Ensuring Compliance Under The FDA's New Proposed Food Safety Rules

The Federal Food and Drug Administration (“FDA”)  has published its long-anticipated proposed rules on Preventive Controls for Human Food (written food safety plans) and Standards for Produce Safety.

According to the FDA, the two rules “are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (“FSMA”).”

The agency also claims that the new proposed rules “build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.”   

FDA also expects to soon issue its proposed rule on importer foreign supplier verification.  In the words of the agency, future proposed rules will address preventive controls for animal food, and also accreditation standards for third-party auditors.

In the paragraphs that follow, we take a few moments to break down the new rules into their most basic form.

Written Food Safety Plans (“HACCP”)

The most anticipated element of FSMA has been the requirement that all FDA regulated food companies develop and implement written food safety (or, HACCP) plans.  The proposed rule on preventive controls for human food (i.e., requiring written food safety pans) would apply to all facilities that manufacture, process, pack or hold human food. In general, with only some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations.  With that said, it will be critical to consult with legal counsel regarding the applicability of the new rules, as certain exemptions and modified requirements have been established for some discreet segments of the industry.

In its most basic form, the new FDA rule requires that firms develop and implement written food safety plans to identify potential food safety hazards, put into place steps to address those hazards, verify that the steps are working, and outline how to correct any problems that arise.  Under the new requirements, the written food safety plans should, at a minimum, include the following:

    a hazard analysis;
    risk based preventive controls;
    monitoring procedures;
    corrective actions;
     verification procedures; and
    record keeping.

In addition to creating plans that will pass the scrutiny of FDA, food companies will also need to demonstrate that these plans have been designed by a “qualified individual.”  In this regard, please contact us for additional information on this requirement, as well as each of the discrete additional regulatory requirements food companies will need to satisfy in order to demonstrate full compliance with FDA.  Click here to view a copy of the Proposed Preventative Controls Rule.

Future proposed rules will address importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.

New Produce Compliance Rules

In addition to publishing its proposed rules governing written food safety plans, FDA has also unveiled new rules governing produce production.  The new FDA proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing designed and validated to eliminate or reduce known pathogens.  The proposed rule focuses on various known areas of risk, and promulgates standards for the following:

    agricultural water;
    biological soil amendments;
    health and hygiene;
    domesticated and wild animals; and
    equipment, tools and buildings.

The proposed produce rule is, according to the agency, the result of extensive outreach by FDA with consumers, government, industry, researchers, and many others.   FDA has also stated that the produce rule is aimed at being flexible for different-sized farms, at complementing conservation laws and rules, and at not conflicting with laws and rules for organic farming.

With that said, it is important to note that certain farms would be exempt from most of the requirements if their sales average less than $500,000 per year during the last three years (adjusted for inflation), and if their sales to qualified end-users exceed their sales to others during the same period.  Moreover, according to the rule, any farms whose average annual value of food sold during the previous three-year period is $25,000 or less would not be covered by the rule.  Such farms would still be responsible for the safety of their produce, however, and the FDA maintains that the exceptions can be revoked under certain circumstances.  In addition, states and foreign countries will be permitted to seek variances from provisions of the rule because of local growing conditions.

Although the rule is still in its draft form, the general compliance date is currently anticipated to be two years after the effective date of the rule . For small businesses, the compliance date would be three years after the effective date, and for very small businesses four years after the effective date. Additional time would be allowed for compliance with certain water requirements.  Click here to view a copy of the Proposed Produce Rule.

Although FDA intends to publish various guidance materials to help industry meet the new requirements, the success of your business will ultimately depend upon your ability from a legal standpoint to demonstrate to FDA that you have achieved full compliance.  In this regard, please feel free to contact our firm for additional insight and information regarding the new proposed rules, and how to best (and most efficiently and quickly) satisfy the new requirements.