Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules 36749

Inspector, who may add comments and then I. Background not lower plaque pH below 5.7. Therefore, send it to the Manager, Los Angeles ACO. before a claim can be made for a new sugar In the Federal Register of August 23, alcohol, it must be shown to meet the Note 2: Information concerning the 1996 (61 FR 43433), the agency adopted existence of approved alternative methods of requirements for § 101.80. When this is compliance with this AD, if any, may be a final rule to authorize the use, on food demonstrated, FDA will take action to add obtained from the Los Angeles ACO. labels and in food labeling, of health the substance to the list in this regulation, (c) Special flight permits may be issued in claims on the association between sugar which has been renumbered as accordance with sections 21.197 and 21.199 alcohols and dental caries (hereinafter § 101.80(c)(2)(ii)(B). of the Federal Aviation Regulations (14 CFR referred to as the sugar alcohol final The present rulemaking is in response 21.197 and 21.199) to operate the airplane to rule) (§ 101.80 (21 CFR 101.80)). FDA to a petition to amend a location where the requirements of this AD adopted this regulation in response to a § 101.80(c)(2)(ii)(B) to include erythritol can be accomplished. petition filed under section as one of the sugar alcohols that is Issued in Renton, Washington, on July 2, 403(r)(3)(B)(i) of the Federal Food, Drug, eligible to bear the sugar alcohol and 1997. and Cosmetic Act (the act) (21 U.S.C. dental caries health claim. Darrell M. Pederson, 343(r)(3)(B)(i)). Section 403(r)(3)(B)(i) of II. Petition for Health Claim on Acting Manager, Transport Airplane the act states that the Secretary of Erythritol and the Nonpromotion of Directorate, Aircraft Certification Service. Health and Human Services (and, by Dental Caries [FR Doc. 97–17848 Filed 7–8–97; 8:45 am] delegation, FDA) shall issue regulations BILLING CODE 4910±13±U authorizing health claims only if he or A. The Petition she determines, based on the totality of On April 4, 1997, the petitioners publicly available scientific evidence submitted a petition to FDA requesting DEPARTMENT OF HEALTH AND (including evidence from well-designed that the agency amend HUMAN SERVICES studies conducted in a manner which is § 101.80(c)(2)(ii)(B) to authorize a claim consistent with generally recognized to authorize a noncariogenicity dental Food and Drug Administration scientific procedures and principles), health claim for the sugar alcohol that there is significant scientific 21 CFR Part 101 erythritol. On May 16, 1997, the agency agreement, among experts qualified by sent the petitioner a letter stating that it [Docket No. 97P±0206] scientific training and experience to had completed its initial review of the evaluate such claims, that the claim is petition, and that the petition would be Food Labeling: Health Claims; Dietary supported by such evidence (see also filed in accordance with section Sugar Alcohols and Dental Caries § 101.14(c) (21 CFR 101.14(c))). 403(r)(4) of the act (see Docket 97P– The sugar alcohol final rule sets out 0206, Letter 1). The following is a AGENCY: Food and Drug Administration, the circumstances in which a sugar HHS. review of the health claim petition and alcohol is eligible to be the subject of a of whether erythritol satisfies the ACTION: Proposed rule. health claim (§ 101.80(c)(2)(ii)). Section requirements of §§ 101.80(c)(2)(ii) and 101.80(c)(2)(ii)(A) states that the food SUMMARY: The Food and Drug 101.14(b) and (c) of FDA’s regulations. must meet the requirement for a sugar Administration (FDA) is proposing to free food defined in 21 CFR B. Preliminary Requirements amend the regulation that authorized a 101.60(c)(1)(i). Section health claim on sugar alcohols and 1. The Substance That Is the Subject of 101.80(c)(2)(ii)(B) lists the sugar dental caries to include the sugar the Petition alcohols that are eligible to bear the alcohol erythritol. FDA is proposing this claim, xylitol, sorbitol, mannitol, Erythritol is a 4-carbon, action in response to a petition filed by maltitol, isomalt, lactitol, hydrogenated monosaccharide polyhydric alcohol. It the Cerestar Holding B.V., Mitsubishi starch hydrolysates, hydrogenated occurs naturally in a wide variety of Chemical Corp., and Nikken Chemicals glucose syrups, or a combination of plants (e.g., watermelons, melons, Co. The agency has tentatively these. Section 101.80(c)(2)(ii)(C) states grapes, and mushrooms) and animals concluded that, based on the totality of that: (e.g., humans, dogs, and cows). publicly available scientific evidence [W]hen fermentable carbohydrates are Erythritol is also a product