Produce Rule is Now Mandatory

Produce Rule Now In Effect

By Sonia Salas, Western Growers, Director of Science and Technology

It’s official: Since January 26, domestic and international produce farms designated as “large” (those with annual sales greater than $500,000) are expected to comply with most provisions of the Produce Safety Rule, a federal law created under the Food Safety Modernization Act (FSMA). Smaller farms will be phased in over the next few years.

The Produce Safety Rule is mandatory throughout the United States and applies to both domestic and imported produce. Any produce farm found to be out of compliance may be subject to regulatory action. The State Departments of Agriculture play a key role in education, outreach and enforcement activities.

The California Department of Food and Agriculture (CDFA) recently announced that it will be launching a new Produce Safety Program, which will operate as part of its Inspection Services Division. This program has been created specifically to conduct on-farm inspections on behalf of the U.S. Food and Drug Administration (FDA) and will be used to verify compliance with the Produce Safety Rule.

Additionally, the program will distribute educational information designed to assist California produce farms in understanding the requirements and how to comply with the rule. More information about CDFA activities can be found in their Produce Safety Rule Fact Sheet. The Colorado and Arizona Departments of Agriculture are likewise taking the lead to enforce this rule and educate growers in their respective states.

The focus in 2018 is on education and on-farm readiness. While on-farm inspections are not likely until 2019, Western Growers encourages members to meet compliance deadlines and has developed resources to help members get ready, including an implementation guide and self-audit checklist, available on our FSMA Portal.

Below is a list of Western Growers’ resources and upcoming training to help growers with the FSMA Produce Safety Rule:

FSMA Portal: Click here to access the portal.

Produce Safety Rule Resources Portal (a full Implementation Guide with audit checklist will be available for download tomorrow): Click here to access the portal.

Webinar on February 26: Are you FSMA Compliant?: Click here to register.

Industry Workshops: Click here to view dates and register.

FSMA Produce Rule – Part 1

Mandatory Training Under Way

By Patrick Cavanaugh, Farm News Director

Jon Kimble, the operations business development manager at Safe Food Alliance in Sacramento, spoke to California Ag Today recently about the Produce Rule of the Food Safety Modernization Act (FSMA)

“The new produce safety rule that FDA has released under FSMA is a rule for growers,” he said. “For part of that rule, certain trainings are required, and the training that we’re conducting has been approved by the FDA. It’s been developed by the Produce Safety Alliance, and meets those requirements that they want to have a supervisor or somebody involved in the operation trained according to this training or equivalent to it.”

“We’re very excited, in that we are working with the California Farm Bureau Federation on many of these trainings. We’re looking forward to working with growers and helping them understand what the regulations say and some practical ways to apply the regulations within their operation,” Kimble said.

Kimble explained that the mandatory training covers every aspect of the operation. “Things that you’re doing before planting, during harvest, and even afterward when the produce is being handled in packing houses,” he said.

The training entails topics such as worker hygiene, water control, soil amendments – the whole gamut of the operation.

“The focus is minimizing potential contamination. We all understand that a farm is not sterile,” Kimble said. “We also understand there are potential sources of contamination that need to be minimize. That’s the focus: minimizing contamination – and the main primary emphasis is really on microbial or biological hazards.”

“Of course, there are chemical and physical hazards, but FSMA is focused on microbiological, including bacteria, viruses and parasites,” he said.

This is Part One of a Three Part Series on Maintaining Food Safety



‘To-do list’ on food safety grows longer for feds

Source: Benjamin Goad; The Hill

The largest food safety overhaul in generations is being starved of funding needed to enforce a host of new regulations for factories, farms and importers, safety advocates warn.

The 2010 Food Safety Modernization Act (FSMA) was billed as creating a fundamental shift in the way government protects the nation’s food supply against the threat of food-borne illness.

But despite bipartisan and industry support for the program, only a fraction of the funding needed to implement and enforce it has materialized. Now, with most fiscal 2015 funding issues likely in limbo until after the midterm elections, uncertainty remains.Without additional funding, priorities of the ambitious initiative could fall short, public interest groups fear.

