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Food Safety Archive

FDA’s Voluntary Qualified Importer Program

November 10, 2016

imgres-2The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the Food and Drug Administration (FDA or the Agency) to better protect public health by helping to ensure the safety and security of the food supply.

This guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals. This document provides guidance on:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

Important reading for anyone in the food industry.

Lab Grown Meat

August 3, 2016

MeatWe will probably be eating lab-grown meat one day soon. So long as it can withstand a few hours in the smoker, we approve. But at the risk of spoiling a good thing with legality, what are we going to call it? FDA and USDA regulate the words we use for various foods, and there are established definitions for meat and poultry. 9 C.F.R. 381.1 defines poultry as “any domesticated bird”, and a “poultry product” as anything derived from a poultry carcass. Red meat is “the part of the muscle of any cattle, sheep, swine, or goats which is skeletal”.

What are your thoughts on how we shall define lab-grown meat?

June 24, 2016

16WHOLEFOODS-master768When a food business signs a supplier agreement with Whole Foods, the supplier agrees to indemnify Whole Foods for any harm caused by its products. This is typical of how food businesses protect themselves from liability for things like a food safety crisis. Whole Foods latest food safety mishapis different. Its recent Warning Letter did not stem from suppliers’ products. Whole Foods processed its own products under unsanitary conditions – there is no supplier to assume the liability.

Lessons Learned From Massive Recalls Due To Peanut-Tainted Cumin

February 20, 2015

by Lauren Handel

FDA recently issued a consumer advisory warning people who are highly allergic to peanuts to avoid products containing ground cumin because peanut protein has been detected in some cumin shipments. Since last December, I have noticed many recalls due to undeclared peanuts in products containing cumin, and I have been wondering what’s going on. How could so many companies be affected by peanut protein in cumin? I have been surprised that, until now, FDA has been silent about the issue, and it has not attracted media attention. Thankfully, Allergic Living magazine has investigated and found some answers, although many questions remain.

cuminAccording to Allergic Living’s investigation, there have been two waves of recalls, which have been traced back to two Turkish suppliers of cumin — although the peanut contamination may have originated farther back in the supply chain and the cause of the contamination is unknown. Allergic Living’s investigation found that the largest set of recalls began in December 2014 when it was discovered that an American company, which had been supplied by one of the Turkish companies, sold a peanut-tainted batch of cumin powder to at least 38 other companies. Those 38 companies, in turn, have supplied cumin products to other companies, further expanding the recalls. According to Allergic Living, 580,000 pounds of beef, pork and chicken have been recalled to date. Whole Foods alone has recalled more than 100 products. Allergic Living has a list of the recalls, which is broader than the one included in FDA’s consumer advisory.

This wave of recalls demonstrates how a problem triggered by one ingredient supplier can cause a ripple effect throughout the supply chain. It also reinforces the importance of supplier verification. Few, if any, food companies have control over the production of every ingredient or raw material they use. Rather, manufacturers must rely on their suppliers to provide unadulterated, accurately labeled products that meet the manufacturer’s required specifications. Supplier verification ensures that such reliance is well placed. It should include review of a supplier’s food safety and production practices, periodic audits, and product testing and/or certificates of analysis.

The growing number of cumin-related recalls also shows that companies down the supply chain are likely to bear the costs of a supplier’s problem. Recalls can be very expensive and devastating for smaller companies that can’t afford recall insurance. Recalls also can harm a company’s reputation and cause it to lose customers and, therefore, revenues. This is why companies should have contracts with their ingredient suppliers requiring the supplier to indemnify the buyer for its costs and losses in the event that the supplier’s problem causes a recall. Such contracts also should explain what each party’s roles and responsibilities will be in the event of a recall.

We will continue to follow the news on the cumin-related recalls.

Listeria outbreak linked to apples serves as reminder of the liabilities food businesses can face

January 12, 2015

by Lauren Handel

The recent outbreak of Listeria monocytogenes linked to commercially-produced caramel apples, has been traced to the apple distributor, Bidart Brothers of Bakersfield, California. As of January 9, 2015, the outbreak has caused 32 people to become infected in 11 states and contributed to three deaths. Bidart Brothers and three manufacturers of caramel-covered apples have issued recalls.

imgres-3Events like this remind us that food — even a product as seemingly innocuous as an apple — can be dangerous. For that reason, it is critically important that growers, manufacturers and other sellers of food products employ rigorous food safety practices to try to prevent hazards and plan ahead to be able to effectively recall products in the event that something goes wrong.

