The food industry has long been concerned about the possibility of pharmaceutical and industrial crops (pharma/industrial crops) contaminating the food supply. In multiple September 2007 submissions to the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS), major food industry groups spoke out strongly against the use of food crops engineered to produce drugs and industrial chemicals. The groups were commenting on the USDA’s environmental impact statement (EIS) on the department’s proposed overhaul of biotechnology regulations, including regulations for pharma/industrial crops (referred to below as crops producing plant-made pharmaceuticals (PMPs) or plant-made industrial compounds (PMICs)).

Following are excerpts from comments various food industry organizations, including the recently merged Grocery Manufacturers Association/Food Products Association (GMA/FPA), several of its largest member companies, and the USA Rice Federation, which represents rice growers, millers, and sellers nationwide.

Grocery Manufacturers Association/Food Products Association

“…We firmly believe…that plant-made pharmaceuticals (PMPs) or plant-made industrial compounds (PMICs) should not be produced in food or feed crops due to legitimate concerns about their negative impacts on food safety, on domestic and international markets for food crops, on the integrity of the wider food supply, and on otherwise avoidable regulatory enforcement actions.

…GMA/FPA has consistently represented the views of its members that food crops should not be used for the production of PMP/PMICs. Experience over the past decade has abundantly confirmed what we noted in the beginning – the potential for unapproved material to find its way into materials intended for use as food is simply too great. Such materials are, under law, adulterated. Past instances of such unintended and undesired commingling have threatened the integrity of enormously valuable brands and cost GMA/FPA members substantial amounts of money through no fault of their own. The concerns we have previously expressed in this regard have not diminished.

…GMA/FPA is not confident that the approach favored by APHIS will be sufficient to ensure the desired outcome – that no materials from PMP/PMIC food crops become accidentally commingled with materials intended for food or feed uses. We reiterate our reasonable request that APHIS apply measures sufficient to ensure this outcome.”

PepsiCo

“…[P]rotecting America’s food supply should be of paramount importance to USDA as well as food manufacturers. The significant risk of crop contamination that is present when plant-made pharmaceuticals (“PMPs”) or plant-made industrial compounds (“PMICs”) are produced in food and/or feed crops leads us to the conclusion that the only way to prevent such a contamination is to prohibit PMP/PMIC production in food and/or feed crops…

…[T]he assessments currently used in determining whether to allow open air field trials and open air commercial production of PMPs/PMICs are inadequate. We believe they do not properly address the risk of crop contamination and the resulting devastating impact on the food supply that is relevant to all field tests involving PMPs/PMICs. Therefore, PepsiCo asks that APHIS/BRS reconsider allowing field trials and commercial-scale production of PMPs/PMICs in food crops and instead choose Alternative 4 as described on page 33 of the DEIS.

…APHIS/BRS has not explained why the anticipated benefit from allowing PMPs/PMICs to be produced in food crops outweighs the very real and huge risk of adulteration of the food (or livestock feed) supply…

…[F]or APHIS/BRS to err on the side of a relatively few companies that might be put out of business while risking the potential adulterations of the American food supply is misguided.”

General Mills

“…[W]e strongly believe that, given the current state of technology and regulations, plant-made pharmaceutical (PMP's) and plant-made industrial compounds (PMICs) should not be produced in food and/or feed crops.

…Unlike other agricultural uses of biotechnology, where the source plant and the resulting product are safe for animal and/or human consumption, PMP and PMIC are not today or in the foreseeable future intended as foodstuffs or have a general safe usage. We urge the Animal and Plant Health Inspection Service (APHIS) to strongly consider the possible adverse impact of PMP and PMIC on food safety, market access, and the potential for regulatory enforcement actions that could impact many indirect stakeholders.

…[W]hile APHIS prefers Alternative 2 (allowing continued use of food and feed crops) we strongly oppose this approach. With currently available technology, 100% confinement can not be guaranteed. Given the non-food nature of PMP and PMIC, without proven 100% containment, the possibility exists for severe disruption when even very trace amounts of PMP or PMIC materials enter into the global food and feed supply chain. Use of food and feed crops to produce PMP and PMIC should not be allowed until such time as technology to provide 100% containment has been proven due to the non-food nature of PMP and PMIC … Again, we strongly urge APHIS to not allow the use of food and feed crops for these biotechnology applications.”

USA Rice Federation

“…APHIS should have…provided a discussion of scenarios regarding the socioeconomic impacts which may result to U.S. growers, millers and associated industries when a plant-made pharmaceutical (PMP) or a plant-made industrial compound (PMIC) finds its way accidentally into commercial food supplies.

…[N]o PMPs or PMICs should be allowed in food or feed crops.  To do otherwise is to court economic and market disruption for the commercial crop industry with which APHIS is totally unprepared to deal. 

…[T]he agency should…consider the economic disaster and resulting environmental problems that would be associated with a food crop suddenly being discovered to house pharmaceutical or industrial compounds and/or animal- or human-based proteins.  Not only would there be environmental problems with the spread of the event, but also the resulting environmental changes as farms, mills and associated businesses are lost.  The current system doesn’t even provide the minimum requirement of ensuring full food and feed safety approvals from other agencies.

…As for nonfood/feed plants, the most stringent and reasonable parameters should be in place.  These may consist of contained facilities, a full EIS study for each event, and full safety approvals from other appropriate agencies (e.g. FDA for PMPs).  In the future, if consumer acceptance is obtained for crossover to food/feed crops, then such a system could be used to eventually allow the growing of PMPs and PMICs in food/feed crops.”