What are the proposed benefits of biotechnological methods of genetic engineering?
According to the FDA, biotechnological methods of genetic engineering are techniques that plant breeders have to make direct modifications of DNA, a living thing's genetic materials. In applying such methods, scientists make copies to genes for desired traits and introduce the gene copy into an organism such as a food crop. The new gene is usually a single gene whose function is well understood. These new techniques avoid one of the major problems encountered by plant breeders who use cross hybridization, including no unwanted or undesirable genes are introduced with the desired gene. Additionally, scientists can make copies of genes from any organism - plant, animal, or microbe – which may yield a desired trait and introduce that gene into a food crop. This process greatly expands the pool of potentially useful traits available to plant breeders to improve food crops.
What is the FDA’s role in monitoring biotechnological developments?
FDA has provided guidance for developers that establishes a standard to care to ensure that foods derived from new plant varieties are safe and wholesome. Regardless of the method by which a food is produced, all foods must meet the same stringent safety standards and be properly labeled in accordance with the Federal Food Drug and Cosmetic (FD&C) Act. Highlights of some of the important factors included in FDA's guidance to industry, address such topics as genetic modification, toxicants, nutrients, new substances, allergenicity, antibiotic resistance markers, animal feeds and labeling. Additional insights on such guidances can be reviewed at the following URL: http://www.cfsan.fda.gov/~lrd/bioeme.html
Why is Federal oversight of biotechnology important?
Although drugs and biologics produced using biotechnology have been widely accepted by the public, this has not been entirely true for foods from bioengineered plants. There are also safety and ethical concerns regarding the use of cell and gene therapies, and without rigorous FDA oversight, the promises of gene therapy and biotech medicines will not be realized. If safety and effectiveness concerns are not adequately addressed, then public confidence in bioengineered foods will not be assured.
What products are impacted by biotechnology developments, for which the FDA will have some degree of oversight?
- Gene Therapy
- Biotechnology Devices
- Animal Drugs
For additional insight into these products, visit the following URL:
Does the FDA have a biotechnology performance plan?
Yes, the FDA maintains a biotechnology performance plan, intended to ensure the safety of food and feed, and safety and effectiveness of drug, device, and biological products that are derived from biotechnology. The key performance goal of the plan is to publish a final rule to require premarket notification for bioengineered foods.
Where does biotechnology fit into the larger organizational structure of the FDA?
Biotechnology is an area of interest to the FDA Center for Veterinary Medicine, with regards to transgenic fish. Additionally, biotechnology is a key program area of the FDA Center for Food Safety & Applied Nutrition (CFSAN). The program site provides information on presentations, announcements, regulations and guidance, information for consumers, food labeling and more.
Does the FDA have offices dedicated to biotechnology products?
The FDA maintains the Office of Biotechnology Products (OBP). The mission of the office is to protect public health by assuring the quality, safety, efficacy, availability and security of therapeutic protein and monoclonal antibody products.
||Research and Review Offices
| Federal Research Center
||National Institutes of Health
| White Oak Office Building #21
||Buildings 29 A and 29B
| 10903 New Hampshire Avenue
||8800 Rockville Pike
| Silver Spring, MD 20993
||Bethesda, MD 20892
| Phone: (301) 796-1688 Fax: (301) 796-9743
||Phone: (301) 827-1790 or (301) 827-0717
Does the FDA offer specific guidance and counseling for biotechnology clinical trials?
Yes, the FDA released a Guidance to Industry document, Independent Consultants for Biotechnology Clinical Trial Protocols, which highlights prerequisites to applicability and underscores the process of putting forth a request to the FDA, to engage such a consultant. The document is available at the following URL: http://www.fda.gov/cber/gdlns/bioclin.pdf .
Outside of the FDA, are their other government agencies with an interest in biotechnology?
The following table spotlights key Federal agencies with an interest in biotechnology developments.
|Federal Government Web Sites Associated with Biotechnology
|United States Department of Agriculture (USDA)
||Agricultural Biotechnology (USDA)
|USDA Animal and Plant Health Inspection Service
||Biotechnology Regulatory Services (APHIS)
|United States Food and Drug Administration (FDA)
|USDA Economic Research Services (ERS)
|National Institutes of Health (NIH)
||National Center for Biotechnology Information (NIH)
|FDA Center for Veterinary Medicine
||Transgenic Fish (FDA)
|United States Environmental Protection Agency (EPA)
||Regulating Biopesticides (EPA)
|United States Regulatory Agencies Unified Biotechnology Website
The U.S. Government agencies responsible for oversight of the products of agricultural modern biotechnology are the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA).
Research by Theresa Pipher