FDA today extended the deadline for information collection provisions to May 16, 2013 for comment on two proposed rules it issued in January under the Food Safety Modernization Act. The rules are “Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food” (HARPC) and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”
England’s consultancy firm, FDA Imports, has posted some videos on the proposed rules. In these, England lays out how these rules change the landscape for food producers and the ways in which FDA has overstepped its bounds in his opinion.
One of the quirks of FSMA, England said, is that during the process of writing the law and hashing out differences between Senate and House versions, some portions of the law that had been vetted by concerned parties were replaced by other versions that had not undergone similar scrutiny. So the final law ended up with some holes in it, holes that England said FDA is attempting to fill on the fly with these new rules.
“FDA decided essentially to write portions of the law for Congress,” England said. “They’ve been known to do that before.”
Creating an adulteration charge
The way FSMA went onto the books, FDA did not technically have authority to seize food that was adulterated under the law. If a producer violated the law they could be charged with a criminal offense, England said. And if the food was deemed to be actually unsafe, FDA’s authority to act was clear. But food that fell into the technically adulterated category was in something of a limbo.
So in the proposed rules, FDA constructed an “adulteration charge,” England said. Food that was “prepared, packed or held under unsanitary conditions” would be deemed to be adulterated under the law.
In England’s view the problem FDA created lies in the language in this adulteration charge itself. FDA equated the growing of food with the preparing, packing or holding of food. England said that while some farms might wash food before boxing it for shipping, that isn’t what most people consider “preparing” food for consumption.
“I think FDA is creating authority here that Congress didn’t give them,” England said.
Issues with HARPC
England also took issues with some portions of the HARPC requirement, issues that he thought concerned individuals and companies should comment on. One of the possible issues is what qualifications FDA would deem adequate for a company official who would manage these processes. In the preamble is some language that talks about training or equivalent work experience, which must be documented.
If FDA defines these qualifications at the highest level it will create a shortage of qualified people in the marketplace, England said.
“Bigger companies will always hire up the best talent,” England said. “The dietary supplement industry is an example of an industry that is consuming experience in the marketplace. Smaller companies are going to be stuck with what they can get.
“I do think there is going to need to be a period of time for companies to train their people,” he said.
Which won’t be cheap.
“I think FDA has underestimated the expense of this provision. I think it’s going to be quite expensive to find and especially to qualify people to meet this requirement under the regulation,” England said.
When 'should' becomes 'must'
Another change made in these draft rules concerns language surrounding food safety. FDA’s food safety regulations have been around for a long time, England noted. The regs included the word “should” in a lot of places, which makes sense, he said, because of the vast and variegated nature of the food industry. It made it hard to write precise regulatory procedures for each individual situation.
In the draft updated food safety regulation issued under FSMA, England said, the word “should” was changed in a number of places to “must.” That’s important, he said, because in the former circumstance, a company could have a discussion with FDA about whether its procedures matched the regulatory requirements. If the word is “must,” England said, the wiggle room is gone.
Comments needed
England stressed the need for a robust response to FDA’s call for comment, both for getting the best regulations possible in the first place, and as a basis for possible remedial action later.
“If they don’t get their comments on the record during the time frame, FDA is not obligated to consider them. If they are on the record, FDA is required by law to read, review and respond to the comments in the preamble of the next version,” England said.
“It gives industry to a way to get FDA on the record of what FDA thinks the regulation language means. Later on, when interpreting the regulations, you are always going to go back to the preambles of the previous versions to see what FDA meant.
"They have to at least articulate what they are doing and a reason why they are doing it that would satisfy a court. Then you’ve got something you can challenge later if you feel you need to,” he said.
The new deadline for comments on the proposed rules is May 16. Comments can faxed to Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the title of the relevant proposed rule.