels of human exposure. These two announcements effectively shut down the market for polycarbonate baby bottles in the U.S., as major retailers renounced their sale and as bottle manufacturers shifted to alternatives.

There was a similar movement away from polycarbonate sport bottles, such as those sold by Nalgene and Camelbak. As detailed in an Investor Environmental Health Network (IEHN) report, the winners in the marketplace were those who saw the science changing and were prepared to make a shift. Whole Foods Market had made the move two years earlier, having become aware of the accumulating science and having been further encouraged to act by a shareholder resolution.

In 2009, BPA action moved forward on the scientific, political, and market fronts. More new scientific studies were published, with independent academic studies raising continuing concerns while some large scientific studies funded by industry dismissed them. Questions were raised as to whether industry lobbyists had inappropriate behind the scenes access to FDA staff and whether FDA staff was giving undue weight to industry studies as they assessed whether FDA's existing standard for BPA was sufficiently protective. European policies remained unchanged. Also in 2009, using funds from the economic stimulus package, NIEHS, a unit of the National Institutes of Health, awarded $30 million in research grants to further refine scientific understanding of the routes of exposure to and the health effects of BPA.

Politically, major battles were fought in county governing bodies and in state and local legislatures over proposed bans on BPA. Minnesota'sban on BPA in baby bottles and cups took effect on January 1, 2010. Connecticut's legislation, which takes effect in October 2011, bans BPA in containers for infant formula and baby food, and for all reusable food and beverage containers. Chicago and Suffolk County, New York have also enacted bans on BPA in baby bottles and sippy cups. In the U.S. Congress, in March 2009, Senator Dianne Feinstein and Representative Edward Markey introduced the Ban Poisonous Additives (BPA) Act of 2009, whose title describes its purpose. In battling these legislative initiatives, the American Chemistry Council and industry allies relied on FDA's position and similar determinations from Europe to argue that BPA is safe.

Remarkably, market and regulatory changes in North America have moved faster than in Europe. This is a noteworthy exception to the customary pattern in recent years of the European Union phasing out chemicals and then major U.S. companies, California and other states, and occasionally the U.S. government, following Europe's lead.

In the marketplace, finding "drop-in" substitutes for BPA has been relatively easy for baby bottles and cups. The larger technical challenge has been finding replacements for epoxy resins containing BPA that are used as can linings. Eden Foods in the U.S. uses non-BPA linings for its packaging, except for acidic foods. While these cans cost 14 percent more than BPA-lined cans, the cost differential might decrease if more food processing companies were to determine that this alternative satisfies their own technical specifications, and higher production volumes achieved greater economies of scale.

Likewise, while Japanese can manufacturers successfully reduced BPA exposures there beginning in the 1990s, for their alternative approach to take root in the United States would also require satisfying manufacturers' and food processors' functionality requirements here.

In April 2009, two participants in IEHN, Green Century Capital Management and the As You Sow Foundation, reported the results of a survey of twenty publicly-owned food processors on their use of BPA and search for alternatives in packaging. Top scores were awarded to Hain Celestial, Heinz, and Nestle for their work on exploring alternatives, and the report noted that Heinz was the only respondent already using a substitute to BPA in some of its can linings.

In follow-up contacts with various of the twenty companies surveyed, it is clear that work on alternatives continues to move rapidly, at least in some companies, although most are publicly silent about their efforts or acknowledgement of consumer concern and fail to state anything more than their current compliance with the FDA's standard.

There's clearly a rich prize to be reaped by the partnership of lining formulators and container manufacturers who are the first across the finish line with a safer, technically feasible, and economically competitive alternative to BPA linings that serves all or most of the needs of major food processors.

The most important part of FDA's January 15th policy shift was the agency's aligning itself with the U.S. National Toxicology Program's scientific judgment about BPA. At a press conference with NIEHS and the Department of Health and Human Services (HHS), FDA said that standardized toxicity tests had thus far supported the safety of BPA but "on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program ... and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children."

FDA then went on to express its support for industry's actions to stop producing BPA baby bottles and cups, facilitate alternatives for infant formula can linings, and efforts to replace or minimize BPA levels in other can linings. With respect to industry initiatives, FDA indicated it would expeditiously review any new applications for use of alternatives. FDA also noted that it was hobbled by limitations in the regulatory framework under which it initially approved BPA for food contact use forty years previous. For its part, HHS released a list of recommendations to parents on reducing infants' exposure to BPA.

Environmental health groups lauded FDA's position shift, though they expressed regret that FDA did not take immediate action to tighten regulation and voiced support for the pending congressional BPA Act. The American Chemistry Council said it was "disappointed that some of the recommendations [to parents] are likely to worry consumers and are not well-founded." ACC also found solace that "The HHS statement today confirms that exposure to BPA in food contact products has not been proven harmful to children or adults."

Companies relying on the existing FDA standard for BPA no longer can so confidently use it as a shield, because the agency itself has clearly acknowledged uncertainty and is expressing support for BPA exposure reduction.

Companies will need to be more forthcoming about their search for alternatives, aligning themselves with customers concerned about involuntary exposures to a toxic chemical that could compromise the health of their children. Companies should look to Whole Foods Markets' website discussion as a model.

Companies eager to gain market share can take advantage of the wave of growing consumer awareness, especially those firms that have banned BPA bottles and cups from their shelves and product lines. These companies stand to raise their visibility (and gain free advertising and promotion) when they publicly endorse proposed legislation that bans BPA bottles and cups. Corporate reputations of downstream users such as retailers are better served by adopting a "better safe than sorry" position—at least for cases of easy replacement—rather than tilting towards a "harm hasn't been proven" position.

Richard A. Liroff, Ph.D., is founder and director of the Investor Environmental Health Network (IEHN). IEHN is a collaboration of investment managers that advocates for safer corporate chemicals policies to grow long-term shareholder value and reduce financial and reputational risks to companies. The business case for corporate safer chemicals policies, a list of shareholder resolutions on safer chemicals policies, and a roster of participants can be found on the IEHN website, www.iehn.org.