– OPINION –

After facing months of criticism about its slow response to the infant formula crisis, and the overall troubles facing the food program at the Food and Drug Administration, Commissioner Robert Califf announced earlier this summer that he was ordering a review of the food program by the Reagan Udall Foundation. Now that the review of the FDA food program is underway, there should be hope that the process could lead to meaningful reform that addresses the fragmented structure and the lack of transparency at the agency that has undermined its effectiveness. 

However, in what appears to be an attempt to maintain the status quo, the FDA is preventing a true top-to-bottom review of the food program from being conducted by insisting that the Center for Veterinary Medicine (CVM) be excluded from the process.

By all accounts, there is no reason to doubt that the review process being implemented by the Reagan-Udall Foundation will be inclusive and transparent. They have gathered a distinguished panel of experts that will provide the knowledge and insight that is appropriate for this effort. 

Unfortunately, because of the CVM exclusion, this expertise will not be fully leveraged because of FDA’s unwillingness to address difficult internal issues involving structure and accountability. FDA has explained that it’s because of CVM’s broad portfolio regulating both animal medical products and animal foods and that the agency wants to keep the review focused on its human food safety work.  

What is troubling about this explanation is that it demonstrates a lack of understanding of the food program and how the food system works. Virtually every element of CVM’s program relates in some way to the food system and food safety, including the animal drug approval program, which mainly applies to human food animals and also ensures the safety of drug residues in human food. CVM also regulates animal feed, which affects both human and animal health. 

Additionally, under the common framework mandated by the Food Safety Modernization Act (FSMA), the safety of animal food, including pet food, is regulated nearly identically to the regulation of human food, and many human food byproducts are used in the manufacture of animal food. 

The FDA’s reasoning also contradicts the agency’s support of the “One Health” approach, which aims to solve health problems by recognizing the interconnection of people, animals, plants and the environment. Food safety is one of the main intersections between human and animal health. FDA is one of several federal agencies that support the “One Health” approach and encourages its use, except apparently when it applies to critical reviews of the agency’s fragmented structure.

It is this fragmented structure and dynamic that led an unprecedented collaboration between consumer groups, industry trade associations, and state and local regulators in calling on FDA to unify the food program under a deputy commissioner for foods. This position would have direct oversight authority over the Center for Food Safety and Applied Nutrition (CFSAN), CVM, and the food-related operations of the Office of Regulatory Affairs (ORA). A unified structure and a full-time expert leader would bring focused leadership and accountability to FDA’s food program and establish a foundation toward the culture change that is desperately needed. 

We can no longer afford or tolerate the status quo in how the FDA regulates food. Excluding CVM from the Reagan-Udall Foundation review perpetuates the current fragmented structure and the culture of siloing the different components of FDA’s food program. It increases the risk of future crises, similar to what we have seen transpire with the infant formula situation, and virtually ensures that the food program will continue to have second-class status at FDA. 

About the author: Brian Ronholm is the director of food policy for Consumer Reports. He leads the organization’s advocacy efforts to advance a safe and healthy food system. He previously served as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA) and, prior to that, served in the office of Rep. Rosa DeLauro of Connecticut. 

(To sign up for a free subscription to Food Safety News,click here)

By Brian Ronholm

Imagine using a radar gun to detect speeding in cars, but then manipulating the radar so that it only detects speeding in cars going over 100 mph. This means any reading below 100 mph would be considered undetectable and any data results would conceal any problems by showing that minimal or no speeding has occurred.

Based on FDA test results on per- and polyfluorinated alkyl substances (PFAS) in food released last week, the FDA appears to have employed a similar approach when it conducted its survey/testing. The testing methodology used by the agency applied limits of detection and quantitation that likely underrepresented the presence of PFAS in food. Had lower detection and quantitation limits been applied, the FDA likely could have found PFAS contamination in the tested food to be much more pervasive, as the FDA’s own earlier released results and testing at commercial laboratories suggest.

Presenting these test results using this less sensitive methodology unnecessarily minimizes the risk that consumers are facing. PFAS are an ever-expanding group of thousands of man-made toxic chemicals that are widely used to make fluoropolymer coating that allows products to be more resistant to heat, stains, grease and water. Consumers can be exposed to PFAS in myriad ways — food, food packaging, water, clothing, cosmetics, cooking surfaces, etc.

Several PFAS characteristics make them especially dangerous to humans.

First, they are extremely persistent, resistant to breaking down naturally in the environment, and remain in people’s bodies for years. This is why they are often described as “forever chemicals.”

Second, they are highly mobile, spreading quickly and remain prevalent throughout our environment. Finally, they can be toxic at very low doses and have been linked to a variety of severe health effects, including an increased risk of cancer, thyroid disease, and birth defects.

The high detection level the Food and Drug Administration used for this survey is only part of the reason to be skeptical of their results. The FDA’s current PFAS testing method is only capable of detecting and quantifying 16 of the more than 600 PFAS that are currently in use. The agency itself has acknowledged that their sampling is very limited.

Returning to the radar gun analogy — in addition to the radar only being able to detect cars going over 100 mph, it’s further limited in that it can only measure 16 of more than 600 cars that pass by the radar; this means hundreds of cars going over 100 mph still would go undetected because the radar gun is only equipped to detect 16 cars.

Yet another issue of concern about the FDA’s PFAS testing methodology is that none of the PFAS tested were ones approved for food packaging. This was a missed opportunity, as the FDA could have provided updated data on how much PFAS in food packaging leaches into food products. The Environmental Working Group (EWG) found nearly half of fast food wrappers collected in 2014 and 2015 had high fluorine counts, a reliable indicator of PFAS use in food packaging products.

Granted, testing for PFAS in food can be difficult. There are many PFAS chemicals for which there are no analytical standards and many complex food matrices that can hinder unbiased detection and quantification of PFAS chemicals.

Also, serious efforts to develop test methods for investigating the occurrence of, and potential exposure to, PFAS chemicals from food began only recently, so there currently are no robust methods that could be used to test and report on an adequate number of food-relevant PFAS chemicals.

However, in releasing these misleading test results, the FDA is conveying a false sense of security about PFAS contamination in food that has the potential to be harmful, especially in the long-term. If the FDA would like to do something meaningful, they should move quickly to ban PFAS in all food packaging.

Brian Ronholm is the Director of Food Policy for Consumer Reports. He leads CR’s advocacy efforts to advance a safe and healthy food system. He previously served as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA) and, prior to that, served in the office of Rep. Rosa DeLauro of Connecticut.

(To sign up for a free subscription to Food Safety News, click here.)

Opinion

If you enjoyed a slice of cherry pie over the holidays, chances are you weren’t aware of the tyranny this delicious dessert suffers under, and the 15-year effort to unleash the poor, huddled cherries yearning to breathe free. At least, that’s what you would think if you read a proposed rule the Food and Drug Administration (FDA) is on the verge of approving that seeks to revoke the definition of frozen cherry pie.

This proposed rule is based on an industry petition filed in 2005 that suggests bakers apparently are longing to include more cherries, more sugar, and bigger crust in frozen cherry pies, but have been prevented from doing so by supposedly burdensome regulations. The regulations in question allow the FDA to establish a reasonable definition and standard of identity or quality for any food in order to promote honesty and provide transparency to consumers. Foods for which standards of identity have been established include bread, fruit jams, certain vegetables and fruit juices, certain types of chocolate and, of course, frozen cherry pie.

On the surface, it sounds terrible, right? Big government is dictating what goes into cherry pies and preventing consumers from experiencing more deliciousness! Grab your dessert forks and let’s storm White Oak!

However, once the nuance of this issue is examined more thoroughly, you realize that the proposed rule has the potential of removing safeguards that are in place to protect consumers against food fraud. As we have seen over the years, standards of identity sometimes are asserted for pretentious reasons, which is usually disguising trade protection efforts.

Ultimately, however, the purpose of these standards is to protect consumers against food fraud — also known as economic adulteration — and reflect consumers’ expectations about food; for example, consumers expect fruit to be included in fruit jam, go figure.

Unfortunately, the need for these standards can be quite apparent. For example, according to separate studies from the University of California-Davis and the National Consumers League, more than 50 percent of the bottles of extra virgin olive oil sold at grocery stores would fail to meet International Olive Council standards or the voluntary standards established by the USDA. Unlike the frozen cherry pie industry, producers of olive oil are begging the FDA to issue a standard of identity for their product to prevent this seemingly wide scale fraud.

In the case of frozen cherry pie, the FDA wants to revoke the established definition and standards of identity and quality. “The standards do not appear necessary to ensure that these products meet consumer expectations, and the FDA has tentatively concluded that they are no longer necessary to promote honesty and fair dealing in the interest of consumers and may limit flexibility for innovation,” the agency declared in its announcement.

Whenever industry claims that flexibility for innovation is being limited, consumers should be skeptical. The standard of identity for frozen cherry pie describes it as unbaked, and as being comprised of a filling of mature, pitted, stemmed cherries contained in a pastry shell, which is frozen. It can contain other optional ingredients, but artificial sweeteners are prohibited. The standard of quality includes requirements for the cherries used in these pies, including that the cherry content cannot be less than 25 percent of the weight of the pie, and that no more than 15 percent of the cherries can be blemished.

Based on this definition, there doesn’t appear to be a barrier to including more cherries in the pie. However, the industry petition opposes the use of any food standards to establish quality characteristics and argues that food manufacturers and consumers should determine food quality and whether they wish to spend more on higher-quality products or less on lower quality products. The petition also observes that there are no standards of identity and quality for any other types of frozen fruit pies or any non-frozen fruit pies.

I suppose these are fair arguments. Consumers will ultimately determine which pies are awful and decide accordingly. They also may decide cherry pies are on the same level as pizza and ice cream in that when they are good, they are very good, and when they are bad, they are still pretty good.

However, the “innovation” that consumers should expect to see when this standard of identity and quality is revoked is a lower quality frozen cherry pie with fewer and blemished cherries, and artificial sweeteners at a lower price point. To suggest that manufacturers are eager to add more cherries and crust but are prevented from doing so by burdensome government regulations, as former FDA Commissioner Scott Gottlieb claimed in this tweet, seems like fake bake news.

Now, who is hungry for cherry pie?

(To sign up for a free subscription to Food Safety News, click here.)

In his welcoming remarks at the Global Food Safety Initiative (GFSI) conference last week, Peter Freedman, managing director of the Consumer Goods Forum, which convenes the annual conference, asserted that building consumer trust is at the very foundation of GFSI. Curiously, a perusal of the conference agenda would reveal that none of the plenary sessions and panel discussions taking place during the three-day conference included a representative from a consumer group.

