Good Manufacturing Practices (GMPs) and FDA Food Code guidelines, handwashing and temperature control
With the rise of Coronavirus overseas and now in the United States, Good Manufacturing Practices—and all that it entails, including handwashing—are more important than ever. The FDA Food Code guidelines cover handwashing as well as hand hygiene and temperature control.
“When we discuss employee cleanliness, we’re really talking about two main areas: personal hygiene and organizational hygiene processes,” says Paul Barnhill, CTO, Meritech, Golden, CO.
“With personal hygiene, employees should always come to work with clean outer garments, hair that is clean and tidy, and fingernails short and trimmed. When it comes to organizational hygiene processes, it is especially important to practice consistent and effective hand hygiene events,” he notes.
When working in or around food, employees should always follow recommended handwashing steps, including scrubbing hands for at least 20 seconds and making certain to wash the fingertips, in-between the fingers, the palms, and the back of the hands, Barnhill explains.
“Hands should be thoroughly rinsed under a stream of running water to remove the soap suds and pathogens. Finally, hands should then be dried thoroughly, preferably with a paper towel, as it is quicker and actually aids in removing any pathogens that may be remaining on the hands. Overall, this manual handwashing process, when done properly, may take up to 40 seconds.”
Facilities equipped with automated handwashing stations ensure consistent, effective hand hygiene events for their employees with less time as each hand wash only takes 12 seconds while removing more than 99.9 percent of pathogens, Barnhill adds.
“These automated systems are also recommended as they are consistently effective for every user while using less water and producing less waste than traditional handwashing.”
Eric Moore, director of food safety & regulatory compliance, Testo North America, West Chester, PA, recommends providing visual aids to illustrate expectations.
“Leverage a digital food safety management platform to support daily observation-based checklists for managers to verify that employees are properly following your company’s cleanliness policies. These systems enable real-time visibility of operational compliance, which enables managers to adopt an exception-based management process,” he says.
This allows [managers] to focus their time on managing the business and responding to problems as they occur, notes Moore.
“The platforms also require detailed and mandatory workflows to document corrective actions are executed properly.”
Moore recommends the following:
- Basic Hygiene Requirements: Employees should bathe daily and keep fingernails neat. Long hair should be pulled back into a ponytail or bun and uniforms, including aprons, should be clean. Restrict employees from wearing uniforms to and from work. Aprons and chef coats should not be worn into the restroom.
- Basic Handwashing Requirements: Managers must actively observe, educate, train, reinforce and practice proper handwashing procedures. Hands and exposed portions of the arms should be properly washed immediately prior to taking part in food preparation. Hands should be washed after using a restroom, then again when entering a food preparation area. Provide signage at handwash sinks that illustrates the proper handwashing procedures.
- Basic Disposable Gloves Requirements: Avoid use of latex products, provide employees with the correct size options, provide glove dispensers in close proximity to handwash sinks and food preparation areas.
- Basic Tobacco Use Requirements: All forms of tobacco use should be restricted to break times in designated areas.
- Basic Eating/Drinking Requirements: Restrict employees from eating and drinking in food storage, preparation and service areas. Eating and drinking should only be permitted in designated areas. Employees that work in hot areas (grill, dish room, etc.) should have a designated and labeled drink station to store a beverage that has a resealable cap or a cup with a lid and straw. Beverage stations should also be positioned away from exposed food and food preparation areas where beverages may be stored.
- Basic Tasting Requirements: When tasting food during the cooking process, utensils may only be used once.
Guidance from the Food Code
The Food Code addresses hand hygiene in many areas and includes references for the types of sinks and automated handwashing stations that can be used, says Barnhill.
“It also includes the steps for performing a proper hand wash, the minimum length of time required to properly wash hands, the recommended frequency of handwashing in a given day, and even the proper temperature of a hand wash,” he adds.
While the Food Code presents a set standard and rules for compliance, it is truly the responsibility of an organization’s leadership to create a culture that reinforces hygiene best practices to ensure they are always followed, Barnhill recommends.
“This culture should be introduced right at the beginning of a new employee’s onboarding process, and continually reinforced throughout the year across all levels of the organization with team hygiene mentors, hygiene re-training days—and even leadership setting the example of good hygiene behaviors with their own actions.”
However, the Food Code can sometimes fall short in some areas, says Jim Mann, founder and executive director, Handwashing for Life, Libertyville, IL.
“Food Code guidelines on handwashing are most helpful in pointing out how and when to wash, but fall short by focusing on the needs of the inspector rather than the safety of the public. Its core failing stems from its lack of being risk based,” he explains.
It also suffers full compliance by treating all contaminated hands as equals and demanding the same protocol for all situations, Mann says.
“This makes the inspector’s job easier and the operator’s impossible. If a food handler adjusts his or her glasses, the same handwash is expected as when they handle raw ground beef or chicken.”
Employee health and hygiene are covered in several parts of the FDA Model Food Code, first by providing clearly defined science-based regulations, says Moore.
“The regulations are then further supported through detailed information on why the regulations are necessary. Also included are instructions for how these regulations should be evaluated by a regulatory inspection official.”
He says that Chapter 2 - Management and Personnel is the section of the food code that establishes regulations for management and employee responsibilities, employee health and hygiene practices, personal cleanliness and contamination response.
In 2017, the Food Code was amended, and several clarifications were added.
“The Food Code continues to be a model for adoption by states to safeguard public health and ensure food presented when offered to the consumer is not adulterated and a cause for illness outbreaks,” says Angel Suarez, independent consultant, EAS Consulting Group, LLC, Alexandria, VA.
“It continues to be the best advice offered to the retail and food service industry addressing the safety and protection of food with the objective for reduction of the risk of foodborne illnesses caused by retail food and restaurant establishments, thus protecting consumers and industry from potentially devastating health consequences and financial losses,” Suarez explains.
The Food Code 2017 contains several amendments and clarifications for the food service industry, he says.
“These changes were made throughout the document for internal consistency, to correct some errors in the 2013 Code. Although there were not specific changes into employees’ practices for cleaning their hands, [it covers] its importance and relationship between the prevention of foodborne illness and the management and control of cross contamination.”
Bare hand contact with ready-to-eat (RTE) food products is to be avoid under any circumstance to provide needed safeguards: It is important the employee be trained and practice thorough handwashing in order to avoid contamination of the food or food serving places, dishes and eating utensils, as outlined in the Code, Suarez says.
“Handwashing is considered a critical factor in reducing fecal-oral pathogen transfer by unclean and contaminated hands to RTE food. Foodborne pathogens can also be transmitted by hand contact with floors, garbage bins, dirty plates, eating utensils, electrical switches and other environmental sources. Therefore, effective handwashing must include scrubbing, rinsing, and drying the hands,” he recommends.
Even though bare hands should never contact exposed, RTE food, thorough handwashing is important in keeping gloves or other utensils from becoming vehicles for transferring microbes such as viruses, bacteria and parasites to the food, Suarez notes.
“Overconfidence on the use of gloves must also be addressed as a contaminated glove and transfer foodborne pathogens as easily as any bare hand.”
Suarez says that some of the changes in the 2017 Retail Food Code are as follows:
- Focus on additional responsibilities for the person in charge of the retail food or restaurant establishment to ensure employees are routinely monitoring food temperatures during hot and cold holding. It also clarifies that a person in charge, or a food employee, may be responsible for taking corrective action when a critical limit is not met in particular to temperature control for food items during preparation and service; (Section 2-103.11)
- Other changes in food temperature are reflected on new parameters for cooking time for poultry, baluts, wild game animals, stuffed foods or stuffing containing fish, meat, poultry or ratites from 15 seconds to <1 second (instantaneous. reflect new cooking time (Section 3-401.11)
The FDA Retail Food Code’s “Good Manufacturing Practices (GMP)” establishes the basic operational and environmental conditions required to produce safe retail foods, says Suarez.
“In the food area, the GMPs ensure that ingredients, products and packaging materials are prepared, presented and handled safely and that food products are prepared in a suitable environment. Industry must adhere to the practices required to conform to FDA recommendation and regulations. The Retail Food Code GMPs address the safety and protection of food with the objective of reducing the risk of foodborne illnesses cause by food prepared and served within food establishments, thus protecting consumers and industry from potentially devastating health consequences and financial losses.”
Retail and foodservice establishments should be taking steps to comply with Food Code guidance for personal hygiene.
“Handwashing must become a process in order for it to be controlled. Operator developed frequency standards are needed. In the spirit of HACCP, measurement is required and handwashing’s principal control point is that of the worker,” recommends Mann.
Barnhill agrees. “Organizations should always have well-maintained handwashing stations that are either manual or automated to comply with Food Code guidance. Each handwashing station should be fully supplied with hand soap, paper towels, and an instructional sign posted above the handwashing area detailing the steps necessary for a proper hand hygiene event. It is equally important to train staff on when they should wash their hands and to detail certain events that may occur within their jobs that will require re-washing.”
He says that when it comes to cultivating a culture of hygiene excellence, leadership must consider the people, the places, and the products within their facility in order to implement effective hygiene processes and zones within the facility’s operational flow.
“By considering these factors, you can decide on the proper handwashing and critical control measures that must occur to prevent cross-contamination between staff and products across different areas within the facility. For example, if a staff member is working with RAW products and then enters an RTE area, they may cross-contaminate surfaces or food products with harmful pathogens from the RAW products they were working with, and vice versa for RTE.”
Additionally, any area that deals with an allergen needs to be considered as a potential risk to other individuals and products, and steps should be taken to prevent a cross contamination of a product or person with these allergens, Barnhill adds.
“Specifically, hygiene intervention steps should be implemented in your high risk zones between, RAW, RTE, and allergens.”
Moore agrees, and says that segregation of RTE and Raw products is the best way to limit potential cross-contamination issues.
“A great starting point is to review your menu or preparation and production practices and then designate specific areas or times for raw animal product preparation. Having designated employees for each product category is also a good practice,” he recommends.
A good rule of thumb is to ensure RTE food production takes place after RAW food production has been completed, and all equipment and utensils have been properly washed, rinsed, sanitized and air-dried, Moore says.
“Use disposable aprons when handling/preparing raw animal products. Using color-coded utensils is another best practice.”
Mann says that operators must first address customer care standards, worker behavioral realities and then the regulatory requirements—in that order.
“Operators need the flexibility to interpret and align the many variables. Employee motivation is of higher value than routine training. Workers need to know the Why before the How and the When. Make all training personal, using visuals and very few words, if any.”
Food Processing GMPs
The food industry has undergone considerable change in the almost 35 years since the food processing cGMPs were revised in 1986, says Suarez.
“The revision led into what we know as the Food Safety Modernization Act (FSMA), signed into law on January 4, 2011. FSMA gives the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested, processed and held. The law grants the FDA a number of new powers, including mandatory recall authority (required court order in the past), assessment of penalties, the ability to collect expenses (travel costs and salaries) for repeat or follow-up inspections, etc.”
The primary purpose of FSMA is to focus on preventive measures in order to drive improvements in public health for the U.S. consumer, Suarez explains.
“This new law and the seven associated new supporting regulations required FDA to change from a reactive enforcement agency to a preventive one, in order to stop foodborne illness instead of reacting after it happened. FSMA regulations also requires the industry to develop plans to prevent intentional acts of food contamination and sabotage caused by employees or originating from outside the processing environment. This has already increased the food processing industry’s efforts to reduce this intentional food safety threat to consumers,” he says.
Suarez notes that some of the FSMA GMP revisions include:
- Required registration of all facilities, foreign or domestic that manufacturer or hold (warehouse) food intended to be sold in the US as well as allow FDA to suspend such a registration, which effectively puts that food manufacturer out of business
- “Large” food manufacturing facilities are required to create a food defense plan, built after conducting a vulnerability assessment. FDA has taken an approach similar to a food safety strategy called the Hazard Analysis Critical Control Point (HACCP) system, used all over the world to improve food safety practices by identifying, evaluating and controlling food safety hazards
- A written environmental pathogen control program for manufacturers of RTE foods to identify the presence of pathogens in the environment before they find their way to the food.
- Allow FDA inspectors access to almost all operational records of a food manufacturer as well as clearly identify the minimum acceptable types of operational records that must be maintained by a food manufacturer.
- Require all food importers to develop a written food safety and risk assessment program specific to each food manufacturer that provides the imported food as well as documents verifying the effectiveness of foreign food manufacturer’s food safety system.
- FDA has committed to a significant increase in the number of on-site inspections of foreign food manufacturers, particularly for high-risk imported foods.
- Increased FDA authority to refuse entry into the U.S. of food from a foreign facility for any noncompliance or violation issues with all existing FDA laws and regulations.
- FDA can administratively detain products that are potentially in violation of the law (a procedure to keep suspect food from being moved).
- Leverage FDA resources by allowing FDA to develop an accreditation program to certified private third-party companies to conduct foreign food facility inspections on behalf of FDA standards.
Following the FDA Food Code and other Good Manufacturing Processes will help ensure a healthier work environment for all, as well as a quality end product.