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Murray M. Lumpkin, M.D.
Deputy Commissioner for International and Special Program
Committee on Commerce, Science, and Tranportation
United States Senate
"Safety of Chinese Imports: Oversight and Analysis of the Federal Response"
Mr. Chairman and Members of the Committee, I am Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs at the U.S. Food and Drug Administration (FDA or the Agency). Thank you for the opportunity to discuss the important issues relating to the safety of FDA-regulated products imported from China.
As you may know, China is a major producer, exporter, and importer of FDA-regulated products and, of all countries in the Asia/Pacific regions, presents the most diverse range of issues for FDA. FDA-regulated products include food and animal feed, human and animal drugs, cosmetics, vaccines and other biological products, and medical devices. In my testimony, I will discuss some specific products and issues in more detail, outline some of the actions FDA has taken in the past to help assure the safety of these products, and outline deliberations currently underway between the United States and China to improve the safety of products we receive from China. Additionally, please note that the Office of Management and Budget and the relevant food safety agencies, including FDA, are collaborating on ways to most effectively address issues raised in the Government Accountability Office’s designation of Federal Oversight of Food Safety as a high-risk item in February 2007.
China is presently one of the world’s largest producers and consumers of agricultural products, and hopes to further increase agricultural production through improved plant stocks, fertilizers, and technology. China is now a major supplier to the U.S. of seafood, canned vegetables, fruit juices, honey, and numerous other varieties of processed foods. During the 1980’s through the late 1990’s, FDA encountered several serious compliance problems with Chinese food exports, including lead and cadmium in ceramicware used to store and ship food products, and staphylococcal contamination of canned mushrooms.
While improvements have been made in some Chinese products with which we have had concerns in the past, there is unfortunately still a pattern of substandard products that continue to be shipped to the U.S. As all of you are very well aware, this pattern has continued, and the safety of food and other FDA-regulated products from China have become a concern for FDA, Congress, and U.S. consumers.
The Chinese food industry consists of large multi-national corporations, mid-size corporations and many small family-run operations. One of the challenges with the Chinese food industry is its sheer size and the number of people involved in the production and distribution chains. A good example of this challenge is evident in Chinese fishery and aquaculture production.
Aquaculture
Commercialization and consumption of aquacultured (or farm-raised) seafood products has increased worldwide. Aquacultured seafood has become one of the fastest growing sectors of the world food economy, accounting for approximately half of all seafood production worldwide. Approximately 80 percent of the seafood consumed in the U.S. is imported from approximately 130 countries, including China. Over 40 percent of that seafood comes from aquaculture operations.
China is the largest producer of aquacultured seafood in the world, accounting for approximately 70 percent of the total production and approximately 51 percent of the total value of aquacultured seafood exported around the world. In terms of monetary value, China is currently the second largest exporter of seafood to the U.S. including exports of shrimp and catfish. In terms of sheer volume, China is the largest exporter of seafood to the U.S. Shrimp and catfish products represent two of the top ten most consumed seafood products in the U.S. FDA and the National Oceanic and Atmospheric Administration work cooperatively regarding seafood safety risk assessment, management, and seafood safety research and monitoring.
As the aquaculture industry continues to grow in developing economies, concerns regarding the use of unapproved animal drugs and unsafe chemicals in aquaculture operations have increased substantially. The use of unapproved antibiotics or chemicals in aquaculture raises significant public health concerns. There is clear scientific evidence that the use of antibiotics, and other drugs and chemicals, such as malachite green, nitrofurans, fluoroquinolones, and gentian violet, during the various stages of aquaculture can result in the presence of residues of the parent compound or its metabolites that are found in the edible portion of the aquacultured seafood and can be potentially harmful to human health. Also, the use in aquaculture of unapproved antibiotics may significantly increase antimicrobial resistance to those antibiotics in human pathogens of public health concern.
Fluoroquinolones have been prohibited from extra-label use in the U.S. and many other parts of the world in aquaculture because of public health concern about the development of such antimicrobial resistance. Moreover, prolonged exposure to nitrofurans, malachite green, and gentian violet, or metabolites to these chemicals, has been shown to induce cancer in humans or animals.
From a legal and regulatory perspective, in the U.S., use of malachite green, nitrofurans, fluoroquinolones, or gentian violet as drugs in food-producing animals would require an approved new animal drug application under section 512 of the Federal Food, Drug, and Cosmetic (FD&C) Act. FDA has not approved these substances for use as drugs in aquacultured animals. Therefore, if they are used in aquaculture with an intent that they treat disease in, or affect the structure or function of, any aquacultured animal, they are considered to be unapproved new animal drugs within the meaning of section 512 of the FD&C Act, and the presence of their residues in seafood adulterates the seafood under 402(a)(2)(C)(ii) of the FD&C Act.
