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Growing Plants for Pharmaceutical Production vs. for Food and Feed Crops
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Comparison to agricultural biotechnology
It is important to distinguish between genetically modified plants used to produce pharmaceuticals and genetically modified crop plants grown for food or feed. The first are used exclusively to produce pharmaceutical proteins and are intended not to be used in food or feed consumption. Like other prescription pharmaceuticals, those developed from plants will be packaged, sold, prescribed and administered. These pharmaceutical proteins will be subject to strict oversight by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS), under the Biotechnology Regulatory Services (BRS) department.
Pharmaceutical proteins also are only being grown in a limited number of plants, including alfalfa, corn, duckweed, rice, safflower and tobacco to generate essential proteins for life-saving drugs.
Grown and processed separately from food and feed
The production and handling of pharmaceutical-containing plants is strictly regulated under rigorous federal guidelines for the safety of humans and the environment. APHIS requires companies to obtain permits for field tests and for pharmaceutical protein production. Strengthened permit conditions for the 2003 growing season were announced by APHIS in March 2003. Permit conditions can be found online at http://www.aphis.usda.gov.
Pharmaceutical protein-producing plants are grown and processed separately from food and feed crops - a system known as confinement, or in a completely closed loop system. After harvest the plant material is processed to separate and purify the proteins, which are then delivered to pharmaceutical manufacturers. In addition, the seeds to grow plant producing pharmaceutical proteins are available only to the registrant, their personnel, or contract grower and cannot be purchased off the shelf at a local seed store.
Growing Commodity Crops Improved through Biotechnology vs. Plants for Pharmaceutical Production
| | Commodity Crops | Plant-Made Pharmaceuticals |
| Intended Uses | Crops are harvested for food and feed use. | Plants are improved through biotechnology to manufacture therapeutic proteins which are extracted, refined and used in regulated pharmaceutical products. |
| Permits Required | Permits are required for the field trial phase of crops developed through agricultural biotechnology. Once federal approval is received, no permits are required. | Can only be grown under USDA/APHIS permit and will never be de-regulated. |
| Inspections Required | Inspections are required for the field trial phase of crops developed through agricultural biotechnology. Once federal approval is received, no inspections are required. | APHIS or state officials inspect records, facilities (including laboratories and greenhouses) and each field site is inspected a minimum of seven times over two years. |
| Who Can Plant | Anyone. | Only a few select growers under contract with the manufacturer are identified and undergo annual APHIS-approved training programs on permit conditions and implementation. They are then carefully supervised to grow PMP crops. |
| Number of U.S. Acres | Hundreds of millions. | In 2002 the total U.S. test trials consisted of 20 permits governing 34 field sites for a total of 130 acres. Plants growing pharmaceutical proteins can only be grown under USDA permit. |
| Dedicated Equipment | No. | Yes. Most equipment that comes into direct contact with plant-made pharmaceuticals must be dedicated for PMP production only and cannot be used with any crops intended for food or feed. |
| Confinement Measures | Confinement measures are required for commodity crops developed through agricultural biotechnology when they are under permit and, when necessary, to maintain proper segregation of crops with limited global approvals. | Confinement measures are based on the type of plant, the specific target protein, the location of the intended production area and agronomic and plant handling practices relevant to the circumstances. |
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