By Kevin Westerling,
Due to new rules proposed by the FDA, monitoring services and new pumps will likely be shopping-list items for food processors.
As the food industry is well aware, the 2011 FDA Food Safety Modernization Act (FSMA) mandated that the U.S. Food & Drug Administration (FDA) develop minimum standards for food safety to help curtail foodborne illnesses. According to the Centers for Disease Control and Prevention (CDC), these illnesses cause 48 million Americans (1 in 6) to get sick each year, including 128,000 hospitalizations and 3,000 deaths. Two of the seven proposed rules pertain to water and water-related equipment; with the comment periods on both of those rules now closed, their impact will soon be felt by food processors.
A press release from Frost & Sullivan detailed one of these impacts — a significant boost in sales for centrifugal and positive displacement (PD) pumps. What’s the connection to food safety and water quality? To get the answers, I turned to Anand MG, Frost & Sullivan’s industrial automation and process control industry manager. He provided insight on the two upcoming FDA rules applicable to water, and their repercussions for food suppliers, consumers, and water technology providers.
Produce Safety Rule
The Produce Safety Rule has a wide scope (read in full here), with subparts including the following: Agricultural Water; Biological Soil Amendments; Domesticated and Wild Animals; Equipment, Tools, Buildings, and Sanitation; and Sprouts.
With regard to water quality, it’s all about Agricultural Water: Subpart E, which essentially states that any water that will come in contact with fruits or vegetables — also water used for handwashing during and after harvest — must be regularly monitored. Sources subject to monitoring include groundwater and surface water (with different regulatory parameters for varying sources), but not public water systems. The rule affects growers and harvesters, as well as anyone associated with the packing and holding of covered produce. Therefore, in addition to irrigation water, the rule also applies to water used for washing, cleaning, cutting, or slicing processes. The FDA will require inspection, maintenance, monitoring, and follow-up actions related to these activities.
According to Frost & Sullivan’s MG, water-quality monitoring requirements will likely be handled through third-party lab testing. If a contaminant is found, it is also incumbent upon the business to have a contingency plan in place to neutralize the contaminant(s).
The comment period on the proposed rule had closed on March 15, 2014, but the National Association of State Departments of Agriculture (NASDA) and other groups fought for an extension due to concerns over the burden of compliance for produce growers.
“Compliance with water quality standards promulgated in the proposed rule will be the single greatest obstacle for fruit and vegetable producers regulated under the rule,” NASDA stated. “Many farms that use surface water indicate that the water quality requirements and testing intervals proposed in the rule will put farms out of business.”
The expiration date on comments has been removed, as decided by court settlement, but Underwriters Laboratories Inc. (UL) reports that a deadline of October 31, 2015 has been installed for final rulemaking.
Once the final rule is effective — 60 days after publication — large businesses will have two years to comply. Extremely small farms/businesses with annual sales of less than $25,000 are exempt, while FDA-designated “very small businesses” (average annual value of food sold >$25,000 and ≤$250,000) have four years to comply and “small businesses” (average annual value of food sold >$250,000 and ≤$500,000) have three years. The FDA states that qualified exemptions and modified requirements can also be granted.
Preventive Controls Rule
The proposed rule on Preventive Controls for Human Food is less focused on water per se, but is applicable to pumps and other water-handling equipment used in food processing. Businesses that manufacture, process, pack, or hold human food are required to have a written food safety plan in place to prevent and resolve threats to food contamination. The plan must address hazard analysis and prevention, monitoring and recording procedures, steps for corrective action, and verification that the plan is being effectively followed.
One area of concern, under the category of hazard prevention, is the cleanliness of equipment that comes in contact with food — including water used in food processing — thus giving rise to the need for clean-in-place (CIP), stainless steel pumps.
Centrifugal, PD pumps, and gear pumps are all common in food processing, according to MG, but the latter may fall out of favor due to the Preventative Controls Rule. This is particularly true for FDA-classified “high-risk” facilities, which must undergo FDA inspection every three years. “Low-risk” facilities, meanwhile, are subject to inspection every five years.
Pumps that aren’t CIP and stainless may pose biological, chemical, and physical threats to process water and food. Biological threats are germs and viruses; chemical threats can derive from cleaning-fluid residue, for instance; and physical threats may include small metal parts released during pump thrust.
MG projected that most large-scale businesses will already be in compliance with the proposed law due to adherence to Global Food Safety Initiative (GFSI) benchmarking. Once again, the compliance schedule is dependent on size of business, and is effective 60 days from publication of the rule.
- Very small businesses (three-year compliance) — The FDA has proposed three options for defining a “very small business”: those generating less than $250,000, less than $500,000, or less than $1,000,000 in total annual sales of food, adjusted for inflation.
- Small businesses (two-year compliance) — Defined as a business employing fewer than 500 people that does not qualify for an exemption.
- Other businesses (one-year compliance) — A business that is not “small,” “very small,” or qualified for an exemption.
While many laud the upcoming rules as a win for consumer safety, smaller farms and businesses fear economic loss. With the comment period open once again, all sides are encouraged to weigh in before it’s too late.