Dear Colleagues, FDA Foods Community:
On October 21, 1999, the FY-2000 appropriations bill became effective allocating $11.4M in new base monies to the Center for Food Safety and Applied Nutrition for the Center's (CFSAN's) premarket review programs for food and color additives. Of the new monies, $6.0M was earmarked for supporting the new Premarket Notification Program for food contact substances established under the Food and Drug Administration Modernization Act of 1997 (FDAMA)1. The sum of $5.4M was provided to accelerate the rate of review of direct food and color additive petitions, including those with food safety benefits.
By means of this letter I am announcing several specific steps we are taking now to improve the food and color additive petition review process. This letter also provides an interim progress report on the scope of changes we anticipate making in our premarket processes as a result of implementing a number of other planned short- and long-term initiatives.
Specific new initiatives
Beginning immediately, we are prepared to grant to petitioners, at their request, the opportunity for a "post-filing technical update" meeting to occur any time after 120 days have elapsed from the date of filing of a petition. (Of course, should any issues be identified before 120 days, we will, as usual, communicate this to the petitioner.)
At the technical update meeting, CFSAN review scientists assigned to the petition will be available to provide the petitioner with a synopsis of the state of the petition review at that point in time, along with a summary of principal issues the review team will be focusing on during the course of its review. The review team will be prepared to discuss the broad outlines of its management plan for completing the review of the petition, will exchange information with the petitioner, and clarify any issues of data content or interpretation that may be apparent at that stage of the review.
This initiative is in response to frequently expressed concerns that the petition review process is not transparent and that petitioners have historically had little or no access to those reviewing their petitions, and have little knowledge of the state of the petition review and what problems, if any, are being encountered or need to be addressed.
CFSAN has prepared for publication in the Federal Register an announcement of availability of two draft guidance documents entitled: "Draft Guidance for Industry -- Providing Regulatory Submissions in Electronic Format, General Considerations;" and "Draft Guidance for Industry -- Providing Regulatory Submissions in Electronic Format for Food Additive and Color Additive Petitions."
These documents, whose notice of availability will be published soon in the Federal Register, will be the first in a series of documents intended to provide guidance for industry petitioners regarding the preparation of regulatory submissions in electronic format to the Office of Premarket Approval. Once implemented, we believe this new approach to organizing information in petitions and to submitting such petitions to FDA will facilitate both the preparation and review of food and color additive petitions because these forms will serve to organize information necessary to support the safe uses of food and color additives. In the time period prior to publication of the draft guidance documents, OPA will implement the guidance on a pilot basis. Those seeking to consider submitting petitions in electronic format should contact the Office of Premarket Approval.
As you may know, this initiative is one component of a larger program, the FARM (food additive regulatory management) Project, aimed at using the latest methods of information technology to review and track progress on petitions under review. The FARM project comprises a comprehensive plan to improve the efficiency and functioning of the petition review program in CFSAN, by allowing reviewers to spend more time reviewing petitions because they will need to spend less time searching for, processing, and sharing information in conventional hardcopy form. It will also address, in part, the comments we have received in response to our May 5, 2000, Federal Register notice (discussed below) requesting additional guidance in regard to formatting and organization of petitions.
The agency has recently awarded a several million dollar contract for the extramural review and evaluation of data packages submitted to the agency. The award of this contract will augment OPA's ability to obtain scientific expertise for the review of petitions for food and color additives and notifications for food contact substances. The technical support provided by the contractor will aid us in conducting these reviews in a timely and scientifically supportable manner. As described below, the contract will provide a "bridge" until the Center can complete the hiring and training of new in-house scientists.
As a result of the success of our hiring initiative described below, we have acquired additional office space at our Vermont Avenue address. The acquisition of new offices will afford us an opportunity to accommodate newly hired employees as well as have additional training facilities and conference room space. While we expect some short-term disruptions due to office moves, we believe that the added space will allow for efficient use of personnel resources working on all aspects of petition review. The Office of Premarket Approval intends to accompany the rest of CFSAN in its move to the College Park, Maryland area sometime in 2002. Until then, the newly acquired office space at Vermont Avenue will be essential in our efforts to improve the efficiency of our review operations.
