Food Safety: FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities
Published: 2010-05-06T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Food imported from around the world constitutes a substantial and increasing percentage of the U.S. food supply. Ensuring the safety of imported food challenges the Food and Drug Administration (FDA) to better target its resources on the foods posing the greatest risks to public health and to coordinate efforts with the Department of Homeland Security's Customs and Border Protection (CBP) so that unsafe food does not enter U.S. commerce. This testimony focuses on (1) FDA's overseas inspections, (2) identified gaps in agencies' enforcement efforts to ensure the safety of imported food, and (3) statutory authorities that GAO has identified that could help FDA's oversight of food safety. This testimony is principally based on GAO's September 2009 report, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food (GAO-09-873) and has been updated with information from FDA.
section_title: What GAO Found
paragraphs: While the number of FDA overseas inspections has fluctuated, FDA has opened up several overseas offices to address the safety of imported food at the point of origin, and is testing a computer-based system to target high-risk imports for additional inspection when they arrive at ports of entry. Specifically, in 2008, FDA inspected 153 foreign food facilities out of an estimated 189,000 such facilities registered with FDA; in 2007, FDA inspected 95 facilities. FDA estimated that it would conduct 200 inspections in 2009 and 600 in 2010. In addition, FDA opened offices in China, Costa Rica, and India and expects to open offices in Mexico and Chile and to post staff at European Union agencies. Furthermore, FDA's testing of a new computer screening system--the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT)--indicates that the system could enhance FDA's risk-based screening efforts at ports of entry, but the system is not yet fully operational. PREDICT is to generate a numerical risk score for all FDA-regulated products by analyzing importers' shipment information using sets of FDA-developed risk criteria and to target for inspection products that have a high risk score. GAO previously identified several gaps in enforcement that could allow food products that violate safety laws to enter U.S. commerce. For example, FDA has limited authority to assess penalties on importers who introduce such food products, and the lack of a unique identifier for firms exporting food products may allow contaminated food to evade FDA's review. In addition, FDA's and CBP's computer systems do not share information. FDA does not always share certain distribution-related information, such as a recalling firm's product distribution lists with states, which impedes states' efforts to quickly remove contaminated products from grocery stores and warehouses. GAO identified certain statutory authorities that could help FDA in its oversight of food safety. Specifically, GAO previously reported that FDA currently lacks mandatory recall authority for companies that do not voluntarily recall food products identified as unsafe. Limitations in FDA's food recall authorities heighten the risk that unsafe food will remain in the food supply. In addition, under current FDA regulations, companies may conclude a food ingredient is generally recognized as safe without FDA's approval or knowledge. GAO recommended that if FDA determines that it does not have the authority to implement one or more recommendations, the agency should seek the authority from Congress. Finally, GAO reported that FDA has identified a need for explicit authority from Congress to issue regulations requiring preventive controls by firms producing foods that have been associated with repeated instances of serious health problems or death. FDA already has preventive regulations for seafood and juice, which require firms to analyze safety hazards and implement plans to address those hazards.

section_title: Letter
paragraphs: I am pleased to be here today to discuss findings from our work on the  Food and Drug Administration’s (FDA’s) efforts to ensure the safety of  imported food and on our other recently issued food safety work.  According to U.S. Department of Agriculture (USDA) data, food imported  from more than 150 countries and territories constitutes a substantial and  increasing percentage of the U.S. food supply. Imported food constitutes  15 percent of the U.S. food supply, including 60 percent of fresh fruits and  vegetables and 80 percent of seafood. Additionally, the volume of  agricultural and seafood products imported for consumption increased 29  percent from fiscal years 2003 to 2008, and the value of these products  increased 65 percent. Ensuring the safety of imported food challenges  federal agencies to better target their resources on the foods posing the  greatest risks to public health and to coordinate efforts so that unsafe food  does not enter U.S. commerce.
