Small Businesses Catch a FSMA Compliance Break

The nation’s new food safety law took effect for a substantial chunk of the vast food industry in mid-September. But the Food and Drug Administration, rightly concerned that smaller sized manufacturers might not have the resources to comply with the complicated new regs, has given that segment a break by putting off compliance for another year, until August. 30, 2017. (There’s even another year added for really small businesses, those with less than a $1 million in annual sales, counting inventory).

In the meantime, and again due to the complicated nature of the law, the FDA has explained that in the first few months following enactment, it will emphasize education in the details of compliance, rather than enforcement of the regs. But manufacturers beware: the agency adds that “egregious” violations of the new standards will be dealt with severely, including the possibility of a mandated recall. That threat alone ought to spur compliance; a major Class I recall can cost a brand millions of dollars in returned or destroyed product, plus incaluable damage to the copany’s reputation.

For additional information, here’s a link to a blog by CRC Industries, Inc., (a food industry supplier of machine lubricants).  The site that has become a “must visit” source for businesses of all sizes in the food manufacturing industry:

FSMA Ushers In New Era of Shared Food Safety Responsibility

The new Food Safety Modernization Act of 2011 is finally here.

As of this weekend, large scale food manufacturing operations in the U.S. and abroad must be in compliance with the sweeping new law, known by its acronym FSMA. This follows five years of regulation writing and review by the Food and Drug Administration, many revisions, deletions and additions, and enough controversies to last a lifetime.

The slow process from enactment to implementation is hardly surprising in view of the scope of the new law and the huge, sprawling industry it oversees. According to the Department of Labor’s Bureau of Labor Statistics, food manufacturing in the U.S. alone consists of 32,200 processing plants and employs 1.5 million people, not even counting agricultural workers, grocery store employees or restaurants!

Following is an overview of the new law and what it means for the food industry, and food safety.


FSMA covers human and animal food production from harvest through distribution. Foods imported from overseas are now covered, as well. However, meat, poultry and seafood products are excluded because they are regulated by separate agencies within the Department of Agriculture (FDA’s parent agency). Also excluded are supermarkets and restaurants, which are regulated by state and local statutes.

frozen-veg-aw-620x0The new law’s focus is squarely on manufacturing and that sector’s vast supplier network. The rationale for this focus is that most food safety outbreaks are the result of breakdowns in the production and distribution of products. Despite the universal belief that America’s food supply is the safest in the world, each year around 48 million Americans become sick due to a foodborne illness. Some 3,000 die as a result, according to the Centers for Disease Control and Prevention.

Under old food safety regulations, first enacted in 1937, the FDA exerted a largely passive role, reacting to food illness outbreaks after the fact, and working with the industry to encourage voluntary recalls when needed.

With FSMA, that approach is changing dramatically.


The basic concept underlying the new food safety law is proactive prevention. Under FSMA, regulated companies must undertake a series of internal measures to meet compliance standards and avoid contaminations. Responsibility for food safety falls more than ever on the shoulders of the firms that make and distribute our food.

The key provisions are as follows (directly from FDA’s website):

  • Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Final rule issued: Sept. 10, 2015.
  • Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Final rule issued: Sept. 10, 2015.
  • Produce Safety: Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Final rule issued: Nov. 13, 2015.
  • Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. Final rule issued: Nov. 13, 2015.
  • Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Final rule issued: Nov. 13, 2015.
  • Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Final rule issued: Apr. 5, 2016.
  • Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. Final rule deadline was May 31, 2016.

These provisions, however, don’t offer a full reckoning of what’s required to insure business compliance. For example, putting in place preventive controls for human (or animal) food will require manufacturers to have conducted a thorough hazard analysis of their facilities to identify trouble spots (hard-to-clean equipment, leaky roofs, etc.), from which a plant specific Food Safety Plan must be created. That plan requires a training requirement for the relevant employees in each facility. Moreover, the plans must be reviewed and updated every 2-3 years, and they also are subject to 24-hour notice by FDA inspectors.

During FSMA’s rollout, much concern was expressed about the ability of companies to meet these requirements, especially smaller-sized suppliers with limited budgets. There are different deadlines for these smaller businesses, but by September 2017, all manufacturing in the U.S. must be in FSMA compliance.


