Food Safety Counsel : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

There has been a lot written in recent months about the perceived complexities of the Food Safety Modernization Act (FSMA).

The new requirements are broad and onerous, stakeholders complain. The proposed rules will be burdensome and costly, experts predict. And FDA enforcement will be varied and inconsistent, others warn. And, yes, even I have been at least partially guilty (I will reluctantly admit) of adding my own voice to the growing chorus detailing all the unfavorable features of FSMA.

But, as I continued to think about the problem, I quickly began to realize that none of this commentary is overly helpful for the business owner simply trying to achieve compliance. Most companies don’t really care about listening to experts pontificate endlessly (which has been going on months and, in some instances, years). Instead, most companies just want to be told what they need to do. So, with that in mind, I thought it would be helpful if we started with a blank canvas, and approached FSMA from a different angle. FSMA for Dummies – or, compliance made simple.
To start out, let’s be clear, the general principles underlying FSMA are really quite easy to grasp. In its most basic form, FSMA requires companies to make safe food.

Second, food companies shouldn’t be misled about the difficulty of compliance. How a company goes about making safe food is, well, with just a few exceptions, left up to the company itself.
So far, so good? I hope so. It’s not very difficult.

Next, to actually demonstrate to the FDA that a company has achieved compliance, a food company needs only to understand what the FDA inspectors will expect to see when they show up at the company’s door. Here too, the answer is very simple. Generally speaking, if you process food products using ingredients sourced from suppliers in the US, there will be just a handful of basic requirements.

Indeed, if you are a food company, and if you source your ingredients domestically, you will only be required to show: (1) that you have a written food safety plan; (2) that you have records to prove that you are following your written food safety plan; and (3) that you have a traceability system in place (or, stated differently, that you have records to demonstrate where your ingredients came from, the products in which your ingredients were used, and the customers to whom your resulting finished products were sold). In turn, the key to actually demonstrating compliance to the FDA (when the FDA visits your facility to perform its first FSMA inspection), is to craft your FSMA materials so that they are aligned as closely as possible with what the FDA will “expect” to see. Finally, if you process foods using ingredients sourced from overseas, you will also need to have a folder in your file cabinet (or on your computer) called “foreign supplier verification program.” More on that later. 

As noted, the real cornerstone of FSMA is the development of a written food safety plan. To create your written plan, you will need to conduct a food safety assessment within your facility, identify those food safety hazards that are reasonably likely to occur within your products, and then develop and implement controls (i.e., critical control points) designed to manage those hazards.

It is important to note that the controls you identify will need to be proven effective (i.e., validation), and you will need to create and maintain monitoring records that will prove that your controls are working as intended (i.e., verification). You will also need to develop prerequisite programs designed to ensure that you are following good manufacturing practices, that your employees are following hygienic practices, and that your facility remains clean. Although you can actually write the first draft of your plan, it will ultimately need to be approved by a “qualified individual.” We, of course, can help you there.

To establish compliance under FSMA, companies will also need to adopt a robust traceability system. From a food safety standpoint, it will be very important in the eyes of FDA that all companies be able to identify the source of their incoming ingredients, the specific products in which those ingredients were used, and the companies to whom the resulting finished products were sent. This way, if there is a downstream problem associated with a product, the FDA can immediately trace the product back upstream, and then quickly identify, contain and then solve any potential problems.

So long as your program enables you to accurately and quickly accomplish these goals, the FDA will likely characterize your program as compliant.

Next, as noted above, if you do decide to source any food ingredients from foreign suppliers, you will also need to ensure that those suppliers are complying with each of the FSMA requirements as well. You can demonstrate compliance under FSMA by having a copy of your supplier’s written food safety plan (developed by a qualified individual) in your file. I would also recommend having your foreign suppliers audited annually, and to perform some type of microbiological testing to verify the effectiveness of their programs and the quality of the products they are shipping. Oh, and remember, both your plan and your supplier’s plan will need to be reassessed any time there is a change in any manufacturing process, or at least once annually, whichever comes first.

Finally, although this column attempts to capture the “essence” of what FSMA requires, I would not be doing my job as a lawyer if I didn’t at least offer the following disclaimer: there are at least a few finer rules contained within FSMA not specifically addressed in this column and, regardless of where they are hidden, all of the rules are and will be changing routinely. Thus, as you work to develop your plan, it will be critical to read the Act and ensure you understand each of the federal requirements and the FDA’s corresponding expectations. But, we, of course, can help with that too. 

So, as you march forward toward compliance, rest assured, it really can be quite simple. Put simply: Yes, you CAN develop a written food safety plan and chew gum at the same time … just don’t do it on the production floor.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

When it comes to the production of food, it is the things industry can’t see which industry fears most.

Lurking somewhere in the darkest corner of a hot box, in the silent throes of a sales cooler, or in a case-ready package being staged for delivery, there are a few colonies of pathogenic bacteria waiting patiently for their chance to wreak havoc in our business and lives.

For more than a decade, our firm has worked closely helping the meat industry with crisis management, regulatory response and complex litigation following large-scale outbreaks and recalls. The unfortunate reality from a business perspective is that, in a disturbing number of instances, when outbreaks and recalls occur, the companies that are involved cease to exist.

Watching innumerable outbreaks unfold over the years, our firm has gained a deep understanding about the science of food safety, the epidemiology of foodborne illness outbreaks and the legal consequences of food product recalls. We have also gained far-reaching experience analyzing why recalls occur in the first instance, and how they, in many instances, could have been avoided.

While all companies want their customers to believe that their products are as safe as possible, and try to communicate this fundamental message through their brand, in today’s world success requires more than just a good advertising campaign. In order so sell food safely, a company needs to demonstrate it can process a safe product. In order to process a safe product, the company needs to invest in making it a reality. Food safety, unfortunately, doesn’t just “happen” by itself.

