The American Society for Microbiology (ASM) is pleased to submit the following testimony on the Fiscal Year (FY) 2014 appropriation for the US Food and Drug Administration (FDA). The ASM is the largest single life science organization in the world with more than 37,000 members.
The Nation’s consumers spend nearly twenty-five cents of every dollar on products regulated by the FDA. FDA protects consumers by assuring the safety, efficacy and security of human and veterinary drugs, biological products, the food supply, and other consumer and health related products. The ASM urges increased funding for FDA to strengthen an agency burdened by too few resources needed to protect public health.
Under budget sequestration, FDA will lose $318 million from its FY 2013 funding level, which will exacerbate difficult choices already facing the agency. The exact effects of sequestration are yet to be determined. However, possible outcomes include more than 1,000 fewer field inspectors, fewer overseas facilities visits, delays in product approvals, or greater numbers of foodborne illnesses. Since FDA is largely a service organization with most of its budget for salaries, training, and travel of its field personnel, cuts in funding are likely to have impacts on product safety. Decreasing FDA’s budget will affect its ability to respond to market globalization and emergent pathogens.
FDA priorities outlined in its 2011-2015 strategic plan reflect the breadth of FDA’s mission: advance regulatory science and innovation, strengthen the safety and integrity of the global supply chain, strengthen compliance and enforcement activities to support public health, expand efforts to meet the needs of special populations, and advance medical countermeasures. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) monitors all cosmetics and 80 percent of our food supply, regulating all food products except meat, poultry and egg products overseen by the Department of Agriculture (USDA). Other FDA units regulate drugs; medical devices; radiation-emitting products like medical imaging equipment; vaccines, blood and biologics; animal/veterinary products including pet food; and tobacco.
FDA scientists and their colleagues at the Centers for Disease Control and Prevention (CDC) investigated the microbial contamination of unopened vials of injectable solutions from a New England manufacturer, implicated in an outbreak of fungal meningitis that to date has killed 50 people and sickened 722 in 20 states.
Other recent FDA actions include recall of US made pet treats due to potential Salmonella contamination; and the closure of a peanut butter processing plant in New Mexico as the source of dozens of illnesses in 20 states (also Salmonella-linked). In January, FDA approved the first trivalent influenza vaccine that will be produced using an insect virus expression system and recombinant DNA technology. Unlike current flu vaccines, the new one does not use eggs or the influenza virus in its production, in a process already FDA approved for certain vaccines against other infectious diseases.
In recent years, food imports have grown by an average of 10 percent each year; over 16 percent of all food products now consumed in the United States are produced elsewhere. More than 20 million import lines of food, devices, drugs, and cosmetics arrived at US ports of entry in FY 2010, over three times the number 10 years before. Nearly 80 percent of pharmaceutical ingredients are now made in other countries, further complicating consumer safety issues. FDA’s Human Drugs Program not only evaluates all new drugs prior to entering the market, but also the quality of more than 10,000 currently marketed drugs. The Animal Drugs and Feeds Program regulates drugs, devices, and food additives that affect over 150 million companion animals and billions of poultry, cattle, swine, and other species in the United States. The public depends upon FDA’s seven product and research centers, staffed by many of FDA’s 12,000 employees, to evaluate and regulate the efficacy and quality of near limitless consumer products.
FDA Funding Improves Quality, Protects Safety of the US Food Supply
FDA is responsible for protecting and promoting public health, in part by ensuring that the Nation's food supply for human and animal consumption is safe, sanitary, wholesome, and properly labeled. Each year, the agency regulates $417 billion worth of domestic food and $49 billion of imported foods. In addition, FDA personnel oversee about 450,000 domestic and foreign facilities registered under the Public Health Security and Bioterrorism Preparedness and Response Act. According to the FDA, the agency expends more than 1,300 full-time staff years (FTEs) to fulfill annual duties in conducting food and feed inspection and investigational activities.
FDA’s food related responsibilities include collecting and evaluating thousands of samples and shipments drawn from the voluminous US food supply chain. The Food Safety Modernization Act (FSMA) of 2011 mandated even greater responsibility to FDA, the first major food safety law in over 70 years. FDA’s performance in food safety has been criticized over the years, with inadequate funding often indicted as the underlying cause. Reports from the US Government Accountability Office (GAO) and other watchdog agencies periodically recommend changes that necessitate increased FDA expenditures. Since 2007, federal oversight of food safety has been on GAO’s high-risk list of areas that need to be transformed for the public good, citing fragmentation caused by 15 agencies collectively administering at least 30 laws.
