Industry responds to possible additional government regulations.
By Tina Caparella
Renderers have long dealt with regulations, whether at the local, state, or federal level. Laws that concern air quality, odor emissions, and worker safety, just to name a few, have long been part of doing business.
But for nearly 20 years, U.S. regulators at the federal level have been targeting ways to keep the country’s food and feed supply safe from what is often referred to as a “European disease” – bovine spongiform encephalopathy (BSE). Since 1986, the United States has taken one step after another to put protective measures in place to prevent the introduction of BSE into the country (see “Protective Measures Put in Place Early On,” April 2004 Render).
For renderers, these measures hit home in 1997 when the Food and Drug Administration (FDA) banned the use of mammalian proteins in ruminant feed. To ensure all parties affected were complying with the regulation, FDA, with the help of state officials under contract, has conducted tens of thousands of inspections. To date, the compliance rate exceeds 99 percent.
Now, seven years later, FDA and several other government agencies are considering further bans after one case of BSE was discovered in December 2003 in a cow imported from Canada.
FDA and the U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) and Food Safety and Inspection Service (FSIS) released a joint advance notice of proposed rulemaking (ANPR) in July 2004 seeking comments and scientific information on several additional measures under consid-eration related to animal feed to help prevent the spread of BSE in the United States. With a deadline of mid-August to FDA, and mid-September to APHIS and FSIS, com-ments have been submitted and are now being weighed as the three agencies contemplate what to do next.
Consequences of SRM Removal
It was a team effort, involving not only the National Renderers Association (NRA) and Animal Protein Producers Industry (APPI), but also individual rendering companies and a study by Informa Economics (formerly Sparks Companies) commissioned by NRA. Thirty questions in the ANPR had to be answered with scientifically based evidence and the affects further regulations would have on the economy of the rendering industry. NRA and APPI submitted a 19-page response to FDA and five page responses to both APHIS and FSIS. Accompanying all responses was a copy of Informa’s 25-page study on the economic and environmental affect of removing specified risk materials (SRMs) and cattle mortalities from existing markets.
One of biggest issues addressed in the ANPR is FDA’s consideration of removing SRMs from all animal feeds, including pet food. SRMs are defined by USDA as the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle.
There is no scientific evidence to support the removal of SRMs from all animal feed. The removal of SRMs from cattle feed, which is already in place under FDA’s 1997 feed rule, has been accepted internationally as central to the control of BSE. This has been referenced in published literature and recommended by various regulatory agencies, including the World Health Organization (WHO), as mandatory to prevent transmission and amplification of the disease. As for the economic impact of removing SRMs from all animal feed, NRA argues in their comments that it would require costly redesign of facilities and processes, significantly increase disposal costs, reduce the value of livestock, and necessitate closure of certain rendering facilities that cannot feasibly exclude SRMs from their raw material supply. Informa’s study provides data and supporting documentation that the annual economic loss to renderers would be $32.4 million from lost meat and bone meal sales and $59.2 million in lost sales of tallow, for a total product loss of $91.6 million. In addition, the total cost to dispose of the 1.423 billion pounds of SRMs currently produced in the United States would be $74.7 million per year. According to NRA, this estimate is consistent with a recent report published by the European Association for Animal Production showing the cost of meat and bone meal disposal is nearly twice the value of meat and bone meal.
In addition to the $166.3 million annual economic impact from product losses and disposal costs, disposing of SRMs, along with dead stock and non-ambulatory (downer) cattle also under consideration, would create a major environmental impact. Without these materials going to renderers, it would be necessary to discard or dispose of animal by-products and mortalities in community landfills, compost piles, burial sites, incinerators, or, worse, could be illegally dumped, causing a potential public health hazard.
Each of these alternative methods has several limitations with respect to disposal of SRMs and mortalities, with limited space being the most obvious. If SRMs and dead and downer cattle were all disposed of in landfills, this would amount to seven billion pounds, or 3.5 million tons annually. Disposal costs would be high and the number of landfills capable of handling this material would be limited since they would have to be in compliance with the Code of Federal Regulations, Title 40, Part 258 requirements, including construction of disposal cells separated by heavy poly liners and leachate collection systems.
Other Products Under Scrutiny
Along with SRMs, FDA is examining whether bovine blood or blood products in feed and plate waste pose a risk of BSE transmission in cattle and other ruminants. NRA cites in its response numerous research results that show no BSE infectivity has been detected in bovine blood in either natural or experimental cases.
As for plate waste, these products consist of predominantly non-meat products, and with current FDA regulations, infective tissues of ruminant origin are extremely unlikely to be included. A conclusion in the 2001 Harvard Center for Risk Analysis study states, “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.”
NRA’s response stated that it is important to note that used cooking oil from restaurants and snack food manufacturers is not plate waste and has no risk since it does not contain SRMs.
The safety of tallow is also being examined, specifically tallow derived from the rendering of SRMs, dead stock, and non-ambulatory cattle with an insoluble impurity level of 0.15 percent or less. The Office International des Epizooties, now the World Organization for Animal Health, categorizes tallow with insoluble impurities of no more than 0.15 percent to be protein-free tallow and indicates tallow meeting this standard can be safety consumed by animals, regardless of the raw material source. In addition, extensive research indicates the safety of tallow with respect to BSE transmission. In 1991, the WHO assembled specialists in transmissible spongiform encephalopathies (TSEs) and determined tallow is not a risk to animal or human health. The organization concluded in 2001 that because of the proteinaceous nature of the TSE agents, these agents tend to remain with the cellular residues of meat and bone meal during the extraction process, rather than being extracted with the lipids of the tallow. Other research projects are cited in NRA’s response that further illustrates the safety of tallow in animal feed.
Summary
The rendering industry recognizes the importance of BSE prevention measures to protect both cattle and public health and is committed to a strong BSE risk control program based on scientific facts and practical justification that can be implemented effectively and consistently. NRA and its members believe sufficient regulations are currently in place and are concerned that control measures proposed in FDA’s ANPR may cause significant unintended consequences adversely impacting animal health, economic dislocation throughout the rendering and livestock industry, and environmental concerns that are unresolved.
Renderers have an excellent record of compliance with the 1997 FDA feed rule, which, with the other BSE prevention firewalls, has provided redundant layers of protection of public and animal health. The success of these measures is illustrated by the continued absence of any indigenous BSE cases in the United States.
In their closing remarks, NRA reiterated to all three government agencies that additional regulations are not needed. Now all the industry can do is wait and hope that science and level heads prevail. v
The complete NRA/APPI comments, which cover other areas not addressed in this article, and Informa Economics’ study are available by clicking here.
October 2004 Render