September 18, 2006
U.S. Food & Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
Re: Draft Manufactured Food Regulatory Program Standards Official Comments to FDA on behalf of the Association of Food & Drug Officials
Docket No. 2006D-0246
The Association of Food & Drug Officials (AFDO) is a professional organization which represents food safety regulatory officials at the Federal, state, and local government levels. AFDO is well known for its vision of a fully integrated food safety system in this country. Having prominently served in numerous capacities with the former National Food Safety System (NFSS), AFDO continues to promote this vision and supports numerous ongoing efforts which bring together government agencies at all levels to work in close partnership on food safety challenges which confront the nation.
One of the strategies needed to establish an integrated food safety system involves the creation of regulatory program standards that serve as models for government agencies. AFDO has a long history of promoting this concept as a means for creating equivalency among regulatory agencies from local, state, and Federal governments. AFDO members, for instance, served on the “Minimum Uniform Standards Workgroup” and the “Roles and Responsibilities Workgroup” created through NFSS where the concept of regulatory program standards was strongly supported. Like the Voluntary Retail Program Regulatory Standards, we believe the Manufactured Food Program Regulatory Standards are needed and will help to advance AFDO’s vision of a truly integrated food safety system.
AFDO has circulated the draft standards among its Food Committee and Executive Board and are submitting the following general comments for consideration:
1) Many of the Standards' objectives and outcomes align with those of comprehensive “Quality Management System Audit Programs” and as such, should be integrated with State audit programs, in states with audit programs lacking in quality program standards.
2) Record collection can be very cumbersome and we suggest limiting this collection to those records essential for program administration.
3) We believe key points of value for this entire venture are as follows:
a) A template for Federal and state manufactured food programs to become “equivalent”;
b) A blend of best practices as well as essential program elements;
c) A model anchored in state “self assessment” of their manufactured food programs;
d) A model that is programmatic and not individually focused; and
e) An overarching concept of continuous incremental improvement;
4) While we believe that some of the standards will stretch state agencies (e.g., Standard 2 –Training Program), we can accept this circumstance since the stated approach of incremental continuous improvement is employed in the program.
5) Clarification of “Program Elements” 1.3-c. is needed as the meaning of this statement is unclear.
6) Subjective terms such as “qualified trainer” and “specialized inspection” are not defined.
7) Complying with the required 10 joint inspections for field training will be very burdensome, in our view, and may take a good deal of time to complete.
8) What is an “established recall system”?
9) Compliance with Standard No. 6 may be complicated when state enforcement activities are conducted by other Divisions within state government such as Attorneys General’s offices.
10) What are the resource calculations for FDA relative to management, training, inspection, audit, equipment, and funding? It is possible that FDA will not be equivalent to the states in these designated areas which should be a universal goal in our opinion.
11) We do not believe that salary and benefits should be an issue here.
12) Examples of necessary lab tests would be a useful inclusion for this Section.
13) In Appendix 3.2 for “Risk Classification”, food allergen potential is not mentioned and it is unclear what category food manufacturers producing allergen and non-allergen containing products would fall. Clarification of this matter will strengthen what we consider to be a very important guidance piece.
14) On page 9, line 318, the term “audit check” is utilized. It would be good to footnote the definition of the term “audit check” used in the context of food recalls.
15) The titles for appendices 4.5 and 4.6, which are very different in form, should be synchronized in our view, as it could be difficult to keep field audits and report audits straight without having these titles uniform. If Appendix 4.5 has been through OMB approval, and, therefore, cannot be changed, we suggest that the title for Appendix 4.6 be changed (e.g., Inspection Report Audit). Ideally, all three audit forms should have parallel titles (e.g., Manufactured Foods Regulatory Program Standards: Field Audit Form, Manufactured Foods Regulatory Program Standards: Report Audit Form, and Manufactured Foods Regulatory Program Standards: Sample Report Audit Form).
16) In Appendix 6.2, the formula format identifies a total as “At” while in Appendices 4.2 and 4.4 the formula format uses the S symbol. To make this document as clear as possible, we recommend a uniform symbol be utilized.
17) We urge FDA to provide information and training to state personnel on the value and use of these standards. While the standards themselves are pretty straightforward, the references to and the use of the forms and worksheets contained in the appendices are not. AFDO recommends a mechanism similar to the Voluntary Retail Food Program Standards Clearing House Committee that serves as a question and answer forum for state and local programs. This forum along with adequate training is very critical, in our view.
AFDO believes these standards can be very valuable and over time, achievable. FDA is urged to work with AFDO in promoting these standards and develop strategies to assist agencies in achieving them.
Uniform regulatory program standards are an essential element in fostering the development of an integrated food safety system for this nation and AFDO is willing to assist FDA in achieving this most important goal.
Respectfully Submitted,
Charlene Bruce, President
