IFT Comments on FDA Transparency Task Force; Public Meeting

October 16, 2009

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852

Re: Docket No. FDA-2009-N-0247 (FDA Transparency Task Force; Public Meeting)

Dear Sir or Madam: Thank you for the opportunity to comment on ways in which the Food and Drug Administration (FDA) might make useful and understandable information about FDA activities and decision making more readily available to the public in a manner compatible with the Agency’s goal of appropriately protecting confidential information.

As advocates for applying scientific exactitude in food science and technology issues, IFT supports FDA’s efforts to increase transparency. IFT believes that increased transparency within the Agency will advance public health by equipping the food industry, scientists, and the public with vital, more constructive and actionable information about the safety and quality of food reaching the American public. Concurrently, increased transparency can serve as a means to improve responses, system-wide, to suspected harmful products. Implementation of the means to achieve increased transparency may, for example, improve consumer confidence and assist the industry in expediting the identification and removal of suspected products from the marketplace to better ensure public safety. Moreover, implementing more deliberate and transparent processes will be important as the new Food Safety Modernization Act 2009 is implemented in the coming years. IFT recognizes and commends the Agency for its successful efforts to date to post regulations, guidance, laboratory methods and training materials on line, and to make these available at no cost.

Transparency is currently heightened by existing policies under the Freedom of Information Act combined with electronic communications technologies (e.g., twitter). Post-market surveillance and risk warnings under the Sentinel Initiative and related programs expand the Agency’s discretionary authority. In view of the increasing liability risks presented for food companies that are in compliance with the Federal Food Drug & Cosmetic Act requirements, IFT encourages FDA to address the need for improved procedural safeguards as it moves forward in enhancing transparency.

IFT offers the following responses to the specific questions posed by FDA in its request for comments.

1. How can the Agency better explain its operations, activities, processes, and decision making? To ensure the safest food possible, IFT recommends that the FDA be transparent in all of its operations, activities, processes and decision making. We recommend that the FDA utilize formal “Rules of Practice,” and make these rules readily available, including online, to the public and food industry alike. In doing so, IFT suggests that the FDA consider providing a “road map” to help interested parties navigate the Agency’s decision-making and regulatory processes. Such a road map could be very helpful with new policy decisions and for the departments that receive petitions.

In using “Rules of Practice,” the Agency may wish to reevaluate when it uses the guidance process vs. the more formal regulatory process. The more deliberative promulgated regulatory process is in the FDA’s interest as well as the industry’s interest because it helps create a better regulatory outcome with less of the confusion and controversy that can occur with guidances. IFT also recommends that the Agency provide copies of forms and compliance documents online with instructions or guidance on how the Agency uses them to make regulatory decisions at the company level. This recommendation applies to activities associated with domestic manufacture of food for domestic consumption, and export and import. Additionally, comments that the Agency receives regarding its processes, operations, activities, and decision making should be posted online. This may help the Agency improve its timeliness, efficiency, and accuracy. Further, routine, regularly scheduled “Town Hall” type meetings would encourage and enhance communication among the FDA, states, industry, and the public.

2. What specific information should FDA provide about Agency operations, activities, processes, and decision-making, including:

a. Enforcement actions

As mentioned, the FDA should provide clear and readily available information on its operations, activities, processes, and decision-making in order to assure all stakeholders that the Agency considers the safest food market possible its priority. By providing the information on which the FDA bases its enforcement actions, the public would be more informed about the efforts the Agency has taken to ensure that food safety, and industry compliance may be improved. In its efforts to provide more information about enforcement, the FDA should provide, including online, information about the basis for why certain products are subject to enforcement action, along with facts (e.g., test results, interviews, investigation findings) used in making the enforcement action decision. This should be done in such a way as to protect the identity of the affected company, and should only be used to provide guidance to the industry as to the thresholds for enforcement actions and the strategies used to garner compliance. Additionally, FDA should provide, including online, with companies’ consent, responses to enforcement actions.

b. Product approvals

IFT is particularly interested in knowing what performance standards and other food safety criteria, technical specifications and factors affecting food safety have been considered for registration of food additives and premarket clearance of genetically modified foods. Considerable information, such as guidance documents, performance standards and other criteria, product clearances, and other information associated with foods, nutraceuticals, supplements, and additives is available on the FDA and CFSAN web site and readily retrievable by those familiar with seeking it out. However, the Agency could improve how it presents and explains for the public its regulatory and other key decisions. Ideally, the information would illustrate how and why a product is cleared for use. This would help assure public confidence in the industry and the FDA. Confidential company information, however, must be protected in this process.

c. Recalls and Import Alerts

While the Agency has an obligation in the removal of unsafe products from the market, it is imperative as part of any Agency program to protect manufacturers’ confidential information as well as the privacy of individual company employees. Thus, to the extent possible without revealing business confidential information or violating employee privacy, all pertinent documents, including test results and related documents, investigation findings, and parameters used in reviewing all facts should be available, including online, for any recall actions related to food, drugs, or devices. The timing of any disclosures, however, must be considered, and risk communication needs to be a key element. The fact that a recall has been completed and affected product located and properly managed should also be posted. Further, FDA should make transparent the risk assessment and underlying scientific basis for its conclusion; and, any assumptions should be made explicit in the risk assessment.