of the presented in the petition, erythritol does present in the sugar alcohol-containing food, fermentation by yeasts and molds of not promote dental caries. Therefore, the food shall not lower plaque pH below 5.7 sugars (Ref. 1, p. 27). FDA is proposing to amend the sugar by bacterial fermentation either during alcohol and dental caries health claim to consumption, or up to 30 minutes after 2. The Substance Is Associated With a include erythritol. consumption as measured by the indwelling Disease for Which the U.S. Population plaque pH test found in ‘‘Identification of DATES: Written comments by September Is at Risk Low Caries Risk Dietary Components,’’ * * * 22, 1997. The agency is proposing that which is incorporated by reference * * *. In the preamble to the proposed sugar any final rule that may issue based upon In the sugar alcohol final rule, the alcohol and dental caries rule (60 FR this proposal become effective upon its agency stated that for other sugar 37507 at 37509, July 20, 1995) and in publication in the Federal Register. alcohols to be included in the regulation authorizing the claim on ADDRESSES: Written comments to the § 101.80(c)(2)(ii)(B), a petitioner must sugar alcohols and dental caries Dockets Management Branch (HFA– show how the substance conforms to the (§ 101.80(a)(3)), FDA established that 305), Food and Drug Administration, requirements of §§ 101.14(b) and 101.80 dental caries is a disease for which the 12420 Parklawn Dr., rm. 1–23, (61 FR 43433 at 43442). FDA stated: U.S. population is at risk. The agency Rockville, MD 20857. For those substances that are to be stated: FOR FURTHER INFORMATION CONTACT: consumed at other than decreased dietary Dental caries is recognized in The Surgeon Joyce J. Saltsman, Center for Food Safety levels, the petitioner must demonstrate to General’s Report on Nutrition and Health * * * as a disease or health-related condition and Applied Nutrition (HFS–165), Food FDA’s satisfaction that the substance is safe and lawful under the applicable food safety for which the United States population is at and Drug Administration, 200 C St. SW., provisions of the act (§ 101.14(b)(3)(ii)). risk * * *. The overall prevalence of dental Washington, DC 20204, 202–205–5483. Likewise, the petitioner would need to caries imposes a substantial burden on SUPPLEMENTARY INFORMATION: provide evidence that the sugar alcohol will Americans. Of the 13 leading health 36750 Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules problems in the United States, dental The large body of published data supports a 15-minute period after the subjects diseases rank second in direct costs * * *. the conclusion that the intake of erythritol chewed a piece of paraffin for 3 Dental caries continues to affect a large would not be expected to cause adverse minutes. The subjects then sucked on proportion of Americans. Although there has effects in humans under the conditions of use the sugar-free throat lozenge containing been a decline in the prevalence of dental in food and that other qualified food safety caries among children in the United States, experts would agree that erythritol is erythritol, followed by plaque pH the disease remains widespread throughout generally recognized as safe (GRAS) under measurements over a 30-minute period. the population * * *. the conditions of its intended use in food. The same test procedure was then Based on these facts, FDA concludes The petitioner also asserted that repeated using a 10-percent sucrose that, as required in § 101.14(b)(1), dental erythritol occurs endogenously and rinse as the control substance in place caries is a disease for which the U.S. naturally in the diet, and that it has a of the erythritol lozenge. population is at risk. history of safe use in foods. The The results of this test showed that petitioner further argued that the safety after the first paraffin chew, baseline 3. The Substance Is a Food of erythritol is supported by its plaque pH measured between 6.9 to 7.0, In the preamble to the sugar alcohols chemical structure, i.e., it is positioned values that were similar to earlier tests proposed rule (60 FR 37507 at 37509) in the homologous series of sugar with the same subjects and plaque ages and in the final regulation itself alcohols, between glycerol and xylitol, a (Ref. 1, Appendix B-2). Following (§ 101.80(a)(4)), the agency states that series that also includes other common consumption of erythritol, plaque pH sugar alcohols can be used as food ingredients such as sorbitol and measured 6.0 to 6.65. The sucrose rinse sweeteners to replace dietary sugars, mannitol. caused plaque pH to drop to a range of such as sucrose and corn sweeteners, in Based on the totality