No company likes being subject to a food recall. They are costly, they cause tremendous internal upheaval, and they can sabotage a company’s brands and overall reputation.

To encourage compliance, FSMA takes the threat of recalls a step further by holding company executives directly responsible for food safety breakdowns. Under the so-called Park Doctrine, the Department of Justice is able to extend civil and criminal liabilities to executives who fail to actively manage food safety practices in their organization. As SAGE Food Safety Consultants reported in April, the significance of the Park Doctrine can not be understated. The doctrine means that businesses that food products for humans and animals now have an affirmative duty to ensure the safety of their products.

However, given the scope of the new requirements, the FDA’s initial post-compliance strategy is to emphasize industry education over regulatory enforcement. This is a stance SAGE Food Safety Consultants supports. Experience tells us that no matter how long the lead time, many organizations procrastinate or operate in a state of virtual denial that they will be subject to the new laws. Additionally, FSMA’s requirements are very complicated, and in places, contradictory. That’s why FDA in August began issuing “guidance” documents for manufacturers on various parts of the new law, beginning with what’s expected in the area of preventive controls. Other guidance reports will be issued periodically to assist companies in understanding their regulatory obligations. A few weeks ago, additionally,

Does this mean that there’s a grace period for the industry to attain compliance? No. The FDA has made it clear that it will take enforcement action against egregious food safety violations under existing regulatory law.


FDA’s budget for carrying out these myriad duties is still under discussion. According to latest figures, Congress has recommended an increase of $103 million in funding for the FDA (including user fee revenue) for Fiscal Year 2017, of which some $40.2 million has been set aside for increased food safety regulation. By Washington standards, that’s a paltry amount and hardly adequate for the FDA to implement industry oversight.

As an acknowledgement of limited budgets, the FDA has built into FSMA provisions that envision a larger regulatory role for state health departments and third-dairyinspector.ashxparty inspection services. FSMA also imposes new user fees for such things as re-inspection of facilities following non-compliance findings, and for a voluntary qualified importer program.

It also has created an “enhanced partnership” program under FSMA to build capacity for food safety compliance. According to the National Council of State Legislatures (NCSL), these are some of the most important collaborations FSMA envisions:

  • State and local capacity building: FSMA directs the FDA to implement strategies that bolster food safety and food defense capabilities of state and local food and health agencies;
  • Foreign capacity building: FDA must create and implement plans to to address food safety training of foreign governments, as well as technical and scientific initiatives to enhance bilateral cooperation for exporters, such as electronic data sharing, and the sharing of the latest laboratory techniques;
  • Reliance on inspections by other agencies: FDA is explicitly authorized to rely on inspections of other Federal, state and local agencies to meet its increased inspection mandate for domestic facilities. FDA also is encouraged to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.


 Given the current number of food recalls, foodborne illnesses, and the changing dynamics of the food supply, it goes without saying that decades-old food safety regulations needed updating. With FSMA, prevention has taken center stage and, along with it, heightened responsibility placed on business to treat preventive food safety programs as a top management priority.

The FDA still seeks (and prefers) voluntary cooperation on the part of the food industry, but it is backing that position with a tough new standard that makes food safety vigilance mandatory. FSMA provides the agency with new enforcement tools such as mandatory recall authority and the ability to withdraw facility registration so a firm would not be able to receive, process or ship food products. While the FDA will encourage compliance through education, it will also, under the Park Doctrine, hold food company executives personally responsible for preventable safety breakdowns.

It is all but certain that food recalls will continue to plague the industry going forward. Even so, FSMA is important if for no other reason than that embedded in the law is an essential food safety goals: bringing business and government into close alignment on the basic premise that food safety  is now an over-arching industry — shared — responsibility.









FDA Issues FSMA Guidance on Preventive Controls for Human Food

The Food and Drug Administration today (August 23) issued a partial guidance report on a key section of the Food Safety Modernization Act (FSMA): the agency’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 today involves 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;
  • Monitoring;
  • 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 others 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?

