Overview of 2011 Food Safety Legislation

On Jan. 4, 2011, President Obama signed into law the Food Safety Modernization Act (“FSMA” or the “Act”), amending the Food, Drug and Cosmetic Act (“FDCA”). Congress passed the FSMA in direct response to recent food safety outbreaks and amid public scrutiny of the nation's food supply. The Act shifts the focus of the FDA from responding to contaminated food outbreaks to prevention of food-borne illness.

The FSMA's Provisions

The FSMA gives the FDA significant authority over food products, including mandatory recalls and expanded inspection authority. Although many of the FSMA provisions do not take effect immediately, a few significant requirements do, including: 1) the FDA's enhanced ability to inspect records; 2) the FDA's mandatory recall authority; 3) the FDA's authority to require imported food to have a certificate of compliance; and 4) the provisions allowing inspection of foreign food facilities. These provisions are discussed more fully below, in addition to some of the Act's other key provisions.

Title I: Improving Capacity to Prevent Food Safety Problems

Title I of the Act addresses various measures focused on enhancing the FDA's ability to monitor and regulate safety procedures in food facilities. (Under the Act, the term “food facility” is defined as “any factory, warehouse, or establishment [including a factory, warehouse, or establishment of an importer] that manufactures, processes, packs, or holds food. Such term does not include farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, or fishing vessels [except such vessels engaged in processing as defined in Section 123.3(k) of title 21, Code of Federal Regulations].”) 21 U.S.C. 350d(b).) Title I requires food facility owners to implement hazard analyses, subject to future regulation by the FDA, and also authorizes the FDA to suspend food facilities' registration and operation where the FDA determines the facilities' products pose a risk of “serious adverse health consequences.” Title I further requires the FDA to evaluate and issue guidance and regulations regarding produce safety, certain food contaminants, protection against intentional adulteration, and the sanitary transportation of food. Key provisions of Title I include:

Sec. 102. Registration of food facilities. Section 102 of the Act expands the food facility registration requirement by: 1) requiring biennial renewal by registrants; 2) giving the FDA the authority to suspend a registration if it deems a food associated with that facility to have “a reasonable probability of causing serious adverse health consequences or death to humans or animals”; and 3) giving the FDA the discretion to require a registration for “any other food categories” it determines appropriate, whether by regulation or guidance. While the Act provides affected facility owners “an opportunity for an informal hearing” before the FDA, it is silent as to judicial review of agency proceedings under Section 102.

Sec. 103. Hazard analysis and risk-based preventive controls. Section 103 of the Act requires food facilities to have various controls in place. Specifically, each owner, operator, or agent in charge of a food facility must: 1) evaluate the hazards that could affect the applicable food products; 2) identify and implement preventive controls to “significantly minimize or prevent” those hazards and provide assurances that the food is not adulterated or misbranded; 3) monitor the performance of those preventive controls; and 4) maintain records of such routine monitoring. These requirements take effect 18 months after the date of enactment.

Sec. 105. Produce safety. Section 105 establishes science-based minimum standards for the safe production and harvesting of the types of fruits and vegetables that are “raw agricultural commodities” for which the FDA has determined that “such standards minimize the risk of serious adverse health consequences or death.” These standards must consider not only man-made risks to fresh produce safety, but also naturally occurring hazards such as those posed by the soil, animals, and water. The FDA is required to promulgate these regulations in coordination with the USDA, state departments of agriculture, and in consultation with Homeland Security.

Title II: Improving Capacity to Detect and Respond To Food Safety Problems

Title II of the Act addresses responsive measures to prevent food safety problems, particularly by authorizing the FDA to order mandatory recalls of hazardous food. Further, Title II allows the FDA to increase its inspections of food facilities, to track food products, to survey food-borne illness outbreaks in coordination with state and local authorities, and to establish a program for testing food by accredited laboratories. Key provisions of Title II include:

Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. Section 201 requires the FDA to increase the frequency of inspections. As an initial matter, the FDA must inspect high-risk domestic food facilities within the next five years. These same facilities must be inspected no less than every three years thereafter. During the next year, the FDA must also inspect at least 600 foreign food facilities and double the number of those inspections every year for the next five years. If an importer refuses U.S. inspection, the FDA now has the authority to refuse entry into the United States.

