FDA opens toolbox for imported food oversight

The FDA is relying on “a range of tools” to ensure the safety of imported foods, in keeping with directives under the FDA Food Safety Modernization Act (FSMA). Because 15 percent of the Food supply is imported, the FDA has developed “a multi-faceted toolkit” to help ensure the safety of imported food. To meet food safety oversight demands, the FDA is allocating resources based upon risk, leveraging the work of other responsible entities in the food supply chain, and combining FSMA tools with existing methods (inspections, physical examinations, sampling/testing).

Food supply

According to the FDA, about 15 percent of the U.S. food supply is imported. However, some aspects of the food supply are predominantly supplied through imports. For example, nearly 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood are derived from imports. Food supply imports come from more than 200 countries and around 125,000 firms.

Oversight

Dr. Donald Prater, Acting Assistant Commissioner for Food Safety Integration in the Office of Foods and Veterinary Medicine (FVM), noted that under changing oversight protocols, while the level of oversight will be comparable across the food supply chain, “the deployment of the tools may be different.” For example, he noted the requirement that importers verify their suppliers produce food consistent with U.S. food safety standards. He indicated that the goal of imported food safety oversight was not to establish the same system of oversight for domestic and imported foods, but, instead, “to ensure that foods imported from abroad are as safe as those produced domestically.”

FDA considers simplifying agricultural water standards under the FSMA produce safety rule

In response to industry feedback, the FDA is considering the simplification of the microbial quality and testing requirements for agricultural water established by the Food Safety Modernization Act’s (FSMA’s) (P.L. 111-353) produce safety rule while still protecting public health.

The FSMA’s produce safety rule (80 FR 74353) establishes two sets of criteria for microbial water quality of agricultural water, both of which are based on the presence of generic E. coli, which can indicate the presence of fecal contamination:

  • No detectable generic E. coli are allowed for certain uses of agricultural water in which it is reasonably likely that potentially dangerous microbes, if present, would be transferred to produce through direct or indirect contact. Examples include water used for washing hands during and after harvest, water used on food-contact surfaces, water used to directly contact produce (including to make ice) during or after harvest, and water used for sprout irrigation. The rule establishes that such water use must be immediately discontinued and corrective actions taken before re-use for any of these purposes if generic E. coli is detected. The rule prohibits use of untreated surface water for any of these purposes.
  • The second set of numerical criteria is for agricultural water that is directly applied to growing produce (other than sprouts). The criteria are based on two values, the geometric mean (GM) and the statistical threshold (STV). The GM of samples is 126 or less colony forming unit (CFU) of generic E.coli per 100 mL of water and the STV of samples is 410 CFU or less of generic E.coli in 100 mL of water.

If the water does not meet these criteria, corrective actions are required as soon as is practicable, but no later than the following year. Farmers with agricultural water that does not initially meet the microbial criteria have additional flexibility by which they can meet the criteria and then be able to use the water on their crops. These options include, for example:

  • Allowing time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
  • Allowing time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
  • Treating the water.

The produce safety rule bases testing frequency on the type of water source (i.e. surface or ground water).

Testing Untreated Surface Water

In testing untreated surface water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of 20 samples, collected as close as is practicable to harvest over the course of two to four years. The initial survey findings are used to calculate the GM and STV (these two figures are referred to as the “microbial water quality profile”) and determine if the water meets the required microbial quality criteria.

Testing untreated ground water

For untreated ground water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of four samples, collected as close as is practicable to harvest, during the growing season or over a period of one year. The initial survey findings are used to calculate the GM and STV and determine if the water meets the required microbial quality criteria.

For untreated ground water that is used for the purposes for which no detectable generic E. coli is allowed, the FDA requires farms to initially test the untreated ground water at least four times during the growing season or over a period of one year. Farms must determine whether the water can be used for that purpose based on these results.

Testing public water supplies

There is no requirement to test agricultural water that is received from public water systems or supplies that meet requirements established in the rule (provided that the farm has public water system results or certificates of compliance demonstrating that the water meets relevant requirements), or if the water is treated in compliance with the rule’s treatment requirements.

Industry feedback

The feedback that the FDA has received in response to the produce safety rule is that some of these standards, which include numerical criteria for pre-harvest microbial water quality, may be too complex to understand, translate, and implement. These factors can be important to achieving high rates of compliance.

FDA response

In response to these industry concerns, the FDA is considering how it might simplify the water standards. The FDA indicates it intends to work with stakeholders as these efforts related to the water standards proceed.

 

Fish advice issued for women and parents of young children

Fish and shellfish provide protein, are low in saturated fat, are rich in many micronutrients, and provide certain omega-3 fatty acids. However, as a result of natural processes and human activity, fish also contain mercury in the form of methylmercury. Methylmercury can adversely affect the central nervous system, particularly the developing brain of the fetus. As a result, women who are pregnant or may become pregnant, as well as breastfeeding mothers and parents of young children, need information to make informed choices when it comes to fish that are healthy and safe to eat.

