Proposed rules: More questions than answers?

01/16/2013 04:59:00 AM
Tom Karst

National Editor Tom KarstToday's Federal Register has published the FDA proposed food safety regulations. Find the html file for the "Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food" (preventive controls)  here and the "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (produce safety)  here.

Readers will find it is much easier to navigate the html versions of these rules than the pdf versions previously available.

Much has been said of the questions FDA asks in both proposed rules. Apart from responding to the proposed rule alone, responding to the questions that FDA poses could keep a scribe burning the midnight oil for months.

From the produce safety rule, here are a few questions found in the very first part of the document, dealing with risk assessment:

Should Sec. 112.11 also apply, for example, in the event of an accident or other unexpected event, such as a likelihood of radiological contamination relevant to a covered farm's location, to require that the covered farm take appropriate measures to prevent the introduction of radiological hazards into or onto the produce or by taking measures to provide reasonable assurances that the produce is not adulterated under section 402 of the FD&C Act?

As another example, ifa covered farm's land was previously used for another activity that may have contaminated the soil with chemical hazards such that using the land to grow covered produce may cause introduction of those hazards into or onto the covered produce, should proposed Sec. 112.11 require the covered farm to take appropriate measures to prevent the introduction of the chemical hazards into or onto the produce or by taking measures to provide reasonable assurances that the produce is not adulterated under section 402 of the FD&C Act?

We seek comment on this issue. Is there information in the QAR that could be used to develop such a system of risk-based exemptions? Are there commodity characteristics or growth conditions that could be used as a basis to develop such a system? Do the proposed provisions for variances (see section V.P. below) adequately address this issue?

Are there specific commodities or categories of commodities that should be excluded from the scope of the rule, based on data related to their relative risk considerations?


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