FDA Comment Number : EC1
Submitter : Mr. Jeffrey Abels Date & Time: 07/19/2004 05:07:58
Organization : Foreign Trade Service Corp.
Food Industry
Category :
Issue Areas/Comments
We have serious concerns with Proposed 59.105, a provision in the Proposed Rule that would continue to allow importers or persons with a vested interest in an imported food to collect their own enforcement samples from detained products. Further, Proposed 59.3 (c) needs to define those companies or persons who have a vested interest in the product and are therefore not an independent sampling service.
Allowing importers, companies or persons with a vested interest to collect their own samples in connection with an FDA enforcement action is analogous to permitting airline passengers to screen their own luggage or themselves before boarding aircraft. This is a matter of food safety and security. Independent sampling by trained professionals is in the best interest of public safety and effective enforcement action.
Importers and warehouse companies have a vested interest in the product. For an importer, the financial risk of an FDA detention and refusal is great. Though most importers are persons of high integrity, it is naive to assume that an importer or a party that has a vested interest in the product can always be trusted to take unbiased representative samples. It is also naive to expect that employees of an unscrupulous importer will never be coerced, or that a public warehouse will always report insanitary conditions in their facility. It is unlikely that a less reputable importer will always alert FDA if some of the detained product has already been distributed or if it is mislabeled, misbranded, or missing an allergen warning. If importers and parties with a vested interest could always be trusted to comply with 21 CFR, you would not need FDA intervention at all. Enforcement samples and the subsequent analytical data are forensic evidence used by FDA to enforce federal law. An independent sampler acts on behalf of FDA.
Importers and warehouse companies do not meet the criteria of an independent sampling service and this should be specified in the definition contained in Proposed 59.3 (c). Goods stored in a public warehouse serve as collateral and can be held against payment of storage and handling fees. Refused or detained products are a liability and could be abandoned to the warehouse or trucking company by a defaulting importer. As such, warehouses and even transportation companies have a vested interest in the product. Consider Sections 402(a)(3) and 402(a)(4) of the Food Drug and Cosmetic Act that address filth in foods and foods held under insanitary conditions. It would be unlikely that a party with a vested interest would report that they have held the food under insanitary conditions. Further, once a product is removed to a warehouse from a pier, airport, or border crossing, it could be repacked, remarked, or otherwise manipulated for any number of reasons.
Professional independent sampling services and private laboratories have personnel that are trained in lot identification, sample identification,photo documentation, labeling laws, product coding, aseptic sampling technique, random sampling, sand how to avoiding cross-contamination of samples. Chapter 4 of the FDA IOM describes a valid sample as, 'the starting point and keystone for most administrative and legal actions. As evidence, the sample must support the government's charge there is a violation of the law. Also, it must conform to the rules on admissibility of evidence.'
We support the required use of independent sampling services as an integral part of the goal to ensure food safety and security. However, if importers are permitted to collect their own enforcement samples, there is nothing in the Proposed Rule that will effectively deter an unscrupulous importer or a party with a vested interest from substituting foods or manipulating samples.