Since the Federal Register notice of January 5, 1999, in which FDA announced its guidance on expedited review of petitions for uses of food additives that are intended to decrease the incidence of foodborne illness through antimicrobial action against human pathogens that might be present in food, the agency has completed the review of, or has pending, a total of 19 petitions of this type (the receipt of four of which predate the announcement of the new policy). The time for reaching decisions on these petitions has been considerably shorter than the same figure for reviewing petitions of this type prior to the implementation of the expedited review program. Our goal for FY-2000 has been to complete the scientific review of 80-90% of these petitions within 360 days of filing, and we have generally met this goal. We reaffirm our commitment to continue to expedite such petitions and to the extent possible, to further decrease the total review times of such petitions.
We exceeded our goal in the CFSAN priorities document for FY-2000, and placed five new chapters of the "Redbook" (Toxicological Principles for the Safety Assessment of Food Ingredients) on the CFSAN worldwide website. This guidance has been important to petitioners in determining the types and protocols of toxicological studies needed to demonstrate the safety of new food additive uses. We plan to place an additional four chapters on the site within the next several months.
FDA's request for input from stakeholders
On May 5, 2000, the agency published a Federal Register notice requesting public comment on ways to improve the food and color additive petition review process based on the new appropriations. In its notice the agency posed four broad questions regarding the food and color additive review process summarized as follows:
In response to the notice, FDA received comments from consumer groups, companies and trade associations. The comments covered a range of issues relating to the food and color additive petition review process; these are available at the public docket (00N-1262).
The comments we received offered suggestions for a range of different short-term and long-term improvements to the petition review process. CFSAN plans to implement a number of these improvements, some of which are addressed in this letter, and will refer in specific detail to the comments received when specific initiatives are announced. The Center has also declared its commitment to making improvements in the food and color additive program in its annual compilation of priority projects2. This commitment will continue to be made in future editions of the CFSAN priorities document. This letter is a further opportunity to provide an overview of several other short- and long-term initiatives we have begun or will begin soon to make tangible progress toward improving the process of petition review. As always, the overall goal is to improve the petition review process by addressing long standing difficulties with the responsiveness and predictability of the process, while ensuring that the well established integrity, scientific credibility and attendant safety assurances of the current process remain solidly intact.
Other Short- and long-term initiatives
As a result of the availability of new funds, CFSAN has initiated several new short-term and long-term improvements. The new funds will be focused on increased personnel resources, new electronic infrastructure capability, and a range of new process improvements, including leveraging outside resources.
Starting at the beginning of FY-2000, we created a new recruiting and hiring plan in response to the new appropriations. The plan calls for the hiring ca. 50 new employees, of which a considerable proportion will be devoted to work on the direct food and color additive petition and related processes. (Another large proportion will be allocated for work on the food contact substance premarket notification program.) A segment of the hiring plan is devoted to increasing staff available for food additive related work pertaining to Federal Register documents, and a segment is targeted to enhancing support staff.
Implementing the hiring plan required considerable groundwork, including establishing a hiring team within the Office of Premarket Approval, establishing and/or rewriting of position descriptions, advertising of position openings, and the recruiting, interviewing and selection of the most highly qualified candidates. The new employees coming on board comprise a diverse group of chemists, toxicologists, consumer safety officers, and environmental scientists. The qualifications of the candidates who have accepted positions have been exceedingly high. CFSAN plans to continue hiring according with this plan into the coming fiscal year until a full cadre of new hires is on board.
Once on board, new employees will require training, much of which will be on-the-job and conducted by many of the most effective current employees. Thus, there will necessarily be a temporary period of less productivity from the new employees (as well as their mentors) as they receive the necessary training and experience. However, the time spent in adequate training is an important investment in the long-term enhancement of in-house expertise.
In the interim, as mentioned above, CFSAN has devoted considerable new funds to a major extramural contract under which diverse scientists can be hired to perform safety data review work on pending petitions. While it is of value to maintain the capability to use some contractor support for petition in the future, the major contract is intended more to be a "bridge" to enhance performance until the hiring and training of the full cadre of permanent employees is complete. Thereafter, a more modest contract will remain in force to allow for the continued capacity to contract out work of specific types when in-house resources are not available, or in periods of urgent need.
