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FDA Releases Compliance Guide for Small Businesses under FSMA Produce Safety Rule

September 5, 2017

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced today the availability of an SECG to help small businesses comply with the Produce Safety Rule mandated by FSMA.

The SECG provides information that can help small and very small businesses understand how the requirements of the Produce Safety Rule apply to them. Specifically, the SECG can help farmers determine whether they are eligible for a qualified exemption, which would modify the requirements they are subject to under the Produce Safety Rule. The SECG can also help them understand those modified requirements.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. The main compliance dates for small businesses and very small businesses under the Produce Safety Rule are January 28, 2019, and January 27, 2020, respectively, but certain agricultural water requirements have extended compliance dates. Sprout operations also have different compliance dates, and sprout operations that are small businesses and very small businesses have compliance dates of January 26, 2018, and January 28, 2019, respectively. Businesses that intend to claim a qualified exemption by their primary compliance date were required to begin keeping documentation supporting their eligibility for a qualified exemption on January 26, 2016.

Visit FDA.gov/FSMA for more information about the FSMA rules and compliance dates.

Food Safety Modernization Act compliance dates (revised 10/09/17)

Farm-Based Food Safety Video Series

 

Now that the food safety regulations are being implemented under the Food Safety Modernization Act, many growers are confused about how the regulations apply to their farms. Regardless of whether your farm is exempt from the regulations, it is important to have an understanding of food safety risks on your own farm and apply simple food safety measures. The videos in this series will show one farm’s approach to implementing their food safety plan. Videos courtesy of ATTRA – National Sustainable Agriculture Information Service

Why Food Safety in Indian Country?

 

The Food Safety Modernization Act (FSMA) was passed into law in ­­­­­­­­­­2014 to further the food safety of produce produced and consumed by the public. The US Food and Drug Administration was tasked to develop and implement regulations related to FSMA. Included in this is a comprehensive effort to train growers and suppliers such that they meet certification requirements of FSMA. FDA is working with public and private partners to ensure training programs meet the needs of those who must comply with the new FSMA standards, no matter their size, nature or location. It is important to make sure that those involved in the food supply chain know what training and education resources are available and how to gain access to the trainings.

Understanding and implementing produce safety practices are important to the safety of fruits and vegetables and to the viability of their farm business. Produce safety practices may be required by many buyers, as well as federal regulation if the farm is subject to the FSMA Produce Safety Rule.

In September 2016, the Indigenous Food and Agricultural Initiative (IFAI) at the University of Arkansas was named as the Native American Tribal Center for Food Safety Outreach, Education, Training and Technical Assistance. IFAI is cooperating with a wide array of partners, including the Intertribal Agricultural Council, to bring a series of webinars and face-to-face certification trainings to tribal producers and food businesses to fulfill requirements of FSMA. The four primary regulations that concern Tribal producer and food businesses are the Produce Safety Rule, The Preventive Control Act for Human Food, The Preventive Control Act for Animal Food and the Sanitary Transportation of Human and Animal Food, all of which are summarized below:

 

Standards for Produce Safety Final Rule: The FDA Food Safety Modernization Act (FSMA) Produce Safety rule is now final, and the earliest compliance dates for some farms begin one year after the effective date of the final rule (see “Compliance Dates” below). The rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The final rule is a combination of the original proposal and revisions outlined in the supplemental proposal, with additional changes as appropriate. The definition of “farm” and related terms were revised in the final Preventive Controls for Human Food rule, and the same definitions of those terms are used in this rule to establish produce safety standards. Operations whose only activities are within the farm definition are not required to register with FDA as food facilities and thus are not subject to the preventive controls regulations. 

Preventive Control Act for Human Food Final Rule: The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016. This final rule is the product of an unprecedented level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local and tribal regulatory counterparts, academia and other stakeholders. The final rule has elements of both the original and supplemental proposals, in addition to new requirements that are the outgrowth of public input received during the comment period for both proposals. For example, flexibility has been built into key requirements, including control of the supply chain, and the definition of farms—which are exempt from these regulations—has significantly changed to reflect modern farming practices. 

Preventive Control Act for Animal Food Final Rule: The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food rule is now final, and compliance dates for some businesses begin in September 2016. In response to input received during the comment period and during hundreds of engagements that included public meetings, webinars, listening sessions, and visits to farms and food facilities across the country, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions were designed to make the originally proposed rule more practical, flexible, and effective for industry, while still advancing the FDA’s food safety goals. The final rule has elements of both the original and supplemental proposals, in addition to new requirements that are the outgrowth of public input received during the comment period for both preventive controls proposals. 

