NSAC's Blog

Ready or Not, Here Comes FSMA! – Part 1

July 27, 2015

All eyes are on Washington as the Food and Drug Administration (FDA) prepares to publish final food safety requirements for produce farms and food processing facilities this fall. These rules are just a few of the many new requirements that FDA will be finalizing in the coming months as part of the Food Safety Modernization Act’s (FSMA) prevention-oriented approach to reducing risks in the food supply, both domestically and abroad.

This is the first of a two-blog series exploring key FSMA issues. Read on for a recap of where we are in the process and key issues to watch in the coming months. The second post zooms in on funding for food safety training.FDA_FSMA_act1

[Need a refresher on what this is all about? We have lots of background material and information on our website.]

Recap: Where are We in the Process?

Throughout this post, we’ll be focusing on two major FSMA rules FDA is expected to finalize in 2015: the Produce Safety Rule, and the Preventive Controls Rule for Human Food. These are the two rules with the greatest impacts on farmers and businesses making food for people to eat.

FSMA directed FDA to engage in a series of public rulemakings to establish these new food safety standards. The first round of proposed rules were open for public comment during much of 2013 and – based largely on concerns raised by NSAC and the sustainable agriculture community – FDA re-proposed certain portions of the rules for a second round of public comments in 2014.

That final comment period on the second draft of the proposed rules ended in December of 2014.

FDA is under a court-ordered deadline to finalize the Preventive Controls Rule by August 30, 2015 and the Produce Rule by October 31, 2015. Both of those rules are currently under final review by the White House Office of Management and Budget (OMB), and at this point there is no reason to believe FDA will not meet those timelines.

So Then What Happens?

Once OMB releases the rules, they will head to the Federal Register for final publication. The rules become effective 60 days after they are published; however, farms and facilities covered by the rules have staggered timelines to come into compliance based on the size of the operation.

Assuming FDA finalizes the timelines from the proposed Produce Rule, all farms will have at least two years to come into compliance with the Produce Rule. Small farms would have three years, and very small farms would have four years. Additionally, all farms would have two extra years to come into compliance with the agricultural water standard.

Assuming FDA finalizes the timelines from the proposed Preventive Controls Rule, all food facilities will have at least one year to come into compliance. Small facilities would have two years, and very small facilities would have three years.

The definitions of what qualifies a farm or facility as a small or very small business under each rule have not been finalized, but are likely to be similar to what was proposed in the supplemental round.

So let’s say the Produce Rule is finalized on October 31, 2015.  It would then go into effect 60 days later — on December 30, 2015.  This means farms that are not small or very small businesses would still have until at least December 30, 2017 before they are expected to be fully compliant with the Produce Rule – except they would have until December 30, 2019 to be compliant with the agricultural water standard. A small farm would have until 2018 and 2020, and a very small farm would have until 2019 and 2021.

Many of the specifics about FSMA implementation may not be fully apparent until the rules are finalized and guidance documents and other interpretative outreach materials are developed. But this lag time gives farms (and food facilities) time to figure out:

  • whether the rules – in full or in part – apply to them;
  • how various provisions will be implemented;
  • what the best training option is for an operation of their size, type, or complexity;
  • what changes they need to make to be compliant; and
  • what standards and approaches FDA will be using to verify compliance with the rules.

Compliance and Enforcement

There are a lot of questions about how the rules will be implemented, and what FDA will do to verify compliance. In light of that fact, back in May 2014 FDA released an operational strategy document laying out the framework or guiding principles for its implementation activities. It emphasized FDA’s intention to rely on traditional and new oversight tools, including:

  • Commodity- and sector-specific guidance on implementation of prevention-oriented standards;
  • Education and outreach to industry to ensure expectations and requirements are understood;
  • Technical assistance to facilitate compliance, especially by small and mid-size operators;
  • Regulatory incentives for compliance, such as less frequent or intense inspection for good performers;
  • Reliable third-party audits to verify compliance;
  • Public education, transparency, and publicity to promote compliance and prevention; and
  • Modernized approaches to inspection and enforcement based on the prevention framework and the enhanced inspection and enforcement tools provided by FSMA.

The principles and activities FDA identified to drive Produce Rule implementation include:

  • Deploying a cadre of produce safety experts in headquarters and the field with the depth and breadth of capacity to develop the guidance needed to support implementation and provide technical support to government and industry parties working to foster compliance;
  • Actively supporting education and technical assistance for growers, primarily through collaboration with other public and private parties;
  • Supporting public and private parties involved in audits and other accountability functions with technical assistance and other collaborative support;
  • Conducting targeted on-farm surveys and inspections to understand current practices and identify gaps in compliance;
  • Taking administrative compliance and enforcement action when needed to correct problems that put consumers at risk;
  • Responding to produce outbreaks effectively to lessen impact on public health; and
  • Conducting in-depth environmental assessments where appropriate to identify root causes of outbreaks associated with produce and inform future prevention efforts.

