Withdrawal of Certain Proposed Rules and Other Proposed Actions

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Withdrawal of proposed rules.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the withdrawal of certain advance notice of proposed rulemakings (ANPRMs), proposed rules, and other proposed actions that published in the Federal Register more than 5 years ago. These proposals are no longer considered viable candidates for final action at this time. FDA is taking this action to reduce its regulatory backlog and focus its resources on current public health issues. The FDA's actions are part of an overall regulatory reform strategy initiated by Health and Human Services (HHS) Secretary Tommy G. Thompson.

DATES:

The proposed rules are withdrawn as of November 26, 2004.

FOR FURTHER INFORMATION CONTACT:

Lisa M. Helmanis, Regulations Policy and Management Staff (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

On June 8, 2001, Secretary Thompson announced his regulatory reform initiative designed to reduce regulatory burdens in health care and respond faster to the concerns of health care providers, State and local governments, and individual Americans who are affected by HHS rules. In December 2001, the Secretary announced the membership of his Regulatory Reform Committee designed to carry out his initiative. In November 2002, the Committee released its final report with over 255 specific recommendations for simplifying, streamlining, and generally reducing the regulatory burden while continuing to require accountability by those doing business with HHS and its agencies. Over 25 of the recommendations have been adopted, and the Secretary charged the Office of the Assistant Secretary for Planning and Evaluation to continue the efforts of the Regulatory Reform Committee. FDA's continuing efforts to finalize or withdraw regulations that have been proposed but not finalized are part of this overall initiative.

In 1990, FDA began this process of conducting periodic, comprehensive reviews of its regulations process that included reviewing the backlog of ANPRMs, notices of proposed rulemaking, and other notices for which no final action or withdrawal notice had been issued. In the Federal Register of December 30, 1991 (56 FR 67440), FDA issued its first notice withdrawing 89 proposed rules that had published before December 31, 1985, but had never been finalized. Then again, in the Federal Register of January 20, 1994 (59 FR 3042), the agency withdrew an additional nine outstanding proposed rules.

Once again, on April 22, 2003, FDA published a notice in the Federal Register (68 FR 19766) announcing its intent to withdraw 84 proposed rules and other proposed actions that had published in the Federal Register more than 5 years ago, but that had never been finalized. Included in this list were 19 proposed rules that were originally proposed for withdrawal in 1991, but at that time the agency decided to defer its decision to withdraw or finalize them until a later date.

The agency undertook this most recent review because it believes that the backlog of pending proposals dilutes its ability to concentrate on higher priority regulations that are mandated by statute or are necessary to address current public health issues. Because of the agency's limited resources and changing priorities, FDA has been unable to: (1) Consider, in a timely manner, the issues raised by the comments on these proposals and (2) complete the action on them. Additionally, because many of the proposals have become outdated in the time that has elapsed since their publication, the agency would need to obtain further comment on them before proceeding to final action. FDA has determined that the proposals identified in this document are lower in priority than those on the Unified Agenda and the Regulatory Plan. It is unlikely that the agency will have sufficient resources in the foreseeable future to further consider or prioritize these proposed rules. Although not required to do so by the Administrative Procedure Act or by regulations of the Office of the Federal Register, the agency believes the public interest is best served by withdrawing the proposals identified in this document. In some instances, the agency has already completed action on alternatives (e.g., the issuance of guidance or inclusion of provisions in related regulations) that have obviated the need to complete the proposed action. In addition, the agency notes that upon reviewing the comments and other records related to the rulemaking, the agency found that “Amend Animal Care Regulations” (Docket No. 89P-0320 (July 3, 1990, 55 FR 27476)) was the subject of a petition, and the agency assigned another docket number to that action. This action was finalized on July 15, 1991 (56 FR 32087), and therefore it is not necessary to be included in this withdrawal notice.

The withdrawal of the proposals identified in this document does not preclude the agency from reinstituting proceedings to issue rules concerning the issues addressed in the proposals listed in table 1 of this document. Should FDA decide to undertake such a rulemaking sometime in the future, it will repropose the actions and provide new opportunities for comment.

The agency notes that withdrawal of a proposal is not intended to affect whatever utility the preamble statements may currently have as indications of FDA's position on a matter at the time the proposal was published, and in some cases the preambles of these proposals may still reflect the current position of FDA on the matter addressed. Anyone unsure whether a statement in one of the preambles reflects the agency's current thinking should contact FDA.

II. Summary of and Responses to Comments

FDA received a total of 37 letters, each containing 1 or more comments, in response to its notice of intent to withdraw certain proposed rules. The following is a discussion of the comments and the agency's response to those comments.

A. General Comments

(Comment 1) One comment provided recommendations on FDA's overall withdrawal process and the way information in the notice of intent was presented to the public. The comment requested that the agency identify how it intended to handle each individual item included in the notice of intent including reasons for withdrawal and future actions. The comment also requested that the agency identify which preambles will continue to reflect the agency's current thinking even after the proposed rule has been withdrawn. Finally, the comment thought that FDA should have made all the proposed actions listed in the notice of intent available on FDA's Web site for easy access to all interested parties.

(Response) The agency disagrees with these comments. The agency's decisions on the items proposed to be withdrawn were based on the general factors described in the notice of intent and whether the proposals fell within the listed factors. When the agency published the notice of intent, it did not have definite future plans for any of the items listed. The reason the agency stated that it may take future action was to emphasize that the withdrawals were based on resources and priorities. A withdrawal does not prevent the agency from taking action in the future on its own initiative or as a result of being prompted by the public. Also, a withdrawal of a proposed rule neither affirms nor rejects the views contained in the preamble. If someone wants a clarification of any agency policy or position, they should contact FDA.

While not providing copies on its Web site, the agency provided the title, docket number, and Federal Register publication date and cite. The agency believes that, in most cases, this information was sufficient to allow readers to find the documents whether online or in a library. Also, the agency provided the name, address, and phone number of an FDA contact who was prepared to provide copies of each proposal, if requested. Therefore, none of these issues raised by this comment would have affected the ability of the public to comment on the items listed in the notice of intent.

(Comment 2) One comment opposed the withdrawal of all the proposed generally recognized as safe (GRAS) actions listed in the notice of intent unless FDA could provide assurance that the agency would continue to permit the use of these food ingredients as detailed in the preamble statements.

(Response) This withdrawal does not affect the regulatory status of the ingredients listed in these documents. Furthermore, the comment did not raise any issues not considered by FDA before publication of the notice of intent to withdraw. Therefore, FDA is withdrawing all the GRAS proposed rules listed in the notice of intent.

(Comment 3) One comment recommended that the agency withdraw an ANPRM on hearing aids (58 FR 59695, November 10, 1993) that was not included in the notice of intent.

(Response) While the agency agrees that this ANPRM is a good candidate for withdrawal, because it was not included in the original notice of intent, we will withdraw or take other action with respect to this proposal separately, in a future Federal Register notice.

B. Specific Comments

The agency received specific comments on 17 of the documents listed in the notice of intent. These comments generally supported FDA's attempt at streamlining the regulations process, and in some cases, supported the agency's decision to withdraw a certain proposed rule. However, several of these comments opposed the agency's decision to withdraw a proposal. The specific comments received, and the agency's responses are as follows:

1. Cosmetic Products Containing Certain Hormone Ingredients—Docket No. 91N-0245, September 9, 1993, 58 FR 47611

FDA received 9 comments opposing the withdrawal of this proposed rule.

(Comment 4) These comments argued that the withdrawal of this proposed rule would call into question the findings presented in the proposed rule and possibly change the marketing status of cosmetic products containing hormone ingredients.

(Response) With regard to the first concern, as stated previously in this document, this withdrawal neither affirms nor rejects statements contained in the preamble. With regard to the second concern, the proposed rule was never finalized, and therefore withdrawal of the proposed rule does not affect the marketing status of these products. The agency intends to issue a new proposed rule regarding these products in the future.

