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OPINION & ORDER Plaintiffs Natural Resources Defense Council, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Environmental Defense Fund, and Environmental Working Group (together, “Plaintiffs”) seek declaratory and injunctive relief against Defendants United States Food and Drug Administration (“FDA”) and Robert M. Califf, M.D. (“Califf”) in his official capacity as Commissioner of the Food and Drug Administration1 (together, “FDA”). Specifically, Plaintiffs seek declaratory and injunctive relief with respect to the FDA’s denial of Plaintiffs’ citizen petition regarding a Threshold of Regulation (“TOR”) exemption that allowed the inclusion of the chemical compound sodium perchlorate monohydrate in plastic food-contact articles. Currently before me are Plaintiffs’ motion for summary judgment on the grounds that the FDA’s denial of its citizen petition violated the Administrative Procedure Act (“APA”) and the Food Safety Act (“the Food Act”), and the FDA’s cross-motion for summary judgment arguing that the decision did not violate either act and that its agency expert judgments are entitled to deference. Because I find the FDA’s decision denying Plaintiffs’ citizen petition was neither arbitrary nor capricious in violation of the APA and did not violate the Food Act, the FDA’s motion for summary judgment is GRANTED and Plaintiffs’ motion is DENIED. I. Factual Background2 Sodium perchlorate monohydrate (“perchlorate”) is a chemical compound used as an additive in plastic packaging and other food-contact articles3 to reduce the buildup of static charges resulting from the movement of dry foods, like cereal, flour, and spices. (Compl. 2; FDA 1821.) If the accumulated static charge reaches a high enough level, it can produce a spark that can ignite the dust and powder created in dry foods and cause a dust explosion. (Compl. 53; FDA 2473.) The purpose of an antistatic agent such as perchlorate is to dissipate the charge that accumulates from the flowing dry food. (Compl. 54; FDA 1487-88, 3145.) Historically, perchlorate has also been used in rocket fuel, ammunition, fireworks, and explosives. (Compl. 58; FDA 1936.) Once ingested, perchlorates can disrupt the human endocrine system and can affect normal growth and development in fetuses, infants, and children. (FDA 1886, 1948, 2191, 2195-202.) A. Regulatory and Statutory Background The Food Act prohibits the introduction of any “adulterated” food into interstate commerce. 21 U.S.C. §331(a). A food is “adulterated” if it contains an “unsafe” “food additive.” Id. §342(a)(2)(C)(i). A “food additive” includes “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food[).]” Id. §321(s); see also id. §348(h)(6) (defining the subset of food additives known as “ food contact substance[s]“). A “food additive” is “deemed unsafe,” and thus food containing the additive is “adulterated,” id. §342(a)(2)(C), unless a “regulation issued under this section prescribing the conditions under which such additive may be safely used” is “in effect,” and “such substance and the use of such substance are in conformity with” that regulation, id. §348(a)(3). The Food Act requires that the FDA, “[i]n determining…whether a proposed use of a food additive is safe,” consider “the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet.” Id. §348(c)(5)(B). The FDA has also developed the TOR procedures for any food additive that migrates from a food-contact article to food itself at such low concentrations as to be “below the threshold of regulation.” 21 C.F.R. §170.39(a). Under this procedure, such food additives are not subject to the requirement under 21 U.S.C. §348 that a food-additive regulation be in effect. (Compl. 39.) To qualify for a TOR exemption, the “use in question” must be “shown to result in” or “be expected to result in.…dietary concentrations at or below 0.5 parts per billion,” (“ppb”), which the FDA calculates as “corresponding to dietary exposure levels at or below 1.5 micrograms/person/day (based on a diet of 1,500 grams of solid food and 1,500 grams of liquid food per person per day).” 21 C.F.R. §170.39(a)(2)(i). Once a TOR exemption is in place, any manufacturer may use the substance in accordance with the exemption, and use of a substance in accordance with a TOR exemption is not limited to use by the entity that requested the exemption. Id. §170.39(g). The FDA did not receive any public comments advocating for lower thresholds or expressing safety concerns with the agency’s TOR exemption proposal. (FDA 1368-69.) On June 17, 2005, Ciba Specialty Chemicals Corporation (“Ciba”) submitted a request for a TOR exemption allowing for the use of sodium perchlorate monohydrate in a packaging material to be known as Irgastat P18. (Compl.

68-69; FDA 3124-47.) The FDA issued TOR Exemption No. 2005-006 (“TOR Exemption”), (Compl.

 
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