Federal Register Vol. 82, No.5,

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amends the FD&C Act and provides FDA with the authority to regulate tobacco products. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product” as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Excluded from the definition of a tobacco product is any article that is a drug, device, or combination product. Any article that is a drug, device, or combination product will be regulated as such rather than as a tobacco product.

Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, FDA is taking this action to provide clarity regarding our interpretation of the drug and device definitions in the FD&C Act with respect to products made or derived from tobacco. This final rule will provide assistance for entities intending to market products made or derived from tobacco. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. The final rule is also intended to increase clarity regarding the intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a drug, device, or combination product, helping consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses.

In addition, FDA is taking the opportunity to make changes to existing regulations at §§ 201.128 and 801.4 (21 CFR 201.128 and 801.4), and to conform them to how the Agency currently applies these regulations to drugs and devices generally.

Conceptually, the final rule follows the disease prong and the structure/function prong (with certain specified limitations) of the statutory definitions of “drug” and “device” (section 201(g) and (h) of the FD&C Act). Under the final rule, a product made or derived from tobacco and intended for human consumption is regulated as a drug, device, or combination product in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. The final rule also clarifies remaining circumstances where a product is subject to regulation as a tobacco product.

In addition, FDA is amending its existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to the final rule to clarify the interplay between these regulations and this final rule. FDA has made further changes to conform §§ 201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices.

The final rule clarifies the regulatory status of products made or derived from tobacco and our interpretation and application of the existing intended use regulations. This will reduce the ambiguity and may create some efficiency gains associated with submitting an application for approval or marketing authorization of a new tobacco-derived product, or with initiating research for a new tobacco-derived product. In addition, we assume that the regulation will clarify for consumers when products made or derived from tobacco are intended for medical uses rather than for other uses.

We assume that all tobacco-derived product manufacturers would incur one-time costs to learn the rule. There may also be a one-time cost incurred by a small number of manufacturers of tobacco products to review and revise product communications such as labeling and associated promotional materials. The following table reports these one-time costs.

In the Federal Register of September 25, 2015 (80 FR 57756), FDA issued a proposed rule entitled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses.' ” We received over 1,900 comments on the proposed rule. Two comments requested that the comment period be extended due to the complexity of the legal issues involved. One of these comments related to the original 60-day comment period. In the Federal Register of November 30, 2015 (80 FR 74737), FDA reopened the comment period for an additional 30 days. The second comment appears to relate to the additional 30-day comment period announced in 80 FR 74737. With respect to the comment requesting an extension beyond the additional 30-day comment period, FDA believes this comment to be misplaced as it generally references “nine questions” that are related to a different rulemaking—the proposed version of the deeming rule.1

The Tobacco Control Act was enacted on June 22, 2009 (Pub. L. 111-31), amending the FD&C Act and providing FDA with the authority to regulate tobacco products. Section 101(a) of the Tobacco Control Act amends section 201 of the FD&C Act by adding paragraph (rr), which defines the term “tobacco product.” In general, a “tobacco product” is defined as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Section 201(rr)(2) of the FD&C Act excludes from the definition of a tobacco product any article that is defined as a drug under section 201(g)(1), a device under section 201(h), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C. 353(g)). Section 201(rr)(3) of the FD&C Act explains that any article that is a drug, device, or combination product shall be subject to chapter V of the FD&C Act (the authorities for drugs and devices) rather than chapter IX (the authorities for tobacco products).2

As noted in section I.A, the definition of “tobacco product” excludes anything that is a “drug,” “device,” or “combination product” under the FD&C Act. The FD&C Act defines “drug” (in relevant part) as an article intended either: (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease (referred to as the “disease prong” of the definition) or (2) to affect the structure or any function of the body (the “structure/function prong”) (section 201(g)(1) of the FD&C Act). The FD&C Act defines a “device” (in relevant part) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended either: (1) For use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or (2) to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes (section 201(h) of the FD&C Act).3 Combination products are products that constitute a combination of a drug, device, or biological product (section 503(g) of the FD&C Act). Under the FD&C Act, the Secretary's determination of the primary mode of action of a combination product determines which Center at FDA will have primary jurisdiction over the product (section 503(g) of the FD&C Act).

FDA had previously interpreted the exclusion in the tobacco product definition to mean that if a product made or derived from tobacco is determined to have a drug or device “intended use,” it will be regulated as a medical product, not as a tobacco product. As discussed in greater detail in this document, this interpretation was qualified in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), in which the D.C. Circuit applied the holding of Food & Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 (2000), to all tobacco products. Thus, the determination of whether a product is a medical product or a tobacco product is based on the FD&C Act and associated regulations and also takes into account relevant legal precedent (further described in section I.D).

In determining a product's intended use, the Agency may look to “any . . . relevant source,” including but not limited to the product's labeling, promotional claims, and advertising (see, e.g., Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); United States v. Storage Spaces Designated Nos. “8” and “49,” 777 F.2d 1363, 1366 (9th Cir. 1985), Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff'd, 540 F.2d 947 (8th Cir. 1976)).

For example, FDA may take into account any claim or statement made by or on behalf of a manufacturer that explicitly or implicitly promotes a product for a particular use (see, e.g., § 201.128 (drugs), § 801.4 (devices)).4

To establish a product's intended use, FDA is not bound by the manufacturer or distributor's subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Thus, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold (see id.; see also United States v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)). In the context of medical products, generally, circumstantial evidence often ensures that FDA is able to pursue firms that attempt to evade FDA medical product regulation by avoiding making express claims about their products. As FDA has previously stated, however, the Agency would not, absent extraordinary circumstances, regard a firm as intending an unapproved new use for an approved drug, or a device that has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (for ease of reference, such a device is referred to as “an approved or cleared device” (or similar terms) throughout this preamble) based solely on the firm's knowledge that such product was being prescribed or used by doctors for such use (Ref. 1).

Thus, when a product made or derived from tobacco is marketed or distributed for an intended use that falls within the drug/device definitions, it is regulated as a medical product, subject to the limitations discussed further in this document. Courts have recognized that products made or derived from tobacco marketed with “disease” claims and certain “structure/function” claims are drugs (see United States v. 46 Cartons . . . Containing Fairfax Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953) (cigarettes marketed for the prevention of respiratory diseases); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178 F.Supp. 847, 851 (D. N.J. 1959) (cigarettes marketed for weight reduction)).

Comments were received from tobacco product manufacturers, retailers, academia, medical professionals, advocacy groups, and consumers. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, will appear before each comment, and the word “Response,” in parentheses, will appear before each response. We have numbered the comments to make it easier to distinguish between comments; the numbers are for organizational purposes only and do not reflect the order in which we received the comments or any value associated with them. We have combined similar comments under one numbered comment. In addition to the comments specific to this rulemaking that we address in the following paragraphs, we received many general comments expressing support or opposition to the rule. These comments express broad policy views and do not address specific points related to this rulemaking. Therefore, these general comments do not require a response. Other comments outside the scope of this rulemaking also have not been addressed here. Summaries of the remaining comments, as well as FDA's responses, are included in this document.

(Comment 1) At least one comment stated that FDA is not permitted to regulate the nicotine in cigarettes as a drug and should not be permitted to regulate electronic nicotine delivery systems (ENDS) as medical products.

(Response) FDA disagrees. Section 201(g) of the FD&C Act defines “drug” as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, and articles (other than food) intended to affect the structure or any function of the body of man or other animals. Section 201(h) of the FD&C Act defines “device” (in relevant part) as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory,” that is intended “for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or . . . to affect the structure or any function of the body,” and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes. As explained in this final rule, FDA has the authority to regulate a product made or derived from tobacco, including cigarettes and ENDS, as a medical product if it is distributed or marketed for an intended use that falls within the drug/device definitions, unless the product is intended to affect the structure or any function of the body in any way related to the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

(Comment 2) Several comments stated that there is no need to clarify the medical product and tobacco product definitions that govern FDA regulation of these products. One of those comments also went on to state that there is a clear difference between drug product claims and “consumer-oriented marketing statements” about smoking cessation.

(Response) FDA disagrees that there is no need for additional clarity in this area. The Agency frequently receives inquiries regarding jurisdictional distinctions for products made or derived from tobacco, and given the broad range of intended uses for products made or derived from tobacco and the increasing variety of such products on the market, FDA believes that the potential for consumer confusion is increasing. This is especially true when tobacco-derived products that may otherwise appear to be products intended for recreational use make claims related to quitting smoking and treatment of nicotine addiction.

FDA considers claims about smoking cessation to be more than simply “consumer-oriented marketing statements.” As noted in the preamble to the proposed rule, claims related to smoking cessation have long been recognized as evidence of intended use, conferring drug or device jurisdiction, and smoking cessation claims also have long been associated with the intended uses of curing or treating nicotine addiction and its symptoms. For example, smoking cessation claims have appeared on the approved labeling for nicotine replacement therapies since the mid-1990s. FDA believes it is important to clarify and reiterate that smoking cessation claims on any product can render that product subject to FDA's medical products authorities.

(Comment 3) Comments had differing opinions on whether ENDS meet the definition of “tobacco product” as defined in the FD&C Act. Several comments stated that ENDS fall under the definition of “tobacco product” as defined in the FD&C Act if they contain nicotine derived from tobacco and are not intended to be drugs or devices. However, other comments stated that ENDS, including vaping hardware, do not fall within the definition of “tobacco product.”

(Response) FDA agrees that ENDS meet the definition of “tobacco product” if they are not drugs, devices, or combination products. The term “tobacco product” is defined in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to mean any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product), and excluding drugs, devices, and combination products as defined under the FD&C Act. Unless they are marketed for an intended use that falls within the drug/device definitions, ENDS products meet the definition of tobacco product. Additionally, as discussed elsewhere in the preamble, if ENDS products are intended to affect the structure or function of the body in any way related to the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, they will be regulated as tobacco products. (See section II.C.)

FDA disagrees with comments stating that vaping hardware does not fall within the definition of “tobacco product.” As the Agency explained in the final deeming regulation,5 the definition of tobacco product includes components and parts. Also included in the final deeming regulation is a non-exhaustive list of examples of components and parts used with ENDS products. Examples of components and parts used with ENDS products includes, but are not limited to: E-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software. Thus, vaping hardware meets the definition of tobacco product.

Although the courts have recognized that tobacco-derived products can be regulated as medical products under the FD&C Act in certain circumstances, courts have also held that there are limitations on how the drug and device definitions can be applied to products made or derived from tobacco. This section provides a summary of FDA regulatory action and related litigation relevant to those limitations.

In 1996, FDA issued a regulation restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents (the 1996 rule) (61 FR 44396, August 28, 1996). This rule included FDA's determination that it had jurisdiction over cigarettes and smokeless tobacco under the FD&C Act. The basis for this determination was that cigarettes and smokeless tobacco were intended to affect the structure or function of the body, within the FD&C Act definitions of the terms “drug” and “device,” because nicotine has significant pharmacological effects. In addition, FDA found that cigarettes and smokeless tobacco were combination products consisting of the drug nicotine and device components intended to deliver nicotine to the body. In the 1996 rule, FDA concluded that cigarettes and smokeless tobacco should be regulated under the device authorities of the FD&C Act. The 1996 rule was challenged in court by a group of tobacco manufacturers, retailers, and advertisers on the grounds that FDA lacked jurisdiction to regulate tobacco products “as customarily marketed;” that the regulations exceeded FDA's authority to regulate devices; and that the advertising restrictions violated the First Amendment.

The Supreme Court struck down the 1996 rule in Food & Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 (2000), holding that FDA lacked jurisdiction over tobacco products “as customarily marketed.” The Court found that Congress intended to exclude tobacco products from FDA's jurisdiction. In Brown & Williamson, the Court determined that tobacco products could not be made safe and effective for their intended uses, and therefore, if FDA had authority over them, FDA would have to remove them from the market, but that Congress had foreclosed such action (529 U.S. at 135-139). The Court also observed that Congress, in enacting statutes to regulate the labeling and advertising of conventional tobacco products, such as cigarettes and smokeless tobacco, had “effectively ratified FDA's long-held position” that the Agency lacked jurisdiction to regulate tobacco products “absent claims of therapeutic benefit by the manufacturer” (529 U.S. at 144).

In 2008 and early 2009, FDA detained multiple shipments of electronic cigarettes from overseas manufacturers and denied them entry into the United States on the ground that electronic cigarettes were unapproved drug-device combination products under the FD&C Act. In April 2009, two of the importers who were affected by this action sought a preliminary injunction to enjoin FDA from regulating electronic cigarettes as drug-device combination products and from denying entry of those products into the United States.6 Between the filing of the lawsuit and a decision on the motion for a preliminary injunction, Congress passed the Tobacco Control Act and the President signed it into law. The District Court subsequently granted a preliminary injunction, relying on Brown & Williamson and the recently enacted Tobacco Control Act (Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010)). FDA appealed the decision and the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) affirmed in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010).7 The D.C. Circuit determined that the decision in Brown & Williamson was not limited to tobacco products that were the subject of the specific federal legislation discussed in that case. The D.C. Circuit found that under the Tobacco Control Act, all products made or derived from tobacco and intended for human consumption that are “marketed for therapeutic purposes” are subject to FDA's drug and/or device provisions, whereas “customarily marketed tobacco products” are subject to regulation as “tobacco products” (Sottera, 627 F.3d at 898-899; see also Brown & Williamson, 529 U.S. at 144-156).

The Court in Brown & Williamson frequently referred to “tobacco products as customarily marketed,” but never defined that phrase. The Court contrasted that phrase with “claims of therapeutic benefit” (see, e.g., 529 U.S. at 127, 158), which it also did not define, although it did indicate that tobacco products' purported “therapeutic benefits” included all four of the structure/function intended uses on which FDA had based its 1996 rulemaking: Satisfying addiction, stimulation, sedation, and weight control (529 U.S. at 141). Neither of these terms is used in the FD&C Act. In Sottera, the D.C. Circuit relied on Brown & Williamson and repeated these phrases in describing contrasting types of products. The court in Sottera specifically equated “therapeutic uses” with the disease prong of the drug/device definitions in the FD&C Act and said that customarily marketed tobacco products were sold without therapeutic claims (627 F.3d at 894) and should be regulated as tobacco products under the FD&C Act, as amended by the Tobacco Control Act. As noted, the Brown & Williamson decision indicated that the four intended structure/function effects FDA had identified (satisfying addiction, stimulation, sedation, and weight control) were purported tobacco product “therapeutic benefits” (Brown & Williamson, 529 U.S. at 141). But neither the Brown & Williamson nor the Sottera court defined what might constitute claims of therapeutic benefit, nor did they explain the relationship between “tobacco products as customarily marketed” and the structure/function prong of the drug/device definitions of the FD&C Act. In addition, no court has addressed whether certain structure/function claims for products made or derived from tobacco that generally were not made for “tobacco products as customarily marketed” should be treated as drug or device claims.8

Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, we are issuing this final rule to provide clarity regarding our interpretation of the drug/device definitions in the FD&C Act with respect to products made or derived from tobacco. We believe that this final regulation will provide assistance for entities intending to market products made or derived from tobacco and for entities that plan to study these products. For example, the rule is expected to help sponsors determine which FDA Center should be consulted as they develop their products and make appropriate premarket submissions to bring new products to market. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. In addition, we believe it is important to avoid consumer confusion about which products are intended for medical uses versus recreational or other uses. The rule is expected to increase clarity regarding the types of intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a drug or device, which we expect will help consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses. Finally, the rule is intended to provide clarity for drug and device manufacturers generally regarding FDA's interpretation and application of its existing intended use regulations.

In both the Brown & Williamson and Sottera decisions, the courts set forth (but did not define) two poles—“tobacco products as customarily marketed” and “claims of therapeutic benefit”—and found that the “customarily marketed” pole was not within FDA's drug/device jurisdiction, but that the “claims of therapeutic benefit” pole was within FDA's drug/device jurisdiction. As noted in section I.D, the terminology used by the courts in establishing these two poles is not the terminology used by the FD&C Act in defining drugs and devices. Instead, the FD&C Act's drug and device definitions reference, in relevant part, diagnosis, cure, mitigation, treatment, or prevention of disease (disease prong) and effects on the structure or any function of the body (structure/function prong). In addition, while certain products and claims may fall clearly at one pole or the other, a spectrum of products and claims may fall somewhere between the two poles. In the sections that follow, we describe our interpretation of the jurisdictional lines established by the FD&C Act's drug, device, and tobacco product definitions as informed by the decisions in Brown & Williamson and Sottera.

As discussed in section I.B, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs, devices, or combination products under the FD&C Act. Products made or derived from tobacco have historically been regulated as medical products when they are marketed for intended uses that fall within the disease prong. For example, FDA has approved a number of drug products made or derived from tobacco as nicotine replacement therapies with indications to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Accordingly, FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to bring products within FDA's “disease prong” jurisdiction.

FDA has also taken enforcement action against products made or derived from tobacco that were marketed with claims of therapeutic benefit but that did not have approved new drug applications (NDAs). For example, FDA seized cigarettes on the grounds that they were misbranded drugs when the manufacturer represented that the cigarettes were effective in preventing respiratory diseases, common cold, influenza, pneumonia, and various other ailments (United States v. 46 Cartons . . . Containing Fairfax Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953)); see also United States v. 354 Bulk Cartons Trim Reducing-Aid Cigarettes, 178 F.Supp. 847 (D. N.J. 1959) (similar, where manufacturer made weight-reduction claims for its cigarettes).

The “claims of therapeutic benefit” language used by the Brown & Williamson and Sottera courts has a logical relationship to the disease prong of the drug/device definition, in that “therapeutic” can be defined as “relating to the treatment of disease or disorders by remedial agents or methods” or to “providing or assisting in a cure.” 9 With this rule, FDA is clarifying the categories of claims relevant to products made or derived from tobacco that FDA considers to be evidence of intended use that brings products within the disease prong in light of the Sottera and Brown & Williamson decisions. As discussed previously, claims related to smoking cessation have long been recognized as evidence of intended use conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with intended uses of curing or treating nicotine addiction and its symptoms. For example, the approved labeling for nicotine replacement therapies includes the following statements: “Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.” 10 Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of intended therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose.

Given the availability of FDA-approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking. Therefore, FDA considers claims related to smoking cessation to require careful scrutiny. Where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically because of the likelihood of consumer confusion. In most cases, as discussed in more detail in response to Comment 13, FDA does not believe that disclaimers will sufficiently mitigate consumer confusion due to the product's claimed therapeutic benefit.

FDA will treat several other categories of claims for products made or derived from tobacco as evidence of intended use that brings the products within the disease prong of the drug/device definition. These categories of claims are discussed further in section IV, Description of the Final Rule). We note that sections 911(c) and 918 of the FD&C Act (21 U.S.C. 387k(c) and 387r), as amended by the Tobacco Control Act, contemplate that products intended for the treatment of tobacco dependence and for relapse prevention, among other things, may be subject to FDA's drug/device jurisdiction.

With this final rule, FDA is also clarifying the relationship between FDA's regulation of a certain category of tobacco products—modified risk tobacco products (MRTPs)—and FDA's regulation of medical products that are intended to mitigate disease. MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products (section 911(b)(1) of the FD&C Act). Tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products means a tobacco product:

(1) That represents in its label, labeling, or advertising, either implicitly or explicitly, that:

• The tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;

• the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or

• the tobacco product or its smoke does not contain or is free of a substance;

(2) That uses the descriptors “light,” “mild,” “low,” or similar descriptors in its label, labeling, or advertising; or

(3) For which the tobacco product manufacturer has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.