Sec. 206. Mandatory recall authority. Section 206 of the Act amends the FDCA to add Section 423, which provides the FDA the legal authority to order the recall of dangerous foods. Up until now, the FDA has had authority to order the recall of infant formula, but could only ask, not demand, that other foods be recalled.

Under its new authority, the FDA can order a responsible party to recall a food product if there is a reasonable probability the food is adulterated or misbranded and its use “will cause serious adverse health consequences or death to humans or animals.” This language matches the criteria for a Class I recall, the most serious type, previously defined in the FDA's regulations.

Under the new provisions, the FDA must first provide the responsible party with an opportunity to cease distribution and recall the product voluntarily. If that party fails to do so on the FDA's timeline, the FDA may issue an order requiring an immediate recall. The responsible party may dispute the FDA's recall order at an informal hearing. Civil penalties and fees may be assessed against any party who does not comply with a recall order.

Sec. 207. Administrative detention of food. Section 207 of the Act strengthens the FDA's authority to order an administrative detention of food by broadening the standard from “credible evidence or information” to that of “reason to believe,” and “presents a threat of serious health consequences or death to humans or animals” to “adulterated or misbranded.”

Title III: Improving Safety of Imported Food

Title III of the Act addresses the safety of imported food by requiring importers to verify that food is “produced in compliance with the requirements of section 418 [hazard analyses] or section 419 [produce safety regulations]” and “ is not adulterated ' or misbranded under [21 U.S.C. 343(w)].” Section 303 of the Act requires refusal of admission of any imported food that fails to meet certification requirements. Further, section 306 requires the refusal of admission into the U.S. of any imported food from a foreign facility to which a U.S. inspector refused entry for inspection.

Potential Legal Impact

While the Act substantially increases the FDA's authority to ensure the safety of the nation's food supply, it leaves many questions unanswered. Many of the Act's key provisions rely on FDA regulations that will be implemented at a future date. Further, food manufacturers may have legitimate concerns regarding the extent to which they must simultaneously comply with federal regulations and regulations imposed under state law. Although the Act does not include an express preemption provision, it does expressly allow concurrent regulation under state law with respect to provisions regarding the safety of produce. Still, other provisions are silent regarding state regulation.

That said, the scope of federal preemption of state law claims remains uncertain. Based on the current state of the implied preemption defense at the Supreme Court and lower court levels, any implied preemption argument that the FSMA prohibits parallel state regulation may face legal challenge.

For example, in Wyeth v. Levine, 129 S. Ct. 1187 (2009), the Supreme Court recently rejected the FDA's position that requirements imposed under the FDCA “established both a floor and a ceiling for drug regulation,” holding that FDA regulation of prescription drug labeling did not preempt claims under state law that the label should have been stronger. Id. at 1204. The Court stressed “the longstanding coexistence of state and federal law and the FDA's traditional recognition of state-law remedies.” Id. at 1199-1203.

In the context of food litigation, particularly food labeling and branding, defendants have had similar difficulties arguing that implied preemption exists. See Holk v. Snapple Beverage Corp., 575 F.3d 329, 334 (3rd Cir. 2009) (noting that there is a “presumption against preemption” and that health and safety issues including the labeling and branding of food, has “traditionally fallen within the province of state regulation”); Wright v. General Mills, Inc., 2009 WL 3247148 (S.D. Cal. Sept. 30, 2009) (denying defendant's motion to dismiss based on implied preemption because “natural” has not been defined by the FDA, which would be binding authority, and plaintiff was able to go forward with her contention that a product may be misleading to consumers when it is labeled as natural or misleading to consumers when it is labeled or advertised as 100% natural but contains high-fructose corn syrup).

Conclusion

Although the FSMA has been heralded as bringing about an overhaul of the U.S. food system, questions remain as to its full force and effect. Certain aspects of the Act take effect immediately, while other regulations will be promulgated over the ensuing months and years. Not only will clarification of the Act's requirements be of paramount concern to those in the industry, particularly with respect to the expansive powers granted to the FDA, but its broad language may raise new legal concerns in the future.

Vivan M. Quinn, a member of this newsletter's Board of Editors, is a partner and Tracy B. Ehlers an associate in Nixon Peabody LLP's Products: Class Action, Trade and Industry Representation Group. Their practices involve the health effects of food, chemicals, and medical products, and they devote a significant amount of time to defending medical device and pharmaceutical companies as well as counseling clients regarding safety and regulatory compliance.

On Jan. 4, 2011, President Obama signed into law the Food Safety Modernization Act (“FSMA” or the “Act”), amending the Food, Drug and Cosmetic Act (“FDCA”). Congress passed the FSMA in direct response to recent food safety outbreaks and amid public scrutiny of the nation's food supply. The Act shifts the focus of the FDA from responding to contaminated food outbreaks to prevention of food-borne illness.

The FSMA's Provisions

The FSMA gives the FDA significant authority over food products, including mandatory recalls and expanded inspection authority. Although many of the FSMA provisions do not take effect immediately, a few significant requirements do, including: 1) the FDA's enhanced ability to inspect records; 2) the FDA's mandatory recall authority; 3) the FDA's authority to require imported food to have a certificate of compliance; and 4) the provisions allowing inspection of foreign food facilities. These provisions are discussed more fully below, in addition to some of the Act's other key provisions.

Title I: Improving Capacity to Prevent Food Safety Problems

Title I of the Act addresses various measures focused on enhancing the FDA's ability to monitor and regulate safety procedures in food facilities. (Under the Act, the term “food facility” is defined as “any factory, warehouse, or establishment [including a factory, warehouse, or establishment of an importer] that manufactures, processes, packs, or holds food. Such term does not include farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, or fishing vessels [except such vessels engaged in processing as defined in Section 123.3(k) of title 21, Code of Federal Regulations].”) 21 U.S.C. 350d(b).) Title I requires food facility owners to implement hazard analyses, subject to future regulation by the FDA, and also authorizes the FDA to suspend food facilities' registration and operation where the FDA determines the facilities' products pose a risk of “serious adverse health consequences.” Title I further requires the FDA to evaluate and issue guidance and regulations regarding produce safety, certain food contaminants, protection against intentional adulteration, and the sanitary transportation of food. Key provisions of Title I include:

Sec. 102. Registration of food facilities. Section 102 of the Act expands the food facility registration requirement by: 1) requiring biennial renewal by registrants; 2) giving the FDA the authority to suspend a registration if it deems a food associated with that facility to have “a reasonable probability of causing serious adverse health consequences or death to humans or animals”; and 3) giving the FDA the discretion to require a registration for “any other food categories” it determines appropriate, whether by regulation or guidance. While the Act provides affected facility owners “an opportunity for an informal hearing” before the FDA, it is silent as to judicial review of agency proceedings under Section 102.

Sec. 103. Hazard analysis and risk-based preventive controls. Section 103 of the Act requires food facilities to have various controls in place. Specifically, each owner, operator, or agent in charge of a food facility must: 1) evaluate the hazards that could affect the applicable food products; 2) identify and implement preventive controls to “significantly minimize or prevent” those hazards and provide assurances that the food is not adulterated or misbranded; 3) monitor the performance of those preventive controls; and 4) maintain records of such routine monitoring. These requirements take effect 18 months after the date of enactment.

Sec. 105. Produce safety. Section 105 establishes science-based minimum standards for the safe production and harvesting of the types of fruits and vegetables that are “raw agricultural commodities” for which the FDA has determined that “such standards minimize the risk of serious adverse health consequences or death.” These standards must consider not only man-made risks to fresh produce safety, but also naturally occurring hazards such as those posed by the soil, animals, and water. The FDA is required to promulgate these regulations in coordination with the USDA, state departments of agriculture, and in consultation with Homeland Security.

Title II: Improving Capacity to Detect and Respond To Food Safety Problems

Title II of the Act addresses responsive measures to prevent food safety problems, particularly by authorizing the FDA to order mandatory recalls of hazardous food. Further, Title II allows the FDA to increase its inspections of food facilities, to track food products, to survey food-borne illness outbreaks in coordination with state and local authorities, and to establish a program for testing food by accredited laboratories. Key provisions of Title II include:

Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. Section 201 requires the FDA to increase the frequency of inspections. As an initial matter, the FDA must inspect high-risk domestic food facilities within the next five years. These same facilities must be inspected no less than every three years thereafter. During the next year, the FDA must also inspect at least 600 foreign food facilities and double the number of those inspections every year for the next five years. If an importer refuses U.S. inspection, the FDA now has the authority to refuse entry into the United States.