We have reported on the safety of imported food for many years. In 1998,  we assessed the federal government’s efforts to ensure the safety of  imported foods and determined that federal agencies could not be certain  that the growing volume of imported food was safe for consumers. More  recently, we reported in September 2009 that agencies need to address  gaps in enforcement and collaboration to enhance the safety of imported  food. Federal agencies involved in the oversight of food imports include  the following:    FDA—which is responsible for roughly 80 percent of the food supply,  including dairy products, seafood, fruits, and vegetables—oversees  imported food safety through targeted inspections, sampling, and  surveillance, among other things. Owing in part to the volume of imported  products it regulates, FDA physically examines approximately 1 percent of  imported food; however, the agency is developing the Predictive Risk- Based Evaluation for Dynamic Import Compliance Targeting (PREDICT)  computer system to improve its targeted screening efforts.
Customs and Border Protection (CBP), under the Department of  Homeland Security, is responsible for inspecting food imports for  compliance with U.S. law and coordinating with FDA to enforce food  safety laws at the border, among other things. CBP’s computerized  screening system processes all imported shipments, including food. CBP  requires importers to (1) give a manufacturer identification number for  each imported shipment and (2) post a monetary bond for formal entries  to provide assurance that these shipments meet U.S. requirements, among  other things.
USDA’s Food Safety and Inspection Service (FSIS) has responsibility for  the safety of imported meat and poultry and relies on an equivalency  system whereby exporting countries must demonstrate that their systems  meet standards that are equivalent to those of the U.S. system.
Furthermore, food safety responsibility is further divided among the 50  states, which may have their own statutes, regulations, and agencies for  regulating and inspecting the safety and quality of food products. This  fragmentation is the key reason that we added federal oversight of food  safety to our high risk-series in January 2007 and called for a  governmentwide examination of the food safety system.
Several food safety bills have recently been introduced in Congress, and a  comprehensive bill, H.R. 2749, passed the House of Representatives in July  2009. The House bill would require importers to register annually with  FDA and to submit an appropriate unique facility identifier as a condition  of such registration, among other provisions. The bill would also authorize  FDA to issue a mandatory recall of foods that may cause serious adverse  health consequences or death to humans or animals and would expand the  agency’s authority to assess criminal and civil penalties. Our September  2009 report made some of the same recommendations.
My testimony today will focus on three key issues: (1) FDA overseas  inspections to address the safety of imported food, (2) identified gaps in  agencies’ enforcement that undermine efforts to ensure the safety of  imported food, and (3) statutory authorities that we have identified that  could help FDA’s oversight of food safety.
As detailed in our reports, we found the following:     First, while the number of FDA’s foreign inspections has fluctuated, the  agency has opened several overseas offices to address the safety of  imported food at the point of origin. In addition, FDA testing of PREDICT  indicates that the system could enhance FDA’s risk-based screening  efforts, but the system is not yet fully operational. FDA officials stated that  a scheduled nationwide rollout this summer of PREDICT has been delayed  primarily because of technical problems, such as server crashes and  overloads, which are affecting FDA’s field data systems nationwide.
Second, gaps in FDA’s and other agencies’ enforcement could allow  violative food products to enter U.S. commerce. For example, FDA has  limited authority to assess penalties on importers who introduce violative  food products, and the lack of a unique identifier for firms exporting food  products may allow contaminated food to evade FDA review.
Finally, we have made several recommendations that would help FDA  improve food safety oversight.  For example, we recommended that FDA  seek additional authorities, such more explicit authority to create  preventive controls for high-risk foods, and we have recommended that  Congress consider giving FDA additional authority, such as mandatory  recall authority.  FDA agreed with our recommendations and has sought  authority to order food safety recalls and issue additional preventive  controls for high-risk foods.
This testimony is largely based on our September 2009 report on imported  food safety, as well as other recent reports, and updated with information  from FDA. See appendixes I-IV for highlights of our prior work. We  conducted our work in accordance with generally accepted government  auditing standards.
subsections: section_title: While the Number of FDA Overseas Inspections Has Fluctuated, the Agency Has Opened Overseas Offices, and Has Piloted PREDICT
paragraphs: In 2008, FDA inspected 153 foreign food facilities out of an estimated  189,000 such facilities registered with FDA and estimated that it would  conduct 200 inspections in 2009 and 600 in 2010. In 2007, FDA inspected  95 facilities. Table 1 shows the number of FDA inspections of foreign food  facilities, by country, from fiscal years 2001 through 2008. As the table  shows, FDA conducted 1,186 inspections in 56 countries from fiscal years  2001 through 2008; the majority of FDA inspections were in Mexico,  followed by Ecuador, Thailand, and Chile. FDA conducted a total of 46  inspections in China during this period.
For fiscal year 2009, FDA allocated 272 full-time employees to examine  imported food shipments at U.S. ports of entry and estimated a budget of  approximately $93.1 million for field import activities. The total estimated  2009 FDA budget for all FDA products and programs, including food,  drugs, medical devices, and other products, was $2.7 billion. In 2008, we  testified that if FDA were to inspect each of the 189,000 registered foreign  facilities—at the FDA Commissioner’s estimated cost of $16,700 per  inspection—it would cost FDA approximately $3.2 billion to inspect all of  these facilities once.
Since November 2008, FDA has opened overseas offices to help prevent  food that violates U.S. standards from reaching the United States. These  offices are expected to provide FDA with direct access to information  about foreign facilities’ food manufacturing practices so that its staff at  U.S. ports of entry can make more informed decisions about which food  imports to examine. For example, FDA’s overseas staff are working with  staff at counterpart regulatory agencies overseas, as well as with other  stakeholders who may be knowledgeable about certain industries.  Overseas staff are also educating local exporters to make sure they  understand U.S. food safety laws and regulations and FDA expectations.  FDA opened offices in China (Beijing, Guangzhou, and Shanghai); in  Europe (Brussels, London, and soon in Parma, Italy); in Latin America  (San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico); and in  India (New Delhi and Mumbai). The FDA Middle East Office is operating  out of FDA headquarters because the Department of State denied its  request to locate in Amman, Jordan, due to security concerns.
In addition to having overseas offices assist FDA’s oversight of imported  food, the agency is developing PREDICT. PREDICT is intended to assist  FDA’s oversight of imported food and uses FDA-developed criteria to  estimate the risk of imported food shipments. These criteria are to  incorporate, among other things, the violative histories of the product,  importer, manufacturer, consignee, and country of origin; the results of  laboratory analyses and foreign facility inspections; and general  intelligence on recent world events—such as natural disasters, foreign  recalls, and disease outbreaks—that may affect the safety of a particular  imported food product. In addition, agency officials stated that PREDICT  will assign higher risk scores to firms for which the system does not have  historical data.
PREDICT generates a numerical risk score for all FDA-regulated products.  According to FDA, PREDICT is to present the shipment’s risk score to  FDA reviewers if the score is above an FDA-specified threshold.  Shipments that are below the threshold are to receive a system “may  proceed” (cleared) message unless other conditions are present, such as  an FDA import alert. FDA intends that reviewers using PREDICT will also  be able to view the specific risk factors that contributed to the shipment’s  risk score, such as whether the product or importer has a history of FDA  violations. FDA expects reviewers to use PREDICT to supplement, rather  than replace, their professional judgment when deciding what food  products to inspect.
A 2007 pilot test of PREDICT in Los Angeles for seafood products  indicated that the system could enhance FDA’s risk-based import  screening efforts. When compared with baseline data from FDA’s existing  import screening system, the Operational and Administrative System for  Import Support (OASIS), PREDICT improved FDA’s ability to target  imports that the agency considers to be high risk for further examinations  and allowed a greater percentage of products the agency considers to be  low risk to enter U.S. commerce without requiring a reviewer’s  intervention. Specifically, PREDICT nearly doubled the percentage of field  examinations—and increased by approximately one-third the percentage  of laboratory examinations—that resulted in violations, relative to  baseline OASIS data. In addition, according to FDA, the violations in  shipments that reviewers targeted using PREDICT, on average, posed a  greater risk to human health than the violations that OASIS detected.
FDA told us on April 12, 2010, that PREDICT is fully operational in the Los  Angeles and New York districts, but due to technical problems, FDA has  not determined when the system will be deployed in the Seattle district. In  addition, FDA officials stated that a scheduled nationwide rollout of  PREDICT this summer has been delayed, primarily because of technical  problems, such as server crashes and overloads, which are affecting FDA’s  field data systems nationwide.
