The following is an example of how the FDA has gone from reactionary to prevention:
Previous law: A food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or it is otherwise unfit for food.
Revised law: A food shall be deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated or whereby it may have been rendered injurious to health.
Foodborne illnesses are a significant threat to public health. About 48 million (1 in 6) Americans get sick each year, 128,000 are hospitalized, and 3,000 die from foodborne illnesses. Individuals with compromised immune systems, such as infants and children, pregnant women, older individuals, and those on chemotherapy are most susceptible. Foodborne illnesses are more than just a stomachache; they can cause life-long chronic diseases, such as arthritis and kidney failure.
Pest Management Programs will need to adapt as well. The law, under Sec 117.35 of Current Good Manufacturing Practice (CGMP), as it pertains to pests reads as follows:
(c) Pest Control. Pests must not be allowed in any area of a food plant. Guard, guide, or pest-detecting 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 must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests. The use of pesticides to control pests in the plant is permitted only under precautions and restrictions that will protect against the contamination of food, food contact surfaces, and food packaging materials.
The challenge for the Pest Management Professional (PMP) with Subpart C is the identification of known or reasonable foreseeable hazards associated with the food manufacturing process. The PMP is challenged with documenting these hazards and identifying who will be accountable for the implementation and documentation of resolving these hazards.
- FSMA has shifted the focus from responding to contamination to preventing it.
- Sanitary conditions is the key criteria by which plants will be judged.
- Science and risk assessment are essential for an effective Pest Management Program.
- Pest Management Programs must be living, breathing, adapting and changing.
- All records must reflect the true conditions under which the product was manufactured and are subject to review by the FDA.