See section 911(b)(2) of the FD&C Act.11

Because MRTPs have the potential to be marketed as less harmful than other tobacco products, including as presenting a lower risk of tobacco-related disease than another tobacco product, FDA recognizes that there might be questions about how these products relate to FDA's medical product jurisdiction over products made or derived from tobacco that are intended for use in disease mitigation and prevention. MRTPs may have the ultimate effect of lowering disease risk for users who would otherwise use another, more harmful tobacco product. However, an important distinction between MRTPs and medical products is that, while medical products approved/cleared for disease mitigation or prevention act affirmatively to combat a disease or health condition, MRTPs present relatively less risk of disease (e.g., by presenting reduced exposure to harmful constituents relative to another tobacco product), but do not affirmatively act to mitigate, prevent, or otherwise treat disease. In addition, while medical products approved for disease mitigation are determined to be both safe and effective for their approved use, MRTPs are reviewed based, in part, on a “benefit the health of the population as a whole” standard, and like other tobacco products, still expose users to inherent (if reduced) harms.

For purposes of illustration, claims of modified risk might include claims like “contains less nicotine than [tobacco product X]”, “using [MRTP] reduces your risk of lung cancer compared to using [tobacco product X]”, and “lower level of nitrosamines than other smokeless tobacco products.” In contrast, a claim that a product “inhibits the progression of disease in adult patients with chronic obstructive pulmonary disease” is evidence of intended uses that would bring the product within drug/device jurisdiction.

(Comment 4) At least one comment remarked that research studies and public opinion may come to reflect that a tobacco product appears to have properties similar to those of a medical drug or MRTP. The comment asserted that acceptance of these properties by the scientific and medical community or by the public should not subject the product to regulation as a medical product or MRTP in the absence of any specific claims by the manufacturer.

(Response) As explained in this final rule, with certain exceptions, products made or derived from tobacco are subject to regulation as medical products if they are distributed for an intended use that falls within the FD&C Act's drug/device definitions, and the Agency may look to any relevant source to determine intended use. To the extent this comment suggests that manufacturer claims are always necessary to establish a medical product's intended use, FDA disagrees. As discussed at various points in this final rule (for example, in response to Comment 18), FDA is not bound by the manufacturer or distributor's subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Nevertheless, FDA agrees with the comment that neither the opinions of the scientific and medical communities nor public opinion considered alone should dictate when a product made or derived from tobacco is regulated as a medical product or MRTP. In general, FDA would not regard a manufacturer as intending a medical use for a product made or derived from tobacco based solely on study findings or widespread belief that the product appears to have properties similar to those of a medical product. Similarly, FDA would not regard a manufacturer of a product made or derived from tobacco as selling or distributing a product for use to reduce harm or the risk of tobacco-related disease based solely on study findings or widespread belief that the product appears to have properties similar to those of an MRTP.

As discussed in section I.B, the drug/device definitions in the FD&C Act include articles “intended to affect the structure or any function of the body,” and FDA's assertion of jurisdiction over cigarettes and smokeless tobacco in 1996 was predicated on the pharmacological effects of nicotine on the structure or function of the body. In addition, as explained previously, the Court in Brown & Williamson rejected that assertion of jurisdiction, finding that Congress did not intend for FDA to have jurisdiction over cigarettes “as customarily marketed.”

Based on the Brown & Williamson holding and the Sottera court's application of that holding to all tobacco products, it is necessary to determine whether the intended use of a product made or derived from tobacco was the subject of claimed structure or function effects for tobacco products “as customarily marketed”—and therefore outside of FDA's drug/device jurisdiction. FDA believes the appropriate inquiry is whether the intended structure/function effects relate to effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to the date of the Supreme Court's decision in Brown & Williamson (March 21, 2000).

For example, as discussed in the 1996 rulemaking, claims related to satisfaction, pleasure, enjoyment, and refreshment are euphemisms for the delivery of a pharmacologically active dose of nicotine and thus relate to effects on the structure or function of the body (61 FR 44396 at 45101 and 45175-45178). Nonetheless, FDA does not consider these tobacco satisfaction and enjoyment claims to bring products within its drug and device regulatory authority because these are structure/function claims related to the effects of nicotine and were commonly and legally made before March 21, 2000. Similarly, FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product—such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”—to bring a tobacco product within its drug and device authority.

The Brown & Williamson and Sottera decisions do not reach the issue of intended uses that fall outside the disease prong of the drug/device definition and that are outside the area of “customarily marketed” tobacco product claims. FDA believes certain structure/function intended uses for products made or derived from tobacco continue to fall within our drug/device regulatory authority. FDA believes these structure/function intended uses fall into two main categories: (1) Intended uses that are unrelated to the pharmacological effects of nicotine and (2) intended uses that were not the subject of claims that were commonly and legally made for cigarettes and smokeless tobacco products (i.e., the products addressed in the 1996 rule) prior to the Supreme Court's decision in Brown & Williamson. Thus, to the extent manufacturers intend products made or derived from tobacco to be used to affect the structure or function of the body in any way that is not related to the effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, FDA would consider these intended uses to remain within its drug/device jurisdiction under the final rule. For example, FDA's 1996 rulemaking identified “sedation,” “stimulation,” and “weight loss” as intended structure/function effects related to nicotine in cigarettes and smokeless tobacco products (61 FR 44396 at 44667; see also Brown & Williamson, 529 U.S. at 127). These structure/function effects are similar to “relieve tension,” “restore mental alertness,” and “promote weight loss,” which the proposed rule gave as examples of potential intended structure/function effects (80 FR 57756 at 57760; see also Comment 7 in this document). But absent evidence that “sedation,” “stimulation,” or “weight loss” is both a structure/function effect related to nicotine and was commonly and legally claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, whose intended use includes such structure/function effects, to be medical products.

Similarly, “maintain memory”—another example of a potential intended structure/function effect mentioned in the proposed rule (80 FR 57756 at 57760)—was (as FDA's 1996 rulemaking observed) a pharmacological effect that Philip Morris researchers attributed to nicotine and that R.J. Reynolds Tobacco asserted as a “benefit” in court filings (61 FR 44396 at 44857-44858 and 45029). But once again, absent evidence that “maintaining memory” is both a structure/function effect related to nicotine, and was commonly and legally claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, intended for use to “maintain memory,” to be medical products.

Different facts but a similar analysis apply to the proposed rule's other examples of potential intended structure/function effects, “maintain healthy lung function” and “support the immune system.” (80 FR 57760). In contrast to its findings for “stimulation,” “sedation,” and “weight loss,” (61 FR 44396 at 44667), FDA's 1996 rulemaking did not identify “maintain healthy lung function” or “support the immune system” as intended structure/function effects of cigarettes or smokeless tobacco products. But as with those other potential intended uses, absent evidence that “maintaining healthy lung function” or “supporting the immune system” are both structure/function effects related to nicotine, and were commonly claimed in marketing cigarettes or smokeless tobacco products prior to March 21, 2000, FDA will consider products made or derived from tobacco, intended for use to achieve such structure/function effects, to be medical products.

FDA believes that it is important to recognize structure/function intended uses that were not commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to the decision in Brown & Williamson. Structure/function intended uses are a longstanding and important aspect of FDA's medical product jurisdiction, grounded in the statutory definitions of “drug” and “device” in the FD&C Act. We recognize that products made or derived from tobacco are unique because of the regulatory regime for tobacco products under the FD&C Act, and that some products made or derived from tobacco making certain structure/function claims are now outside our drug/device jurisdiction. However, we believe it is consistent with the FD&C Act, case law, and our public health mission to determine that medical products include products made or derived from tobacco whose intended use includes effects on the structure or function of the body that are distinct from the pharmacological effects related to nicotine that were commonly and legally claimed before March 21, 2000.

FDA believes this final rule will provide clarity to manufacturers about how products made or derived from tobacco will be regulated if they are marketed or distributed for certain intended uses. This clarification will allow regulated industry to plan accordingly during the product development and postmarketing phases and will help researchers understand the applicable regulatory requirements associated with the investigational use of products made or derived from tobacco.

In addition, we believe this final rule will help to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use (i.e., as a drug/device) versus for a recreational use. Specifically, FDA wishes to avoid situations where products intended to be sold as tobacco products are marketed with the same claims as products sold as drugs or devices.

(Comment 5) At least one comment agreed with FDA that the Brown & Williamson and Sottera rulings did not define the phrases “as customarily marketed” or “claims of therapeutic benefit,” leaving the Agency with some discretion as to what claims fall within each category when the distinction is not clear under existing precedent.

(Response) FDA agrees that the lack of definitions of the terms “customarily marketed” and “claims of therapeutic benefit” as they apply to products made or derived from tobacco in the relevant case law has created ambiguity and resulted in confusion among regulated industry, which has led FDA to promulgate this rule. Specifically, in the absence of clear judicial direction about what might constitute “claims of therapeutic benefit” and the relationship between tobacco products “as customarily marketed” and the structure/function prong of the drug/device definitions, the Agency believes it is important to clarify its statutory interpretations of the drug/device definitions with respect to products made or derived from tobacco in light of these terms used by the courts.

(Comment 6) Several comments supported FDA's proposal to treat satisfaction, smoking alternative, and nicotine fix claims as tobacco product claims. However, these comments assert that all products derived from tobacco that lack express therapeutic claims must be regulated as tobacco products. These comments maintained that FDA's proposed approach—which provides that some structure/function claims will cause products derived from tobacco to be regulated as drugs, devices, or combination products—is inconsistent with the Brown & Williamson and Sottera decisions.

Specifically, the comments argued that neither decision “indicates that `customarily marketed' means anything other than `not marketed with therapeutic claims'.” They maintained that the Sottera court “explicitly concluded that the `better reading' of Brown & Williamson was that it deprives FDA of authority to regulate under the FD&C Act any tobacco products marketed `without claims of therapeutic effect,' viewing such products as `customarily marketed.' ” Accordingly, the comments contended that the courts saw only two categories of tobacco products—products marketed with or without therapeutic claims. The comments asked that FDA clarify that it lacks authority to regulate any product made or derived from tobacco as a drug or device absent express therapeutic claims.

(Response) FDA disagrees with these comments and declines to adopt their overly narrow reading of Brown & Williamson and Sottera. First, Brown & Williamson provides no support for the comments' assertion that therapeutic claims must be express for a product to be subject to FDA's drug/device jurisdiction. The plaintiffs in Brown & Williamson made this very argument, and the dissenting opinion noted that the FD&C Act “does not use the word `claimed'; it uses the word `intended'.” See Brown & Williamson, 529 U.S. 120, 170 (2000) (dissenting opinion). The majority specifically declined to resolve the question. See Brown & Williamson, 529 U.S. 120, 132 (2000).

In addition, as noted in section I.C of the proposed rule, as well as section I.D, neither the Brown & Williamson nor the Sottera decisions defined the term “customarily marketed.” Although the court in Sottera did equate the concept of “therapeutic claims” with the disease prong of the drug and device definitions, there was no such equating of the term “customarily marketed” with the structure/function prong of these definitions. In fact, the term “customarily marketed” itself suggests that the term has some meaning independent of its relationship to the structure/function prong of the drug and device definitions. If the Supreme Court had wanted any structure/function claim to exclude a product made or derived from tobacco from FDA's drug/device jurisdiction, it could have said so. The structure of section 201(rr) of the FD&C Act, added by the Tobacco Control Act, further supports this interpretation. Following the Supreme Court's decision in Brown & Williamson, Congress enacted the Tobacco Control Act to give FDA explicit authority to regulate tobacco products. Under section 201(rr)(2), the term “tobacco product” excludes articles that are drugs under section 201(g)(1) and devices under section 201(h) of the FD&C Act. This statutory carve-out includes the structure/function prong of the drug/device definitions.

Having given FDA regulatory authority over tobacco products, if Congress thought that products made or derived from tobacco should never be regulated as drugs or devices under the structure/function prong of the drug or device definitions in the wake of Brown & Williamson, presumably Congress would have written section 201(rr)(2) of the FD&C Act differently. The better reading is that Congress recognized that products made or derived from tobacco as “customarily marketed” would be regulated as tobacco products under the Tobacco Control Act, but that products made or derived from tobacco meeting the drug/device definitions (including the structure/function prong, to the extent such products were not “customarily marketed”) would continue to be regulated as drugs or devices.

(Comment 7) At least one comment disagreed with some of the examples in the proposed rule of structure/function intended uses that FDA believes remain within its drug/device jurisdiction under the proposal. Specifically, the comment argued that claims about nicotine's stimulant and weight-loss structure/function effects “remain permissible `tobacco product' claims,” because FDA's 1996 rulemaking found that stimulant and weight-loss structure/function effects were among the intended uses of cigarettes and smokeless tobacco products (citing 61 FR 44396 at 44630, 44632).

(Response) FDA disagrees with this comment. In the 1996 rulemaking, FDA found that, in addition to causing and sustaining addiction, nicotine in cigarettes and smokeless tobacco causes other psychoactive (mood-altering) effects, including tranquilization and stimulation; and that nicotine in cigarettes and smokeless tobacco controls weight (61 FR 44396 at 44630). The rulemaking further found that these were intended structure/function effects for cigarettes and smokeless tobacco products (id. at 44632). But the central holding of Brown & Williamson was that “customarily marketed” tobacco products were not subject to FDA's medical product authority, even assuming that such products could be considered to have the intended structure/function effects that FDA attributed to them if their manufacturers and sellers did not claim such effects (529 U.S. at 131-32). As discussed in section I.D, this current rulemaking applies Brown & Williamson, as relevant here, by looking to marketing claims for structure/function effects that were commonly and legally made for “customarily marketed” cigarettes and smokeless tobacco products prior to the date the Brown & Williamson decision was issued. To the extent the comment read the examples “relieve tension” and “restore mental alertness” as stimulant intended uses, FDA does not believe that they are structure/function intended uses relating to effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. Similarly, FDA does not believe that “promotes weight loss” was a “customarily marketed” tobacco product claim within the meaning of Brown & Williamson. Section 1100.5 is written such that, if a particular intended structure/function effect for a product made or derived from tobacco is related to the effects of nicotine commonly and legally claimed prior to March 21, 2000, that product would not be subject to FDA's drug/device jurisdiction. FDA expects that in some cases this would be a fact-specific, case-by-case inquiry.

Sponsors should also keep in mind that, regardless of whether a product is regulated as a tobacco product or a medical product, the claims made for the product would misbrand the product and subject manufacturers to enforcement action if the claims are false or misleading in any particular, including if the claims are unsubstantiated. Thus, if a particular claim related to the effects of nicotine was used in the marketing of a tobacco product prior to March 21, 2000, but that claim is not substantiated by appropriate evidence, the use of such a claim in current labeling or advertising would likely misbrand the product. In addition, both medical products and tobacco products would be subject to enforcement action under section 201(n) of the FD&C Act if their labeling or advertising fails to reveal facts material in the light of the representations made or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates.

(Comment 8) Several comments argued that the proposed rule was an improper attempt to undermine the court's holding in Sottera with respect to the regulation of electronic cigarettes. These comments viewed the proposed rule as an attempt to regulate electronic cigarettes as drugs, and characterized it as an effort to bypass the D.C. Circuit's ruling in Sottera. They also suggested that Sottera made a categorical determination regarding the intended use of electronic cigarettes generally, and maintained that FDA declined to appeal the D.C. Circuit's decision and instead represented that it intended to regulate electronic cigarettes as tobacco products.

(Response) FDA disagrees with these comments. Although the Sottera decision determined that the holding in Brown & Williamson was not limited to cigarettes and smokeless tobacco, the court did not say that electronic cigarettes could never be regulated as drugs or devices. Rather, the court held that FDA can “regulate tobacco products marketed for therapeutic purposes under [the FD&C Act's drug/device provisions],” and observed that “the FDA may establish that NJOY does in fact make therapeutic claims regarding its electronic cigarettes.” See Sottera, 627 F.3d at 899. The rule FDA issues here clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product. Manufacturers are free to choose how they would like to market products made or derived from tobacco, but do so in the context of the regulatory framework set forth in the rule.

Moreover, the comments appear to misunderstand the nature of determinations of intended use with respect to FDA-regulated products. As discussed elsewhere in this document, intended use is a case-by-case, fact-specific inquiry in which the Agency may look to any relevant source of evidence, including a variety of direct and circumstantial evidence. See, e.g., Response to Comment 18 in section IV.C. Intended use is not determined on a categorical basis based on product type. Finally, in deciding not to petition for certiorari from the D.C. Circuit's decision in Sottera, FDA did not state or signal that it intended to regulate electronic cigarettes as tobacco products under all circumstances. Rather, in the wake of the Sottera decision, FDA issued a letter to stakeholders,12 noting that the Agency would abide by the jurisdictional lines established by Sottera, and was considering issuing a guidance or rulemaking regarding therapeutic claims. This final rule is the result of FDA's consideration of the issues raised by the Sottera decision and clarifies FDA's interpretation of the statutory definitions of drug and medical device with respect to products made or derived from tobacco.

(Comment 9) Several comments asserted that claims that use euphemisms for the delivery of a pharmacologically active dose of nicotine, or state that a tobacco product provides an alternative way of obtaining the effects of nicotine or will provide the same effects as another tobacco product, do not fall within FDA's medical product authority. Four comments took the opposite view. Three of these latter comments remarked that excluding such claims from FDA's medical product authority would authorize manufacturers to continue using claims that were found to be fraudulent and deceptive by the U.S. District Court for the District of Columbia in United States v. Philip Morris USA Inc., 449 F. Supp. 2d 1 (D.D.C. 2006). These comments asserted that claims suggesting a product made or derived from tobacco provides “satisfaction,” a “nicotine fix,” or “pleasure” are claims about the pharmacological effects of nicotine, and suggested that products bearing such claims should be regulated as medical products. Another comment suggested that FDA treat such claims as evidence of an article's intended use as a drug.

(Response) The Agency disagrees with any suggestion that FDA is authorizing fraudulent claims. The purpose of this rule is to increase clarity regarding the types of intended uses and supporting evidence that make a product made or derived from tobacco subject to regulation as a tobacco product versus as a drug, device, or combination product. Regardless of the outcome of that jurisdictional question, the FD&C Act prohibits false and misleading claims in FDA-regulated labeling and advertising (see sections 502(a), 502(n), 502(r), 903(a)(1), and 903(a)(7) (21 U.S.C. 352(a), 352(n), 352(r), 387c(a)(1), and 387c(a)(7)). Similarly, in concluding that certain claims involving “satisfaction,” “pleasure,” “enjoyment,” and “refreshment” are claims about the pharmacological effects of nicotine that were commonly and legally made prior to March 21, 2000, FDA is not authorizing such claims. Rather, the Agency is explaining in more detail its understanding of how the D.C. Circuit's interpretation of the Tobacco Control Act in Sottera affects the jurisdictional determination. As documented in the annex to the 1996 rule, products made or derived from tobacco were customarily marketed at that time for the pharmacological effects of nicotine, using phrases such as “smoking pleasure” and “satisfaction.” 13 Such terms, as discussed in section II.C, are recognized euphemisms for the delivery of a pharmacologically active dose of nicotine to satisfy addiction—an intended structure/function effect—and were commonly and legally made claims for customarily marketed cigarettes and smokeless tobacco products prior to the date of the Brown & Williamson decision. Thus, FDA continues to believe that Brown & Williamson, as extended and applied to the Tobacco Control Act by Sottera, precludes the Agency from regulating products made or derived from tobacco as medical products on the basis of such claims.

(Comment 10) Comments expressed different opinions about the intended uses of products made or derived from tobacco, primarily e-cigarettes, and whether consumers are able to distinguish products that are intended for medical use from products marketed for other uses. Several comments asserted that e-cigarettes are not intended for use as smoking cessation aids, whereas many other comments asserted that e-cigarettes are vital smoking cessation aids. One comment averred that there is no evidence that consumers are confusing e-cigarette products with products that are marketed, labeled, and sold as medical products. Two other comments, however, cited studies that purportedly show many consumers believe e-cigarettes and smokeless tobacco products are effective smoking cessation aids.

(Response) FDA continues to believe that there is consumer confusion about the intended uses of marketed products made or derived from tobacco. Evidence that at least some consumers are confused about the intended uses of products can be found in the comments themselves. We received many comments from individuals who began using e-cigarettes because they believed that e-cigarettes would help them quit smoking. Moreover, as noted in two comments, studies have shown that many consumers are using e-cigarettes to attempt to quit smoking (Ref. 2) despite the fact that no e-cigarette has been approved for use as a smoking cessation aid. We believe that the rule will help to mitigate this confusion and help ensure that consumers do not mistakenly use tobacco products, which are inherently dangerous, for medical uses.

(Comment 11) Several comments expressed concern that this regulation would increase consumer confusion by not allowing ENDS manufacturers to communicate truthful claims to their customers. These comments believed that the regulation would harm, rather than protect public health. Comments also expressed concern that ENDS manufacturers would not be able to state that e-cigarettes could be used for smoking cessation, and ENDS manufacturers would be forced to deceptively market their products. Several comments discussed FDA's authority under section 911 of the FD&C Act to require premarket authorization of modified risk tobacco products. Some commenters urged FDA to implement section 911 in a manner that does not restrict truthful and non-misleading speech.

(Response) FDA disagrees with concerns that ENDS manufacturers will not be able to make claims that accurately represent their products' intended uses. Manufacturers are free to decide how they would like to market their products, but must meet the appropriate statutory and regulatory standards governing the regulatory pathway they choose. Additionally, the proposed rule would not force e-vapor manufacturers to “deceptively” market their products or risk “being categorized as unapproved medical products and forced off the market.” FDA believes that manufacturers of products made or derived from tobacco, including e-vapor manufacturers, could make many types of claims under the rule that would subject them only to tobacco product jurisdiction; the preamble to the proposed rule provides examples of such tobacco product claims, but is not intended to be an exhaustive list. Moreover, section 911 of the FD&C Act allows manufacturers to make truthful and non-misleading modified risk claims with appropriate authorization. Manufacturers that have data to substantiate modified risk claims for a particular product can submit an MRTP application so that FDA can determine whether the product meets the statutory standard and if appropriate, can issue an order authorizing it to be marketed as an MRTP.

FDA continues to believe that smoking cessation claims require close examination. FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction to be evidence of intended uses that confer drug or device jurisdiction. Manufacturers that have data to substantiate cessation claims for a particular product can submit an NDA so that FDA can determine whether the product meets the statutory standard and can approve the application, if appropriate. The rule's treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products. Treating these products as medical products will help assure that such claims are supported by data demonstrating that a product is safe and effective for this intended use. Otherwise, consumers may attempt to quit smoking with unproven products, threatening both individual consumers' health and the public health generally.

(Comment 12) At least one comment suggested that a disclaimer stating that FDA has not approved e-cigarettes for medical use would be sufficient to mitigate any confusion over the intended use of such products. In contrast, several comments argued that disclaimers are insufficient to mitigate any confusion over whether a product made or derived from tobacco is intended for medical use. One of these comments suggested that disclaimers would foster confusion because they often contain statements that conflict with claims that are made elsewhere in the marketing materials and labeling for e-cigarettes and other products.

(Response) FDA does not believe that disclaimers will be sufficient in most cases to mitigate consumer confusion about whether a product made or derived from tobacco is intended for medical use. Studies have shown that disclaimers are frequently ineffective and can actually increase confusion for consumers (Refs. 3 and 4). Thus, where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically.

(Comment 13) Several comments suggested that excluding claims that are euphemisms for the delivery of a pharmacologically active dose of nicotine and those that suggest a tobacco product provides an alternative way of obtaining the effects of nicotine from regulation under the Agency's drug/device authorities would create consumer confusion because such claims may not be distinguishable from drug or device claims related to the symptoms of nicotine addiction or could be perceived as modified risk claims.

(Response) As stated previously in this section, FDA has determined that the types of claims described in these comments generally do not bring products made or derived from tobacco within its drug and device authority. We acknowledge that there are circumstances in which consumers might be confused by such claims. A consumer might be confused about a product's intended use, for example, if a “satisfying smoking alternative” claim is accompanied by other text or images indicating that the product can help smokers reduce withdrawal symptoms associated with quitting smoking. In that case, the product may be subject to regulation as a drug or device. But as a general matter, FDA does not expect claims that use euphemisms for the delivery of a pharmacologically active dose of nicotine or suggest that a tobacco product provides an alternative way of obtaining the effects of nicotine to cause much confusion. FDA will continue to monitor consumer perception and will take appropriate regulatory action if evidence accumulates showing that consumers are confused by such claims.

FDA is also making changes to §§ 201.128 and 801.4. First, the final rule inserts a reference to § 1100.5 to clarify the interplay between these regulations and the final rule. Second, as discussed previously, the Agency does not, absent extraordinary circumstances, regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm's knowledge that the product was being prescribed or used by doctors for such use (see Ref. 1). Accordingly, FDA is taking this opportunity to amend §§ 201.128 and 801.4 to better reflect FDA's interpretation and application of these regulations. These changes do not reflect a change in FDA's approach regarding evidence of intended use for drugs and devices. These clarifying changes to the intended use regulations apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.

Among the provisions that provide authority for this final rule are sections 201, 503(g), and 701(a) of the FD&C Act (21 U.S.C. 321, 353(g), 371(a)). Section 201 of the FD&C Act defines “drug,” “device,” and “tobacco product” (subsections (g)(1), (h), and (rr)(1) to (rr)(2)), and section 503(g) of the FD&C Act provides that combination products are those “that constitute a combination of a drug, device, or biological product.” Under section 701(a) of the FD&C Act, FDA has authority to issue regulations for the efficient enforcement of the FD&C Act. FDA believes this rule will assist the Agency with efficient enforcement of the FD&C Act because it provides increased clarity to stakeholders, particularly regulated entities, regarding FDA's interpretation of which regulatory framework will apply to particular products and will help consumers differentiate between products that are intended for medical use and products marketed for other uses.

FDA regulates the manufacture, sale, and distribution of drugs, devices, combination products, and tobacco products under the authority of the FD&C Act. Although the regulatory pathways for each product category differ, each product category is subject to similar types of regulatory requirements. For example, FDA's regulatory authority for drugs, devices, combination products, and tobacco products includes authority to review and authorize the marketing of new products as well as to oversee product labeling and advertising. Thus, whether a product meets the definition of a drug, device, or tobacco product under the FD&C Act and this final regulation, the manufacture, sale, and distribution of the product are subject to the applicable requirements of the FD&C Act.

(Comment 14) At least one comment stated that the proposed rule exceeds FDA's authority.

(Response) FDA disagrees. As described in the proposed rule, FDA has the authority to regulate as a medical product any product that meets the definition of drug, device, or combination product in the FD&C Act, including cigarettes and other tobacco-derived products unless their intended use was the subject of claimed structure/function effects of nicotine commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. FDA also has tobacco product jurisdiction over all other products made or derived from tobacco intended for human consumption. The final rule seeks to clarify how products containing nicotine derived from tobacco will be regulated.

As described in section II, the goal of this final rule is to provide clarity regarding the types of intended uses of products made or derived from tobacco that may fall within the drug/device definitions and therefore cause those products to be regulated as medical products under the FD&C Act. In describing these intended uses, the final rule aims to assist regulated entities in the research and development of products made or derived from tobacco by clarifying which regulatory framework (i.e., the drug/device frameworks or the tobacco framework) will apply to particular products based on their intended use. The final rule is also intended to reduce consumer confusion regarding which products are intended for medical use (i.e., as a drug, device, or combination product) and which may be marketed for recreational or other purposes. The final rule reflects the legal and regulatory considerations discussed in sections I and II, including the Brown & Williamson and Sottera holdings. Finally, the final rule amends the existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to § 1100.5 to clarify the interplay among these regulations and this final rule.

The codified language states the circumstances in which a product made or derived from tobacco would be excluded from the definition of “tobacco product” and be subject to regulation as a drug, device, or combination product. Under the final rule, this exclusion could apply in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.

Conceptually, the codified language follows the disease prong and the structure/function prong (with certain limitations) of the drug and device definitions.

Section 1100.5(a) follows the disease prong. The paragraph elaborates on the statutory language for the disease prong by describing several categories of intended uses that would cause a product made or derived from tobacco to be regulated as a medical product. The categories identified in § 1100.5(a) are not intended to constitute an exhaustive list; nor are these categories necessarily mutually exclusive. In addition, these categories are intended to capture concepts, rather than to suggest that the use (or omission) of particular words is dispositive with respect to FDA's medical product jurisdiction. These categories are included as examples of types of intended uses that we believe are particularly relevant for products made or derived from tobacco and that fall within the disease prong.

Section 1100.5(b) follows the structure/function prong, but with some changes to reflect the court decisions in Brown & Williamson and Sottera. Specifically, the language in § 1100.5(b) beginning “in any way that is different from . . . .” reflects the fact that, under Brown & Williamson and Sottera, intended structure/function effects related to nicotine will not confer drug/device jurisdiction to the extent they reflect claims that were commonly and legally made for “customarily marketed” tobacco products before the date of the Brown & Williamson decision. This language also references “the marketing of cigarettes and smokeless tobacco products” because these were the product categories considered by the Supreme Court in Brown & Williamson. March 21, 2000, is the date of the Supreme Court's ruling in Brown & Williamson.

FDA believes that it is important to include a date limitation in § 1100.5(b) to provide greater certainty about the universe of historic structure/function claims the Agency intends to consider when determining whether an intended use of a product made or derived from tobacco is different from effects related to nicotine that were commonly and legally claimed for “customarily marketed” cigarettes and smokeless tobacco products. This bright-line limitation also avoids creating a shifting standard that will cause confusion among consumers and regulated industry. FDA intends to look to the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, to determine the types of structure/function claims that constitute customary tobacco product marketing. Cigarettes and smokeless tobacco products provide a reasonable proxy for determining how nicotine-related structure/function claims were conveyed in tobacco product marketing generally. The codified language, however, applies to all products made or derived from tobacco, not just cigarettes and smokeless tobacco.

As noted in section I.B.2, intended use may be determined from any relevant source and is not based solely on claims made in a product's labeling or advertising materials. For purposes of illustration, however, claims such as “treatment of tobacco dependence,” “wean yourself off of nicotine,” “for people who wish to quit smoking,” “stop smoking aid,” “prevent relapse,” or “stay quit” generally will bring a product within the intended uses described in § 1100.5(a).14

Claims such as “to reduce withdrawal symptoms,” “helps reduce symptoms including things like [list of withdrawal symptoms]” and “relieve withdrawal symptoms when you are prohibited from smoking” would be associated with an intended use for relief of nicotine withdrawal symptoms, and would also fall within the intended uses described in § 1100.5(a). Withdrawal symptoms that are medically recognized as relevant to nicotine addiction may be determined by reference to standard classification and diagnostic tools such as the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).

Certain structure/function claims that were not commonly and legally made in the marketing of cigarettes and smokeless tobacco products before March 21, 2000, such as “promotes weight loss,” would fall within the intended uses described in § 1100.5(b).

In contrast to the examples of medical product intended use claims given in the previous paragraphs, certain other claims made about products made or derived from tobacco would not on their own create an intended use that falls within the codified language.15 For example, claims such as “smoke free, spit free tobacco pleasure” or “full taste and satisfaction” may be associated with the marketing of tobacco products for refreshment, satisfaction, or enjoyment (which, as discussed in section II.C, are recognized euphemisms for the delivery of a pharmacologically active dose of nicotine to satisfy addiction—an intended structure/function effect—and were commonly and legally made claims for customarily marketed cigarettes and smokeless tobacco products prior to the date of the Brown & Williamson decision). Claims such as “great tasting tobacco satisfaction when you can't smoke,” “satisfying tobacco alternative,” or “provides the look, feel, and experience of a cigarette” may be associated with the marketing of tobacco products as smoking substitutes. And claims such as “healthier alternative to smoking,” “contains less nicotine than [another product],” or “reduces your risk of lung cancer compared to cigarettes” might be associated with MRTPs, as discussed in section II.A.2.

For products made or derived from tobacco that are intended for investigational use, FDA will consider whether the product is being used in a clinical investigation for an intended use that brings it within the codified language. If it is, the product would meet the definition of “investigational new drug” in § 312.3 (21 CFR 312.3), and the clinical investigation would be subject to the applicable requirements in part 312 (21 CFR part 312).16 Products made or derived from tobacco that are intended for investigational use but that do not meet the definition of “investigational new drug” in § 312.3 may be subject to regulation as investigational tobacco products.

In the proposed rule, FDA proposed certain changes to FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses (see § 201.128 (drugs), § 801.4 (devices)). These changes were intended to revise the language of the regulations to better reflect how the Agency applies them. As explained in the preamble to the proposed rule, these amendments were intended to clarify FDA's existing position on intended use, not to change it (80 FR 57756 at 57761). Some comments, however, misunderstood FDA's proposal, particularly with respect to the proposed deletion of the last sentence of both regulations (§§ 201.128 and 801.4). FDA has now determined that its clarification goals can be better achieved by amending the last sentence of each regulation, rather than deleting them.

Accordingly, the last sentence of § 201.128 is amended to provide that if the totality of the evidence establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved (if any), he is required, in accordance with section 502(f) of the FD&C Act, or, as applicable, duly promulgated regulations exempting the drug from the requirements of section 502(f)(1), to provide for the drug adequate labeling that accords with such other intended uses.

Similarly, the last sentence of § 801.4 is amended to provide that if the totality of the evidence establishes that a manufacturer objectively intends that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (if any), he is required, in accordance with section 502(f) of the FD&C Act, or, as applicable, duly promulgated regulations exempting the device from the requirements of section 502(f)(1), to provide for the device adequate labeling that accords with such other intended uses.

As described in the preamble to the proposed rule, FDA's longstanding position is that, in determining a product's intended use, the Agency may look to any relevant source of evidence. This position has solid support in the case law (see, e.g., United States v. Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 (9th Cir. 1985); Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); Nat'l Nutritional Foods Ass'n v. Matthews, 557 F.2d 325, 334 (2d Cir. 1977); United States v. Article of 216 Cartoned Bottles, “Sudden Change,” 409 F.2d 734, 739 (2d Cir. 1969); V.E. Irons, Inc. v. United States, 244 F.2d 34, 44 (1st Cir. 1957); Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff'd, 540 F.2d 947 (8th Cir. 1976)). This position is unchanged.

In the preamble to the proposed rule, FDA also stated “the Agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm's knowledge that such product was being prescribed or used by doctors for such use” (80 FR 57756 at 57757). Health care providers prescribe or use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients.17 In these limited circumstances, FDA does not consider a firm's knowledge that a health care provider has used or prescribed its approved/cleared medical product for an unapproved use, by itself, as sufficient to establish the intended use element of a prohibited act related to the lack of premarket approval/clearance of that use or the lack of adequate directions for use.18 Instead, FDA examines all relevant evidence, which could include, among other facts, a manufacturer's knowledge that health care providers are prescribing or using its approved/cleared medical product for an unapproved use, to determine whether there is sufficient evidence to establish a new intended use.

Before FDA issued the proposed rule, some drug sponsors had expressed concern with the last sentence of § 201.128. That sentence provided, “if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses.” (Section 801.4 contains comparable language.) They asserted that, literally read, this sentence would require that, whenever a manufacturer knew that its approved drug was being prescribed for an unapproved use, it would be required to alter the labeling of a drug to provide adequate directions for an off-label use. They further asserted that this addition to FDA-approved labeling would transform the drug into a new drug that cannot be sold without first obtaining approval of a supplemental new drug application pursuant to 21 U.S.C. 321(p) and 355(a). From this they concluded that, under the last sentence of § 201.128, a manufacturer's mere knowledge of an unapproved use of its approved drug automatically triggers requirements for new labeling that in turn render distribution of that approved product unlawful without approval of a supplemental NDA.

In the proposed rule, the proposed deletion of the last sentence of §§ 201.128 and 801.4 was intended to clarify the following: Where a manufacturer is distributing an approved or cleared medical product, evidence that the manufacturer knows that health care providers are prescribing or using that approved or cleared medical product for an unapproved use would not, by itself, automatically trigger obligations for the manufacturer to provide labeling for the uses for which the health care providers are prescribing or using the product.

FDA's clarification of its position and proposed deletion of the last sentence of these regulations in the proposed rule did not suggest that FDA sought to otherwise narrow the scope of evidence of intended use that FDA may consider. However, some of the comments misunderstood the proposal. For example, some comments asserted—incorrectly—that FDA intended to eliminate manufacturer knowledge altogether as a source of evidence of intended use.

FDA has determined that its clarification goals can be better achieved by amending the last sentence of each regulation, rather than by deleting them. The amended language no longer suggests that a manufacturer's mere knowledge that its approved or cleared product was being prescribed or used for an unapproved use was sufficient to trigger the requirement to provide adequate labeling. In addition, this amended language provides further clarification by reminding manufacturers that, where the totality of evidence is sufficient to establish a new intended use for a medical product, relevant provisions of the FD&C Act and its implementing regulations will be triggered.

In addition, these amendments reflect FDA's longstanding position, upheld by the courts, that FDA may consider a variety of direct and circumstantial evidence to establish intended use. For example, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold (see, e.g., United States v. Travia, 180 F. Supp. 2d 115, 119 (D.D.C. 2001)). In the context of medical products, generally, circumstantial evidence often ensures that FDA is able to hold accountable firms that attempt to evade FDA medical product regulation by avoiding making express claims about their products.

(Comment 15) Some comments stated that this clarification of the Agency's interpretation and application of the intended use regulations (§§ 201.128 and 801.4) was helpful because it clarifies a point that has been confusing to industry. Another comment stated that the proposed changes to §§ 201.128 and 801.4 provide less information to manufacturers, not more clarity.

(Response) FDA agrees that clarification was warranted because of the apparent confusion over this point. With this final rule, the Agency is making additional changes to the codified language and providing more explanation to further clarify the meaning of the regulations.

(Comment 16) Some comments asserted that FDA should eliminate another reference to “knowledge” in § 201.128. Before the amendments implemented by this rule, both §§ 201.128 and 801.4 contained the following sentence: “[Intended use] may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.” The comments recommended that FDA delete either the phrase “with the knowledge of such person or their representatives” or the entire sentence from the regulation. At least one comment asserted that its recommended change to delete that phrase is consistent with FDA's intent in amending the regulations.

(Response) FDA disagrees with these comments. It was not the Agency's intention to entirely remove manufacturer knowledge from the types of evidence that may be considered in determining a product's intended use. FDA's proposed and final rule not only retained this sentence containing the other reference to “knowledge” in the text of both §§ 201.128 and 801.4, but also added “for example” to emphasize that FDA may rely on any relevant source of evidence of intended use. Accordingly, the amended version of this sentence (in both regulations) now reads that “intended use may be shown, for example, by circumstances in which the article is, with the knowledge of such person or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.”

In the context of medical products, generally, varied types of evidence, including evidence of a manufacturer's knowledge that a product is being used for an unapproved use, often enables FDA to pursue medical product manufacturers who attempt to evade FDA jurisdiction by avoiding express claims with respect to their products. In addition, as courts have recognized, evidence of a manufacturer's knowledge that a product is being used for an unapproved use can also be used to corroborate other evidence of intended use (see, e.g., United States v. An Article of Device Toftness Radiation Detector, 731 F.2d 1253, 1257 (7th Cir. 1984) (intended use established in part by witness testimony that device had been used to treat patients, together with other evidence regarding a training program and financial arrangements offered by the defendant).

FDA's intention in proposing to amend §§ 201.128 and 801.4 was more focused than these comments suggest. First, FDA's statement about not relying solely on manufacturer knowledge was limited to approved and cleared products because health care practitioners can generally use and prescribe such products for unapproved uses. That position does not apply to products that are not already legally marketed as medical products for at least one use. Second, manufacturer knowledge may be relevant to intended use, but the Agency would not bring an enforcement action based solely on manufacturer knowledge that an approved/cleared product was being prescribed or used by doctors for an unapproved use. If there is other evidence of intended use, FDA may consider manufacturer knowledge as well as other evidence. Third, FDA proposed deleting, and is now amending, the last sentence of the regulations to avoid the potential misinterpretation that a manufacturer's knowledge of an unapproved use of an approved/cleared medical product, without more, automatically triggers requirements for that manufacturer to provide additional labeling.