2. Caffeine in Nonalcoholic Carbonated Beverages—Docket No. 82N-0318, May 20, 1987, 52 FR 18923

3. Shellac and Shellac Wax; Proposed Affirmation of GRAS Status With Specific Limitations as Direct Human Food Ingredients—Docket No. 89N-0106, July 26, 1989, 54 FR 31055

4. Unmodified Food Starches and Acid-Modified Starches; Proposed Affirmation of GRAS Status as Direct and Indirect Food Ingredient—Docket No. 84N-0341, April 1, 1985, 50 FR 12821

5. Caffeine; Deletion of GRAS Status; Proposed Declaration That No Prior Sanction Exists and Use on an Interim Basis Pending Additional Study—Docket No. 80N-0418, October 21, 1980, 45 FR 69817

6. Protein Hydrolysates and Enzymatically Hydrolyzed Animal (Milk Casein) Protein; Proposed GRAS Status—Docket No. 82N-0006, December 8, 1983, 48 FR 54990

7. Cellulose Derivatives; Affirmation of GRAS Status—Docket No. 78N-0144, February 23, 1979, 44 FR 10751

(Comment 5) FDA received five comments on these six GRAS proposed rules. The majority of the comments opposed the withdrawal of these proposals.

(Response) None of the comments raised issues not considered by the agency before publication of the notice of intent to withdraw. Therefore, FDA is withdrawing all the GRAS proposed rules listed in the notice of intent. However, this withdrawal does not affect the regulatory status of the ingredients listed in these documents.

8. Reclassification of Electroconvulsive Therapy—Docket No. 82P-0316, September 5, 1990, 55 FR 36578

(Comment 6) FDA received one comment supporting the withdrawal of this proposed rule. However, the comment was concerned that the information contained in this docket (i.e., reports of adverse reactions) would be disregarded when the proposed rule was withdrawn.

(Response) The agency is withdrawing this proposed rule, and in the future, intends to start a new proceeding on this matter. The agency will retain the data and information contained in this docket and consider it at that time.

9. Food Labeling; Declaration of Ingredients; Common or Usual Name Declaration for Protein Hydrolysates and Vegetable Broth in Canned Tuna; “and/or” Labeling for Soft Drinks—Docket No. 90N-361M, January 6, 1993, 58 FR 2950

(Comment 7) FDA received 15 comments supporting and one comment opposing the withdrawal of this proposed rule. The comment opposing the withdrawal of this proposed rule stated that the proposed rule memorialized the development of the agency's policy on “and/or” labeling for sweeteners in soft drinks and is the sole source of reference on these matters. The comment expressed concern that withdrawal may call into question current and future labeling practices of the soft drink industry regarding sweeteners in soft drinks.

(Response) The agency disagrees with this comment's implication that the proposed rule announced a final FDA policy decision on “and/or” labeling for sweeteners in soft drinks. By definition, a proposed rule only states the agency's tentative conclusions; with limited exceptions not applicable here, final decisions in the rulemaking context must be issued in a final rule after public notice and opportunity for comment (see 5 U.S.C. 553(b) to (c)). Further, the agency stated in the preamble to the proposed rule (58 FR 2950 at 2953) that its final decision on whether to revise its regulations to permit “and/or” labeling for sweeteners in soft drinks would be based largely on whether comments in response to the proposed rule included data demonstrating that it is impracticable to produce the limited number of versions of a label that would be necessary if “and/or” labeling were not permitted. The agency received no such data and therefore did not have sufficient basis to proceed to a final rule allowing “and/or” labeling for soft drinks. Accordingly, this comment does not persuade the agency to reconsider the withdrawal of this proposed rule.

Comments supporting the withdrawal of this proposal asked that the agency initiate enforcement action against soft drink manufacturers that use “and/or” labeling. The agency acknowledges that it has not pursued any enforcement action against soft drink manufacturers who are using “and/or” labeling because of the pending rulemaking. The agency is considering its position on the use of “and/or” labeling.

10. Yogurt Products; Frozen Yogurt, Frozen Lowfat Yogurt; and Frozen Nonfat Yogurt; Petitions to Establish Standards of Identity and to Amend Existing Standards—Docket Nos. 89P-0208 and 89P-0444, May 31, 1991, 56 FR 24760

(Comment 8) The agency received one comment supporting the withdrawal of this proposed rule. The comment agreed that there is no need to complete this rulemaking since the agency issued an ANPRM (68 FR 39873) in 2003 to address this issue.

(Response) The agency agrees. Therefore, FDA is withdrawing this proposed rule.

11. Canned Pineapple; Proposal to Amend Standards of Identity and Quality—Docket No. 88P-0224, March 24, 1989, 54 FR 12237

FDA received two comments opposing the withdrawal of this proposed rule.

