Maryland Sea Grant : Research, Outreach & Education: Outreach & Extension: Coastal Communities & Economies: Seafood Technology: Hazard Analysis Critical Control Points (HACCP): HACCP Countdown: HACCP Countdown 2

ISSUE 2

Contents
FDA Requires Sanitation Monitoring
Sanitation Requirements Regulation
How Do I Monitor Sanitation?
Sanitation Example
For Information and Assistance

In the mid-Atlantic, Maryland, Virginia and North Carolina Sea Grant and Cooperative Extension Programs are assisting the seafood processing industry to implement HAACP in training sessions, which FDA recognizes as the standard for compliance, and in HACCP COUNTDOWN, a series of six newsletters during 1997.

The newsletters keep processors informed of developments in training and sources of information, and highlight steps processors can take to prepare for HACCP inspection.

This issue of HACCP COUNTDOWN addresses the monitoring of Sanitation Standard Operating Procedures (SSOPs), including the sanitation requirements of the U.S. FDA HACCP regulation.

FDA Requires Sanitation Monitoring

When implementing HACCP, the first step is to review existing programs to verify that all the prerequisite requirements are met and that all necessary controls and documentation (e.g., SSOP program description, the individual responsible and sanitation monitoring records) are in place. Specifically, this includes Good Manufacturing Practices (CFR 21 Part 110) and the sanitation requirements detailed in the HACCP regulation. Records shall document control of eight sanitation-related areas.

Please see Sanitation Requirements Regulation box for language quoted from the regulation. As a general rule, sanitation controls and related records should not be included in the company's HACCP plan. SSOPs are best used to control food safety hazards associated with the plant environment (e.g., maintenance of facilities and employee hygiene) and HACCP is most effectively applied to hazards related to product characteristics and processing steps.

Sanitation Requirements Regulation

(a) Sanitation SOP. Each processor should have and implement a written sanitation standard operating procedure (herein referred to as SSOP) or similar document that is specific to each location where fish and fishery products are produced. The SSOP should specify how the processor will meet those sanitation conditions and practices that are to be monitored in accordance with paragraph (b) of this section.

(b) Sanitation Monitoring. Each processor shall [must] monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in part 110 [Good Manufacturing Practices (GMPs)] of this chapter that are both appropriate to the plant and the food being processed and relate to the following:

Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;
Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;
Maintenance of hand washing, hand sanitizing, and toilet facilities;
Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
Proper labeling, storage, and use of toxic compounds;
Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
xclusion of pests from the food plant. The processor shall correct in a timely manner, those conditions and practices that are not met.

(c) Sanitation Control Records. Each processor shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are subject to the requirements of Sec. 123.9.

(d) Relationship to HACCP Plan. Sanitation controls may be included in the HACCP plan, required by Sec. 123.6(b). However, to the extent that they are monitored in accordance with paragraph (b) of this section they need not be included in the HACCP plan, and vice versa.

How Do I Monitor Sanitation?

Note: Contact plates or other microbiological growth media require careful handling and disposal. For information on proper use or for an example form for recording results, contact the Extension/Sea Grant program in your state.

Your SSOPs should, at a minimum, directly address the eight sanitation monitoring areas required by the FDA regulation. From these, develop an audit procedure and checklist for recording observations. Where possible, substantiate the record with objective measurements such as sanitizer concentration from test strips. To confirm adequate cleaning and sanitation, consider using contact plates. These are simple, disposable devices used to estimate the number of microorganisms on plant surfaces. Low numbers indicate the use of effective cleaning procedures. A log of results provides a valuable record of sanitary control and identifies areas requiring additional attention.

Sanitation Example

To illustrate the integration of the regulation, SSOP and sanitation records consider the following example:

Regulation - Requires assuring "Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;"

SSOP - Company Goal. Gloves and outer garments that contact food or food-contact surfaces are made of an impermeable material and are kept clean and sanitary.

Company Procedure. The company will issue line workers rubber aprons and work gloves. The line supervisor will ensure that his or her employees are issued this gear. Employees are not allowed to use personal gear in place of these items unless authorized by the line supervisor and foreman. Employees are required to maintain this apparel in a sanitary and operable condition and, if necessary, must replace it through the line supervisor. Supervisors must require all employees to comply. In addition, the quality-control supervisor will check this apparel at the beginning of each day's operations. Observations will be recorded on the daily sanitation audit form.

Record (combine with the other sanitation monitoring requirements on one or two forms):

For Information and Assistance

HACCP courses nationally, HACCP models and HACCP links are available on the Internet: http://www-seafood.ucdavis.edu/

For information and assistance on the subject of HACCP, contact the seafood specialist in your state:: David Green, North Carolina State University, (919) 726-7341
George Flick, Virginia Tech, (540) 231-6965
Tom Rippen, University of Maryland, (410) 651-6636

A Publication of the Sea Grant and Cooperative Extension Programs of the
University System of Maryland, Virginia Sea Grant College Program and North Carolina