Although the PREDICT pilot produced positive results and demonstrated  the system’s potential to improve import screening efforts, we reported  that further agency actions were needed to help ensure that the system is  effective. For example, FDA had not yet developed a performance  measurement plan to evaluate, among other things, PREDICT’s ability to  identify high-risk shipments for manual review while simultaneously  returning “may proceed” messages for low-risk shipments and enabling  them to enter U.S. commerce. We recommended FDA develop such a plan.  According to agency officials, since our report was issued in September  2009, FDA had completed a draft performance measurement plan.  However, we have not reviewed this draft plan.
section_title: FDA and Other Agencies Face Gaps in Enforcement That Undermine Efforts to Ensure the Safety of Imported Food
paragraphs: We identified specific gaps in enforcement that could allow violative food  products to enter U.S. commerce: (1) FDA’s limited authority to assess  civil penalties on certain violators; (2) lack of unique identifiers for firms  exporting FDA-regulated products; (3) lack of information-sharing  between agencies’ computer systems and (4) FDA’s not sharing product  distribution information during a recall.
subsections: section_title: FDA Has Limited Authority to Ensure Importers’ Compliance
paragraphs: Importers can retain possession of their food shipments until FDA  approves their release into U.S. commerce. However, FDA and CBP  officials do not believe that CBP’s current bonding procedures for FDA- regulated food effectively deter importers from introducing violative food  products into U.S. commerce. Specifically, importers post a monetary  bond for formal entries (i.e., all shipments exceeding $2,000 and certain  shipments valued below that amount) to provide assurance that these  shipments meet U.S. requirements. According to these officials, many  importers still consider the occasional payment of forfeited bonds as part  of the cost of doing business. Indeed, as we reported in 1998, forfeiture of  the shipment’s maximum bond value is often not sufficient to deter the  sale of imported goods that FDA has not yet released. In its response to  our September 2009 report, FDA agreed with this finding. According to  FDA’s regulatory procedures manual, the bond penalty is intended to  make the unauthorized distribution of articles unprofitable, but liquidated  damages incurred by importers are often so small that they, in effect,  encourage future illegal distribution of imported shipments. Even though  the bond may be up to three times the value of the shipment, for a large  importer, this sum may be negligible, especially when the importer  successfully petitions CBP to reduce the amount.
We recommended that the FDA Commissioner seek authority from  Congress to assess civil penalties on firms and persons who violate FDA’s  food safety laws and that the Commissioner determine what violations  should be subject to this new FDA civil penalties authority, as well as the  appropriate nature and magnitude of the penalties. FDA agreed with this  recommendation and was working with Congress to include civil penalty  authority in food safety legislation. FDA officials also told us that if the  agency had the authority to impose civil penalties on importers, which is  also provided for in H.R. 2749, FDA might be better able to deter  violations.
section_title: FDA and CBP Do Not Provide Unique Identification Numbers to Firms
paragraphs: High-risk foods may enter U.S. commerce because the identification  numbers that FDA uses to target manufacturers that have violated FDA  standards in the past are not unique, and therefore these manufacturers  and their shipments, may evade FDA review. Importers generate a  manufacturer identification number at the time of import, when, among  other things, they electronically file entry information with CBP. (CBP is  responsible for validating the manufacturer identification numbers and  ensuring they are unique.) CBP electronically sends this information to  FDA’s computer system. From this new manufacturer identification  number, FDA’s computer system automatically creates an FDA firm  identification number—called the FDA establishment identifier. Officials  told us that a single firm may often have multiple CBP manufacturer  identification numbers—and therefore multiple FDA establishment  identifiers. FDA officials told us that because CBP has multiple  identification numbers for many firms, FDA has an average of three  “unique” identifiers per firm, and one firm had 75 identifiers.