(Comment 9) One comment requested that, if FDA withdraws the proposed rule, FDA allow marketing for canned pineapple as a nonstandardized product.

(Response) FDA is denying this request because a product that purports to be or is represented as a food for which a standard of identity has been prescribed (e.g., canned pineapple) that does not comply with the provisions of that standard is misbranded under section 403(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(g)). FDA notes, however, that regulations in § 130.17 (21 CFR 130.17) provide that manufacturers may market foods that deviate from established standards of identity if they receive temporary marketing permits from FDA.

(Comment 10) The second comment stated that there are temporary marketing permits issued under this proposal that would not be valid if the proposal is withdrawn.

(Response) The comment is incorrect. There are no active temporary marketing permits to market test a “whole” style of canned pineapple that are the basis of this proposed rule. There were two temporary market permits that were issued in 1988 to Dole Packaged Foods Co. (53 FR 16471, May 9, 1988) and to Del Monte Corp. (53 FR 23602, June 22, 1988), which expired after 15 months. The agency is withdrawing this proposed rule.

12. Current Good Manufacturing Practices; Proposed Exemption From Active Ingredient Identity and Strength Testing for Homoeopathic Drug Products—Docket No. 79P-0265, April 1, 1983, 48 FR 14003

(Comment 11) The agency received one comment opposing the withdrawal of this proposed rule which would have exempted homeopathic drugs from the current good manufacturing practice (CGMP) requirements that drug products be tested for identity and strength of each active ingredient prior to release for distribution. The comment expressed concerns about possible changes in our enforcement policy towards final release testing of homeopathic drugs.

(Response) There may be instances where testing of a homeopathic product for identity and strength of the active ingredients prior to release for distribution would be appropriate and consistent with protection of the public health. For example, in instances where a product includes an active ingredient that at certain levels could be toxic or otherwise pose a public health concern, finished product testing may be appropriate because the testing could identify a significant manufacturing or labeling error. Since requiring this testing when necessary to protect the public health is consistent with FDA's mandate, we are withdrawing the proposed rule.

13. Pineapple Juice; Proposal to Amend U.S. Standards of Identity and Quality—Docket No. 86P-0338, May 21, 1987, 52 FR 19169

FDA received two comments opposing the withdrawal of this proposed rule.

(Comment 12) One comment requested that if FDA withdraws the proposed rule, FDA allow marketing for pineapple juice as a nonstandardized product.

(Response) FDA is denying this request because a product that purports to be or is represented as a food for which a standard of identity has been prescribed (e.g., pineapple juice) that does not comply with the provisions of that standard is misbranded under section 403(g) of the act. FDA notes, however, that regulations in § 130.17 provide that manufacturers may market foods that deviate from established standards of identity if they receive temporary marketing permits from FDA.

(Comment 13) The second comment stated that this proposed rule allowed the addition of pineapple juice from concentrate to pineapple juice to increase the brix level. Because the proposed rule addressed the use of pineapple juice from concentrate, the comment asks the agency either to complete this rulemaking or to publish a notice of policy that 21 CFR 102.33 (which applies to nonstandardized juices) would apply to pineapple juice.

(Response) The comment is incorrect in stating that the proposed rule allowed the addition of pineapple juice from concentrate to increase the brix level of pineapple juice in § 146.185 (21 CFR 146.185). The proposed rule only proposed to amend the standard of identity to allow this change. This amendment would not be effective until the rule was finalized. Thus, currently, the standard of identity for pineapple juice in § 146.185 does not permit the use of pineapple juice from concentrate to increase the brix level. A manufacturer who wishes to market pineapple juice with added pineapple juice from concentrate to increase the brix level may apply for a temporary marketing permit to do so. The agency is withdrawing this proposed rule.

14. Regulation of Medical Foods—Docket No. 96N-0364, November 29, 1996, 61 FR 60661

(Comment 14) The agency received one comment opposing the withdrawal of this ANPRM. The comment stated that manufacturers are marketing therapeutic products directly to consumers without prior FDA approval of health claims or FDA review of the suitability of the ingredients for the intended population. The comment stated that current FDA policies in this area create a loophole for manufacturers to make unauthorized health claims and use ingredients that may not be GRAS.

