Human food safety

Figure 3 Structures of phenethanolamine /3-adrenergic agonists of potential human food safety concern. Multi-residue methods have been developed with the goal of broad cross-reactivity so that simultaneous screening may occur efforts have not been particularly successful...

Unlike the naturally occurring hormones for which human food safety assessment is based on a ratio of their amount consumed in food compared to their amount produced endogenously by the consumer, safety assessment for the synthetic trenbolone acetate and zeranol hormones is based on alternative... 

In some instances additional specialized studies may be required to assess drug-specific toxicological concerns. For example, hypersensitivity tests may be required for the -lactam antibiotics FDA has recently been concerned with how this standard human food safety assessment process accurately determines the safe concentration of antibiotic residues based on the traditional toxicological end-points. Of particular concern was the impact of low levels of antibiotics on the intestinal microflora. 

The authors would like to express sincere appreciation to the following individuals for their invaluable comments and suggestions Dr. Steven Vaughn and Dr. Joan Gotthardt (general manuscript review) Dr. Mark Robinson (human food safety) Dr. Margaret Oeller (veterinary pharmaceuticals for minor uses and minor species) and Dr. Richard Ellis (international harmonization efforts). 

Greenless, F.J. Animal drug human food safety toxicology and antimicrobial resistance—the square peg. Int. J. Toxicol. 2003, 22, 131-134. 

Craigmill, A.L. Cortright, K.A. Interspecies considerations in the evaluation of human food safety for veterinary drugs. AAPS PharmSci. 2002, 4 (4)Article 34. 

Any effort to develop performance criteria for screening test for animal drug residues must have the twin goals of providing for good method performance and of not unnecessarily restricting the development and maturation of an analytical technology that has potential benefits for human food safety and public health. 

Prediction models for residue transfer into eggs are being developed. Recent results indicate that the developing egg yolk serves as an important storage depot for chemical residues. From the view point of human food safety, the current study was conducted to visualize incorporation and potential compart-mentalization of drug residues in developing egg yolks. For details see Section 12.3. 

J.C. Juskevich, C.G. Guyer. Bovine Growth Hormone Human Food Safety Evaluation. Science, Vol. 249, pgs. 875-884, August 24,1990. 

The remainder of this article will outline the major parts of the human food safety portion of the new animal drug approval process with emphasis on the important interface between drug toxicology and residue chemistry. However, before the discussion of the guideline material a brief discussion of some important historical aspects and definitions needs to be given. 

SOM final rule Sponsored Compounds in Food Producing Animals Criteria and Procedures for Evaluating the Safety of Carcinogenic Residues Animal Drug Safety Policy Final Rule, Availability of Guidelines for Human Food Safety Evaluation Notices, Federal Register, No. 251, December 31,1987, 52, 49572-49590. 

The FDA approval was based on over 100 studies of the human food safety of BST (17). 

TABLE 2.12 Classification of Studies Required by Regulatory Authorities to Satisfy Human Food Safety Requirements on AMDs Residues... 

Friedlander LG, Brynes SD, Fernandez AH, The human food safety evaluation of new animal drugs. Vet. Clin. North Am. Food Anim. Pract. 1999 15 1-11. 

Leslie Dickson, Canadian Food Inspection Agency, Saskatoon Laboratory, Centre for Veterinary Drug Residues, Saskatoon, Saskatchewan, Canada Rick Fedeniuk, Canadian Food Inspection Agency, Saskatoon Laboratory, Centre for Veterinary Drug Residues, Saskatoon, Saskatchewan, Canada Lynn G. Friedlander, Residue Chemistry Team, Division of Human Food Safety, FDA/CVM/ONADE/HFV-151, Rockville, Maryland... 

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