FDA Issues Guidance on Regulating Genetically Engineered Animals

The U.S. Food and Drug Administration recently issued a final guidance for industry on the regulation of genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA).

The guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," clarifies FDA's statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it is called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

"Genetic engineering is a cutting edge technology that holds substantial promise for improving the health and well being of people as well as animals. In this document, the agency has articulated a scientifically robust interpretation of statutory requirements," said Randall Lutter, Ph.D., deputy commissioner for policy. "This guidance will help the FDA efficiently review applications for products from GE animals to ensure their safety and efficacy."

FDA released the draft guidance in September 2008 with a 60-day public comment period, and received about 28,000 comments. The agency has summarized and responded to these comments at www.fda.gov/cvm/GEanimals.htm.

Product Showcase

  • Magid® D-ROC® GPD412 21G Ultra-Thin Polyurethane Palm Coated Work Gloves

    Magid’s 21G line is more than just a 21-gauge glove, it’s a revolutionary knitting technology paired with an advanced selection of innovative fibers to create the ultimate in lightweight cut protection. The latest offering in our 21G line provides ANSI A4 cut resistance with unparalleled dexterity and extreme comfort that no other 21-gauge glove on the market can offer! Read More

  • Glove Guard® Clip

    Safety should never be compromised, especially when it comes to proper glove usage. The Glove Guard® clip enhances safety by encouraging employees to keep their gloves with them at all times. This reduces the risk of accidents and injuries on the job. By ensuring everyone has their gloves readily available, we help promote a culture of safety and efficiency. The Glove Guard® clip is designed to withstand the toughest work environments. Constructed from robust materials made in the USA, it can endure extreme conditions, including harsh weather, and rigorous activities. Read More

  • Safety Knives

    The Safety Knife Company has developed a quality range of safety knives for all industries. Designed so that fingers cannot get to the blades, these knives will safely cut through cardboard, tape, strapping, shrink or plastic wrap or a variety of other packing materials. Because these knives have no exposed blades and only cut cardboard deep, they will not only protect employees against lacerations but they will also save product. The Metal Detectable versions have revolutionary metal detectable polypropylene knife bodies specifically for the food and pharmaceutical industries. This material can be detected and rejected by typical detection machines and is X-ray visible. Read More

Featured

Webinars