Greenfield, IN., April 7, 2009 – Elanco is pleased that the European Food Safety Authority (EFSA) has aligned with 26 other regulatory authorities in determining that "... ractopamine is not mutagenic and is not likely to present a carcinogenic risk to consumers." "The safety of Ractopamine for use in swine and beef has been well established through rigorous scientific studies and regulatory reviews," notes Dr. William Weldon, Senior Director of Research and Development for Elanco.1,2,3
Further, "Elanco looks forward to meeting with EFSA scientific experts to address their technical questions on study design and purpose and statistical aspects," Weldon notes. The FEEDAP Panel under EFSA has been reviewing the human safety data as part of the process toward establishing a Codex international food safety standard for Ractopamine. Normally, the regulatory process involves the exchange of data, questions and responses, but unfortunately due to time constraints the interaction between Elanco and FEEDAP has not been possible.
Also, the FEEDAP Panel report notes that, "If the pre-requisites of JECFA [Joint FAO/WHO Expert Committee on Food Additives] of an ADI [Acceptable Daily Intake] value of 0.06 mg/person1 and free ractopamine as the marker residue are taken as a basis, the FEEDAP Panel would reach a similar conclusion that consumer safety would be ensured without applying a withdrawal period to pig and cattle."
In their review, the FEEDAP Panel raises a number of technical questions as the reason for not supporting the international food safety standard for Ractopamine determined by JECFA. Elanco recognizes that there can be varying interpretations of scientific data amongst experts. However, Elanco differs with the technical positions of the FEEDAP Panel (See key questions raised by FEEDAP and Elanco's more detailed responses below in Appendix A.). Elanco believes that all these questions can be resolved through scientific interaction with the EFSA and FEEDAP scientists.
FEEDAP technical questions and Elanco's response points include:
Whether the relevant effect, which would serve as basis for consumer safety must be a NOAEL (No Observable Adverse Effect Level) verses a NOEL (No Observable Effect Level):
Historically the scientific assessment has been based on adverse effects.
Whether chronic or acute exposure should determine the human safety standard:
Regulatory bodies have traditionally based NOAEL on chronic studies.
Whether the safety standard, i.e. the MRL (maximum residue limit), should be based on toxicological verses pharmacological considerations:
The Codex procedure manual describes the MRL as, "... the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake ..." 4
Whether an animal model should be used verses a human study to determine the human safety, and whether the animal model should be based on a dog or a monkey:
Typically animal models are used as surrogates for human studies, and in unique cases where human studies are conducted, the study group is limited.
Monkeys are physiologically more similar to humans than dogs.
Dogs are uniquely sensitive to beta-agonists and have a receptor population different from humans and non human primates.
Whether the statistical power of the population in the human study is sufficiently robust to be determinative:
The six person human study was not designed to be a definitive study.
Whether the human safety assessment should be based on oral verses intravenous (IV) use in food animals:
ADIs and MRLs are developed to determine the safety of residues in food from animals administered a substance that is destined to be used as human food; thus the only route of exposure of consequence to humans is therefore the oral route.
"Elanco is looking forward to working with the EFSA and FEEDAP scientists to resolve all these technical questions," said Dr. Weldon. "With the extensive human safety-record already established for Ractopamine worldwide, we are confident that we will be able to come to a similar assessment outcome with EFSA".
For background, ractopamine hydrochloride (Ractopamine) is the compound used in Elanco's brands Paylean® and Optaflexx® that are used as feed ingredients in swine and cattle production.1,2,3
Twenty-six regulatory authorities have extensively reviewed the full Ractopamine data submission and based on a series of stringent human and animal food safety criteria concluded it is safe for use in swine and/or cattle production. It is registered in countries including the United States, Canada, Australia, New Zealand, Mexico, Brazil, South Korea, the Philippines and Hong Kong. Since first approval in 1999 in the United States, the product has been used in well over 300 million swine worldwide producing more of the quality lean meat that consumers desire.
Ractopamine has a recommended international food safety standard from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and is currently at Step 8 in the Codex process.5,6 It has been discussed multiple times during the Codex process and the recommended draft MRLs have been advanced via consensus process and recognized as sound.
An international food safety standard is established by Codex for compounds used in food animal production to ensure a common threshold for food safety for consumers around the world. JECFA is the scientific expert review committee that prepares the international food standard assessment before such a standard is determined by Codex.
*Safety Evaluation of ractopamine. Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed. (Question No EFSA-Q-2008-433) Adopted on 2 April 2009
The label contains complete use information including cautions and warnings. Always read, understand and follow the label and use directions.
1Elanco Data on File
2Directions for use in swine: Feed at 4.5 to 9.0 g/ton to finishing swine in a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain (group average). Clinical registration studies showed no statistical difference between the effects of 4.5 g/ton and 9 g/ton. Caution: Ractopamine may increase the number of injured or fatigued pigs during marketing. Not for use in breeding swine.
3Directions for use in cattle: Optaflexx is approved for feeding during the last 28 to 42 days prior to harvest to be fed at 8.2 to 24.6 g/ton to provide 70 to 430 mg/hd/d for the last 28 to 42 days on feed. For increased rate of weight gain, improved feed efficiency and increased carcass leanness feed Optaflexx during the last 28 to 42 days prior to harvest at 9.8 to 24.6 g/ton to provide 90 to 430 mg/hd/d. Caution: Not for animals intended for breeding.
4http://www.codexalimentarius.net/web/procedural_manual.jsp. P. 43.
52004 WHO_TRS_925 [1] - 62nd JECFA – Ractopamine Review
6Source: Reports of the 15th, 16th and 17th Sessions of the Codex Committee On Residues Of Veterinary Drugs In Foods and Reports of the 29th, 30th and 31st Session of the Codex Alimentarius Commission. http://www.codexalimentarius.net/web/index_en.jsp
Paylean® is a trademark for Elanco's brand of ractopamine hydrochloride used in swine.
Optaflexx® is a trademark for Elanco's brand of ractopamine hydrochloride used in cattle.
For more information, click here to view Elanco Ractopamine Background and Q&As Regarding EFSA Opinion