Updated: FDA Releases New Rules for Food Processors and Manufacturers | Practical Law

Updated: FDA Releases New Rules for Food Processors and Manufacturers | Practical Law

The Food and Drug Administration (FDA) has recently published final rules and amendments that enact the FDA Food Safety Modernization Act of 2010 (FSMA). Under the final rules and amendments, processors and manufacturers of food for human and animal consumption must establish preventive food safety systems and risk-based supply chain programs. The rules and amendments also, among other things, establish and clarify good manufacturing practices for processed food manufacturers.

Updated: FDA Releases New Rules for Food Processors and Manufacturers

Practical Law Legal Update w-000-5863 (Approx. 8 pages)

Updated: FDA Releases New Rules for Food Processors and Manufacturers

by Practical Law Commercial Transactions
Law stated as of 02 Nov 2016 • USA (National/Federal)
The Food and Drug Administration (FDA) has recently published final rules and amendments that enact the FDA Food Safety Modernization Act of 2010 (FSMA). Under the final rules and amendments, processors and manufacturers of food for human and animal consumption must establish preventive food safety systems and risk-based supply chain programs. The rules and amendments also, among other things, establish and clarify good manufacturing practices for processed food manufacturers.
On September 17, 2015 the Food and Drug Administration (FDA) issued final rules and amendments that enact the FDA Food Safety Modernization Act of 2010 (FSMA). As a result of the new and amended rules, processors and manufacturers of food for consumption by humans (80 Fed. Reg. 55908) and animals (80 Fed. Reg. 56170) must take important steps to avoid or mitigate the impact of food-borne illnesses.
Processing and manufacturing facilities, among other things, must establish:
These requirements are very similar for processors and manufacturers of food for both human and animal consumption and, generally, only reflect the differences between the two industries (see Impact on Animal Food Processors and Manufacturers).
The FDA also establishes (for animal food) and clarifies (for human food) good practices for food processing and manufacturing (see Good Human Food Manufacturing Practices Updated and Good Animal Food Manufacturing Practices Established). For general information on good manufacturing practices for processed foods, see Practice Note, FSMA Regulation on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.

Impact on Human Food Processors and Manufacturers

With its new and amended rules, the FDA imposes a number of compliance requirements on processors and manufacturers of food for human consumption.

Establishing and Implementing a Preventive Food Safety System

Companies that own facilities covered by the rule changes must establish and implement a food safety system that includes:
  • Hazard identification and analysis.
  • Risk-based preventive controls.
The risk-based preventive controls (preventive controls) must be written and include:
  • Preventive controls to minimize or prevent identified hazards.
  • Oversight and management of the preventive controls.

Required Supply-Chain Program

The FDA now requires manufacturing and processing facilities to employ a risk-based supply chain program for raw materials and other ingredients identified as potentially hazardous. Facilities are responsible for ensuring that these foods, if received from unapproved suppliers are:
  • Subject to verification activities before the facility accepts the raw materials or other ingredients.
  • Only received on a temporary basis.
Facilities are not required to implement preventive controls when identified hazards will be controlled by subsequent entities, such as:
  • Customers.
  • Other processors.
Other entities in the supply chain, like brokers or distributors, may conduct supplier verification activities but the receiving facility must review and assess the documentation of the hazard control verification.

Good Human Food Manufacturing Practices Updated

Previously nonbinding provisions, which functioned more as guidance, are now binding and required. For example:
  • The management of a covered facility is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties.
  • The employees of a covered facility must have the necessary combination of education, training and experience to manufacture, process, pack or hold clean and safe food, including training in the principles of food hygiene and safety.

Defining "Farm" under the FSMA

Operations defined as farms are not subject to the preventive controls rule. The definition of farm is clarified under the FSMA to include two types of farming operations:
  • Primary production farm, which is an operation under one management but not necessarily on one contiguous location, devoted to:
    • growing crops;
    • harvesting crops;
    • raising animals (including seafood); or
    • any combination of these activities.
  • Secondary activities farm, which is an operation not located on the primary production farm:
    • devoted to harvesting, packing or holding raw agricultural commodities; and
    • majority-owned by a primary production farm.

Effective Compliance Dates for Human Food Processors and Manufacturers

Compliance dates for the preventive controls for businesses producing food for human consumption are staggered over several years after publication of the final rule:
  • Very small businesses must comply within three years after publication (the date of publication is considered January 1, 2016), except for record-retention relating to their status as very small businesses. A very small business is defined as a business that averages annually less than $1 million of a combination of sales of human food and unsold inventory.
  • Businesses subject to the FDA's Pasteurized Milk Ordinance must comply three years after the rule's publication.
  • Small businesses must comply within two years of the rule's publication. A small business is defined as a business with fewer than 500 full-time employees.
  • All other businesses must comply within one year of publication.
Compliance dates for the supply chain program for businesses producing food for human consumption are staggered over several years after publication of the final rule and depend on the type of facility. If the receiving facility is:
  • A small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: two years.
  • A small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: two years or six months after the supplier is required to comply with the applicable rule, whichever is later.
  • Not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: 18 months.
  • Not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: six months after the supplier is required to comply with the applicable rule.

Impact on Animal Food Processors and Manufacturers

Several of the FDA's new FSMA-enacting rules imposed on animal food producers are nearly identical to rules imposed on producers of human food, including:

Good Animal Food Manufacturing Practices Established

The FDA has established a series of good manufacturing practices for animal food producers that specifically account for the unique aspects of the animal food production industry.
Processors that are already implementing human food safety requirements do not need to implement the animal food good manufacturing practices when supplying a byproduct for animal food, except:
  • To prevent physical and chemical contamination when holding and distributing the byproduct.
  • When use of the byproduct requires it to be further processed to be used as animal food. In this scenario, the facility can follow the good manufacturing practices for either human or animal food.

Categorizing Feed Mills

Feed mills that are associated with fully integrated farms (farms where the feed mill, animals, land and establishment are all owned by the same entity) generally meet the definition of farm under the FSMA (see Defining "Farm" under the FSMA) and are, therefore, not subject to the animal food preventive controls. The FDA plans to publish a proposed rule that accounts for the protection gap that results because these facilities produce a significant amounts of animal food.

Effective Compliance Dates for Animal Food Processors and Manufacturers

Compliance dates for the preventive controls for business producing food for animal consumption are staggered over several years after publication of the final rule. The compliance dates fall between the compliance dates for the newly required good manufacturing practices and preventive control requirements:
  • Businesses other than small and very small businesses must comply with:
    • the good manufacturing practices within one year of publication; and
    • the preventive controls within two years of publication.
  • Small businesses must comply with:
    • the good manufacturing practices within two years of publication; and
    • the preventive controls within three years of publication.
  • Very small businesses must comply with:
    • the good manufacturing practices within three years of publication; and
    • the preventive controls within four years of publication, except for record-retention to support their status as very small businesses.
A very small business is defined as a business that averages less than $2.5 million (adjusted for inflation) in sales of animal food plus inventory.
Compliance dates for the supply chain program for business producing food for animal consumption are staggered over several years after publication of the final rule and depend on the type of facility. If the receiving facility is:
  • A small business and its supplier will be subject to the good manufacturing practices but not to preventive controls: six months after the receiving facility’s supplier is required to comply with the good manufacturing practices.
  • Not a small or very small business and its supplier will be subject to the good manufacturing practices but not to preventive controls: six months after the receiving facility’s supplier is required to comply with the good manufacturing practices.
  • A small business and its supplier is subject to the preventive controls: three years after the rule’s publication date or six months after the supplier is required to comply with the rule, whichever is later.
  • Not a small or very small business and its supplier will be subject to the preventive controls for animal food final rule, the later of:
    • two years after the rule’s publication date; or
    • six months after the supplier is required to comply with the rule.

Update

On November 1, 2016, the FDA released the following Small Entity Compliance Guides:
These guides were prepared in accordance with Section 212 of the Small Business Regulatory Enforcement Fairness Act. They were created to give domestic and foreign human and animal food facilities information about the related regulations and to explain the actions a small entity must take to comply with them.
The FDA accepts comments on its guidance on a rolling basis.