Food Safety: USDA Should Take Further Action to Reduce Pathogens in Meat and Poultry Products

The U.S. food supply is generally considered safe, but the Centers for Disease Control and Prevention (CDC) estimate that Salmonella and Campylobacter in food cause about 2 million human illnesses per year in the United States. In 2014, GAO identified challenges USDA faced in reducing pathogens in poultry products, including standards that were outdated or nonexistent and limited control over factors that affect pathogen contamination outside of meat and poultry slaughter and processing plants, such as practices on the farm.

GAO was asked to review USDA's approach to reducing pathogens in meat and poultry products. This report examines (1) the extent to which USDA has developed standards for meat and poultry products and (2) any additional steps USDA has taken to address challenges GAO identified in 2014. GAO reviewed relevant regulations, documents, and data and interviewed officials from USDA and CDC, as well as 17 stakeholders representing industry, consumer groups, and researchers selected based on their knowledge of USDA's meat and poultry slaughter inspections and food safety.

To help ensure the safety of our nation's food supply, the U.S. Department of Agriculture (USDA) has developed standards limiting the amount of Salmonella and Campylobacter —pathogens that can cause foodborne illness in humans—permitted in certain meat (beef and pork) and poultry (chicken and turkey) products, such as ground beef, pork carcasses, and chicken breasts. However, the agency has not developed standards for other products that are widely available, such as turkey breasts and pork chops. Further, its process for deciding which products to consider for new standards is unclear because it is not fully documented, which is not consistent with federal standards for internal control. For example, USDA has informed stakeholders that it will take into account factors including consumption and illness data, but the agency has not documented this process going forward. Previously, USDA had developed new standards after widespread outbreaks indicated the need. For example, in 2016, USDA concluded that new standards were needed for certain poultry products to reduce Salmonella after reviewing outbreaks from these products in 2011, 2013, and 2015—outbreaks in which 794 people were sickened and 1 died. By documenting the agency's process for deciding which products to consider for new standards, USDA could better ensure that such decisions will be risk-based.

USDA is taking steps to address challenges GAO identified in 2014 for reducing pathogens in poultry products, but these challenges are ongoing and could affect USDA's ability to reduce pathogens in meat as well. For example, one challenge GAO identified is that the level of pathogens in poultry products can be affected by practices on farms where poultry are raised. GAO recommended in 2014 that to help overcome this challenge, USDA guidelines on practices for controlling Salmonella and Campylobacter on farms include information on the effectiveness of each of the practices, consistent with a recommendation from a USDA advisory committee. Since GAO's 2014 report, USDA drafted revised guidelines to include information on the effectiveness of on-farm practices for controlling pathogens in poultry and beef cattle, in 2015 and 2017, respectively. However, USDA's draft guidelines for controlling Salmonella in hogs do not contain such information. By including such information as it finalizes its draft guidelines, USDA could better inform industry of the potential benefits of adopting on-farm practices included in the guidelines and encourage implementation of such practices.

GAO is making three recommendations, including that USDA document its process for deciding which products to consider for new standards and that it include information on the effectiveness of on-farm practices in its guidelines for Salmonella control in hogs. USDA agreed with GAO's recommendations and described actions it will take to implement them.

The U.S. food supply is generally considered safe, but foodborne illness  remains a common, costly, yet largely preventable public health problem.  The Centers for Disease Control and Prevention (CDC) estimated in  2011—its most recent estimate—that each year, one in six people in the  United States gets sick from eating contaminated food. According to  CDC, while the source of foodborne outbreaks is often unknown, certain  pathogens in food cause more than 9 million human illnesses per year in  the United States, 2 million of which are caused by Salmonella and  Campylobacter. For example, according to a CDC outbreak investigation  report, in 2015, 192 people in five states became ill from eating pork  contaminated with Salmonella.

The U.S. Department of Agriculture (USDA) is responsible for ensuring  the safety and wholesomeness of meat and poultry products that enter  commerce, as provided by the Federal Meat Inspection Act and the  Poultry Products Inspection Act. Accordingly, USDA’s Food Safety and  Inspection Service (FSIS) inspects and regulates the production of  domestic meat and poultry products sold for human consumption. For  meat and poultry processing and slaughter plants (hereafter referred to as  plants) under its jurisdiction, FSIS sets pathogen reduction performance  standards (hereafter referred to as pathogen standards) limiting the  allowable levels of Salmonella or Campylobacter. FSIS personnel  perform inspection activities at nearly 6,500 plants nationwide, including  testing samples of meat and poultry products to assess compliance with  the pathogen standards, which vary by product. For fiscal year 2016,  Congress appropriated more than $1 billion to FSIS for its activities,  including its food safety inspection program, through the annual  appropriations process.

In September 2014, we found that USDA had taken a number of actions  to reduce the levels of Salmonella and Campylobacter in poultry (chicken  and turkey) products but that the agency needed to do more to assess  the effects of these actions on the incidence of foodborne illnesses. As a  result, we recommended that USDA develop performance measures to  monitor whether its activities to reduce the levels of Salmonella and  Campylobacter in domestic poultry products are meeting agency goals.  USDA agreed with and implemented this recommendation. We also  identified several challenges that could hinder USDA’s ability to reduce  levels of pathogens in poultry products; in particular, we found that  pathogen standards for poultry products were outdated or nonexistent.  Other challenges we identified included limited USDA control over factors  that affect pathogen contamination outside of plants, plants not  designating pathogens as hazards, and the complex nature of pathogens,  among others. We recommended that FSIS include in its guidelines  information on the effectiveness of on-farm practices to reduce the level  of pathogens in live poultry. USDA agreed with and is taking steps to  implement this recommendation.

However, according to CDC data, consumption of poultry products  continues to be associated with foodborne illness in the United States, as  does the consumption of meat (such as beef and pork). Further,  according to a 2016 CDC report, the United States is not on track to  reach its public health goals for reducing foodborne illnesses caused by  Salmonella and Campylobacter.

You asked us to review USDA’s approach to reducing the level of  pathogens in domestic meat and poultry products, including its use of  pathogen standards. This report examines (1) the extent to which USDA  has developed pathogen standards for meat and poultry products and (2)  any additional steps that USDA has taken to address challenges we  identified in 2014 in reducing the level of pathogens.

To examine the extent to which USDA has developed pathogen  standards for meat and poultry products, we reviewed our prior findings  and recommendations from September 2014 on pathogen standards for  poultry products. We also reviewed relevant laws and regulations, FSIS  strategic plans covering the period from 2011 through 2021, and FSIS  annual performance plans from 2014 through 2018. We reviewed relevant  Federal Register notices on specific pathogen standards for meat and  poultry from 1996, when FSIS first established the standards, through  2016, when the agency set or revised the most recent pathogen  standards. We identified relevant performance goals and measures in  FSIS annual performance plans from 2012 through 2017. We reviewed  FSIS reports on pathogens in meat and poultry products and annual  sampling plans—estimates of the type and number of products the  agency will test for certain pathogens—to understand the range of meat  and poultry products FSIS monitors for pathogens. In addition, we  interviewed current and former FSIS officials on the history of the 1996  Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP)  regulations, related pathogen standards, and the process and criteria for  developing new pathogen standards and revising existing ones. We  reviewed documents and interviewed staff from USDA’s Agricultural  Marketing Service—which purchases commodities, including meat and  poultry products, for federal nutrition assistance programs such as the  National School Lunch Program—to determine any additional steps  USDA takes to prevent pathogens in meat and poultry products used for  school meals. We reviewed data FSIS collected on compliance rates for  meat and poultry plants from 2014 through 2017 and data on foodborne  illness rates from CDC from 1998 through 2016, the most recent data  available. To assess the reliability of the data, we interviewed CDC  officials about the steps they took to ensure the reliability of the data and  determined that these data were sufficiently reliable for viewing trends in  compliance rates and trends in foodborne illness rates.

We identified an initial group of stakeholders from our prior work,  specifically from those we interviewed in our 2013 report on USDA’s  changes to poultry and hog inspections and our 2014 report on poultry  pathogens. In addition, we asked these groups for recommendations on  other stakeholders we should consider contacting and expanded the list,  as needed. We selected these stakeholders because they are  knowledgeable about FSIS’s food safety programs and provide a range of  views on the topic. In the end, we identified a nongeneralizable sample of  17 stakeholders: 7 representatives from industry, 4 representatives from  consumer advocacy groups, 4 food safety researchers, and 2 former  federal food safety experts. Views from those we selected based on their  knowledge cannot be generalized to all stakeholders who have  knowledge about FSIS’s food safety programs (i.e., those we did not  interview), but they provide illustrative examples. We obtained information  from agency documentation and interviews with FSIS officials regarding  the process for developing new pathogen standards and compared this  process with federal standards for internal control. We also obtained  information from FSIS documentation and interviews with agency officials  on the agency’s plans to review or revise pathogen standards. We  compared these plans with the Project Management Institute’s standards  and leading practices for project management.

