In a long-awaited and highly anticipated announcement, the Food and Drug Administration (FDA or the Agency) just released two of five major proposals to implement fundamental provisions of the FDA Food Safety Modernization Act (FSMA or the Act). FSMA was enacted with much fanfare in January 2011, with the goal of enhancing the safety of the US food supply and preventing foodborne illness outbreaks. The Agency rulemaking process has been lengthy and has involved significant consultations with industry stakeholders and other regulatory bodies, including state agencies and foreign governments.

These first two Proposed Rules would establish standards for hazard analysis and risk-based preventive controls for human food, as well as standards for produce safety. Proposals to implement other FSMA-mandates for foreign supplier verification and third-party audit certification programs, as well as preventive controls for animal food and feed, are expected to be released “soon,” according to FDA Deputy Commissioner for Foods Michael Taylor.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

FSMA requires each non-exempt registered food facility (both domestic and foreign) to conduct periodic analyses of potential contamination hazards and to implement preventive controls to mitigate or prevent those hazards. Preventive controls include such things as employee hygiene training, good manufacturing practices, allergen control programs, sanitation procedures, supplier verification activities, environmental testing programs, and a recall plan. The Act also requires FDA to promulgate regulations establishing “science-based minimum standards” for analyzing hazards and implementing preventive controls.

FDA’s newly released proposal to implement these requirements of FSMA would create Part 117 in Title 21 of the Code of Federal Regulations. The new Part 117 would build on industry-pioneered HACCP programs (Hazard Analysis & Critical Control Points) that are currently in place for seafood, juice, and low-acid canned food facilities and also would modernize the existing current good manufacturing practice (cGMP) regulations contained in Part 110. Due to the staggered compliance periods proposed for new Part 117 (described below), the general cGMP requirements of Part 110 would remain in effect for three years after the modernized cGMP/HACCP regulations go into effect in order to ensure that all businesses can remain in compliance with Agency standards until the date when they must be in compliance with the more demanding requirements of Part 117.

Generally, the proposal would require most registered food facilities to have in place a written food safety plan that would:

1. Analyze potential natural, unintentional, and intentional hazards, including biological, chemical, physical, and radiological hazards.
   
   
2. Identify appropriate preventive controls to prevent or significantly minimize the hazards that are reasonably likely to occur and to ensure that food is not adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act; preventive controls should include the maximum and minimum parameters determined necessary to control such hazards, as well as a written recall plan for any food with hazards identified as reasonably likely to occur.
   
   
3. Monitor the facility’s preventive controls to determine their effectiveness and whether they are being consistently performed.
   
   
4. Delineate appropriate corrective actions if the preventive controls are found to be ineffective or not properly implemented. The corrective actions should ensure that appropriate action is taken to reduce the likelihood of a recurrence, that all affected food is evaluated for safety, and that all affected food is prevented from entering into commerce if the facility cannot ensure that the food is not adulterated or misbranded.
   
   
5. Require certain verification activities, such as verification that the facility is making appropriate decisions about corrective actions.
   
   

The proposal also includes recordkeeping provisions for a covered food facility, such as records of its corrective actions and verification activities. A facility’s food safety plan would need to be reanalyzed at least once every three years, unless certain changes require an earlier reanalysis. Further, a “qualified individual” would be responsible for preparing the written food safety plan, validating preventive controls, conducting verification activities, reviewing records, and reanalyzing the facility’s food safety plan when necessary. FDA’s Proposed Rule seeks comments regarding the qualification requirements it should establish for the “qualified individual.”

Moreover, while the Proposed Rule itself does not require that certain types of preventive controls be incorporated — such as product testing, environmental monitoring, or supplier approval and verification — these “elements of a preventive controls system” are discussed extensively in the rule’s Appendix. Agency watchers consider the inclusion of the appendix discussions to be an indication that these other preventive controls could be integrated into the Final Rule pending further evaluation, so stakeholders are encouraged to review and comment on all parts of the Proposed Rule and the Appendix.

The Proposed Rule also would establish and seeks comments on various exemptions to the requirements for hazard analysis and preventive controls. Facilities already in compliance with HACCP rules (i.e., seafood, juice, and low-acid canned food activities), as well as dietary supplement facilities subject to separate cGMP regulations, would be exempted from Part 117. In addition, facilities (such as warehouses) that only store packaged foods that are not exposed to the environment may be exempt if the food does not require any refrigeration — or else they may be subject to modified preventive controls if the packaged foods require refrigeration for safety. Facilities (such as grain elevators) that store raw agricultural commodities intended for further distribution or processing would be exempt from the new requirements, and most facilities handling fruits and vegetables also would be exempt because they would be subject to the Standards for Produce Safety discussed in the next section. Also exempt would be “qualified facilities” that meet the future regulatory definition of a “very small business” or whose average monetary value of food manufactured, processed, packed, or held by the facility and sold directly to consumers or restaurants located within a 275-mile radius of the facility is not more than $500,000 per year.

Compliance dates for these new preventive standards for human food would be staggered to allow smaller business additional time to comply. The majority of non-exempt food facilities would be required to comply within one year after publication of the Final Rule, but “small” and “very small” businesses would be given compliance dates within two and three years, respectively, of publication of the Final Rule. As part of this rulemaking notice, FDA is seeking input on three possible definitions of “very small business” for purposes of new Part 117.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

The Act also requires FDA to promulgate regulations establishing minimum standards for the safe production, harvesting, and handling of produce deemed to have a high risk of contamination. FDA’s Proposed Rule to establish those produce standards would apply to domestic and imported fruits and vegetables grown for human consumption and focuses on microbiological hazards to the raw or natural (unprocessed) produce. An Agency risk assessment led to the decision to omit chemical, physical, and radiological hazards to produce contamination, at least for the present time. FDA notes that the 131 outbreaks of foodborne illness documented between 1996 and 2010 and associated with contaminated produce were caused mainly by biological hazards (e.g., Salmonella, E. coli, Listeria).

The proposal would create new 21 C.F.R. Part 112 and would target commodities and practices for which FDA believes intervention can minimize the risk of serious adverse health consequences or death to consumers of fresh produce. FDA is proposing to establish “science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms” in five key areas known to be major pathways for the introduction of microbiological hazards. The five areas and examples of the types of standards that would be required are:

1. Employee health and hygiene. For example, the rule would establish training requirements for workers who handle produce and hygienic practices to prevent all persons, including visitors, from contaminating produce.
   
   
2. Agricultural water, which would be defined as water that is intended to, or likely will, come into contact with the harvestable portion of produce. For example, the rule would require treatment of agricultural water if the farm knows or has reason to believe that the water is not safe for its intended use.
   
   
3. Biological soil amendments (i.e., anything biological added to the soil to improve its physical properties, such as composted manure). For example, the rule would establish requirements for the treatment of and application of soil amendments of animal origin, as well as the timing of crop harvest following applications.
   
   
4. Incursion by domesticated or wild animals. For example, the rule would require an adequate waiting period before harvesting produce from fields in which animals are allowed to graze or work.
   
   
5. Equipment, tools, and buildings. For example, the rule would establish requirements related to issues such as pest control and the availability of hand-washing stations for workers.
   
   

The proposal includes several exemptions in addition to the ones required by provisions of the FSMA, and the Agency is seeking comments about the scope of these regulatory exemptions. For example, the proposal would exclude produce determined to pose the lowest risk of microbiological hazard to human health, such as produce that is rarely consumed raw (e.g., potatoes) and produce that will be commercially processed with a “kill step” (e.g., green beans destined for a canning operation). Produce used for personal or on-farm consumption also would be exempted.

As with the preventive controls rule, the proposed compliance dates for the new produce safety regulations would be staggered to allow smaller farms additional time to comply. Non-exempt farms would be required to comply with the majority of the rule within two years after final publication, although they may have up to four years to implement some of the water requirements. Small businesses (no more than $500,000 in average annual food sales) would have three years to comply and five years for some of the water requirements; very small businesses (no more than $300,000 in average annual food sales) would have four years and six years, respectively.

Both Proposed Rules will be published in the Federal Register on January 16, 2013, making public comments due to the Agency by May 16, 2013. Arent Fox urges interested clients and friends to read the proposals in their entireties and to submit comments to the relevant dockets (Docket No. FDA-2011-N-0920 for preventive controls, and No. FDA-2011-N-0921 for produce safety). Given the high-volume of comments that are expected, industry experts do not anticipate Final Rules to be published until after the end of this year.