On January 4, 2013, the FDA issued two rules implementing portions of the Food Safety Modernization Act. The first proposed rule focuses on the implementation of written plans to prevent contamination and respond in the event of contamination or an outbreak. It applies to domestic and foreign companies that manufacture, process, pack, or hold human food. Essentially, it covers facilities required to register with the FDA under its current food facility registration regulations. It requires companies to implement written plans to identify potential hazards, put in place steps to address hazards, verify that the steps are working, and outline how to correct any problems that arise. If this sounds familiar, it is because the hazard analysis and risk-based preventive controls are similar to the Hazard Analysis and Critical Control Points ("HACCP") system. The FDA intends to review and evaluate plans and inspect facilities to ensure the plans are implemented properly.
This rule is set to take effect 60 days after the final rule is published. Small businesses (those that employ fewer than 500 persons) will have two years after final publication to comply. The FDA is asking for comments related to the definition of "very small businesses." The FDA proposes three options to meet the criteria of very small business: less than $250,000, less than $500,000, or less than $1,000,000 in annual sales of food. Very small businesses will have three years after publication of the final rule to comply. Companies that do not meet the criteria for small or very small businesses will have one year to comply.
The second proposed rule focuses on produce. The FDA stated, "Foodborne illness outbreaks associated with contaminated produce over the last decade have highlighted the need to focus on preventing foodborne illness in the first place, and not just react once it happens." The FDA analyzed foodborne illness outbreak data between 1996 and 2010 and noted the main cause of these outbreaks were biological hazards such as Salmonella, E. coli O157:H7, Shigella, Hepatitis A, and Cyclospora. Accordingly, the proposed FDA produce rule focuses on preventing the introduction of known or reasonably foreseeable biological hazards.
The proposed produce rule covers farms; however, there are some exceptions. Farms will be exempt if they have food sales averaging less than $500,000 per year during the last three years and their sales to qualified end-users exceed their sales to others during the same period. A qualified end-user is either a consumer or a restaurant or retail food establishment located in the same state as the farm or not more than 275 miles away from the farm. If a farm is directly linked to an outbreak, the FDA may withdraw this partial exemption or if the FDA determines it is necessary to protect the public health and prevent or mitigate an outbreak the partial exemption may be withdrawn. Farms with an average annual value of food sold during the previous three-year period of $25,000 or less also would not be covered.
The proposed produce rule covers most fruits and vegetables while they are in their raw or natural (unprocessed) state. While the proposed rule covers fruits and vegetables grown for human consumption, it does not cover certain produce that constitute the lowest risk with respect to biological hazards. Examples include produce that is rarely consumed raw, such as potatoes, or that is bound for commercial processing, such as green beans destined for a canning operation.
The proposed produce rule sets science-based standards for the production and harvesting of fruits and vegetables to minimize the risk of serious adverse health consequences or death. The FDA proposes to set standards associated with identified routes of microbial contamination of produce, including: (1) agricultural water, (2) biological soil amendments of animal origin, (3) health and hygiene, (4) animals in the growing area, and (5) equipment, tools and buildings. In summary, the proposed rule requires the following:
- Agricultural Water: The rule proposes that all agricultural water be safe and of adequate sanitary quality for its intended use. The proposed rule would require that, at the beginning of the growing season, the agricultural water system components under a farm's control be inspected to identify conditions that are reasonably likely to introduce pathogens to produce or food-contact surfaces.
- Biological Soil Amendments: The rule proposes reasonable time intervals between the application of a biological soil amendment of animal origin and crop harvest. The proposed rule also has provisions pertaining to the handling and storage of biological soil amendments of animal origin.
- Health and Hygiene: The rule proposes basic hygienic practices to prevent bacteria, viruses, and parasites that are frequently transmitted from person to person and from person to food.
- Domesticated and Wild Animals: Where there is a reasonable probability that animals could contaminate produce, the rule proposes farms be required to take reasonable measures to prevent pathogens from being introduced onto the produce and not harvest produce that is visibly contaminated with animal excreta.
- Equipment, tools and buildings: The rule also proposes standards for sanitation used for produce operations on farms and for certain equipment, tools, buildings, and sanitation.
The proposed rules will remain open for comment for 120 days, after which time the FDA will issue its final rule. Companies affected by the proposed rules are encouraged to begin taking measures to comply. Despite the comment period, it is anticipated the final rules will be the same or contain substantially similar requirements as the proposed rules. The FDA also indicated it intends to issue rules implementing the FSMA's foreign supplier verification requirements "soon."
For further information, please contact any of the following Roetzel attorneys:
Ronald B. Lee
330.849.6648 | rlee@ralaw.com
Brian E. Dickerson
239.649.2702 | bdickerson@ralaw.com
John D. Rybarczyk
216.696.7794 | jrybarczyk@ralaw.com
Moira H. Pietrowski
330.849.6761 | mpietrowski@ralaw.com
Jonathan R. Secrest
614.723.2029 | jsecrest@ralaw.com