(Comment 17) At least one comment suggested that the First Amendment requires the exclusion of knowledge as a category of evidence that may be considered as evidence of intended use.

(Response) FDA disagrees. The First Amendment protects, among other things, freedom of speech, and knowledge and speech are not coextensive. A variety of direct and circumstantial evidence can establish a person's knowledge; a person's speech can be one source—but is not the only source—of evidence of that person's knowledge. Thus, the inclusion of evidence of knowledge within the types of evidence that may be relevant to establishing intended use does not in itself implicate the First Amendment.

(Comment 18) At least one comment asserted that, under relevant statutory text, legislative history, and case law, evidence of intended use is limited to a manufacturer's promotional claims. Another comment similarly proposed that the Agency focus principally on statements in the product labeling to establish intended use (using advertising material only to a lesser extent). In contrast, still another comment urged FDA to consider manufacturer statements in a variety of contexts, including advertising; press statements; official or unofficial statements made by corporate officials; statements made in social media and other online arenas; and statements made in point-of-sale locations (both traditional retail and online).

(Response) FDA disagrees with the comments urging FDA to narrow the scope of evidence it will consider in determining intended use, and FDA agrees with the comment asserting that evidence relevant to intended use should include a manufacturer's statements in a variety of contexts. Under the former set of comments, FDA could not consider, for example, evidence of a manufacturer's marketing plans or directions to its sales force, evidence of the well-known uses and abuses of its products, and circumstantial evidence relating to the sale and distribution of the product. These comments' suggested narrow view of evidence of intended use would not only create a loophole for manufacturers and distributors to evade FDA oversight of the marketing of approved/cleared medical products for unapproved uses but would also open the door to the marketing of wholly unapproved medical products—all to the detriment of the public health.

As courts have recognized, “[s]elf-serving labels cannot be allowed to mask the vendor's true intent as indicated by the overall circumstances” (United States v. Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 n.5 (9th Cir. 1985)). As one court explained, “[a] disease claim made with a wink and a nudge is still a disease claim. To hold otherwise would create an `obviously wide loophole' that would defeat the `high purpose of the Act to protect consumers.' ” (United States v. Cole, 84 F. Supp. 3d 1159, 1166 (D. Or. 2015) (citation omitted)). Examples of cases where the government has relied on circumstantial evidence to establish intended use include situations where products were labeled as herbal supplements, leather cleaner, incense, potpourri, bath salts, or `for research purposes only,' but in fact contained a pharmacological ingredient such as the active ingredient from approved erectile dysfunction and hair-loss products, albuterol, steroids, or street-drug pharmacological agents (“synthetic marijuana” or “imitation cocaine”). Similar examples for devices include products labeled as laser pointers, massagers, exercise equipment or diving chambers, but actually intended to treat serious conditions such as cancer, HIV, and autism. The government has also considered manufacturers' directions to their sales forces in determining intended use.

Nothing in the statute requires the narrow scope the comments suggest. As four justices of the Supreme Court recognized in rejecting the arguments reflected in these comments, “The [FD&C Act] . . . does not use the word `claimed'; it uses the word `intended' ” (FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 170 (2000) (dissenting opinion) (the majority declined to resolve the issue, id. at 131-32)). The language of the regulations is consistent with the statutory framework. As one court recently explained, “[N]owhere does the regulation state that such statements or claims cannot be used to show objective intent unless they were published to the marketplace. To see the absurdity of defendants' argument, consider a hypothetical in which a medical device manufacturer sells device D, which is approved for use A but frequently prescribed by doctors for off-label use B. If the manufacturer creates a bumper sticker with the words `I intend D to be used for B: Prescribe D for B Today,' by defendants' logic that poster is inadmissible evidence of subjective intent so long as it sits in his briefcase, but admissible evidence of objective intent once he sticks it on his car. The Court is not persuaded that there is a legally relevant distinction here; in either scenario, the defendant has manifested into the physical world `oral or written statements' that may be weighed as evidence of objective intent” (United States v. Vascular Solutions, Inc., 181 F. Supp. 3d 342, 347 (W.D. Tex. 2016)).

FDA also disagrees that the case law requires that evidence of intended use be limited to marketing representations by firms, to the exclusion of other types of evidence such as internal firm documents and circumstances surrounding the sale of products. Courts have repeatedly held that intended use is determined by looking to all relevant evidence, including statements and circumstances surrounding the manufacture and distribution of a medical product (see, e.g., United States v. Article of 216 Cartoned Bottles, “Sudden Change,” 409 F.2d 734, 739 (2d Cir. 1969) (“It is well settled that the intended use of a product may be determined from its label, accompanying labeling, promotional material, advertising and any other relevant source.”) (citations omitted); V.E. Irons, Inc. v. United States, 244 F.2d 34, 44 (1st Cir. 1957) (observing that a court is “free to look to all relevant sources in order to ascertain what is the `intended use' of a drug”)). As explained by one court: “Whether a product's intended use makes it a device depends, in part, on the manufacturer's objective intent in promoting and selling the product. All of the circumstances surrounding the promotion and sale of the product constitute the `intent'. It is not enough for the manufacturer to merely say that he or she did not `intend' to sell a particular product as a device. Rather, the actual circumstances surrounding the product's sale . . . determine the `intended' use of the product as a device under the Act” (United States v. 789 Cases, More or Less, of Latex Surgeons' Gloves, 799 F. Supp. 1275, 1285 (D. Puerto Rico 1992) (emphasis in original) (internal citations omitted)).

Indeed, courts have rejected the comments' proposition that evidence of intended use is limited to a manufacturer's public claims concerning a device or drug (see Nat'l Nutritional Foods Ass'n v. Matthews, 557 F.2d 325, 334 (2d Cir. 1977) (“In determining whether an article is a `drug' because of an intended therapeutic use, the FDA is not bound by the manufacturer's subjective claims of intent but can find actual therapeutic intent on the basis of objective evidence. Such intent also may be derived or inferred from labeling, promotional material, advertising, and any other relevant source.”) (internal citation and quotations omitted); United States v. Travia, 180 F. Supp. 2d 115, 119 (D.D.C. 2001) (“Labeling is not exclusive evidence of the sellers' intent. Rather, as the very language quoted by the defendants themselves states, `it is well established `that the intended use of a product, within the meaning of the [FD&C Act], is determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source' . . . even consumer intent could be relevant, so long as it was pertinent to demonstrating the seller's intent . . . [I]f the government's allegations are true, the sellers did not need to label or advertise their product, as the environment provided the necessary information between buyer and seller. In this context, therefore, the fact that there was no labeling may actually bolster the evidence of an intent to sell a mind-altering article without a prescription—that is, a misbranded drug.”) (citations omitted); United States v. Vascular Solutions, Inc., 181 F. Supp. 3d 342, 347 (W.D. Tex. 2016) (“Even were this Court at liberty to depart from the Fifth Circuit's position, however, it would still deny defendants' motion; though [21 CFR] § 801.4 indeed says that `objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives,' nowhere does the regulation state that such statements or claims cannot be used to show objective intent unless they were published to the marketplace.”); see also United States v. Storage Spaces Designated Nos. 8 and 49, 777 F.2d 1363, 1366 n.5 (9th Cir. 1985) (concluding that products innocuously labeled as “incense” and “not for drug use” were in fact drugs where the “overall circumstances” demonstrated vendor's intent that products be used as cocaine substitutes); United States v. An Article of Device Toftness Radiation Detector, 731 F.2d 1253, 1257 (7th Cir. 1984) (intended use established in part by witness testimony that device had been used to treat patients, together with other evidence regarding a training program and financial arrangements offered by the defendant); United States v. Undetermined Quantities of an Article of Drug Labeled as “Exachol”, 716 F. Supp. 787, 791 (S.D.N.Y. 1989) (explaining that “FDA is not bound by the vendor's subjective claims of intent” and that “[a]n article intended to be used as a drug will be regulated as a drug . . . even if the products labeling states that it is not a drug”)).

(Comment 19) At least two comments asserted that FDA should significantly contract its proposed definitions of “intended uses” because the First Amendment protects truthful speech. One comment stated that, under Central Hudson Gas and Electric Corp. v. Public Services Commission, 447 U.S. 557, 566 (1980), government regulation of truthful speech concerning a lawful activity violates the First Amendment unless government regulators can establish that: (1) They have identified a substantial government interest; (2) the regulation directly advances that asserted interest; and (3) the regulation is no more extensive than is necessary to serve that interest. The comment then argued that a complete prohibition of truthful speech by manufacturers and their representatives concerning the off-label uses of a drug or device does not satisfy this test.

Similarly, another comment urged FDA to confirm that truthful and non-misleading speech cannot form the basis of a manufacturer's intended use of a medical product. That comment asserted that courts have recently held that enforcement actions based on truthful, non-misleading speech to health care professionals violates core First Amendment values, citing United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) and Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).

(Response) FDA is separately examining its rules and policies relating to firm communications regarding unapproved uses of approved/cleared medical products, with the goal of determining how best to integrate the significant and sometimes competing public health and safety interests served by FDA's regulatory approach related to unapproved uses of medical products with ongoing developments in science and technology, medicine, health care delivery, and constitutional law. To that end, FDA held a two-day public hearing on November 9 and 10, 2016, to obtain input on these issues, and created a docket for the submission of written comments (see, e.g., 81 FR 60299, Sept 1, 2016, announcing a public hearing and request for comments on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, available at: http://www.fda.gov/NewsEvents/MeetingsConferences Workshops/ucm489499.htm). That examination is ongoing. In contrast, the purpose of amending §§ 201.128 and 801.4 in this rulemaking is to clarify the scope of these regulations in response to assertions by industry that they did not understand the meaning of the regulations in their previous form.

The broader policy questions and the related First Amendment issues are thus being considered in a separate proceeding. Nevertheless, it is important to note here that we do not agree with the assertion that the current case law allows FDA to consider speech as evidence of intended use only when it is false or misleading. Courts have held that the government's reliance on speech as evidence of intended use under the FD&C Act does not infringe the right of free speech under the First Amendment based on Supreme Court precedent establishing that “[t]he First Amendment . . . does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent” (Wisconsin v. Mitchell, 508 U.S. 476, 489 (1993)). The D.C. Circuit applied that precedent in the context of the FD&C Act and held that “th[e] use of speech to infer intent, which in turn renders an otherwise permissible act unlawful, is constitutionally valid” and hence “it is constitutionally permissible for the FDA to use speech [by the manufacturer] . . . to infer intent for purposes of determining that [the manufacturer's] proposed sale . . . would constitute the forbidden sale of an unapproved drug” (Whitaker v. Thompson, 353 F.3d 947, 953 (D.C. Cir. 2004); see also Flytenow, Inc. v. FAA, 808 F.3d 882, 894 (D.C. Cir. 2015) (upholding “us[e of] speech (postings on Flytenow.com) as evidence that pilots are offering service that exceeds the limits of their certifications”)). Courts applying that reasoning have found that the government's reliance on speech as evidence of intended use under the FD&C Act does not infringe the right of free speech under the First Amendment (see United States v. Lebeau, 654 Fed. App'x 826, 830-31 (7th Cir. 2016) (per curiam), petition for cert. filed, NO. 16-7125 (U.S. Oct. 13, 2016); Whitaker v. Thompson, 353 F.3d 947, 953 (D.C. Cir. 2004); United States v. Article of Drug Designated B-Complex Cholinos Capsules, 362 F.2d 923, 927 (3d Cir. 1966); United States v. Cole, 84 F. Supp. 3d 1159, 1166 (D. Or. 2015); United States v. Regenerative Sciences, LLC, 878 F. Supp. 2d 248, 255-56 (D.D.C. 2012), aff'd, 741 F.3d 1314 (D.C. Cir. 2014); United States v. Livdahl, 459 F. Supp. 2d 1255, 1268 (S.D. Fla. 2005); United States v. Lane Labs-USA, Inc., 324 F. Supp. 2d 547, 579-80 (D.N.J. 2004); United States v. General Nutrition, Inc., 638 F. Supp. 556, 562 (W.D.N.Y. 1986); see also Spectrum Pharms., Inc. v. Burwell, 824 F.3d 1062 (D.C. Cir. 2016) (manufacturer promotion of a generic drug for use approved for the sponsor but not for the generic may lead to enforcement action for misbranding)).

Although the district court in Amarin Pharma, Inc. v. FDA held that the Caronia decision foreclosed reliance (in the Second Circuit) on this doctrine in the context of an FDA enforcement action where the misbranding was based solely on truthful, non-misleading speech regarding the unapproved use of an approved drug, the Second Circuit has more recently confirmed that “Caronia left open the government's ability to prove misbranding on a theory that promotional speech provides evidence that a drug is intended for a use that is not included on the drug's FDA-approved label” (United States ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613 n.2 (2d Cir. 2016)).

In addition, FDA's consideration of speech as evidence of intended use under its statutory and regulatory framework advances substantial public health interests relevant to analyses under Central Hudson Gas & Electric Corp. v. Public Service Comm'n, 447 U.S. 557, 563-64 (1980). The medical products FDA regulates have the potential to adversely impact public health and safety. Congress specifically developed the premarket review frameworks for medical products in response to public health tragedies 19 and after determining that: (1) Exclusive reliance on postmarket remedies, such as enforcement actions for false or misleading labeling, is unacceptable as a public health strategy for medical products because it does not sufficiently prevent harm and injury to patients and (2) safety and effectiveness must be evaluated for each marketed intended use of a medical product to prevent the harm that occurs when patients are prescribed or use ineffective treatments and to ensure that the benefits of an intended use outweigh its risks. The premarket review requirements of the FD&C Act and the Public Health Service Act provide mechanisms to help ensure that protections are in place that will allow the public to obtain the benefits of these products while mitigating the risks. More specifically, FDA's statutory authorities, regulations, and implementation policies advance substantial public health interests including: Motivating the development of robust scientific data on safety and efficacy; 20 maintaining the premarket review process for safety and efficacy of each intended use in order to prevent harm, protect against fraud, misrepresentation, and bias, and prevent the diversion of healthcare resources toward ineffective treatments; 21 ensuring required labeling is accurate and informative; protecting the integrity and reliability of promotional information regarding medical product uses; protecting human subjects receiving experimental treatments; ensuring informed consent; maintaining incentives for clinical trial participation; protecting innovation incentives, including statutory grants of exclusivity; and promoting the development of products for underserved patients.

At the same time, health care providers also prescribe and use approved/cleared medical products for unapproved uses when they judge that the unapproved use is medically appropriate for their individual patients. Scientific or medical information regarding unapproved uses of products may in some cases help health care providers make better decisions regarding patients, such as where the patient has a disease for which there is no approved/cleared treatment, where the patient is part of a population that has not been studied, or where all approved/cleared treatments have been exhausted. However, in other cases, the use of approved/cleared medical products for unapproved uses has also been associated with significant harm to patients, fraud, and waste of health care resources.22

FDA's current implementation approach seeks to integrate the complex mix of numerous and sometimes competing interests at play while also taking into account First Amendment issues. For example, FDA has issued guidance documents to describe some of the circumstances when it would not consider a firm's distribution of reprints, clinical practice guidelines, or reference texts regarding unapproved uses of approved/cleared medical products to be evidence of intended use; and issued a draft guidance on unsolicited requests, confirming FDA's longstanding position that it would not consider a firm's providing truthful, balanced, non-misleading, and non-promotional scientific or medical information (including information about an unapproved use) that is responsive to unsolicited requests for information about FDA-regulated medical products to be evidence of intended use. FDA takes the same view of firms' presenting truthful and non-misleading scientific information about unapproved uses at medical or scientific conferences when done in non-promotional settings and not accompanied by promotional materials.

There are several points worth noting regarding the Central Hudson evaluation conducted by Second Circuit panel majority in United States v. Caronia. First, the panel majority's analysis was limited to addressing the constitutionality of a specific “construction of the FDCA's misbranding provisions to prohibit and criminalize off-label promotion” (see 703 F.3d 149, 161-64, 166-69 (2d Cir. 2012)). The Caronia majority did not conduct a Central Hudson evaluation of FDA's actual approach to manufacturer communications regarding unapproved uses of approved medical products, as described in the preceding paragraph. Second, the panel majority did not consider the multiple facets of public health advanced by FDA's statutory authorities, regulations, and implementation policies, which include motivating the development of reliable scientific evidence that enables the evaluation of the safety and effectiveness of each intended use of a medical product; maintaining the premarket review process for safety and efficacy of each intended use in order to prevent harm, protect against fraud, misrepresentation, and bias, and prevent the diversion of healthcare resources toward ineffective treatments; ensuring required labeling is accurate and informative; protecting the integrity and reliability of promotional information regarding medical product uses; protecting human subjects receiving experimental treatments; ensuring informed consent; maintaining incentives for clinical trial participation; protecting innovation incentives, including statutory grants of exclusivity; and promoting the development of products for underserved patients. The court's limited review of the interests at stake necessarily affected the rest of its Central Hudson analysis. Furthermore, the results of an exceptionally large Canadian study showing an association between unapproved uses and adverse drug events 23 were released more than three years after the Caronia decision. Accordingly, the Caronia court, in conducting its Central Hudson evaluation, did not have the benefit of considering the significant findings of this study.

(Comment 20) Several comments asserted that FDA should take this opportunity to bring other related regulations and guidance documents into conformance with modern First Amendment case law. These comments suggested, for example, that FDA reconsider its approach to substantial evidence to support manufacturer communications to health care professionals about approved drugs, reconsider its interpretation of the term labeling, and revise its regulations to confirm that FDA will abide by restrictions on FDA authority imposed by federal courts in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and similar First Amendment decisions. At least one comment asserted, citing United States v. Caronia, that FDA's interpretation and implementation of the FD&C Act restricts speech based on the identity of the speaker. The comment further asserted that any restrictions on truthful and non-misleading speech are subject to “heightened judicial scrutiny” and are “presumptively invalid” under Sorrell v. IMS Health Inc., 564 U.S. 552, 565, 571 (2011), Reed v. Town of Gilbert, 135 S. Ct. 2218, 2226 (2015), and Rosenberger v. Rector & Visitors of the Univ. of Va., 515 U.S. 819, 828 (1995). Another comment, quoting Bolger v. Youngs Drug Prods., 463 U.S. 60, 66 (1983), asserted that FDA should recognize that commercial speech is limited to speech that “does no more than propose a commercial transaction.” Another comment urged FDA to open a separate docket related to free speech issues regarding medical products.

(Response) To the extent these comments propose that FDA consider, in this rulemaking, issues that are beyond the scope of this rulemaking, FDA declines the suggestion. FDA agrees with the comment that suggests that broader First Amendment issues should be considered in the context of separate proceedings. FDA notes that there are separate proceedings that are currently ongoing (see, e.g., 81 FR 60299, Sept 1, 2016, announcing a public hearing and request for comments on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, available at: http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm489499.htm).

In addition, FDA notes its disagreement with certain characterizations of the existing case law. First, as discussed earlier, the court in Caronia based its analysis on a legal theory that is more proscriptive than the one FDA actually holds. Second, the cited Supreme Court cases did not overrule the Central Hudson test for commercial speech. The Supreme Court in Sorrell confirmed that, where, as here, the speech in question is commercial, the Court applies the “commercial speech inquiry” as outlined in Central Hudson (Sorrell v. IMS Health Inc., 564 U.S. 552, 571-72 (2011); see also 1-800-411-Pain Referral Service, LLC v. Otto, 744 F.3d 1045, 1055 (8th Cir. 2014) (observing that Sorrell held that content- or speaker-based restrictions on commercial speech are subject to “heightened scrutiny,” and using the Central Hudson test to determine the constitutionality of such restrictions)). The Sorrell Court also confirmed that “content-based restrictions on protected expression are sometimes permissible, and that principle applies to commercial speech” (Sorrell, 564 U.S. at 579).

