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[SANET-MG] pharm crop not being considered as food pollutants by FDA
FDA seems unwilling to consider regulating pharm crop pollution of food
because they are not intended to be there. The same reasoning may apply
to E coli 0157?
Pesticide & Toxic Chemical News
March 21, 2005
Early food safety review of biopharm crops seen as unlikely
Early food safety evaluation of unapproved proteins from plant-made
pharmaceuticals and industrial crops that might inadvertently enter the
food supply may be a useless exercise, Eric Flamm, a senior policy
advisor to the FDA Commissioner, said last week.
FDA late last year proposed long-awaited guidance for early food safety
evaluation of inadvertent ("adventitious") presence of unapproved
transgenic material from crops intended for food use. In comments of
the draft guidance, food industry and consumer advocacy groups
questioned why FDA had not widened the scope to include crops not
intended for food (see PTCN Feb.7,Page 14).
Flamm told a March 15 "Second Generation Ag Biotech Conference"
sponsored by the National Corn Growers Association that food safety
reviews of biopharm and industrial crops not intended for food might be
a waster of FDA's resources. Asked why the draft guidance covers food
crops only, he said the agency had decided to "start with the easy
Acknowledging pressure to widen the scope, Flamm asked, "If [the
unapproved protein] is never supposed to be in food, what's the point?
What message does it send? It would be a little odd for FDA to say
'Consult with us on a product that will never be in the food supply.'"
Flamm said food companies are unlikely to want biopharm or industrial
proteins in their products even if the substances are determined to be
"It's a PR issue," he said, acknowledging that the outcome of the
adventitious presence debate also depends on what USDA and the food
industry decide to do.
In prepared remarks, Flamm stressed that early food safety consultation
is not a substitute for a full-blown review to determine whether a new
protein is an allergen or a toxin.
"When we developed the policy, we were thinking of first generation
crops [with input traits benefitting farmers]," he said. "Our hope is
that it will be relevant to second generation crops. If we need to
adjust the policy based on science, we will."
Reviewing issues raised by second-generation crops with output traits
benefitting processors and consumers, Flamm questioned whether
nutritionally-enhanced food products need special labeling.
"Is the food essentially the same or must it be labeled?" he asked.
"What kinds of labels are appropriate? Are health claims appropriate?
"Do high levels of micronutrients in enhanced crops raise safety issues,
he asked, noting that these are "science questions, not really biotech
Regulating biotech imports
David Heron, assistant director for policy coordination in USDA's
Biotechnology Regulatory Services, acknowledged future challenges facing
the agency, including new technologies, more products from foreign
countries, an increasing number of reviews of field trial applications
and petitions for deregulation, and a continuing need for transparency.
"There are a broad range of applications in the pipeline, both at home
and abroad," Heron said. "Products will be developed in other countries
and brought here - how do we regulate them?"
Terri Dunahay, BRS team leader for international policy, described
imports of biotech commodities into the U.S. as a "hot topic," citing
reports that Iran has already approved a transgenic rice variety and
China will approve several such rice varieties within the year.
Dunahay noted that importers seeking unconfined release of biotech
commodities must petition BRS for deregulated status. However, current
regulations make no distinction between import intended for release and
commodities intended for processing only.
"What should our be approach for safety assessment of commodities
intended for food, feed or processing?" she asked. "We want to be sure
our regulatory oversight is appropriate for the risk."
Choices include full environmental review, streamlined review, or
conditional approval, she said, adding, "All bets are open."
Noting that biotech imports will be covered under the environmental
impact statement to be proposed by USDA's Animal and Plant Health
Inspection Service later this year, Dunahay said import policy must be
consistent with the Cartagena Biosafety Protocol, the International
Plant Protection Convention, and with U.S. import policy for
conventional agricultural commodities.
Bobby Richey, deputy administrator of USDA's Foreign Agricultural
Service, stressed that biotech is "no longer just a U.S. issue," citing
the emergence of China as a major player and the recent passage of
biosafety legislation in Brazil and Mexico. Intellectual property
rights are likely to be an issue in the developing world, he said.
Richey said that, as biotech products come on the market in developing
countries, governments will look to more established countries such as
the United States for safety assessments.
"There will be a sea change in the next couple of years as developing
countries gain ownership of biotech," he forecast.
Jeff Stein, regulatory affairs director for Syngenta Seeds, described
the company's efforts to gain approval for new biotech corn varieties
producing enzymes that aid in processing and animal feed. He said a
full safety assessment of a corn amylase variety for ethanol production
Thomas Nickerson, leader of Monsanto's Ecological Technology Center,
described efforts by a global industry coalition toward harmonized
environmental risk assessments for living modified organisms intended
for food, feed or processing (LMO-FFPs) in line with the Cartagena
Protocol. He said the coalition is exploring opportunities to develop
"reasonable, science-based regulations for LMO-FFPs in import markets."
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