The creation of multiple identifiers can happen in a number of ways. For  example, if information about an establishment—such as its name—is  entered by importers incorrectly at the time of filing with CBP, a new  manufacturer identification number, and therefore a new FDA  establishment identifier, could be created for an establishment that  already has an FDA number. In this scenario, an importer may— intentionally or unintentionally—enter a firm’s name or address slightly  differently from the way it is displayed in FDA’s computer system. This  entry would lead to the creation of an additional FDA number for that  firm. If an import alert was set using the original FDA establishment  identifier, a shipment that should be subject to the import alert may be  overlooked because the new number does not match the one identified in  the alert.
In addition, foreign facilities that manufacture, process, pack, or hold food  for consumption in the United States, with some exceptions, are required  to register with FDA. Upon registration, FDA assigns a registration  number. FDA calculated that in 2008, 189,000 foreign firms were registered  under this requirement. However, some of the firms included in that total  may be duplicates because the facility may have been reregistered without  the cancellation of the original registration; consequently FDA may not  know the precise number of foreign firms registered. As we previously  reported, FDA officials told us they are working to address the unique  identifier problem by establishing an interactive process in which FDA’s  systems recognize when a product’s identifier does not match its  manufacturer’s registration number.
As we reported, FDA could consider requiring food manufacturers to use a  unique identification number that FDA or a designated private sector firm  provides at the time of import. However, the use of this unique number  would necessitate collaboration with CBP, since importers would use such  a number each time they file with CBP to ship goods to the United States.  That is, CBP’s computer system would need to be programmed to accept  an FDA unique identification number. According to CBP officials, it is  unknown if or when CBP’s system will have this capability. To improve  FDA’s and CBP’s ability to identify foreign firms with violative histories,  we recommended that the FDA Commissioner explore ways to improve  the agency’s ability to identify foreign firms with a unique identifier and  that the CBP Commissioner ensure that its computer system is able to  accept a unique identification number for foreign firms that export FDA- regulated foods. Both FDA and CBP agreed with our recommendation, and  CBP officials told us that the agency has developed a plan for  implementing a unique identifier. However, we have not reviewed this  plan. We observe that H.R. 2749 contains a provision that may allow the  Secretary of Health and Human Services, in consultation with the  Commissioner of CBP, to specify the unique numerical identifier system to  be used, taking into account compatibility with CBP’s automated systems.  Such actions would help prevent high-risk foods from entering U.S.  commerce.
section_title: Information Is Not Shared between Computer Systems
paragraphs: When we issued our report in September 2009, we reported that CBP’s  computer system did not notify FDA’s or FSIS’s systems when imported  food shipments arrive at U.S. ports, which increases the risk that  potentially unsafe food may enter U.S. commerce, particularly at truck  ports. If FDA chooses to examine a shipment as part of its admissibility  review, the agency notifies both CBP and the importer through its  computer system, OASIS. However, once the shipment arrives at the port  and clears CBP’s inspection process, the importer is not required to wait at  the port for FDA to conduct its examination. Instead, the importer may  choose to transport the shipment to the consignee’s warehouse or other  facility within the United States. The importer might choose to do so  because, for example, CBP and FDA do not have the same hours of  operation at some ports, and FDA’s port office may be closed when the  shipment arrives. In such cases, as a condition of the bond with CBP, the  importer agrees to hold the shipment intact and not distribute any portion  of it into U.S. commerce until FDA has examined it.
CBP and FDA officials told us that, occasionally, an importer will  transport the shipment to the consignee’s warehouse without first  notifying FDA. If this occurs, FDA will not quickly know that the shipment  has arrived and been transported to a U.S. warehouse because CBP’s  computer system does not notify FDA’s OASIS computer system when the  shipment arrives at the port. Instead, from the perspective of an FDA  reviewer using OASIS, it will appear as if the shipment’s arrival is still  pending. FDA port officials told us that it could be 2 or 3 days before FDA  reviewers become suspicious and contact CBP to inquire about the  shipment’s arrival status. By this time, an unscrupulous importer could  have distributed the shipment’s contents into U.S. commerce without  FDA’s approval. As we reported, if CBP communicated time-of-arrival  information directly to OASIS, then FDA would be able to quickly identify  shipments that are transported into the United States without agency  notification and arrange to examine them before they are distributed to  U.S. markets. Since our report was issued in September 2009, CBP told us  that it had modified its software to notify FDA of a shipment’s time of  arrival. However, we have not reviewed the effectiveness of these  modifications. We are still waiting to see whether CBP has an agreement  with FSIS regarding time of arrival modifications.
section_title: FDA Does Not Always Share Product Distribution Information During a Recall
paragraphs: One key issue of concern, according to officials we spoke with from  several states, is that FDA does not always share with states certain  distribution-related information, such as a recalling firm’s product  distribution lists, which impedes the states’ efforts to quickly remove  contaminated products from grocery stores and warehouses. According to  one state official, because FDA does not provide this information, the state  has to spend time tracking it down on its own. Public health may be at risk  during the time it takes for the states to independently track distribution  information when a product is found to be contaminated. FDA told us that  it usually considers such information to be confidential commercial  information, the disclosure of which is subject to statutory restrictions,  such as the Trade Secrets Act. However, FDA’s regulations allow for  sharing of confidential commercial information with state and local  government officials if, for example,  the state has provided a written statement that it has the authority to  protect the information from public disclosure and that it will not further  disclose the information without FDA’s permission, and FDA has  determined that disclosure would be in the interest of public health, if  such sharing is necessary to effectuate a recall, or the information is shared only with state and local officials who are duly  commissioned to conduct examinations or investigations under the  Federal Food, Drug, and Cosmetic Act. In certain circumstances, FDA may  also seek a firm’s consent to disclose its market distribution information.
section_title: Statutory Authorities We Identified Could Help FDA Oversee Food Safety
paragraphs: In our past work, we have pointed out that mandatory recall—the  authority to require a food company to recall a contaminated product— would help ensure that unsafe food does not remain in the food supply.  We also reported that FDA should strengthen its oversight of food  ingredients determined to be generally recognized as safe for their  intended use and to seek the authority if the agency deems necessary.  Likewise, we reported that FDA has identified a need for explicit authority  from Congress to issue regulations to require preventive measures by  firms producing foods that have been associated with repeated instances  of serious health problems or death.
subsections: section_title: FDA Lacks Mandatory Recall Authority
paragraphs: We have reported that food recalls are largely voluntary and that federal  agencies responsible for food safety, including FDA, have no authority to  compel companies to recall contaminated foods, with the exception of  FDA’s authority to require a recall for infant formula. FDA does have  authority, through the courts, to seize, condemn, and destroy adulterated  or misbranded food under its jurisdiction and to disseminate information  about foods that are believed to present a danger to public health.  However, government agencies that regulate the safety of other products,  such as toys and automobile tires, have recall authority not available to  FDA for food and have had to use their authority to ensure that recalls  were conducted when companies did not cooperate.
We have noted that limitations in the FDA’s food recall authorities  heighten the risk that unsafe food will remain in the food supply and have  proposed that Congress consider giving FDA similar authorities. H.R. 2749  authorizes the Secretary of Health and Human Services to request that a  person recall an article of food if the Secretary has reason to believe it is  adulterated, misbranded, or otherwise in violation of the Federal Food,  Drug, and Cosmetic Act and to require a person to cease distribution if the  Secretary has reason to believe the article of food “may cause serious  adverse health consequences or death to humans or animals.” It also  requires the Secretary to order a recall of such an article of food if the  Secretary determines (after an informal hearing opportunity) it is  necessary. Finally, it authorizes the Secretary to proceed directly to a  mandatory recall order if the Secretary has credible evidence that an  article of food subject to an order to cease distribution presents an  imminent threat of serious adverse health consequences or death to  humans or animals. As our previous work has shown, mandatory recall  authority would allow FDA to ensure that unsafe food does not remain in  the food supply.
section_title: FDA Has Limited Oversight of Food Ingredients Determined to be Generally Recognized as Safe
paragraphs: We have reported that FDA should strengthen its oversight of food  ingredients determined to be generally recognized as safe (GRAS) for their  intended use. Manufacturers add these substances—hundreds of spices  and artificial flavors, emulsifiers and binders, vitamins and minerals, and  preservatives—to enhance a food’s taste, texture, nutritional content, or  shelf life. Currently, companies may conclude a substance is GRAS  without FDA’s approval or knowledge. We reported that FDA only reviews  those GRAS determinations that companies submit to the agency’s  voluntary notification program. The agency generally does not have  information about other GRAS determinations companies have made  because companies are not required to inform FDA of them. Among other  things, we recommended to FDA that it develop a strategy to require any  company that conducts a GRAS determination to provide the agency with  basic information about this determination, and to incorporate such  information into its public Web site.
