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U.S. Department of Health and Human Services

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Guidance for Industry: Food Additive Petition Expedited Review

Contains Nonbinding Recommendations

January 4, 1999; Revised October 2010

You may submit written comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the title of the guidance document.

Additional copies are available from:
Office of Food Additive Safety (HFS-200)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD  20740
(Tel) 301-436-1200 (Updated phone: 240-402-1200)

http://www.fda.gov/FoodGuidances

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
January 4, 1999; Revised October 2010


Contains Nonbinding Recommendations

Table of Contents

  1. Introduction
  2. Expedited Review

Contains Nonbinding Recommendations

Guidance for Industry[1]
Food Additive Petition Expedited Review

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction

This guidance is intended for industry and describes the criteria and procedures under which expedited review will be conducted for certain food additive petitions that are expected to have a significant impact on food safety. This guidance is a revision of the January 4, 1999 guidance titled "Guidance for Industry and Center for Food Safety and Applied Nutrition Staff: Food Additive Petition Expedited Review."

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Expedited Review

FDA believes it is in the interest of enhanced food safety to review petitions for certain food additive uses in an expedited manner. Expedited review will generally be considered when an additive is intended to decrease the incidence of food-borne illness. For example, FDA has received petitions for the use of sources of radiation and for chemicals such as chlorine dioxide to reduce the levels of pathogenic organisms in various foods.

Designating food additive petitions for expedited review means that the food additive petition would be reviewed ahead of other pending food additive petitions, i.e., the petition will be placed at the beginning of the appropriate review queues.

Petitions under expedited review would be subject to all other controls and requirements applicable to comparable petitions in the standard review process. Accordingly, valid scientific evidence, as defined by Title 21 of the Code of Federal Regulations, section 171.1, would be required to support an expedited review petition. Likewise, the standard for safety and data presentation would remain unchanged.

Criteria

In order to provide more rapid approval of food additives that are intended to significantly increase the safety of the food supply, FDA will consider expedited review of petitions for additives that meet the following criteria:

  1. Use of the additive as proposed is intended to significantly decrease exposure to human pathogens (e.g., E. coli, Salmonella, Campylobacter, Cyclospora, or Listeria) or their toxins in/on food.
  2. The petition is complete in terms of 21 CFR 171.1 and appears to contain sufficient data and information to support a decision whether to approve the additive, i.e., the petition satisfies the criteria for filing.

Procedures

  1. Identification of Applications for Expedited Review. As food additive petitions are received by FDA, the Office Director, in consultation with the appropriate Division Director, will identify those petitions that meet the criteria for expedited review. In addition, if a sponsor believes that their petition meets the criteria for expedited review listed above, they should identify it as such along with their reasoning when the petition is submitted to FDA.
  2. Determination of Expedited Review. The decision to expedite review will be made at the time a petition is filed. FDA may also designate a petition already under review for expedited review if it determines, during the review, that the petition qualifies for expedited review. Consumer Safety Officers and review staff should take the opportunity during the post-filing review and decision period of petitions not already undergoing expedited review to determine whether these petitions should be designated for expedited review.
  3. Documentation and Processing. After the determination to expedite review has been made, the Consumer Safety Officer assigned to the petition will prepare a written memorandum to the administrative record that identifies, using the criteria outlined above, the reasons for designating the petition for expedited review. FDA will notify the petitioner in writing of the expedited review designation. FDA also will notify the petitioner when any food additive petition is subsequently removed from expedited review designation.
  4. Resource Management. It will be the responsibility of the Director of the reviewing Division to ensure that an expedited review petition is reviewed in the most efficient manner, tracked as an expedited review, and completed within established time frames. FDA recognizes that implementation of this policy may affect other review work of FDA because additional resources may be required to review petitions designated for expedited review. All of the following resource issues should be considered as part of the implementation of the expedited review process:
    1. a shift in the workload within the affected reviewing Division may be necessary;
    2. scientists from other Divisions may be called upon to provide support to those areas where the standard review queue would otherwise be significantly affected by the needed redistribution of the workload; and
    3. review of the standard (i.e. non-expedited) petitions in reviewing Divisions may occur after the review of petitions designated for expedited review.
  5. Review of petition. Except for the position in the review queue, there will be no change in the procedures for review of petitions designated for expedited review.
  6. Monitoring. The Director of the reviewing division will periodically review, approximately every 90 days, the status of petitions designated for expedited review and will evaluate the effect of the expedited review both on expedited petitions and standard petitions in the review queue to determine whether the allocation of review personnel is appropriate.
  7. Public Disclosure. The fact that a petition is being reviewed under these expedited procedures is information that will be publicly disclosed to any interested party. For information about petitions designated for expedited review contact FDA's Office of Food Additive Safety, 5100 Paint Branch Parkway, College Park, Maryland, 20740-3835, 301-436-1200 (Updated phone: 240-402-1200).

 


[1] This guidance has been prepared by the Division of Petition Review in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.