Docket Management
Docket: 01N-0423 - Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed.
Comment Number: EC -20

Accepted - Volume 4

Comment Record
Commentor Ms. Catherine Rieff Date/Time 2001-11-21 15:02:58
Organization Hubbard Feeds Inc.
Category Company

Comments for FDA General
Questions
1. General Comments HUBBARD FEEDS INC. 424 NORTH RIVERFRONT DRIVE,MANKATO,MN 56002-8500 November 21, 2001 Docket Management Branch [HFA-305] Food and Drug Administration 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 Ridley Inc. is a leading manufacturer and distributor of scientifically formulated animal feeds and animal health products that support and improve the productivity of livestock herds and poultry flocks throughout North America. On a volume base, we are positioned No 5 in North America. Ridley markets a broad range of complete feed products, nutritional supplements, concentrated feeds and vitamin/mineral premixes directly to livestock producers and through dealer organizations. Ridley operates from 41 production plants in Canada and the United States. Ridley markets its feed products under a number of brand names, including “Feed-Rite”, “Hubbard”, “Wayne Feeds”, “Ridley Feed Ingredients”, “Prairie Pride”, “Crystalyx®”, “Tradition Feed Products”, “Renata Nutrition”, “CSI”, “Farmix”, “Quality Feeds”, “Green Valley Feeds” and “Daco Western Canada”. Ridley’s U.S operations include 26 mills with an annual production capacity of 1,450,000 tons of feeds, supplements and nutritional aids. Hubbard Feeds Inc., the US entity of Ridley Inc. was the first full-service U.S. animal feed manufacturer to gain ISO 9001 registration. All of the feed plants that Hubbard operates are accredited at the Level 1 under the FCI. auditing scheme. Hubbard, wishes to participate in the Public Review of existing regulations in place to help prevent the establishment and amplification of Bovine Sponigiform Encephalopathy (BSE) in the U.S. cattle herd as requested in the notice of federal register (volume 66, No. 194, dated Friday, October 5, 2001). In response to the specific questions posed, we make the following statements: 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? Hubbard believes the top priority of the FDA should be broader education within the feed and ruminant livestock industries, along with action against any firm or individual knowingly distributing or feeding prohibited material to ruminants. We would also like to see involvement from the FDA to ensure all BSE inspections are uniform, eliminating disparity between districts. Inspections should be targeted at tracing forward the movement and use of prohibited animal protein products (PAPP’s), starting at the source. Furthermore, the CVM should review their documentation and recording processes, to reflect more accurate and current compliance status, resulting in greater confidence among consumer groups. It is our belief that the American Rendering Association is advocating federal licensing of such facilities. We support this initiative and the obvious documentation trail of their products into the animal feed industries. The use of fallen or dead stock within this feed ingredient stream should be banned. 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 objectives in applying the rule have not changed since it was implemented in 1997. The effectiveness of the “3 fire-wall” strategy has been demonstrated with the passing of time, in that no breach has occurred. The U.S. does not have BSE, indicating the current rule has prevented the establishment of BSE. At this time, there is no new scientific knowledge warranting changes to the rule. FDA adopted the current restrictions based on sound science and a review of industry practices. Any proposed broadening of the rule by the FDA, to achieve lateral, disassociated objectives, should not be the intent of new legislation. Again, Hubbard believes education directed at past and future violators of the current rule, to accomplish FDA’s goal of 100% compliance, should be FDA’s priority. 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? NO. Recent review of the scientific literature indicates that no other ingredients, outside of the current schedule of PAPP’s, have been shown to pose a risk of transmitting BSE infective agents, as we know them today. Hubbard believes that current scientific data still justifies the current ban on those listed ingredients. European data and regulatory principles would support this premise; although in affected countries elevated precautionary measures are in place. 4. Should FDA require dedicated facilities for the production of animal feed containing mammalian protein to decrease as much as possible the possibility of co-mingling during production? Note: This and the next two questions should be specifically directed at PAPP’s and discussions exclude the permitted mammalian protein products. The FDA should not lose sight of the fact that BSE does not occur in North America and extraordinary production practices, like dedicated manufacturing facilities, are economically and scientifically unnecessary for our existing animal health status. This decision should be left to individual companies and manufacturers based on their market demands and manufacturing infrastructure. An active trace-forward paper trail on PAPP’s from renderers would more easily support full compliance. Hubbard believes FDA should not require dedicated facilities and/or transportation vehicles for feeds containing PAPP’s. The current system has effectively curtailed prohibited product from reaching the human food chain. 