of the evidence, 4.25 to 4.9, levels that were significantly foods such as chewing gums and certain the agency is not prepared, at this time, lower than pH of plaque during the confectioneries. Therefore, FDA to take issue with the petitioner’s view erythritol period and well below the concludes that erythritol satisfies the that the use of erythritol is safe and critical pH value of 5.7, the level at preliminary requirement in lawful. Therefore, FDA tentatively which demineralization of enamel § 101.14(b)(3)(i). concludes that the petitioner has occurs. The key finding for this 4. The Substance Is Safe and Lawful provided evidence that satisfies the proceeding is that there were no requirement in § 101.14(b)(3)(ii) that use significant differences in plaque pH The petitioner has submitted a of erythritol at the levels necessary to between the paraffin and erythritol petition requesting that FDA affirm that justify a claim is safe and lawful. periods. the use of erythritol is generally Kawanabe and coworkers evaluated recognized as safe (GRAS) (62 FR 10285, III. Review of Scientific Evidence the cariogenicity of erythritol in vitro March 6, 1997). The agency notes that The petitioner submitted two and in pathogen-free rats (Ref. 1, this GRAS affirmation petition (GRASP scientific studies evaluating the Appendix B-3). The authors used 7G0422) is still under review, and that relationship between erythritol and microorganisms of various authorization of a health claim should dental caries: A human study and an Streptococcus, Lactobacillus, and not be interpreted as affirmation that the animal study that included an in vitro Actinomyces species to determine proposed uses of erythritol are GRAS. evaluation. whether the organisms could use Such a determination can be made only The human study included an erythritol as a substrate for lactic acid after the agency has completed its interdental plaque pH telemetry test, production and plaque formation. The review of the GRAS petition. A one of the methods described in the text results of this study showed that preliminary review of the GRAS entitled ‘‘Identification of Low Caries erythritol was not utilized as a substrate affirmation petition, however, reveals Risk Dietary Components,’’ which the for lactic acid production or for plaque that it contains significant evidence agency incorporated by reference in the formation by Streptococcus mutans or supporting the safety of the use of this sugar alcohol regulation (see certain other oral microorganisms. substance at the levels necessary to § 101.80(c)(2)(ii)(C)). The test was In the animal study, the rats were justify a health claim. conducted at the Bioelectronic Unit of randomly divided into six groups. Three In the GRAS affirmation petition, the the Clinic of Preventive Dentistry, groups of animals were fed modified petitioner relied heavily on published Periodontology, and Cariology of the diets for 5 days. These diets contained animal subchronic and chronic toxicity University Dental Institute of Zurich, either starch alone, with no sugars or studies and reproduction studies Switzerland (Ref. 1, Appendix B-2). sugar alcohol; starch plus sucrose; or (GRASP 7G0422, App. IV: C4, C12, D5, For this test, each subject had a starch plus erythritol. Then the animals D7, D8, D17, D20, D27, and D30), on mandibular telemetric prosthesis were infected with Streptococcus human toleration and absorption studies incorporating a miniaturized glass pH- sobrinus, after which they continued to (GRASP 7G0422, App. IV: C9, C19, C27, electrode placed directly opposite the consume the modified diet for an E2, E6, E8, and E11), and on the interproximal area of an adjacent additional 50 days. In a similar conclusions about the safety of abutment tooth. Once the prosthesis was experiment, the other three groups of erythritol by a panel of independent inserted into the subject’s mouth, the animals were fed diets that contained experts qualified by scientific training subject was asked not to alter his or her starch chocolate; sucrose chocolate, or and experience to evaluate the safety of eating habits. The prostheses were worn erythritol chocolate, and the animals foods. The panel of independent throughout the 3-to 4-day test period to were infected with Streptococcus scientists based their conclusions on allow an undisturbed growth of mutans. Mandibular caries scores were their review of various published and interdental plaque over the tips of the determined at 70 days of age in all unpublished scientific studies which electrodes. With the exception of water groups. included animal toxicological studies rinses, the subjects were also asked to The results of this study showed that and clinical studies. In their report refrain from all oral hygiene measures. the group fed starch plus erythritol entitled, ‘‘Erythritol: A Review of At the end of the 3-to 4-day plaque experienced significantly fewer caries Biological and Toxicological Studies’’ buildup period, the interdental plaque compared to the starch and starch plus (GRASP 7G0422, App. I-1), the panel pH telemetry test was conducted. sucrose groups. The total caries scores concluded that: Baseline plaque pH was measured over for groups fed diets of starch, starch Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules 36751 plus sucrose, and starch plus erythritol to state ‘‘[T]he sugar alcohol in the food Some manufacturers are using FDA’s were 12.5, 60.5, and 3.1, respectively. shall be xylitol, sorbitol, mannitol, approved health claim regarding the Similarly, the group consuming maltitol, isomalt, lactitol, hydrogenated benefits of sugar alcohols. This erythritol chocolate experienced starch hydrolysates, hydrogenated proposed health claim will allow them significantly fewer caries compared to glucose syrups, erythritol, or a to highlight the effects of another sugar the starch chocolate and sucrose combination of these.’’ alcohol, erythritol. The benefit of chocolate groups. The caries scores for The agency is not specifying a level of establishing this health claim is to the starch chocolate, sucrose chocolate, erythritol in the food product because, provide for new information in the and erythritol chocolate groups were like the other sugar alcohols, erythritol market regarding the relationship of 18.5, 82.8, and 6.7, respectively. There is being used as a substitute for sugars. erythritol and dental caries, and to were no significant differences in the Therefore, the amount of the substance provide consumers with the assurance body weights of the rats between required is that needed to achieve a that this information is truthful, not groups. desired level of sweetness. misleading, and scientifically valid. The authors stated that, although the Costs will be incurred by small VI. Environmental Impact group fed starch usually experienced entities only if they opt to take the least dental caries, the caries score The agency has determined under 21 advantage of the marketing opportunity for the group fed starch was CFR 25.24(a)(11) that this action is of a presented by this regulation. FDA significantly higher than that of the type that does not individually or cannot predict the number of small group fed starch plus erythritol. The cumulatively have a significant effect on entities that will choose to use the same trend was reported in the animals the human environment. Therefore, claim. However, no firm, including consuming the chocolate diets. The neither an environmental assessment small entities, will choose to bear the authors suggested that the cariogenicity nor an environmental impact statement cost of redesigning labels unless they of starch in these experiments may be is required. This finding is based on believe that the claim will result in explained by the contamination of information submitted by the petitioner increased sales of their product. mono- and disaccharides. The main in an environmental assessment Therefore, this rule will not result in conclusion from this study is that prepared using the format described in either a decrease in revenues or a erythritol did not induce dental caries. 21 CFR 25.31a(b)(5). significant increase in costs to any small IV. Decision to Propose a Health Claim VII. Analysis of Impacts entity. Accordingly, under the Regulatory Flexibility Act, 5 U.S.C. Relating Erythritol to the FDA has examined the economic 605(b), the agency certifies that this Nonpromotion of Dental Caries implications of the proposed rule as proposed rule will not have a significant required by Executive Order 12866 and The petition set out the results of an economic impact on a substantial the Regulatory Flexibility Act (5 U.S.C. indwelling plaque pH test and the number of small entities. results of an in vitro and animal study 601–612). Executive Order 12866 directs that evaluated the cariogenicity of agencies to assess all costs and benefits VIII. Paperwork Reduction Act erythritol. FDA reviewed this of available regulatory alternatives and, FDA tentatively concludes that this information and has tentatively when regulation is necessary, to select proposed rule contains no reporting, concluded that there is significant the regulatory approach that maximizes recordkeeping, labeling, or other third scientific evidence to demonstrate that net benefits (including potential party disclosure requirement. Thus, erythritol does not promote dental economic, environmental, public