How Many Food Defects are Allowed?

Patient Presentation
In late September 2010, a leading infant formula manufacturer voluntarily recalled some infant powdered formula because they “detected the remote possibility of the presence of a small common beetle in the product produced in one production area in a single manufacturing facility.” In the clinic, several pediatric residents were aghast that manufacturing incidences like this could occur. A faculty pediatrician then talked about her own experiences as a young adult working in a fruit processing plant. She told about the great care taken with mechanical processing and with the workers to produce exceptional quality fruit, yet unavoidable defects were uncommonly found such as fruit pits and insect parts. She pointed out that even with locally grown food, there are still defects that are unavoidable but most defects are not harmful. A couple of residents shared her view, but others didn’t.

As she prepared dinner that night using food from her own garden that her children had just picked, the pediatrician had to smile as she found a spider in several basil leaves, and gnaw marks from slugs on the green beans.

During food growing, processing and preparation, appropriate steps to ensure the quality and wholesomeness of the food are important. It is not economically or humanly possible to detect and eliminate all natural or unavoidable defects in food that present no health hazards to humans. While some of these defects may cause an odious feeling such as insect parts or rodent hair, these do not pose inherent hazards to health. The Food and Drug Administration (FDA) sets standards for various foodstuffs that manufacturers must follow. The “…levels do not represent an average of the defects that occur in any of the products–the averages are actually much lower. The levels represent limits at which FDA will regard the food product “adulterated”; and subject to enforcement action….” These food defects are distinctly different than food adulteration. One example of adulteration was the purposeful addition of melamine to infant formula in China in 2008. Melamine is a known toxin to humans.

Food defects include insect, parasites, mammalian excreta, rodent hair, mold, sand and grit, fruit pits, shells, rot and decomposition.

For example, cloves naturally have a stem and a certain amount of them are allowed. Canned tomatoes can have insect parts and mold. Raisins can have sand, grit and mold. Cocoa powder that is manufactured is allowed to have mold, insect parts and mammalian excreta.

Personal food handling and preparation is always important. Storing food at the proper temperature (i.e. room, chilled or frozen), washing fruits and vegetables, cooking for the proper length of time and to the proper temperature, and serving and maintaining food at the proper temperature are musts for consuming healthy food.

Learning Point
The FDA has the Defect Levels Handbook – Levels of natural or unavoidable defects in foods is available online,

The FDA also provides information about the regulation of commercial infant formula, including an overview of manufacturing processes for infant formula.

Questions for Further Discussion
1. How should pumped breast milk be properly handled and stored?
2. How should infant formula be properly handled and stored?
3. Most fruits and vegetables can be prepared at home for infants. What vegetables should not be prepared at home because of health risks?

Related Cases

To Learn More
To view pediatric review articles on this topic from the past year check PubMed.

Evidence-based medicine information on this topic can be found at, the National Guideline Clearinghouse and the Cochrane Database of Systematic Reviews.

Information prescriptions for patients can be found at MedlinePlus for these topics: Food Safety and Infant and Newborn Nutrition.

To view current news articles on this topic check Google News.

To view images related to this topic check Google Images.

United States Food and Drug Administration. Defect Levels Handbook.
Available from the Internet at (cited 10/22/10).

United States Food and Drug Administration. Infant Formula.
Available from the Internet at (rev. 9/23/10, cited 10/22/10).

United States Food and Drug Administration. Powdered Infant Formula: An Overview of Manufacturing Processes.
Available from the Internet at (cited 10/22/10).

ACGME Competencies Highlighted by Case

  • Practice Based Learning and Improvement
    12. Evidence from scientific studies related to the patients’ health problems is located, appraised and assimilated.
    16. Learning of students and other health care professionals is facilitated.

  • Interpersonal and Communication Skills
    19. The health professional works effectively with others as a member or leader of a health care team or other professional group.


    Donna M. D’Alessandro, MD
    Professor of Pediatrics, University of Iowa Children’s Hospital