5. Should FDA require dedicated transportation of animal feed containing mammalian protein to decrease as much as possible the possibility of commingling during transport? For monogastric feeds containing PAPP's separation does naturally occur within bulk transports due to bin configurations. In the case of packaged pet food, which may contain PAPP's, today’s efficient shrink-wrapping systems effectively contain and segregate these products. In 2001, the South Dakota legislature enacted a new law and rules, which now require Hubbard to use two separate vehicles to deliver bagged pet food (which may contain PAPP’s), and bulk ruminant feeds to our customers. This was previously done efficiently and safely with one vehicle. This new law has significantly increased our cost structure and inefficiencies, with little risk reduction in an environment where BSE is absent. 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? Hubbard is not opposed to the licensing of renderers and facilities using PAPP's in the products they manufacture. Indeed feed manufacturers’ products can only be as safe and compliant as the ingredients that are procured. However, if FDA decides to license renderers or other firms/facilities that produce products containing PAPP’s, consideration needs to be given to the additional cost and record keeping required. Hubbard would not want to see the current limited resources that the FDA has for education and inspection stretched to cover more facilities and the necessary documentation demands. The resources required to maintain such a system could be better spent inspecting facilities using PAPP’s and providing better overall surveillance of the higher risk categories. FDA can adequately trace PAPP’s utilizing “trace-forward” techniques, which is far less resource intensive than a licensing scheme. 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)? A significant period of time has elapsed since the implementation of ban on PAPP’s in ruminant feed. During that period of time no scientific evidence, from around the world, has come forward identifying other animal-derived ingredients which represent a threat to the transmission and amplification of BSE. No change to the list of PAPP’s is warranted nor scientifically substantiated. 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? Hubbard does not support the feeding of poultry litter, irrespective of processing systems pre-feeding. While the litter has a nutritive profile, it is our belief that consumers do not support these types of recycled poultry waste materials as feedstuffs. Moreover, litter may be contaminated with spilled poultry feed, which may contain PAPP’s. Even within the most modern poultry facilities this form of contamination cannot be prevented. Hubbard advocates adding poultry litter to the “list”, as it may be a potential means of contaminating ruminant feed with PAPP's. 9. Should FDA remove the exemption for pet foods from labeling with the precautionary statements? No. Hubbard strongly supports the current cautionary labeling requirement for feeds containing PAPP’s. We do not support removing the exemption for pet foods from the cautionary statement. Hubbard made the business decision to add the following label statement to all of our dry-feed livestock products: Hubbard does not use “Restricted-use Proteins” in their products and is in compliance with FDA and state requirements regarding the use, handling and storage of “Restricted-use Protein” products. The recently invoked law by the South Dakota Legislature has created an enormous confusion in the marketplace with disparities in transportation for pet food products offered for sale in convenience stores, compared to pet foods sold via dealer and traditional rural outlets. This precedent has been expensive to the feed industry and added nothing to reducing the risk of a BSE event. 10. Should FDA extend its present record keeping requirements beyond 1 year? If so, how many years? Hubbard Feeds Inc. is not aware of any justification for lengthening the 1-year record-keeping requirement. As studies to date have been unable to describe the actual incubation periods for the various facets of the disease, a period greater than 1 year would only be a guess. Given the mass of documentation requiring archiving, an expansion beyond this time period would also be economically burdensome. Extending the time would have little practical value in determining the source of a TSE in an animal/feed incident. 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”. Hubbard strongly opposes any change to the current rule that endorses the use of “collective terms.” Using the “collective term” allows industry to least cost rations, which gives customers the most cost effective nutrition program. This group categorization of ingredients with similar function has proved beneficial for more than 30 years. If industry were required to list the species of origin for each ingredient our labeling costs would be exorbitant, as it would be necessary to change thousands of labels every time an ingredient within that ration was changed. FDA guidance documents list the two means of determining if a prohibited protein is used in a feed: 1. If the label lists the cautionary statement “Do not feed to cattle or other ruminants” or 2. The formula lists a prohibited protein product. It has been Hubbard’s experience that if a FDA inspector or customer has a question about our use of the collective term, a phone call is all that has been needed to clarify the inquiry. Hubbard cannot perceive what the benefits might be from such a change, the cost of resultant education, which would be required with such a change, would be very high and unnecessary. As a business decision, Hubbard sent a letter to customers twice since the implementation of the rule, explaining the use of the collective term on our labels. Across the years we have received few inquiries on our use of the “collective term”, which indicates to us that our customers understand its use and meaning. 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?” The livestock industry is very well educated to the meaning of the word “ruminant”, with individual owners understanding the species differences. Hubbard does not currently use any PAPP’s in any rations, but when they were used, with the cautionary statement, we were unaware of any problems with the understanding of the term ruminant. Hubbard opposes any such changes, on the grounds of negligible reduction in risk of a BSE event with the cost of significant label changes that this would invoke within the industry. 