health there is no ‘‘information collection’’ caries. The results of the plaque pH test and safety effects; distributive impacts; necessitating clearance by the Office of clearly demonstrate that erythritol does and equity). Executive Order 12866 Management and Budget. However, to not lower plaque pH below 5.7, and classifies a rule as significant if it meets ensure the accuracy of this tentative that, therefore, it does not promote the any one of a number of specified conclusion, FDA is seeking comment on demineralization of dental enamel. The conditions, including having an annual whether this proposed rule to permit results of the in vitro and animal study effect on the economy of $100 million health claims on the association are consistent with the results of the or adversely affecting in a material way between erythritol and the indwelling plaque pH study and show a sector of the economy, competition, or noncariogenicity of dental caries that erythritol does not support the jobs, or if it raises novel legal or policy imposes any paperwork burden. growth of oral microorganisms issues. If a rule has a significant responsible for producing the acid in economic impact on a substantial IX. Effective Date plaque and has little to no cariogenic number of small entities, the Regulatory FDA is proposing to make these potential. The results of these studies Flexibility Act requires agencies to regulations effective upon publication of are consistent with the results of the analyze regulatory options that would a final rule based on this proposal. studies that investigated the cariogenic minimize the economic impact of that X. Comments potential of the sugar alcohols listed in rule on small entities. FDA finds that § 101.80(c)(2)(ii)(B). Therefore, FDA this proposed rule is not a significant Interested persons may, on or before tentatively finds that erythritol has rule as defined by Executive Order September 22, 1997, submit to the satisfied the requirements set forth in 12866 and finds under the Regulatory Dockets Management Branch (address §§ 101.14(d) and 101.80, and the agency Flexibility Act that the proposed rule above) written comments regarding this is proposing to add erythritol to the list will not have a significant impact on a proposal. Two copies of any comments of eligible sugar alcohols. substantial number of small entities. are to be submitted, except that The establishment of this health claim individuals may submit one copy. V. Description of Modifications to results in benefits and in costs only to Comments are to be identified with the § 101.80 the extent that food manufacturers elect docket number found in brackets in the Section 101.80(c)(2)(ii)(B) lists the to take advantage of the opportunity to heading of this document. Received sugar alcohols that are eligible to be the use the claim. This rule will not require comments may be seen in the office subject of a dental claim. FDA is that any labels be redesigned, or that above between 9 a.m. and 4 p.m., proposing to amend § 101.80(c)(2)(ii)(B) any product be reformulated. Monday through Friday. 36752 Federal Register / Vol. 62, No. 131 / Wednesday, July 9, 1997 / Proposed Rules

XI. Reference ACTION: Request for comments. disseminating licenses among a wide The following reference has been variety of applicants, including small SUMMARY: On July 2, 1997, the Federal businesses, rural telephone companies, placed on display in the Dockets Communications Commission released a Management Branch (address above) and businesses owned by members of public notice requesting comment on minority groups and women. and may be seen by interested persons the Commission’s use of competitive between 9 a.m. and 4 p.m., Monday bidding to award licenses to provide In the four years since grant of auction through Friday. wireless services as part of its authority, the Commission has 1. Cerestar Holding B. V., Mitsubishi preparation of a report to Congress, as completed fourteen auctions. These Chemical Corp., and Nikken Chemicals Co., required by Section 309(j)(12) of the auctions have resulted in the ‘‘Petition to amend the regulation for 21 CFR assignment of over 4,300 licenses for § 101.80 to authorize a noncariogenicity Communications Act, 47 U.S.C. 309(j)(2). The public notice solicits spectrum-based services, which include dental health claim for the sugar alcohol narrowband Personal Communications erythritol (1,2,3,4-butanetetrol),’’ April 4, comment from the public on a variety of 1997 [CP1]. issues relating to the Commission’s Service (PCS), broadband PCS, spectrum auction program to date, and Interactive Video Data Service (IVDS), List of Subjects in 21 CFR Part 101 announces that comments are due on or Multipoint Distribution Service (MDS), Food and Drug Administration, Food before August 1, 1997. 900 MHz Specialized Mobile Radio Service (SMR), unserved cellular areas, labeling, Nutrition, Reporting and DATES: Comments are due on or before Direct Broadcast Satellite (DBS), Digital recordkeeping requirements. August 1, 1997. Therefore, under the Federal Food, Audio Radio Service (DARS) and FOR FURTHER INFORMATION CONTACT: Wireless Communications Service Drug, and Cosmetic Act and under Mark Bollinger or Alice Elder, Wireless authority delegated to the Commissioner (WCS). Auctions to date have raised a Telecommunications Bureau, Federal total of $23.1 billion for the U.S. of Food and Drugs, it is proposed that Communications Commission, (202) 21 CFR part 101 be amended as follows: Treasury. Future auctions being planned 418–0660. include those for licenses to provide SUPPLEMENTARY INFORMATION: This is a PART 101ÐFOOD LABELING Local Multipoint Distribution Service, summary of the public notice released paging, narrowband PCS, and the 800 1. The authority citation for 21 CFR on July 2, 1997. The complete public MHz SMR and 220 MHz services. notice is available for inspection and part 101 continues to read as follows: Section 309(j)(12) of the copying during normal business hours Communications Act requires that the Authority: Secs. 4, 5, 6 of the Fair in the FCC Reference Center (Room Packaging and Labeling Act (15 U.S.C. 1453, Commission conduct a public inquiry 239), 1919 M Street, N.W., Washington, 1454, 1455); secs. 201, 301, 402, 403, 409, regarding the use of competitive bidding D.C., 20554, and also may be purchased 701 of the Federal Food, Drug, and Cosmetic to award licenses and submit a report to from the Commission’s copy contractor, Act (21 U.S.C. 321, 331, 342, 343, 348, 371). Congress by September 30, 1997. International Transcription Services, 2. Section 101.80 is amended by Pursuant to the statute, the report must: revising paragraph (c)(2)(ii)(B) to read as (202) 857–3800, 2100 M Street, N.W., follows: Washington, D.C. 20037. The complete (1) Contain a statement of the public notice is also available on the revenues obtained, and a projection of § 101.80 Health claims: dietary sugar Commission’s Internet home page future revenues, from the use of alcohols and dental caries. (http://www.fcc.gov). competitive bidding systems; * * * * * Summary of the Public Notice (2) Describe the competitive bidding (c) * * * methodologies established by the (2) * * * Commission Opens Inquiry on Commission pursuant to Sections (ii) * * * Competitive Bidding Process for Report 309(j)(3) and (4) of the Communications (B) The sugar alcohol in the food shall to Congress Act; be xylitol, sorbitol, mannitol, maltitol, (3) Compare the advantages and isomalt, lactitol, hydrogenated starch Comment Due Date: August 1, 1997 disadvantages of the competitive hydrolysates, hydrogenated glucose I. Introduction and Background bidding methodologies established by syrups, erythritol, or a combination of The Omnibus Budget Reconciliation the Commission in terms of attaining these. Act of 1993 (the ‘‘Budget Act’’) added the objectives described in Sections * * * * * Section 309(j) to the Communications 309(j)(3) and (4) of the Communications Dated: June 17, 1997. Act of 1934, as amended, 47 U.S.C. Act; William K. Hubbard, §§ 151–713 (the ‘‘Communications (4) Evaluate whether and to what Associate Commissioner for Policy Act’’). Section 309(j) authorized the extent: Commission to employ competitive Coordination. (i) Competitive bidding significantly bidding to choose from among mutually [FR Doc. 97–17797 Filed 7-8-97; 8:45 am] improved the efficiency and exclusive applications for initial BILLING CODE 4160±01±F effectiveness of the process for granting licenses in services where the licensee radio spectrum licenses; receives compensation from subscribers. It requires the Commission to promote (ii) Competitive bidding facilitated the FEDERAL COMMUNICATIONS introduction of new spectrum-based COMMISSION the development and rapid deployment of new technologies, products and technologies and the entry of new 47 CFR CHAPTER I services for the benefit of the public, companies into the telecommunications including those residing in rural areas, market; [WT Docket No. 97±150; FCC 97±232] without administrative or judicial (iii) Competitive bidding Competitive Bidding delays. It further requires the methodologies have secured prompt Commission to promote opportunity delivery of service to rural areas and AGENCY: Federal Communications and competition by avoiding excessive have adequately addressed the needs of Commission. concentration of licenses and by rural spectrum users; and