Writer G.K. Chesterton once suggested that, “Whenever you remove any fence, always pause long enough to ask why it was put there in the first place.” This advice seems particularly relevant to the current deregulatory environment in the United States. A 2017 Executive Order required federal agencies to eliminate two regulations for every new regulation, which resulted in the withdrawal or delay of 1,579 regulations. How might the removal of positive regulatory initiatives impact food safety, public health and your business in the new year?
During 2017, the FDA reclassified the Food Safety Modernization Act (FSMA) rule for laboratory accreditation to “inactive” status despite the significant impact of this rule upon other FSMA regulations. The USDA reclassified both its genetically modified (GM) food labeling regulation and a proposed rule for the nutrition labeling of meat and poultry products to “inactive” status last year. Moreover, the compliance date for the FDA’s revision of the Nutrition Facts labeling regulations was delayed until 2020.
The deregulatory approach will continue this year, which could trigger an uncertain regulatory future for food companies. According to the latest Unified Agenda of Federal Regulatory and Deregulatory Actions (December 2017), federal agencies have been advised to issue “at least three deregulatory actions for every one new regulation” introduced during FY 2018.
Below are six significant food regulatory issues to watch in 2018:
1) GM food labeling rule
Under the 2016 law, National Bioengineered Food Disclosure Standard, the USDA must develop regulations to establish a national mandatory bioengineered food labeling standard. Food companies will be required to disclose the GM content of products using approved labeling options. While the labeling regulation was demoted to “inactive” status last year, the agency updated the regulation to “active” status for the FY 2018 regulatory agenda. The regulation is expected to be completed by July 2018.
2) Laboratory accreditation
Food testing performed by an accredited laboratory is an important component of several FSMA regulations. The objective of laboratory accreditation per FSMA is to align commercial laboratories with government labs, which would enable the FDA to accept analytical data from third-party labs. The accreditation of both foreign and domestic laboratories would be required only for regulatory testing. The FDA is expected to propose the laboratory accreditation rule by September 2018.
3) FSIS to modernize inspection systems
The Food Safety and Inspection Service (FSIS) will continue the implementation of new inspection programs for poultry and Siluriformes fish during FY 2018. Also, the agency is expected to issue new regulations for modernizing the inspection systems for swine and egg products. The FSIS regulatory proposal for egg products would require plants to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (SOPs) similar to the current requirements for meat and poultry products. A proposed rule is expected this year.
4) FSMA mandate for ‘customer assurance’
The ‘customer assurance’ or ‘written assurance’ disclosure statements are mandated by three of the foundational FSMA rules, including the rules for Preventive Controls for Human Food, Preventive Controls for Animal Food and the Foreign Supplier Verification Program (FSVP). The requirements apply to situations in which food safety controls are applied downstream by a customer of a manufacturer/processor. In response to industry concerns, the FDA will issue a proposed rule by August 2018 to rescind the burdensome customer assurance requirements.
5) FSMA requirements for produce safety
In recent months, the FDA has issued guidance and proposed an extension of the compliance date for produce firms, aside from those growing sprouts, covered by the FSMA rule, Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption. Also, the agency proposed a two-year extension of the water testing requirements and might issue a final rule this year. Additionally, in 2018 the FDA plans to clarify the “registration requirements for food facilities to better align how facilities and farms that perform similar activities are treated under the preventive controls rules and the produce safety rule.”
6) Nutrition labeling and claims
Later this year, the FDA will revoke a health claim regarding the benefits of soy protein intake for reducing the risk of coronary heart disease, and the agency will issue a final rule to officially authorize the use of gluten-free labeling for fermented, hydrolyzed and distilled foods. The restaurant menu labeling rule will be enforced in May 2018, after a one-year extension, but the nutrition labeling rule for packaged food will not take effect until 2020.
Uncertain Regulatory Future
While the federal government is often associated with excessive regulations, food companies should know the value of consistent food safety and nutrition regulations for protecting their brands and public health.
For the U.S. food industry, the upcoming year should have less red tape in terms of new regulations, but the uncertainty of this dynamic regulatory environment could challenge the ability of food companies to plan for the future. Recently, FDA Commissioner Scott Gottlieb stated that many additional regulatory priorities will be addressed this year through guidance documents and other policy efforts.
An emphasis on regulatory guidance is not surprising. During the second half of 2017, the agency issued several guidance documents related to:
- Sanitary Transportation
- Menu Labeling
- Refusal of Inspection by a Foreign Entity,
- Supply Chain Program Requirements and Co-Manufacturer Supplier Approval
- FSMA “Solely Engaged” Exemptions
- Produce Safety (small entity compliance guide)
- Intentional Adulteration (FSMA food defense rule)
As these food safety regulations are finalized in 2018, you can count on Mérieux NutriSciences as the one stop to help you reach compliance. Our expert consultants provide support to meet FSMA requirements, including performing an FDA readiness gap assessment, building your plants’ food safety plans and providing on-site training. To meet labeling requirements, our regulatory compliance specialists can analyze menu recipes and nutrition data to create new labels. Utilizing targeted analytical expertise, we provide an array of GMO testing services to best fit your company’s needs. Contact us today to get started on the road to compliance!
Meet the Author
Information Services Manager, Mérieux NutriSciences
Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.