Many of the specifics surrounding how these activities will be carried out have not been fully fleshed out. According to FDA,

“FDA’s implementation of produce safety standards will entail a broad, collaborative effort to foster awareness and compliance through guidance, education, and technical assistance, coupled with accountability for compliance from multiple public and private sources, including FDA and partner agencies, USDA audits, marketing agreements, and private audits required by commercial purchasers.”

Significant attention has been paid to the respective roles of the states and the federal government in implementing these rules, but it is yet unresolved which entities will take the responsibility of enforcing these rules at the farm level.

Questions Remain Regarding Inspections, Audits, Training

At a public meeting on FSMA implementation in April 2015, FDA solicited public input on many of these topics, including how to best do outreach, education, and training and what an on-farm inspection program might look like.

Some of these questions (i.e. how to apply the agricultural water standard; how to interpret the provisions relating to wild and domesticated animals; how to claim a qualified exemption) will most likely be answered through interpretive materials like guidance documents, which provide more detail and specifics on how certain provisions of the rules are to be implemented. Guidance documents are typically released first as drafts to allow the public and the regulated industry the opportunity to provide comment before they are finalized.

For other issues, however, we still do not know the processes that will be put in place to address them, or what further opportunity stakeholders will have to weigh in on them as they are developed and ultimately implemented. For example, how will FDA be approaching first-time visits to farms subject to the new rules? NSAC recently worked with FDA to improve the protocol for surveillance sampling on farms, and we believe that any farm visits under FSMA should also have a clear protocol that takes into account input from organizations that work with farmers.

Another big questions is: what relative significance FDA is placing on third party audits for domestic farms and food facilities? NSAC has been among others in the industry to caution against placing outsized significance on third party audits to demonstrate a farm’s compliance with food safety requirements, or as evidence of a “culture of food safety” within an operation.

Although the issue of third party audits has not been fully explained for domestic operations, FDA recently released a draft guidance for public comment on accreditation standards for third-party auditors and certification bodies that conduct food safety audits and/or issue food and/or facility certifications for imported foods. The guidance was accompanied by a proposed rule to establish a user fee program through which FDA would assess fees and require reimbursement for its work to establish and administer the third-party accreditation program.

It is important to note that, while FSMA directed FDA to establish this audit-based program for imported foods, FSMA prohibited FDA from requiring US farms or food facilities to hire an auditor or certifier to verify compliance with the Produce or Preventive Controls Rules. Nonetheless, FDA has indicated that it will take third party audits into account as it allocates it limited resources to do domestic inspections. While there is certainly a role for third party audits in domestic markets, it is important that FDA does not violate FSMA’s clear statutory prohibition on mandatory audits for domestic farms and food facilities.

We encourage FDA to also consider alternative approaches to the traditional third-party audit as it allocates limited resources to do inspections, including the GroupGAP model that USDA is currently piloting (with NSAC member the Wallace Center), participation in education and training programs, or even voluntary self-assessments. Each of these activities can inform FDA’s assessment that an operation is demonstrating a culture of food safety, and help FDA allocate its limited resources in a risk-based way.

Outreach, Education, and Training

A common theme throughout these implementation discussions is that education, outreach, and training are critical components of successful FSMA implementation. Particularly for produce growers, valued-added farming operations, and small food processors – many of which have never had to comply with requirements of this nature before – outreach, education, and training are crucial.

Currently, there is only one FDA-recognized curriculum for Produce Safety trainings (through the Produce Safety Alliance) and one for Preventive Controls trainings (through the Preventive Controls Alliance). However, FDA has made public its commitment that the FSMA rules, and FSMA implementation, will not be one-size-fits-all. Therefore, it is likely that – once the rules are finalized – alternative FSMA training programs will start cropping up, providing farmers and food processors with an array of training options outside of the Produce Safety or Preventive Controls Alliances that may be better suited to their operations.

It is important to note that training is a requirement under the proposed FSMA rules, and is likely to be part of the final rules. However, the rules do not require farmers or food businesses to take the Alliance training courses, nor do they require you to pay for a certificate from a training course to satisfy the training requirement. However, a certificate from one of the Alliance training courses is considered one way to satisfy that requirement. NSAC has advocated for FDA to provide a process by which alternative training programs will also be validated, so that farmers and food businesses can choose trainings that may be better tailored to their operations, and know that the training they take will satisfy the FSMA training requirement.

Up Next: Funding for Food Safety Training. The second post in this series will take a closer look at the appropriations process, focusing particularly on critical funding to support farmer food safety training and education.

Categories: Food Safety, General Interest, Local & Regional Food Systems

One response to “Ready or Not, Here Comes FSMA! – Part 1”

  1. […] Agriculture Coalition’s analysis of what the  Food Safety Modernization Act (FSMA) rules and implementation timetable are likely to look like and the NSAC’s  update on the FSMA training […]