In Reed v. Town of Gilbert, the Court applied strict scrutiny to content-based restrictions on non-commercial speech in public fora. That holding has no bearing on the commercial speech at issue here (see, e.g., Sarver v. Chartier, 813 F.3d 891, 903 n.5 (9th Cir. 2016) (stating that Reed does not apply to laws governing commercial speech); Mass. Ass'n of Private Career Sch. v. Healey, 159 F. Supp. 3d 173, 192-93 (D. Mass. 2016) (same); San Francisco Apt. Ass'n v. City & Cnty. of San Francisco, 142 F. Supp. 3d 910, 922 (N.D. Cal. 2015) (same), appeal docketed, No. 15-17381 (9th Cir. Dec. 3, 2015). The Supreme Court's 1995 decision, Rosenberger v. Rector & Visitors of the Univ. of Va., 515 U.S. 819, likewise did not involve commercial speech.

Third, we disagree with the one comment that asserts, quoting Bolger v. Youngs Drug Prods., 463 U.S. 60, 66 (1983), that the Supreme Court limited the application of the Central Hudson test to speech that literally “does no more than propose a commercial transaction.” Although the Court in Bolger referred to speech that proposes a commercial transaction as “the core notion of commercial speech,” the Court then explained that “informational pamphlets” that “cannot be characterized merely as proposals to engage in commercial transactions” were nevertheless commercial speech based on a combination of relevant circumstances, such as mentioning the seller's product in the pamphlet and the economic motivation of the seller (see Bolger, 463 U.S. at 66-68 (emphasis added); see also Conn. Bar Ass'n v. United States, 620 F.3d 81, 93-94 (2d Cir. 2010)).

(Comment 21) Several comments suggested that FDA replace the phrase “is intended for use” in the first sentence of § 1100.5 with other phrases, such as “is commonly used” or “is primarily used.”

(Response) FDA declines this suggestion. The phrase “is intended for use” is necessary because it reflects the fact that FDA's regulatory authority over a product made or derived from tobacco is, in the context of regulating them as medical products, dependent upon the product's intended use.

(Comment 22) Several comments urged FDA not to consider a manufacturer's knowledge when determining a manufacturer's intent with respect to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The comments also request that the Agency use notice and comment rulemaking instead of guidance to make changes regarding manufacturer intent related to HCT/Ps.

(Response) These comments concern regulations and guidance documents relating specifically to HCT/Ps and are outside the scope of this rulemaking.

(Comment 23) At least one comment suggested that FDA amend § 1100.5(a) to incorporate the following points: (1) Products intended for use in the cure and treatment of smoking or any other tobacco product use are subject to regulation as medical products; (2) products intended for use for the prevention of relapse into any smoking, tobacco product, or nicotine relapse are subject to regulation as medical products; and (3) relief from nicotine withdrawal symptoms also includes relief from smoking or tobacco use withdrawal symptoms.

(Response) FDA agrees that the three uses identified in the comment appear to be intended uses that would render the products subject to regulation as medical products. Section 1100.5(a) explains that a product made or derived from tobacco is subject to regulation as a medical product if it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. For illustrative purposes, the section also provides several examples of intended uses that will subject a product to regulation as a medical product. We believe the list of examples, which is not intended to be exhaustive, adequately illustrates the types of intended uses that will subject a product made or derived from tobacco to regulation as a medical product. Thus, while we agree that the three identified uses appear to be intended uses that would render the products subject to regulation as medical products, we decline to amend the list to incorporate the uses identified by the comment.

(Comment 24) At least one comment objected that the rule would limit e-cigarettes to marketing claims of “smoking pleasure” and “smoking satisfaction” since that is how traditional tobacco products were “customarily marketed” prior to March 21, 2000. The comment asserted that the rule would either force e-cigarettes off the market as unapproved medical products, or require e-cigarettes to be marketed similar to how traditional tobacco products were marketed prior to March 21, 2000, which would be deceptive because e-cigarettes are not intended for smoking pleasure or tobacco satisfaction. The comment argued that FDA should treat e-cigarettes differently from products that both contain tobacco leaf and were commercially available before March 21, 2000, when considering the types of claims that will subject a product made or derived from tobacco to regulation as a medical product.

(Response) FDA disagrees. As explained elsewhere in this document, we believe that the rule gives manufacturers and retailers ample flexibility to market e-cigarettes in a manner that is distinct from how cigarettes were marketed prior to March 21, 2000. The date of March 21, 2000, is relevant only to considering claims about a product's effects related to nicotine on the structure or function of the body as evidence of a product's intended use. E-cigarette manufacturers' and retailers' claims related to customizability, number of puffs per cartridge or charge, and various other differentiating features that do not relate to nicotine structure/function effects, irrespective of whether such claims were customarily and legally made in the marketing of cigarettes and smokeless tobacco products before March 21, 2000, should generally not affect the determination of a product's intended use. A manufacturer's making a modified risk claim for a specific tobacco product renders the product an MRTP, which can be marketed only after the manufacturer substantiates any modified risk claims in an MRTP application and after FDA determines that the product meets the statutory standard. Additionally, if a manufacturer intends that its product be used for cessation, it can submit an NDA, Abbreviated New Drug Application (ANDA), Premarket Approval Application (PMA), or premarket notification submission so that FDA can determine whether the product meets the statutory standard and can approve the application or clear the submission, if appropriate.

(Comment 25) At least one comment questioned whether the marketing for tobacco products that are not MRTPs may contain useful contextual information (e.g., ingredient information).

(Response) This comment is outside the scope of this rulemaking because it does not relate to the circumstances in which a product that is made or derived from tobacco will be regulated as a medical product or a tobacco product.

(Comment 26) Several comments stated that ENDS manufacturers need to be able to inform and explain how to properly use vaping devices to help novices to prevent them from having accidents. The comments stated that vape shops need to be able to correctly educate consumers on how to use the products they sell.

(Response) FDA agrees. FDA recognizes that manufacturers may wish to provide instructions to consumers on how to use novel tobacco products, and instructions may be helpful in some cases in preventing consumer injury, such as nicotine poisoning or injuries from exploding batteries. Manufacturers may provide instructions to the consumer in many ways, including verbal instruction. However, if the instructions provided by the manufacturer convey that the product is to be used as a cessation device, then the product will generally be regulated as a medical product. Additionally, if the instructions make a modified risk claim, then the manufacturer must submit an MRTP application so that FDA can determine whether the product meets the statutory standard and can issue an order authorizing it to be marketed as an MRTP.

(Comment 27) Several commenters noted that tobacco products are advertised in a variety of media, including traditional print or mainstream media, blogs, social media, testimonials, and links to studies or media reports on Web sites. One comment observed that manufacturers of ENDS products often use online blogs as a way to make implicit or explicit cessation claims, and in some cases such assertions run counter to disclaimers posted on the same Web site that hosts the blog. Another comment noted that manufacturers used consumer testimonials that make cessation or MRTP claims on their company Web sites. Commenters observed that conflicting claims in advertising caused confusion among consumers regarding whether ENDS products are FDA-approved smoking cessation aids.

(Response) FDA agrees. Tobacco products are advertised in a variety of media, and advertisements may include conflicting information regarding whether the product is a recreational tobacco product or an FDA-approved smoking cessation product. When conflicting claims are made to the consumer, consumers can be confused by those claims. Thus, FDA believes that manufacturers' making smoking cessation claims for any product creates a strong suggestion of therapeutic benefit to the user that would subject the product to regulation under FDA's medical products authority. Such a suggestion generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose. As discussed in response to Comment 12, where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically because of the likelihood of consumer confusion. In most cases, FDA does not believe that disclaimers will sufficiently mitigate consumer confusion related to the intended therapeutic use of the product.

(Comment 28) Several comments stated that adolescent smokers are especially vulnerable to cessation and therapeutic claims in tobacco product marketing. These comments believe that adolescents misperceive the supposed benefits and underestimate the relative harms, risks, and addictive properties of e-cigarettes and other non-cigarette products.

(Response) FDA agrees that youth and young adults generally “underestimate the tenacity of nicotine addiction and overestimate their ability to stop smoking when they choose” (Ref. 14). For example, one survey found that “nearly 60 percent of adolescents believed that they could smoke for a few years and then quit” (Ref. 15). FDA also believes that unsubstantiated cessation claims that reach adolescents may confuse teens and lead teens to believe that these products are FDA-approved smoking cessation products. For example, a teenager in a recent qualitative study said, “I heard that the only reason they were made is to help people get off from cigarettes for people that want to quit. You would use an e-cigarette to help you quit supposedly. It was on the news” (Ref. 16). FDA believes it is important to avoid consumer confusion about which products are intended for medical uses versus recreational or other tobacco product uses among both adolescents and adults, and this rule will help consumers.

(Comment 29) At least one comment stated that users consider ENDS and smokeless tobacco products effective cessation interventions. The comment believed that many people use these products to try to stop smoking because they are influenced by manufacturers' and sellers' marketing messages that make cessation and therapeutic claims about ENDS and other non-cigarette tobacco products.

(Response) FDA agrees that marketing can influence how consumers perceive tobacco products, and products advertised with cessation claims can lead consumers to believe that the product is an FDA-approved smoking cessation device. FDA also agrees that many consumers are using ENDS products for therapeutic purposes. One study concluded that, among State tobacco cessation quitline callers, the most common reported reason for using e-cigarettes was to cut down on, or quit, traditional tobacco use (Ref. 17). Another study concluded that some smokers who were interested in quitting were using ENDS for cessation purposes, possibly discouraging the use of proven smoking cessation treatments, delaying cessation, and thus prolonging exposure to harmful agents in combusted tobacco as an unintended consequence. Additionally, FDA received a large number of comments from individuals using ENDS for therapeutic purposes. One purpose of this regulation is to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use versus for a recreational use.

(Comment 30) At least one comment expressed concern that since the Sottera decision, FDA has not taken action against products made or derived from tobacco and making claims that were “clearly therapeutic.” In order to protect consumers from “false, misleading, and confusing tobacco industry claims,” the comment asks that products made or derived from tobacco making claims without an MRTP order be regulated as drug/device products in the Center for Drug Evaluation and Research.

(Response) FDA disagrees with the comment to the extent that the comment suggests that tobacco products properly regulated as MRTPs be regulated as drugs or devices in the absence of an MRTP order. Tobacco products making modified risk claims are regulated under the tobacco product authorities in the FD&C Act, and an MRTP marketed without an MRTP order would be subject to enforcement as a tobacco product, rather than subject to regulation as a drug or medical device product. With respect to enforcement generally, FDA notes that it is issuing this rule to clarify its interpretation of the drug and device definitions with respect to products made or derived from tobacco, and that it expects this clarification to assist industry in determining the applicable regulatory framework for particular products and help consumers differentiate between products that are intended for medical use and products intended for other uses.

(Comment 31) At least one comment observed that researchers may wish to study the effects that a product made or derived from tobacco has on health outcomes (e.g., withdrawal symptoms, hypertension, etc.) or on the structure and function of the body (e.g., blood pressure, lung function), or the effects of substituting one product made or derived from tobacco for another product. The comment asserted that the methods and measures of such studies are not evidence that the product being investigated is a drug and that FDA should not require an investigational new drug application (IND) for these studies unless they are sponsored by a manufacturer with the intention of supporting a health or medical drug claim.

(Response) The regulations in part 312 set forth the circumstances in which an IND is required for clinical investigations in which a drug is administered to human subjects. The IND requirement applies irrespective of whether the investigation is sponsored by a manufacturer or an academic institution. A study involving a product made or derived from tobacco will generally require an IND if the product, as used in the study, is subject to regulation as a drug. Whether the product, as used in the study, is subject to regulation as a drug depends on whether the product is being investigated for any of the purposes described in § 1100.5(a) or (b) of this rule. To determine if a product made or derived from tobacco is being investigated for one of these purposes, FDA generally would review the protocol for the study, including the proposed methods and measures. In the Agency's experience, the proposed methods and measures for a study can provide insight into the purposes for which a product is being investigated. Ultimately, however, whether a product is being investigated for a therapeutic purpose, and thus whether the study requires an IND, is a fact-specific, case-by-case inquiry. Additional information about the IND requirement can be found in the FDA guidance document entitled “Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.” We encourage researchers to review this guidance document, which is available on FDA's Web site at http://www.fda.gov/downloads/UCM229175.pdf.

(Comment 32) At least one comment encouraged FDA to coordinate between centers to promote development of safer tobacco products as well as more effective medical products for the treatment of nicotine addiction. This comment also argued that FDA should not allow similar or identical products to be marketed as both tobacco products and medical products, and should consider approving categories of products, rather than individual products, for smoking cessation. This comment also expressed concern about dual use between tobacco product categories.

(Response) FDA agrees with this comment to the extent the comment considers the proposed rule to promote effective coordination between centers by clarifying which center should take the lead in review of premarket applications and postmarketing regulation of particular products. We note that FDA currently interprets the standards in various medical and tobacco product premarket review pathways to refer to individual products rather than product categories, and the question of whether a particular product could obtain marketing authorization as both a tobacco product and as a medical product is beyond the scope of this rule. By clarifying the jurisdictional lines between tobacco and medical products, FDA believes that finalization of this rule will make it less likely that manufacturers will attempt to market products made or derived from tobacco both as tobacco products and as medical products—for example, if a tobacco product manufacturer attempts to add claims to a currently marketed tobacco product that would require the product to be regulated as drug, device, or combination product.

(Comment 33) Several comments recommended that the Center for Tobacco Products (CTP) have sole regulatory jurisdiction over tobacco and nicotine-containing products and provided suggestions for how CTP should structurally reorganize itself to better regulate these products.

(Response) CTP oversees the regulation of products made or derived from tobacco that are intended for human consumption. As stated in this preamble, when a product made or derived from tobacco is marketed or distributed for an intended use that falls within the drug/device definitions, it would be regulated as a medical product unless it is intended to affect the structure or any function of the body in any way related to the effects of nicotine that were commonly and legally claimed prior to March 21, 2000. In this situation, one of FDA's medical product centers would have regulatory oversight over these products because CTP does not oversee the regulation of medical products. As these comments relate to potentially undertaking a structural re-organization, CTP is not considering a structural reorganization at this time.

(Comment 34) At least one comment suggested that FDA create a separate regulatory category for e-cigarettes that is based on the Agency's medical product regulations, but with less stringent quality standards.

(Response) This recommendation is not consistent with the statutory definitions in the FD&C Act. Under the FD&C Act, a product made or derived from tobacco is subject to regulation as a tobacco product unless it meets the definition of a drug or device or is a combination product, in which case it is subject to regulation as a medical product.

(Comment 35) Several comments stated that the cost and resources required to complete FDA's drug application process would be simply too great and would shut down many small manufacturers.

(Response) This regulation simply clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product; it does not create new jurisdictional lines or impose new obligations on product manufacturers. Because the jurisdictional lines already exist, tobacco product manufacturers currently making claims that would render their product subject to regulation as a medical product or who wish to make such claims in the future are within FDA's drug and device jurisdiction, absent limited exceptions, and they must follow the applicable statutory and regulatory requirements.

(Comment 36) Many comments believed that the regulation would make e-cigarettes less available to consumers.

(Response) FDA disagrees. This regulation simply clarifies the circumstances under which a product made or derived from tobacco will be regulated as a drug, device, or combination product, and the circumstances under which it will be regulated as a tobacco product. This regulation will not add any additional burden to manufacturers who sell ENDS for recreational use. However, if a manufacturer is selling ENDS and making medical product claims, then the product would be subject to regulation as a drug, device, or combination product if those claims are not structure/function claims related to the effects of nicotine that were commonly and legally claimed prior to March 21, 2000.

(Comment 37) At least one comment suggested that the final rule should include a discussion of how the regulation will affect public health.

(Response) The preamble to the proposed rule contained some discussion of this topic, and this preamble to the final rule further expands on various public health protections.

(Comment 38) FDA proposed that a product made or derived from tobacco that is intended for use in smoking cessation be subject to regulation as a medical product. Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence. One comment asserted that promoting a product as suitable for continued nicotine use after stopping smoking traditional cigarettes is the functional equivalent of a “smoking alternative” claim, which FDA has said does not fall within the Agency's medical product authority, and, therefore, should not subject the product to regulation as a medical product.

(Response) Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult smokers want to quit smoking completely for health reasons (Ref. 18). Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose. We recognize, however, that public perception can change and evidence may be developed showing that, in some situations, “smoking cessation” is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco. We have revised the codified language in § 1100.5(a) in the final rule, to reflect that “smoking cessation” is one type of intended use related to “the cure or treatment of nicotine addiction.” FDA intends to closely scrutinize “smoking cessation” claims to ensure that consumers are not misled about the intended use of a product made or derived from tobacco.

(Comment 39) One comment stated that this regulation should not require companies that handle raw materials to determine whether those raw materials would be used in tobacco products or whether those materials would be used in medical products. The comment stated that the intended use of the product is completely within the discretion of the sellers and distributors of the finished products, and the Agency should not extend regulations to cover companies that handle raw materials.

(Response) This comment is beyond the scope of this rule. This regulation does not create new jurisdictional lines or impose new obligations on product manufacturers or companies that handle raw materials. Rather, this rulemaking simply clarifies the circumstances under which a product made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product. If FDA were to consider extending its authority in such a way that would place additional requirements on companies handling raw materials, the Agency would do so through a separate rulemaking.

To eliminate redundancy, we deleted “or prevention or mitigation of disease” from the end of § 1100.5(a), as the opening text already includes similar language. Because of this deletion, we inserted the word “or” in front of “relief of nicotine withdrawal symptoms.”

This final rule will become effective 30 days after the date of its publication in the Federal Register. During those 30 days, manufacturers will continue to be under an obligation to comply with all applicable provisions of the FD&C Act and applicable regulations.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the final rule does not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency concludes that the final rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a tribal summary impact statement is not required.

FDA has determined under 21 CFR 25.30(h) and (k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because, as described in detail in the section entitled “Final Small Entity Analysis” in the full analysis of economic impacts available in the docket for this final rule (Ref. 19) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm, the clarifications in this final rule will not significantly increase costs on manufacturers of products made or derived from tobacco, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in expenditure in any year that meets or exceeds this amount.

The final rule will reduce ambiguity in the market for products made or derived from tobacco and clarify FDA's interpretation and application of its existing intended use regulations. The rule clarifies the intended uses and supporting evidence that would result in these products being regulated as drugs, devices, or combination products rather than tobacco products. Products derived from tobacco that are intended to: (1) Diagnose, cure, mitigate, treat or prevent disease, including use in smoking cessation or (2) affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco prior to March 21, 2000, such as an intended use for improving respiratory function, will be subject to regulation as drugs, devices, or combination products. We estimate that there would be one-time costs for tobacco manufacturers to evaluate current product communications such as labeling and associated promotional materials in light of the clarifications in this final rule, and to revise them if needed. We expect that only a small number of product communications such as labeling and associated materials will undergo a one-time change as a result of this rule.

The final rule will provide greater clarity to producers regarding the regulatory requirements for products made or derived from tobacco and to consumers to distinguish products intended for medical uses from those marketed for other uses. The reduction in ambiguity will enhance consumers' understanding of the products they purchase and may increase consumer welfare as a result.

The full analysis of economic impacts is available in the docket for this final rule (Ref. 19) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

FDA concludes that this final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m. Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter 1 is amended as follows:

Pursuant to the Further Continuing and Security Assistance Appropriations Act, 2017 (Pub. L. 114-254), the United States of America, acting through the U.S. Agency for International Development, may issue certain loan guarantees applicable to sums borrowed by the Republic of Iraq (the “Borrower”), not exceeding an aggregate total of U.S. $1 billion in principal amount. Upon issuance, the loan guarantees shall ensure the Borrower's repayment of 100% of principal and interest due under such borrowings and the full faith and credit of the United States of America shall be pledged for the full payment and performance of such guarantee obligations.

This rulemaking document is not subject to rulemaking under 5 U.S.C. 553 or to regulatory review under Executive Order 12866 because it involves a foreign affairs function of the United States. The provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) do not apply.

The Department is eliminating references to the Employment Standards Administration at the DOL. The Employment Standards Administration is a former branch of the DOL and was eliminated in an agency reorganization in 2009. In addition, the Department is updating references to OMB information collection control numbers. OMB has assigned different information collection control numbers to WHD information collections and the Department is updating these references in the appropriate regulations so the reader can find the information collection corresponding to a specific regulation.

