From Field to Fork

Recently, FDA and APHIS launched an online tool to help farmers and producers assess and mitigate vulnerabilities in their production processes. Called Agriculture CARVER + Shock, the tool is designed to help the food industry at the farm level implement food production security methods. The software is free and available here.

While originally developed for U.S. military use, CARVER has been adapted for the food and agriculture sector. The software currently evaluates potential vulnerabilities in the supply chains of different foods and food processes. The tool’s special agriculture module is designed primarily for harvest and pre-harvest food production operations.

In addition to providing members with information about CARVER + Shock, PMA also offers extensive food security resources via our Web site. We have information about the various components of the Bioterrorism Act as well as guidance for many links in the supply chain. For more details, visit PMA.com.

On September 8, FDA launched the Reportable Food Registry (RFR), which food industry officials – including produce companies – must use to alert the FDA when they find their products might sicken or kill people or animals. FDA sees the registry as a way to head off potential cases of foodborne illness quickly through an electronic portal. The requirement to use the registry took effect with the launch of the portal.

PMA participated in a stakeholders conference call with FDA when the portal was launched. You can get the latest information about the registry and FDA’s guidance at PMA’s Food Safety page.

Anyone who has to submit registration information to the FDA now must also tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal. This requirement applies to all fresh produce. Examples include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

When reporting, a responsible party must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party; must submit initial information followed by supplemental reports; and must work with the FDA authorities to follow up as needed. Companies are not required to report if they found the problem before the food was shipped and corrected the problem or destroyed the food.

The agency issued draft guidance on the RFR in June and sought comment; PMA offered comments to improve the registry for industry use and worked with a member to test the system at FDA.

Should you need to use the registry and find there are problems, please notify us at PMA so we can work with FDA to further improve the system.

Today our friends at FDA let us know that proposed guidance implementing a Reportable Food Registry will be published in the Federal Register June 11. The guidance will help food companies understand how to report food products that could make consumers ill at a new online portal that will open September 8.

The proposed guidance will apply to all firms that currently are required to register with FDA under the Bioterrorism Act rules – including non-U.S. firms through their U.S.-based contacts. The guidance will explain who must submit these reports and how, when and where to submit them. And it will explain when you don’t have to file a report (e.g., if the product never left your control or if you were able to correct the problem). It will also outline information about notifying others in the supply chain about these reports.

There will be a 45-day comment period; comments are due July 27.

Prompted by Congress in 2007 legislation, this expands on FDA’s efforts to enhance food safety, which as you know from this blog and our other activities is one of PMA’s top priorities.

After an initial uproar heard ‘round the world, calmer heads are now prevailing regarding the H1N1 influenza virus as a public health issue and not a food issue. While cases are still being reported, the U.S. enters the summer months health officials believe that the number of cases will decline in the Northern Hemisphere. However, as the Southern Hemisphere begins its winter season, there is a possibility more flu cases may appear there.

To help our members around the world stay current about this flu outbreak, PMA has added a H1N1 flu resource page to its Web site. The page contains links to various U.S. and global health agencies, and will be updated with new links should more information become available. At a pandemic planning meeting I attended last week, health officials recommended that pandemic plans be updated in the event the H1N1 flu reemerges in the coming Northern Hemisphere fall and winter seasons. If you’re a PMA member and would like to receive our email issue alerts, please contact the PMA Solution Center to subscribe.

Rumors are circulating out there in Produce Land. Just to put it plainly: swine flu is not being transmitted by food. It is being transmitted like other flu or a cold, person-to-person, according to top officials in the U.S. government. There’s no reason to question fresh produce, regardless of where it is grown. And contrary to those rumors, the U.S.-Mexico border is open for trade. The border discussions being had at this point are more about the movement of people, not the movement of commerce.

PMA members received our issue alert on this topic earlier today. You’ll find it and other alerts – as well as instructions on how to sign up to get future alerts – here (scroll to the bottom of the page).

To help food companies comply with its prior notice final rule that will go into effect May 6, the U.S. Food and Drug Administration has published a fact sheet, a Powerpoint presentation, and a draft compliance policy guide on its Web site. The fact sheet includes information on several aspects of prior notice, including, but not limited to:

• The foods included/excluded from prior notice requirements (hint: fresh fruits and vegetables are included);
• when and how to submit prior notice;
• how to correct prior notice information; and
• where to turn for help.

The final rule implements section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires that FDA receive prior notice of food imported into the United States. Prior notice can be submitted by using Customs and Border Protection’s Automated Broker Interface of the Automated Commercial System or FDA’s Prior Notice System Interface. FDA uses this information in advance of the arrival to review, evaluate, and assess the information, and determine whether to inspect the imported food.

Compliance with prior notice, as well as other segments of the Bioterrorism Act, is mandatory. Recently we wrote about a Department of Health and Human Services Inspector General’s report which found that some companies aren’t meeting Bioterrorism Act recordkeeping requirements.

Whether it’s prior notice or recordkeeping, PMA members are encouraged to visit the food security section of our Web site to learn more about how to comply with these important regulations.

Some food companies, including produce firms, appear to be unaware they must be able to trace foods one step up and one step back as required under the Bioterrorism Act of 2002, according to a new report from the Department of Health and Human Services’ Office of the Inspector General. The IG at HHS – which houses the U.S. Food and Drug Administration – recently released a report finding that one-quarter of the companies they audited didn’t know about the recordkeeping requirements. More than half had incomplete records. Of 40 products audited, the IG could fully trace only five. Those 40 included eight produce items – four tomatoes and four bags of salad – none of which were among the five that were completely traceable.

The report said: “Several factors limited our ability to trace the specific food products through each stage of the food supply chain. These factors included: (1) processors, packers, and manufacturers not always maintaining lot-specific information, as required; (2) other types of facilities not maintaining lot-specific information because it is not required; (3) retailers receiving products not labeled with lot-specific information; and (4) the mixing of products from a large number of farms. These factors also affect the speed with which FDA can trace specific food products through the food supply chain.”

Traceability is a critical topic for our industry these days – the law already requires it, FDA and Congress are talking about taking it further, and consumer confidence depends on it. Any company in the industry who can’t comply with the Bioterrorism Act is subject to federal prosecution at least – and should expect additional consequences once your customers and consumers find out your capabilities are lacking.

If you need help, we’ve got it. PMA offers several resources to help our members with traceability and related compliance. Check out the summary of the bioterrorism rules on our food security page. And take a look at all the resources available at the Produce Traceability Initiative Web site.