To examine any additional steps that USDA has taken to address the  challenges we identified in 2014 that it faces in reducing the level of  pathogens in meat and poultry, we reviewed agency documentation on  the steps it has taken to address these challenges since 2014, including  documentation on relevant laws and regulations; Federal Register  notices; FSIS’s 2017-2021 strategic plan, annual performance plans and  related performance reports from 2015 through 2017, and 2016  Establishment-Specific Data Release Strategic Plan; and USDA and  FSIS websites. We reviewed FSIS guidance regarding on-farm practices  for reducing the level of pathogens in live animals before they enter plants  and compared this information with recommendations on such practices  made in 2011 by the USDA National Advisory Committee on Meat and  Poultry Inspection. We also reviewed reports from the Interagency Food  Safety Analytics Collaboration, USDA’s Office of Inspector General, and  the National Academy of Sciences.

We obtained testing data from FSIS for the period from May 2016 through  August 2017, the most recent data available, to determine the number of  plants that did not meet the chicken carcass Salmonella and  Campylobacter standards. To assess the reliability of FSIS’s data, we  interviewed FSIS officials about the steps they took to ensure the  reliability of the data and determined that the data were sufficiently  reliable for analyzing the number of plants that did not meet the pathogen  standards during the reporting period. We reviewed CDC data on  foodborne illness outbreaks from beef and pork from 2006 through 2016  and obtained recall documents from FSIS on plants that produced  products involved in those outbreaks. We interviewed FSIS officials about  any challenges the agency faces in reducing pathogens in meat and  poultry and steps the agency has taken since 2014 to address previously  identified challenges. Additionally, we interviewed FSIS and CDC officials  on steps the agencies have taken to improve the methods used to  estimate the burden of foodborne illness in the United States and the use  of emerging technologies to detect the pathogen strains most harmful to  human health. Further, we interviewed the stakeholder groups we  identified for our first objective about USDA’s efforts to address the  challenges we identified in 2014.

We conducted this performance audit from June 2016 to January 2018 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

Contact with infected animals or consumption of contaminated water and  food—including produce, meat, poultry, and processed products—can  cause foodborne illness. Many different pathogens can contaminate food,  including harmful bacteria such as Salmonella and Campylobacter. CDC  reported that in 2015 there were 902 foodborne disease outbreaks  reported in the United States that resulted in 15,202 illnesses, 950  hospitalizations, 15 deaths, and 20 food product recalls. According to  CDC, fish, chicken, and pork were the most common single food  categories implicated in these outbreaks. More recently, in 2016, there  were 233 foodborne illnesses from 10 outbreaks linked to beef, 426  foodborne illnesses from 17 outbreaks linked to pork, and 417 foodborne  illnesses from 20 outbreaks linked to poultry, according to CDC’s National  Outbreak Reporting System (see fig. 1). Common symptoms of  foodborne diseases include nausea, vomiting, stomach cramps, and  diarrhea. Symptoms can sometimes be severe, and some foodborne  illnesses can be life-threatening. Although anyone can get a foodborne  illness, some people are more likely to have one. Those groups include  young children, older adults, pregnant women, and people with immune  systems weakened from medical conditions, such as diabetes, liver, and  kidney disease. Patients receiving chemotherapy or radiation treatment  are also more susceptible.

We have previously reported that to improve its food safety approach,  FSIS moved to an increasingly science-based, data-driven, risk-based  approach by adopting the Pathogen Reduction; HACCP regulations in  1996. Under the HACCP approach, each plant is responsible for (1)  identifying food safety hazards, such as fecal material, that are  reasonably likely to occur and (2) establishing controls that prevent or  reduce these hazards in its processes. As part of this approach, plants  must develop plans that identify the point (known as the critical control  point) where they will take steps to prevent, eliminate, or reduce each  hazard identified. FSIS inspectors at slaughter and processing plants  routinely check records to verify a plant’s compliance with those plans.  FSIS inspectors also observe operations at plants as part of their  inspection activities. Under the 1996 HACCP regulations, the agency also  established Salmonella pathogen standards used to assess the  effectiveness of plants’ controls in reducing levels of pathogens in meat  and poultry products. According to the regulations, FSIS selected  Salmonella for pathogen standards because, among other things, it was  the most common bacterial cause of foodborne illness, and they believed  that intervention strategies aimed at reducing fecal contamination and  other sources of Salmonella on raw product should be effective against  other pathogens. FSIS has a verification-testing program in which FSIS  inspectors at plants collect samples of certain products and test them to  determine whether plants meet the pathogen standards. Test results from  this program help FSIS inspectors verify that plant HACCP plans are  working and identify and assist plants whose process controls may be  underperforming. FSIS also requires products to be labeled with  instructions for safe handling.

In contrast to Salmonella and Campylobacter, which are subject to  pathogen standards, FSIS considers certain serotypes of Escherichia coli  (E. coli),  another type of disease-causing pathogen, adulterants under  the definition of “adulterated” in the Meat Inspection Act and the Poultry  Inspection Act. The acts define an adulterant in meat and poultry  products to include, among other things, “any poisonous or deleterious  substance which may render it injurious to health.” Meat and poultry  products contaminated with any level of adulterants are not permitted to  enter commerce—a stricter standard than the pathogen standards, which  allow certain levels of contamination. FSIS initially declared E. coli  O157:H7 as an adulterant in ground beef following an outbreak from 1992  to 1993 that involved Jack-in-the-Box hamburgers and, in 2011, declared  an additional six non-O157 Shiga-toxin-forming E. coli in certain raw beef  products as adulterants.

In the early 1990s, a strain of Escherichia coli  (E. coli) bacteria linked to hamburger resulted  in a deadly foodborne outbreak and led to  changes in food regulations. E. coli are  bacteria found in the environment, food, and  intestines of people and animals. E. coli are a  large and diverse group of bacteria. Most  strains of E. coli are generally harmless, but  others can cause diarrhea, urinary tract  infections, respiratory illness and pneumonia,  other illnesses, and death.  From November 1992 through February 1993,  more than 500 laboratory-confirmed infections  with E. coli O157:H7 and four associated  deaths occurred in four states—Washington,  Idaho, California, and Nevada. During the  outbreak, contaminated hamburger patties  were traced to a fast food restaurant chain  and then ultimately to five slaughter plants in  the United States and one in Canada as likely  sources of carcasses used to produce the  contaminated ground beef. No one slaughter  plant or farm was identified as the source. In  1994, USDA’s Food Safety and Inspection  Service declared that any raw ground beef  found contaminated with E. coli O157:H7  would be adulterated under the Federal Meat  Inspection Act—rendering the meat unlawful  to sell in commerce.

Meat and Poultry in the United States  Beef: According to the U.S. Department of  Agriculture (USDA), beef is a highly consumed  meat in the United States, averaging 56  pounds per person per year. Beef comes from  full-grown cattle that are about 2 years old and  weigh about 1,000 pounds. There are at least  50 breeds of beef cattle, but fewer than 10  make up most cattle produced. Veal is meat  from a calf (young cattle) that weighs about  150 pounds. Calves that are mainly milk-fed  usually are less than 3 months old.  Pork: According to the USDA, the United  States is the world’s third-largest producer and  consumer of pork and pork products. Pork is  meat from hogs, or domestic swine, and is  from young animals (6 to 7 months old) that  weigh from 175 to 240 pounds.

FSIS coordinates with numerous federal agencies, state agencies, and  local entities to help ensure the safety of meat and poultry products from  the farm to the consumer (known as the farm-to-table continuum). FSIS  coordinates with USDA’s Animal and Plant Health Inspection Service  (APHIS) to share information when investigating foodborne illnesses.  FSIS also coordinates with the Department of Health and Human  Services’ Food and Drug Administration (FDA) and with CDC on a  number of activities. For example, FSIS works collaboratively with FDA  and CDC through the Interagency Food Safety Analytics Collaboration to,  among other things, estimate foodborne illness source attribution.  Attribution entails identifying which foods are the most important sources  of selected major foodborne illnesses. According to FSIS officials,  determining the sources of illness is an important part of identifying  opportunities to improve food safety. FSIS also coordinates with CDC and  state health departments to respond to foodborne illness outbreaks,  including identifying the pathogen, the product, and where the product  became contaminated along the farm-to-table continuum (see fig. 2).

Poultry: According to USDA, consumption of  poultry (chicken and turkey) in the United  States is higher than beef or pork. Chicken  includes broiler-fryer chickens and roaster  chickens. Broiler-fryer chickens are young,  tender chickens about 7 weeks old that weigh  from 2 ½ to 4 ½ pounds. Roaster chickens are  young chickens from 8 to 12 weeks old with a  ready-to-cook carcass weight of 5 pounds or  more. Turkey is a large, widely domesticated  North American bird. They grow to full maturity  in about 4 to 5 months, depending on the  desired market weight.

USDA’s FSIS has developed or revised pathogen standards for  assessing the effectiveness of plants’ controls in reducing the level of  pathogens in certain meat and poultry products. More specifically, the  agency has developed pathogen standards for some beef, pork, chicken,  and turkey products but not for other products that are widely available,  and its basis for deciding which products to consider for new pathogen  standards is unclear. In addition, as of 2011, the agency has revised  pathogen standards for chicken and turkey products, but standards for  other products are outdated, with no time frames for revision.

