DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration [Docket No. 2004N-0230]
21 CFR Part 110
Food; Current Good Manufacturing Practice Regulations; Public Meetings
September 3, 2004
Additional Comments from the Association of Food and Drug Officials
The Association of Food and Drug Officials (referred to henceforth as “AFDO”) is pleased
to provide the following additional comments to the U.S. Food and Drug Administration
regarding 21 CFR Part 110 – “Current Good Manufacturing Practice in Manufacturing, Packing
or Holding Human Food.”
AFDO recognizes the importance of modernizing Part 110 and wishes to provide more specific
recommendations than those which were previously provided to FDA both verbally and in
written form.
Many states have adopted 21 CFR Part 110 in whole or in part and it is generally recognized that this regulation serves as a foundation to other regulations which have been promulgated at the state level. A number of states will also apply Part 110 to retail processing establishments along with their own version of the FDA Model Food Code. Clearly, there is widespread application of Part 110 at the state level. For this reason, AFDO believes these regulations must be comprehensive, science based and have a clear food safety focus.
As states conduct more than 80 percent of all food safety inspections of food processors and distributors and as the number of contract inspections to the states are increasing, AFDO again wishes to recommend that FDA seek “buy in” from the states on what proposed new changes or philosophy the new GMP’s may encompass.
Our specific Section by Section recommendations are as follows:
Part 110.3 Definitions
We believe the following definitions should be removed from the regulation:
1) “Batter”
2) “Blanching”
3) “Microorganisms”
4) “Quality Control Operation”
5) “Should”
We believe the following definitions should be added to this Section:
1) “Adulterated” has the meaning stated in the Federal Food, Drug, and Cosmetic Act, §402.
2) “Approved” means acceptable to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.
3) “Critical control point” means a point or procedure in a specific food system where loss of control may result in an unacceptable consumer health risk. (Note: Modification of current definition).
4) “Food employee” means an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.
5) “HACCP plan” means a written document that delineates the formal procedures for following the Hazard Analysis Critical Control Point principles developed by The National Advisory Committee on Microbiological Criteria for Foods to prevent food from becoming adulterated within the meaning of the Act.
6) “Hazard” means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.
7) “Person in Charge” means the individual present at a food establishment who is responsible for the operation at the time of inspection.
8) “pH” means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution.
9) “Potentially Hazardous Food”
a) means a food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting:
(i) The rapid and progressive growth of infectious or toxigenic microorganisms.
(ii) The growth and toxin production of Clostridium botulinum; or
(iii) In raw shell eggs, the growth of Salmonella enteritidis.
b) “Potentially hazardous food” includes any food of animal origin that is raw or heat-treated; a food of plant origin that is heat-treated or consists of raw seed sprouts; cut melons; and garlic-in-oil mixtures that are not modified in a way that results in mixtures that do not support growth as specified under Subparagraph (a) of this definition.
c) “Potentially hazardous food” does not include:
(i) An air-cooled hard-boiled egg with shell intact, or a shell egg that is not hard-boiled, but has been treated to destroy all viable Salmonellae;
(ii) A food with an aW value of 0.85 or less;
(iii) A food with a pH level of 4.6 or below when measured at 240C (750F);
(iv) A food, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution;
(v) A food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious or toxigenic microorganisms or the growth of S. enteritidis in eggs or C. botulinum can not occur, such as a food that has an aW and a pH that are above the levels specified under Subparagraphs (C)(ii) and (iii) of this definition and that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms; or
(vi) A food that does not support the growth of microorganisms as specified under Subparagraph (a) of this definition even though the food may contain an infectious or toxigenic microorganism or chemical or physical contaminant at a level sufficient to cause illness.
10) “Ready-to-Eat Food” means food that is in an edible form without the need for additional preparation.
11) “Regulatory authority” means the local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.
12) “Risk” means the likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.
13) “Sanitize” means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of 5 logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.
14) “Scheduled process” means the process selected by a processor as adequate for use under the conditions of manufacture for a food to achieve and maintain a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority.
15) “Standard Sanitation Operating Procedures (SSOPs)” – means all daily sanitation procedures conducted by a food plant to prevent direct contamination or adulteration of product(s). SSOPs shall describe the activity and how to properly complete the task, as well as specify the frequency with which each procedure is conducted and identify the employee(s) responsible for the implementation and maintenance of the SSOP.
Part 110.10 Personnel
1) Section (a) name should change from Disease Control to Employee Health. This Section should be more in tune with the 2001 FDA Model Food Code as it relates to food employees including listing the big 4 (Hepatitis a virus, Salmonella typhi, Shigella, and Shiga toxin
producing e-coli). The section should also include a list of symptoms associated with foodborne illness, (Diarrhea, Fever, Vomiting, Jaundice, or Sore Throat with fever in addition to the lesions and open wounds already addressed by this section. This section should also apply to current employees as well as applicants to whom a conditional offer of employment is offered. Some thought should be given to including high-risk activities that might lead to secondary infection. Exclusion and restriction needs to be defined along with specific steps necessary for a restricted/excluded employee to resume duties. An employee must be required to report symptoms or illness to the Person in Charge immediately and the Person in Charge must be required to notify the regulatory authority that a food employee is diagnosed with one of the four mentioned illnesses.
2) Section (b) (1) should indicate that no street clothing would be allowed unless protective outer garments are worn.
3) Add the following to (b) (4):
“While preparing food, food employees shall not wear jewelry on their arms and hands. This does not apply to jewelry on the hand which is covered and protected.”
4) Add the following to (b) (5):
“The gloves shall be of an impermeable material unless covered by a durable tight fitting disposable glove made of impermeable materials.” This Section should also include a statement related to minimizing bare hand contact with Ready to Eat foods. Fingernails should also be addressed in this section.
5) Part (c) must be mandated. Remove “should” and replace with “shall” in 2 areas for education and training.
6) Section (d) supervision should include some or all of the following related to demonstration of knowledge by the person in charge:
Based on the risks of foodborne illness inherent to the food operation, during inspections and upon request the person in charge shall demonstrate to the regulatory authority knowledge of foodborne disease prevention, application of the Hazard Analysis Critical Control Point principles, and the requirements of this regulation. The person in charge shall demonstrate this knowledge by:
a) Complying with this Code by having no critical violations during the current inspection;
b) Being a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program; or
c) Responding correctly to the inspector’s questions as they relate to the specific food operation. The areas of knowledge include:
1) Describing the relationship between the prevention of foodborne disease and the personal hygiene of a food employee;
2) Explaining the responsibility of the person in charge for preventing the transmission of foodborne disease by a food employee who has a disease or medical condition that may cause foodborne disease;
3) Describing the symptoms associated with the diseases that are transmissible through food;
4) Explaining the significance of the relationship between maintaining the time and temperature of potentially hazardous food and the prevention of foodborne illness;
5) Explaining the hazards involved in the consumption of raw or undercooked meat, poultry, eggs and fish;
6) Stating the required food temperatures and times for safe cooking of potentially hazardous food including meat, poultry, eggs, and fish;
7) Stating the required temperatures and times for the safe refrigerated storage, hot holding, cooling, and reheating of potentially hazardous food;
8) Describing the relationship between the prevention of foodborne illness and the management and control of the following:
a) Cross contamination,
b) Hand contact with ready-to-eat foods,
c) Handwashing, and
d) Maintaining the food establishment in a clean condition and in good repair;
9) Explaining the relationship between food safety and providing equipment that is:
a) Sufficient in number and capacity, and
b) Properly designed, constructed, located, installed, operated, maintained, and cleaned;
10) Explaining correct procedures for cleaning and sanitizing utensils and food-contact surfaces of equipment;
11) Identifying the source of water used and measures taken to ensure that it remains protected from contamination such as providing protection from backflow and precluding the creation of cross connections;
12) Identifying poisonous or toxic materials in the food establishment and the procedures necessary to ensure that they are safely stored, dispensed, used, and disposed of according to law;
13) Identifying critical control points in the operation from purchasing through sale or service that when not controlled may contribute to the transmission of foodborne illness and explaining steps taken to ensure that the points are controlled in accordance with the requirements of this regulation;
14) &nb
