The Food Safety Modernization Act will affect the entire supply chain, are you prepared for the safety, traceability, and record keeping challenges ahead?

FSMA affects producers, processors, and middlemen — such as storage facilities, transportation and hauling companies, and packaging producers of commodities — where the end product is for food consumption. For example, not only do nuts need to be tracked, but so do the almond hulls sold to a cattle operations for feed. Guidelines apply to different sectors and some sectors must adhere to more than one set of guidelines. Complete compliance will be mandatory in 2016. Until then, the FDA will continue to hold hearings to receive comments from affected parties in order to revise the law and make it practical for real-world application. Information on how FSMA applies to each type of business and open comment periods is available here.



FSMA Public Meeting February 10, 2015:

FSMA Meetings, Hearings, & Workshops Main Page

Environmental Impact Statement (EIS) for the FSMA Proposed Rule for Produce Safety

February 10, 2015
1:00 pm – 4:00 pm EST

Harvey W. Wiley Federal Bldg., Wiley Auditorium,
5100 Paint Branch Pkwy., College Park, MD 20740

The purpose of this public meeting is to discuss the Draft Environmental Impact Statement (EIS) for the proposed rule to establish standards for the growing, harvesting, packing and holding of produce for human consumption. This rule was proposed in January 2013 to help implement the FDA Food Safety Modernization Act (FSMA), with updates to certain provisions published in September 2014.

The FDA is seeking public input on the impacts identified in the Draft EIS. The purpose of the public meeting is to

  • inform the public of the provisions of the proposed rule that may significantly affect the quality of the environment and the identified impacts,
  • to provide information about the EIS process (including how to submit comments, data, and other information to the rulemaking docket),
  • to solicit oral stakeholder and public comments on  the Draft EIS, and
  • to respond to questions about the EIS.

For general questions about the meeting, contact: Cynthia Wise, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, telephone: 240-402-1357, e-mail: cynthia.wise@fda.hhs.gov.

Meeting Information

Please note the following important dates:

  • March 10, 2015: Approximate closing date to submit either electronic or written comments to FDA’s Division of Dockets Management. See Docket No. FDA-2014-N-2244 on http://www.regulations.gov for the official closing date.

Food Safety Modernization Act: What You Didn’t Know.

Take a moment to consider some of the foods found in a supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and processes that food went through to get all the way to those shelves.

While the ice cream likely went through more processes than, say, the tomatoes, most food items found in a supermarket likely underwent a multitude of steps and passed through several hands before ultimately reaching their destination. The decision of food suppliers to record those steps could make a significant difference in the impact those products have on public health in the event of an outbreak or recall.

But when it comes to food, the variety of traceability systems in the marketplace nearly parallels the number of ingredients in a pint of that chocolate chip peppermint brownie ice cream. Not only do most competitors use different systems and technology, most firms along the same supply chain — from farm to processing plant to retailer — record and translate their data in different ways.

Picture a pile of tomatoes in the produce section. Farms supply tomatoes to a distributor, who gives them a product code before passing them onto a retailer who may give them a different identifying code. Go find a can of diced tomatoes in another aisle and the number of changed hands and identification codes may have doubled. Find a jar of salsa — the ingredients, codes and suppliers compound exponentially.

Now, throw a Salmonella outbreak into the mix. Hundreds of people around the country report illnesses and face interviews with investigators asking them to recall several weeks of meal histories.

At first, interviews seem to point to tomatoes as the most likely source — maybe a lot of the victims ate salsa — and so investigators begin tracing back through the tomato supply chain in search of the contamination. Eventually, however, the investigation into tomatoes dries up, and it only later becomes apparent that the outbreak was instead likely caused by contaminated jalapeño peppers.

That’s what happened across 43 states in the spring of 2008, and while investigators were tracing back through tomato supply chains, the jalapeños were granted more time to sicken additional consumers, according to Christopher Waldrop, director of the Food Policy Institute at the Consumer Federation of America.  Investigators might have ruled out tomatoes and moved on to jalapeños faster if suppliers had implemented better functioning traceability systems, saving more people from illness, Waldrop said.

“If you work quickly, you can save lives,” said Jennifer McEntire, Ph.D., senior director of the Food and Import Safety Practice at Leavitt Partners.

McEntire served as lead author of a report published by the Institute of Food Technologists (IFT) and commissioned by the U.S. Food and Drug Administration which details pilot projects for improving tracing through the food system. That report, in part, looked at a number of well-researched outbreaks to perform a cost-benefit analysis of using traceability systems.

If the duration of tracebacks during outbreak investigations could be reduced by half — or even a quarter — through the use of effective traceability systems, the impact of outbreaks could be significantly reduced, McEntire said. The money saved on healthcare alone would have reached into millions of dollars in some of the outbreaks IFT studied — and that’s not to mention the damage caused to industry when investigations persist in the spotlight and the public loses trust in a food product.

The FDA asked IFT to compose that report to better inform rules on traceability to be proposed as part of the Food Safety Modernization Act (FSMA), signed into law in 2011. While the FDA has released detailed proposals for some rules in the FSMA, the current section on traceability is still relatively open-ended, McEntire said.

Thus far, the FDA has suggested that it will require producers of “high-risk foods” to implement traceability programs, though no one has yet established what counts as a high-risk food. Given that there are a wide variety of traceability systems available to food makers, McEntire said it is highly unlikely that the FDA would endorse any particular traceability technology.

“I assume FDA will come out with an objective-based requirement: ‘Here is what you need to be able to do. Here are the data that need to be captured. Here’s the format you need to share it in,’” McEntire said.

The first goal should be to make sure producers and distributors are working with the same information and everyone knows what information they need to have, McEntire said. Data as simple as names, locations, and lot numbers can get muddled as product switches hands on the way to the supermarket, and everyone prioritizes information differently.

One of the biggest challenges for traceability systems, both McEntire and Waldrop agreed, is that they require human input at every link in the supply chain to function effectively. But traceability can require a lot of paperwork, and data may be subject to human error — assuming companies can find the resources and interest to have someone record it in the first place.

Companies view traceability as an additional cost, McEntire said, and so few of them adopt traceability systems for the sake of having traceability in the event of an outbreak. It’s better sold as a tool to improve supply chain efficiency and accuracy.

“Traceability is best positioned as a byproduct,” McEntire said. “Companies want to have it for other reasons, like improved record-keeping, inventory purposes, a better grasp of suppliers in order to gauge quality. That’s how you build traceability — sneaking it in on the side.”

Until the FDA makes its formal proposal on FSMA traceability rules, both IFT and the Consumer Federation of America are encouraging the agency to reconsider requiring all foods to have some sort of traceability — not just those deemed “high-risk.”

That’s mainly for two reasons, Waldrop said.

First, food once thought to be low-risk could become high-risk. Cucumbers, for example, were never connected to a foodborne illness outbreak until last month. The second reason is that some producers would be making both low-risk and high-risk foods, meaning that their facilities could theoretically be operating under two different record-keeping rules.

For now, though, Waldrop expressed a hope that the FDA would soon form a more clear impression of its plans for traceability requirements.

“FDA needs to articulate its traceback information needs so that everyone has a better sense of the information they should be collecting,” Waldrop said. “If FDA could provide that, it would help push this issue along and address concerns about what information they’re collecting and not collecting.”

(This blog post by Dr. Ben Chapman was published June 2, 2014, on Barfblog and is republished here with his permission.)

A couple of years ago, I heard a retailer food safety dude tell a group of farmers that his team keeps track of companies linked to illnesses and recalls. The buyer paid attention to how the incident was handled, especially watching for an expanding recall (indicating poor sanitation or traceability) and any public comments by the company. The collected info. was used to evaluate whether they would buy from the supplier in the future.

Being linked to tragic illnesses usually results in more than just writing off product; fallout also often includes a loss of trust within the buying community and a poor reputation with consumers.

And that’s what I told Bill Shea of Crain’s Detroit Business when he asked what might be ahead for Wolverine Packing Co. Here’s part of his story:

The business fallout from Detroit-based Wolverine Packing Co.’s May 19 recall of 1.8 million pounds of ground beef that may be contaminated with potentially deadly E. coli bacteria won’t be known for some time.

Investigations, both internal and by government officials, are underway. So is at least one lawsuit.

Wolverine, which had $1 billion in revenue last year, declined to discuss any business practices that may change, or how it may be affected financially, until it completes its own internal investigation.

“Since the voluntary recall was launched, the company still is conducting an internal investigation into the recall and assisting the U.S. Department of Agriculture’s Food Safety and Inspection Service as it continues to look into the matter,” said Chuck Sanger, Wolverine’s outside spokesman via Hartland, Wis.-based food industry public relations firm Charleston Orwig Inc.

Shea’s article continues:

Bad press and lawsuits trigger worry by suppliers, who may turn elsewhere.

“Trying to sell back to that industry that is purchasing can be an uphill battle,” said Ben Chapman, an assistant professor and food safety extension specialist at North Carolina State University.

“The loss of that 1.8 million pounds is one thing. It’s difficult to put a monetary value on (goodwill); it’s more than just the product.”

Companies that have closed in the wake of a major recall couldn’t survive the combination of lawsuits and loss of trust, Chapman said.

In Wolverine’s case, he expects customers to have questions no matter what investigations show.

“If everything is up to what’s expected, the buyers may say, “What are you to doing to address what went wrong?’ ” he said. “It’s not a random act. Something happened. Either the system they have failed or the system they have wasn’t good enough.”

Add, “If I buy from these folks, will I be increasing the risk of foodborne illness for my customers – because that’s unacceptable,” to the list.

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This is an example of a farm record that will follow the commodity throughout the supply chain. Complete and secure.



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