| Comment Record|
Dr. Gary Weber ||
2001-11-20 13:41:55 |
National Cattlemen's Beef Association |
| Comments for FDA General |
1. General Comments
November 21, 2001
Food & Drug Administration
Dockets Management Branch HFA-305
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
RE: Docket 01N-0423 Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Public Hearing; Request for Comments
The National Cattlemen’s Beef Association (NCBA) appreciates the Food and Drug Administration requesting comments and holding public meetings to address issues associated with the role the agency plays in preventing the potential amplification and spread of Bovine Spongiform Encephalopathy (BSE). The NCBA is the producer-directed and consumer-focused trade association of America’s cattle farmers and ranchers, and the marketing organization for the largest segment of the nation’s food and fiber industry.
Regarding the questions raised in the public hearing notice published in the Federal Register on October 5, 2001, The NCBA provides the following responses:
1. What additional enforcement activities, if any, regarding the present rule are needed to provide adequate public health controls? Are there other suggestions for ways to improve compliance with the rule?
We believe that for the most part, the feed and rendering industries have been largely in compliance with the existing regulations. We acknowledge there have been some compliance failures, but these have been more of a technical nature, rather than a finding of actual prohibited materials in the diets for ruminants.
We strongly urge the agency to continue to engage in education, and ensuring a risk based regulatory strategy is developed. We support aggressive action against any firm or individual knowingly feeding prohibited material to ruminants or distributing prohibited material for that use.
Put simply, the agency needs to enforce the current regulations in a strategic manner, rather than focus on any new initiatives or directions.
2. Is the present rule at Sec. 589.2000 adequate to meet its intended objectives? If not, what are its inadequacies? Are there additional objectives that this rule should now address? If so, what are these new objectives?
The feed ban rule is an integral component of three firewalls the government, in concert with industry, has developed. This rule meets the objectives established in 1997. Two government studies have indicated our risk of BSE is nearly zero. The industry and FDA must strive for 100% compliance and 100% inspections. FDA made a compelling argument to adopt the current restrictions based on sound science and a review of industry practices. NCBA believes that enforcement of the current rule will result in a greater reduction in risk than any or all the proposed issues raised here for changing the rule.
We also anticipate the risk analysis developed by Harvard University in concert with Tuskegee University will further document the fact we have taken appropriate action in the United States to prevent BSE.
3. Should the present FDA ban on the use of certain mammalian proteins in ruminant feed be broadened? If so, what should the new parameters of use be? Should the rule be broadened beyond ruminant feed? Beyond mammalian protein?
There is no scientific nor risk analysis based reason to expand the scope of the current regulations. Indeed, simply ensuring full compliance with the existing rule will contribute more to risk management than any specific expansion of the rule. We support a routine reevaluation of the rule to ensure we consider new risks or to remove restrictions if they are no longer justified by scientific analysis.
4. Should FDA require dedicated facilities for the production of animal feed containing mammalian protein to decrease as much as possible the possibility of comingling during production?
Our recommendation to the FDA and the feed industry would be to discourage the use of prohibited materials in plants preparing premixes, supplements and complete feeds for ruminants. However, we believe full compliance with the present rule is the most important issue at hand.
5. Should FDA require dedicated transportation of animal feed containing mammalian protein to decrease as much as possible the possibility of comingling during transport?
At this time, in the absence of BSE, this is not necessary. We do believe proper clean out procedures should be carried out and documented for compliance review purposes.
6. In order to improve production practices and increase assurance of compliance with the rule, should FDA require FDA licensing of renderers and other firms/facilities engaged in the production of animal feed containing mammalian protein?
This issue needs to be addressed more fully. It seems that the main benefit of this would be to increase confidence in the identity of facilities that use such components. Perhaps, rather than a license, a requirement that such facilities purchasing prohibited materials be reported to the FDA and or State feed control officials might be more appropriate.
7. Should FDA revoke or change any/all of the current exclusions for certain products allowed in the current rule at Sec. 589.2000(a)(1)?
We believe the current exemptions are consistent with all available scientific data and are therefore, scientifically justified. Recently, in fact, the safety of blood products has been reconfirmed. We strongly support the current exemptions from the feed rule and urge FDA to monitor the science in this area and consider changes only when there is compelling scientific evidence.
8. Should FDA add to the list of prohibited material in ruminant feed (i.e., add to the definition of ``protein derived from mammalian tissues'') poultry litter and other recycled poultry waste products?
We believe the use of poultry litter is safe when AAFCO instructions for use are followed. We are on record discouraging its use as a feed ingredient and we support alternate uses. However, there is truly little if any risk of this feed ingredient effecting the BSE status of the United States, since all evidence points to the fact the disease is not present in this country.
9. Should FDA remove the exemption for pet foods from labeling with the precautionary statements?
In 1997 FDA concluded that “...the cautionary statement serves no useful purpose on the pet food and feed for nonruminant laboratory animals and has amended the rule by creating [a new section]...to exclude pet food products that are sold or intended for sale at retail to non-food-producing animals and feeds for nonruminant laboratory animals.”
