It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.
The act covers five major areas of food safety:
- Inspection and compliance
- Enhanced partnerships
The act provides an outline that directs FDA to produce the specific regulations food companies must follow, for each of the sections. For each of the five areas there are various timelines for the release of final rules, implementation and enforcement.
For dairy plants, a subsection of the Prevention section mandates those hazard and risk prevention practices that are likely to have a familiar ring. These include evaluating hazards that could affect food safety, specifying preventative steps and controls, specifying how controls will be monitored, maintaining routine records and specifying a system of corrective actions should problems arise.
Final FDA rule for the Prevention section had been scheduled for 18 months after the January 2011 passage of the act – that would be this July. With preliminary rules having not yet been released as of April, it is highly unlikely that the schedule will be met.
IDFA's Detlefsen says FDA has given indications the agency will give processors plenty of breathing room before enforcement begins.
"It's a very comprehensive act," Detlefsen adds. "The regulations include 50 different rules, some of which are going to require further decisions from FDA. Some of these took effect with the passage on Jan. 4, 2011, including mandatory recall authority. Others will not be finalized for several years."
Will milk spoil?
What does concern IDFA, and that concern is echoed by BGC and others, is the slim possibility that there will be a requirement of post-production pathogen inspection. While this might seem like a logical preventative step, IDFA is lobbying to keep it out of the final rule.
"IDFA does not believe that FSMA authorizes that," Detlefsen says. "It's OK if members want to do it. But it can be problematic, especially for fresh dairy companies.
"The trouble is that the processor would have to hold the product until the tests come back. Where are you going to hold all that milk while you are waiting for the tests to come back? It's not a good strategy, and there are better ways to verify and ensure."
Indeed, milk processors like to take fresh dairy products from their initial state — fresh, raw milk — to a finished, packaged product that is in the distribution chain within 24 hours, says BGC's Miller.
"The potential mandated pathogen testing is troubling mainly because our dairy items have such short code dates that any delay in releasing product … is a loss in shelf life for our products and to our customers," Miller says.
Other concerns being discussed include increased government oversight and access to records, which worries Miller, and some wording on identification of radioactivity in raw inputs. "That has not been real clear," Wittenbrink says. "FDA has given us the parameter but not what the requirement is. And dairies will now need to include it in their hazard analysis."
Decades of operating under the PMO and the more recent adoption of HACCP have led dairy processors to claim that they are both the most highly regulated segment of the food industry and one of the most proactive.
What dairy processors have done, in the past decade or so, is to find ways to develop tighter parameters on sanitation and process control through better analysis of data. This, combined with increased testing of incoming raw milk (and subsequent feedback and incentives to farm-based producers) has led to raw milk that is lower in somatic cell counts and fewer opportunities for it to become compromised during processing. It comes down to decreasing variability by having more information and greater control, says Wittenbrink, and this will continue to help dairies meet new requirements.
"No. 1 is that dairy processors have done a better job of developing prerequisite programs [sanitation and raw milk testing, and record keeping], and they have become more proactive. They have increased both food safety, which you would expect, but also quality."
Of course this requires that things like HACCP plans and GSFI standards become a part of the company's dairy operations, rather than just a book on the shelf or a plaque in the lobby. IDFAs Gardner says HACCP becomes part of a dairy's routine.
"A HACCP program is a living document, if you will. Once it is developed it has to be updated, and they actually follow it," Gardner says. "They have staff that keeps track of the program, and they are looking at it a great deal in every part of the manufacturing processes including management, QC, shipping and plant operations. It's an all-inclusive process."
Mike Giles is the general manager for BGC Manufacturing. Giles said increased emphasis on quality and the anticipation of FSMA led to additional staffing in Miller's QA department.
"We are looking at not only FSMA, but at a higher level of SQF (Safe Quality Food certification) at the same time," Giles says. "It really goes hand in hand."
Giles says the company's well-developed HACCP plan will be helpful but that Brookshire still expects that FSMA will bring considerable change.