GAO: FDA sorta slow responding to produce industry

From the U.S. Government Accountability Office:

Although the United States has one of the safest food supplies in the world, foodborne illness is a common public health problem. Some of this illness can be linked to produce. In 2006, for example, an E. coli outbreak associated with baby spinach sickened 205 people and killed 3; in 2011, 147 people fell ill and 33 died as a result of eating melons contaminated with Listeria. Other produce-related outbreaks in recent years have involved cucumbers, alfalfa sprouts, bean sprouts, and packaged salads.

lettuce-skull-e-coli-o145The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has responsibility for ensuring the safety of produce, along with many other foods. Overall, FDA is responsible for ensuring the safety of more than 80 percent of the U.S. food supply.

Because produce is often consumed raw without processing to reduce or eliminate contaminants, preventing contamination is key to ensuring safe consumption. In January 2011, the FDA Food Safety Modernization Act (FSMA) was signed into law, representing the largest expansion and overhaul of U.S. food safety law since the 1930s.1 FSMA, according to FDA, marked a historic turning point by focusing on preventing rather than reacting to foodborne illnesses. FSMA did so, in part, by requiring FDA to promulgate new rules that together provide a framework for industry to implement preventive measures and for FDA to oversee implementation. In response to FSMA, FDA developed seven foundational rules; among them was the rule entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption—widely referred to as the produce safety rule.2 This rule, which FDA promulgated in November 2015, established the first enforceable national standards for on-farm growing, harvesting, packing, and holding of domestic and imported produce.3 Among other things, the rule established standards related to agricultural water quality; the use of soil amendments, such as raw manure; the presence of domesticated and wild animals; worker training, health, and hygiene; and sanitation of equipment, tools, and buildings. The rule includes staggered compliance dates depending on average annual produce sales of a business and other factors. For example, compliance for some of the largest businesses comes due beginning in 2017 and 2018, while compliance for certain smaller businesses is not due until 2020. FDA has been developing guidance and training for those affected by the new standards under the produce rule; the agency has also set aside funding for states to help them support implementation of the rule. In addition, the agency is hiring experts with backgrounds in science and policy to work in different regions of the country assisting state officials with implementation of the rule, according to FDA officials.

Some in the produce industry have expressed concerns about the new produce rule standards, including concerns about the scientific basis for standards in such areas as water quality. Some have also expressed concerns about the costs associated with meeting the new standards, particularly for smaller businesses. The Agricultural Act of 2014, also referred to as the 2014 Farm Bill, required that FDA ensure the final produce rule include “a plan to systematically…develop an ongoing process to evaluate and respond to business concerns.”4

The act included a provision for GAO to report, 1 year after the promulgation of the final produce rule and again the next year, on the ongoing evaluation and response process. This first report examines (1) how FDA evaluates and responds to business concerns regarding the produce rule and (2) how FDA plans to assess the effectiveness of its efforts to evaluate and respond to business concerns regarding the rule.5

lettuceTo examine how FDA evaluates and responds to business concerns regarding the produce rule, we reviewed the final rule, including FDA’s responses to public comments on the rule; reviewed relevant information on FSMA and the produce rule on FDA’s website; interviewed FDA officials involved in implementation of the rule; and interviewed representatives from two organizations assisting FDA with implementation of the rule.6 We also interviewed representatives from six produce industry associations and one large retailer for their views on any FDA efforts to respond to business concerns.7 We selected industry associations with large memberships, those representing both large and small businesses, and those representing differing types of produce. These interviews provided a sampling of views and are not generalizable to all produce industry associations, businesses, or others affected by the produce rule. To determine how FDA plans to assess the effectiveness of its efforts to evaluate and respond to business concerns, we interviewed FDA officials to learn about any ongoing or planned efforts.

We conducted this performance audit from August 2016 to November 2016 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.

FDA has developed an information clearinghouse to evaluate and respond to concerns from businesses and other stakeholders regarding any of the FSMA rules, including the produce rule. Operational since September 2015, this clearinghouse, called the Technical Assistance Network (TAN), serves as a central source of information to support understanding and implementation of the FSMA rules. Businesses and other stakeholders—such as industry associations, academia, and consumers—can submit questions online or by phone or traditional mail. Phase 1 of the TAN, which is currently operational, evaluates and responds to questions related to the publication of FSMA rules. Phase 2, which FDA expects to begin in 2017, will evaluate and respond to questions from FDA and state inspectors working to ensure industry compliance with FSMA rules. FDA officials we interviewed told us the agency intends to maintain the TAN as a mechanism to respond to stakeholder questions and concerns even after the produce rule and other FSMA rules are fully implemented.8

We examined FDA data on TAN questions received by the agency from early September 2015 through early September 2016.9 During that period, FDA received 2,626 TAN questions, most of which had been submitted online.10 About 14 percent of questions (363) pertained to the produce rule, and about 60 percent of questions (218) pertaining to the produce rule came from those who identified as belonging to “industry/business.”11 According to FDA, the agency tracks TAN questions to help inform FSMA policy, guidance, and training. For example, officials at FDA told us that many of the questions it received related to the produce safety rule sought clarification regarding uses of water that meet the definition of “agricultural water.” FDA also received many questions seeking clarification on the requirements for collecting samples of agricultural water. Because of the large number of questions on both of these topics, FDA considers them high-priority areas to address in developing guidance. Specifically, FDA identified these topics as those most important to include in the first phase of its general compliance and implementation guidance for the produce rule, whereas other topics will be addressed in the second phase of the guidance.

In addition to addressing business concerns through the TAN, FDA officials told us they will continue to reach out to industry during produce rule implementation, just as they did while developing the rule. For example, FDA officials plan to meet with industry as they develop guidance documents, which provide direction on complying with produce rule standards. According to these officials, the guidance development process will provide another opportunity to hear and respond to business concerns. FDA may incorporate industry suggestions into the final guidance, as appropriate. Representatives from industry associations we interviewed generally praised FDA’s level of collaboration during the rulemaking process, noting that FDA had been willing to engage with them and address their concerns.12

FDA Is Developing a Survey and Other Metrics to Assess Its Information Clearinghouse

FDA officials we interviewed said the agency is developing a stakeholder survey to assess the effectiveness of its information clearinghouse, the TAN. FDA will send a copy of the survey to businesses and other stakeholders when providing responses to TAN questions submitted online. Most TAN questions are submitted online. Officials told us surveys will be sent starting in fiscal year 2017, after the required Office of Management and Budget (OMB) review is complete.13 FDA plans to implement the survey in two parts, according to officials. The first part will begin in early fiscal year 2017 and will solicit feedback from stakeholders about the web page FDA provides for submitting questions online. In late fiscal year 2017, FDA will begin soliciting feedback about the quality of information the agency provided in its responses to TAN questions. In addition, officials said the agency is developing metrics to measure overall success in implementing the produce rule and plans to begin using these metrics in January 2018, when compliance with most of the produce rule standards comes due for most large businesses. These metrics will be used to examine how effective the TAN is in responding to questions and will ultimately be used to assess whether additional training and outreach to business are needed to help implement the produce rule.

We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN.

FDA officials told us that, as of early October 2016, the agency had responded to about 72 percent of all TAN questions received. Officials said FDA is currently studying how long it takes, on average, to respond to questions submitted to the TAN, and the agency is working to decrease its response time. Also, according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved.

Sounds like a lot of meetings: Additional actions needed to improve planning and collaboration for US food safety

A new report from the U.S. Government Accountability Office found the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) have taken steps to implement GPRA Modernization Act of 2010 (GPRAMA) requirements but could more fully address crosscutting food safety efforts. For example, GPRAMA requires agencies to describe in their strategic and performance planning how they are working with other agencies to achieve their goals.

Meeting.1HHS and USDA vary in the amount of detail they provide on their crosscutting food safety efforts. In addition, they do not include several relevant crosscutting efforts, such as the National Antimicrobial Resistance Monitoring System, which tracks whether foodborne bacteria are resistant to the antibiotics used to treat and prevent illness.

Fully addressing crosscutting efforts in individual strategic and performance planning documents is an important first step toward providing a comprehensive picture of federal food safety performance. However, individual agencies’ documents do not provide an integrated perspective on federal food safety performance. In 2011, GAO recommended that the Office of Management and Budget (OMB), in consultation with the federal agencies having food safety responsibilities, develop a government-wide performance plan for food safety. OMB has not acted on that recommendation. Without such a plan, Congress, program managers, and other decision makers are hampered in their ability to identify agencies and programs addressing similar missions and to set priorities, allocate resources, and restructure federal efforts, as needed, to achieve long- term goals. In addition, without such a plan, federal food safety efforts are not clear and transparent to the public. GAO continues to believe that a government- wide performance plan for food safety is necessary.

HHS’s Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS) have mechanisms in place to facilitate interagency coordination on food safety that focus on specific issues, but none provides for broad-based, centralized collaboration. For example, FDA and FSIS are collaborating with the Centers for Disease Control and Prevention through the Interagency Food Safety Analytics Collaboration to improve estimates of foodborne illness sources. However, this and other mechanisms do not allow FDA, FSIS, and other agencies to look across their individual programs and determine how they all contribute to federal food safety goals. Nearly all the experts GAO interviewed agreed that a centralized collaborative mechanism on food safety is important to foster effective interagency collaboration and could enhance food safety oversight. The Food Safety Working Group (FSWG) served as a centralized mechanism for broad-based food safety collaboration and resulted in a number of accomplishments, including improved coordination. However, the FSWG is no longer meeting.

A prior centralized mechanism for broad-based collaboration on food safety also was not sustained. Without a centralized collaborative mechanism on food safety, there is no forum for agencies to reach agreement on a set of broad-based food safety goals and objectives. Experts suggested that a centralized collaborative mechanism on food safety—like the FSWG—could provide sustained leadership across agencies over time if it were formalized in statute. Without such formalization, centralized collaborative mechanisms on food safety may continue to be short- lived.

GAO: FDA can better oversee food imports by assessing and leveraging other countries’ oversight resources

Audits and inspections have problems – so the feds should leverage resources in other countries to monitor the safety of U.S. food imports.

I see problems there as well.

A new report by the U.S. Government Accountability Office concludes the U.S. Food and Drug Administration should use comparability assessments that can enable the agency to leverage other countries’ oversight capacity and enforcement authority. This could result in some of the same advantages as the equivalence approach used by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) and the European Union (EU) before specific food products can be imported.

Unless, like USDA, they just stop doing the equivalency audits.

Or, as argued by FDA-types, the agency expects few countries to seek comparability with the United States because, in part, most countries will not meet the FDA requirement that a foreign government’s domestic and export food safety systems be comparable to the U.S. system for food products under FDA’s jurisdiction. According to FDA documents, some countries have robust export certification programs for a specific food product, but their overall food safety systems, including domestic production systems, may not be comparable with those of the United States. Consequently, FDA would be unable to leverage the resources of countries with comparable systems for just one food product, such as seafood, which FDA has experience in assessing through its foreign country assessments. 

Going public: there may be some rules but FDA says they’re a secret

The same agencies that tout a science-based approach to foodborne illness aren’t so good at one of the 3 legs of the risk analysis stool – risk communication.

It gets lots of pandering, but almost all government agencies and industry groups, regardless of geography, are really bad at risk communication when performance is stacked up against what has been proven to work (not very much).

When to go public about health warnings – like potential outbreaks of foodborne disease – remains contentious. And no one is willing to come clean about it and say, this is when we go public and why. Or at least write it down. Bureaucrat 101 – write it down, have to do it; so don’t write it down.

I understand the flexibility public health types require to do their jobs effectively, but much of the public outrage surrounding various outbreaks – salmonella in tomatoes/jalapenos, 2008, listeria in Maple Leaf deli meats, 2008, the various leafy green recalls and outbreaks of 2010, 2011, 2012, the 1996 outbreak of cyclospora linked to Guatemalan raspberries, and the delay in clamping down on Iowa eggs – can be traced to screw ups in going public.

It’s long been a tenet of risk communication that it is better to go early with public information rather than later. People can handle all kinds of information, especially when they are informed in an honest and forthright manner.

So it’s of no surprise that the U.S. Government Accountability Office (GAO) couldn’t find anyone within the Food and Drug Administration (FDA) to say, this is how we decide when to go public.

“FDA has interim internal procedures describing the steps it will take to order a food recall, but these procedures have not been made public, and the agency has not provided information on when they will be. Federal internal control standards call for federal agencies to clearly document
policies, procedures, techniques, and mechanisms for implementing management directives and to make that documentation readily available for examination.”

“Similarly, FDA officials told us that they have not decided whether they will issue regulations or industry guidance to clarify for the public FDA’s procedures for ordering food recalls and that FSMA has no requirement to do so. Federal internal control standards direct federal agencies to
ensure adequate means of communicating with and obtaining information from external stakeholders who may have a significant impact on the agency achieving its goals.

“About a week-and-a-half before our closing meeting, FDA officials provided us interim internal procedures for ordering recalls of food. These interim procedures include detailed information on such topics as which officials are to be involved in an ordered food recall decision and what methods and timelines FDA officials will use to communicate with companies involved in such a recall. The interim procedures also state that FDA is to incorporate procedures into the
agency’s publicly available Regulatory Procedures Manual and other FDA documents. FDA officials have not, however, provided timelines on when they expect to make procedures publicly available."

And it goes on like that for 61 pages.

GAO recommends, among other things, that FDA issue regulations or industry guidance to clarify its ordered food recall process and implement recommendations from others to address FDA communication challenges in advising the public about food recalls and outbreaks. The agency neither agreed nor disagreed with GAO’s recommendations but cited ongoing agency actions that are to address most recommendations.

To strengthen FDA’s process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document FDA’s process for ordering food recalls in regulations or industry guidance to include information on how the agency will weigh evidence on whether a recall is necessary.

To address FDA’s communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from the Institute of Medicine and National Research Council to develop, in conjunction with other federal agencies, a coordinated plan for crisis communications.

To address FDA’s communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from FDA’s risk communication committee to develop a policy for communications during emerging events.

The full report is available at http://www.gao.gov/products/GAO-12-589.

GAO: preslaughter interventions could reduce E. coli in cattle

A new report concludes the federal government should provide more specific public guidance on the license approval requirements of vaccines that could reduce the incidence of E. coli O157:H7 and friends in cattle.

Because right now, it’s bureaucratic, and no one can offer a clear explanation.

The U.S Government Accountability Project in report GAO-12-257 (for sticklers) also concluded the Secretary of Agriculture should explore practices employed by other countries that are not currently used in the U.S. for reducing shiga-toxin producing E. coli (STEC) in cattle and consider whether the identified practices can inform U.S. efforts.

From the report:

U.S. Department of Agriculture (USDA) and university researchers identified several treatments administered before cattle are slaughtered, or preslaughter interventions, that could reduce Shiga toxin-producing Escherichia coli (STEC) in cattle. Such preslaughter interventions include bacteriophages (viruses that infect and kill bacteria), probiotics (live bacteria that can benefit the digestive system), vaccines (biological preparations that alter the immune system), and sodium chlorate (chemical that kills the STEC O157:H7 strain). However, few manufacturers have submitted applications for preslaughter intervention products to target STEC according to officials from USDA and the Food and Drug Administration. One exception is for vaccines to reduce STEC O157:H7.

For preslaughter interventions, USDA exercises responsibilities for licensing and regulating STEC vaccines. However, USDA’s approval requirements for these vaccines are unclear, according to some industry representatives. Specifically, USDA’s general guidance does not address some of the unique challenges faced by manufacturers of animal health products seeking STEC vaccine approval. For example, the guidance does not explain that, if studies conducted in the laboratory are insufficient to demonstrate efficacy, the manufacturer would also need to demonstrate that the vaccine is effective in a field setting such as a feedlot. In contrast, the Canadian Centre for Veterinary Biologics provides more specific guidance about when it requires the use of laboratory or field studies to demonstrate efficacy for vaccine license applications. Without guidance that gives manufacturers clear and more specific information they need to submit for an acceptable application, the approval process for STEC vaccines could face potential delays.

In addition to STEC O157:H7, which it stated in 1994 was an adulterant—a substance that renders food injurious to human health—in September 2011, USDA determined that six other STEC strains were adulterants in raw ground beef and beef trim (meat left after steaks and roasts are cut from beef). USDA has tests for these six strains and plans to use them in slaughter plants starting in June 2012. However, it may be difficult and time-consuming to confirm positive test results because certain test components are either not commercially available for all strains or do not always provide clear results. USDA is working to improve the tests and to find a commercial supplier for one key test component. Also, a few companies voluntarily test for these strains.

Some foreign governments have practices that could be relevant to U.S. efforts to reduce STEC in cattle such as the following:

The European Parliament and the Council of the European Union require certain measures, such as verification of cleanliness by an inspector, to ensure that the cattle going to slaughter are clean. In contrast, USDA assesses the health of cattle but does not inspect for cleanliness.
At least 12 European Union member countries collected and reported data on STEC in live cattle in 2009. USDA has conducted STEC testing in live cattle, but has not tested since 1999.
When a person becomes ill from E. coli in Sweden, government officials try to determine the specific farm that sold the contaminated cattle so that other carcasses from the farm can be tested for STEC. USDA does not trace the STEC source back to the farm.

The complete report is available at http://www.gao.gov/products/GAO-12-257.

FDA lax in produce oversight

The U.S. Government Accountability Office reported today that the Food and Drug Administration’s efforts to combat foodborne illness are hampered by infrequent inspections, not enough staff and the failure to implement a program devoted to the safety of fresh produce.

The report said that inspections at produce-processing facilities are rare and that when problems are discovered, the FDA relies on the industry to correct them without oversight or follow-up. …

The report also cited previously unpublished FDA data showing that 14 people died and 10,253 were sickened in 96 outbreaks associated with fresh produce from 1996 through 2006. This summer, salmonella sickened at least 1,440 people in 43 states and Washington, D.C.

But the report found that only 3% of the FDA’s food safety budget goes toward efforts to protect fresh produce.


 

GAO and a single food inspection agency: Will it actually make food safer? Will fewer people get sick?

When it comes to the safety of the food supply, I generally ignore the chatter from Washington. If a proposal does emerge, such as the creation of a single food inspection agency, I ask, Will it actually make food safer? Will fewer people get sick?

Much is being made this morning about a new report from the U.S. General Accounting Office, and how the U.S. is lagging behind other countries – countries that have single food inspection systems. The Chicago Tribune says, On food safety, U.S. not No. 1, while the L.A. Times  offers an editorial, U.S. lags on food regulation.

So I spent the end of another stellar day in Melbourne, and the beginning of a new day back home, by reading the report and comparing it to some of the Washington chatter.

Senator Dick Durbin (D-IL) said,

"Today’s GAO report shows that America ranked eighth out of eight countries — dead last — in terms of national food safety systems.”

There was no such ranking in the report. There was no ranking at all in the report.

Congresswoman Rosa L. DeLauro (CT-3) said,

“This GAO report highlights how effectively a single food safety agency could protect our food supply. … By focusing on the entire food supply chain, placing primary responsibility for food safety on producers, and ensuring that food imports meet equivalent safety standards. …”

The U.S. system already does that. And the report says nothing about how a single food inspection agency could better accomplish such tasks.

The Center for Science in the Public Interest says,

“The GAO report also shows that creating a unified food safety program is technologically and economically feasible, and most important, effective in helping to reduce foodborne illness.”

There were no measures of effectiveness for any of the single food inspection agencies, other than whether public opinion or confidence in the shiny, happy new agencies increased over time based on self-reported surveys. A few advertisements could have accomplished that.

There was certainly no mention of any agency reducing the incidence of foodborne illness. The seven countries studied – Canada, UK, New Zealand, Ireland, Denmark, Germany and The Netherlands – said they reorganized their food inspection agencies to improve effectiveness and efficiency; not one said to improve public health and have fewer sick people.

The GAO report — Selected Countries’ Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness – did say:

“The burden for food safety in most of the selected countries lies primarily with food producers, rather than with inspectors, although inspectors play an active role in overseeing compliance. This principle applies to both domestic and imported products.”

That’s good.

“None of the selected countries had comprehensively evaluated its reorganized food safety system … Most of the selected countries use proxy measures, such as public opinion surveys, to assess their effectiveness. Public opinion in several countries has improved in recent years.”

That’s bad.

In Canada, “At the consumer end of the spectrum, the food safety agency educates Canadians about safe food-handling practices and various food safety risks through its Web site, food safety fact sheets, and the Canadian Partnership for Consumer Food Safety Education, a group of industry, consumer, and government organizations that jointly develop and implement a national program to educate consumers on how to safely handle food.”

That’s awful.

To summarize: no rankings, no measures of effectiveness, and not much fact-checking.

Should there be a single food inspection agency in the U.S.? Maybe. But will it enhance the safety of the food supply? Will it mean fewer sick people?

GAO: FDA should be clearer on food safety plan

Christopher Doering of Reuters reports that the U.S. Government Accountability Office said in a report today that the U.S. Food and Drug Administration’s failure to discuss clearly its strategy and the money needed to better protect the country’s food supply could make it harder for a plan to succeed.

The GAO report also noted that FDA must better leverage its existing resources "as staffing levels and funding have not kept pace with the agency’s growing responsibilities" to oversee the food supply.

GAO noted that even as food imports surge, FDA inspectors of foreign food firms has dropped from 211 in fiscal year 2001 to fewer than 100 in 2007. About 15 percent of the overall U.S. food supply is imported.

Rep. John Dingell, chairman of the House Energy and Commerce committee, said,

"Our constituents are growing weary of these events. They are losing confidence in this agency’s ability to protect them from the products they use daily."