Michael F. Jacobson, Ph.D.
Center for Science in the Public Interest
Commissioner's Consumer Roundtable
December 13, 2000
Thank you very much for holding this meeting and inviting me to participate. I would
like to focus on two general areas: the Center for Food Safety and Applied Nutrition's (CFSAN)
resources and its inadequate attentiveness to specific consumer concerns.
Over the past quarter-century, the complexity of America's food system has increased
greatly. Thousands more foods are on the market. More and more foods are imported from
around the world. Dietary supplements and functional foods have become the rage. And
genetically engineered foods have entered the market. Moreover new laws, such as the NLEA
and DSHEA, have given the FDA new responsibilities.
Unfortunately, as Mr. Levitt explained so clearly, CFSAN's staffing has not increased
along with the increased challenges. Indeed, staffing has actually declined. According to Mr.
Levitt, CFSAN's staffing, notwithstanding targeted budget increases, has declined by seven
percent since 1978. That decline is scandalous -- and endangers the public's health and welfare.
Speaking plainly, inadequate funding means more contaminated food and dishonest labels, fewer
analyses and less research, slower product reviews, and more unsafe or untested products.
Without adequate resources, CFSAN simply cannot do its job. The FDA's overriding
priority regarding CFSAN should be to have its overall budget and staff for both Headquarters
and Field Operations (inspectors) at least doubled over the next four years.
Let me provide a few more details. The FDA is responsible for inspecting over 57,000
domestic food establishments and millions of shipments of imported food. One indication of a
problem is that the FDA analyzed one-fourth fewer domestic food samples in FY 1999 (9,000)
than it did in FY 1996 (12,000). When the President's Food Safety Initiative was first developed,
FDA inspectors visited food plants on average once every 10 years. Unfortunately, following
nearly four years of funding increases under the Food Safety Initiative, things don't appear to be
much better today. In fiscal years 1998, 1999, and 2000, Congress appropriated approximately
$37 million in new money to fund inspections. While that money should have been enough to
hire more than 350 new inspectors, FDA staffers familiar with this issue have told us that the
inspection staff in the Office of Regulatory Affairs has not increased by nearly that much. One
wonders where all the money went.
Specific Consumer Concerns
Let me turn now to several specific issues about which CSPI has been concerned.
1. CFSAN is a great believer in Hazard Analysis/Critical Control Point (HACCP) systems, but its
seafood HACCP program has serious problems. For instance, 30% of seafood plants have poor
HACCP systems and another 46% have no plans at all. By FDA's own estimate, in 1999 only
54% of all seafood firms were in compliance with the HACCP program, but that includes the
30% of firms that FDA exempted from the program altogether. Unlike USDA's meat and
poultry HACCP regulation, there are no pathogen-reduction standards and mandatory microbial
testing, which together provide a systematic check of the quality of the HACCP plans. In
addition, while seafood is one of the most hazardous foods that FDA regulates, seafood plants
are visited by FDA only once every one to two years.
Although FDA published a proposal for HACCP in all food plants, industry opposition
thwarted the proposal. Now the agency is using a piecemeal approach for HACCP
implementation, an approach that will take many years, if not decades, to implement and will
never work without pathogen-reduction standards, microbial testing, and frequent, unannounced
inspections. FDA needs to rethink its approach to food safety regulation. In addition, we urge
the agency to seriously consider the need for comprehensive statutory reforms to its food-safety
mandate, including a bill -- the Consumer Food Safety Act -- filed by Senator Byron Dorgan.
2. A recent National Academy of Sciences' (NAS) report concluded that mercury-contaminated
fish potentially harms as many as 60,000 infants and children each year. Yet the FDA has down-graded to its B priority list the development of a better mercury-in-fish standard. That,
unfortunately, is standard operating procedure for CFSAN, which long has failed to provide
adequate protection to at-risk consumers, principally women and children, from this hazard. We
urge CFSAN to act now to set and enforce an action level for methylmercury in fish that is
consistent with the NAS's findings.
3. Each year, shellfish contaminated with Vibrio vulnificus bacteria kill one to two dozen people.
Another shellfish hazard, Vibrio parahaemolyticus, has caused outbreaks sickening nearly 700
people since 1997. For years, CFSAN has tacitly accepted those illnesses and deaths by not
requiring pasteurization or other processes to ensure that shellfish harvested from warm waters in
the summer months -- which carry a near certainty of contamination -- are safe. In 1999, the
FDA solicited comments on our petition for a zero-tolerance for Vibrio vulnificus in shellfish, but
has not taken any further action. Meanwhile, more people died.
4. Genetically modified foods pose new challenges. CFSAN may institute a mandatory pre-market reviews, but we fear that that will be an opaque, not transparent, process and will not
provide for formal approvals. That plan will provide more fuel for biotech critics and will not
maximize public confidence. The FDA either should establish a mandatory, transparent approval
process or, if it believes it lacks the authority to do so, call on Congress to provide clear
authority. Senator Richard Durbin (D-IL) and Representative Dennis Kucinich (D-OH) have
introduced sensible bills that would give the agency such authority.
5. Several food additives raise health concerns. CSPI has filed petitions concerning the approval
or labeling of the carcinogen potassium bromate, the stimulant drug caffeine, the allergenic
coloring carmine, diarrhea-inducing sorbitol, and other additives, but CFSAN has not acted on
any of those and many other petitions. In addition, in the last few years unapproved ingredients,
including herbs, have been added to so-called functional foods. CFSAN has failed to nip that
problem in the bud.
6. While food-borne illnesses, GMOs, and food additives are controversial, the biggest cause of
disease and premature death in our food supply is the food itself -- all too often loaded with fat,
sodium, and refined sugars. The nutrition label may be the FDA's best -- and only -- means of
helping consumers choose more healthful foods. We applaud the FDA for moving, albeit slowly,
to add trans fat to the Nutrition Facts label, a change that could save thousands of lives a year.
Over the past 17 years, per capita consumption of added sugars has increased by
30 percent. That's probably the single biggest adverse change in our diet -- and has probably
contributed to soaring increases in obesity. Clear labeling, including listing percentages of a
Daily Value, could inform people about the added-sugars content of foods and help people eat
less, as the Dietary Guidelines for Americans recommends. Health groups like the American
Public Health Association, many nutrition experts, and even the U.S. Department of Agriculture
have endorsed labeling of added sugars. However, makers of junk foods have mobilized massive
opposition. We hope that the FDA will not succumb to industry pressure and instead will help
7. Other parts of the label are also of concern. The FDA has long failed to vigorously enforce the
misbranding section of the law. Deceptions abound. Companies lead people to think that certain
products are made of whole wheat, when they're not. Other foods are labeled to exaggerate their
fruit content. Such tricks cheat people and make it difficult to choose a healthy diet...and they
also hurt honest companies. It's high time that CFSAN devoted adequate resources to preventing
those kinds of unhealthful, costly deceptions.
To summarize, CFSAN, notwithstanding the many things it does well, is not a
sufficiently aggressive protector of consumers. It should be CFSAN, not a small nonprofit
group, that discovers Cry9c contamination in corn products and solves the problem. It should be
CFSAN, not a consumer group, that identifies dishonest labels and unsafe ingredients and gets
the products off the shelves. I urge CFSAN to do everything it can to promote the public health,
despite sometimes-fierce opposition from industry and Congress. The FDA must fight for a
doubling of its "foods" budget over the next four years and for the authority to recall and seize
unsafe foods and to levy civil penalties. CSPI and other consumer groups will do everything we
can to help from the outside.
Thank you once again for the opportunity to participate in this meeting.