Since the Food Safety Modernization Act (FSMA) was signed into law in 2011, the U.S. Food and Drug Administration’s (FDA’s) rule-making efforts have been laborious. Faced with the overwhelming task of implementing the most comprehensive reform of this nation’s food safety system in more than 70 years, FDA understandably moved cautiously. But delays in regulations resulted in public criticism, which peaked with the filing of a lawsuit against FDA by the Center for Food Safety and Center for Environmental Health. Whether in spite of or because of these outside pressures, both 2013 and 2014 have seen a flurry of proposed FSMA regulations, public meetings and public comments.

FDA has organized its efforts around what it refers to as the “7 Pillars” of FSMA. These Pillars include Preventive Controls for Human Food, Preventative Controls for Animal Food, Produce Safety, Sanitary Transportation, Food Defense, Foreign Supplier Verification and Third Party Auditor Rules. The publication of each proposed regulation was followed by a public comment period during, which various interested persons, companies and groups had the opportunity to voice support, raise concerns or make alternative suggestions.

The public comment period on each of these original proposed regulations has closed. But those comments led FDA to determine that revisions were necessary in some instances. Thus, on September 29, 2014, four supplemental rules were published that pertain to Preventative Controls for Human Food, Preventative Controls for Animal Food, Produce Safety and Foreign Supplier Verification. These supplemental rules remain open for public comment only until December 15, 2014. After that date, these FSMA regulations will be closed for comment and the opportunity to provide input before the FDA’s issuance of final rules will have come to an end.

A summary of the regulations still open for comment is set forth below:

A. Human Food Risk Analysis:
Original Proposed Regulation: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, Docket Number: FDA-2011-N-0920, was issued on 1/16/2013. Public comment period closed on 11/22/2013.

Supplemental Regulation: Issued on 9/29/2014. Public comment period will close on 12/15/2014.

Highlights of the supplemental rule include the following:

1. The original definition of hazard analysis and risk based preventative controls was based in large part on Hazard Analysis and Critical Control Points (HACCP) regulations. FDA specifically differentiated the FSMA Hazard Analysis to require that controls be considered at locations other than CCPs. To further emphasize the distinction, the supplemental rule provides that all references in the rule to “hazards reasonably likely to occur” (language also found in HACCP) will be stricken and changed to “significant hazards.” The term “significant hazard” analyzes both the severity of the potential hazard and the likelihood it will occur.

2. Where a Hazard Analysis determines it appropriate for the facility, the food and the nature of the preventative controls, product testing must be used to verify both implementation and verification of controls.

3. Environmental monitoring must be conducted as a means to verify implementation and verification of controls when a hazard analysis determines it appropriate for the facility, the food and the nature of the preventative controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard.

4. Where a facility’s Hazard Analysis identifies a significant risk from raw materials or ingredients received from a supplier and that risk is appropriately managed before receipt, the rule requires a supplier verification control procedure.

5. In a change from the original rule, the facility’s Hazard Analysis must consider the possibility of economically motivated intentional adulteration.

Deadline for Final Rule: The deadline for issuance of a final rule is 8/30/2015. The proposed compliance date is 1 year after the issuance of the final rule, or 2 years for small businesses (employing fewer than 500 employees).

B. Animal Food Risk Analysis:    
Original Proposed Regulation: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Docket Number: FDA-2011-N-0922, was issued on 10/29/2013. Public comment period closed on 2/26/14.

Supplemental Regulation: Issued on 9/29/2014. Public comment period will close on 12/15/2014.

Highlights of the supplemental rule include the following:

1. The original rule for the first time introduced current Good Manufacturing Practices (cGMPs) for animal food. Those cGMPs were patterned after cGMPs for human food. The supplemental rule revises the proposed Animal cGMPs to be more particularly tailored to the manufacture of animal food.

2. Facilities that are subject to human food safety requirements and which sell by-products as an ingredient for animal food will not be subject to additional preventative controls or cGMPs, except as appropriate during any holding or distribution of the by-products.

3. All references in the rule to “hazards reasonably likely to occur” will be stricken and changed to “significant hazards.” (See, A.1. above).

4. Product testing must be conducted where a Hazard Analysis determines it appropriate. (See, A.2. above).

5. Environmental monitoring must be conducted where a Hazard Analysis determines it appropriate. (See, A.3. above).

6. Supplier verification controls must be conducted where appropriate. (See, A.4. above).

7. A facility’s Hazard Analysis must consider the possibility of economically motivated intentional adulteration. (See, A.5. above).

Deadline for Final Rule: The deadline for issuance of a final rule is 8/30/2015. The proposed compliance date is 1 year after the issuance of the final rule, 2 years for small businesses (employing fewer than 500 employees) or 3 years for very small businesses (< $2.5M in total annual sales of animal food).

C. Produce Safety:
Original Proposed Regulation: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Docket Number: FDA-2011-N-0921, was issued on 1/16/2013. Public comment period closed on 11/22/2013.
 
Supplemental Regulation: Issued on 9/29/2014. Public comment period will close on 12/15/2014.

Highlights of the supplemental rule include the following:

1. The supplemental rule revises the proposed microbial standards for water used in the growing of produce. FDA is proposing a more tiered and targeted approach to the testing of untreated water. Farmers whose water does not initially meet the microbial standards will have alternative means to verify its safety and allow for its use.

2. The supplemental rule eliminates the previously proposed 9-month minimum interval between use of raw manure and crop harvest. For now, the issue will continue to be investigated by the FDA in conjunction with the U.S. Department of Agriculture and others.

3. The supplemental rule also eliminates the proposed 45-day minimum interval between the use of compost containing manure and crop harvest so long as it is applied in a manner that prevents the likelihood of its contact with the produce both during and after application.

Deadline for Final Rule: The deadline for issuance of a final rule is 10/31/2015. The proposed compliance date is 2 years after the issuance of the final rule, 3 years for small businesses ($250,000 to $500,000 in annual produce sales) or 4 years for very small businesses ($25,000 to $250,000 in annual produce sales).

D. Foreign Supplier Verification:    
Original Proposed Regulation: Foreign Supplier Verification Programs (FSVPs) for Importers of Food for Humans and Animals, Docket Number: FDA-2011-N-0143, was issued on 7/29/2013. Public comment period closed on 1/27/2014.

Supplemental Regulation: Issued on 9/29/2014. Public comment period will close on 12/15/2014.

Highlights of the supplemental rule include the following:

1. Importers conducting a hazard analysis must not only evaluate the risks related to the imported food, but must equally analyze risks relating to the foreign supplier when determining appropriate supplier verification methods. The supplier risks to be considered include: a) the entity’s application of hazard controls; b) the supplier’s safety procedures and safety performance history; c) the supplier’s compliance with U.S. food safety laws; and d) the hazards to the subject food.

2. The original proposed regulation offered two options for FSVPs. The supplement puts forth a broader approach, which requires the importer to evaluate the risks associated with the food and with the supplier in creating its verification procedures. The importer will have more flexibility to determine the verification processes and frequencies appropriate.

3. The concept of “hazards reasonably likely to occur” will be replaced with “significant hazards.” (See, A.1. above).

 4. An FSVP must consider the possibility of economically motivated intentional adulteration. (See, A.5. above).

Deadline for Final Rule: The deadline for issuance of a final rule is 10/31/2015. The proposed compliance date is 18 months after issuance of the final rule.

In summary, public comment on these proposed supplemental rules will close on 12/15/14. Final rules will be issued between August and October 2015. The new rules will have staggered enforcement dates, for most beginning 1 year later.

Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is comprised of a team of attorneys from every legal practice area and who each have a focused background in the food industry.