Thus, when working to protect the interests of my own clients, I usually start with a Brand Protection Audit. Usually, I can accomplish what I need in just a single day. I like to interview employees to learn more about the company’s real food safety culture, and review food safety training materials to suggest improvements. I also like to assess a company’s written food safety plans, and look for hidden gaps that create additional exposure. Moreover, many companies are surprised to find out that their policies are not actually being executed as written.

In addition, companies can easily developing stronger and more effective supplier specifications, and indemnity agreements, that provide added protection, as well as ensuring that existing insurance coverage is sufficient to cover potential liabilities. We also work closely with companies to develop and then conduct mock recall training, in as close to a real-world scenario as possible, to test their ability to trace and also contain a potential problem.

Finally, we provide advice to our clients on to best respond to government-issued NRs (so as to avoid criticisms months or years later from a judge or jury), and also prepare for and respond to both routine and for cause Food Safety Assessments. Many companies simply do not realize that what they say today can (and always will) be used against them tomorrow.

With that said, merely creating the “image” that you care about food safety is no longer enough. History has taught us that by taking a few additional proactive steps right now, such as auditing the true depth and survivability of your brand (i.e., the Brand Protection Audit), companies can significantly and strengthen the trust in, and longevity of, their most important assets – their image and their brand.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The Federal Food and Drug Administration (“FDA”)  has now published its long-anticipated proposed rules on Preventive Controls for Human Food (written food safety plans) and Standards for Produce Safety. 

According to the FDA, the two rules “are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (“FSMA”).” 

The agency also claims that the new proposed rules “build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.”   

FDA also expects to soon issue its proposed rule on importer foreign supplier verification.  In the words of the agency, future proposed rules will address preventive controls for animal food, and also accreditation standards for third-party auditors.

In the paragraphs that follow, we take a few moments to break down the new rules into their most basic form.

Written Food Safety Plans (“HACCP”)

The most anticipated element of FSMA has been the requirement that all FDA regulated food companies develop and implement written food safety (or, HACCP) plans.  The proposed rule on preventive controls for human food (i.e., requiring written food safety pans) would apply to all facilities that manufacture, process, pack or hold human food. In general, with only some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations.  With that said, it will be critical to consult with legal counsel regarding the applicability of the new rules, as certain exemptions and modified requirements have been established for some discreet segments of the industry.

In its most basic form, the new FDA rule requires that firms develop and implement written food safety plans to identify potential food safety hazards, put into place steps to address those hazards, verify that the steps are working, and outline how to correct any problems that arise.  Under the new requirements, the written food safety plans should, at a minimum, include the following:

1. a hazard analysis;
2. risk based preventive controls;
3. monitoring procedures;
4. corrective actions;
5.  verification procedures; and
6. record keeping.

In addition to creating plans that will pass the scrutiny of FDA, food companies will also need to demonstrate that these plans have been designed by a “qualified individual.”  In this regard, please contact us for additional information on this requirement, as well as each of the discrete additional regulatory requirements food companies will need to satisfy in order to demonstrate full compliance with FDA.  Click here to view a copy of the Proposed Preventative Controls Rule.

Future proposed rules will address importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.

New Produce Compliance Rules

In addition to publishing its proposed rules governing written food safety plans, FDA has also unveiled new rules governing produce production.  The new FDA proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing designed and validated to eliminate or reduce known pathogens.  The proposed rule focuses on various known areas of risk, and promulgates standards for the following:

1. agricultural water;
2. biological soil amendments;
3. health and hygiene;
4. domesticated and wild animals; and
5. equipment, tools and buildings.

The proposed produce rule is, according to the agency, the result of extensive outreach by FDA with consumers, government, industry, researchers, and many others.   FDA has also stated that the produce rule is aimed at being flexible for different-sized farms, at complementing conservation laws and rules, and at not conflicting with laws and rules for organic farming.

With that said, it is important to note that certain farms would be exempt from most of the requirements if their sales average less than $500,000 per year during the last three years (adjusted for inflation), and if their sales to qualified end-users exceed their sales to others during the same period.  Moreover, according to the rule, any farms whose average annual value of food sold during the previous three-year period is $25,000 or less would not be covered by the rule.  Such farms would still be responsible for the safety of their produce, however, and the FDA maintains that the exceptions can be revoked under certain circumstances.  In addition, states and foreign countries will be permitted to seek variances from provisions of the rule because of local growing conditions.

Although the rule is still in its draft form, the general compliance date is currently anticipated to be two years after the effective date of the rule . For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date. Additional time would be allowed for compliance with certain water requirements.  Click here to view a copy of the Proposed Produce Rule.

Although FDA intends to publish various guidance materials to help industry meet the new requirements, the success of your business will ultimately depend upon your ability from a legal standpoint to demonstrate to FDA that you have achieved full compliance.  In this regard, please feel free to contact our firm for additional insight and information regarding the new proposed rules, and how to best (and most efficiently and quickly) satisfy the new requirements.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The FDA's Reportable Food Registry (“RFR”) first went into effect in September 2009. Since then, we have been watching closely the application and enforcement of the RFR.

At its core, the RFR is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Since its launch in September 2009, we've been watching closely the application and enforcement of the FDA's Reportable Food Registry (“RFR”).

According to the FDA, the purpose of the RFR is to provide a “reliable mechanism to track patterns of adulteration,” and “to target the agency's limited inspection resources where they're needed most.”

The RFR, at its core, is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).  They're a good read.

Ultimately, sharing helpful perspective and feedback with FDA today could help mitigate downrange confusion and, perhaps, even save your company from appearing in the RFR in the future.

• Email This
• Print
• Comments
• Trackbacks
• Share Link