By Dave Fairfield, Senior Vice President of Feed Services
The U.S. Food and Drug Administration (FDA) issued two guidance documents to assist “small and very small” businesses in understanding compliance obligations established by the agency’s major rules under the Food Safety Modernization Act.
The guidance documents address the Current Good Manufacturing Practice (CGMP) and Preventive Controls for Human and Animal Food that are required under FSMA.
Among the topics addressed by the guidance documents are:
- Who must comply with the rules;
- Who is exempt from parts of the rules or subject to modified requirements;
- Compliance dates for the various subparts established by the rules;
- Exemptions provided for on-farm low-risk activities performed by small or very small businesses;
- How to determine if a business is a “qualified facility” and subject to modified requirements;
- Overviews of the CGMP and preventive control requirements; and
- Definitions used within the requirements.
FDA previously released on Aug. 24 more detailed draft guidance for CGMP requirements for animal food and partial draft guidance for preventive control requirements for human food.
The CGMP and hazard analysis and preventive controls regulations issued by the Food and Drug Administration (FDA) on Sept. 17, 2015 form the cornerstone of the new animal food regulatory framework mandated by FSMA. The regulations apply to most animal food facilities registered with FDA under the Bioterrorism Act of 2002 – including feed, feed ingredient and pet food manufacturers; grain processors; biofuels companies manufacturing co-products as feed ingredients; and foreign facilities that ship products intended for consumption in the United States.
Covered facilities have a staggered number of years to comply with the regulations, based upon business size. The regulations also establish staggered compliance dates for the CGMP requirements a year prior to the deadline for implementing the preventive controls requirements. The following table shows the compliance dates for various business sizes and regulations.
|Business Size||CGMP Compliance Date||Preventive Controls Compliance Date|
|Business other than Small and Very Small||Sept. 19, 2016||Sept. 18, 2017|
|Small Business||Sept. 18, 2017||Sept. 17, 2018|
|Very Small business||Sept. 17, 2018||Sept. 17, 2019|
The regulations establish the following definitions for business size:
- Small Business: A business employing fewer than 500 full-time equivalent employees. All employees within the business and all of its subsidiaries and affiliates, regardless of whether an employee is involved in animal food-related activities, are to be counted in this determination.
- Very Small Business: A business (including any subsidiaries and affiliates) averaging less than $2.5 million, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of animal food, plus the market value of animal feed manufactured, processed, packed or held without sale (e.g., held for a fee or supplied to a farm without sale).