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News Release from: ACIL
Edited by the Laboratorytalk Editorial
Team on 02 September 2004
Food rule 'will fail'
American Council of Independent Laboratories submits comments in response to FDA's proposed rule governing laboratory testing and imported food
The microbiology and analytical chemistry (MAC) section of the American Council of Independent Laboratories (Acil) submitted extensive comments in response to FDA's proposed rule governing 'Requirements pertaining to sampling services and private laboratories used in connection with imported food proposed rule (docket 2004N-0184) The Section's executive committee believes this to be one of the most important proposed regulations it has addressed in many years
This article was originally published on Laboratorytalk on 17 May 2004 at 8.00am (UK)
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Its impact on the independent food testing industry would be substantial.
Acil recognises the value of this rulemaking effort.
It is important to deter the importation of unsafe food.
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Further, ACIL agrees with the agency that there is a clear need to establish uniformity in private laboratory submissions and to seek improved consistency in the analytical data upon which the agency may rely to make imported food admissibility decisions.
A critical component to improving this process is to develop standards that will establish uniformity among FDA district offices in receiving and reviewing private laboratory submissions.
Ensuring integrity in this process will directly benefit Acil members, the FDA, and most importantly, the consumers who rely upon their combined efforts.
Acil and its members are committed to working with the agency in this process.
However, Acil believes that this proposed rule does not accomplish the its stated objectives.
Acil included in its comments a number of serious objections regarding the proposed rule's contents, structure, and regulatory reach.
For example, FDA has issued this proposal while relying on outdated data and information and without taking into consideration the dramatic and recent changes in business practices in the food and private laboratory industries.
This rule has been in development since 1996.
Because of its many concerns, Acil recommended that FDA withdraw this proposal, re-enter discussions with industry stakeholders, and reissue the proposed rule after FDA completes implementation of its new bioterrorism authorities.
Alternatively, and at a minimum, Acil recommended that FDA should reengage the industry regarding this exercise of its regulatory authority and issue its final rule in interim form.
This would permit the agency's stakeholders to make additional comments regarding any changes from this proposal.
Further, Acil urged FDA to recognise private laboratory accreditation by granting a presumption that analytical results submitted by accredited laboratories are accurate and competent.
It also encouraged FDA to reduce the supporting information that an accredited laboratory must include in its submissions to FDA.
More than a dozen food related associations and individuals submitted comments in addition to Acil.
The MAC executive committee will continue to monitor this activity and gladly offers to work with the FDA to design a rule that will enhance enforcement activities and food safety without undue negative impact on the food and testing industries.
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