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? The FDA should be encouraged to conduct a critical review of all diagnostic and analytical assays currently being applied within European countries. Obviously this would be alongside current tests US agencies are reviewing and developing. It is Hubbard’s belief that in the UK particularly, worthwhile tests have been in place for a number of years, which screen both ingredients and finished feeds. The enormous range of animal protein products, whether in a raw material form or finished goods, processed and partially denatured within the myriad of production systems, demands a very robust test. Obviously, in the real world 100 percent accuracy in each of these environments is unattainable. The best available test(s) should be brought forward as screening tools, with their sensitivities and constraints described. In this way the industry will have detection assays to allow for a further degree of confidence to be instilled into the general community. 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?) Hubbard believes the current federal and state statutory penalties for violation of this rule are significantly severe and sufficient. Several states have exercised their stop-sale authority and may move to condemn feed if serious violations are encountered. Hubbard is aware that FDA and various states have cooperated in enforcement actions in the past, thereby saving the resources of FDA; this is to be encouraged. It is worth repeating that the education of the industry and identification of demands by the food chain will contribute most to achieving full compliance of the feed ban. 15. Regarding helping to increase compliance with the rule, what role, if any, should public or private certification program supply? The AFIA endorsed FCI auditing and licensing program represents a significant step forward in both industry and end-user education and compliance with the rule. The FDA should review this program with consideration for national implementation of the elements audited and monitored, across facilities in the U. S. feed industry. All US manufacturing plants operated by Hubbard Feeds Inc are certified Level 1 FCI facilities. Hubbard also acknowledges and supports the rendering industries third party inspection and certification program –Animal Protein Produces Industry (APPI). Again this auditing and inspection program demands compliance and invokes assurance downstream to uses and consumer groups, with respect to BSE prevention strategies. 16. Regarding the import of feed, what should the restrictions on such import be (country specific? comparison between domestic and foreign controls?) The importation of animal feeds or ingredients containing any animal derived material from countries with BSE or from those countries not conforming to the regulatory, surveillance and management practices, as detailed by the Office of International Epizootics (OIE) should be strengthened and continued to be strongly enforced. New countries infected with BSE will be added to the list in the course of time. However, if that country has been operating under the OIE recommendations, the risk to the US from previously imported materials, should be negligible. 17. Are there any other additional measures necessary to guard against BSE and vCJD in the United States? Firstly, Hubbard would like to see the FDA increase its emphasis on education to all segments of feed industry. Secondly, we would like to see the agency increase their inspections on past violators to attain 100% compliance to the feed ban, therefore impacting consumer confidence. Hubbard believes FDA should recognize true independent, third party certification programs, like FCI as valuable tools in further assuring compliance with the rule. Hubbard is aware the FCI has filed a request for partnership with FDA and we believe FDA and FCI can benefit from a partnership arrangement, which would free up the agency resources for education and enforcement. Hubbard attained the highest level of certification at all Hubbard plants from the Facilities Certification Institute (FCI). The American Feed Industry Association (AFIA) created the Facility Certification Institute (FCI) and Certified Facility Program for Restricted Use Protein Products (RUPP’s) to enhance consumer confidence in feed supplies to our food chain. The FCI incorporates the FDA’s inspection program for compliance with “Title 21, CFR § 589.2000, Substances Prohibited in Ruminant Feed.” The FCI program demands, among other things, an independent inspection to visit and audit facilities for compliance to this FDA policy. This highest level of certification is awarded to plants that neither stock nor use RUPP’s. Requirements for the highest level certification include:  A written procedure in place to prevent accidental contamination of ingredients and products  A testing method in place to identify meat and bone meal  Written procedures to assure bulk shipments of all ingredients are inspected and free of RUPP’s  Written agreements from suppliers that ingredients are free of RUPP residue  Written agreements with transportation carriers that containers are free of RUPP residue  An internal quality assurance training program that provides direction and education regarding RUPP’s  An indemnification agreement with vendors and transportation carriers who do not comply with carryover restrictions In conclusion, Hubbard remains proactive in its role as a premium animal nutrition provider in the US, to help ensure a safe food supply, while meeting all statutory demands and supporting the nation’s policies to ensure the country remains free of BSE. Sincerely, HUBBARD FEEDS INC. Steve VanRoekel General Manager, Dry Feed Operations SJV/ljf HFI Submission to FDA -Feedban rule.doc




EC -20