Furthermore, malachite green, nitrofurans, fluoroquinolones and gentian violet are not generally recognized as safe under any conditions of intended use that may reasonably be expected to result in their becoming a component of food. Therefore, if intended for any such use, they are unsafe food additives within the meaning of section 409 of the FD&C Act and would render the food adulterated under section 402(a)(2)(C)(i) of the FD&C Act.
FDA has been actively working to protect Americans from unsafe Chinese aquacultured seafood. For many years, FDA has been testing imports and has been working with counterpart agencies in other countries that also have been testing Chinese aquacultured seafood that is being offered for import into their countries. Using data from these testing programs, FDA has been placing companies whose products have been found to be violative on an import alert, whereby future shipments of the products can be refused admission into the U.S. until they are demonstrated to FDA to be free of these residues. In addition, FDA scientists have been working with their Chinese counterparts for several years in an effort to help them better understand our standards and the science that supports those standards. FDA colleagues have made trips to China to inspect specific aquaculture facilities and have conducted seminars and workshops in China to try to raise awareness among producers of the safety expectations of FDA regarding aquacultured seafood that they wish to ship to the U.S.
In addition, the senior leadership of FDA and the senior leadership from its counterpart agencies in China (the State Food and Drug Administration [SFDA] and the General Administration for Quality Supervision, Inspection, and Quarantine) have had annual formal bilateral meetings since 2006 at which issues of special concern along with general topics regarding scientific approaches to product safety and quality are discussed.
Despite a ban in China on the use of nitrofurans and malachite green in seafood farm operations, these and other unapproved drugs and chemicals continue to be found in farm-raised seafood from China. Since November 2001, FDA has tested shipments of these species of seafood from China and placed specific firms on import alerts if their shipments tested positive for antibiotic residues. In 2006, FDA broadened these restrictions significantly by issuing an import alert providing for the detention without physical examination of eel from anywhere in China. FDA also met with Chinese officials in the fall of 2006 to evaluate their system of controls for aquaculture drugs and to stress our concern about repeated violative findings. The violative product continued to be shipped.
Based on an increased monitoring of imported aquacultured seafood from October 1, 2006, through May 31, 2007, FDA continued to find residues of unapproved new animal drugs and/or unsafe food additives in farm-raised seafood imported from China. During that period, FDA tested samples of catfish, basa, shrimp, dace, and eel from China. Twenty-five percent of the samples were found to contain drug residues. These residues include nitrofurans detected in shrimp at levels above 1 part per billion (ppb); malachite green detected in dace, eel, catfish, and basa at levels ranging from 2.1 to 122 ppb; gentian violet detected in eel and catfish at levels ranging from 2.5 ppb to 26.9 ppb and fluoroquinolones in catfish and basa at levels ranging from 1.9 to 6.5 ppb. Furthermore, Chinese authorities have acknowledged permitting the use of fluoroquinolones in aquaculture. As noted above, the use of fluoroquinolones in food animals may increase antibiotic resistance in human pathogens. Such resistance can compromise the effectiveness of the use of this critically important class of antibiotics in human medicine.
It is important to note that the levels of the drug residues that have been found in seafood are very low, most often at or near the minimum level of detection. FDA is not seeking recall of products already in U.S. commerce and is not advising consumers to destroy or return imported farm-raised seafood they may already have in their homes. FDA is very concerned, however, about long term exposure as well as the possible development of antibiotic resistance.
When FDA continued to see problems from many different companies located in various parts of China, despite these previous efforts to engage with the Chinese exporters and despite trying to help assure the safety of aquacultured seafood by restricting the importation of product from companies which had been shown to have presented adulterated aquacultured seafood for import into the U.S., further action was required. Thus, on June 28, 2007, FDA announced a broader import control, called a “countrywide import alert,” of all farm-raised catfish, basa, shrimp, dace (related to carp), and eel from China. Under this import alert, FDA can detain these products until each shipment is proven to be free of the residues that led to the import alert. This most recent FDA action includes steps for exempting individual firms from the countrywide import alert covering catfish, basa, shrimp, dace, and eel from China. To exempt a firm from the import alert, information would need to be provided to FDA to adequately assess whether a manufacturer has the appropriate controls and processes in place to ensure the safety of the product such as documentation illustrating that a minimum of five consecutive entries have been released by FDA based on third party analysis and documentation that the processor is in compliance with all Chinese government requirements for exporting aquacultured seafood to the U.S. These additional import controls placed on seafood from China will last as long as appropriate.