We believe education and enforcement of producers will be sufficient to prevent this from being an issue.
10. Should FDA extend its present record keeping requirements beyond 1 year? If so, how many years?
In the 1997 feed rule preamble FDA adequately justified its change from a two-year record retention to a one-year record retention. FDA stated that the recordkeeping requirement is to help FDA determine compliance with the rule. It further noted that extending the time would have little practical value in determining the source of a TSE in an animal.
We agree with the analysis of the American Feed Industry Association that the record keeping requirements relate principally to documentation of compliance. The 3-5 year latency period between exposure and disease manifestation would require considerably longer recordkeeping requirements if these data were to be of use for investigatory purposes should BSE be identified in the US. The relative value of these saved records, given the overall small probability that BSE will occur in the US and the large number of feed sources used by the average producer, suggest that the cost-effectiveness of additional recordkeeping would be minimal
11. Should FDA change its rule to require labeling of protein- containing feed to specify what type(s) of mammal was used in the production of the protein, e.g. ``porcine MBM'', ``bovine MBM''.
We believe a change of this type would provide little if any true benefit. If the label includes the cautionary statement “Do not feed to cattle or other ruminants” or if the formula lists a prohibited protein then the product can not be used in ruminants. If the label lists one or more specific animal protein products, in lieu of the collective term “animal protein products,” then any investigator must still check the formula and batch records to determine if a prohibited protein were utilized or not.
12. In order to make the statement clearer, should the required cautionary statement on the label of products that contain protein derived from mammalian tissues and that are intended for use in animal feed be changed to read: ``Do not feed to cattle, sheep, goats, bison, elk, or deer.''?
We do not believe this has been an issue affecting compliance. Continued educational campaigns will prove more effective in accomplishing the intended protection than expanding the cautionary statement.
13. What new information is available on potential efficient, accurate analytical methods that may be used in detecting mammalian proteins, especially the prohibited mammalian proteins, in feed and what should the sampling parameters of such a program be?
We believe there is definitely a need for new tests, which are both sensitive and specific in order to ensure compliance and investigate illegal activities. No current tests meet these requirements. Further, false positives must be avoided as they generate unnecessary perceptions of violations.
14. Regarding enforcing compliance with the rule, what further authorities, if any, would be desirable in order to enforce the rule adequately (civil monetary penalties?, others?)
We believe the current authorities are sufficient and that current federal and state statutory penalties for violation of this rule are severe and adequate. Several states have exercised their stop sale authority and may move to condemn feed if serious violations are encountered
15. Regarding helping to increase compliance with the rule, what role, if any, should public or private certification programs play?
We support the AFIA established Facility Certification Institute approach. However, we also support the “right” of individual companies to develop and “market” there own quality assurance programs.
We are encouraging all members of the beef and diary industry to only purchase feeds from companies involved in certification programs or that have provided a letter indicating they are in compliance with the feed prohibitions. We also support the signing of affidavits by producers marketing cattle indicating they have been fed in compliance with FDA regulations.
16. Regarding the import of feed, what should the restrictions on such import be (country specific? comparison between domestic and foreign controls?)
There is a real need for strengthening the certification for imported products and import controls. USDA has regulations in place and enforced to ensure import of feed and animal protein products are tightly restricted from those countries with BSE or which are not actively performing surveillance in accordance with the Office of International Epizootics (OIE). USDA has regionalized certain areas like the European Union because of the free flow of commerce among and between countries within the EU, and the announcement that the EU believes considerable commingling occurs in animal protein products. We support this concept and believe this is a scientifically sound approach.
We are concerned about the potential for transshipment of animal protein products from the EU and other countries through third countries and misbranding. The USDA and FDA need to define the appropriate regulatory strategy to effectively deal with this issue.
Preventing the introduction of the BSE agent is the first and most important firewall in the prevention of BSE, as such, we believe this effort should receive the greatest attention and funding.
17. Are there any other additional measures necessary to guard against BSE and vCJD in the United States?
We believe that the Harvard risk analysis will shed light on this important question and we need to review the report before responding to this question. However, we do believe that the proactive decisions on the part of industry and government, dating back to 1989, have been effective in preventing the introduction, amplification or spread of BSE in the United States.
The National Cattlemen’s Beef Association and our industry partners supports achieving full compliance with all existing regulations to prevent the introduction, amplification or spread of BSE. We are confident we have taken the proper actions. We support aggressive enforcement of the FDA feed prohibitions, the development of industry certification programs, producers requesting letters of compliance and the submission of affidavits of compliance by beef and dairy producers. Together, we have and will continue to prevent BSE in the United States through the application of science-based regulations, government and industry education and cooperation.
We appreciate the opportunity to submit these comments.
Gary M. Weber, Ph.D.
Executive Director, Regulatory Affairs