Government regulation of business is always a hot button issue during national election years. But so far in 2016, not much is being said or reported about the Food Safety Modernization Act (FSMA) which will be all but fully implemented in mid-September.

The new law has a multitude of complementary purposes, but of these, the most revolutionary is a new government mindset: intstead of dealing with food contaminations only after they happen, the better approach is to require manufacturers and their suppliers to put in place preventive controls to isolate and fix food safety problems on a daily basis.

Here’s a link to a blog on the subject.

A Consumer Role in Food Safety?

SAGE has posted many articles on the rollout of the new Food Safety Modernization Act (FSMA) and the new law’s unmistakable focus on holding the food industry responsible for preventing costly recalls that endanger the public.

But what about the public — food consumers? Do they have a role to play in assuring a safe food supply?

The answer depends upon what you mean by responsibility. Obviously, no one is going to bring charges against a housewife who undercooks chicken, or a teenager who loves to snack on raw cookie dough. These are mistakes, not criminal actions, although they can endanger health — the housewife’s family or the teenager.

Still, a recent decision by a prominent food manufacturer to recall 10 million pounds of raw flour presents a rare case of the industry saving consumers from themselves by withdrawing from sale an item that if ingested prior to heating, baking or frying can create serious intestinal problems. The recall was prompted by reports that people were eating raw flour, the company said.

Here’s a link to a blog by SAGE consultant Paul Bernish that explores this issue in more detail.

Is the Food Industry Ready for FSMA?

With just a few months until full compliance with the Food Safety Modernization Act (FSMA) takes effect, the vast and complex food industry confronts a difficult management challenge: how to gear up for a raft of new regulations, standards and best industry practices while also maintaining production and avoiding food contamination outbreaks.

The Food & Drug Administration, the agency that will enforce FSMA, has spent the past five years drawing up page after page of detailed regulations covering all aspects of food manufacturing, shipping and distribution. The overall purpose of the new law is to prevent costly food recalls by enforcing strong food safety protocols in the plant, loading dock and distribution center.

Here’s a checklist for food manufacturers:



The Challenge of Date Labeling

One of the food industry’s most vexing challenges is creating a food package date label that everyone understands.

The problem, and potential solutions, are well-documented; here’s a report from 2014 that I co-authored that spells out the issue in detail. In fact, a comprehensive (albet voluntary) model open dating regulation created by the National Conference of Weights & Measures has been available for some 40 years. But adoption of the model law has been slow and spotty and as yet, there is no national labeling law other than one for infant formula.

Food LabelClearly, a universally acceptable date label remains a frustratingly elusive goal, and no wonder. The manufacturer and retailer need a package code that would help them trace a product involved in a food safety recall. The retailer also needs a date code (“Sell By”) to insure proper inventory circulation. Consumers need something different altogether: a date that tells them if the items in their freezer or pantry shelf are still good — and safe — to eat. Balancing these complementary needs has been a difficult condundrum that, among other negative impacts, has resulted in the wasteful loss of tons of perfectly edible and safe food each year — food discarded at the manufacturing plant, the grocery store, the restaurant and cafeteria, and the home kitchen.

Now, efforts are underway once again to tackle the problem. Those efforts appear to coalesce around a handful of potentially realizable goals:

  • A uniform, national regulation requiring all packages sold to consumers to include an open (i.e., “Best if Used By) date;
  • A national regulation requiring packagers to imprint a coded label that shows the date of manufacture and the lot number for use in the event of a recall;
  • A concerted customer-directed public service program to inform the general public what, precisely, “Best if Used By” means. Such a program would include media public service advertising, social media and, perhaps, tags on products that require strict handling and storage methods to avoid contamination;

For these goals to be reached, Congress will need to understand the benefit of uniform open dating. Manufacturers will need to upgrade their packaging and labels to accomplish product uniformity, and end-users (you and me, and our friends and neighbors) will need to be informed about the critical relationship of open dating labels and proper product handling and storage.



Tracking Food Contamination Outbreaks

There is dramatic evidence for consumers that food safety measures are increasingly sophisticated, which is a good thing.