“They’re just not going to make enough of a dent in their to-do list,” said Sandra Eskin, director of food safety at The Pew Charitable Trusts. “They’re going to be really strapped to effectively enforce it.”

The Food and Drug Administration in January of last year began rolling out the first of seven draft rules in support of the FSMA, the biggest food safety update in 70 years.

The rules add a slate of standards for the agriculture industry and food manufactures, and create third-party audits and a new supplier verification program to prevent contaminated foods from entering the country.

Together, the rules are meant to replace a decades-old system built to respond to illness outbreaks with one set up to prevent them through better practices at production plants, warehouses and farms.

The rule-making process has been fraught with delays, as the FDA grapples with a litany of questions about how to impose the regulations. The agency has been forced to revise and re-propose some of the rules in response to industry concerns.

The FDA’s failure to meet a July 2012 deadline under the law drew a lawsuit from food safety advocates and a subsequent federal court order requiring the agency to complete all final regulations under the FSMA by mid-2015.

But merely putting the rules in place is one matter; creating a system to enforce them is another.

During budget hearings this year, Michael Taylor, the FDA’s first ever deputy commissioner for foods, made clear that current funding levels would be insufficient.

“Simply put, we cannot achieve our objective of a safer food supply without a significant increase in resources,” he told members of the House Energy and Commerce Committee.

Upon approval of the FSMA in 2010, the nonpartisan Congressional Budget Office estimated the FDA would need an additional $583 million over five years to carry out its new mission.

Following boosts totaling just under $100 million in fiscal 2011 and 2012, the administration estimated last May that an additional $400 million to $450 million would be required “to make FSMA a fully successful initiative.”

Since then, the funding allocated to the effort has been much less than requested, thanks to budget cuts and competing priorities. An omnibus funding bill for fiscal 2013 included $40 million for food safety, but that total was reduced to $37 million by sequester-related cuts.

A fiscal 2014 omnibus passed in January added $53 million more. As of Tuesday, the agency said an additional $362 million to $412 million was needed.

Spending bills now pending in both chambers of Congress contain increases of around $25 million, sowing angst among groups who say funding is required to fully implement the law.

Even business groups with reservations about the new restrictions support additional funding, which they view as bringing certainty to the industry.

“In order to keep consumer confidence in the safety of America’s food supply high and to reduce the number of foodborne illnesses, it is important that FDA also have the infrastructure in place to implement FSMA once the rules are finalized and after the appropriate compliance period ends,” a coalition of major businesses including Wal-Mart, General Mills and Coca-Cola wrote in a letter to congressional appropriators.

Specifically, the groups are calling for funding to retain and hire additional scientific experts, modernize the FDA’s information technology and increase food safety inspections to meet the targets set out in the law.

Sophia Kruszewski, a policy specialist at the National Sustainable Agriculture Coalition, said the group is worried that a lack of funding would imperil programs authorized by the law to help farmers and other food producers come into compliance.

“Funding will be critical because so much of what proper implementation of FSMA is gong to require is training,” Kruszewski said. “It’s hard to know where all the money is going to come from.”

The Obama administration has proposed new user fees to help meet the funding goals. The president’s 2014 budget request calls for a new registration fee for domestic and foreign food facilities that are required to register with FDA. The fee would have yielded an estimated $59 million this year.

A second fee on imports would have brought in $166 million, according to estimates.

Congress, however, has not approved legislation establishing the fees, which industry groups have denounced as a “food tax.”

In prodding Congress to direct more money to the safety effort, public interest groups say the cost of inaction could be made clear in the event of a major illness outbreak.

There have been 26 multi-state outbreaks of food-borne illness since Obama signed the FSMA into law, according to a Pew analysis.

Food safety advocates say they are trying to raise the public profile of an issue that affects all Americans.

“Every time they sit down for a meal, they want to know that the government is doing to make sure their food is safe,” Eskin said.