Key Elements of the Food Safety Modernization Act of 2010
The Food Safety Modernization Act (the Act) contains various sweeping provisions that will expand the FDAs power to regulate food facilities. With provisions for a more stringent registration process, the Act provides for increased oversight by the FDA. In addition to the registration process, another feature added by the Act requires food facilities to formulate and implement various procedures to combat risks that may otherwise lead to contamination. The Act also provides for the regulation of produce safety, which calls for the FDA to engage in rulemaking to establish standards for the production and harvesting of fruits and vegetables. Finally, and most troubling to some, is the power the Act gives to the FDA to issue mandatory recalls. Although many of the provisions in the Act contain exemptions, they are very restricted and only the smallest of businesses and farms may apply.
A. Changes to the Registration Process
Several changes are made to the food facility registration process by the Act. First, the Act contains a provision that requires all registrants to renew their registration every two years, regardless of whether any problems have occurred in connection with their facility. Second, greater detail is provided which will aid in determining whether the primary function of an establishment is retail-based, as opposed to being a food facility. Third, the Act contains provisions for suspension of registrations by the Agency, which can be implemented immediately by the issuance of an order.
1. Biennial Registration of Food Facilities
The Act provides for the mandatory renewal of registration with the FDA every two years for registered food facilities. However, there will be an abbreviated renewal process where a registrant “. . . has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.” While the Act does not contain the substance of this abbreviated process, the Secretary is authorized to formulate this process under the Act.
Mandatory biennial registration renewal alters the current framework, as the FD&C Act does not mandate renewal once the registration process is complete. Additionally, it must be noted that this requirement is not restricted to those who have gotten into trouble with the Agency. Rather, this provision applies to all registrants under the Act.
2. Changed Definition of “Retail Food Establishment”
The Act clarifies definition of “retail food establishment”, to guide the Agency in determining whether an establishments primary function may be properly called a “food facility.” Under the FD&C Act, retail food establishments are not considered “facilities” for the purposes of registration.
While the Act does not change this exemption, it explicitly lists three types of sales that would be considered activities undertaken by retail food establishments. First, when considering the primary function of an establishment, the direct sale of food to consumers at roadside stands or farmers markets is considered an activity of a retail food establishment. Second, the sale and distribution of food through a community supported agricultural program is considered an activity of a retail food establishment. Finally, the Act provides a catch-all exemption to any other direct platform for sale and distribution of food that the Secretary deems proper.
3. Suspension of Registration
The Act authorizes the Agency to suspend the registration of a food facility if the food manufactured, processed, packed, or held by the facility has a “reasonable probability” of causing serious adverse health consequences or death to humans or animals. If registration is suspended, no one may import or export food to or from the United States from such facility, or otherwise introduce food into commerce.
Under this provision, the Agency can suspend the registration of a facility by order, in certain enumerated circumstances. First, registration may be suspended it is determined that the facility “created, caused, or was otherwise responsible. . .” for the reasonable probability of serious adverse health consequences. Second, a facility may have its registration suspended where the facility: 1. either “knew of, or had reason to know of, such reasonable probability, and” 2. “packed, received or held such food.”
Once an order for the suspension of registration has been issued, the Act further provides the registrant an opportunity for an informal hearing. However, this hearing may not be held more than 2 business days after the issuance of the order, unless otherwise agreed by both parties. The substance of the hearing is to concern “. . . the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated.” “The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.” Additionally, it must be noted that the Act prohibits the delegation of authority to suspend or vacate an order of suspension to anyone other than the Commissioner.
B. Hazard Analyses and Risk-Based Preventive Controls
The Act requires owners, operators, or agents in charge of facilities to formulate and implement various procedures to deal with problems that may arise during the course of business. These procedures include things like: developing a written hazards analysis, implementing preventive controls and a means of monitoring these preventive measures, a planned course of corrective action to take if the preventive measures are faulty, etc. Further, the Act provides that the person “. . . in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with [these requirements].”
These provisions apply to facilities where food is manufactured, processed, packed, or held. However, there are provisions under the Act to allow flexibility for small businesses. “A qualified facility . . . shall not be subject to the requirements under subsections (a) through (i) and subsection (n) in an applicable calendar year.” If qualified under this provision, these facilities do not need to comply with a number of requirements, but must still file documentation to show that the facility has identified hazards and is in compliance with other (non-federal) law.
To be considered a “qualified facility” under the Act, there are two separate routes that a facility may take. The first means of qualification is to be deemed a “very small business,” which Congress has mandated the Secretary define no later than 18 months after the enactment of the Act. Second, a facility may qualify if it has only a limited monetary value of sales, which requires two conditions be met. First, during the three-year period preceding the applicable calendar year, the average annual monetary value of the food sold directly to qualified end-users must be greater than the value sold to all other purchasers during the period. Second, the annual average monetary value of food sold during the period must be less than $500,000 (adjusted for inflation).
C. Standards for Produce Safety
The Act contains provisions requiring the FDA to promulgate standards to ensure the safe production and harvest of fruits and vegetables. As required in the Act, within one year from the date of enactment, the Secretary “. . . shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities [which are determined by the Secretary to minimize health risks].”
This Section also provides the FDA with the express authority to exempt small businesses and very small businesses from the promulgated standards where these businesses produce and harvest fruits and vegetables that the FDA determines to be low risk. The FDA may also modify the rules applicable to these businesses under this Section. The Act also expressly exempts produce produced by individuals for their personal consumption from the requirements of this Section.
Additionally, the Act contains an exemption for direct farm marketing if two conditions are met. First, “the average annual monetary value of food sold by such farm directly to qualified end-users. . .” must exceed the average annual value of the food sold to all other buyers during the period. Under the Act, “qualified end users” are either consumers (not businesses) or restaurants or retail food establishments. However, in order for a restaurant or retail food establishment to be considered a qualified end user, the establishment must be located within the same state as the farm that produced the food or within 275 miles from the farm. Second, the average annual monetary value of all food sold must be less than $500,000 (adjusted for inflation).
D. Mandatory Recall Authority
The Act provides the FDA with the authority to issue a mandatory recall authority where the FDA determines there is a reasonable probability that a food is adulterated or misbranded and exposure to the article will cause serious adverse health consequences to humans or animals and the parties do not voluntarily cease distribution of the food. Before issuing a mandatory recall, “the Secretary shall provide the responsible party with an opportunity to cease distribution and recall such article.” However, if the responsible party does not voluntarily comply, the Agency may, by order, require the party to immediately cease distribution of the article and may notify all persons involved in the manufacturing, distribution, importing, packing, etc., and require these persons to cease distribution of the article.
In sum, the Food Safety Modernization Act sets forth a number of important changes to the current framework. Because of these changes, it may be seen as a sweeping piece of legislation that increases the FDAs authority in a number of areas. While some of the Acts provisions are aimed at providing greater detail to the current framework, several sections break new ground and delve into new areas that the FDA had yet to regulate.
This entry was posted on Wednesday, December 15th, 2010 at 12:42 pm and is filed under FDA.
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