It’s been two years since President Obama signed the Food Safety Modernization Act (FSMA) – the biggest change to food safety laws in the last seventy years. It wasn’t until last week, however, that the Food and Drug Administration (FDA) released two proposed rules that will provide enforcement guidelines for the Food Safety Modernization Act.
The two rules are particularly important because they cover fruits and vegetables and the rest of the 80 percent of the nation’s food supply that is regulated by FDA. The U.S. Department of Agriculture handles the rest of the food supply, which is mostly meat, fish, and other animal products.
The two proposed rules that were released last week deal with “Preventive Controls for Human Food” as well as “Standards for Produce Safety.”
Proposed Standards for Produce Safety
This rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or used for commercial processing that will reduce health concerns. The proposed rule focuses on several areas of risk, including:
- agricultural water
- biological soil amendments
- health and hygiene
- domesticated and wild animals
- equipment, tools and buildings.
The produce rule is the result of extensive outreach by FDA to consumers, government, industry, researchers, and others. The proposed rule builds on existing voluntary industry guidelines for food safety, which many growers and processors currently follow. The rule is designed to be flexible for farms of varying size, at complementary to conservation regulations, and at not conflicting with laws and rules for organic farming.
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 their sales to qualified end-users – like restaurants or consumers – exceed their sales to others, such as processors or bulk handlers, during the same period, with some exceptions. In addition, farms with an average annual value of food sold during the previous three-year period is $25,000 or less would not be covered by the rule. These farms would still be responsible for the safety of their produce. Additionally, states and foreign countries can seek variances from provisions of the rule because of local growing conditions.
While the effective date for this rule would be 60 days from publication of the final rule, the general compliance date would be two years after the effective date. 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.
Preventive Controls for Human Food
The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, the new preventive control provisions would apply to facilities that are already required to register with FDA. A number of exemptions and modified requirements are also included in the rule.
The rule proposes firms have written plans in place to identify potential hazards, establish steps to address them, verify that the steps are working, and detail how to correct any problems that may arise in the future.
The rule proposes each covered facility to prepare and implement a written food safety plan that addresses:
- hazard analysis
- risk based preventive controls
- monitoring procedures
- corrective actions
- record keeping
More Rules to Come
There are still three other key draft rules that remain under review at the Office of Management and Budget. Two of those rules have been there for over a year and deal with verification of foreign suppliers and preventive controls for the feed industry. The third rule is about third-party audit certification, which has only recently been submitted to OMB. All of these rules are also subject to the ability of FDA to enforce them, as appropriations bills in recent years have cut or limited FDA’s capabilities.
Still, the rules offer modest direct enforcement from FDA, which has a limited budget which could grow smaller in the coming months, as well as a limited number of inspectors. FDA monitors about 166,000 food production facilities that account for about 80 percent of the food that is consumed in the U.S.
More information about the proposed rules and the docket for submitting comments can be found at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm261689.htm