In June 2014, the FDA and the U.S. Environmental Protection Agency (EPA) jointly released a draft update to a March 2004 document entitled “What You Need to Know About Mercury in Fish and Shellfish.” The agencies have now announced revised fish advice that contains advice and supplemental questions and answers for those who want to understand the advice in greater detail. The fish advice contains a reference chart that sorts 62 types of fish into three categories:

  • Best Choices (36 types of fish)
  • Good Choices (19 types of fish)
  • Choices to avoid (7 types of fish: King mackerel, Marlin, Orange roughy, Shark, Swordfish, Tilefish (Gulf of Mexico), and Tuna (bigeye))

The reference chart suggests that women of childbearing age (16-49 years old), especially pregnant and breastfeeding women, and parents and caregivers of young children should observe the following guidelines:

  • Eat two to three servings of fish a week from the Best Choices list or one serving from the Good Choices list.
  • Eat a variety of fish.
  • Serve one to two servings of fish a week to children, starting at age two.
  • If you eat fish caught by family or friends, check for fish advisories. If there is no advisory, eat only one serving and no other fish that week.

The recommended serving size for an adult is four ounces. For children age four to seven, the recommended serving size is two ounces.

How were fish categorized?

The agencies note that they took a cautious and highly protective approach in determining which fish belonged in each category. They calculated how many servings the average pregnant woman could eat in a week using information on mercury content of each fish type from FDA’s database for commercial fish and other sources. If she could eat that fish at least three times a week, then they listed it in the “Best Choices” category. If she could eat that fish only once a week, or twice but not three times a week, then they listed it in the “Good Choices” category. If she could not eat a serving of that fish once a week, then they listed the fish in the “Choices to Avoid” category.

Why are some fish in more than one category?

The agencies explain why tuna and tilefish appear in multiple categories on the chart. Tuna comes in different types (or species), such as albacore, bigeye, and yellowfin. And because some types of tuna that are bigger or live longer tend to have higher mercury levels, they are in different categories. For example, canned light tuna is in the Best Choices category. Albacore (or white) tuna and yellowfin tuna are in the Good Choices category, and bigeye tuna is in the Choices to Avoid. In addition, fish of the same species that are caught in different geographic locations can vary in mercury content. For example, tilefish are in two categories because tilefish in the Gulf of Mexico have higher mercury levels than those in the Atlantic Ocean. As such, Gulf of Mexico tilefish is in the Choices to Avoid and Atlantic Ocean tilefish is in the Good Choices.

If some species of fish are not on the reference chart, such as mussels, that means the agencies did not have enough reliable mercury data to include it.

 

ConAgra subsidiary hit with $8M criminal penalty for role in salmonella-tainted peanut butter poisonings

ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., pleaded guilty to a criminal misdemeanor charge that it had shipped contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of salmonellosis, or salmonella poisoning, the Department of Justice announced. Following its guilty plea, the company was sentenced to pay an $8 million criminal fine and forfeit an additional $3.2 million in assets. The sentence represents the largest fine ever paid in a food safety case. ConAgra Grocery Products LLC is based in Omaha, Nebraska, with a manufacturing facility in Sylvester, Georgia.

The criminal information specifically alleged that on or about December 7, 2006, the company shipped from Georgia to Texas peanut butter that was adulterated in that it contained salmonella and had been prepared under conditions whereby it might have become contaminated with salmonella.

The company’s guilty plea was entered pursuant to a plea agreement filed last year in federal district court in the Middle District of (see ConAgra to pay $11.2M for its peanut butter and salmonella sandwich, May 20, 2015). In pleading guilty to violating the federal Food, Drug and Cosmetic Act (FDC Act), the company not only admitted that it had been aware of some risk of salmonella contamination in peanut butter, but it also admitted that (1) it had introduced Peter Pan and private label peanut butter contaminated with salmonella into interstate commerce during the salmonellosis outbreak; (2) samples obtained after a 2007 recall showed that peanut butter made at the Sylvester plant on nine different dates between August 2006, and January 2007, was contaminated with salmonella; (3) between October 2004 and February 2007, employees charged with analyzing finished product tests at the Sylvester plant failed to detect salmonella in the peanut butter; and (4) it was not aware some of the employees did not know how to properly interpret the results of the tests.

Following the outbreak and shutdown, the company made significant upgrades to the Sylvester plant to address conditions the company identified after the 2004 incident as potential factors that could contribute to salmonella contamination, according to the Department of Justice. The company also instituted new and enhanced safety protocols and procedures regarding manufacturing, testing and sanitation, which it affirmed in the plea agreement it would continue to follow.