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.

Will fewer people barf? FSMA and audits, especially third party, still suck

Allen L Mozek, MPH, a Fellow of the International Food Protection Training Institute (IFPTI) and public health advocate for prevention of areca nut diseases, writes in this (as yet unpublished) letter to the editor of Food Safety magazine that the October/November 2016 issue sings “Kumbaya” about the Food Safety Moderization Act (FSMA)  – let’s step back and be politically incorrect:

barf-o-meter-dec-12HACCP was never supposed to be a regulation but “an approach to inspection” – per Dr. Frank L. Bryan – HACCP pioneer.

Ready-to-eat produce and sprouts, due to outbreaks and lack of CCP, would not be permitted if not for Salinas CA producers and sprout association lobbying.

Preventive controls is “another regulation” that will mitigate hazards but not provide the conventional 5 log reduction of pathogens with these products.

Second, food fraud is intentional adulteration for economic gain and not amenable to either HACCP or preventive controls but is rather an ethical problem. See the essay:

Market Economies With Churches and Market Economies Without Churches, by Zhao Xiao

Third, I would like to see thorough answers to three questions (courtesy of economist Thomas Sowell):

1.     What is the empirical evidence for this legislation?

2.     Compared to what will this legislation be an improvement?

3.     What is the cost?

Fourth, please answer the charge of “conflict of interest” and “sham”, regarding third party auditors, exclaimed by renowned foodborne illness attorney Bill Marler and barfblog.com editor Doug Powell.

FDA’s role in the global food system

Michael R. Taylor and Howard R. Sklamberg write in the Harvard International Review (introduction only):

michael.taylor.fdaWe work for a public health regulatory agency – the United States Food and Drug Administration (FDA) — that oversees products accounting for 20 percent of US consumer spending. FDA regulates industries that meet fundamental human health needs in the areas of pharmaceuticals, vaccines, blood and blood products, and medical devices. FDA also regulates the tobacco, dietary supplement, and cosmetic industries. In addition, we regulate the food industry. Twenty-five years ago, the FDA could afford to think and act as the domestic agency we were. Today we can’t. Every industry we regulate has become global in terms of how they source ingredients, manufacture finished products, and seek markets for the products they make here in the United States. Annual import entries of FDA-regulated products have almost tripled from 2004 to 2014, rising to about 33 million. The companies we regulate are often multinationals that have an international outlook and are affected by international standards, which they seek to harmonize.

So, FDA has had to become global, too. Since 2011, the US Congress has given us two new import safety laws with mandates and tools to ensure that imported medical and food products are as safe as domestic products. We now have offices in seven foreign countries compared to zero in 2007. We have full-time staff working on international harmonization of regulatory standards, trade policy issues, and regulatory partnerships with foreign governments. Our international engagement — and the importance of international relations to our success — is only increasing. In this article, we will highlight the international dimension of our food program, which has responsibility for the safety, composition, and labeling of all human and animal food products — except meat, poultry, and some processed egg products regulated by the US Department of Agriculture. We will focus specifically on the global public health and economic challenge of protecting the safety of our food supply to show how fully intertwined our domestic consumer protection mission is with challenges facing the global food system. Furthermore, we will explain how implementation of the FDA Food Safety Modernization Act (FSMA) of 2011 brings home the lesson that when it comes to food safety, we’re all in this together.

Congress and FDA share a vision of how the United States must engage internationally on food safety for the good of its citizens and the good of the global community. Our work in the years ahead is to fully execute that vision.

But will it make fewer people barf? US FDA issues final food defense regulation

The U.S. Food and Drug Administration today finalized a new food safety rule under the FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.

imagesUnder the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.

“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., incoming deputy commissioner for foods and veterinary medicine, FDA. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

The rule was proposed in December 2013 and takes into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.

Truckin: FDA releases final rule to ensure food safety during transport

The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation.

truckinThe rule will require those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.

The action is part of a larger effort to focus on prevention of food safety problems throughout the food chain, and the rule implements the Sanitary Food Transportation Act of 2005 (SFTA) as well as the requirement in section 111 of FSMA that instructed FDA to issue SFTA regulations. The regulation will apply to food transported within the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. Shippers, loaders, carriers and receivers engaged in transportation operations of food imported by motor or rail vehicle and consumed or distributed in the United States are also subject to the final rule.

“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The rule was proposed in February 2014 and takes into consideration more than 200 comments submitted by the transportation industry, food industry, government regulatory partners, international trading partners, consumer advocates, tribal organizations and others. It also builds on the transportation industry’s best practices for cleaning, inspecting, maintaining, loading and unloading and operating vehicles and transportation equipment.

Implementation of the sanitary transportation rule and all FSMA final rules will require partnership, education and training.

New food safety rules will affect Canadian growers exporting to the U.S.

Susan Mann of Better Farming writes that Canadian horticultural industry leaders are poring over documents issued by the United States Food and Drug Administration last month outlining new food safety requirements for American growers and businesses shipping produce to the United States.

onion.water.oregonCanadian and Ontario growers exporting produce to the United States may be impacted by the new rules released as part of the American Food Safety Modernization Act and slated to take effect January 26, 2016. The American Food and Drug Administration (FDA) released the three sets of rules November 13. They are: the produce rule governing growing, harvesting, packing, and holding of produce; foreign supplier verification and accreditation of third-party auditors and certification bodies.

Companies and farmers in the states along with those exporting to the United States are being given time to meet the new requirements.

Jim Gorny, vice president of food safety and technology for the U.S.-based Produce Marketing Association, says the rules will have “a significant impact on produce businesses, in that they will affect how businesses operate on a daily basis and set definitive regulatory compliance expectations for FDA regulated businesses.”

The compliance dates depend on the size of a business, Gorny says. Large businesses with more than US $500,000 annually in sales have two years to comply with the new regulations and four years to meet the new water testing provisions. Small farms, defined as US $250,000 to $500,000 a year in sales, have three years to comply with the rules and five years to fall in line with the water rules. Very small farms, US $25,000 to $250,000 in sales annually, have four years to comply with the rules overall and six years for the water rules.

Heather Gale, executive director of CanadaGAP, the Canadian food safety program for the fresh fruit and vegetable sector, says they will be reviewing the new U.S. rules and comparing them to the requirements in Canada’s program. The program’s analysis will be published on its website sometime “in the new year,” Gale says.

Al Krueger, executive assistant with the Ontario Processing Vegetable Growers, says by email Ontario cucumber growers are “already doing what’s required under the new Food Safety Modernization Act.”

Another part of the American package of new food safety rules is the Foreign Supplier Verification Program. It specifies importers are required to verify food imported into the United States has been produced to the same food safety standards required of U.S. producers, Gorny says.

Guidelines are nice, enforcement II: Will fewer people barf under new produce and import rules (no)

New produce safety rules from the government Friday are intended to help prevent the kind of large-scale outbreaks of foodborne illness that occurred over the past decade linked to fresh spinach, cantaloupes, cucumbers and other foods.

rulesUnder the rules, the government soon will have new oversight of the farms that grow Americans’ food. That means, for example, making sure workers are trained to wash their hands, irrigation water is monitored for harmful bacteria and animals do not leave droppings in fields.

The regulations are tailored to cover foods and growing methods that pose the greatest risk, and they target produce such as berries, melons, leafy greens and other items usually eaten raw and more prone to contamination. A farm that produces green beans that will be cooked and canned, for example, would not be regulated. There are also exemptions for smaller farms.

The rules require farmers to test irrigation water quality, regularly train workers on the best health and hygiene practices, and monitor wildlife that may intrude on growing fields, among other measures.

Compared with the original proposal, the final rule requires less stringent standards for irrigation water quality and reduces the frequency of testing, in some cases. The organic industry had expressed concerns about the rules, especially because many organic farmers use raw manure as fertilizer and try to treat irrigation water with fewer chemicals.

Advocates for food safety laws have cited the pressing need after several high-profile foodborne illness outbreaks. In 2006, E. coli in fresh spinach was linked to several deaths, including a 2-year-old. A 2011 outbreak of listeria linked to cantaloupes killed 30 people. This year, four people have died in a salmonella outbreak linked to Mexican cucumbers.

Also on Friday, the FDA released new rules to ensure the safety of food imported for the U.S. market.

These rules could help prevent against outbreaks such as the salmonella in Mexican cucumbers or cyclospora illnesses linked to Mexican cilantro. The FDA said the cilantro was grown in fields where American investigators found toilet paper and human feces.

New US FDA rules tighten requirements for food manufacturers

Sweeping new federal rules will require USA food manufacturers to implement more stringent food-safety operations and preventive measures to avert deadly outbreaks of foodborne illnesses like listeria and salmonella.

bureaucrat.pink.flyodThe rules, released Thursday by the U.S. Food and Drug Administration, follow years of work by regulators amid a rash of foodborne illnesses linked to dirty food processing equipment and poorly designed facilities.

Michael Taylor, the FDA’s deputy commissioner for foods, called the new rules the most sweeping overhaul of our food safety system since the first federal law was enacted in 1906. The rules, he said, will focus on prevention, as most of the recalls consumers have faced in recent years “are largely preventable.”

The FDA will phase in the new rules over time, beginning in September 2016 for larger food manufacturers. Smaller companies will have longer to comply with the regulations. All of the rules should be in place, Taylor said, by late summer 2018.

The rules, once promoted as an Obama administration priority, ran into long delays and came out under a court-ordered deadline after advocacy groups had sued. Even then, the Food and Drug Administration allowed the Aug. 30 deadline to pass without releasing the rules to the public.

The new rules will require food manufacturers to submit food safety plans to the government to show they are keeping their operations clean. Once the rules go into effect later this year, companies will have to prepare detailed plans that lay out how they handle the food, how they process it, how they clean their facilities and how they keep food at the right temperatures, among other safety measures.

Roy writes Michael: something about food safety

On May 20, 2015, Michael Taylor  (right, exactly as shown) of the U.S. Food and Drug Administration posted in a FDA blog that, “we’ve got to build prevention into the food safety system globally.”

Mike_Taylor_7624-199x300Taylor, FDA’s deputy commissioner for foods and veterinary medicine, also wrote the Food Safety Modernization Act is about providing assurances that the food system is doing everything it can to prevent problems and to provide food in grocery stores and restaurants that is as safe as it possibly can be.

Friend of the barfblog.com, Roy Costa responded by writing:

I appreciate Michael Taylor’s comments and also believe that FSMA is a step in the right direction. The fact, however, is that companies around the globe have already adopted food safety systems. This article makes it sound like preventative controls are something new and that such programs will be brought about by new federal law. The fact is in most major operations the preventative controls are in place right now. There are firms that have not adopted such in their operations, and FSMA may help to address this, but by and large, the large foodborne illness outbreaks we have seen are not the result not having a prevention program, but the failure of the program to prevent the hazard from occurring.

Breaking a law, however, comes with a high cost for non-compliance, and that hammer is needed for some. But for most operators, this is not the answer to the microbial contamination control problem in their facilities. Our overarching goal in industry should be to be in compliance with FDA’s new laws, however, we need effective food safety management systems and we do not always have them. This is illustrated by the findings of serious sanitation issues, after the fact, in the investigation of the Blue Bell ice cream plant outbreak and many others.

As a regulator, consultant, auditor and investigator for almost 40 years, I am painfully aware of the difficulties in the implementation of complicated quality assurance and safety programs. In light of this, I feel simply more or different “preventative controls” are not likely to improve the situation much, by themselves.

 roy.costaStill, we look to FDA to help us, and I am still wondering if we will get what we need from the agency. We need consistent application and enforcement of the rules, and FDA has to get agents into the field, but most importantly, firms must organize their companies around food safety. This means establishing active and effective committees, appointing dedicated food safety staff, and a planned approach to assuring the safety of products. Companies must also effectively train and educate everyone in the organization, and maybe most importantly, apply the available science and technology to the food safety problem.

A lack of commitment within companies is a root cause of much of the failures of the existing programs, along with a lack of resources. We waste tons of money on audits, manuals, record keeping etc, etc, when we should be investing in educating our employees, improving our  infrastructures and applying technology. These applications should include onsite laboratory capability, remote monitoring of critical processes, and sophisticated traceability and recall programs.

I totally support what FDA is doing with FSMA, but we should recognize that a new system of preventative controls is only a solution if our food safety management systems are working effectively.

If you try sometimes, you’ll get what you need: FDA says can’t have it both ways on food safety

Two of the things growers and shippers want to see in new federal food safety rules — flexibility and simplicity — are mutually exclusive according to officials from the Food and Drug Administration.

mick.taylorCoral Beach of The Packer writes the more flexible the rules, the more complicated they have to be. That was the message from FDA’s top food safety staff during a Nov. 21 session in Florida where they fielded questions on proposed rules required by the Food Safety and Modernization Act.

Mike Taylor (right, not exactly as shown), FDA deputy director of foods, and Samir Assar, director of produce safety at the FDA’s Center for Food Safety and Applied Nutrition, also said time has not been on the agency’s side in terms of developing the rules.

“It’s an incredibly rapid, very tight time frame were on,” Taylor said, adding that a court order requires the agency to publish the final rule for produce in October next year.

Taylor and other federal officials spent about 90 minutes reviewing the proposed rules and revisions before taking questions during the session, which was sponsored by the Florida Agriculture Department. It was the fifth such state session Taylor and the others have attended since Nov. 6.

(Terrible pretend playing in the video below; and this guy interviewed Nixon.)