News on Adulterated Milk

New FSMA rules will affect all farmers, in many ways 
Tuesday, 27/05/2014

Comment periods have closed for five of the seven proposed rules that are part of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA).

The comment period for the rule addressing Sanitary Transportation of Food closes on May 31 and the comment period for the rule addressing Intentional Adulteration of Food closes on June 30.

Both Steve Ingham, administrator of the Department of Agriculture, Trade and Consumer Protection’s division of food safety, and John Petty, administrator of the division of agricultural resource management (ARM), described for the DATCP board on May 14 their concerns about how FSMA will impact farmers.

Early this summer, the FDA is to release for comment revised language relating to farmers.

These three rules deal with Preventive Controls, Human Food, Produce Safety and Preventive Controls, Animal Feed.

Troublesome to Ingham and Petty is the fact “each of these rules differently defines farming activities and criteria for exemptions differently.”

While the sentiment among state regulators is that such inconsistencies should be eliminated to avoid conflicting requirements and confusion, there are no guarantees.

“The FDA is responding to concerns that each of these rules defines a farm, farming activities and status for exemptions differently. There is fear that a farm could be subject to all three rules, and find the requirements to be confusing and conflicting,” Ingham noted in his written summary.

“The rules should all mesh together,” Ingham said, “but a sticking point right now is federal-state sharing of information.”

A document released on May 2 by FDA, “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA),” says the FDA expects its implementation of the Preventive Controls rules to be similar to their approach in implementing Hazard Analysis Critical Control Point (HACCP) rules in the seafood and juice industries.

Ingham called the HACCP approach “an unqualified success.”

A concern of food and ethanol manufacturers is how the Preventive Controls-Food for Animals rule will affect the sale of food processing and distilling wastes for animal feed.

Comments on this rule closed on Mar. 3. Of the 2,500 comments received, 1,500 were related to brewers-spent grain, which was not included in the rule, while distillers’ grain is still under FSMA.

Prior to the Aug. 30 deadline, the FDA will release final rules, Petty said.

Sanitary transportation rule

Ingham submitted comments from his division of food safety related to the proposed rule dealing with Intentional Adulteration and how it might affect dairy farms.

“The aim of the rule is to prevent intentional adulteration of food done to cause large-scale public harm. But the rule does not focus on adulteration dome to damage an establishment, such as that done by tampering by competitors or disgruntled employees, or economically motivated adulteration, which may or may not harm consumers,” Ingham said.

While the basic requirements of the proposed Intentional Adulteration are a written food defense plan, training and record-keeping, that plan includes four activity types already identified by FDA. A vulnerability assessment can be a part of this process.

On dairy farms

“These activity types include bulk liquid receiving and loading, which obviously is pertinent to a dairy farm,” Ingham pointed out.

“We have commented that access to milkhouses and bulk tanks presents special challenges. Currently the milkhouse must be accessible at any reasonable time to our Sanitarians or Milk Sanitation Rating Officers for inspection.

“Veterinarians and equipment repair personnel also are accustomed to having easy access. Any requirement that the milkhouse be locked could create significant logistical hurdles, which we discussed in our comments,” Ingham said.

“Mandating restricted-access to the bulk tank presents many of the same hurdles,” Ingham continued. “We feel that any decision to mandate restricted access to milkhouses and bulk tanks must be made after carefully weighing the potential public health benefits of easy access against the food defense benefits of restricted access.

“It’s a balancing act,” Ingham suggested.

Farm size

“Farm size and destination of the farm’s milk also may be important considerations in the rule-writing process,” Ingham said.

“We have commented that adequate food defense safeguards may already be in place on larger-scale farms where milk is directly cooled and loaded into a sealed tanker truck.

“Large-scale dairy farms obviously have a greater amount of milk potentially subject to intentional adulteration and they may have correspondingly large numbers of employees, perhaps making them more vulnerable to a terrorist posing as a new employee.

“On the other hand, these large scale farms also may have more resources available to institute security measures such as keypad access, time-clocks or a security system. Federal requirements might be appropriate on such farms, although we believe these requirements still must be flexible enough to allow for innovation and a variety of approaches,” Ingham stated.

