[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR110.110]

[Page 229-230]
 
                        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 
 
                     Subpart G_Defect Action Levels
 
Sec.  110.110  Natural or unavoidable defects in food for human use that 


present no health hazard.

    (a) Some foods, even when produced under current good manufacturing 
practice, contain natural or unavoidable defects that at low levels are 
not hazardous to health. The Food and Drug Administration establishes 
maximum levels for these defects in foods produced under current good 
manufacturing practice and uses these levels in deciding whether to 
recommend regulatory action.
    (b) Defect action levels are established for foods whenever it is 
necessary and feasible to do so. These levels are subject to change upon 
the development of new technology or the availability of new 
information.
    (c) Compliance with defect action levels does not excuse violation 
of the requirement in section 402(a)(4) of the act that food not be 
prepared, packed, or held under unsanitary conditions or the 
requirements in this part that food manufacturers, distributors, and 
holders shall observe current good manufacturing practice. Evidence 
indicating that such a violation exists causes the food to be 
adulterated within the meaning of the act, even though the amounts of 
natural or unavoidable defects are lower than the currently established 
defect action levels. The manufacturer, distributor, and holder of food 
shall at all times utilize quality control operations that reduce 
natural or unavoidable defects to the lowest level currently feasible.
    (d) The mixing of a food containing defects above the current defect 
action level with another lot of food is not permitted and renders the 
final food adulterated within the meaning of the act, regardless of the 
defect level of the final food.
    (e) A compilation of the current defect action levels for natural or 
unavoidable defects in food for human use that present no health hazard 
may be obtained upon request from the Center for Food Safety and Applied 
Nutrition

[[Page 230]]

(HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740.

[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 
FR 56035, Nov. 6, 2001]