About one in every six people in this country get sick each year from food contaminated with microbial pathogens. Most of these 50 million-plus cases go unreported, but too many cause serious illness with nearly 130,000 hospitalized. Salmonella alone causes $365 million in direct medical costs each year. FDA and its food safety partners like CDC have had successes like cutting E. coli O157 cases nearly in half since 1997. But foodborne illnesses remain significant threats to public health―in 2009-2010, CDC investigated 1,527 foodborne disease outbreaks, most due to norovirus or Salmonella. Outbreaks and subsequent federal enforcement exact both human costs and economic losses. USDA estimated that during the 2011 Listeria outbreak linked to cantaloupes, prices for cantaloupe dropped about 34 percent. The 2008 Salmonella tomato-pepper outbreak forced about $145 million in losses to tomato growers and shippers in several states, according to industry representatives.
FDA faces daunting numbers of regulated food-production sites in the United States, with more than 171,500 FDA registered food facilities and two million farms. FDA inspection activities require the best available laboratory and computing tools. In addition to other responsibilities, FDA strives to advance research on food related technologies. For example, it has joined with CDC, the University of California, and Agilent Technologies to create a public database of 100,000 foodborne pathogen genomes to help speed identification of bacteria in foodborne outbreaks. The database will guide diagnostic test development that has potential to shorten outbreak investigation from weeks to days.
As part of its oversight activities, FDA inspects a targeted number of foreign facilities that process foods under its jurisdiction. The goal is to identify potential food safety problems before products enter the United States and to help make risk based decisions when imported foods reach US ports. Last year, we imported goods worth nearly $2.3 trillion, a large portion as food. Imported food keeps increasing, as a percentage of all food consumed from about 9 percent in 2000 to over 16 percent today. Some food categories have higher percentages, for example, 60 percent of fruits and vegetables consumed in 2009 and 84 percent of seafood in 2011.
In 2011 FDA created the Office of Global Regulatory Operations and Policy to help address its growing global responsibilities. Like other FDA duties, regulating imported foods involves very large numbers that create logistical challenges. Today, there are more than 130,000 importers of record and about 300 US ports of entry, handling products from about 278,300 FDA registered foreign food and feed facilities in countries worldwide. Import volumes have risen steadily since 1994, from fewer than 3 million lines up to an estimated 28.1 million lines in 2012. Yet FDA’s inspector FTE numbers remained essentially unchanged. In FY 2011, FDA inspected only about 0.4 percent of registered foreign food facilities. That year, FDA examined about 2.2 percent of all food entry lines and tested samples from less than 0.5 percent of all lines.
FDA Funding Supports Advances in Regulatory Science
FDA’s role in public health has been changing, pushed by evolving science and technology and an increasingly globalized world. In recent years, the agency has placed greater emphasis on its regulatory science, incorporating “embracing innovation” into its vision for a stronger FDA. Personnel must utilize the latest scientific knowledge to assess effectively the growing list of FDA regulated products. The diversity of these products and their end-users mandates that FDA stay current in its science and technology capabilities, as these examples from the past year illustrate:
- Proposed two new FSMA rules, requiring food manufacturers to submit food safety plans to FDA and enforcing safety standards for farms growing fresh fruits and vegetables; proposed in January, these rules are still open for public comment.
- Approved the first nucleic acid test that can simultaneously identify 12 different bacterial types known to cause bloodstream infections, including Staphylococcus (including methicillin-resistant MRSA), Streptococcus, Enterococcus (including vancomycin-resistant VRE), and Listeria. Results are available within a few hours after initial bacterial growth, versus traditional methods that might require two to four days.
- Approved a combination vaccine for infants and children ages 6 weeks through 18 months, preventing disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b.
- Issued two draft guidance’s regarding nanotechnology in the food and cosmetics industries, outlining FDA safety assessments of its use in cosmetic products and food processing.
The FDA must access the most advanced scientific knowledge, to support both regulatory activities and public health education of the public. Congress has demonstrated strong support for FDA in the past, evidenced by the recent bipartisan approval of the FDA Safety and Innovation Act to bring drugs and devices to market more quickly and encourage innovation in the biomedical industry.
The ASM strongly urges Congress to increase the FY 2013 and FY 2014 budget for the FDA which is so critical the Nation’s public health.