Dear Colleagues, FDA Foods Community:
In my letter to you of October 5, 2000, I addressed the possibility of reorganizing the Office of Premarket Approval (OPA). The reorganization has recently been approved, and I want to review for you the reasons for the reorganization and the benefits that I think will result from it.
As I mentioned in my October letter, two major changes have occurred in recent years regarding OPA's premarket safety review activities. The first was the creation of multiple new pathways for FDA safety review of food additives and ingredients of various types prior to marketing. For example, the Food and Drug Administration Modernization Act (FDAMA) of 1997 created (subject to adequate funding) the Food Contact Substance (FCS) Premarket Notification Program; the FR proposal of April 17, 1997, launched the GRAS Notification program; and the biotechnology policy statement in the FR of May 29, 1992, delineated the basis for conducting biotechnology consultations for new foods created using modern methods of biotechnology. (The latter is currently the subject of a FR premarket notification proposal published on January 18, 2001.) Second, and equally important, were two sizeable and targeted FY-2000 appropriations for streamlining the direct additive petition review process and for implementing the FCS PMN program respectively. With these new resources, and the promise that they provide of enhancing the staffing levels of the office, we now have the basis for creating a much more responsive premarket function for food ingredient safety review.
These two major changes present us with the opportunity to dramatically enhance the efficiency and effectiveness of our reviews of each type of application, whether a petition, a notification for a FCS, a GRAS notice, or a biotechnology consultation, while at the same time preserving the solid scientific basis for our decisions that is the foundation of the public health protection goals that are central to our mission. We have concluded, after careful assessment, that we can best achieve the promise that these changes afford, if we reorganize the OPA into a new Office of Food Additive Safety.
The primary notion underlying the reorganization is to tailor our functional processes to the type of submissions we receive; that is, to create organizational units structured specifically to review each type of application. This, coupled with sufficient staffing levels, assures that FDA can process applications of all types more responsively than ever before. It will provide greater accountability in creating and adhering to a management plan for each pending petition or other action; more easily identifiable points of contact to agency review teams and project managers; and clearer lines of responsibility and authority throughout the review process.
I am excited about the future of the new Office of Food Additive Safety. I see the potential for greatly increased responsiveness to pending applications; greater potential for conducting meaningful prefiling consultations with prospective applicants; greater accessibility of our scientific reviewers to petitioners for the purpose of issue clarification and scientific dialog; greater ability to set priorities and to shift resources where needed and when needed; the ability to tailor our approaches in response to the different types of issues that may arise, rather than forcing all applications "through the same hoops;" and greater ability to attend to legitimate monitoring, and when needed, enforcement action, to deal with unsafe food ingredient situations that may arise.
Overall, I see in our new organizational structure the possibility for improved accountability and transparency, priority setting, and responsiveness in the way we perform our work in support of the food safety mission of CFSAN. Our current plans call for beginning to operate under the new organizational structure on June 18, 2001. I welcome your feedback and your continued interaction with us as we roll out the new organization.
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Sincerely yours,
Alan M. Rulis, Ph.D. |
Attachments
The chart below lays out the structure of CFSAN's newly reorganized Office of Food Additive Safety. The major operational units are the Divisions of Food Contact Substance Notification Review; Petition Review; Biotechnology and GRAS Notice Review; and Chemistry Research and Environmental Review. These divisions have within them groups of professionals functioning in the role of consumer safety officers, as well as review scientists, including toxicologists and chemists. While the fourth division is primarily a laboratory research unit, the environmental scientists grouped there will serve as a resource to the entire office, as well as others in CFSAN and FDA.
Each of the primary application review-oriented divisions has a director and deputy director, as well as a "senior special assistant." We have constructed a "flat" organization wherein the respective working level groups report directly to a division director through their respective supervisors. In the coming weeks and months, we will be permanently filling a number of key senior positions in the new organization. (We intend to announce details and rotate individuals into several of these positions on an acting basis, and then advertise and fill these positions permanently.)
Two other features of the new office structure are the Associate Director for Science and Policy, and the office Operations Staff. The former is intended to serve several important functions, namely, to help ensure consistency across the office of our scientific approach on generic issues of importance to the chemistry and toxicology review disciplines; to be responsible for coordinating and liaising with internal and external entities such as the Center's Cancer Assessment Committee and Quantitative Risk Assessment Committee as well as the broader toxicological community; to oversee the conduct and evaluation of Good Laboratory Practices for studies conducted in support of FDA regulated product submissions; to coordinate risk assessment policies within the office and Center; to develop guidance for submitters of applications; and, importantly, to help set priorities for work assignments across the office. In addition, this position provides a visible and focused place in which to give priority and visibility to ongoing public health related activities concerning food additives/ingredients that are not the result of an industry application. Examples of these are citizen petitions for action on current potential public health problems, and the post approval monitoring of safety decisions over time, including post approval surveillance and monitoring of the safety information concerning food additive uses.
The Operations Staff is designed to support the office by centralizing several important functions including the following: the development of a capability to receive and process electronic applications; the use of electronic means of data review, application review, and internal communication, including document management and work flow management; the technical operation of several large contracts we currently manage for the review of data in support of pending applications; the maintenance and update of performance data; and information dissemination via our Website.
(Larger view of
organizational chart)
Hypertext updated by emw/dms 2001-JUN-05