Mission at risk

As first noted by Big Apple of the Fresh Produce Industry Discussion Group, a a new 60-page report from a subcommittee of the U.S. Food and Drug Administration's science board was released today. Titled "FDA Science and Mission at Risk," the report states that increasing demands and a lack of resources have created an "imbalance" that puts the integrity of the FDA's mission - and the safety of the public - at risk. From the report's reference to food safety (highlights mine):

The Subcommittee found that FDA’s ability to provide its basic food system inspection, enforcement and rulemaking functions is severely eroded, as is its ability to respond to outbreaks in a timely manner and to develop and keep pace with the new regulatory science needed to prevent future problems arising from both novel (prion disease, genetically modified organism) and traditional (resistant microbes, chemical contamination) sources. There is an appallingly low inspection rate: the FDA cannot sufficiently monitor either the tremendous volume of products manufactured domestically or the exponential growth of imported products. During the past 35 years, the decrease in FDA funding for inspection of our food supply has forced FDA to impose a 78 percent reduction in food inspections, at a time when the food industry has been rapidly expanding and food importation has exponentially increased. FDA estimates that, at most, it inspects food manufacturers once every 10 years, and cosmetic manufacturers even less frequently. The Agency conducts no inspections of retail food establishments or of food-producing farms.

There are several reasons for the crisis in CFSAN and CVM. One is a dramatic increase in and diversification of Agency responsibilities, reflecting the sharp increase in FDA regulatory mandates and the challenges of globalization. Another is the increasing complexity of the task: surveillance combined with the complexities of cross-Agency regulatory responsibilities and a general lack of coordination across agencies. A third is the increased scientific demands placed on the Agency due to the emerging sciences that are resulting in new products for humans and animals. Finally, a recurrent theme — that of inadequate resources. In this case, inadequate sensing technology to augment surveillance and investigational activities, inadequate scientific capability to effectively model food supply risks, and inadequate staff to inspect an adequate sample of domestic and internationally produced food products all limit the effectiveness of the Agency.
The Subcommittee’s findings are consistent with those of previous committees that voiced deep concerns about the viability of the foods program and the lack of Agency priority for food issues. Sixteen years ago the Final Report of the Advisory Committee on the Food and Drug Administration to the Secretary of Health and Human Services (HHS) (May 1991) identified the same problems (Appendix D, page 1): "There are deep concerns about the viability of the foods program and the lack of Agency priority for food issues. Decline in resources and program initiatives during the past 10–15 years indicate a lack of Agency management attention and interest in this area, although public interest in, and concern for, an effective food program remain high." Since 1991, continued declines in resources and personnel have exacerbated this situation.
CVM has the authority of ensuring the safety of milk, meat and eggs. However, the Center is faced with myriad other regulatory demands; including assessing safety of genetically modified foods and engineered animals used to make biotechnology-based drugs for humans (so-called biopharming); developing analytical techniques to screen meat, milk and eggs for volatile residues of drugs, pesticides and environmental contaminants; as well as managing the approval of an explosion of new pet-animal drugs that are essentially a microcosm of the human drugs regulated by both CDER and CBER (partially supported by Animal Drug Use Fee Act). When Bovine Spongiform Encephalopathy (BSE), commonly known as mad cow disease, first appeared in Europe and elsewhere, consumers and the industry looked to the FDA to ensure that the disease would not spread to the US through the animal feed that FDA regulates. But Agency officials were denied the funds to bring the feed industry into rapid compliance with the new feed regulations, and the disease did indeed appear in the US. Perhaps if the small sums requested by FDA had been provided, Japan and other countries would not have cut off imports of US beef and American producers would not have suffered multibillion dollar losses. To this day, the BSE research program, as well as others in the CVM See Appendix C, Center for Food Safety and Applied Nutrition (CFSAN) related to detection of newly emerging infectious agents, remains seriously underfunded.
The recent pet food safety crisis has strained this overtaxed system. CVM received more than 18,000 telephone calls concerning melamine pet food contamination. The pet food industry is a $15 to $20 billion a year business and largely falls within FDA’s regulatory purview. It was estimated that about 1 percent of the total volume of pet food was involved with a potential economic impact of $200 million. CVM is able to devote only two people working full time on pet food issues.
It is crucial that both food-based Centers develop the science needed to fulfill their mandated missions. The strengthening of science in these Centers must be insulated from acute crisis management. This will involve a two-pronged approach. The first is to immediately correct the historical lack of support for staff and infrastructure needed to address current issues. Both Centers have accurately defined areas that need attention, and this Subcommittee agrees with this assessment. Directly supporting these initiatives is largely one of funding, as addressed in recommendation 128.
The second phase is to significantly build a 21st Century science-based regulatory science that could anticipate future food safety issues and develop a cadre of professionals capable of applying the new biology, chemistry and bioinformatics to the regulation of foods that exist in the manufacturing, distribution and consumer use environment of today’s global marketplace. A culture must be created in which such individuals have the freedom and support to pursue the regulatory science needed to keep pace with a global economy using the tools provided by a new biology. These individuals must be isolated from acute regulatory crises.
The Subcommittee recommends that CFSAN and CVM leverage other research programs (e.g., National Center for Toxicology Research [NCTR], the Agricultural Research Service [ARS], Cooperative State Research, Education and Extension Service [CSREES], Centers for Disease Control and Prevention [CDC], National Institutes of Health [NIH] and Department of Homeland Security [DHS]) research programs to address food and cosmetic safety priorities in toxicology, microbiology, human and animal nutrition, and issues of emerging science. However, due to the unique regulatory landscape of products managed by both CFSAN and CVM, internal up-to-date scientific expertise is mandatory. CFSAN and CVM need to have resources that can be brought to the partnership and that could be used to fund joint requests for proposals managed through granting agencies. One very successful example of such joint programs is the Plant Genome Initiative, funded by National Science Foundation (NSF), Department of Energy (DOE) and US Department of Agriculture (USDA) and managed by NSF.
Confidential 23 FDA Science and Mission at Risk Report of the Subcommittee on Science and Technology
This second phase should be conducted in parallel with this Subcommittee’s recommendations for Agency-wide changes in science administration and support as embodied in a Chief Scientific Officer with budgetary authority, as well as modernization of IT infrastructure. The unending series of management by crisis in both CFSAN and CVM has seriously eroded the morale of existing dedicated staff and hampered recruitment of new scientists trained in areas of emerging biology, chemistry and bioinformatics. This situation, coupled with the early retirement of senior scientists and the recent departure of the director of CFSAN, puts the state of science in serious disarray. These issues should be a high priority on the agenda of the new Chief Scientific Officer.
Finally, efforts to strengthen the food safety mission of FDA must not adversely affect CFSAN’s legislatively mandated mission to address the science behind nutrition, and the safety of dietary supplements and cosmetic safety. In fact, these areas must be revitalized and prioritized independently of both food and drug issues to redress decades of neglect before a serious crisis emerges29. The dietary supplement industry has grown to more than $20 billion in annual sales, and millions of Americans use those products every day. But the legislation authorizing FDA regulation of those products has never been funded, the practical effect being that the products and their health claims go essentially unregulated. The same can be said of the cosmetics industry, which has more than $60 billion in annual sales, but is overseen by an FDA staff of 14 supported by $3.5 million budget. This industry is rapidly integrating nanotechnology for product delivery and yet, very limited expertise in this newly emerging area of science exists in the entire FDA.