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Food-borne illness — new rules are supposed to help (Part 2)

The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on Jan. 4, 2011. It was supposed to enable the Food and Drug Administration (FDA) to better protect the public health by strengthening our food safety system.

Basically, the FDA was mandated to establish “science-based, minimum standards for the safe growing, harvesting, packing and holding of produce on farms to minimize contamination that could cause serious adverse health consequences or death.”

The new rules under the FSMA of 2011
Under the new rules, rather than react to a food-borne illness outbreak after the fact, the FDA’s new rules require that any facilities that manufacture, process, pack or store food for humans and animals: 1. Must identify anything that could be a hazard to humans or animals in the way they make, package or store their products.
2. Put in place minimum controls to minimize or prevent those threats.

The rules under the FSMA apply to both domestic and imported foods that are regulated by the FDA. This means that food importers have to verify that their suppliers are meeting the same standards and rules that domestic producers are required to follow.

Taiwan has a zero tolerance on glyphosate residues in oat products. Quaker Oats  made in the U.S. fa...

Taiwan has a zero tolerance on glyphosate residues in oat products. Quaker Oats, made in the U.S. failed.
Taiwan FDA / Illustration Digital Journal

This rule also governs foreign countries that have accredited certification bodies, like Canada’s Food Inspection Agency (CFIA), that conduct food safety audits that meet U.S. standards for the safe consumption of foods by humans and animals.

The new rules also require that companies involved in the transportation of human and animal foods, including shippers, loaders and motor or rail carriers, as well as those facilities receiving the foods, use specified sanitary practices to ensure the safety of the food.

And finally, the new rules require companies to create a food defense system. This means a written set of protocols that identify their facility’s vulnerability to intentional adulteration, and the safeguards in place to prevent or minimize the possibility of such contamination or adulteration. The FDA’s FSMA final rules became effective on August 24, 2016.

Creating the FSMA rules
Actually, the FDA was working on modernizing their rules before the FSMA was signed into law. But most people have no idea of the amount of work required to put all the rules in place. This writer is one of those people that would say, “How hard is it to have a few rules that ensure our food is safe?” The answer is harder than we think.

The FDA, like other federal agencies, has to comply with a federal law called the Administrative Procedure Act. Under this act, every rule the FDA issues, including those that apply to domestic growers, producers, shippers, packers, distributors and foreign suppliers and importers, has to be given a period of time for public comment.

The FDA has to issue a Notice of Proposed Rulemaking (NPRM). This proposal is published in the Federal Register (FR) so that interested members of the public can comment on the rule. This procedure usually lasts for 30 to 90 days. The proposed rules are filed on the FDA’s official docket on The FDA also sends the proposed rules to the World Trade Organization so that interested parties in other countries can be aware of what is going on.

After the comment period, the FDA reads all the comments and may make changes based on the public’s interest before issuing a final rule. In the preamble to the final rule, the comments that were deemed significant are discussed. Then the final rule is published in the Federal Register.

An FDA field inspector in Los Angeles checks imported shrimp.

An FDA field inspector in Los Angeles checks imported shrimp.

To make a long story short, it can take as long as six months to a year just to get to the final rule stage. Then, depending if it is mandated by law, an effective or compliance date is set for companies to come into compliance with the rule, which by the way is considered a law.

What’s going on right now?
Why do you need to know all this? Simple, really. The FDA had to extend the period of compliance with four very important rules that are now final rules, meaning they were again published in the Federal Register on August 24, 2016, and entitled, “Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.”
The four final rules in question out of the seven basic rules in the FSMA given extensions on compliance include:
1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
2. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
3. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
4. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

If you were to read down near the bottom of the notice in the Federal Register, you would see that for the four rules the period for compliance with the rules has been extended by as much as two additional years or so. This means that since 2011 when we were made aware of the FSMA, many companies have done little or nothing to get into compliance with the proposed rules in the first place.

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We are deeply saddened to announce the passing of our dear friend Karen Graham, who served as Editor-at-Large at Digital Journal. She was 78 years old. Karen's view of what is happening in our world was colored by her love of history and how the past influences events taking place today. Her belief in humankind's part in the care of the planet and our environment has led her to focus on the need for action in dealing with climate change. It was said by Geoffrey C. Ward, "Journalism is merely history's first draft." Everyone who writes about what is happening today is indeed, writing a small part of our history.

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