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6-Regulation: US academia held accountable for GM products

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TITLE:  US academia held accountable for GM products
SOURCE: Nature Biotechnology 21 (7): 720-721, by Kendall Powell
DATE:   Jul 2003

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US academia held accountable for GM products

The US Food and Drug Administration (FDA; Rockville, MD, USA) sent a
letter dated May 13 to all land grant universities, which do the majority
of livestock research, as a reminder notice that any genetically modified
(GM) animals destined for human consumption must be reported to the FDA
and disposed of properly. The letter reveals federal regulatory agencies'
difficulties in keeping track of the next generation of GM research that
falls under their jurisdiction. The FDA is therefore shifting the
responsibility of regulating GM plant and animal development to
universities and researchers, who may be unaware of their new obligations.

The FDA's letter was in response to the selling of GM pigs' non-GM
offspring into the food supply by the University of Illinois (UI; Urbana-
Champaign, IL, USA) (Nat. Biotechnol. 21, 219, 2003). Bill Murphy,
associate chancellor for public affairs at UI, says the university and
the FDA were not on the same page concerning the handling of the piglets.
He says the new scientific territory for both parties caused the
regulatory breakdown: "There's a learning curve on both sides and there's
going to be a little bit of a shakeout here."

Murphy noted that two important miscommunications were not highlighted in
the FDA letter. The FDA defines 'investigational animal' (around which
the problem arose) as any animal involved in a GM study; and the FDA
considers the university, and not the funding agency, as the research
sponsor of, and ultimately the party responsible for, biotech research
conducted on its premises--a twist from traditional research management,
which holds granting agencies to be sponsors. In addition, the FDA wants
to know when researchers exchange DNA fragments that would be used to
modify food animals. Murphy says the FDA never communicated the first two
policies until after they discovered UI was selling the pigs, and none of
the policies is stated explicitly in the federal register.

With the misunderstandings now clarified, Murphy says the university will
have no problem overseeing its biotech programs. But he emphasized that
agency-university communication needs to be strengthened. Melanie Loots,
associate vice chancellor for research at UI, says, "Universities need to
be aware that we have that monitoring responsibility. How much of a
burden that responsibility puts on us remains to be seen."

Developing next generation agbiotechnology products that raise public
concern has thrust academicians into a regulatory atmosphere previously
only encountered by industry. "This is an important new way of looking at
[regulation]," says William Muir, who works with GM fish at Purdue
University in Lafayette, Illinois. "Making the university responsible for
biosecurity and putting more pressure on us as researchers, I think,
makes a lot of sense."

States are also stepping up to fill the holes left by the "Coordinated
Framework," which was set up by the Reagan administration in 1986 to
outline which federal agencies oversee biotechnology products. According
to the Pew Initiative (Washington, DC, USA), 39 states introduced 158
pieces of legislation related to agricultural biotechnology during the
2001-2002 legislative year. Two-thirds of the 45 bills that passed
regulate the willful destruction of GM products, but the rest deal with
liability and labeling of GM crops.

Most GM organism researchers interviewed by Nature Biotechnology said
they were used to working under the Coordinated Framework and are well
aware of the rules. But they also admit that new types of technology,
especially GM food animals and crops engineered with pharmaceutical and
industrial compounds, could challenge researchers and agencies alike to
anticipate hazards.

Gary Sayler, director of the Center for Environmental Biotechnology at
the University of Tennessee (Knoxville, TN, USA) says the Environmental
Protection Agency (EPA; Washington, DC, USA) is not ready for things like
chemical-sensing microbes designed for use in unmanned aircraft or
microbes built into nano-electronics. "These applications may not
necessarily be any more risky [than current technologies], but they are
distinctly different than what people have thought about before," he says.

Since the US Department of Agriculture (USDA; Washington, DC, USA)
inspections forced recalls of harvested soybeans that were mixed with
corn engineered with a pig vaccine (Nat. Biotechnol. 21, 3-4, 2003), the
USDA has released more stringent rules governing 'pharma' crops and has
increased inspections in response to the events, according to John
Turner, chief biotechnologist at USDA. Turner also says his staff has
boosted public speaking efforts to ensure a high level of awareness of
the new rules.

However, questions still remain about who, among the FDA, EPA and USDA,
is responsible for regulating GM products as new technologies move down
the pipeline. "The whole process has been rubber suited since the
beginning," says Jim Aidala, former assistant administrator of the EPA
pesticides and toxics office and now a private environmental consultant.
"But as biotechnology goes into adolescence, 17 years later, is it ready
for a new set of clothes? Have we started to see some holes? Clearly
there are some very thin patches."


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