(UPDATED COVERAGE, 11:40 a.m.) Revised versions of the proposed produce safety rule and three other proposed rules under the Food Safety Modernization Act are now available for review and public comment.
The Food and Drug Administration pre-published the revisions Sept. 19 with actual publication scheduled for Sept. 29 in the Federal Register.
The agency will begin accepting comments Sept. 29 at www.regulations.gov. The comment period will be open on all four proposed rules for 75 days.
No new comments on unrevised portions of the rules will be considered, but the FDA will con-tinue to review comments on the original proposals that were submitted previously, said Mike Taylor, deputy director of the FDA.
Revised versions of the proposed rules for preventive controls for human food, foreign supplier verification programs and preventive controls for animal food are also set to be published in the Sept. 29 Federal Register.
Industry groups hit the ground running
The United Fresh Produce Association plans a Web seminar for members to discuss the revisions, said Ray Gilmer, vice president for issues management and communication. The association also plans to set up working groups for each of the four revisions because of the relatively short comment period, Gilmer said Sept. 19.
The Produce Marketing Association is encouraging members to participate in an industry call with the FDA at 3 p.m. Eastern time Sept. 19 on the revisions. Bob Whitaker, PMA’s chief science and technology officer, and Jim Gorny, PMA’s vice president for food safety and technology, are scheduled to participate.
The dial-in number for the Web session is 888-942-9652 for the U.S. and Canada. The passcode is FDA2.
Whitaker said PMA also plans a workshop on the supplemental proposals at Fresh Summit in Anaheim, Calif., on Oct. 17, with FDA’s Taylor.
Comment period unusual for revisions
Taylor said this is the only instance he can recall where the agency has revised a proposed rule and sought comment on the revisions. He said the changes in the produce proposal provide flexibility and more finely targeted requirements to ensure food safety.
A major change for packers and shippers who are not growers is that the revisions call for them to be subject to only the produce safety rule and not the human foods rule.
“It would be duplicative to have them have to comply with the (human foods rule) if they are just packing and handling pro-duce grown at another operation,” Taylor said.
The foreign supplier verification proposed rule is also simplified in the revision, Taylor said. The revised proposal is a hybrid of the two options in the original proposal, Taylor said. The revision takes into account whether a supplier has previously been in violation of FDA regulations.
“The approach FDA is proposing would provide importers with the flexibility to determine appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods,” according to the FDA fact sheet.
Many in the produce industry had complained that the initial proposal’s one-size-fits-all approach was inappropriate for dif-ferent commodities and different growing regions and practices. Onion growers were particularly opposed to water require-ments because of the practice of allowing onions to cure in the field, which results in microbial die off, thus reducing the dan-gers from irrigation water.
“We are codifying a ½ log per day die off rate (for microbial contamination),” Taylor said. “We think it will take into account different practices that have impact on microbial loads such as those discussed by the onion growers in Eastern Idaho.”
Key changes also include new microbial standards for irrigation water, with the exception of sprout-growing operations. Many growers had complained the initial water proposal would have been financially and logistically impossible to meet.
“The FDA is proposing to revise the water quality testing provisions in the proposed produce safety rule to account for natu-ral variations in water sources,” according to an FDA fact sheet.
The revision includes new options for growers whose agricultural water doesn’t meet microbial standards such as establish-ing an interval of days between the final irrigation and harvest to allow for microbial die off. There are also revisions to re-duce the frequency of water tests.
Taylor and Samir Assar, director or produce safety at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) traveled to several growing regions in 2013 to talk with growers and review operations to gain insight for the water regulation revisions.
Assar said Sept. 18 that the new proposal is based on scientific data that supports standards from the 2012 version of the Environmental Protection Agency’s recreational water criteria, which is less intense than the 1986 EPA standard that was used for the initial produce rule proposal. The initial produce rule was proposed in January 2011 before the EPA revised the standard.
“The objective is to have a standard that is practical and meets safety goals,” Taylor said. “We needed a benchmark and the revision reflects a new numerical benchmark (for microbial levels.)”
Manure regulations relaxed
Changes in the proposed rules related to manure are in the works, with the FDA having removed the proposed nine-month minimum time interval between application and harvesting. Organic growers in particular had complained that the nine-month rule would hamper their operations.
The agency is working with the U.S. Department of Agriculture on a risk assessment and is deferring its final decision on manure use until that research is concluded, Taylor said.
“At this time, the FDA 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,” according to the agency’s fact sheet on the proposed revision.
The FDA also proposed to drop the 45-day minimum application interval for compost, aka humus, including compost manures.
Defining small and very small businesses
The revisions clarify “very small” and “small” businesses in regard to compliance with the new rule, which is scheduled to be published Oct. 31, 2015.
The FDA proposes that farms or farm mixed-type facilities with average annual produce sales of $25,000 or less will not be covered. The original proposed rule defined that monetary threshold in terms of all food sales.
Also, the definition of farm would be revised. Operation merely packing or holding raw agricultural commodities grown elsewhere would no longer be required to register as food facilities. The FDA proposes those operations would be subject to the produce safety rule rather than the preventive controls rule for human food.
Compliance dates in the revised proposed produce rule are:
- Four years for “very small” businesses with annual produce sales between $25,000 and $250,000;
- Three years for “small” businesses with annual produce sales between $250,000 and $500,000; and
- Two years for all other farms.
Compliance dates for water provisions would be an additional two years beyond the compliance dates for the rest of the final produce rule.