With little public attention, several recent and related recalls of a variety of food items suspected of being contaminated with Listeria have been carried out regionally and nationally since March. That’s the bad news. The good news is that science was put to use to link the tainted products to a single food producer, CRF Frozen Foods, Inc. in Pasco, WA. This was accomplished in large part because state and federal regulators were able to connect reports on eight Listeria-infected people from California, Maryland, and Washington to vegetable products produced by CRF Frozen Foods using both epidemiological and laboratory evidence.

frozen-veg-aw-620x0The evidence began accumulating when, as part of a routine product sampling program, the Ohio Department of Agriculture collected packages of frozen vegetable products from a retail location and isolated Listeria monocytogenes from True Goodness by Meijer brand frozen organic white sweet cut corn and frozen organic petite green peas. Both products were produced by CRF Frozen Foods.

Based upon the positive findings in Ohio, CRF recalled 11 frozen vegetable products on April 22, because they were suspected of Listeria contamination. Further testing using genome sequencing to isolate Listeria in the frozen product clinched the case. The isolate was closely related genetically to bacterial isolates in the stool of people who had been ill after eating the contaminated product. On May 2, 2016, following a conversation with the Food and Drug Administration and the CDC, CRF Frozen Foods expanded its recall to include all of its frozen organic and traditional fruit and vegetable products manufactured or processed in CRF Frozen Foods’ Pasco facility since May 1, 2014. It also initiated a series of secondary food recalls from companies supplied by CRF, including Meijer, Kroger and ConAgra Foods. Approximately 358 consumer products sold under 42 separate brands were recalled.

Sophisticated Sleuthing

The importance of this laboratory sleuthing cannot be under-estimated. Until recently, state and federal regulators and health officials had a difficult time linking food illness outbreaks. They could do it, but it took weeks and sometimes months to determine whether contaminations originated with one supplier or brand. Advances in microbiology and genome sequencing give regulators highly effective tools to establish that contaminated products that infected people in scattered locations came from one source.

There’s another reason this series of related recalls is important. It demonstrates beyond question that the nation’s food supply chain is not only inextricably linked, but also — and because of those links — highly vulnerable to widespread outbreaks of food-borne illness. CRF Frozen Foods supplies not just retailers, but also national brand producers and downstream wholesalers.

Chasing down all these potential leads takes time, effort and staff resources that regulators simply don’t have. But with the advent of new scientific methodology, we are likely to see more quick action to prevent large-scale food illness outbreaks by getting suspect products off the shelves and out of homes as quickly as possible. Doing that — moving swiftly to control outbreaks — is very definitely a good thing.

Washing Your Your Hands is Serious Business

It’s a mantra repeated often, every day, in the food industry: wash your hands. Retail store clerks putting out perishables, or production line workers processing chicken, beef or pork are repeatedly reminded to wash their hands to prevent the spread of harmful microbes that could make them sick and containinate food supplies.

Up to now, however, hand washing was viewed mostly as a voluntary action, and reports surfaced that it wasn’t nearly as prevalent as it needed to be to insure a safe food supply. Now, under the Food Safety Modernization Act (FSMA), hand washing gains a new prominence as a required part of every processing plant’s food safety plan (which we’ve written about previously).

At the same time, in a happy coincidence, the World Health Organization (WHO) put on its scold face to tell global inhabitants (you, me and everybody else) that we needed to not just wash our hands frequently but also thoroughly.

Here’s a link to the website of my colleague, Paul Bernish, where you can watch a brief WHO video that shows you how to wash, and recommends that each session at the sink take at least a minute of your time.

Maybe what the hand washing campaign needs is something like the famous “Got Milk” ad effort, or a Smokey the Bear-type public service campaign. The point, of course, is that proper hand washing is  basic action anyone, even kids, can undertake, with the only cost being soap. Given our increasing knowledge about destructive microbes such as E. coli, listeria and salmonella, our future as a civilization may well depend upon turning hand washing into a habit on a global scale.

Training for FSMA: Who Does It and How?

One of the major, but often overlooked, challenges when sweeping new legislation is enacted involves training the people — managers, production supervisors and shift workers — who will be required to implement and execute the regulations.

Fortunately, the Food and Drug Administration (FDA) took several steps in anticipation of that challenge, as outlined in this blog: