| Comment Record|
Mr. Jeffrey Harger ||
2003-02-04 19:14:10 |
Imperial Western Products, Inc. |
| Comments for FDA General |
1. General Comments
IMPERIAL WESTERN PRODUCTS
3766 E. Conejo Avenue
Selma, California 93662
February 4, 2003
Docket Management Branch
Food & Drug Administration
5630 Fishers Lane
Rockville, Maryland 20852
Docket No. 02N-0273 - Substances Prohibited from use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Advanced Notice of Proposed Rulemaking
Imperial Western Products (IWP) of Selma, California, appreciates the opportunity to provide informed opinion to the above-referenced docket item, i.e. Docket No. 02N-0273, Substances Prohibited from use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Advanced Notice of Proposed Rulemaking (ANPR) (Federal Register, November 6, 2002, page 67572).
IWP will confine its specific comments to that portion of the ANPR which seeks information related to the use of poultry litter in cattle feeds. However, IWP wishes to associate itself with the collective comments dated January 13, 2003, filed on behalf of 15 national organizations involved in animal production, feed manufacture, ingredient processing, meat processing and animal care. IWP also wishes to associate itself with the individual association comments of the American Feed Industry Assn. (02/04/03), the North American Rendering Industry (02/04/03), and the National Cattlemen’s Beef Assn. (02/04/03).
Our company has and continues to support the current science-based federal regulatory framework set in place by the Food & Drug Administration (FDA) in 1997, restricting the use of certain proteins derived from mammalian tissues for use in ruminant feeds. These regulations are part of a comprehensive federal three-tier firewall strategy, i.e. a ban on the import of ruminants and ruminant products from countries with bovine spongiform encephalopathy (BSE); a statistically sound and comprehensive animal surveillance program to continually monitor for the presence of the disease, and ruminant feeding restrictions to prevent the introduction and spread of the infective agent.
IWP concurs with the majority of affected agricultural organizations commenting on this notice that this federal regulatory scheme, coupled with industry voluntary efforts to certify that renderers, feed companies and producers are complying with federal restricted use protein rules, has proven successful in meeting the objectives of FDA and the U.S. Department of Agriculture (USDA) in ensuring not only will BSE not be introduced in domestic cattle herds, but that should such an unlikely event occur, the current system will operate to prevent amplification and spread of the infective agent.
FDA’s goal should not be to tinker with a regulatory mechanism that is working as designed, but rather the agency should work with industry to achieve 100% industry compliance with the existing rules. FDA’s Center for Veterinary Medicine has stated in a recent meeting that inspections of regulated facilities have yielded actionable violations in less than 1% of facilities. This level of compliance is almost unheard of in federal regulatory/inspection programs.
The greatest testimony to the success of these federal actions is that in nearly 20 years of oversight, inspection and surveillance, no case of BSE has been detected in the U.S. cattle herd. Continued rigorous enforcement of the current restricted use protein rule will result in much greater risk mitigation than any of the changes discussed in the ANPR.
* * *
Use of Poultry Litter in Cattle Feed
IWP reminds FDA the Harvard Risk Assessment contracted by USDA did not indict poultry litter feeding to cattle per se as a vector for the BSE agent, nor did Harvard recommend its elimination as a legitimate feed supplement. What the analysts at Harvard suggested is that the feeding of poultry litter bears investigation.
How extensive is the use of poultry litter in cattle feed in the U.S.?
IWP is concerned that FDA may act precipitously in banning the feeding of poultry litter to cattle. The use of poultry litter as a feed supplement or feed ingredient is not sufficiently understood by the agency, and until it is, any action to ban its use in livestock rations would be premature at best, and economically devastating in some states - including California - at worst.
In this vein, IWP respectfully challenges FDA’s legal authority to regulate a feed ingredient not in interstate commerce. Since it appears the majority of poultry litter is fed within states, some with regulatory schemes, and there is little, if any, evidence of an economic incentive to engage in interstate commerce, then IWP respectfully suggests such an action relative to poultry litter as implied by the ANPR, is beyond the agency’s legal authority.
IWP cannot comment on the extent to which poultry litter is fed on a national basis. Our expertise and experience is strictly within California. In the state of California, dried poultry litter (DPL) has been processed and fed under a strict state regulatory program for over 25 years. The California Department of Food & Agriculture (CDFA) estimates that up to 8,000 tons of processed poultry litter is used in ruminant feeds on an annual basis, with DPL commonly fed as a protein and hay replacer in young dairy heifer rations. However, it is prohibited by California feed law from inclusion in lactating dairy animal feeds, and is not, by practice, fed to beef cattle. Currently, five companies are licensed and permitted to process DPL, including IWP, and these facilities are inspected monthly for compliance by the CDFA.
IWP and its competitors strongly believe that by supporting science-based state regulation of DPL processing and feeding, we have successfully eliminated any raw or unprocessed litter sales from poultry operation to cattle rancher. However, to ban the legitimate use of DPL - that processed under state oversight - would be to turn back the clock and potentially inspire sales of unprocessed product.
What is the level of feed spillage in poultry litter?
The following calculations are taken from the ANPR comments of the North American Rendering Industry (02/04/03), and are worth restating here:
“The feed spillage 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”
What are the methods used to process poultry litter before inclusion in animal feed?
Generally, DPL is processed through dehydration using natural or artificial heat to destroy pathogens and microorganisms and to eliminate moisture. At IWP, we first grind the litter in a hammermill through a 3/8” screen. The product is then indirectly heated to 200-plus degrees F. for a period of no less than two minutes. At this temperature and for this period of time, the process kills all pathogens to assure a safe finished product. The litter is then passed through a rotary screen to remove any debris, e.g. feathers, so as to produce a consistent, high-quality feed product. All production records, including temperature recordings, are kept at our facility for a minimum of two years, and local inspectors visit our facility monthly to ensure we’ve complied with the strict regulations set by CDFA.
What will be the adverse and positive impacts (economic, environmental, health, etc.) resulting from banning poultry litter in ruminant feed?
The poultry industry, understandably, has a vested economic interest in both minimizing feed spillage and maximizing the utility of waste products. IWP’s DPL products assist in the latter endeavor.
IWP respectfully disagrees with comments filed in response to this question by the CDFA. There is absolutely no scientific evidence that eliminating the feeding of DPL, as processed under California regulation, will have any material impact on the effectiveness of the federal restricted use protein regulation. Again, it would be regulation for the sake of regulation - “feel good” regulation, if you will.
The economic impact of such action by the federal government - and we continue to respectfully challenge FDA’s legal authority to take such action - would be devastating to industry within the state of California. IWP estimates the impact on the DPL processing industry would be in excess of $10 million a year in lost sales, job layoffs, abandoned freight contracting, etc. IWP would incur a loss in excess of $1 million per year, with one of our competitors likely losing up to $5 million per year, and our remaining competitors losing in the neighborhood of $500,000 per year.
At the same time, the impact on the California dairy industry would be equally devastating. With milk prices hovering near support price levels, any precipitous action by the state or federal government that would remove a safe, low-cost, alternative high-protein feed ingredient/supplement from the farmer’s feed bunk would increase feed costs by as much as $50-100 per ton. We estimate DPL saves California farmers $7-8 million a year in added feed costs, or $60,000 per producer.
The loss to the poultry industry would be equally devastating. In California, approximately 160,000 tons of raw litter is processed each year, and if this product were banned by FDA, the loss to poultry producers would approach $2 million per annum. If that much litter could be absorbed into the fertilizer market, the negative effect on commercial fertilizer sales would equally significant. So, if we do the math:
$10 million loss to the California DPL processing industry
$7-8 million loss to the California dairy industry
$2 million loss to the California poultry industry
$2 million loss to the California fertilizer industry
ESTIMATED ECONOMIC IMPACT PER YEAR FROM A BAN ON DPL = $20-22 MILLION
-- with no scientific evidence that feeding DPL is a problem.
IWP agrees with the CDFA comment that “any change in disposition of poultry litter and wastes could have important environmental and health impacts, as available land to dispose of such material is limited.” IWP would go so far as to say the impact would be disastrous.
Adding 160,000 tons of unprocessed poultry litter to an already strained landfill system is a critical consideration because if it cannot be disposed of, it must be either stored or utilized. To store unprocessed litter on-farm creates a fire hazard from internal temperature build-up. Storing such unprocessed animal waste also contributes to air quality problems, and if simply stored without expensive warehousing, the risk of nitrates leeching into the water table is very real, exacerbating California’s already critical water supply situation.
IWP can only assume similar environmental impact would be felt across the other major poultry growing regions of the country.
Instead of considering a ban on poultry litter feeding, FDA should look to the highly successful, strict California DPL licensing and permitting process which has operated so successfully for the past quarter of a century as a model for how to take a waste product and, using science and technology, turn it into a valuable byproduct, one that provides both animal nutrition, environmental and economic benefit. The California program could serve as a standard by which the federal government could judge the need to improve the effectiveness of controls in other parts of the U.S.
There is no BSE in the U.S. Our current regulatory and surveillance systems are working just as they were designed to work.
IWP wishes to reiterate its support for the manner in which FDA has implemented science-based, effective actions that have materially contributed to preventing BSE from entering the U.S. This approach has been timely, sensible and pragmatic, and in cooperation with USDA and the regulated industries, U.S. government actions have been successful in preventing in this country what devastated the United Kingdom and other nations around the world.
To ban the feeding of DPL would be wrong. Not only would it be ill-advised because there is no science or experience to substantiate the need for such federal action, it would be arbitrary, with serious economic and environmental impacts on not just California, but across the U.S., all without materially improving or strengthening our BSE prevention and control system.
FDA must not succumb to the notion that new regulations are needed simply because no material change in our BSE prevention system has been implemented in the last few years. The Harvard Risk Assessment confirmed we have taken and are taking the right actions. The U.S. took its lessons from the European experience, did not fall prey to its mistakes, and we have created an effective government-industry commitment to a responsible regulation that is working.
What FDA must do now is invest its time, manpower and dollars in unrelenting enforcement of the current regulatory program. Thank you for consideration of our views.