TSCA: Italian Opera or EPA Regulation?
By Keller and Heckman LLP’s Packaging Practice Group
"No good opera plot can be sensible, for people do not sing when they are feeling sensible." - W.H. Auden
Some people hear the word "Tosca," and think of the Puccini opera by that name. Others hear the word and think of something far less lyrical: the U.S. Environmental Protection Agency (EPA) statute that regulates chemical substances, the Toxic Substances Control Act (TSCA). Indeed, it makes one wonder whether Congress was thinking of opera when it enacted a statute that some in industry find indecipherable.
For those who cringe when they hear the word "TSCA," we will show how to make sense of the statute, and in particular, its exemption for substances regulated by the U.S. Food and Drug Administration (FDA).
Statutory and Regulatory Framework of the Toxic Substances Control Act
Before 1976, the manufacture and use of chemical substances in the United States was not comprehensively regulated, except with respect to specific end-use applications, including foods, drugs, and pesticides. Enacted by Congress in 1976, TSCA established a framework to regulate chemicals, yet avoid overlapping federal agency jurisdiction with respect to end-use applications already subject to regulation under other statutes. TSCA was not intended to alter existing regulatory programs, including the Federal Food, Drug, and Cosmetic Act (FFDCA), which already governed the use of certain chemicals for specific purposes.
TSCA provides EPA with a variety of regulatory tools to control the manufacture, import, processing, use, and export of chemical substances. These include testing, notification, and record keeping. Significantly, TSCA requirements apply to chemical substances regardless of whether they are toxic. The federal regulations promulgated by EPA to implement TSCA are found generally at 40 C.F.R. Subchapter R, Parts 700 to 790.
The TSCA Definition of 'Chemical Substance'
Under TSCA, products that are regulated under other federal statutes, including food additives, are excluded from the term "chemical substance" and, aside from an import certification requirement, are not subject to regulation under TSCA.1 The relevant definition of "chemical substance" is as follow
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.
40 C.F.R. ß 720.3(e).
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 ("the Inventory").2 A chemical substance listed on the Inventory can be manufactured, processed, and used in the United States for non-exempt commercial purposes. The Inventory currently contains over 70,000 listings, and includes not only those chemical substances in commerce in the United States but also, implicitly, chemical substances that exist in nature.3
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.4 The notification period may be extended to 180 days by EPA under certain circumstances; as a practical matter, companies normally extend the notification period when requested to do so by EPA based on data concerns.
A substance that is the subject of a PMN is added to the Inventory if and when the manufacturer or importer first manufactures or imports the substance for a non-exempt commercial purpose after the expiration of the review period and submits a Notice of Commencement (NOC).
The FFDCA Exemption
Many substances used in TSCA-exempt applications also are used in non-TSCA-exempt applications. If a substance is not on the TSCA Inventory, the manufacture or import of the substance for a purpose that is not exempt from TSCA results in a violation of TSCA's PMN reporting requirements. Further, if a substance is manufactured, processed, or distributed for undifferentiated uses, the substance is presumed to be subject to TSCA. Because the definition of a "chemical substance" regulated under TSCA only excludes a substance to the extent that the substance falls inside FDA's jurisdiction, it helps to pinpoint where FDA jurisdiction under FFDCA ends and EPA jurisdiction under TSCA begins.
Under the FFDCA, a substance becomes a food, food additive, drug, cosmetic, or device as soon as it is eligible for regulation as such by the 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 all food-contact materials meet the definition of food.5 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.6 Accordingly, food packaging is considered to be excluded from TSCA's definition of chemical substance. Further, intermediates and catalysts intended solely for use in production of substances regulated by FDA are excluded from regulation under TSCA, because they are considered components of substances regulated by the FDA.
While the FFDCA exemption may operate to exempt food packaging from the requirements of TSCA, it is important to note that this exemption applies only as long as end-uses are limited solely to uses regulated by FDA (e.g., food additives, cosmetics, medical devices). Consequently, to rely on this exemption, manufacturers and importers should monitor the end-uses of their products, and ensure that a product is not manufactured for sale into other applications unless or until it is listed on the Inventory.
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"I don't mind what language an opera is sung in so long as it is a language I don't understand." - Sir Edward Appleton.
1See 40 C.F.R. ß 707.20(b)(2)(ii).
2The initial Inventory was compiled from reports submitted by manufacturers and importers during the initial Inventory reporting period, Jan. 1, 1975, to Dec. 31, 1977. See 40 C.F.R. ß 710.3. The best way to access the Inventory is through on-line databases, which are easily searchable and frequently updated.
3The 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.
4TSCA PMN requirements appear at 40 C.F.R. Part 720.
5Indeed, FDA's jurisdiction with regard to foods attaches as long as the article is apparently suitable for use as food even though it may not be intended for a food use. See United States v. Technical Egg Products, Inc., 171 F. Supp. 326 (N.D. Ga. 1959). Unlike the definitions for drugs, devices, food additives and cosmetics, the statutory definition of food in the FFDCA does not depend upon the intended use of the substance. The fact that a substance is of a type used for food triggers the authority of the FFDCA, and thus, the TSCA exemption. A similar argument could be made for substances that are components of food packaging materials when such packaging materials are represented as suitable for food-contact use even though the specific product is not expected to contact food.
6See 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).