Many get more time to meet FSMA record-keeping challenges

Some say today is why so many in the food industry missed out on summer. Today is the compliance day for two major elements of the Food Safety Modernization Act (FSMA), meaning it’s time to begin dotting your documenting i’s and crossing your regulatory t’s.

And it’s best to celebrate compliance day now because the U.S. Food and Drug Administration (FDA) recently moved off many fixed compliance dates in favor of dates that will give many smaller businesses more time to comply with the new law. FDA announced those changes about a month ago, but without drawing much attention.

FDA is moving forward today with these FSMA compliance requirements:

• Human food companies other than small and very small businesses will need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.
• Animal food companies other than small and very small businesses will need to come into compliance with Current Good Manufacturing Practices (CGMPs) under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule. Preventive controls for animal food will follow on Sept. 18, 2017.

From the day President Obama signed FSMA to today’s first implementation of two sections, it’s been 6 years, 8 months and 16 days. And by the time the Act is fully implemented, the 1938 law it was designed to replace will have been in existence for 80 years.

While the food industry has been getting ready for this date since the FSMA was signed into law on Jan. 4, 2011, most acknowledge this past summer was crunch time. Almost every food safety unit reports using the past summer to prepare for FSMA compliance dates. Food safety conferences were overflowing and accredited courses offered through professional groups were turning people away.

Food companies were sending personnel from such varied areas as transportation, trade, and the executive suite to training on a FSMA they are now seeing as increasingly broad in its impacts. That was obvious during the lengthy rule-making process. FDA took time to gather thousands of written comments and meet with stakeholders in person.

This was the first summer since the final rules were all out and the last break before food safety personnel must deal with a rapid-fire series of compliance dates for the FSMA rules. In other words, reality is setting in.

Today’s compliance date for the first two FSMA rules — Preventive Controls for Human Food and Preventive Controls for Animal Food — gets the ball rolling. And it’s not going to stop. Until now, FSMA was used only in instances where rules were not required, such as giving FDA the authority to withdraw the registration of a food facility and thereby closing down its operations.

The sections for human and animal food are intended to prevent outbreaks of foodborne illness. and there is no doubt they are going to mandate their share of record-keeping and red tape. From today on, food facilities must be able to document they have a food safety plan, have conducted a hazard analysis, implemented preventive controls to mitigate hazards, and are conducting environmental monitoring.

“There’s nothing to it as long as you have the right training, tools, and treasury all in place,” said one company food safety manager.

FDA has acknowledged that FSMA is imposing costs on the food industry, but it also makes the point that the goal is to eliminate foodborne illness outbreaks that are just as costly, or more so, for the food industry.

“We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion,” FDA’s economic analysis of the rule explains.

“Our break-even analysis shows that for the rule to be cost effective, it would have to prevent $382 million worth of foodborne illnesses; approximately 17 percent of the total annual illnesses, or approximately 157,000 illnesses when using a discount rate of 7 percent. For the rule to be cost effective using a discount rate of 3 percent, it would have to prevent $381 million worth of foodborne illnesses (about 17 percent or 156,000 illnesses),” according to the agency’s number crunchers.

The Sanitary Transportation of Human and Animal Food rule, issued on April 6, 2016, was to be the next to go live on March 21, 2017. This, however, is now among a number of compliance dates that are being stretched out in the name of giving small business more time to comply. Shippers and receivers with fewer than 500 employee and with annual revenues of less than $27.5 million will have two years after publication of the final rule. All others will get one year.

That means the first compliance date shifts to April 6, 2017.

The transportation rule includes new requirements for the sanitary transportation of both human and animal food and covers shippers, motor vehicle carriers, rail vehicles, loaders, receivers and other elements of the transportation system. It imposes lots of record-keeping, most of which will likely be handled electronically since that’s the norm for the transportation sector.

“Through improved data, information acquired through public comment, and an expert elicitation we have estimated expected costs of this final rule.” FDA economists stated. “Annualized costs over the first ten years of implementation of this final rule at seven percent are expected to be $117 million ($113 million at three percent). FDA does not have sufficient data or evidence to fully quantify the benefits of this regulation,” they added.

The Foreign Supplier Verification Programs rule, by which importers will verify that food imported to the U.S. has been produced according to FDA requirements, has a May 13, 2017 compliance date.

The total costs being imposed on importers are $434.7 million on an annualized basis. FDA could not quantify how much it might save.

It’s certain that the Foreign Supplier Verification rule is both complicated and the most changed in its final version. Should records be accepted only in English, or should importers be permitted to present records first in their native language and only later provide the English versions? The final rule went with giving importers more time to provide documents in English.

The compliance date for the Intentional Adulteration, or Food Defense, rule is July 31, 2017. This one is different from the others in that it does not have to do with food production or shipments, but with protecting food against outside threats.

“The annualized costs per entity due to this proposed rule are about $13,000 for a one-facility firm with 100 employees, and there are about 4,100 small businesses that would be affected by the proposed rule, so we tentatively conclude that the proposed rule could have a significant economic impact on a substantial number of small entities,” FDA estimated.

Food defense requirements fall upon businesses with more than $10 million in annual sales “with significant vulnerabilities and food at a high risk for intentional adulteration caused by acts of terrorism.”

Manufacturers and processors of food might have such “vulnerabilities,” not farms, restaurants, or most warehouses or packers.

Covered facilities must create a food defense plan, identify actionable process steps, implement focused mitigation strategies and related monitoring, corrective actions, and verification activities to protect these steps, train designated employees in food defense, and document these actions.

FDA estimates the annualized costs of these measures to be about $370 million.

Third Party Certification’s compliance date was to be Nov. 21, 2017, but FDA moved it to 18 months after the final rule was published. That is going to shift compliance to the spring of 2018.

FDA has also stated:

• For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations;
• For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions. A range of compliance dates were established in the preventive controls rules for the supply-chain program provisions, which vary based on the size of the receiving facility and when the receiving facility’s supplier is required to comply with the new FSMA regulations.

On that date, third-party auditors will inspect foreign food facilities under FSMA. The new program comes with a rather modest cost, estimated by FDA at $2.8 to $11.6 million per year. And those costs would apparently fall mostly on foreign companies.

The final Produce Safety Rule was to take effect on Jan. 13, 2018, but instead different-sized operations will now have different times to comply.

Produce safety is one of the most politically sensitive elements of FSMA. It not only has to do with water and testing, but also involves FDA with agriculture in a significant way for the first time.

Except for sprout growers, this schedule of compliance dates will be followed:

• Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three-year period: four years.
• Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three-year period: three years.
• All other farms: two years.
• The compliance dates for certain aspects of the water quality standards, and related testing and record-keeping provisions, allow an additional two years beyond each of these compliance dates for the rest of the final rule.

Compliance dates for modified requirements for farms eligible for a qualified exemption are:

• For labeling requirement (if applicable): Jan. 1, 2020.
• For retention of records supporting eligibility for a qualified exemption: Effective date of the final rule.
• For all other modified requirements:
  • Very small businesses, four years after the effective date of the final rule.
  • Small businesses, three years after the effective date of the final rule.

Very small sprout growers will get three years to comply, small sprout growers will get two years, and all others, one year.