Food Court continues its look at the two new rules proposed by the FDA under the Food Safety Modernization Act (FSMA) by exploring a commonality shared by both rules. On the surface the proposed produce safety rule and preventative controls (or HARPC rule) appear quite different. The produce safety rule providing standards for the safe production and harvest of fruits and vegetables, essentially safe farming practices, while the preventative controls rule covers activities post-harvest. Both rules aim, as all of FSMA does, to take a preventative posture at preventing food borne illnesses. To do this it looks at how microbiological contamination typically occurs. Whether its harvesting produce or post-harvest production one common element for all facilities is its employees. Employee hygiene is a common focus of both rules.
The thrust of the preventative controls rule lies in the required food safety plan. The aim there is to identify risks reasonably likely to occur in a facility and develop preventative controls. In its economic analysis of the preventative controls rule the FDA identifies “most frequently mentioned preventive controls with broad applicability across sectors and food safety problems” of which “poor employee hygiene” makes the list. The analysis goes on to cite research to support its assumption:
Numerous studies have shown that poor hygienic practices among employees contribute to the microbial contamination of food (Ref 67). Employee hygiene is necessary for plant sanitation and its absence is one of the leading causes of food contamination (Refs 68, 69).
Unlike the produce safety rule the preventative controls rule does not directly address employee hygiene. Even in the section most likely to address employee hygiene, section 117.135(d)(3) Sanitation Controls, only tangentially touches on employee hygiene. It proposes two new standards:
Proposed § 117.135(d)(3)(i)(A) would require that sanitation controls include procedures for the cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment.
Proposed § 117.135(d)(3)(i)(B) would require that sanitation controls include procedures for the prevention of cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product.
Employee hygiene is implied, but not specifically addressed as in the produce safety rule. Also, notice the focus is also on cross-contamination of allergens in order to mitigate food allergens. The FDA seems aware that employee hygiene could get lost in the wording of its new standards. It goes on in an earlier part of the rule to say:
…Under section 418(o)(3) of the FD&C Act, the procedures, practices, and processes described in the definition of preventive controls may include sanitation procedures for food contact surfaces of utensils and equipment; supervisor, manager, and employee hygiene training…
The langue, however, is permissive “may include” not directive “shall include” making it unclear how it will be enforced. There may be defenses built into the permissive definition.
The produce safety rule is more clear and direct. To begin with Subparts C and D are title “Personnel qualifications, training and health and hygiene.” Not question that employee hygiene is addressed or required. As mentioned in other posts on the produce safety rule, the rule identifies routes of microbial contamination of produce and sets requirements to prevent or reduce the introduction of pathogens. The FDA in its Fact Sheet on the produce safety rule restates a conclusion made in the rule
Bacteria, viruses, and parasites are frequently transmitted from person to person and from person to food, particularly through the fecal-oral route. The proposed rule would require that farm personnel use hygienic practices, including hand washing and maintaining adequate personal cleanliness.
Here are some of the key requirements for personnel qualifications, training, health and hygiene are:
- Requires personnel who handle covered produce or supervise such personnel to receive training including principles of food hygiene and food safety, health and personal hygiene, and other topics as applicable (proposed §§ 112.21 and 112.22).
- Requires measures to prevent contamination of covered produce and food-contact surfaces from any person with an applicable health condition, such as a communicable illness, infection, open lesion, vomiting, or diarrhea (proposed § 112.31).
- Requires personnel who work in operations in which covered produce or food-contact surfaces are at risk of contamination with known or reasonably foreseeable hazards to use hygienic practices to the extent necessary to protect against such contamination. This includes maintaining adequate personal cleanliness, avoiding contact with animals other than working animals, minimizing contact with covered produce when in direct contact with working animals, washing hands thoroughly before or after certain activities and at other times, and maintaining gloves appropriately (if gloves are used) (proposed § 112.32).
- Requires measures to ensure that visitors are aware of policies and procedures to protect covered produce and food-contact surfaces from contamination, ensure they comply with the policies and procedures, and make toilet and hand-washing facilities accessible to visitors (proposed § 112.33.)
These are requirements and not “may include” suggestions. As the rules are finalized look for some push for stronger language in the preventative control rule. Otherwise, during an outbreak or food borne illness ligation that involves an employee contamination, farmers will effectively point to post-harvest facilities as a defense since by law they are required to implement controls and training, which would be documented, whereas a food facility processing the produce may not. In interesting paradox built into the law.
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