(Response) This comment does not persuade FDA that the ANPRM should not be withdrawn. Because of competing priorities that have tied up FDA's limited resources, the agency has been unable to consider, in a timely manner, the issues raised by comments on the ANPRM, and does not foresee having sufficient resources in the near term to do so. Therefore, the agency is withdrawing this ANPRM. However, FDA believes that the basic principles described in the ANPRM provide an appropriate framework for understanding the regulatory paradigm governing medical foods. Therefore, FDA advises that it will continue to refer to the basic principles described in the ANPRM and in FDA's Medical Foods Compliance Program (CP 7321.002) when evaluating medical foods. With regard to the specific points made in the comment regarding regulation of medical foods, the comment is correct that the act exempts medical foods from the nutrition labeling, health claim and nutrient content claim requirements that are applicable to most other foods. However, all statements on food labels (including medical foods) must be truthful and not misleading (see section 403(a)(1) of the act). FDA advises that medical foods with false or misleading labeling are subject to enforcement action. The agency also advises that withdrawal of this ANPRM does not change the requirement that all ingredients used in medical foods must be approved food additives, GRAS, or otherwise exempt from the food additive definition. Medical foods that do not comply with this requirement are subject to enforcement action.

15. Food Labeling: Nutrient Content Claims Pertaining to the Available Fat Content of Food—Docket Nos. 96N-0421 and 94P-0453/CP1, December 20, 1996, 61 FR 67243

(Comment 15) FDA received one comment opposing the withdrawal of this proposed rule. The comment states that misleading claims are being made by producers of products that contain nondigestible fat, including olestra, and that the total amount of fat in a product—regardless of whether it is digestible or nondigestible—should be declared to avoid consumer deception. The proposed rule responds in part to a citizen petition requesting use of digestibility coefficients in determining the quantity of fat declared in the label.

(Response) Currently, FDA regulations require that nutrition labeling and claims reflect the total amount of fat, which is defined as total lipid fatty acids and expressed as triglycerides § 101.9(c)(2) (21 CFR 101.9(c)(2)). The only exceptions to this general requirement are provided in the following: (1) The voluntary nutrition labeling final rule for raw fruit, vegetables, and fish (61 FR 42742, August 16, 1996) with respect to total fat in orange roughy fish and (2) the final rule for olestra (61 FR 3118, January 30, 1996) (61 FR 67243 at 67246). In the final rule for olestra, FDA specified that olestra need not be considered as a source of fat or calories for purposes of nutrition labeling or nutrient content claims (21 CFR 172.867(e)(5)).

By withdrawing this proposed rule, FDA will not be authorizing the use of digestibility coefficients, so that the total amount of fat in a product must be declared on the label whether it is digestible or nondigestible as provided in § 101.9(c)(2). However, withdrawing this proposed rule will have no effect on the nutrition labeling of products containing olestra or how the agency calculates the fat content of orange roughy for the purpose of voluntary nutrition labeling of that raw fish. Due to the agency's limited resources and other higher priority matters, the agency is withdrawing this proposed rule.

16. Food Labeling; Nutrient Content Claims and Health Claims; Special Requirements—Docket No. 95N-0103, February 2, 1996, 61 FR 3885

(Comment 16) The agency received one comment opposing the withdrawal of this proposed rule. The comment states that FDA access to records needed to evaluate the validity of nutrient content claims and health claims is essential to prevent consumer deception and ensure fair competition.

(Response) FDA continues to believe that, for health and nutrient content claims that pose particular enforcement difficulties, it would be valuable for the agency to have access to information that the manufacturer relied on in determining that the food meets the requirements of the claims. As the agency stated in the proposed rule (61 FR 3385 at 3889), the claims that are likely to present enforcement difficulties are those based on new food technology or a new use of food technology, those based on the results of novel or non-standardized testing procedures, and those which the agency cannot evaluate without information because the information is available only to the manufacturer. However, other higher priority matters require the agency's resources at this time, and therefore, the agency is withdrawing this proposed rule.

17. Food Labeling; Declaration of Free Glutamate in Food—Docket No. 96N-0244, September 12, 1996, 61 FR 48102

(Comment 17) FDA received two comments supporting the withdrawal of this ANPRM.

(Response) Thus, the agency is withdrawing this ANPRM.

For the reasons set forth previously, and under the act, the agency announces the withdrawal of the following documents, published in the Federal Register on the dates indicated in table 1: