Under the interim final rule (IFR), which has been issued by the Food and Drug Administration (FDA), the agency will be allowed access to records beyond those relating to specific suspect food articles if it reasonably believes that the other products are likely to be affected in a similar manner.
The amendment, which is the FDA’s latest step in implementing the Food Safety Modernisation Act (FSMA), will bring record-keeping by food firms in-line with the FDA’s access to records.
The FDA expects the costs related to the amendment, which will take effect from 1 March 2012, to be “negligible.”
The interim ruling amendment affected Section 1.361 of the Federal Food, Drug and Cosmetics Act.
Under the ruling any records and other information accessible toFDA “must be made readily available for inspection and photocopying or other means of reproduction,” if the FDA has reasonable belief that an article of food is adulterated and presents a threat to human or animal health.
The FDA can put the amendment to practice when it has “a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner.”
“Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request,” added amended Section 1.361.
The amendment will boost the agency’s ability to prevent potentially harmful food from reaching consumers and thereby improve the safety of the US food supply, said the IFR document.
No additional costs
Implementing the amendment will come at no additional cost for the FDA or taxpayers but costs could be incurred businesses, the IFR added.
“The costs to plan for a records access request are the same under this IFR as they were under the 2004 final rule, regardless of the number of records requested,” added the ruling.
“As this IFR only affects FDA’s authority to access already existing records, most records management procedures will not change.”
“Costs incurred by businesses could result from an FDA access request requiring them to retrieve a larger number of records than they would have otherwise retrieved under the current authority.”
Members of the public can submit either electronic or written comments on the interim final rule until 23 May 2012.