TSCA and the Food (and Food Packaging) Exemptions
The Toxic Substances Control Act (TSCA) is the primary chemical control law of the United States.[1] Initially enacted by Congress in October 1976, it became effective January 1, 1977, and is administered by the U.S. Environmental Protection Agency (EPA).
It is important to note that the “T” in TSCA is misleading; neither the law nor penalties for violations thereof are limited to substances that are toxic. The most important term in the title of this law is control, as TSCA’s jurisdiction extends to “chemical substances” regardless of toxicity. TSCA provides EPA with a broad variety of regulatory tools, including mandatory testing, notification, and recordkeeping, to control the manufacture, import, processing, use, and export of all chemical substances in U.S. commerce.[2]
A Little Background
Prior to 1976, except with respect to certain chemicals having specific end-use applications, such as foods, drugs, and pesticides, the manufacture and use of chemicals in the U.S. was not comprehensively regulated at the federal level. The goal of TSCA was to establish a framework to provide for the comprehensive regulation of chemicals in (or proposed to be introduced into) U.S. commerce while avoiding the creation of overlapping federal agency jurisdiction with respect to end-use applications that were already regulated under other federal regulatory statutes. Thus, for example, TSCA was not intended to alter or supplant pre-existing regulatory schemes such as established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
On June 22, 2016, comprehensive TSCA reform legislation (H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act) was enacted. This law made significant changes to TSCA and provided new authority to EPA to prioritize, review, and regulate all chemical substances used in the U.S.
Definition of ‘Chemical Substance’
Under TSCA, substances, including food additives, that are regulated under other federal statutes, are excluded from the term “chemical substance.” Aside from an “import certification” requirement, substances that are not “chemical substances” are not subject to regulation under TSCA. TSCA defines a “chemical substance,” in relevant part, as:
Any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, any chemical element or uncombined radical except “chemical substance” does not include:
- any mixture;
- any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide;
- tobacco or any tobacco product;
- any source material, special nuclear material, or byproduct material;
- any pistol, firearm, revolver, shells, or cartridges; or
- any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.”[3]
TSCA Inventory and Premanufacture Notification
Section 8(b) of TSCA requires EPA to “compile, keep current and publish a list of each chemical substance which is manufactured or processed in the United States.” This list is known as the TSCA Chemical Substance Inventory (Inventory).[4] A substance listed on the Inventory can be manufactured, processed, and used in the U.S. for non-exempt commercial purposes under TSCA.[5] The Inventory currently contains over 86,000 listings, and includes not only those substances in commerce in the U.S. but also, implicitly, chemical substances that exist in nature.[6]
A “new chemical substance” is any chemical substance that is not listed on the current TSCA Inventory. The term “existing chemical substance” is not defined, but it is commonly used to refer to substances that are on the TSCA Inventory or that exist in nature.
Under section 5 of TSCA, a person who intends to manufacture or import a “new chemical substance” (i.e., a substance not listed on the TSCA Inventory) for a non-exempt commercial purpose must submit to EPA a Premanufacture Notice (PMN) at least 90 days prior to such manufacture or import.[7] The review period may be extended to 180 days by EPA under certain circumstances; as a practical matter, however, companies typically suspend the review period as requested by EPA based on potential human health or environmental concerns.
If EPA approves a PMN substance, the substance may be manufactured or imported by the PMN submitter for a non-exempt commercial purpose after such approval. EPA will then add the substance to the Inventory if and when the manufacturer or importer submits a Notice of Commencement (NOC) to EPA no more than 30 days after the substance is first manufactured or imported for a non-exempt commercial purpose by the PMN submitter after the expiration of the PMN review period. Thereafter, any person may manufacture or import the substance without submitting a PMN.
Food Packaging and the FFDCA Exemption
Many substances used in TSCA-exempt applications also are used in non-TSCA-exempt applications. If a substance is manufactured, processed, or distributed for undifferentiated uses, the substance is presumed to be subject to TSCA. If a substance does not appear on the Inventory, then manufacture or import of the substance for a non-exempt purpose results in a violation of TSCA’s PMN reporting requirements. In the case of foods and food additives, because the definition of a “chemical substance” only excludes a substance to the extent that the substance falls within the U.S. Food and Drug Administration’s (FDA’s) jurisdiction, it is advisable to determine where FDA jurisdiction under the FD&C Act ends and EPA jurisdiction under TSCA begins.
Under the FD&C Act, a substance becomes a food, food additive, drug, cosmetic, or device as soon as it is eligible for regulation as such by FDA. Although FDA regulation clearly arises upon submission of a drug or device application to FDA, such a submission is not necessarily a prerequisite. In fact, FDA interprets the statutory definition of food broadly such that most food-contact materials meet the definition of food.
FDA takes the position, and courts agree, that introduction of a substance into food from a food package need not be intentional to meet the requirement that a substance is used as a component of food.[8] Food-contact substances are considered food additives when, used as intended, they may reasonably be expected to result in their becoming a component or otherwise affecting the characteristics of any food, unless the substances are Generally Recognized As Safe (GRAS) or the subject of an exemption.[9] Further, intermediates and catalysts intended solely for use in the production of substances regulated by FDA are excluded from regulation under TSCA because they are considered components of substances regulated by FDA.
While some may argue that a food-contact material that does not migrate to food is subject to TSCA, that is not necessarily the case. Courts have drawn a distinction between substances that remain under FDA’s jurisdiction as food additives, but should not necessarily be subject to FDA’s pre-market approval requirements.[10]
Conversely, while the FD&C Act exemption may operate to exempt food packaging from the requirements of TSCA, it is important to note that this exemption applies only if the end-uses are limited solely to uses regulated by FDA. Consequently, to rely on this exemption, manufacturers and importers should monitor the end-uses of their products to ensure that a product is not manufactured for sale into other applications unless or until it is listed on the Inventory.
[1] See 15 U.S.C. § 2601 et seq.
[2] The federal regulations promulgated by EPA to implement TSCA are found generally at 40 C.F.R. Subchapter R, Parts 700 to 790.
[3] See 40 C.F.R. § 720.3(e).
[4] The initial Inventory was compiled from reports submitted by manufacturers and importers during the initial Inventory reporting period, January 1, 1975, to December 31, 1977.
[5] The EPA provides several categorical exemptions from the need for filing a PMN for commercial activities. They include:
- Low Volume Exemption
- Research and Development Exemption
- Low Releases and Low Exposures (LoREX) Exemption
- Test Marketing Exemption
- Polymer Exemption
[6] The inclusion of naturally occurring substances also covers substances that are obtained from natural sources through certain limited processes, but the production processes used must not significantly alter the natural state of such substances.
[7] TSCA PMN requirements appear at 40 C.F.R. Part 720. Other types of section 5 notices, with different review periods, exist.
[8] See Natick Paperboard Corp. v. Weinberger, 525 F.3d 1103, 1106 (1st Cir. 1975); see also United States v. Articles of Food Consisting of Pottery, 370 F. Supp. 371 (E.D. Mich. 1974).
[9] See FD&C Act Sec. 201(s).
[10] See Monsanto Co. v. Kennedy, 613 F.2d 947 (D.C. Cir. 1979)