A recently published FDA Warning Letter to a cantaloupe farm reveals FDA’s use of the principles found in its new Proposed Rule for Standards of Produce Safety, recently issued on January 4, 2013 under the Food Safety Modernization Act (FSMA). The Warning Letter, addressed to Chamberlain Farms, Inc., looks normal enough in the opening remarks. However, it gets interesting once FDA states that the agency “documented the following conditions and practices that may have contributed to the contamination of your products with Salmonella.” That language comes from Food Drug and Cosmetic Act section 402(a)(4) – the insanitary conditions food adulteration language.
Below we have taken the seven bullet points listed in FDA’s letter and paired them up with the appropriate section in the new FSMA Proposed Rule for Produce Safety.
| 1. Accumulated organic material on multiple locations of the cantaloupe conveyer, including rollers and belts (which are food contact surfaces). These are likely harborages for pathogenic organisms such as Salmonella. Specifically, Salmonella Newport was found on the belt of 2nd conveyer, below the final belt, and on the north and south belt kicks. | 112.123(d)(1) “You must inspect, maintain, and clean and sanitize, when necessary and appropriate, all food-contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce.” |
| 2. Debris including trash, wood, food pieces, standing water, mud, and dirt beneath the conveyer belt in the cantaloupe packinghouse. | 112.132(a)(1) “You must convey, store, and dispose of trash, litter and waste to minimize the potential for trash, litter, or waste to attract or harbor pests.” |
| 3. Standing water, apparently containing algae, on the floor of the packinghouse, directly below the first four conveyer belts of the packing line and on the drip table below the bristle conveyer belt where cantaloupes are being washed and rinsed. | 112.126(b) “You must provide adequate drainage in all areas where normal operations release or discharge water or other liquid waste on the ground or floor of the building.” |
| 4. Bird excrement in the rafters above food contact surfaces (e.g., brush rollers, conveyor belts, grading table) and directly on the processing line itself. Allowing birds to roost in your packing facility could allow them to defecate directly on to food products during conveyance, grading, and sorting. | 112.128(a) “You must take those measures reasonably necessary to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests in buildings, including routine monitoring for pests as necessary and appropriate.” |
| 5. The roof of the cantaloupe packinghouse was sloped such that any water washing from the roof, along with any debris present on the roof, would flow onto the brush washer and conveyor belt directly under the roof overhang. | 112.126(a)(3) “Be constructed in such a manner that floors, walls, ceilings, fixtures, ducts and pipes can be adequately cleaned and kept in good repair, and that drip or condensate does not contaminate covered produce, food-contact surfaces, or packing materials.” |
| 6. Materials that could not be effectively cleaned or sanitized and may trap and harbor water, organic materials, and pathogens were used as food contact surfaces (i.e., carpeting and wood used as cushioning or directional mechanisms for conveyances). Specifically, Salmonella Newport was found in environmental sample taken from carpet at the northwest end of the middle grading table. | 112.123(a) “You must use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and properly maintained;” |
| 7. Some wellheads were not capped; wells that were capped were not appropriately sealed; there was no apparent grouting of the annular spaces of well shaft; and the wells were not protected from intrusion by standing water. We note that FDA water samples from the wells and spigots utilized for cantaloupe processing were positive for Coliforms and Escherichia coli. A properly protected well should not have any coliforms or Escherichia. coli. | 112.42(b) “You must adequately maintain all agricultural water sources that are under your control (such as wells) by regularly inspecting each source and keeping the source free of debris, trash, domesticated animals, and other possible sources of contamination of covered produce to the extent practicable and appropriate under the circumstances.” |
Even though the regulation is only a proposed rule, and is not effective as a matter of law, and with the comment and review period, one would not expect a Final Regulation for at least a year, we already see FDA itching to implement the principles in the Proposed Rule.
Fruit and vegetable growers, harvesters, exporters and importers should pay careful attention: This outbreak occurred in the summer of 2012. Yet, FDA is already relying on the language of its Proposed Standards for Produce Safety Rule in order to initiate meaningful regulatory action. This FDA likes this new authority and is already implementing it whenever it can.
Need help? Let FDAImports.com be a part of your team for complying with the Food Safety Modernization Act.
Source
www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm332735.htm