Although there have been no reports of illnesses to date, FDA has been in contact with the Chinese authorities and will continue working to protect American consumers from unsafe residues that have been detected in these products.
As many of you are aware, FDA and others within the Department of Health and Human Services are actively engaged with our Chinese counterparts in negotiating a comprehensive Memorandum of Understanding (MOU) that will include actions in many areas of food and feed production that should increase Americans’ confidence in the safety of these Chinese products that are exported to the U.S. Present plans call for this MOU to be signed in early December. Part of this MOU will be based on the positive outcomes experienced with two product-specific understandings that FDA and its Chinese counterparts have had in place for many years: an MOU covering ceramicware in which food is stored, and an arrangement with China regarding canned mushrooms that helps assure the safety of those products. These specific understandings have resulted in a marked decrease in health concerns related to these two Chinese products. The intent of the comprehensive MOU being negotiated at present is to achieve the same results not on a specific product basis, but on a national basis when it comes to FDA-regulated products being exported from China to the U.S.
Honey
In February 2006, the Florida Department of Agriculture and Consumer Services became aware of a problem concerning contamination of honey with fluoroquinolones. They collected and analyzed samples of honey for residues of two of the fluoroquinolones of concern, ciprofloxacin and enrofloxacin. The State reported that residues of these antibiotics were found in honey that was traced back to a firm from China. Subsequently, on August 14, 2006, FDA issued Import Alert No. 36-04 requiring detention without physical examination of honey due to presence of fluoroquinolones. In October 2002, FDA issued Import Alert No. 36-03 (updated March 2007) requiring detention without physical examination of honey due to presence of the antibiotic chloramphenicol (or conversion product thereof). Fluoroquinolone antibiotics, including ciprofloxacin and enrofloxacin, have been used in the treatment of diseases in humans and animals. Enrofloxacin is approved for use in cattle but there are no other approvals for use in other food animals. The use of fluoroquinolones in honey bees or their environment can result in residues in honey. Fluoroquinolones are neither generally recognized as safe and effective to treat any honey bee diseases nor are they approved for such use. The use in apiculture (beekeeping) of unapproved antibiotics may significantly increase resistance to those antibiotics in human pathogens of public health concern. Fluoroquinolones have been prohibited from extra-label use in the U.S. in food producing animals because of concerns about the development of increased resistance and the resultant threat to public health. Use of fluoroquinolones to treat any honey bee disease is considered to be an unapproved new animal drug use within the meaning of section 512 of the FD&C Act.
Furthermore, fluoroquinolones are neither generally recognized as safe for any use in a manner that could reasonably be expected to result in their becoming a component of honey nor are they approved for this use. Therefore, fluoroquinolones in honey are considered to be unsafe food additives within the meaning of section 409 of the FD&C Act.
Because of concerns about the presence of fluoroquinolones in the food supply, the U.S. is continuing to develop methods and strategies to detect illegal residues and prevent their introduction into the U.S. food supply.
Feed and Pet Food Ingredient Safety
On March 15, 2007, FDA learned that certain pet foods were sickening and killing cats and dogs. FDA found contaminants in wheat gluten imported into the U.S. from China and used as ingredients in pet food. Analysis by FDA’s Forensic Chemistry Center revealed melamine and melamine analogues in the pet foods and in the wheat products used as an ingredient. FDA traced the suspect product to a single supplier in China, Xuzhou Anying Biologic Technology. FDA issued an import alert focused on this supplier, and began sampling 100 percent of all wheat gluten from China.
Starting in April, FDA also launched an investigation of imported shipments of rice protein concentrate from China that had been found to contain melamine and melamine analogues. The rice protein concentrate was also used as an ingredient in some pet foods. FDA traced the suspect product to another supplier in China, Binzhou Futian Biologic Technology. FDA issued an import alert focused on this supplier, and began sampling 100 percent of all rice protein concentrate from China. FDA subsequently learned of contaminated corn gluten from a supplier in China that was causing illness and death of pets in South Africa. Based on this information, FDA then initiated a countrywide import alert for all vegetable protein from China that is still in place.
Melamine is a molecule that has a number of industrial uses, including use in manufacturing cooking utensils. It has not been approved for use as an ingredient in human or animal food in the U.S, and it is not permitted to be used as fertilizer in the U.S., as it is in some parts of the world.
