EPA made further progress this week in its efforts to move forward with a potential Bisphenol-A (BPA) Test Rule, publishing an Advance Notice of Proposed Rulemaking (ANPRM) in the Federal Register. Overall this progress is good news, though it’s not without its flaws.
EPA completed a draft of the ANPRM in December and sent it over to the Office of Information and Regulatory Affairs (OIRA) for review, pursuant to Executive Order 12866. Despite a 10-working-day deadline for review of ANPRMs, OIRA spent more than seven months on its review. OIRA’s edits were also released this week and placed in EPA’s docket.
Mind you, this ANPRM is not a notice for the actual BPA Test Rule, but rather a solicitation for comments and input on whether such a rule is necessary, and, if so, what procedures, target test sites, testing standards, and protocols would best serve the intended purpose of such a rule. The actual chemical test rule, authorized by section 4 of the Toxic Substances Control Act (TSCA), would impose specific exposure monitoring and toxicity effects testing requirements on the processors, manufacturers, and importers of the subject chemical. For example, a sewage treatment plant might have to monitor how much BPA remains in the post-treatment sewage sludge that it distributes to farms, incinerators, and landfills, or a plastics manufacturer may have to conduct testing (most likely through a third party) on BPA’s low-dose toxicity effects on certain aquatic populations.
Assuming that EPA determines that a test rule is necessary, it will have to go through another notice and comment period (on the proposed rule) and two more rounds of OIRA review (on the proposed rule and the final rule), before the final test rule can finally be promulgated. Even after the test rule is finalized, EPA will have to wait for the results, analyze them, and start the whole rulemaking process over again if it determines that the results warrant actual regulation under TSCA section 6, for example. Thus, this week’s ANPRM is a small and early step in what is sure to be a long regulatory process.
In this ANPRM, EPA provides a brief “lay of the land” with regard to current scientific findings about BPA’s presence in the environment and risk assessments of a variety of environmental organisms. The ANPRM also identifies who and what would be the subject of the environmental toxicity and exposure testing being considered. Overall, the ANPRM provides a balanced presentation of why EPA is considering a BPA Test Rule and explains to potential commenters what input would be helpful in determining whether to issue the rule.
What comes across as somewhat puzzling, though, is the overly-emphatic and repetitious reminders that the toxicity and exposure testing being considered would focus solely on assessing BPA’s environmental presence and adverse effects on environmental organisms, not human health effects or exposure. Understanding that there is a multi-agency effort between FDA, CDC, EPA, and NIEHS to assess a broad spectrum of BPA’s risks and exposure pathways in humans, one wonders why it is necessary at this stage of the rulemaking process for EPA to set such a narrow scope?
Unsurprisingly, there is not a clear answer to this question, but one source of the overly-emphatic environmental focus reveals itself when one reviews the OIRA redline version of the ANPRM. Of the fewer than 30 substantive edits OIRA made to the 47-page ANPRM during its seven-month review, OIRA’s main contributions focused on repeating the restricted “environmental” scope of the rule that EPA is considering.
Not all of the ANPRM’s narrow environmental focus can be attributed to OIRA, as some of it appears to be driven by agency domain issues. As stated in the ANPRM, present data show primary human exposure sources of BPA to be food contact materials, thus placing risk and exposure assessment responsibilities (and potential regulatory authority) within the purview of FDA. That being said, EPA’s authority over the actual production of the target chemical provides it with an important role in the human health assessment arena—a role EPA recognized in the ANPRM when it wisely stated:
These targeted monitoring data may provide information relevant both to the characterization of environmental risk and to the potential focus of future risk management activities such as those under section 6 of TSCA, if the data indicate such activities are warranted. EPA also considers these data would further inform the issue of potential human exposure levels attributable to sources other than the direct food contact uses believed to be the principal source of human exposure, which are regulated by the FDA.
This measured and logical recognition that humans do in fact live in the same environment as other organisms, and thus new environmental exposure data (and even toxicity effects) might be applicable to humans as well, was followed by an OIRA edit reminding the reader that any crossover of such information would relate only to the collaborative efforts between EPA, FDA, NIEHS, and CDC, and that “EPA is not considering any additional testing specifically in regard to human health issues at this time.” Perhaps recognizing the absurdity of the “environment only” box OIRA attempted to construct around EPA, OIRA also included a footnote reading, “EPA notes, however, that information obtained on the environmental presence of BPA would be relevant to understanding the environmental component of human exposures.”
It seems that deep down even OIRA recognizes that humans might also face exposure and health risks to BPA from environmental sources and that the proposed “environmental” testing would help to evaluate those potential risks. EPA should abandon the arbitrary distinction between human health and other environmental organisms as it makes little sense and places unnecessary barriers around the potential data and findings the proposed test rule hopes to collect and use to make informed regulatory decisions.