The Department is also correcting cross-references to the FMLA's definitions section in two sections of its FMLA regulations, § 825.104(b) and § 825.209(a). A recent rulemaking moved the definitions section of the FMLA regulations from § 825.800 to § 825.102 but did not update the cross-references to the definitions section in § 825.104(b) and § 825.209(a). Additionally, the Department is updating the reference in 29 CFR 3.3 to the Web site location where the public may access the WH-347 form. As part of the agency reorganization of the Web site, the location of the form has changed. Finally, the Department is replacing the term firefighter with the term employee engaged in fire protection activities in two sections of its regulations, 29 CFR 553.221 and 553.231, to conform to an amendment to the FLSA. In December 1999, Congress amended the FLSA to add a definition of employee engaged in fire protection activities. The Department published an FLSA Final Rule on April 5, 2011 (76 FR 18832) that incorporated the new definition into the regulations and made several conforming revisions in part 553, subpart C, but did not conform the language of these provisions.

Section 553(b)(3) of the Administrative Procedure Act (APA) provides that an agency is not required to publish a notice of proposed rulemaking in the Federal Register and solicit public comments when the agency has good cause to find that doing so would be “impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3). The Department finds that good cause exists to dispense with the notice and public comment procedures for this technical correction to its regulations, as it concludes that such procedures are unnecessary. This rule merely memorializes the delegation of administrative authority within the Department; updates references to OMB control numbers and WHD's Web site which are now out of date; corrects cross-references to another section of the Department's regulations; and conforms the terminology in the Department's regulations to an amendment to the definitions section of the FLSA. This rule does not impose any new regulatory obligations or information collection requirements on employers or affect the rights of workers. Therefore, the Department is issuing this technical correction as a final rule.

Section 553(d) of the APA also provides that substantive rules should take effect not less than 30 days after the date they are published in the Federal Register unless “otherwise provided by the agency for good cause found[.]” 5 U.S.C. 553(d)(3). Since this rule is a technical correction that does not change the substance of the Department's regulations, the Department finds that it is unnecessary to delay the effective date of the rule. Accordingly, the Department finds that it has good cause exists to make this technical correction effective on the date of publication.

In 29 CFR 1.2, 1.5, 4.1a, 4.3, 4.5, 4.6, 4.10, 4.11, 4.12, 4.101, 4.191, 5.2, 5.12, 5.13, 6.2, 500.7, 500.20, 500.41, 500.56, 500.215, 505.2, 520.300, 525.22, 530.1, 530.101, 530.102, 530.403, 570.1, 575.2, 575.3, 578.2, 580.1, 801.2, 801.7, and 825.401, the Department has removed the reference to the Employment Standards Administration and replaced it with the Wage and Hour Division where appropriate. In 29 CFR 519.11, the Department has removed the reference to the Assistant Secretary for Employment Standards. The Employment Standards Administration is a former branch of the DOL and was eliminated in an agency reorganization in 2009. See Secretary's Order No. 09-2009 (Nov. 6, 2009), 74 FR 58836 (Nov. 13, 2009). In 29 CFR 5.5, the Department has removed the reference to the Employment Standards Administration and made two additional technical corrections: Correcting an error made in the instructions to the Final Rule issued under the DBRA in 2000 (65 FR 69674) that resulted in the retention of an editorial note referencing a 1993 suspension of paragraph (a)(1)(ii) that should have been removed at that time; and incorporating the undesignated language that follows paragraph (a)(1)(i) into that paragraph.

In 29 CFR 3.3, the Department has updated the referenced Web site location where the public may access the WH-347 form. As part of the agency reorganization of the Web site, the location of the form has changed.

In 29 CFR 3.4, 5.15, 505.5, 520.403, 520.405, 520.501, 520.502, 525.16, 530.3, 530.4, 547.1, 549.1, 570.6, 570.36, 570.37 and 801.30, the Department has updated the OMB control number where the public may access the relevant information collection approved by OMB under the Paperwork Reduction Act. In 29 CFR 4.6, 5.5 and 516.0, the Department has provided updated information collection requests tables showing the current OMB control numbers associated with the referenced recordkeeping requirements. OMB changed the agency information collection control numbers. The correction will allow the public to access the currently approved information collection.

In 29 CFR 553.221 and 553.231, the Department has replaced references to firefighters with references to employees engaged in fire protection activities to conform to a recent amendment to the FLSA. In December 1999, Congress amended the FLSA to add a definition of employee engaged in fire protection activities. See Public Law 106-151, Sec. 1, 113 Stat 1731 (Dec. 9, 1999). The Department published an FLSA Final Rule on April 5, 2011 (76 FR 18832) that incorporated the new definition into the regulations and made several conforming revisions in part 553, subpart C, but did not conform the language of these provisions.

In 29 CFR 825.104 and 825.209, the Department has corrected cross-references to the definitions section of the FMLA regulations. On February 6, 2013, the Department published a final rule under the FMLA. In that rule, the Department moved the FMLA definitions section from the end of the regulations in § 825.800 to the front of the regulations in § 825.102. However, the Department did not update the cross-references to the definitions section in §§ 825.104 and 825.109. The Department is making this correction so the reader may easily locate the definitions section of the regulations currently located in § 825.102.

This rule has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulations. The agency has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, there is no requirement for an assessment of potential costs and benefits under section 6(a)(3) of that order.

This action is not classified as a “rule” under Chapter 8 of the Small Business Regulatory Enforcement Fairness Act of 1996, because it is pertaining to agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties. See 5 U.S.C. 804(3)(C).

Because no notice of proposed rulemaking is required for this rule under section 553(b) of the Administrative Procedure Act (APA), the requirements of the Regulatory Flexibility Act (5 U.S.C. 601) pertaining to regulatory flexibility do not apply to this rule. See 5 U.S.C. 601(2).

This final rule is not subject to section 350(h) of the Paperwork Reduction Act (44 U.S.C. 3501) since it does not contain any new collection of information requirements. The final rule does, however, update the information collection control numbers assigned by OMB to allow the reader to locate the collections where referenced in the regulations. The information collections referenced herein are not subject to OMB review as they do not amend information collection requirements.

This Final Rule has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA). 2 U.S.C. 1501 et seq. For the purposes of the UMRA, this rule does not impose any Federal mandate that may result in increased expenditures by State, local or Tribal governments, or increased expenditures by the private sector, of more than $100 million in any year.

The Department has reviewed this rule in accordance with the Executive Order on Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999). This rule does not have federalism implications as outlined in E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

The Department has reviewed this rule under the terms of Executive Order 13175 (65 FR 67249, November 6, 2000) and determined it did not have “tribal implications.” The rule does not have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” As a result, no Tribal summary impact statement has been prepared.

The Department certifies that this rule will not adversely affect the well-being of families, as discussed under section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277).

The Department has reviewed this rule under the terms of Executive Order 13045 (62 FR 19885, April 21, 1997, as amended by 68 FR 19931, April 18, 2003) and determined this action is not subject to E.O. 13045 because it is not economically significant as defined in E.O. 12866 and it does not impact the environmental health or safety risks of children.

The Department has reviewed this rule in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq., the regulations of the Council of Environmental Quality, 40 CFR 1500.1 et seq., and the Departmental NEPA procedures, 29 CFR part 11, and determined that this rule will not have a significant impact on the quality of the human environment. There is, therefore, no corresponding environmental assessment or an environmental impact statement.

The Department has determined that this rule is not subject to Executive Order 13211 (66 FR 28355, May 18, 2001). It will not have a significant adverse effect on the supply, distribution, or use of energy.

The Department has determined that this rule is not subject to Executive Order 12630 (53 FR 8859, March 15, 1988) because it does not involve implementation of a policy “that has taking implications” or that could impose limitations on private property use.

The Department drafted and reviewed this Final Rule in accordance with Executive Order 12988 (61 FR 4729, February 5, 1996) and determined that the rule will not unduly burden the Federal court system. The rule was: (1) Reviewed to eliminate drafting errors and ambiguities; (2) written to minimize litigation; and (3) written to provide a clear legal standard for affected conduct and to promote burden reduction.

I. Why is the EPA issuing this rule in final form without first issuing a proposal?

Today's final rule is limited to procedural requirements for administrative adjudicatory hearings and appeals from such hearings and from permit decisions. Under the Administrative Procedure Act, an agency may issue “rules of agency organization, procedure, or practice” without first proposing such rules for public comment. 5 U.S.C. 553(b). Accordingly, public comment is not required.

This action affects parties involved in EPA administrative adjudicatory proceedings for the assessment of civil penalties, issuance of various compliance orders, and termination or suspension of certain permits, under part 22 of title 40 of the CFR. See 40 CFR 22.1. This action also affects parties involved in appeal of EPA permits under part 124 of title 40 of the CFR.

Part 22 of Title 40 of the CFR establishes procedures governing administrative adjudicatory proceedings to assess administrative civil penalties, to issue various compliance orders, and to terminate or suspend certain permits. 40 CFR 22.1. These proceedings are conducted under a variety of environmental statutes, including the Clean Air Act, the Clean Water Act, the Solid Waste Disposal Act, and the Federal Insecticide, Fungicide, and Rodenticide Act, among others. Such cases are generally heard by the Administrative Law Judges (ALJs) within the EPA's Office of Administrative Law Judges or Regional Judicial Officers. The part 22 regulations are titled the “Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits” (“Rules of Practice”).

The EPA promulgated the Rules of Practice to establish uniform procedural rules for administrative proceedings required to be held on the record after opportunity for a hearing in accordance with section 554 of the Administrative Procedure Act, 5 U.S.C. 551 et seq., see 40 CFR part 22, subparts A-G, and administrative enforcement proceedings not governed by section 554, id. part 22, subpart I. Consolidated Rules of Practice, 45 FR 24360 (Apr. 9, 1980). The Rules of Practice also establish supplementary rules that recognize the unique procedural requirements of certain environmental statutes within the EPA's jurisdiction. See 40 CFR part 22, subpart H. Finally, the Rules of Practice establish procedures for appeals from decisions of the ALJs and Regional Judicial Officers to the Environmental Appeals Board. See id. part 22, subpart F.

Part 124 of Title 40 of the CFR establishes rules governing the EPA's issuance, modification, and revocation of permits under the Resource Conservation and Recovery Act, the Underground Injection Control program of the Safe Drinking Water Act, the Prevention of Significant Deterioration program of the Clean Air Act, and the National Pollutant Discharge Elimination System program of the Clean Water Act. These permit rules include procedures for appealing permit decisions by the EPA's regional offices to the Environmental Appeals Board. See 40 CFR 124.19.

This action makes several minor changes to part 22 procedures. Many of these changes pertain to the electronic filing and service of documents.

Filing and service. The EPA has amended the filing and service requirements to clarify how these requirements apply to electronic transmission of documents and to otherwise clarify filing and service requirements and make them more consistent with similar requirements in part 124.

Section 22.5(a) currently allows a Presiding Officer or the Environmental Appeals Board to “authorize” filing of documents by “facsimile or electronic filing.” 40 CFR 22.5(a). The EPA is amending this section to also allow a Presiding Officer or the Environmental Appeals Board to “require” filing by “facsimile or an electronic filing system.” Both the Office of the Administrative Law Judges and the Environmental Appeals Board have an operational electronic filing system. This section is also being amended to standardize the Environmental Appeals Board filing methods under part 22 with those currently in the EPA's permit regulations in part 124.

Section 22.5(b)(2) is modified to allow parties to agree with other parties to service by facsimile or other electronic means, including but not necessarily limited to email. A party's consent to such methods of service must be in writing and the party must file acknowledgement of such consent with the Clerk for the Presiding Officer or the Environmental Appeals Board, whichever is appropriate. This section is also modified to allow the Presiding Officer or the Environmental Appeals Board to authorize or require that the parties serve each other by facsimile or other electronic means, including but not necessarily limited to email. To facilitate electronic service, § 22.5(b)(4) is modified to require that a party include an email address in the first document it files in a proceeding.

The EPA emphasizes that the rules on electronic delivery of documents differ depending on whether the document is being filed with an EPA adjudicatory tribunal or served on a party to the proceeding. In the case of filing a document in an EPA administrative proceeding, the Presiding Officer or the Environmental Appeals Board has the sole authority to authorize or require electronic filing, and only these entities may authorize or require electronic filing by facsimile or an electronic filing system. As to service of documents between parties, not only may the Presiding Officer or the Environmental Appeals Board authorize or require service by either facsimile or other electronic means, including but not necessarily limited to email, but the parties may agree to such forms of electronic service.

Additionally, the EPA is revising § 22.5(b) to clarify that in cases before the Environmental Appeals Board, documents a party files with the Board need not also be served on the Board.

Section 22.6 is amended to allow the Regional Hearing Clerk, the Headquarters Hearing Clerk, or the Clerk of the Environmental Appeals Board to serve rulings, orders, decisions, or other documents by electronic means (including but not necessarily limited to facsimile and email).

Section 22.7(c) addresses when service is considered complete and includes a provision allowing an additional period of time for response to documents served using certain procedures. Id. § 22.7(c). The EPA has amended this section to specify that when documents are served by facsimile or other electronic means, the service will be complete upon transmission. This approach is similar to that in Rule 5(b) of the Federal Rules of Civil Procedure. Fed. R. Civ. P. 5(b).

The EPA has also modified the so-called “mailbox rule” in § 22.7(c) providing for additional days to respond to documents served using certain procedures. As modified, the revised mailbox rule in § 22.7(c) allows an additional three days to the time allowed for response to documents served by U.S. mail, the EPA's internal mail,1 or commercial delivery service. Three additional days are not allowed for a response when a document to be responded to is served by personal delivery or electronic means (e.g., facsimile or email). This change allows additional days where needed, but recognizes that extra days for delivery are not needed where same-day delivery is utilized. Further, this change makes part 22 consistent with the Federal Rules of Civil Procedure, including changes made to the Rules effective December 1, 2016. Rule 6(d) of the Federal Rules of Civil Procedure currently grants an additional three days when service is effectuated by U.S. mail, an agreed-to delivery service, or an electronic means. However, an amendment to Rule 6(d) that was effective December 1, 2016, removes electronic service from the types of service to which the additional three-day rule applies. Order (S. Ct. Apr. 28, 2016). This change was based on the conclusion that electronic service has become sufficiently reliable method of providing instantaneous delivery. Fed. R. Civ. P. 6(d) advisory committee's note to 2016 amendment.

Presiding officer prior to respondent filing answer. Generally, the Presiding Officer in part 22 proceedings is an Administrative Law Judge except for proceedings under subpart I, which are not governed by section 554 of the Administrative Procedure Act. See 40 CFR 22.3 (definition of “Presiding Officer”) & subpart I. Regional Judicial Officers are the Presiding Officer under subpart I proceedings. Id. § 22.51. The Environmental Appeals Board hears appeals from interlocutory orders and initial decisions of a Presiding Officer. Id. § 22.29-22.30.

However, sections 22.4(a) and 22.16(c) currently specify, among other things, that the Environmental Appeals Board will act as Presiding Officer in proceedings under part 22 commenced at EPA Headquarters until the respondent files an answer. Id. §§ 22.4(a), 22.16(c). In such proceedings, an Administrative Law Judge replaces the Environmental Appeals Board as the Presiding Officer once an answer is filed. Id. § 22.16(c).

This rule amendment modifies § 22.4(a) and § 22.16(c) to authorize an Administrative Law Judge to serve as the Presiding Officer in part 22 proceedings commenced at EPA Headquarters from the time a complaint is filed. The Environmental Appeals Board will no longer be assigned as a Presiding Officer for the period between the filing of a complaint and the filing of an answer. Rather, an Administrative Law Judge will serve as the Presiding Officer both prior to and after the filing of the answer. Removing the Environmental Appeals Board from the initial stage of enforcement proceedings will enhance the efficiency of proceedings commenced at EPA Headquarters because a single entity will exercise the role of Presiding Officer. This also eliminates the possibility that the Environmental Appeals Board could be asked to review on appeal its own decision on a preliminary motion (filed before an answer is filed).

Other changes. Section 22.28 addresses motions to reopen a hearing. This rule modifies § 22.28 to clarify the effect of filing such a motion and to expand the section to apply to motions to set aside a default order. The revised language clarifies that the filing of a motion to reopen a hearing tolls not only the time by when an initial decision becomes final or by when an appeal of an initial decision to the Environmental Appeals Board must be filed but also the time by which the Board must decide whether it is going to exercise its authority to hear the case on its own initiative. The revised language also applies similar requirements to a motion to set aside a default order.

Additionally, the EPA is making a series of changes to § 22.30 to clarify various issues relating to appeals to the Environmental Appeals Board. See id. § 22.30. Section 22.30 is modified to (1) explain how attachments to a notice of appeal, appellate brief, or response brief should be identified (§ 22.30(a)(1)(iii) and (2)); (2) impose word/page limitations for briefs and motions (§ 22.30(a)(3)); (3) provide more consistency between § 22.30(a)(1)(iii) and § 124.19(a)(4)(ii) pertaining to the need for parties' briefs to contain specific citations or other appropriate references (e.g., by including the document name and page number) (§ 22.30(a)(1)(iii) and (2)); (4) clarify that when the Board initiates review of an initial decision, it will identify any issues to be briefed and a schedule for briefing in its initial order of its intent to review or in a subsequent order (§ 22.30(b)); (5) clarify that the Board may request oral argument on its own initiative, how a party must request oral argument, and that the Board may establish additional oral argument procedures by order (§ 22.30(d)); (6) make explicit that the Board may act on a motion without awaiting a response (§ 22.30(e)(2)); and (7) explain the procedure for parties to request an extension of time (§ 22.30(e)(3)).

Most of the revisions to part 124 also concern filing and service issues. Section 124.19(i) addresses filing and service requirements in permit appeal proceedings before the Environmental Appeals Board. This section has been modified to add language clarifying when service is complete. Specifically, service is complete upon mailing for U.S. mail and EPA internal mail, when placed in the custody of a reliable commercial deliver service, or upon transmission for facsimile or email. This new language is similar to that in Rule 5(b)(2) of the Federal Rules of Civil Procedure and Environmental Appeals Board decisions. Fed. R. Civ. P. 5(b)(2); see In re Beckman Prod. Servs., 5 E.A.D. 10, 15 (EAB 1994) (“When the Region serves a final permit decision by mail, service occurs upon mailing.”). The EPA has revised the language in § 124.19(i)(3) to clarify that parties may agree to electronic service by facsimile, email, or other electronic means. The EPA has also revised § 124.19(i)(3) to require that parties that consent to service by electronic means file acknowledgement of that consent with the Environmental Appeals Board.

The EPA has also made several changes to part 124 on service and filing that duplicate the changes made to part 22: (1) Requiring that a party's first filing contain an email address (§ 124.19(i)(3)(i)); (2) authorizing the Environmental Appeals Board to require that parties file documents by facsimile or through use of the Board's electronic filing system (§ 124.19(i)(2)); (3) allowing the Environmental Appeals Board to authorize or require that the parties serve each other by facsimile or other electronic means, including email (§ 124.19(i)(3)(ii)); and (4) authorizing the Board to serve rulings, orders, and decisions on the parties by electronic means (including but not necessarily limited to facsimile and email). (§ 124.19(i)(3)(iii).

Section 124.19(b)(1) and (2) are modified so that the deadlines for filing a response to a petition for review are based on the date the petition is served, rather than filed. This provides for appropriate notice of the petition for review in advance of the deadline for a response.

Similar to the changes made in the mailbox rule in § 22.7(c), discussed above, the EPA has modified § 124.20(d) to specify that three days are added to a prescribed period of time to act when service is made by U.S. mail, the EPA's internal mail, or a reliable, commercial delivery service. Three days are not added to the prescribed time to act when service is made by personal delivery or electronic transmission (e.g., facsimile or email).

The EPA has also added word/page limitations to § 124.19(f) for motions mirroring the word/page limitations added to § 22.30. Finally, the EPA has amended § 124.19(a)(4)(ii) and (b) to further clarify that parties are to provide in their briefs appropriate reference to the administrative record (e.g., by including the document name and page number) as to each issue raised.