FSIS has developed pathogen standards for beef, pork, chicken, and  turkey carcasses; specific chicken parts (i.e., breasts, thighs, and legs);  and ground beef, chicken, and turkey (see Figure 3). The initial pathogen  standards FSIS developed in 1996 were all for Salmonella because,  among other things, it was the most common bacterial cause of  foodborne illness and intervention strategies aimed at reducing  Salmonella in raw products might be effective against other pathogens,  according to agency documents. Subsequently, in 2011, FSIS developed  Campylobacter standards for chicken and turkey carcasses and in 2016  developed Salmonella and Campylobacter standards for chicken parts.

FSIS has not developed pathogen standards for other widely available  products, such as pork cuts (e.g., pork chops), turkey parts (e.g., turkey  breasts), and ground pork. The agency is taking steps that may lead to  the development of new pathogen standards for additional products. For  example, according to FSIS documents, the agency is collecting  information on the presence of Salmonella and other pathogens in pork  cuts and ground pork, among other pork products. According to FSIS  officials, this could lead to the development of new standards.

However, the agency’s process for deciding which products to consider  for new pathogen standards is unclear because it is not fully documented.  In December 2016, the agency documented a part of its process: who will  make the decisions about which products to consider. According to the  December 2016 document, certain agency officials are to meet as  needed to discuss emerging food safety risks and propose related data  collection efforts to senior management, who will decide which products  to consider for new standards. However, the document does not explain  the basis for management’s decisions. FSIS has informed stakeholders  that it will take into account factors including consumption and foodborne- illness data, as it did when setting standards for chicken parts, but the  agency has not documented this process going forward. Several  researchers and consumer advocacy representatives we interviewed  questioned whether the agency’s process proactively addresses food  safety risks.

Previously, FSIS developed new pathogen standards after the agency  was directed to do so or after widespread outbreaks indicated the need.  For example, in 2011, FSIS revised Salmonella standards for chicken and  turkey carcasses and developed new standards for Campylobacter in  these same products after being charged with doing so by the  Presidential Food Safety Working Group. Additionally, in a 2016 Federal  Register notice, FSIS, after reviewing outbreaks from these products in  2011, 2013, and 2015—outbreaks in which 794 people were sickened  and 1 died—concluded that new pathogen standards were needed for  comminuted (including ground and other mechanically separated) poultry  and chicken parts.

Under federal standards for internal control, federal entities are to design  control activities to achieve objectives and respond to risks, including  appropriate documentation of transactions and internal control. With  appropriate documentation of internal control, management clearly  documents internal control and allows the documentation to be readily  available for examination; the documentation may appear in management  directives, administrative policies, or operating manuals. Until FSIS  clearly documents its process for deciding which products to consider for  new pathogen standards, including the basis on which such decisions  should be made, FSIS will not have assurance that its decisions are risk- based and that agency personnel will know the process when making  such decisions.

USDA Has Revised Some Existing Pathogen Standards but Has Not Revised Others in Decades and Has No Time Frames for Revision

USDA’s FSIS has revised Salmonella standards for chicken and turkey  carcasses and for comminuted chicken and turkey but has not revised  other Salmonella standards since 1996, and the agency has not set time  frames for determining whether revisions are needed. Specifically, as  noted above, FSIS revised Salmonella standards for chicken and turkey  carcasses in 2011 in response to a charge from the President’s Food  Safety Working Group that the agency develop new or revised standards  to reduce the prevalence of Salmonella in poultry products. The agency  revised the pathogen standards for comminuted chicken and turkey in  2016 to help achieve public health goals for reducing human illness from  Salmonella, among other things. The revisions have generally involved  reductions in the maximum allowable percentage of products that test  positive for this pathogen. For example, in 2016, when the agency revised  the Salmonella standards for comminuted chicken, the allowable  percentage changed from 44.6 to 25.0. (See table 1.)

However, FSIS has not revised the Salmonella standards for beef and  pork carcasses and ground beef since they were first developed in 1996.  Although USDA announced in a 2014 Federal Register notice that it  intended to propose new pathogen standards for ground beef, FSIS has  not done so. Furthermore, FSIS set the pathogen standards for beef and  pork carcasses and ground beef at industry-wide prevalence levels found  at that time, not at levels intended to be protective of human health. In  2017, FSIS reviewed data on Salmonella in beef carcasses and ground  beef and determined that the agency will not reach public health goals for  reducing foodborne illness from Salmonella without further reduction in  Salmonella contamination in beef. FSIS officials said that the agency is  developing options for how it might move forward and could determine  that revised or new standards are not needed and that other policies  could suffice in addressing pathogens in beef. In the meantime, however,  the agency in 2014 suspended monitoring against the existing Salmonella  standards for ground beef until the agency develops a revised standard.  The agency also suspended monitoring whether plants were meeting the  pathogen standard for Salmonella on pork carcasses because, according  to agency officials, the percentage of pork carcass samples that tested  positive for Salmonella was consistently low. FSIS officials said that the  agency is collecting data on pathogens in pork that could lead to new  standards for pork products. In the absence of testing against the  standards, the agency has other tools to ensure plants are controlling  pathogens. For example, the agency continues to test beef for levels of E.  coli, and FSIS inspectors at plants are to routinely check records to verify  a plant’s compliance with its HACCP plans. FSIS officials told us that they  would begin monitoring against the Salmonella standards for these  products if the standards are revised or determined to be sufficient (in the  case of beef and pork carcasses and ground beef) or if the agency  develops new standards (in the case of pork cuts and ground pork).  Generally, FSIS begins monitoring against a standard once the agency announces a standard and after a phase-in period has ended. For  example, when FSIS developed new Campylobacter and Salmonella  standards for chicken parts in 2016, the agency began monitoring  whether plants met the standard 5 months after the standards were  announced in the Federal Register.

Monitoring for compliance with pathogen standards is a key tool as  envisioned by the 1996 Pathogen Reduction; HACCP Systems final rule  for verifying the effectiveness of a plant’s processing controls to prevent,  eliminate, or reduce food safety hazards. It is unclear when FSIS plans to  resume the use of this tool and complete the revisions of the Salmonella  standards for beef carcasses or ground beef or develop new standards  for additional pork products because the agency has not set time frames  for doing so. According to FSIS officials, developing or revising pathogen  standards takes time and resources, in part because the agency must  first collect and analyze data to estimate the prevalence of pathogens in  FSIS-regulated products, notify the public of proposed standards, and  open a comment period, all of which can take years. However, according  to FSIS officials, the agency has no time frames for determining what  actions to take. Program schedule planning is recognized as a leading  practice to ensure organizational activities are completed as planned,  according to the Project Management Institute’s Standard for Program  Management. Such planning includes setting time frames for completing  a project. By setting time frames for determining what pathogen  standards or additional policies are needed to address pathogen levels in  beef carcasses, ground beef, and pork products, FSIS could better  ensure it completes these activities in a timely manner to protect human  health.

USDA Is Taking Additional Steps to Address Pathogen Reduction Challenges That We Identified in 2014, but These Challenges Are Ongoing

In addition to taking steps to develop or revise pathogen standards,  USDA’s FSIS is addressing other challenges we identified in September  2014 with respect to poultry pathogens, but these challenges are ongoing  and also apply to meat products. These challenges include FSIS’s limited  control over factors that affect the level of pathogens outside of plants,  pathogens not designated as hazards, the complex nature of Salmonella,  limited Campylobacter research and testing, limited enforcement  authority, absence of mandatory recall authority, and insufficient  prevalence estimates.

Limited Control Outside of Plants  In September 2014, we found that the U.S. Department of Agriculture’s (USDA) Food  Safety and Inspection Service (FSIS) faced a challenge in reducing levels of Salmonella  and Campylobacter in poultry products in part because the agency did not have  regulatory jurisdiction over farm practices to reduce contamination in poultry before they  reach a plant for slaughter and processing. At the time, we noted that FSIS had worked  to address the on-farm limitation by issuing guidelines that detailed, among other things,  several on-farm practices to reduce Salmonella and Campylobacter in live poultry. We  recommended that in future revisions of the guidelines, FSIS include information on the  effectiveness of on-farm practices to explain the potential benefits of adopting such  practices on poultry farms. USDA concurred with our recommendation. In addition, we  found that once poultry products leave a plant, factors beyond FSIS’s control may affect  contamination of poultry products, such as cross-contamination from poultry products  (i.e., when bacteria spread from a food to a surface, from a surface to another food, or  from one food to another) that can occur at retail establishments, in restaurants, and in  consumers’ homes, according to a food safety researcher we interviewed.

Pathogen Contamination after Products  Leave the Plant  According to the Centers for Disease Control  and Prevention (CDC), even if meat and  poultry products leave the processing or  slaughter plant with no detectable pathogen, it  does not ensure that the products are safe, as  opportunities exist for them to become  contaminated at any point along the farm-to- table continuum.  To illustrate, frozen hamburger patties might  be trucked from a plant to a supplier, stored in  the supplier’s warehouse for a few days,  trucked again to a local distribution facility, and  then delivered to a restaurant. According to  CDC, if refrigerated food is left on a loading  dock during transportation for an extended  time in warm weather, the food could reach  temperatures that allow pathogens to grow. among other things, on-farm practices to reduce levels of Salmonella  contamination in hogs. The draft Salmonella guidelines are available  on the agency’s website. Even though the guidelines are not yet  finalized, FSIS encourages producers to use them, according to  agency officials we interviewed. However, unlike the poultry and beef  cattle guidelines, the draft Salmonella guidelines do not contain  information on the effectiveness of on-farm practices, as  recommended in 2011 by USDA’s National Advisory Committee on  Meat and Poultry Inspection. According to the draft guidelines, when  a plant makes changes at the appropriate processing location,  process control should result in raw pork products that have less  contamination with pathogens, including Salmonella. FSIS officials we  interviewed told us that there is not as much research available for  such practices for hogs as there is for beef cattle and poultry.  However, the officials agreed that including available information  would be beneficial. By including available information on the  effectiveness of these practices to reduce the level of pathogens as it  finalizes its guidelines for controlling Salmonella in hogs, FSIS would  have better assurance that it is keeping industry informed of the  potential benefits of adopting on-farm practices and encourage their  implementation.

Contamination can also occur during  preparation in consumers’ homes if food is not  properly stored, prepared, heated, or served.  For example, according to CDC, once  contamination occurs, if meat and poultry are  stored or cooked at unsafe temperatures,  pathogens will grow quickly, which may lead to  foodborne illness.

With respect to reducing pathogens after slaughter, FSIS continues to  update its guidance to consumers and work with federal partners to  ensure the safety of meat and poultry products after they leave the plant.  For example:  In 2015, the agency developed the FoodKeeper mobile application to  educate consumers on how to use food while at peak quality and  store food properly. It updated the application in 2017 so users  could receive automatic notifications when FDA or FSIS announces  food safety recalls.

In 2016, FSIS and FDA announced that they would work together to  revise the FDA Food Code—a model that local, state, tribal, and  federal regulators use to ensure food safety at retail stores,  restaurants, and institutions such as nursing homes, among others— to ensure consistency with FSIS regulations and guidance.

In 2017, FSIS expanded the operating hours for its Meat and Poultry  Hotline, through which consumers could speak with an agency  representative or listen to recorded messages regarding food safety,  such as the proper storage, handling, and preparation of meat and  poultry products.

Pathogens Not Designated as Hazards  In September 2014, we found that the U.S. Department of Agriculture’s Food Safety and  Inspection Service (FSIS) faced a challenge in reducing Salmonella and Campylobacter  contamination in poultry products when plants do not designate these pathogens as  hazards. Under the Hazard Analysis and Critical Control Point (HACCP) approach, plants  have discretion about whether to include Salmonella or Campylobacter as a hazard  “reasonably likely to occur” in their HACCP plans and develop mitigation strategies to  reduce these pathogens. FSIS’s 2014 final rule for modernizing poultry slaughter  inspection requires plants to develop, implement, and maintain written procedures to  prevent contamination of carcasses and parts by enteric pathogens—bacteria that  normally reside in the intestines of many animals, including humans, such as Salmonella  and Campylobacter—as well as fecal material. Plants must incorporate these  procedures into their HACCP plans, sanitation procedures, and other programs.

Since our September 2014 report, FSIS has not required hog and beef  plants to designate Salmonella or Campylobacter as hazards likely to  occur, but it has taken other steps to reduce Salmonella and  Campylobacter contamination when plants do not designate these  pathogens as hazards. More specifically, in February 2018, FSIS  proposed a rule to modernize hog slaughter inspections. The proposed  rule would require plants to develop, implement, and maintain written  procedures to prevent contamination by enteric pathogens in pork.

Stakeholders we interviewed representing industry and consumer  advocacy groups disagreed on whether plants should be required to  designate specific pathogens as a hazard reasonably likely to occur.  However, in response to instances in which inadequate validation of  HACCP plans led to the production of adulterated food, and in some  cases illnesses, FSIS released compliance guidance outlining best  practices for designing and implementing adequate HACCP plans for all  plants in 2015. According to FSIS, plants can use the guidance to  properly design and execute HACCP plans and reduce the likelihood of  contamination of the products they produce. Specifically, the guidance  outlines, among other things, best practices for gathering scientific and  technical support, as part of the HACCP plan validation process, to  demonstrate that the plants’ processes prevent, reduce, or eliminate the  hazards identified.

Complex Nature of Salmonella  In September 2014, we found that the U.S. Department of Agriculture’s Food Safety and  Inspection Service (FSIS) faced a challenge in reducing Salmonella contamination in  poultry products because of the complex nature of this pathogen. The majority of the  representatives from industry and consumer groups we interviewed at the time, as well  as FSIS officials, agreed that Salmonella is difficult to control in poultry products because  it is widespread in the natural environment. According to Centers for Disease Control and  Prevention officials we interviewed for our past work, there are more than 2,500  serotypes of Salmonella (with different strains), some of which pose greater risk to  human health than others. Therefore, it is important to understand the genetic makeup of  each to determine which ones are more or less likely to cause human illness.

FSIS officials said that, in the future, there may be opportunities to  improve how the agency protects human health by focusing inspections  on plants and products that have tested positive for the more dangerous  strains of Salmonella in meat and poultry products. To this end, FSIS  collaborates with USDA’s Agricultural Research Service and APHIS, CDC, FDA, and local and state public health partners to develop new  technologies that can more precisely determine if a strain of Salmonella  detected is particularly dangerous to people. One such technology is  whole genome sequencing, which allows the agency to determine the  complete set of genes, or strain, within a Salmonella serotype.

According to FSIS officials, it is more challenging to link the strain  associated with an illness to a specific meat or poultry product that has  sickened consumers; whole genome sequencing technology can more  definitively identify the strain involved in an outbreak and help reduce  incidents of illness or death due to foodborne pathogens. FSIS is  currently planning how to integrate this technology into its food safety  program. For example, current pathogen standards are based on the  presence or absence of generic Salmonella, not on specific strains. FSIS  held a public meeting in October 2017 to get input from state, federal, and  international public health partners and other stakeholders on the use of  this technology in a regulatory setting to improve food safety and public  health.

Limited Campylobacter Research and Testing  In September 2014, we found that the U.S. Department of Agriculture’s Food Safety and  Inspection Service faced a challenge in reducing levels of Campylobacter in poultry  products in part because less was known about Campylobacter than about Salmonella.  Specifically, technologies, such as clinical diagnostics, used to detect Campylobacter  may have underdiagnosed cases of illness from this pathogen, and the methods used by  many diagnostic laboratories to isolate Campylobacter from samples were not  standardized, according to a 2012 World Health Organization report on illnesses from the  pathogen. Additionally, the agency’s ability to measure a reduction in Campylobacter  illnesses depended on its ability to attribute Campylobacter illnesses to poultry and other  food types, according to agency officials, and attribution analyses needed improvement.

Since our report in September 2014, FSIS has had efforts under way  with other agencies to improve foodborne illness source attribution to  meat and poultry products and has independent data collection efforts  under way to determine the presence of Campylobacter on these  products. More specifically, in collaboration with CDC and FDA through  the Interagency Food Safety Analytics Collaboration, FSIS has taken  steps to improve and standardize methods to estimate the source  attribution for Campylobacter foodborne illness. In 2015, this interagency  collaboration improved the method for estimating the number of  Campylobacter illnesses from meat and poultry products by standardizing  the approach used by all three food safety agencies. The interagency  collaboration’s new estimates for the proportion of Campylobacter  illnesses included all food products—including beef, pork, and poultry.  The interagency collaboration also released updated foodborne illness  source attribution estimates in December 2017. According to FSIS  officials, the three agencies are collaborating on multiple analytic projects,  in line with the interagency collaboration’s 2017–2021 strategic plan, to  improve models to estimate foodborne illnesses from Campylobacter and  other pathogens. These projects involve using new methods and whole  genome sequencing and other data sources.

In addition to this interagency effort, in 2015, FSIS tested about 200  samples of pork products for Campylobacter as part of an exploratory  sampling effort, according to agency documents summarizing the efforts.  FSIS found that about 1 percent of products tested were positive for  Campylobacter and, therefore, chose not to continue testing pork  products for this pathogen. For poultry, in 2016, FSIS revised a  laboratory guidebook describing standard protocols for isolating and  analyzing Campylobacter in raw products. In 2017, the agency concluded  a literature review of Campylobacter contamination in beef and, as of  October 2017, is discussing the development of an exploratory sampling  project to test for Campylobacter in beef products, according to agency  officials.

Limited Enforcement Authority  In September 2014, we found that the U.S. Department of Agriculture’s Food Safety and  Inspection Service (FSIS) faced a potential challenge in reducing Salmonella  contamination in poultry products, according to agency officials and representatives of  some stakeholder groups we interviewed, because (1) a 2000 federal court ruling stated  that FSIS could not withdraw inspectors, effectively shutting down the plant, solely  because a plant did not meet Salmonella pathogen standards, and (2) FSIS has not  classified Salmonella as an adulterant in raw poultry products, so products contaminated  with this pathogen generally may be permitted to enter commerce.

FSIS adopted the position that the court ruling did not affect its ability to use the  Salmonella pathogen standards as part of verifying a plant’s sanitation and Hazard  Analysis and Critical Control Point plans and that it had tools, such as food safety  assessments (an evaluation of a plant’s food safety system), to prevent  contaminated products from entering the market. Representatives from consumer  groups we interviewed at the time said that even with these tools, the agency does  not have sufficient authority to ensure plants comply with the standards because  FSIS cannot shut down plants when they fail the Salmonella standards alone.  Representatives from industry groups we interviewed at the time disagreed and  stated that FSIS has sufficient authority to ensure plants comply with standards  because the agency has broad statutory authority and oversight.

Regarding FSIS not classifying Salmonella as an adulterant, representatives from  consumer groups we interviewed for our previous work said that the agency should  declare some serotypes of Salmonella as adulterants, such as those with specific  antibiotic-resistant patterns. FSIS officials we interviewed for our previous work said  they found no conclusive evidence that antibiotic-resistant strains of Salmonella or  Campylobacter have a greater resistance to the interventions used in plants but that  the agency would continue to review relevant scientific evidence to identify any  potential challenges these serotypes may present to public health.

Since our report in September 2014, FSIS continues to stand by the  position that the 2000 court ruling does not affect its ability to use  pathogen standards as a tool to prevent contaminated products from  entering the market. FSIS reaffirmed its position in a 2016 Federal  Register notice. Our review of FSIS data from 2016 through 2017 for poultry plants shows that some plants are still not meeting pathogen  standards—in some cases repeatedly not meeting the standards—and  are allowed to operate. We were unable to review similar data for beef  or hog plants since, as noted above, FSIS suspended monitoring these  plants against pathogen standards. FSIS stands by its assessment that  its enforcement tools are sufficient. Moreover, in 2015, FSIS announced  an additional tool to help FSIS identify and assess problems or trends that  may be of concern. Specifically, FSIS investigators must now conduct a  public health risk evaluation at every plant that does not meet a pathogen  standard. This is a positive step for those products that have pathogen  standards, such as chicken parts. However, as previously stated, FSIS  does not test for whether plants producing beef carcasses, ground beef,  and pork carcasses meet the pathogen standards for those products, and  other products such as ground pork do not have pathogen standards.  Representatives from consumer groups and industry we interviewed  continue to disagree on whether FSIS’ existing enforcement tools are  sufficient to ensure that meat and poultry plants meet pathogen  standards.

Regarding antibiotic-resistant strains of Salmonella, FSIS officials  continue to state that the pathogen does not meet the criteria for  classifying it as an adulterant and that the agency will continue to  examine options for regulating the presence of antibiotic-resistant strains  of Salmonella in raw meat and poultry products. Agency officials told us  that to classify a pathogen as an adulterant in raw meat and poultry  products, FSIS must determine that the pathogen meets certain criteria  established both in its authorizing statutes and by case law. Specifically,  in American Public Health Association v. Butz, a federal appeals court in  1974 held that Salmonella did not adulterate raw poultry because ordinary  consumer methods of preparing and cooking the product would eliminate  the pathogen. In contrast, FSIS declared certain types of E. coli as  adulterants in beef, as discussed above, because ordinary consumer  cooking does not eliminate the pathogen. According to FSIS officials, the  available data do not appear to indicate that Salmonella presents the  same issues as E. coli or meets the necessary criteria, regardless of  whether it is resistant or susceptible to antibiotics. This issue continues to  be contentious among the stakeholders we interviewed. Six of the seven  industry stakeholders we interviewed stated that FSIS’s current  enforcement authority is sufficient. Two of four food safety researchers  we interviewed stated that the agency does not need additional authority  to label Salmonella as an adulterant because FSIS has labeled other  pathogens as adulterants when it made sense to do so, such as E. coli¸  and there is no need to label naturally occurring bacteria as adulterants  on raw product. In contrast, all four of the consumer advocacy groups and  two of the four food safety researchers we interviewed stated that FSIS  needs more authority to label Salmonella as an adulterant.

No Mandatory Recall Authority  In September 2014, we found that the U.S. Department of Agriculture’s Food Safety and  Inspection Service (FSIS) faced a challenge in reducing Salmonella and Campylobacter  contamination in poultry products because it did not have mandatory food recall authority  similar to that of the Food and Drug Administration (FDA) for the food products FDA  regulates, such as milk, seafood, fruits, and vegetables. In 2011, Congress passed the  FDA Food Safety Modernization Act, giving FDA mandatory recall authority. We  recommended in October 2004 that Congress consider legislation to increase FSIS’s  authority to include mandatory recalls, but the agency continues to not have such  authority. Instead, to protect human health from potentially contaminated meat and  poultry products, FSIS can issue public health alerts, which notify the public on specific  actions to take to avoid illness, or request voluntary recalls, which are voluntary actions  taken by plants, among other actions. Before requesting a voluntary recall, FSIS must  gather sufficient evidence through its investigation and determine that a product is  adulterated and mislabeled, among other things. In September 2014, we reported that  this can be challenging to do. FSIS officials told us at the time that rather than focusing  on the lack of mandatory recall authority, it was more productive to work aggressively  with the tools they had, such as withdrawing inspectors, thus preventing products from  entering commerce. According to FSIS officials, this can be as effective for keeping  unsafe food from the marketplace as FDA’s recall authority.

To encourage poultry slaughter and  processing plants to control for Salmonella and  Campylobacter—disease-causing pathogens  that can sicken consumers—USDA publicly  releases information on individual plant  performance for reducing these pathogens.  According to the agency’s 2017 annual plan,  publishing plant-specific data allows  consumers to make more informed choices,  motivates individual plants to improve  performance, and leads to industry-wide  improvements in food safety. USDA’s  Economic Research Service found that  publicly releasing the identities of plants with  poor or mediocre performance on tests for  Salmonella is strongly correlated with about a  60 percent decline of chicken carcass samples  testing positive for Salmonella from 2006 to  2010.  In 2016, USDA temporarily replaced posting  information on individual plants’ performance  for chicken and turkey carcasses, chicken  parts, and comminuted poultry (e.g., ground),  with information on aggregate results to allow  time for plants to update their food safety  systems. In January 2018, FSIS began  reposting individual plants’ category status for  poultry carcasses on a monthly basis.  According to the agency’s annual plan for  fiscal year 2017, USDA intends to resume  publicly releasing individual plant performance  information for turkey carcasses and to add  data for plants producing chicken parts and  comminuted chicken and turkey. The agency  also intends to release data for plants  producing some beef products, according to its  2016 strategic plan on publicly releasing data.

Since our September 2014 report, FSIS officials said that they continue to  believe that mandatory recall authority is not necessary for the reasons  previously mentioned. According to FSIS officials, the agency continues  to refine and improve its procedures for requesting voluntary recalls of  adulterated and misbranded meat and poultry products, confirming the  effectiveness of these recalls, and alerting the public about adulterated  and misbranded products that may remain in commerce. Therefore,  FSIS officials stated that the agency does not see the lack of mandatory  recall authority as an obstacle or hindrance to its efforts to protect public  health and ensure that meat and poultry products are safe, wholesome,  and properly labeled. In contrast, FDA officials told us that having  mandatory recall authority protects human health from foodborne illness  because the agency does not have to rely upon manufacturers’ voluntary  recall efforts or obtain a court order to remove contaminated or  misbranded food, other than infant formula, from the food supply. In our  review of FDA’s annual reports to Congress on the use of mandatory  recall authority from 2013 to 2016, the most recent available, the agency  has used its mandatory recall authority twice. The majority (12 of 17) of  the stakeholders we interviewed stated that the absence of mandatory  recall authority is not a challenge for FSIS in reducing pathogen  contamination of meat and poultry products. However, according to 3 of 4  stakeholders from consumer groups and 1 of 4 food safety researchers  we interviewed, acquiring mandatory recall authority would enable FSIS  to better protect human health because the agency would then have an  additional tool to stop an outbreak of foodborne illness and address the  level of pathogens in products once they leave the plant.

Insufficient Prevalence Estimates  In September 2014, we found that the U.S. Department of Agriculture’s (USDA) Food  Safety and Inspection Service (FSIS) faced a challenge in reducing Salmonella and  Campylobacter contamination in poultry products as a result of not having sufficient  prevalence estimates. Prevalence is the proportion of a product that would test positive  for a pathogen if the entire population of that product was sampled and analyzed during a  specific period of time. FSIS collects and analyzes data to estimate the prevalence of  pathogens when the agency develops or revises pathogen standards for products it  regulates. However, we reported that there were numerous problems with the data FSIS  used to estimate prevalence. For example, assessing levels of poultry pathogens across  the entire industry was difficult using data from FSIS’s verification-testing program  because the program was not designed to assess prevalence of pathogens industry-wide  and the agency does not randomly select plants for inspection. According to USDA’s  National Advisory Committee on Microbiological Criteria for Food, estimating the  prevalence of pathogens in food is critical to understanding and addressing the public  health risk of foodborne illness, and these estimates provide a mechanism for measuring  performance against public health goals, among other things. FSIS officials told us at that  time that the agency had plans to propose a new testing approach for all of its poultry  products, which would allow for more frequent data collection and improve prevalence  estimates, among other things.

In 2016, FSIS implemented this new testing approach for all poultry  products for which there are pathogen standards and for some meat  products, but according to officials, the agency did not do so for all  products that it regulates because of resource constraints. Specifically,  according to a 2016 Federal Register notice, FSIS now routinely samples  chicken and turkey carcasses, chicken parts (legs, wings, and breasts),  and comminuted chicken and turkey for Salmonella and Campylobacter  pathogens over an entire year—rather than a set period of time—based  on the volume of poultry products produced in plants.  It also uses this  approach to test for Salmonella in ground beef, beef manufacturing  trimmings, and other ground beef components, according to a 2014  Federal Register notice. This new approach allows for better prevalence  estimates and for monitoring changes in prevalence over time, according  to agency officials. As discussed earlier, FSIS began exploratory  sampling of pork products, including pork cuts and comminuted (including  ground) pork, in 2015. According to a 2017 agency notice describing the  sampling, FSIS collects and analyzes samples of pork products in a way  that allows for prevalence estimates. FSIS does not use the same  approach to sample other products, such as raw components used in  ground beef (e.g., esophagus, head meat, cheek meat, and hearts),  chicken half carcasses, and chicken necks, because of limited resources,  according to agency officials. These officials stated that the agency first  conducts exploratory sampling—such as its current program for pork  products—to determine if FSIS should allocate resources for routine  sampling of these products that would allow for prevalence estimates.

To help ensure the safety of meat and poultry products and protect  against foodborne illness, USDA’s FSIS has transitioned to an  increasingly science-based, data-driven, risk-based approach. As part of  this approach, FSIS has taken several actions to reduce levels of  Salmonella and Campylobacter in poultry products, including  strengthening existing pathogen standards for Salmonella in poultry  carcasses and developing new Salmonella and Campylobacter standards  for certain chicken parts. However, the agency has not set pathogen  standards for many widely available products, such as pork cuts and  ground pork, and the agency’s process for deciding which products to  consider for new pathogen standards is not fully documented. Previously,  FSIS has developed new pathogen standards after the agency has been  directed to do so or after widespread outbreaks indicated the need. Until  FSIS clearly documents its process for deciding which products to  consider for new pathogen standards, including the basis on which such  decisions should be made, FSIS will not have assurance that its decisions  will be risk-based and that agency personnel will know the process when  making such decisions.

As part of its new approach, FSIS is collecting data that could enable it to  set new pathogen standards for pork cuts and ground pork, and the  agency is analyzing data that could lead to revising the Salmonella  standards for beef carcasses and ground beef—which are decades old  and not set at levels that are health protective. However, the agency has  not set time frames for completing these efforts. In the absence of  pathogen standards against which the agency tests, the agency is not  using a valuable tool that could be used to help verify that plants’  processing controls to prevent, eliminate, or reduce food safety hazards  are working. By setting time frames for determining what pathogen  standards or additional policies are needed to address pathogens in  these products, FSIS could better ensure it completes these activities in a  timely manner to better protect human health.

In addition, FSIS continues to face several challenges that hinder its  ability to reduce the level of pathogens in meat and poultry products. For  example, practices outside the slaughter plant, such as conditions on  cattle, hog, and poultry farms, can affect levels of pathogens on meat and  poultry products. To help overcome this challenge, the agency has  developed draft guidance on practices for controlling levels of Salmonella  and Campylobacter on beef cattle, hog, and poultry farms, but the draft  guidance for hogs does not include available information on the  effectiveness for each practice, as an internal agency committee  recommended. As FSIS finalizes this guidance, FSIS could better inform  industry of the potential benefits of adopting on-farm practices and  encourage implementation of these practices by including available  information on their effectiveness.

We are making three recommendations to FSIS. Specifically:  The Administrator of FSIS should document the agency’s process for  deciding which products to consider for new pathogen standards,  including the basis on which such decisions should be made.  (Recommendation 1).

The Administrator of FSIS should set time frames for determining what  pathogen standards or additional policies are needed to address  pathogens in beef carcasses, ground beef, pork cuts, and ground pork.  (Recommendation 2).

The Administrator of FSIS should include available information on the  effectiveness of on-farm practices to reduce the level of pathogens as it  finalizes its guidelines for controlling Salmonella in hogs.  (Recommendation 3).

We provided a draft of this report to USDA and the Department of Health  and Human Services. In written comments, reproduced in appendix II,  USDA agreed with our three recommendations and described actions it  will take to implement them.

In particular, with respect to our first recommendation, USDA stated that  FSIS will complete an internal document that delineates the agency’s  process for creating or updating pathogen standards. However, USDA  stated that although it agrees it can take additional steps to document its  process, it does not agree that FSIS does not have assurance its  decisions are risk based. In particular, it cited a Federal Register notice  indicating that it designed its pathogen standards for chicken parts and  comminuted chicken and turkey to achieve certain reductions in illnesses  from Salmonella and Campylobacter. USDA also stated that FSIS has  consistently documented and published its process in the Federal  Register, and it noted that agency personnel use these Federal Register  notices as guidance and historical reference. While these notices can be  a useful historical record and document the steps FSIS took to ensure  that agency decisions were risk-based, we continue to believe that, until  FSIS clearly documents its process for deciding which products to  consider for new pathogen standards going forward—including the basis  on which such decisions should be made—FSIS will not have assurance  that its decisions will be risk-based and that agency personnel know the  process when making such decisions in the future. Completing  documentation of the agency’s process would address our  recommendation.

Concerning our second recommendation, USDA stated that in 2018 FSIS  will continue to assess data from sampling projects, along with baseline  data and outbreak/illness data, to determine whether new or revised  standards or additional policies are needed to address Salmonella in beef  products. USDA further stated that in 2019, it will use data collected  during its raw pork exploratory study to determine whether standards or  additional policies (e.g., training, guidance to industry, or instructions to  field personnel) are needed to address Salmonella in pork products.  Finalizing analysis of these data and determining if additional standards  or policies are needed to address Salmonella in beef in 2018 or pork in  2019 would address our recommendation.

In response to our third recommendation, USDA stated that FSIS will  include available scientific information on the effectiveness of each  recommended farm practice in the guidelines for reducing Salmonella in  market hogs. Doing so would address our recommendation.

USDA also provided technical comments. We incorporated these  comments as appropriate. The Department of Health and Human  Services did not have any comments.

As agreed with your offices, unless you publicly announce the contents  earlier, we plan no further distribution of this report until 30 days from the  report date. At that time, we will send copies of this report to the  appropriate congressional committees, the Secretary of Agriculture, the  Administrator of the Food Safety and Inspection Service, and other  interested parties. In addition, the report will be available at no charge on  the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix III.

Appendix I: Salmonella Testing for Beef Purchased for the National School Lunch Program

In addition to regulating meat and poultry sold in commerce, the U.S.  Department of Agriculture (USDA) also purchases food and, in some  cases, has additional food safety requirements for food it purchases.

USDA’s Agricultural Marketing Service (AMS) purchases beef and other  food for various federal nutrition assistance programs, including the  National School Lunch Program. USDA provides this food to states in  support of about 100,000 public and private nonprofit schools that provide  lunches to about 30 million children. Ground beef is a staple of school  menus. For example, according to AMS officials, during fiscal year 2016,  the agency purchased more than 110 million pounds of raw beef, over 90  percent of which was delivered to the National School Lunch Program.  Further, according to AMS officials, about 41 million pounds (37 percent)  were delivered raw while the rest was delivered to a federally inspected  processing facility for cooking prior to delivery to school lunch program  agencies.

Beef to be delivered raw to the National School Lunch program is tested  for pathogens (Salmonella and Shiga-toxin-producing E. coli, two  pathogens that can cause foodborne illness in humans) and certain  microorganisms such as aerobic plate count bacteria, coliform bacteria,  and generic E. coli that serve as indicators of the effectiveness of  slaughter and processing plants’ process controls to limit pathogens.

National School Lunch Program  According to USDA, the National School  Lunch Program is a federally assisted meal  program operating in public and nonprofit  private schools and residential childcare  institutions. It provides nutritionally balanced,  low-cost or free lunches to children each  school day. The program was established  under the National School Lunch Act, signed  by President Harry Truman in 1946.  USDA’s Food and Nutrition Service  administers the program at the federal level. At  the state level, the program is administered by  state agencies, operating through agreements  with school food authorities. Participating  school districts and independent schools  receive cash subsidies and food. In exchange,  participating institutions must serve lunches  that meet federal nutrition requirements and  offer the lunches at a free or reduced price to  eligible children. USDA’s Agricultural  Marketing Service purchases beef and other  food for various federal nutrition assistance  programs, including the National School Lunch  Program.

According to AMS officials, these indicator microorganisms indicate the  quality of the food safety controls at the plant. For raw beef products that  AMS considers for purchase for its programs, the agency rejects any beef  that tests positive for Salmonella, a pathogen that can cause foodborne  illness in humans. According to AMS officials, this requirement that beef  purchased for these programs not test positive for Salmonella differs from  the regulatory standard for beef inspected by USDA’s Food Safety and  Inspection Service (FSIS). Further, according to AMS officials, AMS set  this requirement because raw beef was considered the product with the  most risk for recipients and enough plants were able to meet the  requirement. AMS officials said that as a purchaser for various federal  nutrition assistance programs, the agency has discretion to set  requirements for qualified suppliers, and plants can choose whether to  become qualified suppliers.

Appendix II: Comments from the U.S. Department of Agriculture

In addition to the contact named above, Mary Denigan-Macauley  (Assistant Director); Thomas Cook (Assistant Director); James R. Jones,  Jr. (Assistant Director); David Bennett (Analyst in Charge); Kevin Bray;  Cindy Gilbert; Cynthia Norris; Gloria Ross; and Kiki Theodoropoulos  made key contributions to this report.

Foot-and-Mouth Disease: USDA’s Evaluations of Foreign Animal Health  Systems Could Benefit from Better Guidance and Greater Transparency.  GAO-17-373. Washington, D.C.: April 28, 2017.

Antibiotic Resistance: More Information Needed to Oversee Use of  Medically Important Drugs in Food Animals. GAO-17-192. Washington,  D.C.: March 2, 2017.

Food Safety: A National Strategy Is Needed to Address Fragmentation in  Federal Oversight. GAO-17-74. Washington, D.C.: January 13, 2017.

Seafood Safety: Status of Issues Related to Catfish Inspection.  GAO-17-289T. Washington, D.C.: December 7, 2016.

Imported Food Safety: FDA’s Targeting Tool Has Enhanced Screening,  but Further Improvements Are Possible. GAO-16-399. Washington, D.C.:  May 26, 2016.

Food Safety: FDA Coordinating with Stakeholders on New Rules but  Challenges Remain and Greater Tribal Consultation Needed. GAO 16- 425. Washington, D.C.: May 19, 2016.

Federal Food Safety Oversight: Additional Actions Needed to Improve  Planning and Collaboration. GAO-15-180. Washington, D.C.: December  18, 2014.

Food Safety: USDA Needs to Strengthen Its Approach to Protecting  Human Health from Pathogens in Poultry Products. GAO-14-744.  Washington, D.C.: September 30, 2014.

Food Safety: More Disclosure and Data Needed to Clarify Impact of  Changes to Poultry and Hog Inspections. GAO-13-775. Washington,  D.C.: August 22, 2013.

The U.S. food supply is generally considered safe, but foodborne illness—such as salmonella poisoning—remains a common problem.

For some meat and poultry products such as ground beef, there are standards for how much harmful bacteria USDA can find when testing. However, some common products such as turkey breasts and pork chops don't have such standards. It's unclear how USDA decides which products to consider for new standards.

Also, we found that some of USDA's food safety standards are outdated, with no time frames for revision.

We made recommendations to help USDA improve its standards in a timely manner to protect public health.

(This page was changed for accuracy on the issue of time frames.)


Firstnet: Efforts to Establish the Public-Safety Broadband Network

FirstNet is charged with establishing a nationwide public-safety broadband network that is reliable, secure, and interoperable. To inform this work, FirstNet is consulting with a variety of stakeholders. In March 2017, FirstNet awarded a 25-year contract to AT&T to build, operate, and maintain the network. FirstNet's oversight of AT&T's performance is important given the scope of the network and the duration of the contract.

This testimony provides information on (1) FirstNet's efforts to establish the network; (2) stakeholder views on network reliability, security, and interoperability challenges FirstNet faces and its efforts to address them; and (3) FirstNet's plans to oversee its network contractor. This statement is based on GAO's June 2017 report ( GAO-17-569 ). For this report, GAO reviewed FirstNet documentation, key contract oversight practices identified in federal regulations and other sources, tribal communication practices identified by federal agencies, and assessed FirstNet's efforts and plans against these practices. GAO also interviewed FirstNet officials and a nongeneralizable selection of public safety, tribal, and other stakeholders selected to obtain a variety of viewpoints.

In June 2017, GAO reported that the First Responder Network Authority (FirstNet) had conducted key efforts to establish the network, namely releasing the request for proposal (RFP) for the network and awarding the network contract to AT&T. As the contractor, AT&T will be responsible for the overall design, development, production, operation, and evolution of the network. Additionally, FirstNet consulted with state and local, federal, and tribal stakeholders. State officials GAO contacted were generally satisfied with FirstNet's efforts to engage them. However, tribal stakeholders GAO contacted expressed concern that FirstNet has not fully engaged in effective communication with tribes. FirstNet engaged tribes through a variety of mechanisms, such as through state points of contact and a working group, but tribes noted that individuals with first-hand knowledge of tribes' experiences are unable to represent tribal views directly among FirstNet's key decision makers. Although FirstNet is required to consult with tribes through state points of contact, a key principle of effective tribal communication is to seek full understanding of tribal concerns and reach consensus where possible. By fully exploring and proposing actions to address tribal stakeholders' concerns, FirstNet could help improve its relations with tribes and better meet stakeholders' needs.

According to stakeholders GAO contacted, FirstNet faces various challenges to ensure the network's reliability, security, and interoperability. For example, stakeholders raised concerns related to:

providing coverage to rural areas, in buildings, or underground;

ensuring the network's overall resiliency and cybersecurity; and

FirstNet has taken action to address these challenges, such as by opening a test lab to test public safety devices and applications before deploying them on the network. The majority of stakeholders GAO contacted were satisfied with FirstNet's efforts but many noted that much uncertainty remains about how the network will be implemented.

FirstNet established offices to oversee its network contractor, developed policies and procedures to guide contract administration—including management and oversight—and is receiving assistance from another federal agency with contract administration experience, although FirstNet plans to assume full responsibility in the future. For example, FirstNet established the Network Program Office to oversee the contractor's performance and facilitate quality assurance of contract deliverables, among other things. Although this office will perform essential contract-administration functions, FirstNet had not conducted long-term projections of staffing needs for the office as of April 2017. As a result, FirstNet lacks reasonable assurance that it will have sufficient resources to handle increases in its responsibilities over time. Planning for and assigning adequate resources, including people, and assessing resource needs is a key practice for planning and executing effective contract oversight. By performing a long-term staffing assessment for the Network Program Office, FirstNet would be in a better position to fully understand its staffing needs and respond to staffing changes and risks as it assumes full responsibility of contract administration in the future.

In June 2017, GAO recommended that FirstNet fully explore tribal stakeholders' concerns and assess its long-term staffing needs. FirstNet agreed with GAO's recommendations and described actions to address them.

Thank you for the opportunity to discuss our June 2017 report on the First  Responder Network Authority (FirstNet). We have previously reported  and testified on FirstNet, including most recently in a July 2017 hearing  held by the Senate Committee on Commerce, Science, and  Transportation’s Subcommittee on Communications, Technology,  Innovation, and the Internet. Whether conducting daily operations,  overseeing planned events, or responding to emergencies, public safety  officials—especially first responders such as police officers and  firefighters—rely on communications systems to gather and share  information and coordinate their efforts. However, first responders often  have difficulty communicating with their counterparts in other agencies  and jurisdictions because existing systems lack interoperability.

The Middle Class Tax Relief and Job Creation Act of 2012 (the 2012 Act)  created FirstNet and required it to establish a nationwide, interoperable  public-safety broadband network (hereafter, the network)—setting aside  spectrum for the network to operate on and providing FirstNet with $7  billion to fund the network’s initial build-out. FirstNet must be self-funding  beyond this initial $7 billion. Key to the network’s success, given its  purpose, is its reliability, security, and interoperability. To inform its work,  FirstNet must consult with state and local, federal, and tribal  stakeholders. Since 2012, FirstNet has completed a number of tasks to  plan for the build-out of the network, the most significant of which was the  issuance of a request for proposal to solicit proposals from private  companies to build, operate, and maintain the network. From these  proposals, FirstNet selected AT&T as its network contractor and awarded  it a multi-billion dollar, 25-year contract. Due to the size of the project and  duration of the contract, the oversight mechanisms that FirstNet plans to  use to monitor AT&T’s progress and performance in building, operating,  and maintaining the network are important.

My remarks today are based on our June 2017 report and like the report,  addresses (1) FirstNet’s efforts to establish and finance the network; (2)  stakeholder views on network reliability, security, and interoperability  challenges FirstNet faces and its research and other efforts to address  them; and (3) FirstNet’s plans to oversee the deployment of the network  by its network contractor. In our report, we recommended that FirstNet  fully explore tribal stakeholders’ concerns and assess its long-term  staffing needs. FirstNet agreed with these recommendations and, in  September 2017, reported to us on the actions it has taken to implement  them.

For our report, we reviewed the 2012 Act, FirstNet documentation, and  documentation from other federal entities involved in FirstNet’s efforts,  such as FirstNet’s key research partner, the Public Safety  Communications Research (PSCR) program. We compared FirstNet’s  efforts to respond to tribal stakeholders’ concerns with the applicable key  principle of effective tribal communication on federal infrastructure  decisions developed by several federal agencies. We assessed the  PSCR’s and FirstNet’s research activities against our previously identified  criteria on key phases of sound research programs. We assessed  FirstNet’s contract oversight plans against key acquisition and contract  oversight practices and actions established in federal acquisition  regulations, the Department of Commerce’s (Commerce) acquisition  manual, prior GAO reports, and other academic and industry sources.  We also interviewed FirstNet and Commerce officials. To obtain  stakeholder views on all our objectives—particularly the challenges  FirstNet faces—we selected and contacted 33 stakeholders, including  public safety, state and local government, and tribal associations and  organizations; the Department of Homeland Security, the Federal  Communications Commission, and the National Institute of Standards  and Technology (NIST) and the National Telecommunications and  Information Administration; and state government and public safety  officials. We selected these stakeholders to obtain a variety of viewpoints  from a cross section of interests and geographic locations; their views are  not generalizable. Further details on our scope and methodology are  included in our report. The work on which this statement is based was  conducted in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.

FirstNet’s Progress Establishing and Financing the Network and Consulting Stakeholders

In our June 2017 report, we found that FirstNet has conducted key efforts  to establish the network, namely releasing the request for proposal for the  network in January 2016 and awarding the network contract to AT&T in  March 2017. As the contractor, AT&T will be responsible for the overall  design, development, production, operation, and evolution of the network,  as well as the marketing, product management, sales, distribution, and  customer care. Further, we found that FirstNet has established a  framework to meet the financial requirements established in the 2012 Act,  as depicted in figure 1. This framework focuses on leveraging FirstNet’s  spectrum through the use of payments and fees with the aim of ensuring  that the network is financially sustainable over the life of the contract and  that FirstNet sustains self-funding operations.

By establishing a single, dedicated network for public safety use,  FirstNet’s network is expected to foster greater interoperability and meet  public safety officials’ reliability and other needs. However, the actual use  (or “adoption”) of the network by public safety users will be voluntary.  Thus, even with the establishment of this framework, substantial  unknowns remain regarding how many public safety users will adopt the  network, the extent to which AT&T will be successful in monetizing the  spectrum to retain revenue from commercial users, and the extent to  which this revenue will be sufficient or appropriate in relation to the capital  needed to build, operate, and maintain the network. Therefore, we noted  that, at the time of our report, we could not assess the viability of this  framework and whether FirstNet’s structures for overseeing the  contractor’s use of the spectrum for commercial users will be appropriate.

We also found that FirstNet has made progress consulting with state and  local, federal, and tribal stakeholders through a variety of mechanisms.  State officials we contacted were generally satisfied with FirstNet’s efforts  to engage them. However, tribal stakeholders we contacted expressed  concern with FirstNet’s efforts to consult with tribes per the 2012 Act’s  requirements. In particular, four of the five tribal organizations we  contacted said that FirstNet has not fully engaged in effective  communication or has relied on state points of contact too much as  opposed to engaging directly with tribes; the other tribal organization was  not aware of FirstNet or its mission at all. Further, tribes noted that  individuals with first-hand knowledge of tribes’ experiences are not able to  represent tribal views directly among FirstNet’s key decision makers.  FirstNet has stated that, indeed, the 2012 Act requires that it consult with  tribes through state points of contact. Nevertheless, several federal  agencies have identified seeking a full understanding of tribal concerns— and reaching consensus where possible—as a key principle of effective  tribal communication, noting that agencies should adapt to changing  circumstances, contemplate creative problem solving, identify options for  addressing concerns, and exhaust alternatives to achieve mutually  agreeable solutions.

We concluded that, by fully exploring and proposing actions to address  tribal stakeholders’ concerns, FirstNet could help improve its relations  with tribes and better meet stakeholders’ needs. As such, we  recommended in our report that FirstNet fully explore tribal concerns and  propose actions, as needed, to address those concerns. FirstNet agreed  with this recommendation and, in September 2017, described to us the  actions it has taken to implement it. For example, according to FirstNet, in  September 2017 it began a process to formally explore the tribal outreach  concerns raised in our report and expects to propose improvements by  the end of this year. FirstNet has also said that it adopted an  organization-wide tribal consultation policy which it expects to take effect  towards the end of this year. If implemented as planned, these actions  should address the intent of the recommendation.

FirstNet’s Network Reliability, Security, and Interoperability Challenges and Efforts to Address Them

In our report, we found that—according to stakeholders we contacted— FirstNet faces various challenges to ensure the network’s reliability,  security, and interoperability. For example, stakeholders raised concerns  related to: providing network coverage to rural areas, in buildings, or ensuring the network’s overall resiliency and cybersecurity; and managing frameworks for user identity, credentialing of users, access  management, and prioritization of users on the network.

However, we also found that both FirstNet and the PSCR have begun  research and other efforts to help ensure the reliability, security, and  interoperability of the network and address the challenges raised by  stakeholders. For example, in November 2016, FirstNet opened an  Innovation and Test Lab at its technical headquarters in Boulder,  Colorado. According to FirstNet documentation, FirstNet plans to use— and allow AT&T to use—the lab to test public safety devices and  applications before deploying them on the network. Additionally, the  PSCR has conducted research on behalf of FirstNet and, using $300  million in funds provided to NIST by the 2012 Act, is also planning for and  implementing other research activities to support FirstNet. For instance, in  January 2016, PSCR launched its Public Safety Innovation Accelerator  Program to support these research activities, and in December 2016,  NIST issued a funding announcement to fund research in several areas.

At the time of our report, we found that PSCR’s research process  generally aligned with key phases of sound research programs identified  by leading national organizations, including the American Evaluation  Association and the National Academy of Sciences. For example,  PSCR has established a structured process for developing research  priorities that includes both internal and external stakeholders, and has  identified criteria it uses to help it select the research areas to fund and  procedures to help it guide and monitor its research. Similarly, FirstNet  has determined its research priorities to date based on its network- planning needs and in consultation with internal and external  stakeholders, and worked with the PSCR to define criteria to help it select  research areas.

Further, we found that the majority of stakeholders we contacted were  satisfied with the planning efforts to ensure the reliability, security, and  interoperability of the network. However, many stakeholders also said that  there is much remaining uncertainty about how this will be implemented in  practice. Additionally, one public safety official we contacted told us that  FirstNet and its contractor will have to balance the costs associated with  implementing features that make the network reliable and secure with the  need to establish compelling and competitively priced service packages  and fees that will encourage user adoption of the network. Indeed,  numerous stakeholders we contacted cited the cost of subscribing to the  network as a key factor affecting user adoption, noting that the pricing  must be comparable to what they pay for commercial service now, that  budgets are constrained in the public safety community, or that local  governments do not want costs to increase. Further, commercial carriers  could choose to compete with FirstNet. FirstNet has stated that it expects  AT&T to provide services at a competitive price and deliver affordable,  high-quality services that will encourage public safety users to adopt the  network. Ultimately—because the network must be self-funding and  FirstNet has stated that revenue from network users will be critical to this  funding—the success of the network depends on whether FirstNet and  AT&T generate enough revenue to operate it over the long term and  whether public safety users adopt it, no matter how reliable and secure it  is.

FirstNet’s Contract Oversight Mechanisms

FirstNet must manage and oversee the implementation of the network  contract to build, operate, and maintain the network. Federal internal- control standards also state that an entity’s management retains  responsibility for the performance of processes assigned to service  organizations (such as contractors) and that management should hold  these organizations accountable for their performance.

In our report, we found that FirstNet has taken a number of steps to  establish contract oversight mechanisms, but has not fully assessed the  staffing needs of its oversight workforce. FirstNet’s oversight mechanisms  include developing policies and procedures to guide contract  administration and establishing offices to oversee its network contractor.  In particular, FirstNet established the Network Program Office to oversee  the contractor’s performance and facilitate quality assurance of contract  deliverables, among other things. FirstNet is also receiving assistance  from the Department of the Interior, which has experience with contract  administration, although FirstNet plans to assume full responsibility for  contract administration in the future. We also found that FirstNet’s efforts  to develop contract oversight mechanisms aligned with several key  actions that we identified as contributing to effective contract oversight.  However, although FirstNet’s Network Program Office will perform  essential contract administration functions, FirstNet had not conducted  long-term projections of staffing needs for the office as of April 2017.  Planning for and assigning adequate resources, including people, and  performing an assessment of the resources needed to oversee projects is  one of the key actions we identified for planning and executing effective  contract oversight.

We concluded that FirstNet lacks reasonable assurance that it will have  sufficient resources to handle increases in its responsibilities over time  and that, by performing a long-term staffing assessment for the Network  Program Office, FirstNet would be in a better position to fully understand  its staffing needs and respond to staffing changes and risks as it assumes  full responsibility of contract administration in the future. As such, we  recommended in our report that FirstNet assess the long-term staffing  needs in the Network Program Office prior to assuming full responsibility  for administering the network contract. FirstNet agreed with this  recommendation and, in September 2017, described the actions it has  taken to implement it. According to FirstNet, in August 2017 the Network  Program Office adopted a strategic workforce plan for fiscal years 2018 to  2022, which it expects to update annually. According to FirstNet, this plan  provides a comprehensive view of current and future human capital  needs required to support the implementation of the network and  identifies strategies the office will employ to fill gaps between current and  future needs, among other things. If implemented as planned, this action  should address the intent of the recommendation.

Chairman Donovan, Ranking Member Payne, and Members of the  Subcommittee, this concludes my prepared statement. I would be  pleased to respond to any questions that you may have at this time.

If you or your staff have any questions about this testimony, please  contact Mark L. Goldstein, Director, Physical Infrastructure Issues at  (202) 512-2834 or goldsteinm@gao.gov. Contact points for our Offices of  Congressional Relations and Public Affairs may be found on the last page  of this statement. GAO staff who made key contributions to this testimony  are Sally Moino and Nalylee Padilla. Other staff who made contributions  to the report cited in this testimony are identified in the source product.

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