Further investigation revealed that a portion of the melamine-tainted pet food was used to supplement swine and poultry feed on a small number of farms. FDA and the U.S. Department of Agriculture discovered that some animals that ate the tainted feed had been processed into human food. FDA subsequently learned that some of the contaminated wheat gluten was used to make fish feed. Due to the small amounts present and the small amounts that would be consumed in an average U.S. diet, government scientists have determined that there is no significant risk to human health from consuming food from animals that ate tainted feed. FDA and USDA continue their comprehensive investigation of this event.
Chemical counterfeiting generally and diethylene glycol (DEG)-contaminated products specifically coming from China have been, and still are, on-going concerns for the U.S. and other nations. Ten years ago, Chinese counterfeit glycerin killed nearly 100 children in Haiti. Last year in Panama, Chinese glycerin contaminated with DEG again caused scores of deaths. Recently, toothpaste imported from China to the U.S. was found to contain DEG.
It is our understanding that China does not require registration of chemicals that may have a dual use in both industrial chemical products and drug products. This is the case for dual-use chemicals targeted for domestic use as well as for export. With respect to dual-use chemicals, this systemic problem increasingly can pose a hazard to the U.S. drug supply if these products are exported as “chemicals” but used as starting products for the production of pharmaceuticals.
The recent DEG episode has reinvigorated attention on China’s regulation of its drug products, active pharmaceutical ingredients (APIs), and excipients. FDA’s general experience has been that, while some Chinese companies are state-of-the-art in technology and manufacturing expertise, many are at the opposite end of the spectrum. Further, in the past four years, the number of FDA-registered drug manufacturers in China has at least doubled.
Current Good Manufacturing Practices (cGMPs) in China
China is in the process of re-writing its existing cGMPs for drugs. In the meantime, Chinese drug manufacturers (for both human and veterinary products) comply with cGMPs inconsistently and to varying degrees depending, in large part, on the organizational structure of the company. Larger more established companies may implement a higher level of cGMPs, but many manufacturers cannot be relied on to follow cGMPs and therefore to provide dependably safe and effective drug products. Provincial authorities who conduct inspections of drug manufacturing sites are not always equipped with the expertise needed for this complex undertaking.
FDA cGMP Training Program at Peking University
FDA, Peking University, and the International Society for Pharmaceutical Engineering co-sponsored a training program during 2005-2006 to provide the latest updates from FDA on current regulations and guidance for pharmaceuticals, and interactive training workshops on solid oral dosage forms, and API manufacturing. While the program did not specifically target state drug regulatory officials, approximately 10 percent of the participants from 2005 and 2006 were officials from the Chinese SFDA. Industry representatives from pharmaceutical, chemical, trade, consulting, and trade organizations comprised the remaining attendees. The program’s objective was to broaden China’s drug industry participants’ experience with and knowledge of FDA drug regulatory requirements and expectations. This included cGMP, inspection regimen, and testing methods. This program was intended to help ensure effective cGMP programs and help promote the common goals of FDA and providers of quality pharmaceutical products. Since 2005, FDA has conducted four workshops related to cGMPs.
Graduate Program in International Pharmaceutical Engineering Management
In July 2006, Peking University announced a new master’s degree graduate program “International Pharmaceutical Engineering Management,” which is dedicated to quality management and regulatory science. This program is the result of close collaboration between Peking University and FDA. The long-term goal of this program is to accelerate the modernization of China’s pharmaceutical industry, as well as to provide the basis for a satisfying professional career with success and accomplishment for graduates.
FDA and SFDA have had technical exchanges regarding medical devices since the late 1980’s. The U.S. and China have significant bilateral trade in medical devices, and both countries have a regulatory mandate to assure the safety and effectiveness of medical devices commercially distributed within their territories. Currently almost 3000 firms based in China have listed approximately 7000 medical devices with FDA for marketing in the U.S. In turn, the U.S. is the leading exporter of medical devices to China, reflecting over one-third of all their device imports. Starting in 1996, bilateral activity became much more routine when FDA became a participant in the Medical Device Task Force of the U.S.-China Joint Commission on Commerce & Trade Pharmaceutical and Medical Devices Subgroup, with annual meetings in Washington and Beijing.
Collaboration with SFDA and presentations at major device conferences in China have helped hundreds of China-based firms understand, and thus better comply with U.S. FDA medical device regulations. However, FDA still has concerns regarding non-compliant devices and radiation emitting consumer products, especially in light of the huge volume of these products entering the U.S., and the extremely limited resources available to FDA to actively monitor these entries.
Ensuring the safety of FDA-regulated products imported from China is a significant task, but I want to assure you that FDA is diligently working to efficiently and effectively use the resources and authorities we have been provided by Congress to help protect the public health of the U.S. and to help to provide safe products to U.S. consumers. Thank you for the opportunity to testify. I look forward to responding to any questions you may have.
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