Seven rules have been proposed by the Food and Drug Administration to implement the "Food Safety Modernization Act" and several of them deal with farmers and livestock feed.
Officials at the state Department of Agriculture, Trade and Consumer Protection have been keeping a close on the FSMA developments, making comments to the FDA as necessary and watching for how these rule changes will affect safety protocols for human food and feed for livestock. (See related story.)
During a recent meeting of the DATCP board in Friesland, Steve Ingham, administrator of the Division of Food Safety, told board members that early this summer the FDA will release revised language for three of the rules that deal with farmers.
These three rules deal with "Preventive Controls — Human Food," "Produce Safety" and "Preventive Controls — Animal Feed."
One of the very basic problems Ingham sees with these rules is that they each have different definitions of farming activities and set criteria for exemptions in different ways.
"State regulators who are tracking FSMA are tracking this very carefully," he said. "There is widespread sentiment among state regulators that inconsistencies of this type should be eliminated to avoid conflicting requirements and confusion."
Ingham said state regulators have also been providing FDA with input about how the FSMA-linked rules will actually be implemented.
"Effective implementation will depend heavily on state personnel to assist FDA staff," he said. "FDA has so far only generally discussed procedures for assuring that the state-federal integration is effective and efficient."
The federal agency hasn't said much about implementation so far but has said that it would expect that the implementation of Preventive Controls will be similar to their approach in implementing the Hazard Analysis Critical Control Point (HACCP) rule in the seafood and juice industries.
"Now this gives me something to go on," he told the board.
One group that may help in the process of implementing the rule for Preventive Controls — Human Foods, is the Food Safety Preventive Controls Alliance.
The group represents industry, state regulatory agencies and academia and is preparing a model training curriculum that will be used to teach industry how to comply with the new rule. Their efforts are modeled after similar alliances in the seafood and juice industries that were an "unqualified success," he said.
Ingham said the Division of Food Safety has submitted comments related to the proposed rule related to "Intentional Adulteration" and how it might affect dairy farmers.
The aim of the rule is to prevent the intentional adulteration of food done by terrorists or others to cause large-scale public harm.
In writing the rule, the FDA proposed limiting access to milk houses and dairy farmers' bulk milk tanks.
The basic requirements of the proposal are a written food defense plan, training and record-keeping. In preparing a food defense plan an operator can do a vulnerability assessment to figure out what the actionable process steps are, or can determine if their process has any of four "activity types" already identified by the FDA, Ingham explained.
These activity types include bulk liquid receiving and loading, which is obviously pertinent to a dairy farm. The establishment operator must then write down and implement "focused mitigation strategies" at each identified actionable process step.
As part of the proposed rule on Intentional Adulteration, the FDA asked for comments on whether or how access to the bulk tank could be limited on dairy farms.
The DATCP Food Safety Division has explained in its official comments that access to the bulk milk tank is very important — for sanitarians, veterinarians, equipment people and others — and that locking the door on a milk house would pose a "logistical challenge" on the farm.
"Any requirement that the milk house be locked could create significant logistical hurdles, which we have discussed in our comments.
"Mandating restricted-access to the bulk tank presents many of the same hurdles," he explained.
Comments also included the point that larger farms that cool their milk and place it directly into sealed tanker trailers may already have achieved the agency's food defense safeguards.
Ingham said larger scale farms that are shipping more product might be a more enticing target for terrorists — and potentially hire more new employees — but they may also have more resources to install security systems like keypad access, time clocks or a security system.
Smaller 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 board members.
"We have also commented that we believe that 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 powder.
"If milk on these farms were intentionally adulterated, there could be a significant time and distance gap before the effects of the adulteration were felt."
The shock effect, for example, of a terrorist adulterating that kind of product would be lower than if milk for beverage consumption were adulterated, he added.
"We have proposed 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.