Development and posting online of a few models or case studies that do not identify companies by name, and which compile information and redacted sample documents from recent recalls for specific food categories could be beneficial. Such models or case studies could show interested parties the scope of efforts associated with a recall and what type of documentation the Agency seeks from companies during the course of a recall.

Additionally, the Agency must make certain that its move toward greater transparency does not place a disproportionate impact and heavy regulatory burden on domestic food producers and sellers relative to overseas firms. IFT cautions the Agency against implementing strategies that may inadvertently jeopardize the competitiveness of U.S. industries as it pursues its desire to become more transparent.

3. What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information?

a. Internet tools

The FDA website should be made more “user-friendly.” The current search engine is relatively easy to use, but can be difficult to navigate for an individual who is not familiar with Agency jargon. Also, information on whom to contact at FDA when a member of the industry or the general public has a question or issue is not readily available. Additionally, it is sometimes difficult to quickly reach a knowledgeable individual on technical or food safety matters through the consumer hotline. While a list of contacts is provided, there is no way to determine to whom on the list a specific question or issue should be directed. A list of emergency contact numbers for field investigators and for FDA experts on particular issues should also be made available to those involved in food processing. This information should be integrated with state and local (including law enforcement and emergency preparedness) contacts and regularly updated by the FDA. Having this information will provide the food processor or seller with the contacts that they need during an investigation and for foodborne illness incidents or outbreak investigations.

b. Tools to improve targeting and effectiveness of communications, including risk communication

FDA should work with communication professionals in academia, industry, and scientific societies in the development of risk communication materials. IFT members address foodrelated issues with both the private and public sectors, and could serve as resources for the Agency.

5. As FDA becomes more transparent, what information should remain confidential in order to promote key internal and external policy goals, such as preserving patient privacy, and how, in these cases, should FDA explain the importance of confidentiality?

FDA should have a more rigorous process for ensuring confidentiality, including verification of the suitability for release of any company information prior to its release. The Agency explains the importance of confidentiality by iterating that its current regulations and rules clearly safeguard the confidentiality of proprietary information, and the agency has a history of making selective confidential information public only when absolutely required to resolve a food safety matter. Trade secret or company proprietary and business information, however, must remain confidential. Also, names of company personnel and their contact information should remain confidential.

As a further safeguard for industry and the Agency, FDA should consider permitting counsel for a company to execute a “pre-release” review of documents after the Agency has completed its redaction process and prior to their release to the requestor. This would allow someone very familiar with a company’s process and terminology to have a limited amount of time to ensure that all trade secret or company proprietary information, as well as company personnel or contact information, has been appropriately redacted. The Agency would then be free to accept those it agreed with before information was released. This additional step could prevent the unintended release of confidential information and would add little time to the current process as the opportunity to execute the pre-release review could be limited to ten (10) or fifteen (15) days from receipt of the redacted documents.

6. What metrics should FDA use to gauge the effectiveness of its transparency efforts?

Metrics other than FOIA requests, such as website hits, survey data, town-hall input, and perhaps speed at which questions or issues are resolved might be used to gauge the effectiveness of the Agency’s transparency efforts. As the FDA seeks to assess its progress towards becoming more transparent, it should consider having an assessment conducted by qualified professionals either within the agency or outside of it to ascertain this along with a general survey of customer satisfaction.

IFT thanks the FDA for providing this opportunity to comment on its effort to increase transparency. IFT shares the FDA’s goal of protecting the public’s health. We applaud the FDA and urge the Agency to continue to seek ways to better work together with the industry, public, and scientific organizations such as IFT in improving the communication and exchange of information that will allow investigations, etc., to proceed in a timelier manner to better facilitate this priority. Should you wish to talk with us about our views and suggestions for increasing transparency about FDA activities, or pursue development of risk communication materials, please contact Mr. Will Fisher, IFT Vice President of Science and Policy Initiatives. Mr. Fisher may be reached at 202-466-5980 and wfisher@ift.org.

Sincerely,

Marianne Gillette
IFT President

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