Sanitary Transportation of Human and Animal Food Final Rule: The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. Because of illness outbreaks resulting from human and animal food contaminated during transportation, and incidents and reports of unsanitary transportation practices, there have long been concerns about the need for regulations to ensure that foods are being transported in a safe manner. The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law. Specifically, the FSMA rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training and waivers.

 

Templates for Developing Food Safety Plans

 

Penn State Food Safety Plan Template
A sample food-safety plan developed by Penn State Extension.

Food Safety Plan for You – FSP4U; University of Minnesota
Explains all components of a food-safety plan and provides food safety plan and record keeping templates.

On Farm Food Safety Project
This organization provides a free and easy-to-use online template for you to develop a food-safety plan on your farm. It prompts you to fill in only the areas that are relevant to your farm, similar to TurboTax®. Just click on the tab “Create a Food Safety Manual.”
También disponsible en español.

Primus Labs Local Farmer Program
This is another online platform for developing a food-safety plan. It also has trainings for auditors and verifiers.

 

We Are Part of a National Food Safety Effort

 

The U.S. Food & Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) was passed in 2010 and the final regulations implementing the Act were put in place in 2016. FSMA requires that the FDA take steps to implement a national food safety system based on principles designed to prevent foodborne illness.

FDA has provided funding to create a network of training centers and cooperative agreements to provide food safety training for farm owners and operators and food processors. These centers have been provided funding to reach critical regional and national groups to provide training, education and technical assistance according to standards that were established under FSMA. These are:

National Coordination Center (NCC) :  International Food Protection Training Institute (IFPTI), Battle Creek, MI

 

Regional Centers (RCs) (funded through USDA)

Southern Region:  The University of Florida received the grant to establish the Southern Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Produce Safety.

Western Region:  Oregon State University received the grant to establish the Western Training, Education, Extension, Outreach, and Technical Assistance Center to Enhance Food Safety.

 

Regional Centers (RCs) (funded through FDA)

North Central Region:  Iowa State University has received the grant to establish the North Central Regional Center for Food Safety Training, Education, Extension, Outreach and Technical Assistance.

Northeast Region:  University of Vermont and State Agricultural College has received the grant to establish The Northeast Center for Food Safety, Training, Education, Extension, Outreach and Technical Assistance.

 

Additional Cooperative Agreements to reach special audiences:

Local Producers:  National Farmers Union Foundation will establish the Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance

Native American Producers:  University of Arkansas Fayetteville School of Law, through the Indigenous Food and Agriculture Initiative, will establish the Native American Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance

Food Safety Needs Assessment

Are you a Native American farmer, rancher of food business in the marketplace?

Then we need your feedback!

Glossary of Terms Often Used in FSMA Training Documents:

Standardized training curriculum: A structured program in which the training materials will be recognized by the FDA as meeting the training standards and requirements in the Produce Safety rule (as proposed) and the Preventive Controls rules. The three FDA-funded Alliances (Produce Safety, Food Safety Preventive Controls, and Sprout Safety) are developing model, standardized curricula designed to meet the needs of, and be used by, the majority of stakeholders who must comply with the FSMA rules.

Alternate curriculum: FDA-recognized training programs to be developed through cooperative agreements. The agreements currently planned will support curricula development and dissemination among local food producers and tribes. The agency plans to provide additional information regarding how training programs developed by other entities (including universities, trade associations, and non-profit organizations) will be evaluated.

Train-the-Trainer: Programs offered to those interested in becoming trainers and providing training for others on the FSMA regulations. The lead trainers would be schooled in foundational food safety principles, the applicable FSMA regulations, the content of the training curriculum and how to deliver it, conducting working group exercises (as appropriate), and the principles of adult education. These are being developed by the Alliances and may also be part of alternative training programs.

Training delivery: The dissemination of training curricula. (The approach may vary as appropriate for the target audience.)

Regional needs: Regions may have unique needs based on target audiences and the nature of their food operations. This could include environmental differences, cultural considerations, the type of product, and marketing strategies. Examples include dry-climate farming practices, organic products, and direct-marketing channels.

Cooperative agreements: An FDA cooperative agreement is a grant funding mechanism that involves significant FDA participation during the performance of the work. These usually involve FDA-funded partnerships with entities in the public or private sector, or both, that are designed, in this case, to lay the groundwork for FSMA implementation.

Local food production: Food marketing channels that focus on providing food to a community or region directly or through intermediated markets. The farms and food enterprises that utilize these market channels include diversified, sustainable, organic, and identity-preserved agricultural operations; owner-operated and family farms; beginning and socially disadvantaged farmers; value-added farm businesses and small-scale processors; and direct and intermediated supply chain participants.

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