This action is exempt from review by the Office of Management and Budget (OMB) because it is limited to agency organization, management, or personnel matters.

This action does not impose an information collection burden under the PRA. This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources. Specifically, the modifications to the Rules of Practice will codify the electronic service of documents between parties and by EPA adjudicative bodies. In addition, the modifications will facilitate the efficient issuance of rulings on motions by substituting an Administrative Law Judge for the Environmental Appeals Board to serve as the presiding officer in civil penalty cases initiated at EPA Headquarters before an answer is filed.

This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule pertains to agency management or personnel, which the APA expressly exempts from notice and comment rulemaking requirements under 5 U.S.C. 553(a)(2).

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175. This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action will modify the EPA's procedural regulations governing administrative adjudicatory proceedings and appeals of adjudicatory proceedings and permit decisions to allow flexibility in the methods of serving and issuing documents and to promote efficiency in allocation of judicial resources.

This rule is exempt from the CRA because it is a rule relating to agency management or personnel.

For the reasons set out in the preamble, 40 CFR parts 22 and 124 are amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

Organization of this document. The following outline is provided to aid in locating information in this preamble.

This rulemaking addresses infrastructure SIP submissions from the State of Rhode Island for the 1997 fine particle matter (PM2.5), 2006 PM2.5, 2008 lead (Pb), 2008 ozone, 2010 nitrogen dioxide (NO2), and 2010 sulfur dioxide (SO2) National Ambient Air Quality Standards (NAAQS). The state submitted these infrastructure SIPs on the following dates: 1997 PM2.5—September 10, 2008; 2006 PM2.5—November 6, 2009; 2008 Pb—October 26, 2011; 2008 ozone—January 2, 2013; 2010 NO2—January 2, 2013; and 2010 SO2—June 27, 2014. Details of Rhode Island's submittals and EPA evaluation of those submittals can be found in our Notice of Proposed Rulemaking (NPR) (81 FR 10168; February 29, 2016).

On April 20, 2016, EPA took final action on the vast majority of the elements included in these submittals (see 81 FR 23175). In today's action, EPA is taking final action on its proposal to remove the following sections from the Code of Federal Regulations (CFR): 40 CFR 52.2073(b); 52.2075(b); and 52.2078(b). As discussed in detail in the NPR, these sections related to the public availability of emissions data and enforcement procedures are no longer necessary and have become obsolete since EPA has approved the relevant infrastructure SIP elements. Removal of Federal Implementation language is reserved for the Administrator, and has not been delegated to the Regional Administrator, who signed the April 20, 2016 final rulemaking referenced above.

EPA did not receive any comments in response to the NPR.

EPA is removing the following sections from the CFR: 40 CFR 52.2073(b); 52.2075(b); and 52.2078(b). The Federal Implementation Plan requirements in these sections are no longer necessary since EPA has since approved the relevant Clean Air Act infrastructure SIP revisions submitted by Rhode Island (see 81 FR 23175; April 20, 2016). A detailed discussion of the rationale for our action is included in the NPR (see 81 FR 10168; February 29, 2016).

This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under EOs 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b).

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. Entities potentially affected directly by this rule include state, local and tribal governments and none of these governments are small governments. Other types of small entities are not directly subject to the requirements of this rule.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in E.O. 13132.

This action does not have tribal implications as specified in E.O. 13175. These regulation revisions do not affect the relationship or distribution of power and responsibilities between the federal government and Indian tribes.

The EPA interprets E.O. 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the E.O. has the potential to influence the regulation. This action is not subject to E.O. 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

This action is not subject to E.O. 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under E.O. 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action is not subject to E.O. 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action is a procedural change and does not have any impact on human health or the environment.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C section 804(2). This rule will be effective February 8, 2017.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 10, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Elsewhere in this Federal Register, we are proposing approval and soliciting written comment on this action. Throughout this document, the words “we,” “us,” or “our” mean EPA.

We are approving the second 10-year maintenance plans for the Ajo and Morenci, Arizona SO2 maintenance areas and correcting an error in the boundary description of the Ajo maintenance area in the Code of Federal Regulations (CFR).1 2

Sulfur dioxide (SO2) is the pollutant that is the subject of this action. The NAAQS are health-based and welfare-based standards for certain ambient air pollutants. SO2 is among the ambient air pollutants for which we have established a health-based standard. SO2 causes adverse health effects by reducing lung function, increasing respiratory illness, altering the lung's defenses and aggravating existing cardiovascular disease. Children, the elderly, and people with asthma are the most vulnerable. SO2 has a variety of additional impacts, including acidic deposition, damage to crops and vegetation, and corrosion of natural and man-made materials.

In 1971, the EPA established both short- and long-term primary NAAQS for SO2. The short-term (24-hour) standard of 0.14 parts per million (ppm) was not to be exceeded more than once per year. The long-term standard specifies an annual arithmetic mean not to exceed 0.030 ppm.3 See 40 CFR 50.4.

In 2010, the EPA revised the primary SO2 NAAQS by establishing a new 1-hour standard of 75 parts per billion (ppb). The EPA revoked the existing 1971 primary standards at that time because they would not provide additional public health protection. See 75 FR 35550 (June 22, 2010). This action relates only to the revoked 1971 NAAQS. The State has requested that we take action on these maintenance plans.4

The Clean Air Act (CAA or “Act”) requires states to attain and maintain ambient air quality equal to or better than the NAAQS. The state's commitments for attaining and maintaining the NAAQS are outlined in the State Implementation Plan (SIP) for that state. The SIP is a planning document that, when implemented, is designed to ensure the achievement of the NAAQS. The Act requires that SIP revisions be made periodically as necessary to provide continued compliance with the standards.

SIPs include, among other things, the following: (1) An inventory of emission sources; (2) statutes and regulations adopted by the state legislature and executive agencies; (3) air quality analyses that include demonstrations that adequate controls are in place to meet the NAAQS; and (4) contingency measures to be undertaken if an area fails to attain the standard or make reasonable progress toward attainment by the required date, or a contingency plan if the area fails to maintain the NAAQS once redesignated. The state must make the SIP available for public review and comment through a public hearing and the SIP must be adopted by the state and submitted to us by the governor or her/his designee.

The EPA takes action on the SIP submittal, thus rendering the rules and regulations federally enforceable. The approved SIP serves as the state's commitment to take actions that will reduce or eliminate air quality problems. Any subsequent revisions to the SIP must go through the formal SIP revision process specified in the Act.

Ajo is located in northwestern Pima County. On March 3, 1978, at 43 FR 8968, for lack of a State recommendation, we designated Pima County as a primary SO2 nonattainment area based on monitored violations of the primary SO2 NAAQS in the area between 1975 and 1977. At the request of the Arizona Department of Environmental Quality (ADEQ), the nonattainment area was subsequently reduced to five townships in and around Ajo. See 44 FR 21261 (April 10, 1979). As a result, townships T11S, R6W; T11S, R5W; T12S, R6W; T12s, R5W; and T13S, R6W made up the nonattainment area. Townships T11S, R7W; T12S, R7W; T13S, R7W; and T13S, R5W were classified as “cannot be classified” areas.

Morenci is a town in eastern Greenlee County near the border of Arizona and New Mexico. On March 3, 1978, at 43 FR 8968, for lack of a state recommendation, we designated Greenlee County as a primary SO2 nonattainment area based on monitored violations of the primary SO2 NAAQS in the area between 1975 and 1977. At the request of the ADEQ, the nonattainment area was subsequently reduced to the townships in and around Morenci. See 44 FR 21261 (April 10, 1979). As a result, within Greenlee County townships T3S, R28E; T3S, R29E; T3S, R30E; T4S, R28E; T4S, R29E; T4S, R30E; T5S, R28E; and T5S, R29E made up the nonattainment area. Township T5S, R30E was classified as a “cannot be classified” area.

On the date of enactment of the 1990 CAA Amendments, SO2 areas meeting the conditions of section 107(d) of the Act were designated nonattainment for the SO2 NAAQS by operation of law. Section 107(d) describes the processes by which nonattainment areas are designated, including the pre-existing SO2 nonattainment areas. Thus, the Ajo and Morenci areas remained nonattainment for the primary SO2 NAAQS following enactment of the 1990 CAA Amendments on November 15, 1990.

In 2004, we redesignated the Ajo and Morenci areas under the criteria used for areas with shut-down smelters and discontinued monitoring described in a memorandum from John Seitz to Regional Office Air Division Directors titled “Redesignation of Sulfur Dioxide Nonattainment Areas in the Absence of Monitored Data,” dated October 18, 2000 (“Seitz Memo”).5

Phelps Dodge Mining Company's Ajo Incorporated (PDAI) operation was the largest point source in the Ajo SO2 nonattainment area. On April 4, 1985, the PDAI smelter was permanently deactivated. Dismantling of the Ajo facility began in 1995. By February 1996, the facility was completely dismantled. On October 15, 1997, ADEQ confirmed that the facility was dismantled and no longer existed at the former site. On November 3, 2003, the EPA finalized approval of the maintenance plan and redesignation request for the Ajo area, effective January 2, 2004 (see 68 FR 62239). At that time, we incorrectly identified the maintenance area as townships and ranges T11S-T13S, R5W-R6W as “better than national standards.” However, T13S, R5W was originally designated as “cannot be classified” and should have remained such. Additionally, townships T13S, R5W; T11S, R7W; T12S, R7W; and T13S, R7W were dropped from the CFR, and should be listed in 40 CFR 81.303 as “cannot be classified,” as they were upon Ajo's original designation in 1979. Today, we are correcting those errors.

The Phelps Dodge Morenci Incorporated (PDMI) operation was the largest SO2 point source in the Morenci nonattainment area during its operation. PDMI was located next to the Morenci copper mine, one of the largest copper producing operations in North America. PDMI was located close to the community of Morenci, in eastern Greenlee County, near the Arizona/New Mexico border.

On December 31, 1984, the PDMI smelter was permanently deactivated. Dismantling of the Morenci facility began in 1995 and was complete by December 1996. On October 29, 1997, ADEQ confirmed that the facility was dismantled and no longer existed at the former site. On April 26, 2004, the EPA finalized approval of the maintenance plan and redesignation request for the Morenci area, effective June 25, 2004 (see 69 FR 22447).

The Ajo and Morenci areas remain sparsely settled, and only minor industrial or commercial activities that produce small quantities of SO2 emissions are located in or near the nonattainment areas.

In Ajo, the only remaining SO2 point sources consist of emergency generators run by Freeport-McMoRan Corporation and Minerals Research and Recovery, which have a potential to emit (PTE) of 0.374 tons per year (tpy) of SO2.6 The 50 kilometer (km) buffer area required to be evaluated by the Seitz Memo includes an Arizona Public Service emergency generator, a paper mill, the Gila Bend Air Force Auxiliary Field, and a cotton gin, with a combined PTE of 7.388 tpy.7

Currently, no ambient SO2 monitors operate in the Ajo area. However, we do not expect the cumulative impact of the sources in and around Ajo to cause a violation of the NAAQS because the area's emissions are so low. No significant new sources have located in the area since our redesignation of the area to attainment in 2003.

Minor industrial or commercial activities such as Freeport-McMoRan mining operations and emergency generators for the Morenci wastewater treatment plant operate in the area. The 50 km area around the nonattainment area also contains a construction company, well fields, and several other sources that all still have active permits and together produce about 135 tpy of SO2 emissions.8

Currently, no ambient SO2 monitors operate in the Morenci area. However, we do not expect the cumulative impact of the sources in and around Morenci to cause a violation of the NAAQS. No significant new sources have located in the area, and the smelter was the cause of past violations.

Section 175A of the CAA provides the general framework for maintenance plans. The initial 10-year maintenance plan must provide for maintenance of the NAAQS for at least 10 years after redesignation, including any additional control measures as may be necessary to ensure such maintenance. In addition, maintenance plans are to contain such contingency provisions as we deem necessary to assure the prompt correction of a violation of the NAAQS that occurs after redesignation. The contingency measures must include, at a minimum, a requirement that the state will implement all control measures contained in the nonattainment SIP prior to redesignation.

Section 175A(b) of the CAA requires states to submit a subsequent maintenance plan revision (second 10-year maintenance plan) eight years after redesignation. The Act requires only that this second 10-year maintenance plan maintain the applicable NAAQS for ten years after the expiration of the first 10-year maintenance plan. Beyond these provisions, however, section 175A of the CAA does not define the content of a second 10-year maintenance plan.

Our primary general guidance on maintenance plans and redesignation requests is a September 4, 1992 memo from John Calcagni, titled “Procedures for Processing Requests to Redesignate Areas to Attainment” (“Calcagni Memo”). Specific guidance on SO2 redesignations also appears in a January 26, 1995 memo from Sally L. Shaver, titled “Attainment Determination Policy for Sulfur Dioxide Nonattainment Areas” (“Shaver Memo”).

Guidance on SO2 maintenance plan requirements for an area lacking monitored ambient data, if the area's historic violations were caused by a major point source that is no longer in operation, is found in the Seitz Memo at section II.C.2 and footnote 4. The Seitz Memo exempts eligible areas from the maintenance plan requirements of continued ambient air quality monitoring.

While the Seitz Memo primarily addresses redesignations, we find it is appropriate to apply the Seitz Memo to second 10-year maintenance plans for areas that were redesignated in accordance with the memo and continue to experience similar conditions to those at the time of redesignation.

Our historic redesignation policy for SO2 has called for eight quarters of clean ambient air quality data as a necessary prerequisite to redesignation of any area to attainment. The Seitz Memo provides guidance on SO2 maintenance plan requirements for an area lacking monitored ambient data, if the area's historic violations were caused by a major point source that is no longer in operation. To allow for these areas to qualify for redesignation to attainment, this policy requires that the maintenance plan address otherwise applicable provisions, and include:

(1) Emissions inventories representing actual emissions when violations occurred; current emissions; and emissions projected to the 10th year after redesignation; all three inventories should include estimates of emissions in a 50 km buffer zone around the nonattainment area;

(2) dispersion modeling showing that no NAAQS violations will occur over the next 10 years and that the shut-down source was the dominant cause of the high concentrations in the past;

(3) evidence that if the shut-down source resumes operation, it would be considered a new source and be required to obtain a permit under the Prevention of Significant Deterioration (PSD) provisions of the CAA; and

(4) a commitment to resume monitoring before any major SO2 source commences operation.

On February 22, 2013, ADEQ submitted to the EPA the “Final Arizona State Implementation Plan Revision, Maintenance Plan for the Ajo Sulfur Dioxide Planning Area (1971 NAAQS)” (“2013 Ajo Maintenance Plan”). The State verified that it had adhered to its SIP adoption procedures in Appendix E to the 2013 Ajo Maintenance Plan, which includes the notice of public hearing, the agenda for the February 7, 2013 public hearing, the sign in sheet, the public hearing officer certification and transcript of the hearing, and the State's responsiveness summary.

On August 22, 2013, the 2013 Ajo Maintenance Plan was deemed complete by operation of law. See 40 CFR part 51, appendix V, for the EPA's completeness criteria, which must be satisfied before EPA formal review.

On December 18, 2014, ADEQ submitted to the EPA the “Proposed Arizona State Implementation Plan Revision, Maintenance Plan for the Morenci Sulfur Dioxide Planning Area (1971 NAAQS)” (“2014 Morenci Maintenance Plan”). The State verified that it had adhered to its SIP adoption procedures in Appendix E to the 2014 Morenci Maintenance Plan, which includes the notice of public hearing, the agenda for the December 15, 2014 public hearing, the sign in sheet, the public hearing officer certification and transcript of the hearing, and the State's responsiveness summary.

On May 10, 2015, the 2014 Morenci Maintenance Plan was deemed complete by operation of law. See 40 CFR part 51, appendix V, for the EPA's completeness criteria, which must be satisfied before EPA formal review.

As discussed above, the only major source of SO2 emissions within the Ajo nonattainment area was the Phelps Dodge Mining Company's PDAI copper smelter, which ceased operation in 1985 and was completely dismantled by February 1996. The last recorded 24-hour or annual average exceedances of the primary NAAQS at PDAI occurred in 1984. During the monitoring network's history, annual average SO2 levels were generally half of the current NAAQS (0.030 ppm). See 2013 Ajo Maintenance Plan, page (p.) 17. ADEQ removed the SO2 monitor in 1985, and the smelter operating permits expired. The smelting equipment was removed over a period of years, and the smelter was completely dismantled by February 1996. No new sources of SO2 of the magnitude of PDAI have located in the area. Thus, Ajo meets this criterion for review under the Seitz Memo.

As discussed above, the only major source of SO2 emissions within the Morenci nonattainment area was the Phelps Dodge Mining Company's PDMI copper smelter, which was permanently deactivated by December 31, 1984 and was completely dismantled by December 1996. The last recorded 24-hour or annual average exceedances of the primary NAAQS at PDMI occurred in 1984. During the monitoring network's history, annual average SO2 levels were generally half of the current NAAQS (0.030 ppm). See 2014 Morenci Maintenance Plan, p. 15-16. ADEQ removed the SO2 monitors in 1985, and the smelter operating permits expired. The smelting equipment was removed over a period of years, and the smelter was completely dismantled by December 1996. No new sources of SO2 of the magnitude of PDMI have located in the area. Thus, Morenci meets this criterion for review under the Seitz Memo.

The 2013 Ajo Maintenance Plan and 2014 Morenci Maintenance Plan both extend the maintenance period for ten years after the expiration of the first 10-year maintenance plans, as required by Section 175A(b) of the CAA. As discussed below, the State has addressed the requirements in the Seitz Memo for emissions inventories, modeling, permitting of major new sources, and agreement to commence monitoring if a new major source locates in either the Ajo or Morenci areas. Therefore, the State has met the specific criteria in the Seitz Memo for approval of maintenance plans and redesignation requests where a single source was the historic cause of violations and the source is now shut down. We provide more details on each requirement and how the 2013 Ajo Maintenance Plan and the 2014 Morenci Maintenance Plan meet each requirement in the following sections.

In addition to reproducing the emissions inventories in the Ajo Sulfur Dioxide Nonattainment Area State Implementation Plan and Maintenance Plan (June 18, 2002) (“2002 Ajo maintenance plan”), the 2013 Ajo Maintenance Plan includes new emissions inventories for 2008, representing an updated “current” emissions inventory (the most recent National Emissions Inventory (NEI) available at the time), 2010, 2015, 2020, and 2025 for the second 10-year maintenance period.9 Continued maintenance of the Ajo area for 10 years following the initial 10-year maintenance period is demonstrated in part by showing that future SO2 emissions in the area are not expected to exceed the level of the attainment emissions inventory.

The emissions inventories in the 2013 Ajo Maintenance Plan include estimates of SO2 from all relevant source categories, which the 2013 Plan divides among stationary, and area and mobile. Point source information was received from the Pima County Department of Environmental Quality (PDEQ) and the Maricopa County Air Quality Division's annual emissions inventory data. The Ajo maintenance area contains two point sources (i.e., Freeport-McMoRan Corporation Childs Well Field Emergency Generator, and Minerals Research and Recovery, Inc.), which together emit less than 1 tpy SO2. The 50 km buffer area contains four point sources, including a cotton gin, a paper mill, an Air Force auxiliary field, and an emergency generator. The 2013 Ajo Maintenance Plan includes a description of current facility types, emitting equipment, permitted emissions limits, operating rates, and emissions calculation methods.

Area and mobile sources in ADEQ's 2008 and subsequent year inventories were derived from the EPA's NEI and local agency records. Historical and 2008 emissions inventories demonstrate that no significant area or mobile sources existed in the Ajo area prior to or subsequent to the smelter operation, which closed in 1985.

Based on our review of the emissions inventories in the 2013 Ajo Maintenance Plan and the supporting information in Appendix C, we conclude that the inventories are complete, accurate, and consistent with applicable CAA provisions and the Seitz Memo.

