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US: FDA releases final rule detailing preventive standards for farms that grow produce for human consumption

FDA released the much-anticipated final rule detailing preventive standards for farms that grow, harvest, pack, or hold covered produce for human consumption. Once officially published in the Federal Register – scheduled for November 27, 2015 – the rule will go into effect in sixty days and compliance clocks will start ticking for farms covered by this rule.

This final rule – authorized under the Food Safety Modernization Act (FSMA) -- comes after significant public outreach and two rounds of public comment on certain key provisions, and follows the recent publication of the final rule governing food facilities.

“We commend FDA for its continued engagement with stakeholders throughout this process, and appreciate the agency’s responsiveness to our concerns” said National Sustainable Agriculture Coalition (NSAC) Policy Specialist Sophia Kruszewski. “The final rule reflects many of the issues raised by the sustainable agriculture community that led to the improvements we saw in the second draft, and that are retained in the final rule.”

The final rule retains many of the important modifications offered for public comment during the supplemental proposed rule phase, including much-improved language clarifying that the Produce Rule standards neither require nor are intended to encourage farmers from taking any actions to avoid or undo on-farm conservation and wildlife practices. It confirms FDA’s new approach to the use of raw and composted animal manure, which involves encouraging and conducting the necessary research and risk assessment of raw manure before finalizing a standard related to its application. It also finalizes standards that align the use of compost with the National Organic Program, reducing barriers to farmers who use compost. These are all important and helpful modifications.

Disappointingly, the rule does not base coverage thresholds on sales of covered produce. NSAC advocated for more clarity and consistency in defining the coverage thresholds. To avoid discouraging on-farm diversification, and given that the rule only governs the production of covered produce, sales thresholds should be based on covered produce. Unfortunately, FDA did not make these requested changes, and, as a result, implementation of the rule will require significant oversight to ensure diversified family farms have the education and resources they need to prepare for and adapt to these new requirements.

The rule also finalizes the approach to water quality and testing set forth in the supplemental rule, with some modifications. NSAC – together with many in the farm community – raised significant concerns regarding the burden and costs associated with the frequency of water testing now codified in the final rule. In the final rule, FDA emphasizes that farmers can take advantage of the provisions related to alternatives in applying a more appropriate testing frequency, but whether and how farmers can access the necessary research and information needed to support the justification of using alternate testing frequencies remains to be seen. A deeper analysis is needed to fully understand these requirements and alternates.

The preamble to the rule contains language that hints at FDA’s plans for FSMA implementation, but raises more questions than it does provide answers. Of particular note, FDA makes much mention of the role of “reliable” audits and certification programs in its compliance strategies, without providing details on the process for assessing which audits are deemed “reliable” and how such reliance on third party audits is appropriate in light of FSMA’s clear language prohibiting FDA from requiring audits. Utilizing audit results as a component of FDA’s compliance strategies raises concerns of audits becoming a de facto requirement, despite Congress’s clear intention to the contrary.

An outsized reliance on third party audits will overshadow the important role of training and education as a way for farmers to demonstrate a culture of food safety and move toward FSMA compliance. NSAC will continue to urge FDA to be transparent in their intentions regarding the role and relative importance of third party audits, and to consider alternative compliance indicators – such as group certification and self-certification – particularly for the most vulnerable entities shouldering disproportionately higher costs of compliance.

Additionally concerning are the discussions in the preamble related to on-farm inspections. FDA frequently references the partnership between the States and FDA in developing and leveraging resources for inspections. FDA describes a “risk-based” approach to farm inspections, but also references “routine” farm inspections.

“Unlike the Preventive Controls Rule, Congress did not mandate a particular inspection frequency for the Produce Rule,” Kruszewski said, “How does that align, then, with FDA’s statements regarding ‘routine’ farm inspections? FDA must proceed carefully on this issue, making sure to seek the same degree of engagement with and input from the farming community on this issue in order to develop flexible and appropriate implementation processes.” 

NSAC looks forward to continued participation in the FSMA implementation process to ensure a regulatory framework that supports strong public health goals, while simultaneously supporting thriving family farms, sustainable agricultural operations, and local and regional food systems that increase access to fresh, healthy foods. We will also continue to work with congressional appropriators to ensure greater resources are provided for farmer food safety training projects as a critical part of the effort to ensure adequate resources for FMSA implementation as a whole.

We will continue to analyze the rules and their potential impacts, and will continue providing information on the rules through our FSMA website and blog. 

Source: National Sustainable Agriculture Coalition
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