Sec. 206. Mandatory recall authority. Section 206 of the Act amends the FDCA to add Section 423, which provides the FDA the legal authority to order the recall of dangerous foods. Up until now, the FDA has had authority to order the recall of infant formula, but could only ask, not demand, that other foods be recalled.

Under its new authority, the FDA can order a responsible party to recall a food product if there is a reasonable probability the food is adulterated or misbranded and its use “will cause serious adverse health consequences or death to humans or animals.” This language matches the criteria for a Class I recall, the most serious type, previously defined in the FDA's regulations.

Under the new provisions, the FDA must first provide the responsible party with an opportunity to cease distribution and recall the product voluntarily. If that party fails to do so on the FDA's timeline, the FDA may issue an order requiring an immediate recall. The responsible party may dispute the FDA's recall order at an informal hearing. Civil penalties and fees may be assessed against any party who does not comply with a recall order.

Sec. 207. Administrative detention of food. Section 207 of the Act strengthens the FDA's authority to order an administrative detention of food by broadening the standard from “credible evidence or information” to that of “reason to believe,” and “presents a threat of serious health consequences or death to humans or animals” to “adulterated or misbranded.”

Title III: Improving Safety of Imported Food

Title III of the Act addresses the safety of imported food by requiring importers to verify that food is “produced in compliance with the requirements of section 418 [hazard analyses] or section 419 [produce safety regulations]” and “ is not adulterated ' or misbranded under [21 U.S.C. 343(w)].” Section 303 of the Act requires refusal of admission of any imported food that fails to meet certification requirements. Further, section 306 requires the refusal of admission into the U.S. of any imported food from a foreign facility to which a U.S. inspector refused entry for inspection.

Potential Legal Impact

While the Act substantially increases the FDA's authority to ensure the safety of the nation's food supply, it leaves many questions unanswered. Many of the Act's key provisions rely on FDA regulations that will be implemented at a future date. Further, food manufacturers may have legitimate concerns regarding the extent to which they must simultaneously comply with federal regulations and regulations imposed under state law. Although the Act does not include an express preemption provision, it does expressly allow concurrent regulation under state law with respect to provisions regarding the safety of produce. Still, other provisions are silent regarding state regulation.

That said, the scope of federal preemption of state law claims remains uncertain. Based on the current state of the implied preemption defense at the Supreme Court and lower court levels, any implied preemption argument that the FSMA prohibits parallel state regulation may face legal challenge.

For example, in Wyeth v. Levine , 129 S. Ct. 1187 (2009), the Supreme Court recently rejected the FDA's position that requirements imposed under the FDCA “established both a floor and a ceiling for drug regulation,” holding that FDA regulation of prescription drug labeling did not preempt claims under state law that the label should have been stronger. Id. at 1204. The Court stressed “the longstanding coexistence of state and federal law and the FDA's traditional recognition of state-law remedies.” Id. at 1199-1203.

In the context of food litigation, particularly food labeling and branding, defendants have had similar difficulties arguing that implied preemption exists. See Holk v. Snapple Beverage Corp. , 575 F.3d 329, 334 (3rd Cir. 2009) (noting that there is a “presumption against preemption” and that health and safety issues including the labeling and branding of food, has “traditionally fallen within the province of state regulation”); Wright v. General Mills, Inc., 2009 WL 3247148 (S.D. Cal. Sept. 30, 2009) (denying defendant's motion to dismiss based on implied preemption because “natural” has not been defined by the FDA, which would be binding authority, and plaintiff was able to go forward with her contention that a product may be misleading to consumers when it is labeled as natural or misleading to consumers when it is labeled or advertised as 100% natural but contains high-fructose corn syrup).

Conclusion

Although the FSMA has been heralded as bringing about an overhaul of the U.S. food system, questions remain as to its full force and effect. Certain aspects of the Act take effect immediately, while other regulations will be promulgated over the ensuing months and years. Not only will clarification of the Act's requirements be of paramount concern to those in the industry, particularly with respect to the expansive powers granted to the FDA, but its broad language may raise new legal concerns in the future.

Vivan M. Quinn, a member of this newsletter's Board of Editors, is a partner and Tracy B. Ehlers an associate in Nixon Peabody LLP's Products: Class Action, Trade and Industry Representation Group. Their practices involve the health effects of food, chemicals, and medical products, and they devote a significant amount of time to defending medical device and pharmaceutical companies as well as counseling clients regarding safety and regulatory compliance.