Past EPA policy memoranda on SO2 redesignations all recommend dispersion modeling to show that the NAAQS is met and will be maintained. The Seitz Memo recommends dispersion modeling of all point sources within50 km of the nonattainment area boundary. Screening modeling can be used to conservatively show that non-smelter sources have only an insignificant contribution to average SO2 concentrations in a nonattainment area.

For the 2002 Ajo Maintenance Plan, screening dispersion modeling was performed using the SCREEN3 model run with conservative assumptions about source parameters and meteorology. At the time of the 2002 Ajo Maintenance Plan, the Ajo nonattainment area had one minor point source of SO2 emissions (i.e., Phelps-Dodge Generating Station) and one permitted minor point source in the 50 km buffer (i.e., the proposed Gila Bend Regional Landfill). The model predicted that the impact from these two sources would not exceed 66% of the 1971 SO2 NAAQS, even assuming constant worst-case conditions about high-sulfur content fuel use.

The Seitz Memo also requires a modeling analysis that shows that the point sources that were shutdown were the dominant sources contributing to high SO2 concentrations in the airshed. Since the emissions of non-smelter sources in the area had changed relatively little since the time that emission controls were placed on the smelter, this same screening modeling was used to show that the non-smelter sources were insignificant in the past, and thus the smelter was the dominant source contributing to past high SO2 concentrations.

ADEQ did not conduct a new modeling analysis for the 2013 Ajo Maintenance Plan. As described above, the modeling for the 2002 Ajo Maintenance Plan modeled the existing two sources at maximum projected emissions rates from 2004 to 2015 and showed the area would not exceed 66% of the NAAQS. Since that modeling analysis was conducted, the Phelps-Dodge Generating Station has shut down, the Gila Bend Regional Landfill was never constructed, and the permit for the landfill was allowed to expire.

Currently, only two sources operate within the nonattainment area (i.e., Freeport-McMoRan Incorporated Childs Well Field Emergency Generator, and Minerals Research and Recovery), and they are permitted to emit less than 1% of the emissions modeled in the 2002 Ajo Maintenance Plan. Point sources within the 50 km buffer surrounding the nonattainment area emit about 25% of emissions modeled in the 2002 Ajo Maintenance Plan. 2025 projections show that these low emissions are expected to persist through the second 10-year maintenance period. See 2013 Ajo Maintenance Plan, pp. 33 and 34.

ADEQ proposes, and we concur, that because current emissions in the maintenance area and the 50 km buffer are a small fraction of modeled emissions from 2002, the ambient SO2 modeling requirement for second 10-year maintenance plans is met by the prior modeling, and the State has demonstrated that the 1971 SO2 NAAQS is adequately protected.

In nonattainment areas, section 172(c)(5) of the CAA requires New Source Review (NSR) permits prior to the construction and operation of new major stationary sources and major modifications at existing major stationary sources. However, in attainment areas, section 165 of the CAA requires major sources and major modifications to obtain PSD permits. The PSD program requires stationary sources to apply the best available control technology and ensure that projects will not cause or contribute to a violation of a NAAQS or maximum allowable increase.

ADEQ and the PDEQ have PSD permitting programs (i.e., Arizona Administrative Code (A.A.C.) R18-2-406 and Pima County Code 17.16.590) that were established to preserve the air quality in areas where ambient standards have been met. The State's updated PSD program was approved into the SIP on November 2, 2015 (80 FR 67319). PDEQ's PSD program is not SIP-approved, but the federal PSD permitting program at 40 CFR 52.21 was delegated to PDEQ effective April 14, 1994.

The PSD program has applied to any major source or major modification in the Ajo area since the area was redesignated to attainment for SO2 in 2003, except for coarse particulate (PM10), for which the area is designated nonattainment. Under section 172(c)(5) of the CAA, major sources and major modifications of PM10 in the Ajo area remain subject to the nonattainment NSR program, while all other NSR regulated pollutants are subject to the PSD program. Thus the existing ADEQ and PDEQ PSD and NSR programs satisfy the preconstruction permit provision of the Seitz Memo as one of the prerequisites to redesignation for the Ajo SO2 nonattainment area.

ADEQ commits to resume monitoring before any major source of SO2 commences to operate in the Ajo maintenance area. See 2013 Ajo Maintenance Plan, p. 38. This addresses the monitoring provision of the Seitz Memo.

The 2014 Morenci Maintenance Plan includes historical inventories that were submitted as part of the Morenci Sulfur Dioxide Nonattainment Area State Implementation Plan and Maintenance Plan (submitted June 21, 2002) (“2002 Morenci maintenance plan”) as well as a current-year inventory for 2011 (the most recent NEI available at the time), and projected inventories for 2015, 2020, 2025, and 2030 for the second 10-year maintenance period.10

The emissions inventories in the 2014 Morenci Maintenance Plan include estimates of SO2 emissions from all relevant source categories, which are divided among stationary, area, and mobile source categories. Additional information on how the inventories were developed, including activity data and emissions calculations, is provided in Appendix C of the 2014 Morenci Maintenance Plan. Point source information was developed by ADEQ from permit information and the NEI. The 2011 inventory identifies two existing point sources within the Morenci maintenance area: The Freeport-McMoRan Morenci mine with 2011 actual emissions of 48.5 tpy SO2, and the Morenci Townsite Wastewater Treatment Plant Emergency Generators with 2011 actual emissions of 0.003 tpy SO2. In 2011, 13 point additional sources with actual emissions of 38.05 tpy SO2 were located within 50 km of the Morenci maintenance area boundary. As of 2014, six of these sources had terminated their permits, resulting in slightly lower emissions.

Area and mobile source emissions in ADEQ's 2011 and subsequent year inventories were derived from the NEI. The year 2011 was a historically high wildfire year, and included the largest wildfire in Arizona history (i.e., the Wallow fire), which burned in Greenlee County and surrounding areas.11 ADEQ assumed the 2011 wildfire emissions remained constant when projecting emissions into the future.

Based on our review of the emissions inventories in the 2014 Morenci Maintenance Plan and the supporting information in Appendix C, we conclude that the inventories are complete, accurate, and consistent with applicable CAA provisions and the Seitz Memo.

The EPA policy memoranda on SO2 redesignations recommend dispersion modeling to show that the NAAQS is met and will be maintained. The Seitz Memo recommends dispersion modeling of all point sources within 50 km of the nonattainment area boundary. For the 2002 Morenci Maintenance Plan, screening dispersion modeling was performed using the SCREEN3 model, which was run with conservative assumptions about source parameters and meteorology. The modeling results indicated that the impact of existing sources on concentrations within the nonattainment area would not exceed 25 percent of the 1971 SO2 NAAQS.

The Seitz Memo also requires a modeling analysis that shows point sources that were shutdown were the dominant sources contributing to high SO2 concentrations in the airshed. The screening modeling described above was used in the 2002 Morenci Maintenance Plan to show that the non-smelter sources have an insignificant contribution, and thus the smelter was the dominant source contributing to past high SO2 concentrations.

For the 2014 Morenci Maintenance Plan, ADEQ conducted a modeling analysis similar to the analysis in the 2002 Morenci Maintenance Plan. The two largest sources in the maintenance area and within the 50 km buffer area were modeled. The two sources are Freeport-McMoRan Morenci Mine (FMMM) in the maintenance area, with a PTE of 88 tpy SO2, and the Freeport-McMoRan Safford Mine (FMSM) in the 50 km buffer area, with a PTE of 81 tpy SO2. Other point sources were not modeled because of their small or negligible emissions.

The EPA dispersion model AERSCREEN (version 11126) was used to conservatively estimate the impact of FMMM and FMSM on maintenance in the Morenci planning area.12 The results of the AERSCREEN modeling indicated that the impact of these existing sources would have a cumulative potential impact of 42-53% of the 1971 annual and 24-hour SO2 NAAQS respectively. See 2014 Morenci Maintenance Plan, p. 29. Projections for 2030 show that this low level of emissions is expected to persist through the second maintenance period. See 2014 Morenci Maintenance Plan, p. 32. We therefore conclude that the State has demonstrated that the 1971 SO2 NAAQS is adequately protected.

In nonattainment areas, section 172(c)(5) of the CAA requires NSR permits prior to the construction and operation of new major stationary sources and major modifications at existing major stationary sources. However, in attainment areas, section 165 of the CAA requires major sources and major modifications to obtain PSD permits. The PSD program requires stationary sources to apply the best available control technology and ensure projects will not cause or contribute to a violation of a NAAQS or maximum allowable increase.

ADEQ has a PSD permitting program (i.e., A.A.C. R18-2-406) that was established to preserve the air quality in areas where ambient standards have been met. The State's updated PSD program was approved into the SIP on November 2, 2015 (80 FR 67319). The PSD program has applied to any major source or major modification in the Morenci area since the area was redesignated to attainment for SO2 in 2004. Thus the ADEQ's existing PSD program satisfies the preconstruction permit provision of the Seitz Memo as one of the prerequisites to redesignation for the Morenci SO2 nonattainment area.

ADEQ commits to resume monitoring before any major source of SO2 commences to operate. See 2014 Morenci Maintenance Plan, p. 16. This addresses the monitoring provision of the Seitz Memo.

As discussed above, section 175A of the CAA sets forth the statutory requirements for maintenance plans, and the Calcagni, Seitz and Shaver Memos cited above contain specific EPA guidance. The only maintenance plan element not covered by the Seitz Memo is the contingency provisions. Section 175A(d) of the CAA requires that maintenance plans contain contingency provisions deemed necessary by the Administrator to assure that the state will promptly correct any violation of the standard which occurs after the redesignation of the area as an attainment area.

The 2013 Ajo Maintenance Plan includes the State's commitment to continue to track maintenance of the SO2 NAAQS through updates to the emissions inventory. Additionally, ADEQ commits to reestablish an appropriate air quality monitoring network before any major source of SO2 begins operations in the Ajo maintenance area. See 2013 Ajo Maintenance Plan, p. 38.

Since the primary cause of future violations of the 1971 SO2 NAAQS in the area would be from modified or new point sources, ADEQ's current operating permit program places limits on SO2 emissions from existing sources. Should a new facility be constructed in the Ajo area or an existing facility want to upgrade or increase SO2 emissions, the facility would also be subject to PSD as required in the Calcagni Memo.

The Calcagni Memo emphasizes the importance of specific contingency measures, schedules for adoption, and action levels to trigger implementation of the contingency plan. Since there are no remaining sources of SO2 emissions of the magnitude of the PDAI smelter, and there is no SO2 monitoring in the Ajo area, we agree with the State that the level of specificity recommended in the Calcagni Memo is not necessary, and we conclude that the State's commitment satisfactorily addresses the CAA provisions. We find that the State's commitment to continue to track maintenance of the SO2 NAAQS through updates to the emissions inventory and the State's PSD permitting programs are sufficient to assure that the Ajo area will not violate the NAAQS.

The 2014 Morenci Maintenance Plan includes the State's commitment to continue to demonstrate maintenance of the SO2 NAAQS through updates to the emissions inventory. Additionally, ADEQ commits to reestablish an appropriate air quality monitoring network before any major source of SO2 begins operations in the Morenci maintenance area. See 2014 Morenci Maintenance Plan, p. 32.

Since the primary cause of future violations of the 1971 SO2 NAAQS in the area would be from modified or new point sources, ADEQ's current operating permit program places limits on SO2 emissions from existing sources. Should a new facility be constructed in the Morenci area or an existing facility want to upgrade or increase SO2 emissions, the facility would also be subject to PSD as required in the Calcagni Memo.

The Calcagni Memo emphasizes the importance of specific contingency measures, schedules for adoption, and action levels to trigger implementation of the contingency plan. Since there are no remaining sources of SO2 emissions of the magnitude of the PDMI smelter, and there is no SO2 monitoring in the Morenci area, we agree with the State that the level of specificity recommended in the Calcagni Memo is not necessary, and we conclude that the State's commitment satisfactorily addresses the CAA provisions. We find that the State's commitment to continue to track maintenance of the SO2 NAAQS through updates to the emissions inventory and the State's PSD permitting programs are sufficient to assure that the Morenci area will not violate the NAAQS.

Conformity is required under section 176(c) of the CAA to ensure that federal actions are consistent with (“conform to”) the purpose of the SIP. Conformity to the purpose of the SIP means that federal activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant NAAQS or interim reductions and milestones. Conformity applies to areas that are designated nonattainment and to maintenance areas. The requirement to determine conformity applies to transportation plans, programs and projects developed, funded, or approved under Title 23 U.S.C. and the Federal Transit Act (“Transportation conformity”) as well as to other federally supported or funded projects (“general conformity”).

Transportation conformity applies to projects that require Federal Highway Administration or Federal Transit Administration funding. 40 CFR part 93 describes the requirements for federal actions related to transportation plans, programs, and projects to conform to the purposes of the SIP. Because the EPA does not consider SO2 a transportation-related criteria pollutant,13 only the requirements related to general conformity apply to the Ajo and Morenci areas.

Section 176(c)(4) of the CAA establishes the framework for general conformity. Besides ensuring that federal actions not covered by the transportation conformity rule will not interfere with the SIP, the general conformity regulations encourage consultation between the federal agency and the state or local air pollution control agencies before and during the environmental review process, as well as public notification of and access to federal agency conformity determinations, and allows for air quality review of individual federal actions.

Section 176(c) of the CAA required the states to revise their SIPs to establish criteria and procedures to ensure that federally supported or funded projects in nonattainment and maintenance areas “conform” to the air quality planning goals in the applicable SIP. SIP revisions intended to meet the conformity requirements in section 176(c) are referred to as “conformity SIPs.” In 2005, Congress amended section 176(c), and under the amended conformity provisions, states are no longer required to submit conformity SIPs for general conformity, and the conformity SIP requirements for transportation conformity have been reduced to include only those relating to consultation, enforcement, and enforceability. CAA section 176(c)(4)(E).

The EPA believes it is reasonable to interpret the conformity SIP requirements as not applying for purposes of a redesignation request under section 107(d)(3)(E)(v) because state conformity rules are still required after redesignation and Federal conformity rules apply where state rules have not been approved. See Wall v. EPA, 265 F. 3d 426 (6th Cir. 2001), upholding this interpretation. Because both Ajo and Morenci have already been redesignated for this standard, we believe it is reasonable to apply the interpretation of conformity SIP requirements as not applying for the purposes of redesignation to the approval of second ten-year maintenance plans.

Criteria for making determinations and provisions for general conformity are contained in Arizona Administrative Code R18-2-1438. Arizona has an approved general conformity SIP.14

ADEQ commits in the 2013 Ajo Maintenance Plan to review and comment, as appropriate, on any federal agency draft general conformity determination it receives consistent with 40 CFR 93.155 for any federal plans or actions in this planning area, although none are currently planned for the area. See 2013 Ajo Maintenance Plan, p. 13.

ADEQ commits in the 2014 Morenci Maintenance Plan to review and comment, as appropriate, on any federal agency draft general conformity determination it receives consistent with 40 CFR 93.155 for any federal plans or actions in this planning area, although none are currently planned for the area. See 2014 Morenci Maintenance Plan, p. 11.

On November 3, 2003, the EPA finalized approval of the maintenance plan and redesignation request for the Ajo area, effective January 2, 2004 (see 68 FR 62239). To codify this rulemaking, we amended 40 CFR 81.303 that lists the designations for air quality planning areas in Arizona, but we incorrectly identified the Ajo maintenance area in the Arizona SO2 table by dropping township T13S, R5W from the maintenance area, and inadvertently deleted other townships and ranges in the “cannot be classified” description. Township T13S, R5W as well as townships T11S, R7W; T12S, R7W; and T13S, R7W should have remained “cannot be classified.”

Section 110(k)(6) of the CAA provides that when the EPA's action approving any plan or plan revision (or part thereof), area designation, redesignation, classification, or reclassification was in error, the EPA may in the same manner revise such action. Under the EPA's authority under section 110(k)(6) of the Act, we are taking direct final action to amend the Arizona-SO2 table in 40 CFR 81.303 by re-codifying and correcting the previous detailed descriptions of the Ajo maintenance area and townships identified as “cannot be classified.”

The maintenance area consists of townships T11S, R6W; T11S, R5W; T12S, R6W; T12S, R5W; and T13S, R6W. In addition, townships T13S, R5W; T11S, R7W; T12S, R7W; and T13S, R7W are listed in 40 CFR 81.303 as “cannot be classified,” as they were upon the Ajo area's original designation in 1979.

We are approving the second 10-year SO2 maintenance plans for the Ajo and Morenci areas in Arizona under sections 110 and 175A of the CAA and correcting an error made in the description of the Ajo maintenance area and in the identification of townships as “cannot be classified” in the CFR when we redesignated the area in 2003. As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted SIPs because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted SIPs. If we receive adverse comments by February 8, 2017, we will publish a timely withdrawal in the Federal Register to notify the public that some or all of the provisions of the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on March 10, 2017. This will incorporate these SIPs into the federally enforceable SIP.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 10, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

Chapter I, title 40 of the Code of Federal Regulations is amended as follows:

On June 30, 2016, the President signed into law the FOIA Improvement Act of 2016. The Act prescribes a range of procedural requirements that affect the Commission's FOIA regulations, and which this final rule implements, including requirements that the Commission:

• Provide publically available documents and its FOIA Annual Reports in an electronic format;

• provide FOIA requesters the right to seek dispute resolution services from the Commission's FOIA Public Liaison and/or the Office of Government Information Services during the FOIA process;

• provide a minimum of 90 days for FOIA requesters to file an administrative appeal; and

• not apply the deliberative process privilege to records created 25 years or more before the date on which the records were requested.

The Regulatory Flexibility Act requires an agency to review regulations to assess their impact on small entities and prepare an initial regulatory flexibility analysis, unless the agency determines that a rule is not expected to have a significant impact on a substantial number of small entities. This final rule will affect only persons who file FOIA requests, and therefore, the Commission certifies that this final rule will not have a significant or negative economic impacts on a substantial number of small entities.

The Paperwork Reduction Act of 1995 requires an agency to seek and receive approval from the Office of Management and Budget (OMB) before making most requests for information if the agency is requesting information from more than ten persons. 44 U.S.C. 3507. The agency must submit collections of information in proposed rules to OMB in conjunction with the publication of the proposed rulemaking. 5 CFR 1320.11. This final rule does not impose any collections of information, as defined by 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).

This final rule will have no physical impact upon the environment, and therefore, will not require any further review under NEPA.

The Commission assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document may be used to find this action in the Unified Agenda, available at http://www.reginfo.gov/public/do/eAgendaMain.

For the reasons set forth in the preamble, the Federal Maritime Commission amends 46 CFR part 503 as follows:

I. Discussion of Changes

The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) part 552, Solicitation Provisions and Contract Clauses at 552.216-74 Task and Delivery Orders. The final rule clarifies that the jurisdiction and responsibility to review and resolve fair opportunity complaints placed against GSA multiple-award contracts lies with the ordering-agency task and delivery order Ombudsman. Also, the final rule requires the ordering agency to include contact information for their task and delivery order Ombudsman when placing task or delivery orders against GSA multiple-award contracts. Finally, so that GSA can maintain insight into fair opportunity complaints that arise on orders other agencies place against these contracts, the final rule requires the contractor to provide a copy of its complaint to the GSA Procurement Ombudsman for informational purposes, at the same time the contractor files its complaint to the ordering agency for action.

41 U.S.C. 1707, Publication of proposed regulations, applies to the publication of the General Services Administration Acquisition Regulation. Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure, or form (including amendment or modification thereof) must be published for public comment if it has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it does not have a significant impact on the public, contractors or offerors. This rule brings internal GSAR policy up-to-date with FAR policy. The change clarifies internal operating procedures by the Government by clarifying GSA's jurisdiction regarding fair opportunity complaints. The proposed rule comment period is impracticable as the FAR has already directed specific regulatory action.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives; and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant GSAR revision and 41 U.S.C. 1707 does not require publication for public comment.

This final rule does not contain any information collection that requires additional approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. Chapter 35).

Therefore, GSA amends 48 CFR parts 516 and 552 as set forth below: