Guidance Issued on Preventive Controls for Human Food

The Food and Drug Administration has issued a partial guidance report on preventive controls for human food — a key section of the Food Safety Modernization Act (FSMA).

Peanut ButterThe report is FDA’s “current thinking” on the requirement of food manufacturers to conduct a thorough hazard analysis, from which a comprehensive Food Safety Plan then must be prepared. Specifically, the guidance report issued involves actions manufacturers should take to implement risk-based preventive controls for human food (PCHF). The guidance is intended to help manufacturers comply with the following specific PCHF requirements in the new food safety law:

A written food safety plan (FSP);
Hazard analysis;
Preventive controls;
Corrective actions;
Verification; and
Associated records.

This guidance covers the first five chapters of what will be a total of 14 chapters covering all aspects of FSMA. The remaining chapters will be rolled out periodically.

The FDA issues guidance reports on a regular basis to enable interested parties to comment, suggest and request changes to regulations. The agency refers to this guidance as its “current thinking” on the subject, not its final regulations. To download the initial PCHF guidance, go the FDA’s website.


A Safer Food Supply?

Will the nation’s food supply be safer under FSMA?

The new Food Safety Modernization Act, or FSMA, which takes full effect in September, has a multitude of goals, but foremost of these is insuring that the nation’s food supply (human and animal) is safe – safer than it already is. Will the new law do that?

That was certainly the motivation for passage of FSMA in 2011. Congress recognized that the vast American food supply from farm to table was very safe, but also persistently vulnerable to microbiological contamination, accidents, and terrorist threats. FSMA addresses these dangers directly and indirectly. Here are three of the primary goals behind the new food safety regulations.

1. Responding to the new realities of a global food chain. America’s food supply throughout much of its history has been largely self-contained: American growers, ranchers and manufacturers accounted for the vast majority of food items available to consumers. But it was never 100% domestic: Coffee from Africa and Central America; winter produce from Mexico; Canadian wheat, spice from Southeast Asia. As the consumer palate has become more varied and reflective of diverse cultures, our food supply is incredibly global in scale. FSMA is intended to insure that all food items and ingredients coming from overseas are subject to stringent safety protocols.
foodmfg2. Placing more aggressive regulations on suppliers, not just manufacturers. If the world’s food supply were envisioned as an iceberg, the portion above the water line would represent manufacturers, processors, and retailers. The portion of the iceberg below water – by far the largest segment – would represent the thousands upon thousands of suppliers that play a pivotal but often overlooked role in food safety. It’s a supply chain that is both widespread and granular in scope: it includes makers of conveyor equipment, as well as suppliers of lubricants for that equipment.

3. Preventing food safety issues rather than relying upon government intervention only when there’s a problem, is at the very heart of FSMA, and one that should have the most immediate and beneficial impact on food safety over time. That’s because, for the first time, food manufacturers and processors, along with their supply chain partners, have clear direction in preventing food contamination by creating and maintaining a food safe environment up and down the supply line. One requirement alone – having in place a comprehensive food safety plan – is perhaps the single most significant of all of FSMA’s many regulations.
Of course, maintaining a 100 percent safe food supply is literally impossible. But as an aspirational goal, FSMA represents forward thinking on the part of the government and the food industry, both of which have an obvious, vested interest in producing and selling products that are as safe as they can possibly be.


Say No to Raw Dough

My wife and daughter occasionaly will snack on raw cookie dough before baking a batch of cookies. I’ve warned them several times not to do that, because raw flour can be contaminated with e.coli and salmonella bacteria (from raw eggs in the flour), both of which can make you very sick.  But my warnings have generally gone unheeded. I’m sure ours is not the only household with a cookie dough fetish.

Yet there is a larger point to be made about raw dough: it’s an issue that should focus more responsbility for food safety on consumers themselves.

cookie1Food safety is by and large the responsibility of manufacturers, processors and retailers. The new Food Safety Modernization Act (FSMA) places a legal responsibility for safe food on the industry.  Manufacturing plants must create and maintain a detailed food safety plan, as must their ingredient suppliers. The whole idea behind FSMA is to prevent food-borne illnesses and costly recalls, rather than wait for a contamination outbreak.

Not nearly as much discussed is the responsibility of food consumers to know the risks of certain items, like raw dough, in part because outbreaks have been infrequent. Food with raw dough carries warnings not to eat the product before baking, but more aggressive efforts to warn households to carefully read food labels and preparation directions have not been nearly as prominent as, for example, campaigns to persuade consumers to read nutrition labels.

