| Comment Record|
Mr. David Kirstein ||
2003-02-04 13:57:07 |
National By-Products, LLC |
| Comments for FDA General |
1. General Comments
NATIONAL BY-PRODUCTS, LLC.
907 Walnut Street, Suite 400
PO Box 615 Des Moines, Iowa 50303-0615
Phone: (515) 288-2166
Fax: (515) 288-1007
February 4, 2003
Dockets, Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Dear Sir or Madam:
I am writing in response to Docket No. 02N-0273 and the agency’s solicitation for comments on the current rule, “Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed” (21 CFR 589.2000). National By-Products, Inc., is one of the largest independent renderers in the United States. Almost all of our finished protein by-products contain some ruminant material, thus are considered restricted materials and are governed by the present rule. The following comments represent National By-Products’ current thinking and recommendations regarding the five questions posed by the agency in their Advanced Notice of Proposed Rulemaking published in the Federal Register, Volume 67, Number 215, November 6, 2002.
1. “Should high risk materials, such as brain and spinal cord from ruminants 2 years of age and older, be excluded from all rendered products?”
The Food Safety Inspection Service (FSIS) published its “thinking paper” on January 17, 2002, in which it was seeking comments on a number of steps to reduce the potential exposure of humans to the BSE agent were it ever to be introduced in the United States (US). One of those steps was to ban specific risk materials (SRMs) from use in human food. Another step was to strengthen the prohibition of central nervous system tissue from meat produced using advanced meat recovery (ARM) systems. Yet another was to prohibit the use of certain stunning devises. Since the publication of that paper, FSIS has only acted upon the ARM and stunning devise issues. National By-Products (NBP) is unaware that FSIS is advancing the initiative to ban SRMs from human food.
On another level, US officials representing other USDA agencies have been in communication with the European Union (EU) Commission attempting to accelerate the EU process of Geographic BSE Risk Assessment for the US. Over a year ago, US representatives presented the EU Commission with a dossier arguing that due to steps the USDA agencies have taken to protect the US from the importation or recycling of animals with BSE, the US should be given a GBR classification of “1” in the current classification scheme. Such a classification would state that the US does not have BSE and is highly unlikely to experience a BSE outbreak. By definition, countries in this category do not have SRMs.
It seems contradictory that at one level the USDA is trying to prove to the EU that we do not have SRMs, while on another level contemplating the prohibition of those same tissues in US food and feed. This sends a mixed and damaging message to our domestic and export trading customers. At a minimum, the FSIS and FDA should support all efforts made by other parts of the USDA to gain a favorable GBR status that would eliminate the need to address SRM issues in the US for purposes of trade. One way the FSIS and FDA can do this is by postponing any further actions regarding the removal of SRMs until the GBR status of the US is determined. Postponement is a legitimate course of action because strong compliance with the FDA “feed ban”, shown by both recent FDA inspections and industry 3rd party audits, provides an adequate barrier to the recycling of these ruminant tissues back to ruminants.
On the other hand, if the FDA chooses to prohibit SRMs from finished feed and feed ingredients, it should do so in cooperation with other USDA agencies that have jurisdiction over these tissues in their raw form. It the FDA does not coordinate their efforts, the prohibition of SRMs in finished meat and bone meal (MBM) will only serve to diminish the control the USDA agencies have over the disposal of these tissues. The current rule and this proposed extension would regulate only finished ruminant-containing MBMs. Raw materials containing SRMs and ruminant tissues disposed of by other means remain unregulated and represent unacceptable risks for damage to the environment and transmission of disease among animals and humans. These raw materials should also be regulated. For example, the spreading of composted SRMs or dumping of raw materials of ruminant origin on land used for grazing and/or hay production would still be permissible under the current or proposed rule. Although States have rules regulating the proper composting and burial of dead animals and raw animal materials, they are not uniform and are poorly enforced. If the disposal of SRMs and ruminant raw materials is not regulated, neither the current or proposed rule will prevent the exposure of ruminants to materials of ruminant origin.
NBP strongly encourages the FDA to consider postponing further action regarding the prohibition of SRMs until the GBR status of the US is determined. If the FDA chooses not to postpone, then NBP encourages the FDA to allow APHIS to take the lead in formulating regulations concerning the control and proper disposal of these and other ruminant tissues in their raw form rather than in their finished form.
2. Use of Poultry Litter in Cattle Feed
NBP collaborated with the National Renderers Association (NRA) in formulating a response to the questions in this section. Rather than reiterate those comments and calculations, we refer you to the NRA comments. In brief, they illustrate that the feeding of poultry litter (containing ruminant meat and bone meal that was infective) would not expose cattle consuming that litter to infective doses of BSE.
3. Should pet food for retail sale be labeled with the statement, “Do not feed to cattle or other ruminants”? What would be the adverse and positive impacts of such a labeling requirement?
In 2002, the Pet Food Institute conducted a survey to determine the impact of the proposed warning label on pet food consumers. The survey showed a significant negative reaction by consumers to the label. PFI estimates it would result in at least the loss of $2 billion in pet food sales. As a result, PFI also distributed information throughout the feed, feed ingredient, and pet food industry that reiterated the law regarding the proper disposition of salvaged and distressed pet food containing prohibited ruminant proteins. Cooperative, self-initiated efforts by the stakeholders affected by the FDA “feed ban” have resulted in high compliance rates. If the FDA is aware of situations of non-compliance, vigorous enforcement should be pursued. Requiring more labeling will not accomplish better compliance or provide further benefits to animal or human health. Requiring a precautionary statement on all pet foods would only serve to stigmatize pet foods containing restricted proteins and further damage markets for the rendering and pet food industries. The end result makes the sustainability of animal agriculture in the US that much more difficult.
4. Are there practical ways, other than dedicated facilities, for firms to demonstrate that the level of carry-over could not transmit BSE to cattle or other ruminants? If so, what is the safe level of carry-over in a feed mill; and what is the scientific rationale used to establish this safe level?
NBP collaborated with the National Renderers Association (NRA) in formulating a response to these questions as well. Rather than reiterate those comments and calculations, we refer you to the NRA comments. In brief, they illustrate that allowing a 5% carry-over of prohibited into non-prohibited material following a clean-out/flush procedure, would still provide a 27-540 fold margin of safety depending upon whether the contaminated non-prohibited MBM was sold directly to a dairy for feeding or further blended by a protein blender also having a 5% carry-over. Although, FDA inspections have documented smaller rates of carry-over (0.19% with proper cleaning and flushing and 0.39% following improper cleaning and flushing) a 5% allowance was chosen to permit verification by testing. A rapid, inexpensive ELISA test is currently being marketed by Neogen Corporation that is capable of detecting 5% ruminant proteins in MBM, thus making surveillance and enforcement of this provision practical.
5. Elimination of the Plate Waste Exemption
This issue seems to be out of any meaningful disease control context when addressing BSE. It should not be a component of any rule designed to control and minimize the spread of BSE if ever introduced to the US. The Harvard Study concluded that “Plate waste consists of little mammalian protein, and the tissues that are included in this waste are unlikely to contain BSE infectivity.
However, there are other animal disease issues stemming from the misuse of plate waste exemplified by the recent outbreak of foot and mouth disease in the United Kingdom. The best means of controlling any potential non-BSE animal diseases associated with plate waste would be best addressed by the proper disposal of this raw material. Controlled cooking and drying conditions could render this material safe in the context of conventional disease pathogens.
NBP would recommend that the FDA allow APHIS to take the lead in evaluating the need to regulate plate waste and any potential benefits associated with its controlled use or nonuse.
National By-Products thanks the FDA for the opportunity to make comments as it re-examines the suitability of the current rule five years after its implementation. NBP has taken seriously its role in protecting animal and human health by being in full compliance with the current rule, as well as, implementing other controls beyond the current rule’s requirements. We feel the current rule has been a successful component in protecting the US cattle and human population from exposure to BSE and vCJD. We have offered strong justifications for why the FDA need not pursue further prohibitions at this time.
Mark A. Myers, CEO & President
David Kirstein, Director of Technical Services