As Life Sciences Decoded looks forward in 2017, it is clear that FDA-regulated industries have a great deal of change confronting them. Last year, 2016, was a landmark year for the FDA and food regulations, as the agency finalized and began enforcing four of the major Rules promulgated under the 2011 Food Safety Modernization Act (FSMA). These include Hazard Analysis and Risk-based Preventive Controls (HARPC), the Produce Safety Rule, the Sanitary Transport Rule, and the Foreign Supplier Verification Program (FSVP). These Rules, along with several others and in-progress Guidance documents, represent the practical application of the FSMA, what is expected of the food industry and the first major overhaul of the U.S. food safety system in more than 70 years.

These programs have been discussed at length by Life Sciences Decoded and represent a new vision for how a food facility must implement a food safety plan to prevent the adulteration of food for both humans and animals. These four Rules all have triggers for compliance in 2017 which will affect how the food industry does business going forward.

The following is a brief description of these Rules with their respective compliance dates and the impending 2017 implications. It is worth noting that some of these Rules have already been extended (see those with an *) and may be extended again. Those dates that have already past or appear in 2017 are in bold.

Current Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-based Preventive Controls (HARPC) for Human Foods

This is the core of the FSMA’s impact for most members of the food industry that are involved with processing foods. HARPC requires a food facility to have in place a Food Safety Plan that addresses, in detail, the hazards present in the facility, its processes and equipment that could result in the adulteration of the foods handled in the facility. A HARPC-compliant food safety plan requires facilities to perform a full analysis of every component of their manufacturing, packaging, labelling, holding and other processing activities, identify the hazards these activities pose, create preventive controls to minimize the risks these hazards pose, and create corrective actions in the case that these hazards impact the food (including recalls, market withdrawals and reprocessing). HARPC requires this entire process to be documented, and employees must be thoroughly trained on the new food safety plan when it is implemented. Finally, the GMPs that have applied to human food for decades have been updated with a new emphasis on hygiene, training and allergen cross-contact prevention.

  • Location: 21 C.F.R. § 117
  • Rule Date: September 30, 2015
  • Compliance date for most businesses:
    • September 19, 2016
    • Supply Chain Program - March 17, 2017
  • Compliance date for small businesses: September 18, 2019*

Impact in 2017: The Supply Chain Program will have the greatest impact on food businesses and the evaluation of the industry’s intra-company manufacturing processes, as well as its relationship with its suppliers and customers in 2017. To implement this supply chain requirement, not only will the industry need to better track both inbound and outbound product, but it is intended to create better communication and a continuous vigilance on food safety. These supply chain programs should be written and must be integrated into the food safety plan and should be consistent with the inbound and outbound providers of products plans as well. The regulatory requirements are detailed in its requirements and those requirements must be accounted for including, but not limited to audits, records keeping and other verification activities.

Current Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-based Preventive Controls (HARPC) for Animal Foods

This is, essentially HARPC for facilities that process animal feeds. However, new to animal feed production are GMPs that also govern product handling and production. Historically, animal feed manufacturing has not been subject to GMP regulation, and now with the passing of this Rule, animal feeds are subject to nearly the same amount of safety regulation that human foods are.

  • Location: 21 C.F.R. § 507
  • Rule Date: September 30, 2015
  • Compliance date for most businesses:
    • September 18, 2017
  • Compliance date for small businesses:

Impact in 2017: All animal food/feed will have to be manufactured in accordance with GMPs and are now required to have in place a HARPC plan. Animal food/feed companies are now being held to a much higher level of compliance than ever before. These new regulations will change the way animal food/feed companies process/manufacture and generally do business. These companies must develop written food safety plans and in so doing must evaluate the manufacturing process it utilizes to ensure not only that the manufactured product meets GMPs but must account for hazards and hazard controls.

Produce Safety Rule

Whereas HARPC does not apply to farms, the new Produce Safety Rule does apply to many farming facilities throughout the U.S., particularly those involved in the growing and harvesting of raw agricultural commodities that are consumed raw such as sprouts. The new Rule is expansive, and covers everything from the buildings, storage facilities, employee restrooms, worker training, wildlife and even a farm’s water source. Do note that there are many crops that are exempt from the rule because they are rarely consumed raw (such as coffee beans).

  • Location: 21 C.F.R. § 112
  • Rule Date: October 31, 2015
  • Compliance date for most businesses:
    • January 27, 2020*
    • Compliance dates for small businesses and very small businesses: January 26, 2021 and January 26, 2022.*
  • Compliance date for businesses involving sprouts:
    • January 28, 2019*
  • Compliance dates for small and very small businesses involving sprouts:
    • January 27, 2020 and January 26, 2021.*

Impact for 2017: In spite of the fact that the compliance dates are after 2017, the produce industry as defined under this rule, has never been subject to this level of regulation. Therefore, 2017 is a year in which the produce industry needs to begin to prepare itself to comply with the lengthy and detailed regulatory requirements. These new regulations include sanitary measures, equipment safety, facilities and grounds, as well as an increased focus on managing biological sources of contamination. For an industry experiencing these FDA regulations for the first time, 2017 is the time to begin conforming business practices.

Foreign Supplier Verification Program

The new Foreign Supplier Verification Program is designed to ensure that not only is food manufactured and processed in the US safe, under HARPC and the Produce Safety Rule, but also those food products made overseas and brought into the U.S. This program in part recruits U.S. entities to work on behalf of the FDA to police foreign suppliers of food products to make sure that HARPC’s new more stringent requirements are not just followed domestically.

  • Location: 21 C.F.R. § 1.500 et seq.
  • Rule Date: October 31, 2015
  • Compliance Date: May 28, 2019*

Impact for 2017: The compliance date for the FSVP is somewhat misleading as domestic food companies are currently required to have a safe food supply. For those companies sourcing from outside the U.S., once the product is in the U.S., the domestic importer is solely at risk without the benefit of ensuring that the foreign supplier has been inspected and has an appropriate food safety plan until such time as this rule becomes effective. Therefore, verifying a foreign supplier’s practices now makes a great deal of sense for all domestic food businesses.

Sanitary Transport Rule

The Sanitary Transport Rule dictates a new set of procedures for documenting the movement of food through the U.S. via rail or motor vehicle. Anyone who participates in a “transportation operation,” including anything that impacts the sanitary condition of food in transportation such as cleaning, inspection, loading, unloading, receiving, etc. Note, this rule does not apply to transportation via air or water.

  • Location: 21 C.F.R. § 1.900 et seq
  • Rule Date: April 6, 2016
  • Compliance date for most businesses: April 6, 2017
  • Compliance date for small businesses: April 6, 2018

Impact for 2017: This rule brings the transport industry into the safe food equation. The domestic food industry will be responsible (unless delegated through a transport agreement) to ensure that the food it is having transported is transported under the same safety standards in which it was manufactured. Records will need to be kept on cleaning transport by vehicles, inspections of those vehicles and preventing cross contamination, particularly with known allergens. Trucking and rail industries are not familiar with FDA and its regulations, and therefore educating these transport industries is likely to fall on the food industry itself.

The FSMA’s regulations are not the only ones which will be impacting the food industry this year. In addition to the Rules described above, the FDA will also be enforcing the following.

Vending Machine Nutrition Labeling

The new rule requires operators of vending machines to enable the disclosure of caloric content information for products sold in vending machines. Derived from the Patient Protection and Affordable Care Act, this rule’s compliance date in 2017 requires significant amount of coordination between snack and food manufacturers and vending machine companies to ensure compliance. The FDA has not required labeling for vending machines previously, and many aging vending machines lack the technology or shelf space to accommodate the new rule. Additionally, vending machine operators will need to re-think machine stocking procedures and retrain employees.

  • Location: 21 C.F.R. § 101.8
  • Rule Date: December 1, 2014

While the original compliance date for the Rule was December 1, 2016, the FDA has stated that, consistent with a clause entered into the 2016 Omnibus Bill passed by Congress, the FDA will not be enforcing the rule until May 5, 2017. Glass-front vending machines with foods that have labelling on the front of their packages, which is visible from the outside of the machine, have a compliance date of July 26, 2018. However, Life Sciences Decoded encourages members of the industry to ensure compliance as quickly as possible, as this may change.

Nutrition Labeling of Menu Items in Restaurants

Restaurants that are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods: This new Rule will require the disclosure of calorie information for menu items on menus, but restaurants subject to the rule will also need to have available to the customer, upon request, additional nutrition information similar to that found on the Nutrition Facts panel of packaged foods.

  • Location: 21 C.F.R. § 101.11
  • Rule Date: May 5, 2016
  • Compliance Date: December 1, 2016 was the original compliance date. However, on December 2, 2016, the FDA announced that it would extend this compliance date to May 5, 2017.

Compliance dates that have either already passed or are soon approaching, enforcement can be expected. This means more inspections. Additionally, inspectors will be expecting to see ongoing evidence of efforts toward compliance before final compliance dates arrive for those rules with future compliance dates.

While rules with compliance dates that have already passed should be a priority for all involved, small businesses with dates that are farther out should take the opportunity in 2017 to begin the process of building their compliance programs to not only address these issues before the required date, but also to reflect how these regulations are enforced on larger companies subject to earlier compliance dates. As usual, getting an early start on these programs, particularly for companies with limited resources, will be key to ensuring that they are ready when the FDA first appears at their door for inspections aimed at the new food safety plans.

Training

The FDA also continues to ramp up and support its training programs. Through the Produce Safety Alliance, the Foods Safety Preventive Controls Alliance, and the Sprout Safety Alliance, the FDA has created FDA-funded industry organizations that are in charge of “training the trainers” for food industry members. In other words, these alliances provide the training that can be used to train employees on food safety regulations and compliance under the FSMA as well. While these are not the only training options available, they will be the industry standard for the foreseeable future. With the approach of so many FSMA and other food safety deadlines quickly approaching, all members of the food industry will be looking to these, and similar FDA-recognized training organizations, for education in 2017.