April 17, 2014 / Week N° 16

New FDA rules to bring “legal teeth” to food safety, says O’Brien

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January 17th, 2013

The Produce Marketing Association (PMA) will start hosting webinars today in a bid to educate the industry about the U.S. Food and Drug Administration’s (FDA) recently proposed rules that will impact food safety procedures. Involved will be the association’s representative in Washington, Tom O’Brien, who told www.freshfruitportal.com it was important to spark dialogue amongst stakeholders to help provide comments. He also outlined his hopes for the outcome of a rule that is yet to come on verification systems for imports.

Tom O'Brien _ PMA _ small

Tom O’Brien

O’Brien said there has been “a lot of outreach” from the FDA to understand the draft regulations made under the Food Safety Modernization Act (FSMA).

While he said the process has taken longer than expected, O’Brien was positive about how the recent proposals drew references from existing industry standards, such as the leafy green requirements in California that followed the 2006 spinach E.coli scare.

“There’s a real sense they did their homework and they’re trying to get that consistency that we said was important,” he said.

“The FDA released two rules – one on preventative controls which applies to food facilities, and they released another one on those that grow produce; what’s really important I think is that they’re intending to apply it to food consumed in the United States regardless of where it’s grown.

“The way that’s implemented is with a rule that’s not yet published, so it’s a little hard to evaluate some of this just yet.”

He said the upcoming rule was expected within a month, concerning what verification systems importers need to have in place to demonstrate food grown outside the U.S. is consistent with food grown domestically.

“Part of what we need to do in the produce industry is make sure to the extent that we can, that the FDA processes mirror the existing processes so that it’s not two sets of requirements that are going on.

He said the difference between the proposed changes and existing food systems was the force of law.

“They’ll be part of government enforcement, and that will be a significant change. That’s that congress thought by passing the law was really important.

“For imports, there will probably be – and we don’t know what the law says – a strong reliance on third party certifications, so to some extent that’s not going to be that different to what it is now, but it will have some legal teeth that are part of it.

When asked about the cost burden of proposed changes, O’Brien highlighted the amount would differ depending on the types of fruits and vegetables grown and how certain companies approached food safety procedures currently.

“If you’re a company that takes food safety seriously, and if the FDA has done its job correctly and put out rules that demand serious food safety steps that are consistent with industry practices, then you may feel very little additional cost,” he said.

“But if food safety’s brand new to you and suddenly you’re having to do things that have never been  done before, then the costs are higher.

“A lot of the actions required are based on an assessment of risk. So if for example you’re using agricultural water that isn’t posing a risk, either because of its source or it doesn’t come from food or transmit anything to food, it might not change anything that happens.”

He added the intended purpose of certain products was also an important factor in determining risk.

“For example, if it’s a potato which is primarily a cooked product, that doesn’t apply, so there are a lot of variables there.”

Implementation expectations

O’Brien highlighted the FDA was accepting comments on the proposals until May 16, because the agency wanted all stakeholders to analyze the proposals closely for formulating comment submissions.

“They’ll then go back and write the final regulations; those are going to go through the laborious process that took so long to get these rules out.

“Once they’re published, there’s an implementation period of a couple of years or longer, depending on your size.”

“We’re certainly going to provide comments. Right now what we’re doing is analyzing the rule and disseminate information to the industry, because we want to spark a dialogue within the produce industry to talk about what exactly might need changing and what doesn’t.”

He said industry players would need to look at what they were doing to make sure it was consistent with the law.

“The open question is, are you already doing that or not? And if not, there may be changes to your practices.

“I think it’s of paramount importance for consumers to trust the food safety system. I think this adds to consumer confidence that produce is safe as well as nutritious.”

Tom O’Brien and the PMA’s chief science and technology officer Dr. Bob Whitaker will host a series of weminars this month about the proposed rules. The first will be at 1pm today (Jan. 17) at 1pm EST called “10 Things You Need to Know about the Produce Rule”, followed by the session “10 Things You Need to Know about Preventive Controls” at 2.15pm EST.

Next Thursday (Jan. 24), FDA experts will join Whitaker for two additional webinars titled ” FDA’s proposed Produce Safety Rule with FDA Speaker Samir Assar at 1pm EST, followed by the session “FDA’s proposed Preventive Controls Human Food Proposal with FDA Speaker Jenny Scott” at 2.15pm EST.

Registrations for the webinars can be made at the PMA’s FSMA Resource Center.

www.freshfruitportal.com

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