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The US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced on December 30 the approval of SALMONELEX as a "GRAS" (Generally Recognized as Safe) food processing aid against Salmonella.
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The new product consists of natural phages against Salmonella and is produced by Micreos of The Netherlands. The company confirms that industrial scale projects with US poultry processors will start in January 2014.
According to a report published in December by USDA's Food Safety & Inspection Services (FSIS), Salmonella contributes most to the FSIS's "All-Illness" performance measure and Salmonella illness estimates have continued at a steady high or slightly increased rate, despite FSIS interventions.
According to Micreos' CEO Mark Offerhaus: "Now that the FDA and USDA have given the green light, we can offer food processors a new and natural solution against Salmonella, including antibiotic resistant strains. SALMONELEX is seen as a very elegant solution as it targets only Salmonella and has no other effect on the treated food product, neither in taste, nor texture. Following the successful launch of LISTEX against Listeria, we are now further expanding the 'green' arsenal of weapons against foodborne pathogens. Given the prevalence of Salmonella in raw poultry, we expect poultry processors to be the first and largest users of SALMONELEX."
According to Dirk de Meester, business development manager for Micreos: "Research has shown that SALMONELEX does not dissipate in the presence of protein. Thus, the product enables processors to reduce the use of chemicals and reach Salmonella in places where antimicrobial chemicals are ineffective, for example in follicles which close when exposed to cold water in a chiller."
The American Feed Industry Association submitted comments to the US Food and Drug Administration regarding FDA’s final rule amending the procedures for substances generally recognized as safe (GRAS).
FDA’s Center for Veterinary Medicine recently started to review GRAS submissions for new animal feed ingredients, while the human food industry has had hundreds reviewed and allowed on the market, according to AFIA.
“While the industry is still able to self-determine the GRAS status of a substance, it is in the best interest for all entities to work together. Finding a workable solution will ensure that the U.S. feed industry continues to be the world leader in bringing novel ingredients to market to help the animal agriculture industries safely feed the growing population,” said Leah Wilkinson, AFIA’s director of ingredients and state legislative affairs.
CVM stated during several public forums that proof of utility of an ingredient must be published. However, AFIA said it believes that an absolute requirement for proof and publication of utility is inappropriate and unnecessary, claiming the pivotal issue is whether the ingredient is safe to feed to animals at the intended level. AFIA also said CVM should accept safety data extrapolated from other species, instead of requiring separate tests for each species.
“The additional cost and time alone will deter companies from pursuing new feed ingredients or more efficient ways to produce existing feed ingredients regardless of the well-established safety of these ingredients. CVM should recognize that good scientific procedures can prevail to allow the use of other data or information in the available literature to extrapolate the safety data from one species to another,” Wilkinson said.
In the third main issue commented upon, AFIA said it believes GRAS-notified substances reviewed by FDA without objection need to be listed in the Association of American Feed Control Officials' Official Publication. In its comments, AFIA strongly encouraged CVM to work with AAFCO and the industry to create a new section in the AAFCO Official Publication for GRAS-notified substances reviewed by CVM and found to present a sufficient basis for a GRAS conclusion.
The US Food and Drug Administration (FDA) issued a letter to clarify the marketing of a substance as generally recognized as safe (GRAS) for use in animal food.
A substance marketed as GRAS is not subject to premarket review or approval by FDA, the letter explains. This marketing is done at the company's own risk, however the substance and firm are subject to FDA enforcement action if the agency determines a substance is not GRAS.
The letter also explains FDA’s voluntary pilot program for GRAS notifications. A firm may participate in this program by submitting a "GRAS notice" to FDA, summarizing information the firm relied on as its basis for the GRAS label. FDA then evaluates the "GRAS notice" to determine if there is sufficient evidence for the firm's GRAS product marketing.
The Food and Drug Administration’s Center for Veterinary Medicine is implementing a voluntary pilot program to accept and review GRAS (generally recognized as safe) notices for animal feed ingredients directly from manufacturers.
The new program will allow feed producers (deemed “notifiers” in the program) to inform the FDA that they determined the use of their ingredients are GRAS, instead of the prior system when producers asked the FDA to confirm that the ingredients’ use was GRAS.
The GRAS notices manufacturers can submit should include a GRAS exemption claim that contains the following:
*A succinct description of the ingredient containing chemical, toxicological, and, if applicable, microbiological characteristics;
*The applicable conditions of use including what food it will be used in; levels of use in such foods, the purposes for which the ingredient is used, and the specific animal species intended to consume the ingredient;
*And the basis for the GRAS determination (scientific procedures or common use in food).
The FDA will then evaluate whether the submitted notice provides a sufficient basis for a GRAS determination.
The agency strongly encourages potential participants to contact the CVM’s Division of Animal Feeds prior to submitting notices to discuss their submission plans.
The animal-related division of the Food and Drug Administration (FDA) looks at what it can do to prevent a problem before it becomes a problem, FDA Deputy Commissioner Joshua Sharfstein told those attending the Pet Food Institute (PFI) annual meeting in Washington, DC.
He said the agency strives to make sure all parties affected know what the standards are and what they have to do to comply.
He also noted that if there is an issue, FDA needs to know about it. On the topic of generally recognized as safe (or GRAS) clearances, Sharfstein said he finds that area "interesting" but said FDA wants it to work.
The following is a summary of the Pet Food Institute's (PFI) recommendations on self-affirmed generally recognized as safe ingredients (SA-GRAS). Geoffery Wong of the Food and Drug Administration (FDA) will present on this topic October 15 at the PFI Annual Industry Meeting.
1. FDA's Center for Veterinary Medicine (CVM) does not have the resources to review ingredients under both SA-GRAS and the Association of American Feed Control Official's (AAFCO) Ingredient Definition Committee (IDC). The firm seeking the approval should determine which way they want to submit.
2. A firm can make a determination that a particular use of a substance is GRAS and go to market. Or, notify FDA of its notification.
3. The scientific standard for a determination of GRAS requires the same quality and quantity of information in a food additive petition.
4. Proceeding with the AAFCO process has a lower data hurdle, in part because these ingredients are ones for which FDA does not have safety concerns.
5. If they notify FDA the result will be: Letter of no questionsLetter stating insufficient basisCVM does not support listing an ingredient that goes through the FDA-SA-GRAS process in the OP.If a state takes action against an ingredient that is the subject of a no questions letter and is listed on the Web site, FDA will not support the state challenge.
6. An ingredient the firm wants listed in the OP must go through the AAFCO-IDC process.
At the PFI Annual Industry Meeting, The Update Session, October 15, at 2 p.m., will feature:
*Ricky Schroeder, manager, Feed & Fertilizer Reg., Texas A&M University (AAFCO Perspectives)
*Bill Burkholder, petfood specialist, FDA, CVM (Current state of petfood regulations)
Geoffery Wong, supervisor, Ingredient Safety Team, FDA, CVM (More information on Self-Affirmed GRAS)
*Kim Young, deputy director, Division of Compliance, FDA, CVM (Reportable Food Registry)
*Kristin Schmitz, senior staff veterinarian, USDA, APHIS, VA, NCIE (Canadian Export Issues)
