21 CFR 117.10 establishes the personnel hygiene requirements for food manufacturing facilities covered under 21 CFR Part 117 — the FSMA Preventive Controls for Human Food rule. These are minimum cGMP requirements that apply to all covered employees and visitors who work in or move through food manufacturing areas.

Who Must Comply

Under 21 CFR 117.10, the requirements apply to:

• All employees who work in food contact, packaging, or processing areas

• Supervisors and quality personnel who enter production areas

• Visitors (including contractors, auditors, and management) who enter food production areas

The facility is responsible for ensuring that all individuals — including those not employed directly by the facility — comply with the hygiene requirements when in the facility.

Disease and Illness Controls

Under 21 CFR 117.10(a), management must exclude from food handling any employee who has a communicable disease or illness that could contaminate food. Specifically:

Excluded conditions (employee must be excluded from food contact):

• Any illness or condition that could reasonably be expected to cause food contamination

• Open cuts, sores, or lesions on hands or exposed skin (if contact with food or food-contact surfaces occurs)

• Jaundice, diarrhea, vomiting, fever, sore throat with fever

Reporting requirement: Employees must notify management of any illness, open wound, or condition that might pose a contamination risk.

The facility must have a written illness policy that employees acknowledge — this is typically documented in the food safety plan's sanitation preventive controls or in a standalone employee health policy.

Handwashing Requirements

Under 21 CFR 117.10(b), employees must wash hands thoroughly:

• Before starting work in food production areas

• After each absence from the work station (including restroom use)

• After engaging in activities that may contaminate hands — handling trash, touching face/nose, coughing, sneezing

• After contact with raw materials that could contaminate finished product or food-contact surfaces

• After handling any non-food items in the production area

Hand sanitizer does not substitute for handwashing — handwashing with soap and water is required. Hand sanitizers may be used as an additional measure after handwashing.

Gloves and Hand Protection

When gloves are worn for food contact:

• Gloves must be of an impermeable material suitable for the food contact application

• Gloves must be maintained in an intact and clean condition

• Gloves do not eliminate the requirement for handwashing — employees must wash hands before putting on gloves and after removing them

Gloves may be required as a sanitation preventive control or as a cGMP requirement for certain high-care product types (e.g., ready-to-eat products).

Protective Clothing and Hair Restraints

Under 21 CFR 117.10(b):

• Employees must wear hair restraints (hairnets, beard nets) that prevent hair from falling into food or onto food-contact surfaces

• Outer garments (lab coats, aprons, uniforms) must be suitable for food production — clean and maintained to prevent food contamination

• Personal belongings — jewelry (rings, watches, earrings), pens in breast pockets, and personal electronics — that could fall into or contaminate food must not be worn or brought into food contact areas

• Footwear must be appropriate for the facility environment

Prohibition on Eating, Drinking, and Smoking

Under 21 CFR 117.10(b)(7), in food manufacturing and processing areas:

• Eating food is prohibited

• Chewing gum is prohibited

• Drinking beverages is prohibited (except water in sealed, closeable containers in certain circumstances — facility policy governs)

• Tobacco use is prohibited

• Taking medications is permitted only in break areas, not in food production areas

Training Requirements

Under 21 CFR 117.4, all personnel who handle food or food-contact surfaces, or whose activities may affect food safety, must be:

• Qualified to perform their assigned duties through training or experience

• Trained in personal hygiene applicable to their role

• Trained on applicable cGMP and food safety requirements

Training must be documented — records of employee training are reviewed during FDA inspections. New employees must be trained before they begin working in food production areas.

Interaction with Dietary Supplement cGMP

Dietary supplement manufacturers subject to 21 CFR Part 111 have parallel personnel hygiene requirements under 21 CFR 111.10, which are substantively similar to 21 CFR 117.10. The two frameworks overlap, and a facility's hygiene procedures will generally satisfy both sets of requirements if they meet the more stringent standard.

Common FDA 483 Observations Related to Personnel Hygiene

Personnel hygiene violations are among the most common observations in FDA food facility inspection reports:

• Employees not wearing hairnets or beard nets

• Employees wearing jewelry in food contact areas

• Handwashing facilities not readily accessible, or employees observed not washing hands at required times

• No documented illness policy or employees not trained on illness reporting

• Eating or drinking in food production areas

• Inadequate training records for hygiene requirements

How Truli Helps with Personnel Hygiene Compliance

• Hygiene policy documentation review: Truli evaluates whether written illness reporting, handwashing, and personal hygiene policies exist and cover the required elements

• Training records audit: Truli verifies that employee training records are maintained for hygiene requirements and are current for all food-contact employees

• Inspection readiness assessment: Truli reviews personnel hygiene documentation for completeness and flags gaps that are commonly cited in FDA 483 observations

Related Regulations

• 21 CFR Part 117 — FSMA Preventive Controls — Full FSMA rule overview

• 21 CFR Part 111 — Supplement cGMP — Supplement-specific personnel and hygiene requirements

• 21 CFR 117 Food Safety Plan — The food safety plan that includes sanitation and personnel controls

Frequently Asked Questions

Can employees drink water at their work stations?
21 CFR 117.10 prohibits drinking beverages in food production areas. Some facilities permit closed, sealed water bottles for employees in non-food-contact areas — but this is a facility-specific decision and must be documented in the facility's cGMP procedures. In food-contact areas, no drinking is permitted.

What if an employee has a cut on their hand but uses a glove?
An employee with an open cut must be covered with an impermeable bandage that is fully covered by a glove before handling food or food-contact surfaces. If the cut cannot be adequately covered or the employee refuses, they must be excluded from food contact until the wound has healed. Supervisors should not allow production pressure to override this requirement.

Do we need to document that visitors comply with hygiene rules?
Yes — the facility is responsible for all individuals who enter food production areas. Visitor logs with attestation of compliance with hygiene requirements are standard practice and are reviewed during FDA inspections. Visitors who don't comply must not be permitted in production areas.

A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.

Last updated: April 2026. Reflects 21 CFR 117.10 as of April 2026. Book a demo to see how Truli monitors food safety compliance.