Recently, 10 million pounds of a well-known flour brand was recalled due to safety concerns over the presence of an e.coli strain that is present in flour in its raw stage. No one has died, thankfully, but more than 40 consumers have reported illness and 11 people have been hospitalized with intestinal problems. (One reason for the recall was the practice of some pizza restuarants to let children eat raw dough while waiting for their pies). The recall was initiated out of an abundance of caution to, in effect, protect consumers from themselves. That’s a new concept in food safety recalls; seldom has the FDA pointed a warning finger at food consumers.

That may be changing in the years ahead as manufacturers and regulators gingerly try to get consumers to play their part in preventing food borne illnesses. Maybe a place to launch would be a public awareness campaign about raw dough. Here’s a suggestion for messaging: “Say No to Raw Dough!”



Ready for FSMA?

Full compliance with the Food Safety Modernization Act is only a few months away — mid-September, in fact. Is the food industry ready? If they haven’t already, here’s what food manufacturers need to do:

Hazard Analysis — the first compliance step required of all but the smallest food manufacturers is a thorough analysis of any potential food safety problems in production plants and shipping areas. Remember, under the new FMSA, the core idea underlying regulatory oversight is prevention of food safety problems. The obvious place to start is in the production facility. Included in the hazard review are “foreseeable hazards,” which are possible trouble spots for contamination that must be dealt with. Here’s a link to hazard analysis implementation.
Food Safety Plan — after the hazard analysis, this is the logical next step for manufacturers, but also the requirement that will take up the most time to implement properly. FSMA requires manufacturers to lay out a step-by-step risk-based preventive control plans that identifies real and possible food contamination weaknesses, and what will be done to mitigate or address the problems. Additionally, FSMA requires that the appropriate production line employees be given thorough food safety training, with regular review sessions. A plan’s food safety plan also must include a specific recall procedure in the event one is needed. This requirement is especially important because food contamination events can create serious, even deadly, public health emergencies. How well affected product can be tracked back to the source, and how quickly it can be removed from sale, is an essential component of the new food safety law.

food-processing-industry-image-4697FSMA also applies to suppliers in the long and complex food chain. As an example, food production lines convey thousands of pounds of raw food ingredients every day. The machines that control the manufacturing process need regular maintenance to keep them in good running order. Maintenance is performed by employees assigned to the task, and these workers use lubricants that are specifically formulated for food production. The lubricants must be “food grade;” that is, they cannot be potentially harmful to food being produced. FSMA requires that suppliers of these lubricants also perform a hazard analysis in their production facilities, and then create their own food safety and recall plans — just in case. (NOTE: one of my clients, CRC Industries, Inc., mankes a variety of food grade lubricants).

Management Oversight — Perhaps the most controversial requirement of FSMA is a strengthened emphasis, backed by the force of possible legal action, on top management oversight of food safety. While this feature has long been assumed by the Food and Drug Administration (FDA), the responsibility has been codified in the new food safety law. Top executives, including the CEO, can be held liable for food safety violations within their companies; using the so-called Park Doctrine, the FDA and the Department of Justice can mount civil and criminal actions against corporate executives whose companies become involved in a food safety crisis, even if the executives argue that they didn’t know about the safety problems and expected underlings to handle such matters.
The Food Safety Modernization Act is a watershed standard in food safety responsibility. The emphasis on prevention requires a higher level of vigilance for food manufacturers, their suppliers, as well as the companies that transport food products to warehouses and stores. It could reasonably be said that under FSMA, there can’t be enough food safety, which is a standard that could positively guide food production for years to come.


Food Labels and Needless Waste

A challenging, and so far unresolved, issue for the food industry is finding a package “use by” label that will prevent consumers from needlessly wasting food.

food-labelsResearch has shown that widespread misunderstanding of “use by” or “sell by” dates on packages and cans is resulting in millions of pounds of perfectly edible food being thrown away every year. A carton of milk, a package of frozen chicken, a bag salad all have sell or use by dates, but often, how that information is conveyed varies. The sell by date, for example, is really intended for grocery retailers to keep track of inventory rotation. It is not a use by date for consumers.

A solution — using “open code” dating — is generating a lot of attention, but faces an enormous hurdle: consumers may not understand current labeling information, but they are at least familiar with it.

The issue has been kicked around for decades, but a workable solution remains elusive. Here’s a summary of the problem and possible solutions from my business associate, Gale Prince, of SAGE Food Safety Consultants, LLC: