FDA clarifies earlier announcement
The Food and Drug Administration announced a proposed delay in the implementation of the final rule titled, “Substances Prohibited from Use in Animal Food or Feed” – more commonly referred to as the 2008 BSE final rule. The final rule, which would have gone into effect on April 27, 2009, is proposed to be delayed 60 days to June 26, 2009. The agency is taking this action in response to comments from affected parties expressing concerns about their ability to fully comply with the rule by the April 27, 2009 effective date. In addition, some affected parties are finding it difficult to identify appropriate alternate ways of disposing of material that may no longer be rendered for animal feed use once the rule takes effect.
The FDA is also providing 7 days for public comment solely on the question of whether to delay the effective date. Comments must be submitted within 7 days of publication in the Federal Register of the notice of proposed delay of effective date.
Interested persons may submit written comments on or before April 16, 2009 to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.regulations.gov. Identify all submissions to the docket with the following docket number: FDA–2002–N–0031 (formerly Docket No. 2002N–0273).
For additional information, please see http://www.federalregister.gov/OFRUpload/OFRData/2009-08127_PI.pdf and http://www.fda.gov/cvm/bsetoc.html.
Questions may be directed to Burt Pritchett, Center for Veterinary Medicine (HFV-22), FDA, 7519 Standish Place, Rockville, MD 20855, 240-453-6860, firstname.lastname@example.org.
The National Cattlemen’s Beef Association (NCBA) criticized FDA’s decision to solicit public comments solely on delaying the implementation of a new feed ban, rather than soliciting public comment on the ban itself.
NCBA has been opposed to the enhanced feed ban since it was originally proposed in 2005, and continues to urge FDA to open the rule to public comment and delay implementation until they have had adequate time to consider the many problems caused by the ban.
“Cattle producers across the country have been suffering as a result of this proposed rule months before it is scheduled to take effect,” explained Dr. Elizabeth Parker, NCBA chief veterinarian. “Members of Congress and the Senate have joined NCBA in petitioning the FDA to reopen the rule itself for public comment so that the people impacted by the rule can share their stories. Instead, the FDA is only allowing seven days of comments on whether to delay the implementation of the rule by 60 days. This is a weak and ineffective response to the issues already arising from this ill-considered action.”
Over the past two decades industry and government have worked together to put in place science-based measures which have proven successful in preventing and reducing the spread of Bovine Spongiform Encephalopathy (BSE) in the U.S. Furthermore, the incidence of BSE worldwide has dramatically decreased due to the many measures put into place, including a series of interlocking safeguards and science-based mitigation practices.
“We must continue to look to the science to avoid over-regulating the industry and creating policy that doesn’t meet our objective of a safer animal health system,” said Dr. Parker.
Since 1997, the U.S. has prohibited ruminant feed from including parts of other ruminants. This proactive “ruminant to ruminant” feed ban, combined with other government and industry safeguards, has proven to be highly successful in limiting BSE in the U.S. herd. The U.S. has an extremely low level risk of BSE, as demonstrated by years of robust USDA surveillance and confirmed by the U.S. “BSE Controlled Risk” designation by the OIE, the international animal health standard setting body.
“The FDA did not do a risk assessment for this so-called enhanced feed ban,” said Dr. Parker. “The prevalence of BSE in the healthy cattle population of the United States is negligible, and globally this situation has nearly been eradicated.”
The enhanced feed ban would move beyond the current ban in that it would prohibit certain cattle-derived risk materials from all animal feed. As such, the enhanced feed ban would provide negligible benefits to animal health or food safety. It would also create tremendous costs for ranchers, exacerbate disposal issues, and generate environmental concerns.
Beginning as early as December 2008, many renderers stopped picking up dead livestock because of the severe economic realities of this proposal. For several months, NCBA has received numerous reports from producers and veterinarians having increased difficulty in getting dead animals picked up, and if they are able to find pick-up services, the prices charged by the haulers and renderers are significantly higher than they ever have been.
“This rule has essentially ended rendering services in many parts of the country, and left producers with no legal alternatives,” Dr. Parker said. “These are 1,200 pound animals. It is unrealistic and simplistic to think that producers can dispose of them in their backyards. The environmental and economic consequences are enormous and FDA has the responsibility to consider those concerns before implementing this rule.”
FDA estimates the new regulations would generate an additional 28 million pounds of prohibited material derived from healthy cattle at the slaughter plant level and will create an estimated 26.2 – 41.6% decrease in cattle carcasses being picked up by rendering services, which translates into an additional 369 – 577 million lbs. annually that will have to be disposed by some other means. This is in addition to the approximately 3 billion lbs. of ruminant carcasses resulting annually from natural causes. While FDA acknowledges these very real concerns, it has yet to identify any viable solutions.
This rule, as originally proposed in October 2005, failed an economic cost benefit analysis as required by the Office of Management and Budget and was sent back to FDA for revision. The revised final rule published in April 2008 was a political decision, disregarding the economic consequences of such a rule, as well as ignoring risk analysis, the current U.S. herd BSE status, the current world BSE status and ignoring the facts of the multiple firewalls existing in this country for decades, including a strong, historical and existing feed ban compliance.
“FDA says they have no jurisdiction over these disposal issues,” Dr. Parker said. “But that does not absolve the Federal government from their responsibility to provide solutions to the problems this rule creates if they go ahead with implementation.”