One of the proposed rules dealing with national food safety could affect every milkhouse in Wisconsin — and in the country for that matter.
It is intended to protect the U.S. food supply from adulteration intended to cause widespread harm and it is part of a package of rules that have drawn a lot of flack from agriculture.
"The Food Safety Modernization Act is a jobs bill — it will create ample employment throughout the food industry," quips Steve Ingham, administrator of the division of Food Safety at the Department of Agriculture, Trade and Consumer Protection.
Since the FSMA was signed into law in January 2011 the U.S. Food and Drug Administration's (FDA) has been working on the regulations by which the law will be implemented. There has been lots of controversy.
So far, seven proposed rules have been issued to implement the FSMA and the public comment periods on four of the rules are now closed.
These rules deal with Preventive Controls for Human Food, Produce Safety, Foreign Supplier Verification and Accreditation of Third-party auditors and Certification Bodies.
The comment period for rules addressing Preventive Controls for Food for Animals and the Food Defense rule will close on March 31. The comment period on rules for Sanitary Transportation — the rail and trucking transportation of food — are due May 31.
Some in the industry, he says, are calling for a rewrite of some of these rules. "I don't know how that's going to work since the FDA got sued for being too slow." The decision in that court case has essentially speeded up the process of getting to a final set of rules — no matter how onerous they are for agriculture and the food industry.
Ingham said that although the comment period for the Produce Safety rule has ended, this proposed rule is very contentious and the FDA is still taking comments.
Many in agriculture and in Congress have questioned the science that was used by FDA to promulgate this particular rule, he said, or whether relevant scientific knowledge was available.
The recently signed farm bill contains language that requires the FDA to conduct scientific and economic impact analyses that must be published with the final rule. The agency is supposed to systematically evaluate the impact of the rule once it is implemented and outline ways to respond to business concerns.
"This requirement reflects a perception that the gains in public health protection were not great enough to justify the costs of compliance that would be borne by industry. This perception may have been fueled by an estimate FDA provided on how many cases of illnesses the rule would prevent: 1.75 million."
Ingham explained that assuming each American eats three meals a day and that each illness case arises from one meal, then the Produce Safety rule would prevent illness associated with five out of every million meals eaten each year.
The year-one cost of compliance with the rule has been estimated at $630 million — about $360 for each case of prevented case of illness. That comes to about $1.14 per American resident.
"Whether this is a good return on investment is not for me to judge."
Congress has told the FDA that it needs to take into consideration the diversity of farming and ranching operations across the country, which vary in size and scope and how the rules would affect them.
The newest proposed rule deals with Food Defense, the focus of which is to prevent intentional adulteration of food intended to cause large-scale public harm — food terrorism.
The basic requirements of this rule are a written food defense plan, training and record-keeping. Most farms are exempt from the requirements of the proposed Food Defense rule, but not dairy farms, he said.
The FDA is seeking input on dairy farm related topics like restricting access to the bulk milk tank, requiring training to limit bulk tank access and possible criteria for exempting certain farms.
Ingham said this proposed rule would require written food plans for those who are impacted — which at this point would include dairy farmers. In preparing this food defense plan, the operator would need to identify what are being called "actionable process steps."
These steps are defined as a point or procedure at which food defense measures can be applied and are essential to "prevent or eliminate a significant vulnerability or reduce the vulnerability to an acceptable level."
Operations with bulk liquid substances are being targeted by the rule because of the fear that a terrorist could contaminate a small amount of ingredient which then gets put into other products.
The rule would require that the operator write down and implement "focused mitigation strategies" at each identified actionable process step, follow plans for monitoring the mitigation strategies and write down corrective actions to be taken if the mitigation strategies fail.
Ingham said there is some disagreement among the experts about whether or not dairy farms would be covered by the rule, but it appears to him that they are not exempt.
"For example, they are asking for comments on whether and how access to the bulk milk tank could be limited and how we would do it.
"They are also asking for comment on whether mandatory food defense awareness training for dairy farm operators could replace mandatory implementation of focused mitigation strategies."
Ingham said the FDA is also asking whether dairy farms smaller than a particular size should be exempt from this rule, or if farmers distributing their milk in a certain way — as to a cheese plant — should be exempt.
"It is quite likely we will be providing feedback to FDA on these topics. I would welcome ideas and feedback from industry as we prepare our comments for FDA," Ingham said.
Ingham said he's been surprised at how little public reaction there has been to the proposed Food Defense rule. "I'm not sure why. One possible explanation is that a publication date of Christmas Eve meant that many people are unaware of the rule or have not read it.
"It has been amazingly quiet compared to the Produce Safety rule."