It is also important to understand that, no matter how careful a food manufacturer or supplier may be, it can be held strictly liable for all damages caused by contaminated food. Strict product liability means liability without regard to fault. In other words, an injured party may recover without having to prove negligence or intentional wrongdoing. The only way for a business to protect itself from such liability is to have insurance and contracts that appropriately put the responsibility for losses on the party that caused the harm. Food manufacturers and sellers, therefore, should make sure that their business liability insurance includes adequate product liability coverage and that their agreements with suppliers and customers include enforceable indemnification and insurance provisions.

FDA Changes Produce Safety Regulations to Exempt More Small Farms

November 19, 2014

by Lauren Handel

In late September 2014, FDA issued revised versions of its proposed produce safety regulations under the Food Safety Modernization Act (FSMA). Of particular relevance to farms with small produce operations, the revisions significantly change which farms would be covered by or exempted from the rules.

As initially proposed, the Produce Safety Rule would have exempted any farm with total food sales of not more than $25,000 on average, per year during the previous three years. Thus, a farm with very small fruit and vegetable sales of $25,000 or less annually would not have qualified for the exemption if its combined annual sales of produce and all other foods (such as grains, dairy, meat or processed foods) exceeded $25,000. In response to criticisms that the rule would have served as a disincentive for diversification of farming operations, FDA has revised the exemption criteria so that only produce sales are counted toward the $25,000 limit.

Similarly, FDA has proposed to count only produce sales, rather than sales of all food, in determining whether a farm is a “small business” (defined as having average annual produce sales not exceeding $500,000) or “very small business” (defined as having average annual produce sales not exceeding $250,000). Under FDA’s proposal, small businesses and very small businesses will have three years and four years, respectively, to comply with the final Produce Safety Rule after it takes effect, whereas all other covered farms will have only two years to comply.

While these revisions make good sense, they do not go as far as some commenters had hoped in that all produce sales, and not just sales of “covered produce,” will be counted in the dollar limits. A covered farm is subject to the Produce Safety Rule’s requirements only with respect to its “covered produce” operations. Covered produce is, generally, fruits and vegetables that are likely to be consumed raw and that will not undergo a kill-step in processing. Thus, for example, a farm that sells less than $25,000 per year of leafy greens and tomatoes (covered produce) will have to comply with the Produce Safety Rule with respect to the greens and tomatoes if it also sells enough potatoes (not covered produce) to bring its total annual produce sales above $25,000.

FDA’s revisions also do not satisfy critics who argued that the eligibility criteria for the qualified exemption (known to many as the Tester-Hagan Amendment) should, likewise, be based on sales of produce or covered produce, rather than sales of all food. Under the Tester-Hagan Amendment, a farm is eligible for a conditional exemption from most requirements of the Produce Safety Rule if its total food sales are less than $500,000 on average, per year, and more than half of its food sales are directly to consumers and/or to restaurants or food retailers located in the same state or not more than 275 miles from the farm. While it would be logical to base eligibility for this qualified exemption on produce sales, rather than sales of all food, FDA cannot make that change unless Congress amends the FSMA statute.

FDA’s revisions also make significant changes to the Produce Safety Rule’s requirements for water quality testing, the use of raw manure soil amendments, and the process for withdrawing and reinstating a farm’s qualified exemption. As these rules will have an enormous impact on covered farms, it is critical that farmers understand what the regulations will require and participate in the rulemaking process. I encourage farmers to read the proposed Produce Safety Rule, as well as the revisions. Interested parties may submit comments on the revisions to FDA by December 15, 2014.

Raw Milk Liabilities and Independent Certification

August 15, 2014

by Jack Hornickel

NPR recently highlighted a new tool for raw milk producers: third-party quality control standards and independent certification. The Raw Milk Institute (RAWMI), a non-profit that supports a strong and safe raw milk industry, has published safety criteria for raw milk producers. If farmers meet RAWMI’s Common Standards and draft an adequate Risk Analysis and Management Plan, they can be listed on the RAWMI website as exemplar producers of “reliable, clean raw milk.” Doctors, veterinarians, epidemiologists, farmers, and consumers all participated in developing the safety measures.

The Common Standards include water and milk testing that probes for the presence of coliforms, salmonella, listeria, and E. coli. They also require testing the dairy herd to ensure the animals are free of tuberculosis and brucellosis. The Risk Analysis and Management Plans are developed uniquely for each farm. Generally they must address contamination risks that occur during animal transportation, cleaning of milk containers, management of bedding and manure, feed storage, and contact with farm employees. The Plan mandates responsible reflection on the entire dairy process and seeks to identify all points where contamination can occur, thereby mitigating risk.