We also reported that FDA is not systematically ensuring the continued  safety of current GRAS substances. According to FDA regulations, the  GRAS status of a substance must be reconsidered as new scientific  information emerges, but the agency has not systematically reconsidered  GRAS substances since the 1980s. Rather, FDA officials said, they keep up  with new developments in the scientific literature and, on a case-by-case  basis, information brought to the agency’s attention could prompt them to  reconsider the safety of a GRAS substance. We recommended that FDA  develop a strategy to conduct reconsiderations of the safety of GRAS  substances in a more systematic manner. We also recommended that, if  FDA determines that it does not have the authority to implement one or  more of our recommendations, the agency should seek the authority from  Congress. FDA generally agreed with the report’s findings and  recommendations.
In addition, we reported that FDA has taken steps to make information  about its GRAS notification program available to the public by posting its  inventory of all GRAS notices FDA has received on its Web site. By placing  information about the GRAS notice and its response on its Web site, FDA  enhances the ability of Congress, stakeholders, and the general public to  be better informed about GRAS substances. H.R. 2749 contains provisions  on GRAS substances, including a requirement that the Secretary post on  FDA’s Web site information about GRAS notices submitted to FDA within  60 days of receipt of the notice.
section_title: FDA Lacks Explicit Authority to Issue Regulations Requiring Food-Producing Firms to Institute Preventive Measures
paragraphs: We have also reported that FDA should strengthen its oversight of fresh  produce. For example, we noted that FDA has identified a need for  explicit authority from Congress to issue regulations requiring preventive  controls (risk-based safety regulations) by firms producing foods that have  been associated with repeated instances of serious health problems or  death. FDA already has preventive regulations for seafood and juice,  which require firms to analyze safety hazards and implement plans to  address those hazards. According to FDA, such authority would  strengthen the agency’s ability to implement risk-based processes to  reduce illnesses from high-risk foods. FDA officials told us that issuing  preventive regulations may be one of the most important things they can  do to enhance their oversight of fresh produce. We therefore  recommended that the Commissioner of FDA seek authority from  Congress to make explicit FDA’s authority to adopt preventive controls for  high-risk foods. FDA agreed with this recommendation and has sought  authority to issue additional preventive controls for high-risk foods.  Furthermore, H.R. 2749 requires FDA to create preventive controls for  produce and certain raw agricultural commodities. Such measures could  help the agency reduce illnesses from these high-risk foods.
In conclusion, food imports from around the world constitute a substantial  and increasing volume of imported foods. Our work has shown that FDA  could strengthen its oversight of imported food by improving its  enforcement, such as by assessing civil penalties and providing unique  identification numbers to firms. Additional statutory authorities, such as  mandatory recall authority, could also help FDA oversee food safety. FDA  generally agreed with our recommendations and has some taken actions  to address them.
Mr. Chairman, this concludes my statement. I would be pleased to answer  any questions that you or other Members of this Subcommittee may have.
section_title: Contact and Staff Acknowledgments
paragraphs: For further information about this testimony, please contact Lisa Shames  at (202) 512-3841 or shamesl@gao.gov. Contact points for our Offices of  Congressional Relations and Public Affairs may be found on the last page  of this statement.
Key contributors to this statement were José Alfredo Gómez, Assistant  Director; Kevin Bray; Candace Carpenter; Anne Johnson; Carol Herrnstadt  Shulman; Nico Sloss; and Rebecca Yurman.
section_title: Appendix IV: GAO-08-1047 (Fresh Produce)
paragraphs: This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.