European and U.S. legislation tends to pave the way for the feed industry’s regulation worldwide. As reported in October 2001 (Victam Preview), the
European feed industry has been besieged by new codes and rules. Here, AFIA’s resident feed control expert helps us keep an eye on U.S. regulatory activity.
his year began with the usual feed regulatory issues in the U.S. — BSE, dioxin and nutraceuticals — and each one seemed to move to a heightened activation level as government and external forces exerted their influence.
After last year’s BSE public meeting in October, the Food & Drug Administration indicated it would likely amend the BSE feed rule promulgated in 1997. The second and third meetings of the "dioxin panels" of the National Academies (including the National Academy of Sciences, National Academy of Engineering and Institute of Medicine) were alarming to industry in that the panelists appeared directionless. The Association of American Feed Control Officials (AAFCO) met in January and decided to pursue an "enforcement event" nationwide against one unapproved nutraceutical ingredient yet to be named.
These three issues seemed to symbolize business as usual in the feed regulatory arena. Add to this the finding of dioxin in Ireland from a U.S. firm’s feed ingredient, and it has become a year that will keep the regulators and industry quite busy for some time.
Among all of these issues, there are many opportunities to strengthen the feed industry’s food safety firewalls. Because, after all, feed is part of the food chain and food safety must be our passion.
Here’s a more detailed rundown of some of the current regulatory issues.
BSE FEED RULE
In the first quarter of 2001, FDA was expected to publish an advanced notice of proposed rulemaking (or ANPRM) on the BSE prevention feed rule. This will likely be released this summer. An ANPRM is a precursor to a proposed rule and allows the agency to collect comments on broad issues before publishing a more refined proposed rule. FDA held a public hearing October 30, 2001, to collect answers to 17 questions dealing with all aspects of the feed rule.
In addition, FDA’s Center for Veterinary Medicine (CVM) announced it was looking at several areas of the current BSE feed rule, which would include labels for pet foods, carryover/contamination of mammalian products, plate waste, poultry litter feeding and specified risk materials (SRMs) — primarily brains and spinal cords. Each of these issues, CVM believes, could effect further risk reductions, but wants comments.
The American Feed Industry Association (AFIA) believes the current rule is working, but states and FDA need to put more effort into enforcing compliance and continuing education before working to change the rule.
The compliance rate is 98% for all firms inspected by FDA/states, which total more than 11,000. For firms handling restricted use protein products, the rate is 85% compliance; AFIA believes the industry and FDA need to make a concerted effort to address the 15% non-compliant firms. Many of these are minor issues of labeling and recordkeeping.
AFIA continues to support the Facility Certification Institute’s efforts to provide private certification to firms. There are 210 facilities in the program, and a new program certifying plasma and hemoglobin producers in the U.S. and Canada began Jan. 1. (For more information, visit www.certifiedfeed.org.)
The ANPRM will offer the feed industry an opportunity to highlight educational efforts and put to rest FDA’s continuing threats of a new rule.
EPA’s impending release of the draft reassessment of dioxin will challenge the industry again, as the release has been ongoing for more than a year, since parts of drafts have been leaked to the public and media. The reassessment will likely state that the tetra form of dioxin is a human carcinogen. The feed industry is challenged with dioxin from a variety of sources.
FDA is continuing to collect samples of feed and feed ingredients for dioxin analyses in order to build a "baseline" of data. Results from samples collected in 2000 have yet to be released, as the agency is plagued with laboratory backups. Samples have again been taken in 2001 and are awaiting analyses. EPA will also collect forage samples for analyses.
The opportunity in these samples is to find the sources of any dioxin, as it is believed that no feed manufacturer or ingredient producer knowingly adds ingredients with dioxin to feed. However, that changed in March with the discovery that an organic, complexed mineral supplier had appeared to manufacture dioxin in the ingredient processing. The industry will continue to work with FDA to determine how dioxin enters the feed chain. Promising tests are on the horizon to lower the cost of dioxin analyses, which is near $1,000 per sample.
FDA has also been routinely sampling for Salmonella bacteria in feed and notifying firms of positive findings. Regulatory actions will likely be taken on positive findings soon.
A recent CVM/FDA report noted that Salmonella and Campylobacter microbes might be found in a wide variety of feed ingredients, including corn, wheat and oats. This demonstrates how ubiquitous these organisms are.
Similarly, FDA is gearing up to develop and publish a proposed rule mandating HACCP for animal and vegetable protein producers. FDA recently indicated that mandatory HACCP for feed mills will not occur.
HACCP is a very specific quality control program that attempts to scientifically control critical control points for physical, chemical and microbiological hazards. A hazard analysis is performed, and identified hazards are to be controlled. The industry has concerns about identifying the microbiological hazards for feed. There is very little scientific evidence indicating that these hazards can exist in the normal flow of manufacturing feed.
These products promote health in the context of nutrition. The regulated nutraceutical industry worked with AAFCO to refine a regulatory approach to these ingredients with limited success. The road has been "rocky" and will likely continue that way for many months.
Use of these products is primarily in pet foods and horse feed, and efforts continue to demonstrate the safety of the most commonly utilized ingredients — glucosamine and chondroitin sulfate. AAFCO and FDA are taking more regulatory action against undefined ingredients. Firms should make a concerted effort to work with AAFCO and the states with nutraceuticals.