GFSI describes itself as the world’s largest collaboration for food safety that has grown into a vast, global multi-stakeholder movement. “We enable the extensive collaboration that is so critical to ensuring a safe global food supply, involving both the private and public sectors,” the GFSI web site declares.

Additionally, GFSI explains that its community is composed of the world’s leading food safety experts from retail, manufacturing and food service companies, including upstream suppliers, as well as international organizations, governments, academia and service providers to the global food industry. Notice which stakeholder group is not listed?

In the sessions I attended, the consumer perspective was missing and would have been very useful in these discussions. One breakout session entitled “Engaging the Masses: How Consumers Feed the Supply Chain,” provided a good example.

This panel outlined how the use of new technology was the best way to connect with consumers, especially on recalls and alerts. One panelist argued that a seamless mobile experience would allow stores to communicate in real time and alert consumers of a recalled product if they purchased the item.

Using peanut butter as an example, the panelist explained that technology could target a specific jar, and then provide the customer a voucher for a non-tainted replacement, thus not breaking the consumption cycle; the panelist suggested that retail stores needed an incentive to alert customers that they may have purchased a tainted product.

It would seem alarming that stores would need an incentive to alert customers of a tainted product. When I asked about using shopping cards to alert customers of recalled products, the panel noted that the stores often lack the resources or technology to perform that function. If true, it would be curious and distressing if available technology and resources allowed stores to notify customers that an item they bought previously is on sale, but not to notify customers if the product they purchased was subject to a recall.

Other sessions that could have benefited from consumer input included ones on working together towards one safe food supply through public-private partnerships, and another on consumer perception in the social media age.

During the conference, I had the opportunity to meet with Mike Robach, a well-regarded figure in the food policy arena and the outgoing chair of GFSI. He indicated that GFSI has attempted to incorporate consumer group insight during previous sessions, but it could not be sustained for various reasons.

Admittedly, cost is likely a major factor; the airfare and hotel rates for a multi-day conference can be high, especially for international meetings, and that does not factor in the conference registration fee of over $1,000. For consumer-focused, non-profit groups, continuous participation in this initiative is likely cost prohibitive.

Fortunately, Robach understands the importance of having more formal consumer input and expressed a willingness to discuss the issue with the GFSI board. Hopefully, the board and the incoming chair will be receptive to the message.

The goal of building consumer trust on food policy is critical and laudable. However, if this effort is being pursued through the lenses of industry, government, and academia, and what these groups think consumers should trust, then it runs the risk of falling far short of that goal. Consumers will trust who and what they want, and will dismiss any attempts to force trust on them, especially if they are not even included in the discussion. 

About the author: Brian Ronholm is Director of Food Policy for Consumer Reports, an independent, nonprofit member organization that works with consumers for truth, transparency, and fairness in the marketplace. He is a former deputy under secretary for food safety at the U.S. Department of Agriculture and prior to that, worked for Rep. Rosa DeLauro, D-CT. 

(To sign up for a free subscription to Food Safety News, click here.)

During the recent Good Food Institute conference on cell-cultured meat, an industry executive remarked that he tries to stay away from politics and focus on his company and developing the technology. That certainly is an understandable approach, especially given the turbulent political climate we are experiencing. 

However, considering that this emerging industry is the focus of so much attention and investment, and is attempting to disrupt the status quo while incurring the ire of traditional agriculture groups, politics has a way of finding you in these situations.

Jurisdictional skirmish
Much is being made of this upcoming joint USDA-FDA meeting on cell-cultured meat. While very useful information and data will be exchanged, the meeting likely is being convened mostly as a pro forma exercise. Reportedly, the joint meeting had long been planned, but then FDA jump-started the debate by convening the recent public meeting without inviting USDA to participate. This upset some stakeholder groups and USDA, which supposedly led to a very tense White House meeting in an attempt to broker a truce.

Regardless of the veracity of these rumors, one can only hope that the source of the tension at the White House meeting centered on which agency is better equipped to prevent food-borne illness and protect consumers. However, as we all are aware, when it comes to jurisdictional skirmishes between federal agencies, history tells us otherwise.

The USDA-FDA tension notwithstanding, the FDA public meeting was very informative, and the message from FDA was clear – the agency has the expertise and the infrastructure to oversee these products.

Stakeholder strategy
As the process for working through the jurisdictional dilemma continues, stakeholder groups also seem to be trying to sort out their respective issue management strategies in determining how to advocate for their positions. 

For instance, while the cell-cultured meat industry mostly appears to support FDA jurisdiction over the technology, there is a thought among the companies that it would be acceptable if jurisdiction fell to USDA’s Food Safety and Inspection Service (FSIS). The rationale for this position is that it would provide them with preemption under the Federal Meat Inspection Act, thus preventing states from imposing barriers to entry for their products. 

However, it is very likely that states that strongly support traditional agriculture will create other hurdles for the cell-cultured meat industry. Therefore, the question for them to deliberate is whether these markets should factor into their thought process as they consider their position on jurisdictional authority. If a high concentration of their market will be in states that would be supportive of the technology, then they should consider whether preemption is a legitimate concern, especially if it is their view that FDA is better equipped to oversee this industry. 

