Comment period expires for two FSMA regulations

FDA has let the comment period lapse for two key components of the Food Safety Modernization Act. The deadline was Friday, Nov. 22 for the produce safety and preventive controls rules.

The comment period for two other rules, covering imported food, was extended an additional 60 days and will now expire Jan. 27, 2014. These regulations would cover foreign supplier verification programs and the use of third-party auditors to certify food safety.

Two major national produce organizations have submitted their comments on the produce safety and preventive controls rules.

The United Fresh Produce Association raised several issues, focusing on what it called FSMA’s “one-size-fits-all” approach, irrigation water, alternatives and variances and definitions of farming and farming activities. Below is a summary of United’s comments on each of these issues.

One size fits all: While FDA has shown a willingness to recognize different risk profiles by proposing exemptions for thermally processed fruits and vegetables and certain commodities rarely consumed raw, FDA fails to take into account the potential for substantive differences in risks inherent in different produce commodities. By applying the same standards to all crops without allowing for commodity differences, FDA unnecessarily adds significant economic burdens on some producers with no impact on risk reduction. United recommended that FDA continue to require growers to manage the risks identified in the produce safety rule, but to move all quantitative metrics into accompanying FDA guidance documents. This has been a successful approach with the seafood HACCP rule, in which one regulation must cover a wide diversity of products, United said.

Irrigation water testing: The produce safety rule proposes specific arbitrary metrics, target organisms and testing intervals for irrigation water, which are not based on sound science and differ from other world regulatory standards. United’s comments communicated to FDA the scientific uncertainty underlying such requirements, and emphasize that the risks and appropriate standards for irrigation water differ significantly across different fruits and vegetables. Therefore, such metrics should be addressed in companion guidance that can be tailored to specific commodities as needed, and updated when science is better informed.

Alternatives and variances: FSMA anticipated that differences among commodities, growing regions and practices would require some flexibility in application of appropriate regulatory standards. While FDA attempts to address this need with sections proposing two specific avenues for “alternatives” and “variances” to the rule’s requirements, these opportunities are unnecessarily restricted and not likely to be effective as proposed. Alternatives are only offered as options to a few of the requirements for water and soil amendments, but are not available for all of those requirements or for any other risk factors identified (worker hygiene, equipment contact and animal intrusion). The ability to submit a variance to the proposed practices is limited to state or foreign governments. United’s comments recommend that both restrictions are unnecessary. Provided that they are supported by sound science, alternatives should be allowed to requirements for any of the risk factors, and variances should be accepted from any knowledgeable body such as associations and commodity boards.

Definition of farms and farming activities: The two proposed rules include a new regulatory term, “farm mixed-type facility,” designating operations that would have to comply with both the produce safety and preventive controls rules. United contends that this designation is overly complicated and not risk-based, and would have severe economic consequences to raw produce handling operations without enhancing public safety. FDA has inadvertently grouped very low risk produce packing and handling facilities together with food processing facilities, which require very different food safety practices. United recommended that packing and holding raw, intact fresh produce is covered adequately by compliance with the produce safety rule, regardless of the size of the operation, the owners of the produce handled or the distance from where the produce was grown.

Ultimately, said United, FDA should publish a second round of proposed rules due to the many comments likely to come in that may result in substantial changes to the originally-proposed rules.

To read United’s complete comments on the Produce Safety Rule and Preventive Controls Rule, visit the United Fresh website at

In its written comments, the Produce Marketing Association (PMA) stressed the importance of science- and risk-based regulations for companies of all sizes throughout the supply chain. PMA also encouraged FDA to strengthen enforcement and reduce confusion by better aligning these two rules’ requirements, and requested the agency’s consideration of a second comment period after rules are revised.

“PMA strongly supports advancing produce safety including FSMA implementation,” said Bob Whitaker, PMA chief science and technology officer. “Our goal is to help ensure the final rules protect the public health of all consumers whom receive food products from all market channels in ways practical and efficient for produce industry members.”

PMA’s proposed produce rule comments stressed the need for individual growers, who know their produce operation best, to assess risks and develop a written food safety plan, provisions the organization said are currently lacking in FDA’s proposal and something that should set the framework for any food safety program. PMA also raised issues relative to numerical standards proposed for irrigation water and soil amendments, as well as produce rule coverage issues such as mix-type facilities and exemptions.

PMA’s comments on the preventive controls proposal applaud FDA’s focus on hazard analysis and preventive controls to help reduce contamination risks (HARPC). PMA also commented on preventive controls for product testing, environmental monitoring and supplier verification despite FDA’s not providing regulatory language in these areas, which PMA said was a violation of the rule-making process.

PMA continues to engage its volunteer leaders to develop comments on the proposed rules for foreign supplier verification and third-party accreditation.

Executive summaries of submitted comments are available online at PMA’s FSMA Resource Center. View key highlights of PMA’s comments in this video.

Originally posted Monday, Nov. 25, 2013

Tags: fda, fsma, pma, united fresh