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”.