The FCC Forum—Your Opportunity, Your Responsibility to the Public Standards-Setting Process

From FCC e-Newsletter (Spring 2008, Vol. 1, Issue 2)

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The United States Pharmacopeia (USP) is publishing the next Food Chemicals Codex (FCC) Forum on June 30, 2008, in a new online format at forum.foodchemicalscodex.org. The FCC Forum is free to all and provides the public with an opportunity to review and make comments on proposed new and revised FCC food ingredient standards. The FCC Forum has changed from when the FCC was maintained by the Institute of Medicine (IOM). Public participation and monitoring of the FCC Forum are key components of USP's standards-setting and revision process.

How has the public review and comment process changed?

Public review and comment during the compendial standards-setting process is not a new concept for the FCC, but USP has implemented changes to improve the system. The compilation of the first edition of the FCC under the IOM's leadership included revisions that were initiated by stakeholder comments on provisional food ingredient standards published in the early 1960s. The process of adding new and revised food ingredient standards for subsequent editions of the FCC by the IOM involved two possible steps of stakeholder review and comment. The first step was targeted at known stakeholders for the specific proposals to address controversial issues early in the process. The second step consisted of publishing notice of the proposed food ingredient standard through the Federal Register, trade journals, and/or on the Food and Drug Administration (FDA) website, with a request for comments from all stakeholders. The IOM process was able to sustain revisions to the FCC for more than 40 years, but it placed a burden on the committee/IOM staff to ensure that all appropriate stakeholders were contacted and involved in the first step of review—a challenging task, given the complex and increasingly global nature of food ingredient production. The transparency and effectiveness of the IOM's second step of review also became an issue, given the lack of a consistent place and time to provide adequate notice to all stakeholders and the lack of availability of the proposed food ingredient standards. In addition, stakeholders did not have one easy place to find previously proposed food ingredient standards, making it difficult to trace back and understand previous revisions to the FCC. USP has significantly changed and improved this system into one simple and more transparent system called the FCC Forum.

What is the FCC Forum and why is it important?

The purpose of the FCC Forum is to provide an opportunity for scientific review of proposed food ingredient specifications, monographs, and test procedures for the next effective FCC edition or Supplement, by allowing participation in the standards-setting process on the part of all concerned with food ingredients standards. For those not familiar with USP's food ingredient standards revision process, it is similar in many ways to the Pharmacopeial Forum, which has been used since 1975 for the U.S. Pharmacopeia–National Formulary (USP–NF). One key change from the IOM days is that USP will not be directly contacting individual stakeholders and asking for comments on specific proposed food ingredient standards. To make the system more open and robust, it is now up to FCC users to monitor the FCC Forum for changes to their food ingredients of interest. To ensure that this is easy, USP has made the FCC Forum available for FREE for everyone to use online. To address the need for consistent location and times, the FCC Forum will have a 90-day comment period, and will be published on a consistent schedule tentatively planned for June and December of each year. To address any openness and transparency concerns, each proposed food ingredient standard published in the FCC Forum begins with a briefing to describe and justify the revisions to existing food ingredient standards. The FCC Forum will be maintained on the website for easy accessibility and for FCC users to understand the history of revisions prior to the proposed food ingredient standard. Additionally, a summary of all comments received and the Food Ingredient Expert Committee's responses will be posted on the FCC website .

How does the FCC Forum fit into the standards-setting process?

The FCC, now in its Sixth Edition, is not a static publication, but rather a dynamic compendium of standards for food ingredients. Maintaining the FCC as an authoritative, up-to-date, and comprehensive compendium is a challenge. The food industry is evolving at a fast pace, and USP is committed to evolving the FCC to reflect current industry food ingredient standards. The process of revising the FCC is driven by its stakeholders (industry, government, academia, trade associations, etc.) and starts with a proposed food ingredient standard from a single stakeholder, called a Request for Revision.

A Request for Revision could be for proposed new or revised food ingredient specification monographs, monograph test procedures, or general test procedures. Before a Request for Revision is reviewed and considered by the Food Ingredients Expert Committee for inclusion in the next FCC, shouldn't it be reviewed and scientifically scrutinized by all stakeholders? The obvious answer is YES! If one stakeholder is proposing a change to a food ingredient standard that all must meet in the future, shouldn't the voice of all of these stakeholders be heard first? Absolutely! This is where the FCC Forum fits into USP's standards-setting process. If you find a reason to modify or object to a proposed change for a food ingredient, the FCC Forum is your opportunity to let USP know the basis of your modification or objection. To support your comments, simply submit your scientific justification and batch data to USP. If there is a proposal to revise the test procedures your organization uses to test a food ingredient against FCC monograph specifications, the FCC Forum is your way to evaluate that procedure before it becomes effective in the next edition of the FCC or FCC Supplement. You can conduct your own validation protocol on the proposed test procedure to evaluate if it is suitable for your food ingredient matrix, and let USP know your results. In this sense, the FCC Forum provides a mechanism to further validate a new or revised test procedure by allowing other laboratories to evaluate the procedure. So visit the online site, review the FCC Forum proposed food ingredient standards, let USP know your opinion, and comment on new and revised FCC food ingredient standards. We're counting on you to provide USP with this critical piece of the standards-setting process!

Summary

• What has changed about the FCC's public comment process?
  All FCC users need to be aware of the following two key changes: (1) you as a stakeholder are now responsible to monitor the FCC Forum to keep up with proposed changes to your specific food ingredients, and (2) because of its website access, the new system is more transparent, consistent, and easier to use than the old system.
• When?
  The next FCC Forum will be posted on June 30, 2008, with a 90-day comment period ending September 28, 2008. Proposed food ingredient standards going through this FCC Forum and approved by the Food Ingredient Expert Committee will be published in the first Supplement to FCC 6 in February 2009. Future FCC Forums are tentatively planned to be published in June and December of each year.
• Where?
  The FCC Forum will be published for free on the following website: forum.foodchemicalscodex.org.
• How?
  Once logged on to the FCC Forum, you can browse through a list of food ingredient standards that are either new or intended for revision. Each proposed food ingredient standard has symbols to indicate what is new or intended for revision. USP encourages interested parties to submit comments and scientific data regarding the proposed food ingredient standards. Submissions concerning a particular item that appears in FCC Forum should be submitted to the USP scientific staff liaison identified at the end of the proposed food ingredient standard.
• How much does it cost?
  Nothing. The FCC Forum is FREE! but the benefits are of true value.