External warehouses, along with transporters (to be tackled by the transportation component of FSMA) are all part of the food chain, but have not received as much attention as the processing component - processing facilities and connected/internal warehouses. For the food system to be safe, all components of that chain must utilize food safety practices. Unfortunately, some of these ancillary services have not had the level of attention that they should have had. One exception being where the warehouse had to meet 2nd party or 3rd party inspection requirements.
Senator Pressures FDA To Crack Down On ‘Disgusting’ Warehouses That Supply Our Food
by Sam P.K. Collins Posted on January 12, 2015 at 11:57 am Up
Last year, the Food and Drug Administration (FDA) cited squalid conditions in 90 warehouses, including a Chinese food distributor that the agency found to have rodent nests, carcasses, and feces littering in its warehouse during an inspection in December.
That’s why Sen. Chuck Schumer wants the regulatory agency to up the ante and crack down on food manufacturers that cannot maintain sanitary spaces for food production. He’s calling for more frequent inspections, higher fines, and the creation of an easily searchable food database for distributors and consumers.
“At the end of 2014, the FDA quietly revealed hundreds of food safety violations at food processing facilities over the course of the year, and everyone from restaurant-goers to owners are appalled by some of the disgusting conditions at warehouses that supply our food. Reports of the filthy conditions at some of these warehouses sound like a page straight out of Upton Sinclair’s ‘The Jungle,’” Schumer said in a press release.
Schumer and other FDA critics say that a failure to check negligent food manufacturers has posed deadly consequences for American consumers. The Center for Disease Control and Prevention reports nearly 48 million instances of food poisoning annually, which result in nearly 128,000 hospitalizations and 3,000 deaths. High profile cases of food poisoning include a 2011 food poisoning stemming from listeria-tainted cantaloupe that killed 13 people. In 2009, more than 700 people fell ill after eating peanut butter tainted by salmonella. The salmonella outbreak forced the largest food recall in U.S. history and the first criminal trial of a food manufacturer.
The Federal Food, Drug, and Cosmetic Act requires domestic food manufacturers and distributors to take measures to ensure food safety before products make it to supermarket shelves and stores. The legislation, originally passed in 1938, also allows the FDA to routinely inspect food facilities in conjunction with state regulatory agencies
The frequency of inspections often depends on the type of facility, the type of food processed, and the public health risk associated with certain products. Follow-up inspections occur in the event that inspectors initially find a facility to be in violation of government regulations. In 2010, the FDA took further steps in securing food safety by launching the Safety Reporting Portal, which allows public health officials to open accounts and upload reports. One year later, President Obama signed the Food Safety Modernization Act — legislation that broadened the FDA’s authoritative powers over food harvest and production — into law.
If the FDA takes Schumer’s suggestions into consideration, the agency will increase facilities designated as high risk more often than once every three years and increase the fines for those who are in violation of food sanitation rules.
Despite efforts to strengthen food regulations, the Food Safety Modernization Act has come under scrutiny in recent months from organic farmers who consider the preventative measures outlined in the legislation to be restrictive. Last September, the FDA revised the law so that it would allow easier application of raw manure, relaxed oversight of irrigation water, and exempted small farms from produce safety rules.
The regulations that Sen. Schumer suggested may provoke similar pushback. However, the legislator doesn’t seem deterred in his battle to make the food inspection more transparent, especially since the FDA is only required to release information about violations by the end of the end of the year, a rule that he wants to change.
“The process takes too long and is much too private,” Sen. Schumer told a CBS New York affiliate. “There’s no easy way for the purchasing restaurants and the public to find out which warehouses have violations.”
More - http://thinkprogress.org/health/2015/01/12/3610616/schumer-fda-inspections/
FDA Warning Letters
NYWP Enterprise LLC. 12/9/14
Juan Qing Lin, Co-Owner
New Yung Wah Trading Company
311 Richardson Street
Brooklyn, New York 11222
Dear Mr. Zheng:
The U.S. Food and Drug Administration (FDA) inspected your multiple food warehouse, NYWP Enterprise LLC, located at 1300 Island Avenue, McKees Rocks, PA, on October 15, 2014 through October 30, 2014. The inspection found significant violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products stored at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to Jesse Zheng at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
1. As required by 21 CFR 110.35(c), you must not allow pests in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators visually observed the following evidence of a lack of pest control as follows:
On October 15, 2014, in cooler #2, located adjacent to the east side of the facility, an apparent active rodent nest containing multiple rodents was observed in a plastic lined box containing thawing rib meat, being stored on top of approximately 20/10 lb. Winter Melons, inside a 4 foot x 4 foot x 4 foot cardboard container placed in a wooden pallet.
On October 15, 2014, on the 1st floor of the facility, four (4) apparent rodent carcasses were observed, along the south, east and north walls of the facility and birds were observed throughout the warehouse. On October 16, 2014, birds were observed flying through the facility and landing and defecating on stored food products. On October 20, 2014, birds were observed throughout the warehouse, one (1) apparent rodent carcass was observed on the first floor, two (2) apparent rodent carcasses on the second floor, and one (1) apparent rodent carcass was observed in the courtyard. On October 21, 2014, birds were observed flying through the facility and were landing and defecating on stored food products. On October 15, 16, 20, and 21, 2014, birds were observed throughout the dry storage area landing and defecating on stored food products.
On October 15, 2014 and October 16, 2014, in cooler #2 located adjacent to the east side of the facility, a pallet containing twenty (20) cartons with six (6) (b)(4) brand pineapples in each, was observed to have what appeared to be possible gnaw holes on the top cartons. Inside these cartons there were shavings of the cardboard material and pineapple leaves that appeared to be nesting material. In addition, our investigators observed what appeared to be rodent excreta inside these cartons.
On October 15, 2014 and October 16, 2014, in cooler #2 located adjacent to the east side of the facility, what appeared to be rodent excreta was observed throughout the cooler, specifically along the north and east side walls.
On October 16, 2014, in the dry storage area, what appeared to be rodent excreta was observed on pallets of stored food products near the entrance, which lead a path to a hole inside a bag of flour which appeared to be a rodent gnaw hole. In addition, there was apparent rodent excreta found in the center of the dry storage area as well as along the north, east, and west walls of the facility on October 15, 16, 20, and 21, 2014.
On October 15, 2014, adjacent to the west side of the dry storage area, a pallet containing 45/50 lb. bags of monosodium glutamate was observed containing what appeared to be rodent excreta throughout the plastic wrapping of the products and on the top of the pallet. Additionally, there appeared to be nesting material on the top of the pallet and under a black light, possible rodent urine stains on the paper bags of monosodium glutamate.
On October 20, 2014, what appeared to be rodent excreta, nesting material, and rodent gnaw marks were observed on single service food products, on the 2nd floor of the facility.
2. Your firm failed have plumbing that is properly installed and maintained to provide adequate floor drainage, as required by 21 CFR 110.37(b) (4). Specifically, on October 15, 2014, our investigators observed standing water when entering cooler #2, adjacent to openly stored produce. The water was unable to drain properly from the cooler as a result of a clogged drain, and the floor was not constructed in a manner that allowed the water to reach the drain. These conditions were brought to the attention of Mr. Zheng on October 15, 16, and 20, 2014; however, the produce continued to be stored in the same manner with no corrective action taken to remove the standing water.
3. Your firm failed to use rodenticides without observing necessary precautions and restrictions to protect against contamination of food, food-contact surfaces, and food-packaging, as required by 21 CFR 110.35(c). Specifically, on October 14, 2014, our investigator observed openly placed rodenticide in the dry storage area along the west, east, and north walls. This rodenticide was placed on plastic plates next to stored food products along the exterior walls of the facility.
4. Your firm failed to take proper precautions to reduce the potential for contamination of food, and food-packaging materials with microorganisms, chemicals, filth, and extraneous material, as a result of deficiencies in plant size, construction, and design, as required by 21 CFR 110.20(b)(2). Specifically,
The southwest side of the facility had access holes for piping that were cut through the exterior wall to allow the compressor lines for the interior refrigeration units. The access holes were secured using duct tape to seal the additional space between the piping and the facility wall.
In the Courtyard on the exterior of the facility facing the south and north walls, multiple pest access points were observed in the building to include broken windows, holes in the exterior of the building, breeze louvers, open air ducts, and random drain pipes that were connected.
The exterior of the south wall, adjacent to a low lying area of stagnant water, a series of generators were stored under an exposed overhang connected to the facility. The pipes from the series of generators enter the facility through an approximate 24” x 18” square hole. Directly inside the facility, finished product was observed to be stored.
5. Your firm failed to have adequate drainage of areas which may contribute to contamination of food by providing a breeding place for pests, as required by 21 CFR 110.20(a)(3). Specifically, directly adjacent to the generator storage area, a low lying area filled with standing water, marshy soil, and large rocks was observed by our investigators. This area continues alongside of the exterior perimeter of the building and can provide a harborage area and water source for pests.
6. Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, building material, used equipment and vehicle parts were observed in an exterior enclosed courtyard separating the two sections of the warehouse. Adjacent to this area, on the north wall of the courtyard, our investigators observed what appeared to be rodent tracks and a dead rodent carcass.
7. Your firm failed to construct your plant in such a manner as to allow aisles or working spaces between equipment and walls, and that they are unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food, as required by 21 CFR 110.20(b)(4). Specifically, on the north wall of the dry storage area, pallets storing food products were stacked approximately two high and six to eight deep, covering an area of approximately 3000 square feet. The pallets were stacked directly against one another, which did not allow adequate spacing to inspect or observe possible rodent activity.
8. Your firm failed to store single-service articles in a manner that protects against contamination of food and food-contact surfaces, as required by 21 CFR 110.35(d)(4). Specifically, in the dry storage area of the facility, three (3) buckets were observed collecting water, draining from a leak in the rood. The buckets were placed on top of single service food related items that are distributed for sale. Additionally, the exterior packaging of these items was observed to be wet and deteriorating.
9. Your firm failed to provide safety-type light bulbs and lighting fixtures that are suspended over exposed food, as required by 21 CFR 110.20(b)(5). Specifically, the light fixtures in cooler #2 and freezer #3 were observed to be exposed and unprotected with food items being stored directly under them.
10. Your employees failed to confine the use of tobacco to areas other than where food may be exposed, as required by 21 CFR 110.10(b)(8). Specifically, on October 21, 2014 in front of freezer #3, two (2) employees were observed smoking while handling food products for distribution.
Read More - http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426882.htm