“Small-scale farms are less likely to hire large numbers of employees and are less likely to have resources necessary for elaborate security systems. We believe that compliance with FDA regulations related to on-farm intentional adulteration of milk may not be economically feasible on farms with fewer than 10 employees,” Ingham told the board.

Grade A

In his comments to FDA, Ingham noted “regulations may not be cost-effective if a farm’s milk is solely converted to non-Grade A products, such as cheese or ice cream, or shelf-stable Grade A products such as non-fat dry milk or whey power.”

That is because if milk on these farms was intentionally adulterated, “there could be a significant time and distance gap before the effects of the adulteration were felt,” Ingham indicated.

As an example, Ingham said “adulterated milk might be converted to cheese that is either ripened for several months before it is subdivided, packaged and distributed across a wide area. Or the milk might be made into cheese that ends up on frozen pizzas across the country.

“In these situations, the shock effect of that kind of terrorist attack (adulteration) would be lower than if milk for beverage consumption were adulterated,” he added.

Ingham’s proposal to FDA is that “any food defense regulations pertaining to Grade A dairy products be incorporated into the Pasteurized Milk Ordinance (PMO), following the standard process by which the National Conference on Interstate Milk Shipments and FDA modify the PMO.

“It will be interesting to see what other comments are submitted on this rule,” Ingham said.

FSMA and animal feed

John Petty, ARM division administrator, provided the board with an update on the Preventive Controls, Animal Feed proposed rule.

The Sanitary Transportation of Food Rule involves the link to food safety when human food is converted to animal feed.

“It will be a record-keeping headache and very intense,” Petty predicted. “For instance, records will have to be kept indicating where you (farmers) got the human food product and where did it go?

“Shippers and carriers will have to maintain records of the last three loads that were in each truck and each truck must keep a continuous log that is open to inspection. The rule does not spell out whether the FDA or the Department of Transportation would be inspecting trucks and checking on those records.

“There is now a new definition of record keeping that comes with tracking adulteration,” Petty said.

To illustrate, Petty used the example of a refrigeration unit “where a monitor stepped out for some reason. That absence constitutes adulteration of product.

“Historically, we have been concerned with food safety, now food quality is included in terms of a contract between buyer and seller,” he said.

Under the Food Sanitation Rule, Petty described a situation where a company is shipping chocolate bars and the heat melts the bars, and the buyer does not want melted chocolate bars.

“This is a very dirty, slippery slope,” Petty warned, “where the FDA is almost interchangeably using Food Quality and Food Safety. Does that product become adulterated if not handled in a prescribed way?

“The bottom line in the feed area is this rule is literally the largest rewrite of (food safety) rules in history and will change about every aspect of how these rules are viewed and implemented. It will call for greater cooperation and integration between states and FDA,” Petty said.

Brancel comments

DATCP Secretary Ben Brancel commented on several aspects of the FSMA rules.

“Byproducts from food processing are used in animal feed. On the use of brewers-spent grain, it’s a byproduct issue, yet the Preventive Controls, Food for Animals rule, leaves everyone else hanging. I would like to see the entire food processing industry staying together on this,” Brancel said.

on food packages indicate when the product can no longer be used. Brancel, using crackers as an example, said “the idea is the crackers are the best quality before this date, the one on the box. After that date, are the crackers adulterated? Under FSMA, does an outdated product become an adulterated product because its quality has changed?”

At this point, Ingham said, “it gets down to one word, the definition of adulterated.”

Depending on interpretation, “there would not be enough landfills” to deal with outdated products, if they are considered adulterated.

“This brings to the forefront the system of operation currently in place between states and the FDA,” Brancel said. “When it’s all done, will we be in a compliant relationship with FDA, instead of in a problem-solving relationship?”

The FSMA rule package is to be in place by Aug. 30. Training for FSMA is very expensive, and is all conducted out of state, although FDA is committed to paying a portion of the training expenses.

The DATCP will continue to update the board on FSMA as more information becomes available.


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