By mitigating the risk that a consumer may become ill, RAWMI’s standards should also minimize exposure to civil lawsuits. However, compliance with such voluntary standards will not immunize a raw milk producer from civil liability or from criminal liability where raw milk sales are illegal. Because raw milk laws are different in each state, the independent certification offered by RAWMI will have varying effects depending on the location of the farm.

In New York, for example, dairies can sell raw milk from the farm after receiving a license. The standards for obtaining a license are similar to the RAWMI Common Standards but require additional testing for staphylococcus and organisms that cause mastitis in dairy cows. New York also requires farmers to post a sign reading, “Raw milk does not provide the protection of pasteurization.” Thus, raw milk producers that are independently certified by RAWMI are well on their way to being licensed by the state. By taking a few extra steps, farmers would be shielded from criminal liability.

New Jersey is another story. In that state, all sale of raw milk for human consumption is illegal. The RAWMI certification will do nothing to protect a New Jersey producer from criminal prosecution. In fact, listing on the RAWMI website is likely to draw attention to the illegal enterprise, and the paper trail of bacterial testing and food safety plans is evidence that can be used in a prosecution. Here, independent certification would raise the chances of criminal liability, despite the farmer’s honest attempt to provide safer food.

Now for the final twist: RAWMI’s standards will have only a minimal effect on farmers’ civil liability. In every state, raw dairies face strict liability in civil lawsuits for harms caused by the food products they sell. If anybody becomes sick from consuming a raw milk product, the producer can be held liable for the consumer’s injuries, even if the producer followed the highest safety standards. Raw dairies, like all food producers, have an absolute duty to make a safe product. The only effects RAWMI’s certification could have in a civil lawsuit might be to insulate the farmer from a negligence claim, an alternate theory on which a consumer could sue, as well as punitive damages.

RAWMI’s certification is a practical step forward, falling short of a legal solution. The Common Standards and Risk Analysis and Management Plan are a laudable attempt to legitimize and create industry-wide standards for the raw milk industry. However, they will have varying effects on farm liabilities, and farmers still must continue to navigate the patchwork of state laws. For a comprehensive guide to state raw milk laws, visit the Farm-to-Consumer Legal Defense Fund website.

Responding to an FDA Food Safety Inspection

June 26, 2014

-by Jack Hornickel

Earlier this week, Food Safety News reported on a Los Angeles-based seafood distributor cited in an FDA Warning Letter for deficiencies in its seafood HACCP plan. This quote from the article caught our eye:

FDA’s district office used the warning letter to express its concerns about shortcomings the agency found in the company’s response to its earlier concerns.

Food Safety News drew this conclusion from the Warning Letter itself:

We acknowledge receipt of your written response dated October 18, 2013. We have reviewed your response, which included an updated HACCP plan, as well as corresponding records.  However, based on your response and your HACCP plan that was provided, your canned raw scallops and canned pasteurized crab meat continue to be adulterated.

This is a perfect example of how the FDA will ratchet-up its enforcement authority if it receives an insufficient response from a food processor during an investigation. In this case, an inadequate response to a relatively discrete inspection precipitated a public flogging in the form of this Warning Letter.  This exchange demonstrates why it is so utterly important to respond accurately and comprehensively to any issues raised by regulators during an FDA inspection.

Immediately after a facility inspection, FDA must meet with the company’s manager and discuss the findings. The FDA’s Investigations Operations Manual coaches FDA inspectors to advise the company that its response to the observed violations “may impact FDA’s determination of the need for follow-up action, if FDA receives an adequate response to the [results of inspection] within 15 business days.” While nothing in the law requires an inspected company to reply, a well-crafted response is a company’s best chance of avoiding a public warning and further enforcement.

The key takeaway from all this is to have an attorney review all communication with the FDA to ensure that no statement is made during an investigation that can expose the business to additional liability. FDA has a continuum of powers it can use against food businesses. The strongest administrative actions available are mandatory recall of adulterated food, suspension of food production, and temporary seizure of food products. Communication errors at any step during an investigation could provoke the FDA to use these powers, so food businesses have plenty of reason to tread very carefully throughout an inspection.