As for the traditional agriculture stakeholder groups, they have been clear in their belief that cell-cultured meat should be regulated by FSIS, arguing that this type of product should be subject to the same regulations as animal protein products. Just as catfish jurisdiction was a passive-aggressive attempt at imposing non-tariff trade barriers, FSIS jurisdiction over cell-cultured meat would be a passive-aggressive approach to imposing potential barriers to market entry.

Nevertheless, some of the traditional agriculture groups also have asserted that cell-cultured meat should not be labeled as meat, which would be incongruent with FSIS jurisdiction; the more this labeling argument is made, the more it plays into the hands of those who believe FDA is the more appropriate agency of jurisdiction. You cannot help but wonder whether Commissioner Gottlieb’s recent announcement on modernizing FDA’s standards of identity was made with the jurisdictional debate over cell-cultured meat products in mind.

Consumer/food safety watchdog groups have remained somewhat silent on the issue so far. While Food & Water Watch has urged federal agencies, including FDA, to update their existing frameworks for regulating this technology, the group, along with other members of the Safe Food Coalition, have not declared a particular agency preference. It makes sense strategically for these groups to avoid expending resources on a nascent issue, but if the technology reaches the commercialization point, expect these watchdog groups to become more engaged.

Antibiotic resistance – under the radar?
One issue not yet receiving as much attention in this debate is antimicrobial resistance. Proponents of cell-cultured meat argue that these products eliminate the threat of antimicrobial resistance by virtue of being produced in a sterile environment free of antibiotic use.

However, one industry presenter at the FDA public meeting explained that to remove antibiotics and ensure safety of cell-cultured meat, it is important that a facility has a closed system that eliminates the possibility of microbial growth, and limits human interaction within the system. Additionally, the design of the facility must allow for sterilization, as well as constant and regular in-process sampling of cultures to ensure no microbial growth is possible.

This might signal to policy-makers that the threat of antimicrobial resistance is not completely eliminated under this process. If so, the question becomes whether this process would have the potential of creating antibiotic resistant strains of pathogens through overuse if the design of a facility is not perfect. Although this may seem to be an unlikely scenario, the cell-cultured meat industry should prepare in the event policy-makers develop this type of interpretation.

If the focus on antimicrobial resistance issues is elevated in this debate, it might provide additional validation to those who argue that FDA as being the more appropriate overseer of these products. While USDA certainly has a role in the consideration of antimicrobial resistance issues, the FDA has primary jurisdiction.

Congressional action forecast
There has been thought given to the notion that USDA and FDA should be allowed to figure out the jurisdictional issue, thus obviating the need for Congressional involvement. In addition to being highly unlikely that it would happen, it already is too late since House and Senate agriculture appropriations subcommittee members are negotiating a final FY 2019 spending bill that may include language asserting that USDA should have jurisdiction over cell-cultured meat.

If this language does pass, it is unlikely that it will be Congress’ final declaration on the issue; the authorizing committees probably have some strong beliefs and will want some formal input. Another school of thought among a number of congressional staffers that I have spoken with is questioning the eagerness for legislative action given that the technology is far from reaching mass production. It likely speaks to the influence of livestock groups that Congress is seeking to address the jurisdictional issue so early in the technology’s development. 

Also, there is another dynamic involving USDA-FDA jurisdictional entanglements in play that has the potential of playing a role in any future negotiations over cell-cultured meat regulations.

Although it may not receive as much attention as the debate over cell-cultured meat products, another jurisdictional dispute being discussed relates to gene-editing in animals. The FDA considers this process to be subject to the statutory and regulatory requirements for new drug applications. However, segments of the biotechnology industry, with support from some livestock groups, believe that, in addition to FDA jurisdiction, the gene-editing process should include an enhanced role for USDA’s Animal and Plant Health Inspection Service (APHIS).

As this debate on jurisdiction over gene-editing in animals progresses, it likely will converge with the escalation of deliberations over cell-cultured meat. If this happens, it is difficult not to envision a scenario within Congress where negotiations and deal-making among engaged and motivated stakeholder groups results in split jurisdictions among the agencies over both issues. For cell-cultured meat products, the recent proposal by Memphis Meats and the North American Meat Institute (NAMI) might provide a starting point for discussions. 

The farm bill offers Congress a natural legislative vehicle for this debate. While the opportunity for language to be included in this year’s farm bill may appear closed, an opening may appear if Congress fails to pass it in time and extends current farm bill programs for one year; the additional time might allow for consideration of this issue, especially if the development of the technology, along with the discussion over jurisdictional authority, continues to accelerate.

We are likely years away, if ever, from witnessing the wide-spread commercialization of cell-cultured meat products. However, it behooves stakeholders to position themselves such that they can pivot accordingly as the debate progresses and shifts. Ultimately, the end of this process over determining jurisdictional authority will demonstrate that there is space on the hamburger bun for cell-cultured meat products. It also will demonstrate that there is no avoiding politics either.

(To sign up for a free subscription to Food Safety News, click here.)

More intuitively, another key point is that the work performed by poultry processing line personnel is incredibly difficult and ensuring the safety of these workers is of paramount importance.  It is the intersection of these elements that is vexing the debate over line speed.

Slaughter
When chickens arrive at a typical high volume slaughter facility, numerous workers are present to suspend each bird by their feet on a moving line and, within seconds, the chickens are calmed by rub bars that are intended to provide a comforting sensation on the chest. This procedure usually is accompanied by the use of dim lighting which helps keep birds calm. They are then electrically stunned to render them unconscious before a machine administers a quick, single cut to the throat.

After slaughter, the birds enter the cleaning and evisceration segment, which is a highly automated process where machines remove feathers and internal organs to prepare the birds for processing. The birds are placed in a bath of hot water to loosen feathers and then a machine removes the feathers. The carcasses then go through a quality control part of the slaughter line to ensure that any visual defects – bruises or fecal material – are removed before being washed and then sent to the chiller. After being chilled, microbiological tests are conducted by the company and by the USDA for microorganisms such as Salmonella.

The slaughter practices described above is the subject of the current debate over slaughter line speed, which is limited by regulation to 140 birds per minute (bpm), except in so-called HIMP facilities, which are allowed to operate their slaughter lines up to 175 bpm. The petition submitted to FSIS by the National Chicken Council (NCC) last year requests that the slaughter line speed limit to be set at 175 bpm.

If the petition is approved by FSIS, not every poultry plant would immediately increase the slaughter line speed. Because this part of the process is highly automated, the plants would have to ensure that they have the appropriate technology to allow for the accurate operation of the machines at the higher speed while still being able to maintain process control, or address potential food safety threats. The average slaughter line speed at the so-called HIMP facilities is actually lower than the allowable 175 bpm, and that likely would be the case if the NCC petition is approved.

New poultry inspection system
The quality control segment of the line is the focus of FSIS’ effort to modernize the poultry inspection system. Science informs us that the visual defects on poultry carcasses have very little impact, if any, on food safety and that removing them is essentially a quality control task.

The primary food safety threat in this part of the process is removing visible fecal material.  While feces can be removed through proper cooking, not every poultry product is cooked properly, which increases the risk of cross contamination on surfaces and other foods being prepared if fecal material with live pathogens is present. Because the presence of feces on carcasses is gross, a facility has every incentive to ensure it is removed as no one would purchase the product.  Similarly, since feces can presents a food safety threat, continued visual inspection by FSIS is necessary.

With this in mind, the question becomes whether it makes sense for a government agency (FSIS) to provide a company with subsidized labor by performing its quality control tasks for them, or could agency resources be allocated toward activities directly related to food safety, such as microbiological testing for Salmonella.

More generally, another critical question becomes whether the existing law that has been in effect since the mid-1950s that mandates visual carcass-by-carcass inspection has become antiquated and incapable of addressing current food safety threats that continue to evolve. The fact is poultry slaughter line speeds could be reduced to one bird per minute and it would have no impact on food safety because you cannot see Salmonella.

Under NPIS, the quality control tasks are performed by plant employees, while FSIS inspectors still are present to conduct visual carcass-by-carcass inspections to ensure carcasses are free of visual defects before entering the chiller. Additional FSIS inspection personnel are available to perform tasks that are more directly related to food safety, including sample collection for microbiological testing, ensuring the plant is sanitary, and following its HACCP procedures.

Processing
There are no regulations that limit the line speed for processing where carcasses are typically cut and deboned, and turned into products sold in stores or used in restaurants. While plants can theoretically set the processing line speed as fast as they would like, they still are subject to HACCP principles to ensure that their product is not adulterated and food safety risks are being addressed, regardless of the processing line speed.  Failure to adequately address food safety risks can result in the facility being shut down.

Also, because the process of cutting and deboning is strenuous work, poultry plants must find the right balance between worker safety and delivering a quality product.

Current Debate
A significant concern of increasing line speed is the potential for further endangering the poultry industry’s labor force. Carpal tunnel syndrome is a common injury for poultry workers who perform these grueling and dangerous tasks.  First-time visitors to any slaughter facility often are struck by two images – the slaughter process itself, and the demanding work required over a sustained period of time to transform poultry carcasses into products presentable for sale.

Having to perform these tasks at a higher line speed would exacerbate an already tough work environment. That notwithstanding, it should be noted that the petition to increase line speed for slaughter would not impact the line speed for processing; it is an important component of the debate that should be clarified and that the line speed for both should not be conflated.

However, this does not invalidate the concern about worker safety. If the line speed for slaughter is increased, it is a fair assumption that companies will need to increase the processing line speed or to accommodate the extra inventory in the chiller. While the industry has countered that it instead would add workers to the line or install additional processing lines, it is not clear whether there is enough space in most plants to accommodate additional employees or equipment.

The intersection of food safety and worker safety will continue to vex the debate over line speed issues in poultry slaughter plants. The resolution of this issue will require a level of trust among all stakeholder groups.

Labor groups have to trust that poultry industry companies will not increase processing line speed if the plants are permitted to operate at a higher slaughter line speed.  Consumers have to trust that the poultry industry will be as effective as FSIS in ensuring visual defects are removed from carcasses, and that industry would not advocate for policies that intentionally harm workers or facilitate the production of unsafe foods. Poultry companies have to trust that workers care to make quality products efficiently, and trust that consumers recognize that industry would not intentionally produce unsafe foods that harm their brands.

However, there has been long-standing and extensive levels of distrust between and among all of these groups that has been exacerbated by the current political climate.  Given this, consensus on this issue, regardless of FSIS’ decision, seems highly unlikely.

About the author: Brian Ronholm is currently senior director of regulatory programs at Arent Fox LLP. He previously served as USDA Deputy Undersecretary for Food Safety in the Obama Administration and, prior to that, on the staff of Rep. Rosa DeLauro.

(To sign up for a free subscription to Food Safety News, click here.)

While the move may seem inconsequential on the surface, this realignment will undermine the United States’ credibility in the international food policy arena, and represents yet another effort by the Trump Administration to emphasize trade goals at the expense of food safety.

Codex Alimentarius is a United Nations standards-setting body working under the auspices of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) that establishes food standards that protect public health and ensure fair trade of safe food all over the world. Many countries incorporate Codex standards into their laws, which has the effect of upgrading international food safety efforts. Codex standards also establishes predictability for food traders and are used by the World Trade Organization (WTO) in settling trade disputes.

The U.S. Codex Office is comprised of a small, and very effective, staff within FSIS that manages U.S. participation in Codex by engaging other federal agencies and external stakeholders in the development of these international governmental and non-governmental food standards. Historically, the United States has been a strong presence in Codex, providing leadership in maintaining the organization’s adherence to science.  Aligning the U.S. Codex Office with trade goals within USDA will have a negative impact on this leadership status.

Within Codex, the U.S. faces challenges from other countries who are attempting to impose views of appropriate food standards that are not supported by science. While the challenges from these other countries have been formidable, the U.S. Codex Office has been able to execute a strategic outreach program that has proven successful in gaining support for U.S. positions worldwide.

The primary factor in the success of these outreach programs is the credibility the U.S. Codex Office has possessed from the public health foundation provided by being housed under FSIS. Whether warranted or not, there exists a perception among many countries that U.S. Codex positions are significantly influenced by industry trying to enhance trade opportunities at the expense of consumer and public health interests; this perception has long complicated Codex proceedings and negotiations for the U.S.

However, the U.S. Codex Office has been able to push back effectively on that narrative by virtue of its emphasis on science, and public health goals supported by its standing within FSIS.

Moving the U.S. Codex Office to the trade office within USDA may seem to make sense on the surface. However, when you factor in the nuance and complexities of Codex negotiations on the world stage, this realignment actually will undermine U.S. credibility on food safety and trade.  I hope Secretary Perdue will consider these ramifications and reconsider this particular move.

Note on the author: Brian Ronholm is now in the private sector, but he is a former deputy under secretary of food safety at the U.S. Department of Agriculture. During his time at USDA, Ronholm developed strategic frameworks and engaged in outreach activities to advance FSIS policies and initiatives impacting the meat, poultry, and processed egg industries.

(To sign up for a free subscription to Food Safety News, click here.)

This scenario provides an overly simplified explanation of the equivalency process at the USDA’s Food Safety Inspection Service (FSIS). As many are aware, countries that wish to export meat, poultry, catfish, or egg products to the United States must demonstrate to FSIS that their food safety inspection system is equivalent to the U.S. system. This equivalency determination process allows FSIS to verify that a country’s food safety inspection system achieves the appropriate level of food-borne illness prevention, especially countries with a spotty food safety record.

Recently, FSIS issued a proposed rule that would allow China to ship poultry products from birds slaughtered in China. This proposed rule was the culmination of an extended process that lasted more than a decade and included a number of visits by FSIS and myriad correspondence between the agency and China. The process became prolonged for many reasons, but it always seemed that China’s intentions were always opaque or kept shifting.

During my time at USDA, I was once approached at a conference by someone who claimed to have direct knowledge into the thinking of the Chinese government on their equivalency application pending before FSIS. He explained that China was seeking a better deal than what other Asian countries had received, adding that China viewed itself as the big brother in Asia and therefore should receive special consideration under these circumstances.

Somewhat taken aback by this suggestion, I diplomatically explained that FSIS is required to follow a process in determining whether a country’s food safety system is equivalent and there could be no “deal” when it comes to ensuring the safety of imported foods into the U.S. Assuming this person did have direct knowledge into the thinking of the Chinese government, it provided some insight as to why China intentionally protracted the process. By failing to submit requested information or respond to correspondence in a timely manner, China appeared to be sabotaging itself throughout this process. In actuality, they responded by slowing down other trade-related discussions.

FSIS recently announced it was suspending fresh beef shipments from Brazil because of recurring food safety problems that stemmed from an investigation involving allegations of bribery by meatpacking facilities in exchange for the approval of spoiled meat for export. Food safety considerations notwithstanding, USDA seemed to possess some leverage in suspending these shipments because of the political scandal this caused in Brazil, and other countries already had temporarily banned beef shipments from that country.

Additionally, since U.S. beef shipments to Brazil resumed just this year, the impact of any potential retaliatory measures would seem to be minimal. If faced with a similar situation involving China, USDA is unlikely to possess such leverage, so the question becomes whether the department would be willing to take such a forceful action with China.

If and when the FSIS proposed rule becomes final, an important component of the equivalency process is continually evaluating and verifying that the equivalency determination can be maintained, as the Brazil situation demonstrates. This ongoing equivalence verification process includes document reviews, on-site audits, and point of entry re-inspection. Given China’s recent record on food safety, it will be critical for FSIS to utilize these measures and continue the due diligence — checking under the beds and in the closets — to verify that China’s food safety system maintains its equivalency status.

(To sign up for a free subscription to Food Safety News, click here.)

While some coordination between food safety and trade is appropriate, the inclusion of FSIS on such a committee is potentially troubling, giving the appearance that trade is going to have significant influence over food safety priorities at USDA. The public health mission of FSIS should be an equally separate focus within the department, and trade considerations should not impact food safety policy direction.

As many know, countries wishing to ship meat and poultry products into the United States have to demonstrate that their food safety inspection system is equivalent to the system here in the U.S. This can be a very deliberative process that includes document submissions, lengthy reviews of regulatory structures, and on-site verification audits.

As a result, there sometimes can be tension between FSIS and another USDA sub-agency — the Foreign Agricultural Service (FAS) — over this equivalency determination process. Some countries have found the FSIS process to be onerous, and have been able to find advocates within FAS, especially when the other country is considering opening their markets to U.S. products.

If the role of FSIS on the interagency committee is to merely provide status updates of equivalency applications, it would represent a more appropriate approach that would be consistent with current practice. However, since this panel would be chaired by FAS with FSIS as a member, it gives the appearance that trade will take precedence over food safety.

The recent announcement that cooked chicken from China soon would be eligible to be shipped to the U.S. offers an example of this situation. China has teased the re-opening of their market to U.S. beef for a long time only to change their minds frequently; and then the issue became subtly linked to receiving equivalency status for their poultry products. Despite the impression given in some media reports, there was no direct trade of equivalency for U.S. beef access to China; the process was far more nuanced, and FSIS had been working on an analysis of China’s food safety system for processed poultry for years and had recently completed its evaluation. However, the optics of the announcement are undeniable.

Given the numerous food safety concerns China has experienced in recent years, an equivalency determination from the U.S. presents an opportunity for China to improve their food safety reputation around the world. Also, the potential of the Chinese market is so immense that those in the U.S. beef industry have exercised extreme patience in waiting for China to re-open them. It appears China may be serious this time, given the granularity of the discussions compared to before, but many who have followed this issue continue to take a wait-and-see approach.

It would be easy to believe that the creation a new undersecretary for trade is warranted and would lead to the facilitation of similar types of deals in the future. However, this approach may not have been unnecessary.

Agricultural exports enjoyed the best eight-year period ever during the Obama Administration, topping $1 trillion, and that was due to the strength of people who worked to increase trade opportunities while maintaining high food safety standards – USDA Secretary Tom Vilsack, Michael Scuse, Darci Vetter, Alexis Taylor and Jonathan Cordone. Successful advocacy for increased agricultural exports will not result from the creation of a new undersecretary, it will be derived from the strength and commitment of the personnel involved.

Increased agricultural exports for diminished food safety standards for imported products is a bad trade that should not be made. However, the establishment of an interagency committee that potentially allows FAS to unduly influence FSIS could create a culture at USDA that permits this to happen.

(To sign up for a free subscription to Food Safety News, click here.)

Bill Marler, a noted product liability attorney specializing in foodborne illness cases, alludes to some of these points in a recent posting on his blog. Given the executive order repealing old rules and the proposed across-the-board cut to all federal agencies, it might be easy to assume that President Trump’s interest in food safety issues will be minimal. However, Marler argues that the president is not focused on the issue, implying that the focus is forthcoming.

The president’s proposal for across-the-board spending cuts in order to fund an increase in military spending could facilitate this process because budget cuts are not as straight forward from a food safety perspective.

Inspectors for USDA’s Food Safety and Inspection Service (FSIS) are required by law to be present at slaughter and processing facilities on a continuous basis, meaning these establishments cannot operate without an inspector present. Because of this statutory requirement, the vast majority of the FSIS budget is allocated to inspector salaries and other expenses that support inspection activities. Any significant budget reduction at FSIS would involve a reduction in the inspection force and force meat and poultry establishments to scale back operations or even shut down. This was a possibility that the previous Administration faced when the budget sequestration went into effect in 2013.

As Marler noted, President Trump is a self-described germaphobe and that is reflected in his dining habits: he orders his hamburgers and steaks well done. Food safety education directed at consumers has long been an important piece of the work by FSIS and the Food and Drug Administration to reduce foodborne illness. These two primary food safety regulatory agencies combined on an effort with the Ad Council on a national Food Safe Families campaign launched in June 2011 to raise awareness of the risks of foodborne illness. An important component of this campaign featured public service announcements that educated consumers to take specific actions to reduce personal risk, including cooking foods to the right temperature by using a food thermometer.

Despite the success of the Ad Council’s campaign, the percentage of households using a food thermometer remains low. By ordering his hamburgers well done, President Trump understands the importance of cooking them to the correct temperature of 160 degrees F. It is probably a stretch to think that the President’s dining habits could influence consumer behavior and increased use of food thermometers, but any high-profile attention paid to safe food habits is noteworthy.

A noted consumer of fast food meals, President Trump explained in a campaign interview last year that a big fast food franchise can be destroyed with one bad hamburger. While this could be considered a slight exaggeration, the underlying sentiment is true, and history has demonstrated this. Jack-in-the-Box barely survived the E. coli outbreak in 1993 that sickened more than 600 people and killed four children, and there have been a number of instances where small- and mid-sized companies have gone out of business after an outbreak involving their products. Also, have you seen the most recent earnings report from Chipotle? Profits declined 76 percent from the same period last year, meaning they still are facing a long road in recovering from their major food safety outbreaks in 2015.

Clearly, President Trump comprehends some basic economics of foodborne illness, and the impact it can have on consumers, businesses, and trade. As he becomes more familiar with these economic drivers, he will recognize that these are all costs that need to be avoided. Hopefully, he also will recognize that consumers, industry and government are all valuable partners in the effort to reduce foodborne illness rates.

Of course, any attempts to speculate on President Trump’s food safety agenda could immediately become obsolete after a series of early morning, stream-of-consciousness tweets.

Note on author: Formerly the deputy under secretary for food safety at USDA’s Food safety and Inspection Service, Brian Ronholm is now with Arent Fox LLP. For additional biographical details, click here.

(To sign up for a free subscription to Food Safety News, click here.)

• A company cleans its processing equipment at the end of the day, instead of between production lots. If this is the case, there is no basis to distinguish between production lots, and a day’s worth of production effectively becomes one lot. In this situation, FSIS would assume that the entire day’s production was contaminated and subject to a recall.

• Some plants use multiple lines that converge into common mixers. If contaminated product is being produced by one line, the product from the other lines would become contaminated once it enters the common mixer.

• Detailed distribution records allow FSIS to narrow the scope of a recall. In the absence of such records, FSIS must take into account the possibility that contaminated product was comingled with other products. Therefore, FSIS would include all the products in question in the scope of a recall to protect public health.

The illnesses associated with this particular recall involve a very rare strain of E. coli O157:H7, so if there are additional illnesses, it may be easier for FSIS to establish a direct link to product from this facility; it also will be possible that any additional illnesses will be linked to product that is already subject to the recall. If any additional illnesses are linked to different production dates that are not covered in the initial recall, then the recall would be expanded. So far, we have no evidence to suggest that the recall should be expanded, but the investigation is still very active. We continue to look for additional sources either from Wolverine or a common supplier and will certainly pursue those leads if the investigation uncovers them. If warranted, the new information also may result in an expanded recall. For consumers, we advise all consumers to safely prepare raw ground beef products by cooking them to 160 degrees F. When dining out, this is equivalent to ordering your burger well-done. At the grocery store, check ground beef product labels that bear the establishment number “EST. 2574B” with a production date code in the format “Packing Nos: MM DD 14” between “03 31 14” and “04 18 14.” Industry’s responsibility during any recall follows a consistent pattern. In this situation, Wolverine is responsible for notifying the distributors who received its product to return the product to Wolverine. In turn, the distributor is responsible for alerting any retail outlets or restaurants to which it delivered the recalled product. Retailers and restaurants are expected to pull the product from their shelves or storage area and return it to Wolverine. As the FSIS press release indicated, the recalled products were shipped to distributors for restaurant use in Massachusetts, Michigan, Missouri, and Ohio. If you are a restaurant owner in these states and are wondering if you have received this recalled product, you should receive notification from your distributor that they were supplied recalled products from Wolverine that were sent to you. Or, you can check product labels that bear the establishment number “EST. 2574B” with a production date code in the format “Packing Nos: MM DD 14” between “03 31 14” and “04 18 14.” As always, if you have additional questions, do not hesitate to “Ask Karen,” the FSIS virtual representative that is available 24 hours a day at AskKaren.gov or via smartphone at m.askkaren.gov. Or you can call the toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854), which is available in English and Spanish and can be reached from 10 a.m. to 4 p.m. (Eastern Time) Monday through Friday. You also can access our online Electronic Consumer Complaint Monitoring System 24 hours a day at: http://www.fsis.usda.gov/reportproblem.

As grilling season heats up, the USDA’s Food Safety and Inspection Service is enhancing our food safety testing program for ground beef. While FSIS has a range of safeguards to reduce E. coli in ground beef, this summer we will begin new testing to improve the safeguards against Salmonella as well. Salmonella is commonly found in ground beef and, in fact, caused an illness outbreak in January 2013 in six states. Salmonella is an especially difficult bacteria for food safety experts to address because it is so prevalent in almost all food sources.

Recognizing that we need more information about the prevalence of Salmonella in ground beef to better prevent foodborne illness, FSIS is “super-sizing” our pathogen testing program to include Salmonella every time our laboratories test for E. coli in samples of ground beef and ground beef sources. Because the samples taken for E. coli testing are much larger than those we have taken in the past for Salmonella, there is higher likelihood that we will be able to detect the bacteria if it is present.

Once FSIS has collected enough data about the prevalence of Salmonella in ground beef, we will create a new standard to encourage ground beef processors to strengthen their Salmonella controls, resulting in safer products and fewer foodborne illnesses. The data collection process will take some time, but it is critical that the new standard is supported by meaningful data. Of course, we will continue to analyze any positive samples for multi-drug resistance and specific serotypes to determine whether they are contributing to human illnesses.

Salmonella is the most urgent issue facing FSIS when it comes to protecting consumers and it is why we developed our Salmonella Action Plan. This plan details our strategy for reducing the number of Salmonella-related illnesses, and this enhancement to our sampling and testing programs is part of that comprehensive effort. Another part of our war on Salmonella is encouraging consumers to take steps to protect themselves from illnesses, including cooking all ground beef to 160 degrees F (poultry should be cooked to 165 degrees F). For more information on ways to keep your family Salmonella-free this summer, we invite you to check out FoodSafety.gov or AskKaren.gov before your next cookout.