Confinement Plan Goes the Extra Mile for Safety

Plant-made pharmaceuticals (PMPs) and plant-made industrial products (PMIPs) offer an innovative way to turn biotech plants into "factories" that can produce therapeutic proteins, enzymes, and other industrial compounds and proteins. This technology provides an alternative manufacturing process to traditional systems and has the potential to be more efficient and cost-effective. As this innovative area of plant biotechnology advances, the agricultural biotechnology industry has identified ways to continue its commitment to stewardship and responsible use of the technology.

Stewardship efforts around PMPs and PMIPs focus on confinement issues so these unique plants are used only as intended, and not for food and feed use. In 2003, BIO developed a rigorous set of procedures known as the Containment Analysis and Critical Control Point (CACCP) plan. The CACCP plan helps companies comply with strict federal safety regulations.

The CACCP plan is based on best practices as determined through wide experience in manufacturing and industrial processes, and is endorsed by numerous government agencies and industry associations. Producers use the CACCP procedures to identify potential hazards and apply steps so PMP and PMIP plant materials are restricted to the intended use. Confinement procedures are designed to keep these plants controlled and separate to prevent unintended commingling with food and feed crops, the environment, humans, and other non-target organisms.

Confinement procedures are based on rigorous identification of potential hazards along with sophisticated scientific assessments of the potential for exposure and the likely consequences. These assessments take the following factors into consideration:

  • Characteristics of the biotech plant
  • Qualities of the specific protein
  • Location and timing of PMP and PMIP plants being grown, and nearby plantings of other plants
  • Agronomic and plant-handling practices

Setting a High Standard

Individual companies use the CACCP plan as a reference point for developing their own specific confinement plans, which feature detailed operating procedures and disciplines tailored to their own production systems.

The plan is modeled after the Hazard Analysis and Critical Control Point system, which is the standard for the food industry. BIO incorporated the advice of key government agencies and food industry groups in developing its CACCP, including:

  • U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (FDA CFSAN)
  • Food and Agriculture Organization of the United Nations (UN FAO)
  • World Health Organization (WHO)
  • Grocery Manufacturers Association and Food Products Association (GMA/FPA)
  • National Corn Growers Association (NCGA)
  • North American Millers Association (NAMA)

Widespread Compliance

There is no better stewardship program than an industry whose members are committed to going above and beyond what is required. BIO encourages every organization working with PMPs and PMIPs to implement CACCP and tailor it to meet specific needs. All BIO members involved with PMP/PMIP research and development currently have adapted the CACCP plan to their research and development programs, and these are submitted to federal regulators as part of the permit application process.

This widespread compliance with the CACCP plan is just one more way the biotechnology industry is going the extra mile to make sure emerging biotechnology is as secure for the present as it is promising for the future.