California’s Glove Law: Second Thoughts

April 16, 2014

by Gabriella Agostinelli

Last January, California became the 42nd state in America to enact a law prohibiting bare-hands contact with ready-to-eat foods and beverages.  Under the law, human skin cannot touch anything that has been cooked or can be served immediately, such as bread, fruit, deli meat, sushi, and cocktail garnishes. In the face of major opposition to the new law, the State Assembly’s Health Committee – the very committee that proposed the law – has now unanimously voted for the law’s repeal.  A new bill, which would restore the health code to its previous standards, is now on track to be considered on the Assembly floor.

California had strong public policy concerns when enacting the law. Nearly 1 in 6 Americans (48 million people) are sickened annually by food poisoning. A new study released this month also indicates Americans are twice as likely to get food poisoning from food prepared at a restaurant than from food prepared at home.

Despite lawmakers’ good intentions, the California food and beverage service industry has been swift to point out the law’s many impracticalities. Under the law, you can throw a steak on the grill barehanded, but you better glove-up when plating the cooked meat. Want some lime or ice in your cocktail? Give your bartender time to grab some latex, tweezers, or other kitchen tools first. And don’t forget: every time a bartender takes your money, she will need to replace her gloves. Every time a bartender grabs a glass you have sipped from, it becomes “contaminated” and she will once again need to change her gloves. Sushi chefs, notorious for their reliance on “touch” when crafting seafood delicacies, contend that wearing gloves interferes with this crucial sense. Beyond the inconvenience of wearing and replacing gloves, critics also suggest wearing gloves will affect the taste of food and beverages. (Think: the essence of latex and powder in your mojito.)

Since January 1, more than 18,000 individuals have signed petitions asking for the law’s repeal or to exempt bartenders from the law. Opponents of the law condemn the cost and environmental impact of buying and disposing of millions of latex gloves annually. They also argue that glove use presents a risk of cross-contamination, that the law affords inconsistent exemptions, and that it may create a false sense of security.

The story of California’s glove law demonstrates that, when creating food law in the name of public safety, legislators may not give due attention to practical concerns and costs to industry. It is encouraging that the Legislature is now considering these practical issues.

Legal Tools for Food Hubs, Part 3: Planning to Minimize the Burdens of FSMA

April 11, 2014

by Lauren Handel

Food hubs and the farmers who supply them will be significantly impacted by the new regulations FDA is promulgating under the Food Safety Modernization Act (FSMA) — in particular, the rules relating to produce safety and preventive controls. The rules are only in draft form now, and new drafts are due to be released this June. So it remains to be seen exactly how the exemptions will be defined. We will be looking closely at what changes, if any, are made to the exemptions for small businesses. Businesses that might qualify for the exemptions also should pay attention and plan ahead to minimize their regulatory burdens to the extent possible.

Under both the preventive controls and produce rule, businesses will be exempt from all or most requirements if their annual food sales are below certain dollar amounts. Both rules provide a qualified exemption from most of the requirements if a business’s average annual food sales are less than $500,000 and if the majority of its sales are direct to consumers or to local retailers or restaurants. The preventive controls rule also provides a qualified exemption for “very small” businesses, meaning those with annual food sales less than $250,000, $500,000 or $1 million (FDA has not yet decided which limit to use). Also, if a farming business’s annual food sales do not exceed $25,000, it would be completely exempt from the produce rule.

What food sales count toward these limits differs under the two rules. For the preventive controls rule, all food sales of affiliated companies count. In other words, all food sales of separate food processing or handling facilities under common ownership or control will be counted toward the exemption limit. In contrast, for purposes of the produce rule exemptions, the relevant food sales are those of a “farm,” which is defined as a physical place. Thus, as the produce rule is currently drafted, a farming business with multiple farms in different locations might qualify for an exemption on one farm, but not another, depending on the relative food sales from each farm.

When the rules are finalized, small food and farming businesses should consider whether they can structure their businesses or operations to avoid taking on more of a regulatory burden than necessary. It may be possible for a food hub enterprise to keep various parts of the operation under separate ownership and control so that their total food sales will not be aggregated for purposes of determining whether any one facility is exempt from the preventive controls rule. Similarly, a farming business with more than one farm location should consider the exemption criteria when planning what crops to plant on each farm. Of course, such considerations will have to be weighed against business needs and practical concerns.

We will be monitoring this issue as the FSMA rules continue to take shape. If you would like to discuss strategies you might employ in your small food or farming business to plan ahead for FSMA, feel free to contact me or Jason at (888) 908-4959 or info@foodlawfirm.com.