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FDA Publishes Final Protocol on Tamper Detectability for Milk Closures

Aug 21, 2006

FDA Publishes Final Protocol on Tamper Detectability for Milk Closures

The Food and Drug Administration (FDA) has published the final protocol for plant inspectors to use to determine whether closures on plastic milk containers can be removed without detection. The protocol will formalize the procedure for tests that Regional Milk Specialists and other regulatory officials have been conducting since the beginning of the year.

IDFA and its Tamper Evident Task Force have worked closely with FDA over the past year to develop a measurable and effective protocol.

"We're pleased that a number of comments we made while working with FDA were incorporated into the final protocol," said Michelle Matto, IDFA assistant director for regulatory affairs. "Now there will be a consistent way for regulators to test containers and for members to conduct their own tests to determine tamper detectability."

Caps or closures that can't be removed without detection help to assure consumers that milk has not been tampered with after packaging. Language requiring tamper detectability has been included in the Grade A Pasteurized Milk Ordinance (PMO) for some time, but there was no consistent testing for it. Effective January 1, 2006, FDA reversed its previous regulatory discretion, citing as its reason that the industry had sufficient time to assure the tamper detectability of containers and closures.

According to FDA, the new protocol will be used by State Rating Officers and Regional Milk Specialists to evaluate the PMO's tamper detectability standard during state ratings and FDA check ratings. Container/closure systems that fail these tests will be debited on a pro-rated basis, meaning they will lose points from their inspection score, based on the average daily volume of milk and milk products using the same type of container and closure. The maximum number of points that can be debited for a violation of improper capping, including tamper detectability, is 5 points. If a plant's inspection score is less than 90 out of 100, it runs the risk of losing Grade A status.

To read the "Uniform Protocol to Determine Plastic Fluid Milk Container Closure Removal without Detection (Tamper Detectability)," click here. For more information, contact Michelle Matto at or 202-737-4332.

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Posted August 21, 2006

Dairy Delivers