CFSAN has continuously emphasized its commitment to meet ambitious performance standards for petition review. In the current CFSAN Program Priorities document, the FY-2000 performance goals call for reaching decisions within 360 days on 80-90% of expedited review petitions, 50-60% of nonexpedited review petitions; reduction by half of the number of petitions more than 4 years overdue; and completing the vast majority of biotechnology consultations and GRAS notifications expeditiously, and completing the review of all food contact substance notifications before they become effective. Once fiscal year data become available, CFSAN will be publishing the rates of accomplishment for these goals. Preliminary data suggest that most, if not all, of these goals will have been met.
Similarly high goals will be set for subsequent years. (As the pending inventory of petitions is depleted of food contact substance petitions, the remaining direct and color additive petitions will comprise a greater challenge for timely completion on average. Accordingly performance standards must be adjusted to reflect this reality.) Ultimately, we seek to reach performance in line with the expectations of all our stakeholders such that we can complete work on virtually all received petitions within stringent, publicly articulated time frames.
We have begun to implement pre-filing consultations on an ad hoc basis. Under this approach, CFSAN scientists are made available to prospective petitioners to discuss specific aspects of planned petitions, including contemplated safety testing in animals, chemistry considerations and environmental issues. The goal is to achieve a high quality petition that addresses all of the likely questions from FDA reviewers. In addition we have committed to produce better and more easily available (via the WWW) guidance for petitioners, as mentioned above.
Starting last spring, the current organizational structure of OPA was reassessed. It was decided to consider reorganizing the office in order to create working units that are structured to accomplish the new diverse types of review tasks now being performed by the office. These include direct and color additive petition review; GRAS notice review and biotechnology consultations; and review of premarket notifications for food contact substances. Organizing around these functions, rather than organizing around the historic academic disciplines, will provide a number of advantages including greater accountability in creating and adhering to a management plan for each pending petition, more easily identifiable points of contact to agency review teams and project managers, and clearer lines of responsibility and authority.
At the present time the reorganization plan is being vetted and refined, concurrent with the hiring of new employees discussed above.
Conclusion
We remain committed to improving the food and color additive petition review program while maintaining the high standards of data review and safety assurance that have been the hallmark of CFSAN's petition review process from the beginning. We believe that the newly increased appropriations place us on a track to make substantial improvements both in the short term and over the long term. We believe that the initiatives announced in this letter are evidence of our recent short-term progress toward these goals. We intend to capitalize on this success, further improving the process at each stage.
In the future we will communicate to you progress reports on a number of other longer-term goals of the program. For example, we eventually intend to be able to focus more resources on solving some of the long-standing generic issues that have impeded progress in several areas of food ingredient review. We also plan to devote resources to dealing with several additive issues of public health importance that will be denoted in the CFSAN's Program Priorities documents. We intend to sharpen our criteria for filing petitions, providing better guidance to potential petitioners so that the overall quality of incoming petitions is higher, and rejecting the filing of those petitions that do not meet minimal standards for review. We will make continuous improvements in meeting stringent performance goals. We will begin to bring certain issues before the Food Advisory Committee and the recently chartered Food Additive Subcommittee of the FAC for deliberation, vetting and resolution. By doing so, we hope to contribute to the solution to a number of the generic issues mentioned above.
We look forward to your continued interest in our progress and welcome further comments and ideas you may offer, or any feedback on what is currently working well in the interest of all our stakeholders. We will continue to report periodically on new initiatives and provide data on our performance as we make improvements in the process.
Sincerely yours,
Alan M. Rulis, Ph.D.
Director
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
1 Since the launch of this fully funded program nearly a year ago, over 100 notifications have been received, draft guidance documents have been published, and a proposed rule for administering the program was published in the Federal Register. By every measure, the rollout of this program has been successful. We intend to provide the FDA foods community with updates on this specific program by means of a separate communication.
2 FY-2000 CFSAN Program Priorities; CFSAN/FDA, January 2000. Project 2.1.4, etc.