Inspections, Compliance, Enforcement, and Criminal Investigations
Chamberlain Farms, Inc. 12/14/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
December 14, 2012
Tim D. Chamberlain
Chamberlain Farms, Inc.
5584 W 250 South
Owensville, IN 47665
Dear Mr. Chamberlain:
From August 14 to 31,2012 the U.S. Food and Drug Administration (FDA) conducted an inspection of your produce packinghouse and growing fields located at 5884 W. 200 South, Owensville, IN 47665. FDA subsequently further inspected your growing fields between September 19 to 21, 2012. FDA conducted these inspections under its authority in section 704 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §374] as a result of epidemiological investigations, traceback investigations, and analytical results that linked cantaloupes grown and packed on your farm to a nationwide outbreak involving two strains of Salmonella enterica: Salmonella Typhimurium and Salmonella Newport. As of October 4, 2012 this outbreak sickened approximately 261 persons, including 3 deaths, in 24 states between July 6, 2012 and September 16, 2012. You may read more about the outbreak at the following web address: http://www.cdc.gov/salmonella/typhimuriumcantaloupe-08-12/index.html.
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
On August 16, 2012, during the FDA inspection at your firm, FDA investigators collected multiple cantaloupe samples from your packinghouse. Each sample consisted of twenty cantaloupes taken from cardboard boxes in your packinghouse. One subsample (one cantaloupe) yielded a strain of Salmonella Newport which had a PFGE pattern indistinguishable from the outbreak strain of Salmonella Newport.
On August 17, 2012 FDA investigators collected a sample from a distributor in (b)(4) that consisted of 20 cantaloupes which had been grown, harvested, packed, and introduced into interstate commerce by your firm. Analysis of this sample identified Salmonella Newport, which was indistinguishable by PFGE analyses from the outbreak strain of Salmonella Newport, as well as Salmonella Anatum, a serotype not associated with the outbreak. Accordingly, these cantaloupes from your firm are adulterated within the meaning of Section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that they bear or contain a poisonous or deleterious substance that may render them injurious to health. You may find the Act, and FDA's Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons, in which we recommend a number of practices to minimize microbial food safety hazards associated with melons throughout the entire melon supply chain, through links in FDA's homepage at www.fda.gov.
Further, we note that in the course of the outbreak investigation, inspectors from the Department of Public Health (KDPA) collected cantaloupes labeled in part, (b)(4) at a retail establishment on August 3, 2012. According to the shipping from the retail establishment, these cantaloupes originated at Chamberlain Farms. KDPA conducted analyses, including pulsed-field gel electrophoresis (PFGE), on these samples. Salmonella Typhimurium with a PFGE pattern indistinguishable from that of the outbreak stain of Salmonella Typhimurium was isolated from two of the sampled cantaloupes.
During the inspection, FDA investigators also collected 50 environmental swabs from food contact and adjacent surfaces in your cantaloupe packinghouse. Salmonella Newport with a PFGE pattern indistinguishable from that of the outbreak strain was isolated from seven of 50 these environmental swabs and Salmonella Anatum was isolated from two of 50 environmental swabs. Based on all of these sample results, we have determined that the cantaloupes in your packinghouse are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
During the inspection, FDA investigators documented the following conditions and practices that may have contributed to the contamination of your products with Salmonella:
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.
2. Debris including trash, wood, food pieces, standing water, mud, and dirt beneath the conveyer belt in the cantaloupe packinghouse.
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.
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.
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.
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.
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.
We acknowledge that you made some corrective actions while the inspection was on going. It was noted on 8/15/2012 you made the following corrections:
1. To address the accumulation of organic material and standing water on the processing line and surrounding areas, these areas were cleaned using a pressure washer and sanitized with 10% sodium hypochlorite solution.
2. To address the use of materials that could not be effectively cleaned or sanitized, you made repairs to the cantaloupe processing line to remove carpet and wood and replace those surfaces with cleanable nonporous materials.
Although these corrections were made at the time of inspection, you have not provided FDA with any information demonstrating long-term corrective actions throughout your firm. For example, cleaning frequency of the packinghouse and equipment to ensure buildup does not form or levels of sanitizer to be maintained within the dump tank and how this will be monitored should be addressed.
Appropriate control of Salmonella requires expert knowledge of the unique characteristics of the organism. In an operation that has been shown to harbor Salmonella and has produced product that is adulterated under section 402(a)(1) of the Act, such as in your packinghouse, it is essential to identify those areas where this organism is able to grow and survive (niche areas), and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations. FDA may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Further, we note that environmental samples collected from your growing field during the inspection conducted September 19 - 21, 2012 yielded multiple isolates of Salmonella, including isolates that were indistinguishable by PFGE analyses from clinical isolates and cantaloupes that you packed.
These isolates were recovered from four fields, three of which were separated by more than a mile. FDA does not expect melons to be grown in a Salmonella free environment; however these findings suggest a source of contamination that is wide-spread and not consistent with background contamination.
In FDA's Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Draft Guidance, we recommend certain practices to assist growers and packers of cantaloupes in minimizing microbial food safety hazards. Specifically we recommend the following practices related to growing fields:
• Conducting environmental assessments on the topography, land history, risk of flooding, adjacent land use, and domestic animal and wildlife presence associated with the production environment, using concepts that are outlined in FDA's "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables"(to the extent that any of these environmental factors are present).
• Monitoring and reducing, to the extent possible, domestic animal, wildlife, and insect activity in melon production environments that may contaminate water and soil with human pathogens and directly or indirectly contact melons, thereby increasing the risk of product contamination.
• Evaluating whether to harvest portions of melon fields when there is evidence of unusually heavy wildlife pest infestations (e.g., presence of wildlife feces, large areas of animal tracks, or burrowing).
• Training harvest employees to recognize and report signs and evidence of wildlife pest infestations (e.g., feces) and take appropriate actions.
• Carrying out practices that prevent or minimize surface contamination of melons, especially those with netted rinds (such as cantaloupe), because once surface contamination occurs elimination of contamination is very difficult.
• Evaluating soil amendments where melons directly contact soil.
• Evaluating the type of irrigation (such as furrow or drip) used to minimize soil wetting where melons directly contact soil.
• Using deceleration padding (as part of harvest and post harvest handling equipment) that is constructed of materials that can be cleaned and sanitized.
• Developing and maintaining written food safety plans and SOPs for areas such as handling and storage practices, field, facility and vehicle cleaning and sanitation, and employee training programs.
We also note that your firm did not conduct pre-cooling of melons after harvest. Delays in melon cooling when melon rinds are wet from washing operations or from dew may allow for multiplication of human pathogens on the rind surface of melons. FDA recommends the following practices related to melon cooling:
• Implementing melon handling operations that minimize the incidence of melon surface moisture to reduce potential plant and human pathogen growth.
• Cooling and cold storing melons as soon as possible after harvest, if melons are to be air cooled.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or other similar violations, from occurring in the future.
Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your written reply to the Food and Drug Administration, Attention: CDR Kimberly Martin, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions regarding this letter, please contact CDR Kimberly Martin at (317) 226-6500 ext. 116 or by email at email@example.com.
Glenn T. Bass
Detroit District Office
Cc: Dr. James Howell
2 N. Meridian Street
Indianapolis, IN 46204