[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110]
 
[Page 215]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD--Table of Contents
 
 
                      Subpart A--General Provisions
 
Sec.
110.3  Definitions.
110.5  Current good manufacturing practice.
110.10  Personnel.
110.19  Exclusions.
 
                   Subpart B--Buildings and Facilities
 
110.20  Plant and grounds.
110.35  Sanitary operations.
110.37  Sanitary facilities and controls.
 
                          Subpart C--Equipment
 
110.40  Equipment and utensils.
 
Subpart D [Reserved]
 
               Subpart E--Production and Process Controls
 
110.80  Processes and controls.
110.93  Warehousing and distribution.
 
Subpart F [Reserved]
 
                     Subpart G--Defect Action Levels
 
110.110  Natural or unavoidable defects in food for human use that 
          present no health hazard.
 
    Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
 
    Source: 51 FR 24475, June 19, 1986, unless otherwise noted.
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.35]
 
[Page 218-219]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD--Table of Contents
 
                   Subpart B--Buildings and Facilities
 
Sec. 110.35  Sanitary operations.
 
    (a) General maintenance. Buildings, fixtures, and other physical 
facilities of the plant shall be maintained in a sanitary condition and 
shall be kept in repair sufficient to prevent food from becoming 
adulterated within the meaning of the act. Cleaning and sanitizing of 
utensils and equipment shall be conducted in a manner that protects 
against contamination of food, food-contact surfaces, or food-packaging 
materials.
    (b) Substances used in cleaning and sanitizing; storage of toxic 
materials. (1) Cleaning compounds and sanitizing agents used in cleaning 
and sanitizing procedures shall be free from undesirable microorganisms 
and shall be safe and adequate under the conditions of use. Compliance 
with this requirement may be verified by any effective means including 
purchase of these substances under a supplier's guarantee or 
certification, or examination of these substances for contamination. 
Only the following toxic materials may be used or stored in a plant 
where food is processed or exposed:
    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
 
[[Page 219]]
 
    (2) Toxic cleaning compounds, sanitizing agents, and pesticide 
chemicals shall be identified, held, and stored in a manner that 
protects against contamination of food, food-contact surfaces, or food-
packaging materials. All relevant regulations promulgated by other 
Federal, State, and local government agencies for the application, use, 
or holding of these products should be followed.
    (c) Pest control. No pests shall be allowed in any area of a food 
plant. Guard or guide dogs may be allowed in some areas of a plant if 
the presence of the dogs is unlikely to result in contamination of food, 
food-contact surfaces, or food-packaging materials. Effective measures 
shall be taken to exclude pests from the processing areas and to protect 
against the contamination of food on the premises by pests. The use of 
insecticides or rodenticides is permitted only under precautions and 
restrictions that will protect against the contamination of food, food-
contact surfaces, and food-packaging materials.
    (d) Sanitation of food-contact surfaces. All food-contact surfaces, 
including utensils and food-contact surfaces of equipment, shall be 
cleaned as frequently as necessary to protect against contamination of 
food.
    (1) Food-contact surfaces used for manufacturing or holding low-
moisture food shall be in a dry, sanitary condition at the time of use. 
When the surfaces are wet-cleaned, they shall, when necessary, be 
sanitized and thoroughly dried before subsequent use.
    (2) In wet processing, when cleaning is necessary to protect against 
the introduction of microorganisms into food, all food-contact surfaces 
shall be cleaned and sanitized before use and after any interruption 
during which the food-contact surfaces may have become contaminated. 
Where equipment and utensils are used in a continuous production 
operation, the utensils and food-contact surfaces of the equipment shall 
be cleaned and sanitized as necessary.
    (3) Non-food-contact surfaces of equipment used in the operation of 
food plants should be cleaned as frequently as necessary to protect 
against contamination of food.
    (4) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) should be stored in appropriate 
containers and shall be handled, dispensed, used, and disposed of in a 
manner that protects against contamination of food or food-contact 
surfaces.
    (5) Sanitizing agents shall be adequate and safe under conditions of 
use. Any facility, procedure, or machine is acceptable for cleaning and 
sanitizing equipment and utensils if it is established that the 
facility, procedure, or machine will routinely render equipment and 
utensils clean and provide adequate cleaning and sanitizing treatment.
    (e) Storage and handling of cleaned portable equipment and utensils. 
Cleaned and sanitized portable equipment with food-contact surfaces and 
utensils should be stored in a location and manner that protects food-
contact surfaces from contamination.
 
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]