| Comment Record|
Mr. Thomas Cook ||
2003-02-04 11:23:16 |
North American Rendering Industry |
| Comments for FDA General |
1. General Comments
NORTH AMERICAN RENDERING INDUSTRY
801 North Fairfax Street, Suite 207
Alexandria, Virginia 22314
February 4, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Re: Docket No 02N-0273, Advanced Notice of Proposed Rulemaking “Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed”.
Dear Sir or Madam:
The North American Rendering Industry appreciates the opportunity to comment on the Food and Drug Administration (FDA), Docket No 02N-0273 Advanced Notice of Proposed Rulemaking (ANPR) and the consideration extended to our informed opinion by the FDA.
The agency requested input from those with interest and expertise identifying five (5) aspects of the BSE Feed Regulation 21 CFR 589.2000, 62 FR 30936, June 5, 1997
(Feed Rule) with the intent to improve it; its enforcement, and thus prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) in the United States. These five aspects include:
* Excluding Brain and Spinal Cord from Rendered Animal Products
* Use of Poultry Litter in Cattle Feed
* Use of Pet Food in Ruminant Feed
* Preventing Cross-Contamination
* Eliminating the Plate Waste Exemption
Prior to commenting the undersigned wish to state that, in concert with many other stakeholders and allied organizations, we appreciate the dialogue with FDA in developing all currently existing measures against BSE, set in motion since its diagnosis in the United Kingdom in 1986. We thank you for the exemplary efforts of the agency in putting together a series of scientifically-based preventive measures against BSE gaining foothold in the United States, i.e.:
A. Ban on the importation of cattle and beef products from countries affected by BSE
B. The 1997 Feed Rule
C. Statistically sound on-farm and at slaughter BSE surveillance program
Combined with a comprehensive public education and awareness program, these measures form an effective “triple defense firewall” against BSE.
Concurrently, we would like to point out that the rendering industry in particular has supported, and will continue to unequivocally support, those measures. In this same context, the renderers have genuinely embraced voluntary safeguards and implemented third-party validated certification programs to provide added safety and preclude hazards that may compromise the BSE defenses. Our industry cooperation with the preventive regulations has been substantive and has achieved an unprecedented 99+% level of compliance. As one evaluates all mentioned multi-faceted efforts and the excellent outcomes from the current regulatory framework in the United States, all indications are that our collective efforts have been an unqualified success.
Without any pretence for relaxing our vigilant guard, the mentioned achievements in mind and the careful consideration of all available scientific facts and analyses lead us to conclude that there is no need for additional regulations as proposed in the ANPR. Besides, at numerous public forums many other relevant stakeholders fully expressed their concerns and opinions, reaching the same overwhelming consensus, i.e. the present Feed Rule and other portions of the comprehensive compliance program are adequate, workable and meet the overall objectives of the agency. With this in mind, to preserve our continued freedom from BSE, all focus should be directed towards enhancing the heretofore instituted robust rules and regulations. Sometimes the obvious does stare us in the face. FDA is strongly encouraged to do all it can and ensure rigorous enforcement of total enduring compliance, based on aggressive prosecution of potential violators. Such posture should result in far greater, than the sum of all changes mulled by the agency, diminution of risk.
* * * *
Therefore, we wish to submit for your careful consideration our recommendations and the reasoning behind:
At present BSE is a foreign animal disease that does not exist in North America, with incidence of close to 99% in the locus of origin, i.e., the United Kingdom (UK). The other approximate 1% involves countries in Europe, more or less contiguous to the UK, and others, like Japan, which either imported live cattle or contaminated animal proteins from the locus of origin.
All official epidemiological determinants, including extensive surveillance and testing of high-risk animals, indicate that BSE is not present in the USA. The Harvard Center for Risk Analysis conducted three evaluations on various risk factors and potential pathways for exposure of US cattle to BSE and on November 26, 2001 released its findings (the Harvard Study).
The mathematical modeling, likely the most comprehensive one ever used to assess a zoonotic disease, concluded that, due to the various proactive and preventive controls already in place, the risk to US cattle and US consumers from BSE is very low. A direct quote from the Harvard Study Executive Summary:
“Our analysis finds that the US is highly resistant to any introduction of BSE or a similar disease. BSE is extremely unlikely to become established in the U.S.”.
Here is the place to consider the phenomenon of risk vis-à-vis the premises of this particular ANPR. Likewise with BSE, human experience teaches us that there is no, nor can there ever be, zero risk. The quest for total freedom from risk is admittedly illusory. Hence, it is sensible to accept risk as intrinsic to nature and manage it by: 1.Identifying the elements pertinent to given risk(s), 2. Deciding on practical strategies to mitigate or minimize them and 3. Deciding, after careful weighing all pros and cons, whether these are worth pursuing.
TSE’s are one of those cases in which our imagination is baffled by profound contradictions. Our collective logic and insights with fundamental biological processes are being severely tested. The very nature of causation – infectious (zoonotic) or genetic or both -- and occurrence -- spontaneous or otherwise, etc. -- are all still under severe scientific scrutiny and far from certain. Theories based on the flimsiest foundation of evidence abound. So does speculative bombast and, in a few cases, self-serving vitriol. Setting those aside we shall focus on the meaning of BSE risk and its practical control, in accordance with the most current scientific information and risk assessments, as it pertains to the specific situation in the U.S.
1. EXCLUDING BRAIN AND SPINAL CORD FROM RENDERED ANIMAL
The Food Safety and Inspection Service (FSIS) has proposed that the exclusion of central nervous system tissues (brain and spinal cord), considered “high risk” material from use in human food. However, the fact that FSIS may contemplate precautionary measures to limit human exposure to “high risk’ tissue does not automatically restrict these specified risk material (SRM) from being processed into animal feed ingredients. In this context, the Animal and Plant Inspection Service (APHIS) is making concerted efforts to convince the European Union (EU) that our continent is free of BSE and we should be able to ship bovine byproducts without any consideration for the removal of SRM. On the other hand, our government is working to attain a BSE Status Category I classification from the EU and the Office Internationale des Epizooties (OIE) that will exclude the U.S. from the EU requirement to remove SRM’s from the rendering stream.
Clearly we are sending confusing signals at home and abroad and, among others, disenfranchising the industries, which have collaborated with the government to keep our country BSE-free. The lack of any indications of BSE in the U.S., the fact that food animals other than ruminants have not exhibited BSE, and the robust measures in place, all combined, make adopting indiscriminately the European practices with regard to SRM irrational.
Such a mandate would involve major costs, dramatic restructuring of facilities, and force many smaller rendering plants out of business. Such eventualities would further deprive many areas of the country from access to rendering; exacerbate disposal and related ecological problems, while providing doubtful, if any, benefits to public health.
2. USE OF POULTRY LITTER IN CATTLE FEED
The Harvard Study indicated that the use of poultry litter as a feed supplement for cattle merits further investigation. While the agency is concerned that spilled poultry feed may contain ruminant meat and bone meal (MBM), it begs the question whether using poultry feed inadvertently admixed with MBM constitutes a significant breach of the Feed Rule. The agency, to its credit, realizes that poultry litter may contain a small amount of feed and that the commercial poultry producers are economically motivated to limit and control feed spillage.
The feed spillage, a.k.a. transition and admixture, in poultry litter is minimal. Using well-known production parameters and practical experience on hand, we will assess any likely risk associated with feeding poultry litter to ruminants. This while relying on worst-case scenario assumptions, namely:
Number of broilers produced / year = 8, 000,000,000 (eight billion)
Amount of feed / broiler = 9.0 lbs
Level of ruminant protein in broiler rations = 5.0%
Feed transition (spillage) from feeder to litter = 1.0%
Litter / broiler = 2.0 lbs
8,000,000,000 x 9.0 = 72,000,000,000 lbs feed / year
72,000,000,000 x (5.0%) x (1.0%) = 36,000,000 lbs animal proteins / year
8,000,000,000 x 2.0 = 16,000,000,000 lbs litter / year
36,000,000 / 16,000,000,000 = 0.23% animal protein content in poultry litter
Live weight / bird at processing = 5.0 lbs
Lbs feed / lb weight gain (FCR) = 1.8
Bird placement / rearing cycle = 25,000
Duration of broiler rearing cycle (weeks) = 7.0
Rate of feed spillage = 1.0% (per Dr. Nick Dale, Univ. of Georgia)
Level of animal* protein in broiler ration = 5.0% * 100% ruminant
Litter volume = 500 ft x 40 ft / 0.5 ft = 10,000 cubic feet
Litter density = 30.0 lbs / cubic feet
Litter clean-out after each cycle:
5.0 x 1.8 x 25,000 = 225,000 lbs feed / cycle
225,000 x 1.0% x 5.0% = 112.5 lbs animal protein
(112.5 / 300, 122.5 lbs litter and animal protein) x 100 = 0.037% animal protein
content in poultry litter
Few additional calculations will further underscore the extremely miniscule level of potential infectivity of poultry litter:
1. A BSE infected cow, with 8,316 ID50 is rendered along with 600,000 lbs other material on a given day at a modest size rendering facility:
8,316 / 600,000 = 0.1386 ID50 / lb raw material
2. Rendering concentrates proteins 4 times. Assuming a 25% solid yield:
0.01386 x 4 = 0.0554 ID50 / lb MBM
3. Continuous rendering is shown to lower the “infectious prion” titer by 1 log:
0.0554 x 0.1 = 0.005544 ID50 / lb MBM
4. Based on the 0.23% spill-over protein content in a pound of poultry litter:
0.0023 x 0.005544 = 0.000012751 ID50 / lb litter
As indicated the presence of residual feed in poultry litter at clean-out, is miniscule. Besides, due to nutritional constraints, the actual rate of inclusion of litter in grower and gestation ruminant diets is very low – not more than 10 lbs / cow / day -- yielding significant additional dilution effect at the point of actual feed consumption:
10 x 0.000012751 = 0.00012751 ID50 / lb litter
Consequently, it will require feeding 10 lbs poultry litter / cow / day for 6,442 days, or 17.65 years, to achieve a single ID50 dose!
We should also mention that, being limited by geography, such mixing occurs mostly at the farm level and any attempts to effectively frame the practice into enforceable regulatory context will be severely hampered.
3. USE OF PET FOOD IN RUMINANT FEED
The use of recycled, distressed or salvaged pet food as feed ingredients in ruminant rations should be prohibited. However, labeling retail companion animal food with the cautionary label “Do not feed to cattle or other ruminants” leads the public at large deduce erroneously, that the products in question are unsafe to start with. The consumer survey conducted by the Pet Food Institute is rather telling. It demonstrated clearly that ¾ of the public are confused by such labeling and unable to place it into a proper context, while an undue specter of fear is raised among a not insignificant, i.e., 56% number of the consumers surveyed. We consider the proposed warning label superfluous, counterproductive, as well as economically irresponsible and concur with the pet food industry’s objections to it. Cognizant of the list of counterarguments offered by the pet food industry we draw your agency’s further attention to it.
4. PREVENTING CROSS CONTAMINATION
The agency has formulated three sub-categorized questions relating to cross contamination:
4a. 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?
4b. what is the scientific rationale used to establish this safe level?
4c. what steps are firms currently taking to prevent cross-contamination of prohibited protein into ruminant feed, and what are the costs of those steps?
We performed calculations to determine the potential, worst-case scenario, carry-over following clean-out/flush, as performed normally at an average rendering facility. We estimated that 5% carry-over of prohibited into non-prohibited material would provide 27 to 540 fold safety margin, depending on whether the contaminated non-prohibited MBM was sold directly for feeding at a diary or blended at a protein blending facility, also having 5% carry-over.
The following quantitative calculations are based on assumptions considering for the opinion on BSE risk adopted by the European Commission Scientific Steering Committee, dated March 26–27, 1998:
· A BSE infected adult cow (1,400 lbs body weight), with infectious titer of 8,316 ID50, is rendered just prior to clean-out, flush and switch over to production of non-prohibited material
· The clean-out / flush removes all but 5% of the titer, leaving 415.8 ID50 infectious units
· The remaining infectious units are subsequently distributed among 600,000 lbs of other material, which is the volume processed on a single day at a modest sized rendering plant
· Although, the resulting finished MBM would normally be diluted further by co-mingling with MBM produced on previous and subsequent days, it is assumed that the MBM lot in question is left intact. In this case:
415.8 / 600,000 = 0.000693 ID50 / lb MBM
· Rendering concentrates the protein matter four fold (4X). Assuming 25% solids yield:
0.000693 x 4 = 0.002772 ID50 / lb MBM
· The batch rendering is known to decrease the infectious titer by 3.0 logs, whereas continuous rendering does so to lesser extent, i.e. only by one (1.0) log. Accounting for the latter:
0.002772 ID50 x 0.1 = 0.0002772 ID50 / lb MBM
· Using the Harvard Study methodology as a guide, the infected MBM is then fed as a protein supplement to a dairy cow at the rate of 1.5 lb / day:
0.0002772 ID50 x 1.5 = 0.0004158 ID50 / cow / day
· Since a dairy will purchase no more than a 90-day supply of MBM at a time, there will be no more than 90 feedings / cow with this contaminated MBM:
0.0004158 ID50 x 90 = 0.037422 ID50 fed cumulatively per cow
The above provides roughly 27 fold (27X) margin of safety from accumulating a single ID50 infectious dose.
· The contaminated MBM is sold as prohibited material to a protein blender or feed manufacturer.
· In this case the MBM is either:
Left undiluted and then (mistakenly) sold to a dairy farmer. Thus it will still
possess the 27 fold margin of safety, or
Used to manufacture a batch of prohibited MBM, followed by clean-out/flush with
non-prohibited material. This leaves 5% (700 lbs) prohibited MBM in the system.
Subsequently, these 700 lbs become part of the next 14,000 lbs batch,
resulting in 20 fold (20X) further dilution:
27 x 20 = 540 fold (540X) margin of safety.
· The latter is fed to dairy cows under the same conditions as mentioned in Scenario I.
Similar (540X) margin of safety will be obtained, if the blended MBM were sold to a feed manufacturer, who incorporates the MBM in the final formulation at the rate of 1.5 lbs / dairy cow / day.
Let us also be aware, that targeting (a rather exaggerated) 5% carry-over at rendering plants, entails an advantage due to the availability of rapid and inexpensive ELISA tests able to detect 5% or less ruminant proteins in feed. Although yet to be refined, these tests should make surveillance, self-policing, and regulatory enforcement practical and realistic.
5. ELIMINATION OF THE PLATE WASTE EXEMPTION
The agency’s definition of “plate waste”, found in the Federal Register Vol. 62, No.108, p.30946, 06/05/ 1997, is similar to the American Association of Feed Control Officials’ description of “restaurant waste”, i.e., “material composed of edible food waste collected from restaurants, cafeterias and other institutes of food preparation”. The exemption of plate waste from the Feed rule concerns “inspected meat products, which have been cooked and offered for human food and further heat processed for feed (plate waste and used cellulose casings)”. From the specific perspective of BSE there is hardly a basis to removing the plate waste exclusion. For one, in the course of food preparation plate, the leftovers have undergone heat treatment and subjected to additional heat and pressure, to a degree that would just about eliminate any (potential) infectious titer capable to transmit disease, during subsequent rendering.
To quote the Harvard Study:
“Plate waste consists of little mammalian protein, and the tissues that are included in this waste are unlikely to contain BSE infectivity. Moreover, plate waste undergoes a substantial amount of heat treatment, which would further reduce the level of infectivity in this material”.
Again reminding ourselves that we are in a BSE-free country, rendered plate waste forms only a minute portion of ruminant feed. It helps further dilute any infectious titer, thus adding another layer of safety. Next, the proposed exclusion entails an important, psychologically objectionable aspect. The hint that the leftovers from food produced, prepared and served to the U.S. consumer, could be potentially hazardous to animals is disconcerting, at best. We are talking about inspected meat products that have been passed for human consumption by agencies of the U.S. government. Mindful of this, among others, we express strong reservations in regards to the issue at stake.
* * * *
The proposed ANPR appears to imply that if something can be done, then something should be done. This is a case of fair argument, unfairly applied. In contrast to the initial wavering in Europe, the closer we look at the success of our swift actions in erecting the “triple firewall” against BSE, and contrasting it to the poorly implemented European response the more it becomes apparent that the U.S. does not need new micromanagement regulations, but robust enforcement of the already effective measures. While not self-congratulatory it must be acknowledged, that in respect to BSE, we in the U.S. have done our homework much better than the Europeans.
Our approach was timely, sensible, levelheaded and pragmatic and must remain as such.
Given the contrasting status of BSE in the UK and a few other European countries, the legislative fervor in Strasbourg and Brussels may be justified, but even then it is overzealously Draconian. It is our firm conviction that we must refrain from erroneously emulating the European legislation and instead pursue policies, which closely reflect the true state of affairs in this country. We in the U.S. have proven, time and again, our ability to collaborate in times of need and place trust in the initiative, pragmatism and collective wisdom of our people. Through the mechanism of participative discourse between an informed government and public we can reach the best consensus and determine the most prudent course of action. With this in mind, the North American Rendering Industry is sincerely counting on the fact that this occasion will result in careful reevaluation of the ANPR in question.
Kevin Custer, Chairman Don Davis, Chairman
Animal Protein Producers Industry Fats & Protein Research Foundation
Humphry Koch, Chairman Doug Anderson, Chairman
National Renderers Association North American Rendering TSE Coalition