EPA Chemical Risk Evaluations – Stakeholders Diverge on Whether and How EPA Must Include Dietary Exposures

King & Spalding

In the 2016 amendments to the Toxic Substances Control Act (TSCA), Congress directed EPA to evaluate the risk of all chemicals in U.S. commerce.1 The amendments also set specific deadlines for the initial sets of evaluations, and EPA has issued draft scopes for several risk evaluations that discuss food products. The 2016 amendments did not change the original exclusion for chemical substances that are foods or food additives under the Federal Food, Drug, and Cosmetic Act.2 Due to this exclusion, these chemical risk evaluations may not on the surface seem relevant to the food and beverage industry. However, the amendments also required EPA to assess “information that is relevant to specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations.”3 This directive, combined with statutory text concerning integrating or aggregating exposures, features prominently in the comments several stakeholder groups submitted to EPA on draft scopes for risk evaluations in progress.


In draft scopes that mention foods and food additives, EPA consistently states that such uses are “outside the scope of TSCA.” The draft scope for formaldehyde excludes use of formaldehyde in food packaging adhesives and sugar refineries.4 The draft scope for di-cyclohexyl phthalate excludes articles for packaging, transporting or holding food; cellophane; and paper and paperboard components intended to come into contact with dry food or aqueous and fatty foods.5 The draft scope for butyl benzyl phthalate also excludes food packaging materials.6 However, although EPA does not intend to evaluate food and food additive uses as conditions of use, EPA intends to include production and processing of food packaging and related food and beverage materials in several of the evaluations.7 Not surprisingly, EPA’s hybrid approach prompted discussion in a range of comments.


Several nongovernmental organizations argued in their comments that, even if not conditions of use required to be evaluated, exposures to chemical substances in food must nonetheless be included in the evaluation.

Any potential health effects from exposure to such a chemical would be a function of a person’s total exposure to the chemical, regardless of source. Credibly assessing the risk of that chemical requires considering all sources of exposure to it, even if some of them are deemed “background sources” that either cannot be specifically identified or fall outside of TSCA’s regulatory jurisdiction.8

Other commenters echoed this view of EPA’s assessment of food exposures as “highly variable and problematic.”9

While EPA is only mandated to conduct a risk assessment for TSCA conditions of use, EPA must still account for non-TSCA uses as background exposures when evaluating whether conditions of use EPA does consider present unreasonable risk. This is because it is impossible to determine if the conditions of use that TSCA does regulate present an unreasonable risk if non-TSCA uses that contribute to a baseline level of phthalates in the human body are ignored.10

Yet other commenters focused on the requirement to assess “potentially exposed or susceptible sub-populations,” arguing that exclusion of dietary exposures will overlook most exposures to children.11

In contrast, manufacturer commenters focused on dietary exposures in a limited manner. At most, they requested exclusion of certain uses from the evaluations.12 It is unclear whether such requests concerned only conditions of use or also included the background exposures in which the other stakeholders would place dietary exposures.


After EPA finalizes the scope documents, the substances under review will enter the risk evaluation stage. Although stakeholders weighing in on the draft scopes do not appear to have included food and beverage companies or the prominent trade associations for such companies, the risk evaluation stage provides an opportunity to engage with EPA and directly weigh in on the central question of how EPA should address both the conditions of use directly regulated under TSCA and the dietary exposures asserted to have relevance in the TSCA risk assessment process.

1 15 U.S.C. § 2605.

2 15 U.S.C. § 2602(2)(B)(vi) (citing 21 U.S.C. § 321).

3 15 U.S.C. § 2605(b)(4)(F).

4 Draft Scope for Formaldehyde, EPA-740-D-20-014, at 27 (Apr. 2020) (“Formaldehyde Scope”).

5 Draft Scope for Di-Cyclohexyl Phthalate, EPA-740-D-20-019, at 21 (Apr. 2020) (“DCHP Scope”).

6 Draft Scope for Butyl Benzyl Phthalate, EPA-740-D-20-015, at 23 (Apr. 2020) (“BBP Scope”).

7 Formaldehyde Scope, at 27-28; DCHP Scope at 21; Di-Isobutyl Phthalate, EPA-740-D-20-018, at 71 (Apr. 2020); Di-Ethylhexyl Phthalate. EPA-740-D-20-017, at 93 (Apr. 2020); BBP Scope, at 23, 74.

8 Environmental Defense Fund Comments, at 73 (June 8, 2020).

9 Id.

10 Alaska Community Action on Toxics, et al. Comments, at 10-11 (June 8, 2020) (highlighting that diet is main source of phthalate exposure); see also Safer Chemical Healthy Families et al. Comments, at 8 (June 8, 2020).

11 Comments from Academics, Scientists and Clinicians on the Draft Scopes for 20 Designated High Priority Chemical Substances Under the Toxic Substances Control Act, at 20 (May 26, 2020).

12 See, e.g., American Chemistry Council Comments, at 4 (June 8, 2020) (noting food contact articles as an excluded exposure).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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