April 1, 2004 -- CropChoice news -- Justin Gillis, Washington Post:
Federal regulation of the increasingly exotic products
of the biotechnology industry may soon be inadequate
to assure the public the products are safe, according
to a new report.
Opinion in Washington is sharply divided on whether
the 18-year-old biotech regulatory system can be fixed
with administrative tweaking or whether Congress needs
to pass new laws, said the report by the Pew Initiative
on Food and Biotechnology, a think tank. But either
way, the report cites numerous examples to make the
case that action by the federal government is needed
to ensure credible oversight of an industry that is
tinkering with the very foundations of life.
"The regulatory system isn't broken, but it is
showing signs of wear and tear," said Michael Rodemeyer,
executive director of the Pew Initiative, which has
taken a centrist position in weighing the risks and
benefits of agricultural biotechnology.
The need for fixes is likely to grow pressing as the
industry develops gene-altered fish and insects, farm
animals that produce human drugs in their milk, and
plants that make drugs or industrial compounds in their
leaves and seeds, he added. A handful of these products
are already in the late stages of development, but for
many of them, federal agencies have produced no final
guidance on how -- or even whether -- they will be regulated.
The Pew report, to be formally released today, is the
most detailed analysis in years of a plan devised during
the Reagan administration to oversee the new crops scientists
were designing in their laboratories. The heart of that
plan was to reinterpret existing laws, some of them
passed decades earlier, to apply to the new technology.
The result was a patchwork regulatory system that split
jurisdiction among three agencies, all using different
laws and standards.
The crops commercialized under that system have included
corn, soybeans, cotton and other plants into which new
genes have been inserted to confer better resistance
to weeds and insects. Americans have been eating such
foods for nearly a decade, but polls show most don't
know it. Europeans have been more aware -- and more
skeptical -- of the crops, with European politicians
repeatedly citing the perception that the U.S. regulatory
system is weak to oppose the technology in their own
While maintaining that the current crops are safe to
eat, biotechnology and food companies have feared a
repeat of the controversy as new biotech animals near
commercialization. That is one reason the industry is
among those pressing for clearer regulations.
One proposal for tighter regulation of biotech crops
was endorsed several years ago by virtually every group
with a stake in the issue: the biotech industry, the
food industry, environmentalists and consumer groups.
The proposal was nearing approval as the Clinton administration
left office, but the Bush administration has not acted
Thomas Hoban, a sociologist and food scientist at North
Carolina State University who has followed public opinion
on biotech issues for years, said he visited the Food
and Drug Administration last week to brief lower-level
staff members. He described polls showing rising public
unease with agricultural biotechnology. The staffers,
mostly scientists, "were livid" that the Clinton-era
proposal had languished, he said. "The scientists
are saying, 'We need it,' " Hoban said.
Forthcoming products, ranging from a salmon designed
to grow twice as quickly as normal to plants designed
to act as medicines, are likely to pose tricky new issues
of safety and public confidence, but the FDA has been
slow to clarify how it will regulate some of these products,
he said. "I want a much, much stronger FDA on this,
as do most consumers," Hoban said.
Several people in Washington trade groups, speaking
on condition that they not be identified because they
need to maintain good relations with the FDA, said the
process of creating new rules had been bogged down by
disagreement between some of the scientists in the agency
and the FDA's general counsel, Daniel E. Troy. Troy
is said to be more cautious about expanding the FDA's
authority to regulate various products.
Before joining the Bush administration, Troy was a
lawyer who sometimes represented tobacco and pharmaceutical
companies in disputes with the FDA. He declined requests
for an interview through an agency spokesman. The spokesman,
Brad Stone, issued a statement saying "the agency
and the administration are carefully weighing the public
health, scientific and legal ramifications of this technology."
The statement said this review would necessarily take
time, but it added that "the agency is prepared
to take any appropriate measures necessary to protect
the public health."
Indeed, it is clear that the Bush administration is
well aware of many of the looming issues, and the White
House science office is leading discussions aimed at
clarifying government regulations.
Perhaps the biggest dispute now is how to regulate
genetically engineered animals, such as fish meant for
human consumption and farm animals genetically altered
to produce human drugs in their milk.
Two plans have been widely discussed in Washington.
One would create a system of voluntary consultations
between the FDA and the biotech industry. That plan,
similar to the approach the FDA takes now for biotech
crops, enjoys little support among industry, consumer
or environmental groups, but it is something the FDA
clearly has legal authority to do. A stricter plan,
favored by virtually all groups, would regulate the
animals under a statute originally designed for new
animal drugs, and would involve detailed, mandatory
reviews of food safety. But it would also require a
creative interpretation of the laws governing the FDA.
The Pew report said it's not clear that even the stricter
approach would provide for an adequate review of environmental
questions involving gene-altered animals, one reason
some groups want Congress to pass a new biotech law.