Today'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?
For example, the QAR ranked certain produce commodities, such as bananas and coconuts, as lower risk for illness, in part because such commodities are peeled or shelled before consumption in a manner that can be expected not to transfer contamination onto the interior, edible portion of the commodity. Should such commodities be covered by the rule? Is coverage of these commodities unnecessary? Should they be covered but subject to a less stringent set of requirements?
Some commodities (for example, pears, grapefruit, oranges, and lemons) meet both of these criteria, considering the rankings and outbreak data used in the QAR. Should commodities that meet both of these criteria be covered by the rule?
Is coverage of these commodities unnecessary? Should they be covered but subject to a less stringent set of requirements?
How should the rule address the changing nature of outbreak data over time?
How should the agency account for uncovered commodities in considering a commodity-specific approach that relies on outbreak data?
Are there pathogen surveillance data from sampling programs focusing on produce commodities that have no history of known outbreaks that would be useful in considering a commodity-specific approach?
Can commodity characteristics be used as a basis to consider a commodity-specific approach?
While the outbreak data show no consistent pattern that can be matched to commodity characteristics such as growth habit, our QAR shows that produce commodities that are ranked as higher risk of illness and those ranked as lower risk of illness do share some of the same characteristics.
A further refinement of our assessment might be helpful in developing a commodity-specific approach based on commodity characteristics. Considering the qualitative nature of our assessment, are there quantitative data sets available that would enable a further refinement of our assessment?
Are produce in both direct market channels and other commercial channels subject to the same routes of contamination?
Is the number of opportunities for contamination during packing and holding greater for produce in other commercial channels as compared to produce in direct market channels?
If yes, is this due to greater numbers of touch points and handlers in these channels than there are in direct market channels, or to other factors?
Should market channels be used as a basis for risk categorization?
If so, how?
Is there a need to consider market channels in risk categorization, considering that the statutory qualified exemption already addresses market channels as a possible risk factor?
Are other data or information available that would otherwise be useful in considering a commodity-specific approach?
Lest the FDA be accused of being out of touch, too prescriptive and all-knowing in its food safety rules, let it be remembered the dozens of question marks we find in the proposed regulations. Whether the industry has the time, resources and knowledge to answer them is yet another unanswered question.