Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
Section 229.223 - 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 United States 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) Compliance with defect action levels does not excuse violation of the requirement in the Texas Health and Safety Code, § 431.081(a)(3) that food not be prepared, packed, or held under unsanitary conditions or the requirements in this section that food manufacturers, distributors, and holders must observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated, 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 must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.

(c) 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 regardless of the defect level of the final food.

(d) 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 foods.regulatory@dshs.state.tx.us or Texas Department of State Health Services Foods Group, P.O. Box 149347, Mail Code 1987, Austin, Texas 78714-9347.