Date: Nov 01, 2014
November 2014: Drought Diagnosis--Difficult Year Ahead

In mid-September, the U.S. Food and Drug Administration released its latest iteration proposing changes to four crucial “rules” in the regulations needed to implement the FDA Food Safety and Modernization Act (FSMA): Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food, and Foreign Supplier Verification Programs.  The first two areas are of most concern to Western Growers.

In general, after digesting literally tons of comments from industry and others, the FDA proposed making “the original proposals more flexible, practical and targeted.  The changes are based on the input received during an unprecedented level of outreach to stakeholders and valuable input received from farmers and others directly affected by the rules,” reads the proposals released by FDA on September 19.

At this writing three weeks later, Western Growers Science & Technology department was busy comparing the new proposals, on a line-by-line basis, with comments made by WG and other organizations after the last round of FDA proposals surfaced.  For these new changes, the FDA will accept comments on the revised provisions for 75 days after publication in the Federal Register (Sept. 19), “while continuing to review comments already received on the original proposed rules.  No additional comments will be accepted on the original proposals. FDA will consider both sets of comments—on the original proposed rules and on the revisions—before issuing final rules in 2015,” read the FDA statement accompanying the new proposals.

The agency is planning to hold a public meeting on the revised proposals on Thursday, November 13, 2014, in College Park, MD.

“We are closely looking at their new set of proposals and determining where we should focus our attention,” said Hank Giclas, senior vice president of science, technology and strategic planning for WG.  “I would agree with the characterization that the new proposals do add flexibility and definitely indicate that the FDA digested the input from around the country.”

But Giclas said a quick read indicates  the new proposals just might add a little too much flexibility.  “For example, in California and Arizona, we have been operating under Leafy Green Marketing Agreements for many years now.  We have stringent food safety rules in places that have stood the test of time and proved workable for the grower community.  In many instances, it appears that the new rules are less strict and offer fewer protections than we are using now.”

Giclas said the FDA received comments from all over the country, and many were from small farmers and growers complaining that the original Produce Rule proposals were too restrictive.  “In general that was not our view, but it was the view of many smaller operators.  I would commend the work the FDA has put into this effort.  Flexibility is important as long as it doesn’t trump safety.  We are analyzing the latest effort and will definitely submit comments prior to the deadline.”

In its new proposals, FDA said it has specifically added “more flexible criteria for determining the safety of agricultural water for certain uses and a tiered approach to water testing.”

The FDA is proposing various revisions to the microbial standard for water that is directly applied during the growing of produce (other than sprouts).  Farmers with agricultural water that does not initially meet the proposed microbial standard would have additional means by which they could meet the standard and then be able to use the water.   Giclas said he does have some issues with this proposal as it appears to give growers a “work-around” when their water is below par.  “I have not seen the scientific basis for this and we’d like to see that,” he said.

These options include establishing a sufficient interval of days between last irrigation and harvest to allow time for potentially dangerous microbes to die off.  They could also apply an interval of days between harvest and the end of storage using appropriate microbial die-off or removal rates, provided there is adequate supporting data.  And there is an option to calculate and apply appropriate pathogen removal rates for activities such as commercial washing.

The FDA does make it clear that “any of these options would have to provide the same level of public health protection and not increase the likelihood that the covered produce will be adulterated.”

The new proposals also establish a tiered and more targeted approach to testing each source of untreated water.  The FDA said this proposal recognizes “that water sources have different levels of contamination risk,” and “will be less burdensome on farmers while still protective of public health.”  The revisions reduce how often the water is tested, with the frequency depending on the water source (i.e., surface or ground water) and on the results of prior tests.

The use of manure for organic production was another area where the amended proposals add flexibility.  FDA said it is committed to conduct extensive research and complete a risk assessment on the safe use of raw manure. “Pending those actions, FDA is deferring its decision on an appropriate time interval between the application of raw manure and the harvesting of a crop and removing the nine-month interval originally proposed.  FDA also proposes eliminating the 45-day minimum application interval for composted manure that meets proposed microbial standards and application requirements.”

In the original proposals, FDA had a nine-month proposed minimum-time interval between the application of untreated biological soil amendments of animal origin (including raw manure) and crop harvesting.  While that was eliminated, FDA said it “does not intend to take exception to farmers complying with the USDA’s National Organic Program standards, which call for a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with the soil.”

In eliminating the previously proposed 45-day minimum application interval for compost (also known as humus), including composted manures, FDA said “properly treated and handled compost is safer than raw manure from a public health standpoint, and this change to the proposal would help facilitate its use while still providing an appropriate level of public health protection.”

The new rules also clarify some definitions.  A farm would no longer be required to register as a food facility merely because it packs or holds raw agricultural commodities grown on another farm under a different ownership.  FDA proposes to define such packing and holding as a traditional farming activity.  In general, on-farm packing and holding of produce would be subject to the proposed produce safety rule, not the preventive controls rule.  Farms that conduct additional processing or manufacturing may be subject to preventive controls rules for those activities.

A “very small business” would be defined as firms having less than $1 million in total annual sales of human food, adjusted for inflation.  Previously, three options were proposed: annual sales of $250,000, $500,000 and $1 million.  FDA claims the new proposed definition would exempt less than 1 percent of the dollar value of food produced in the United States.  This continues to be a problematic position for the commercial fresh produce industry.  Many groups continue to believe that the size of the farm should not be relevant when adhering to mandated food safety rules.  Pathogens don’t know the size of the farm where they reside.

With regard to product testing, the FDA is still mulling over this section of the rule.  In its latest proposals, the agency asked for “input on specific language and seeking comment on whether to include it in the final rule.”

WG Staff Contact

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