Record of Decision - Requirements for Sanitizing (post cleaning) Equipment on the Raw Product Side in Dairy Processing Facilities

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Question or Description of Problem

Currently the post cleaning sanitization of equipment in dairy processing facilities is being applied inconsistently across the country. Some areas are requiring the post cleaning sanitizing of equipment on the raw product side and some are not, resulting in inconsistencies in application. In addition to this, the post cleaning sanitizing of equipment on the raw side is a requirement by the USA for equivalency purposes. The Dairy Establishment Inspection Manual (DEIM) (Task 1.10.05.01 and Chapter 16) implies that all equipment, whether on the raw product side or the finished product side is to be cleaned and sanitized. This is not clear and consistent.

Background

Definition of sanitizing or sanitization as defined by the 3A standards is as follows: A process applied to a clean surface which is capable of reducing the numbers of the most resistant human pathogens by at least 5 log10 reductions (99.999%) to 7 log10 reductions (99.99999%) by applying hot water, hot air, or steam, or by applying an Environmental Protection Agency (EPA)-registered sanitizer according to label directions. Sanitizing may be effected by mechanical or manual methods.

Definition of Sanitization as defined in the 2011 Pasteurized Milk Ordinance: Is the application of any effective method or substance to properly cleaned surfaces for the destruction of pathogens, and other microorganisms, as far as is practicable. Such treatment shall not adversely affect the equipment, the milk and/or milk product, or the health of consumers, and shall be acceptable to the Regulatory Agency.

Definition of sterilization: A process affected by heat, chemicals, or other mechanical means that destroys all vegetative bacteria and inactivates relevant bacterial spores of public health concern.

Under the DEIM 1.10.05.01, Sanitation Program specifies the following:

  • Documented program specifies frequency of cleaning and sanitizing.
  • Cleaning can be carried out by the separate or the combined use of physical methods, such as heat, scrubbing, turbulent flow, vacuum cleaning and chemical methods using detergents, alkalis or acids. Cleaning procedures generally involve removing gross debris from surfaces; applying a detergent solution to loosen soil and bacterial film and hold them in solution or suspension; rinsing with water to remove loosened soil and residues of detergent; and where necessary disinfection with subsequent rinsing unless manufacturer's instructions indicate otherwise.
  • Operations must not begin until after sanitation requirements have been met.

Under the DEIM Chapter 16 Equipment Tasks – General Inspection Criteria for Dairy Plant Equipment specifies the following:

  • Construction Materials: Able to withstand repeated cleaning and sanitizing; Able to be effectively cleaned on a repeated basis - Product contact surfaces easily cleaned and disinfected.
  • Equipment Design: (a) Facilitate cleaning, sanitizing and maintenance.
  • Cleanliness: Sanitized prior to start up.

Under FSEP Prerequisite Program Requirements: E.1.1.1:

  • The establishment has and implements a documented Sanitation Program which includes but is not limited to the sanitation schedule/frequency for all equipment, and for all rooms within the establishment;
  • Cleaning and sanitizing procedures including: Details and specifics describing the method and procedures for equipment and room cleaning and sanitizing.

Decision

This is not a new policy but rather a clarification in the interpretation of the DEIM inspection criteria, to provide for consistency of application and evaluation across the country.

  1. Dairy processing equipment on the raw product side is to be cleaned and sanitized by an effective method or substance prior to use.
  2. Dairy processing equipment on the finished product side is to be cleaned and sanitized by an effective method or substance prior to use.
  3. Dairy processing facilities must outline these cleaning and sanitizing procedures in their sanitation program, including procedures, chemicals used, frequency, etc. as per task 1.10.05.01.
  4. Tasks 1.10.05.01, 1.10.05.02, 1.10.05.03 and Chapter 16 of the DEIM will be amended to clarify the application of the above policy decision.

Paul Kirkby
Recommended by: Program Chief March 14, 2013

Jennifer Miner
Approved by: National Manager March 14, 2013

Date modified: