Evaluation Tool




Below are a set of questions about your operation.


As you answer each question, you will see a list of rules, regulations, and standards which MAY apply to you and an explanation describing why a specific rule may apply to you.


After you have answered all of the questions, you will have a list of rules, regulations, and standards which may apply to you. You should read the descriptions and follow links provided in order to gain a better understanding of each rule in order to determine whether or not the rule actually applies to you. Rules may apply to you because you are legally required to comply. Rules may also apply because buyers have requested compliance with them or because you choose to make them your standard.


After you have gone through each rule that may apply, download this PDF template to provide to buyers. This template will show everything that may apply to you, rules which legally apply, and rules which you've chosen to comply with. The template will also include a list of common risks on farms and a space for your to describe how you manage these risks on your farm so buyers are able to easily understand your food safety practices.



Do you retail or wholesale produce in Montana?
...AND/OR Has a buyer asked you for a food safety plan or for your compliance with a specific food safety program?

NOTE: "Retail" means direct sale to the end user.

NOTE: "Wholesale" means sales to an intermediary, not the end user.

NOTE: "Produce" means any fruit, vegetable, or other natural product designated by department rule.

 

Montana Produce Program (MTPP)

If you wholesale produce in Montana, you are required to obtain a produce dealer's license with the MT Dpt. of Ag. You are also required to obtain a produce dealer's license if you retail raw produce grown in the state and your gross retail sales exceed $25,000 annually.

Find out more

Montana Food Safety Law

If you sell at farmers markets, make cottage food products, have a mobile food establishment, or a retail food establishment, you may be required to comply with some rules under DPHHS.

Find out more

Good Agricultural Practices (GAP)

GAP is a voluntary food safety audit program which may be required to sell to a buyer. This program may include a 3rd party audit by an employee of the USDA and/or an internal audit by a trained internal auditor. The GAP program requires a written food safety plan.

Find out more

Group GAP

Wholesale buyers may request adherence to USDA GAP protocols which can be met as a group of growers. GroupGAP utilizes internal audits for all farms in a group as well as 3rd party audits for some farms in the group.

Find out more

Mushroom GAP

If you answered yes and you only want to certify the food safety of mushrooms you are growing, the USDA does provide mushroom specific audits which may be attainable for you.

Find out more

Harmonized GAP and Harmonized GAP Plus+

The Global Food Safety Initiative has created standards for internationally recognized food safety programs. In 2018 the USDA submitted Harmonized GAP Plus+ to GFSI to be approved under the GFSI standard. An audit under this system would most likely.

Find out more
Do you transport produce from out of state for retail sale in Montana?

NOTE: "Retail" means sale to the end user.

NOTE: "Produce" means any fruit, vegetable, or other natural product designated by department rule.

 

If you answer yes; these departmental rules apply:


Mushroom GAP

Although you are not legally required to comply, buyers you work with may require compliance with Mushroom GAP's.

Find out more
Do you import or export seed potatoes?


You answered yes, thus these departmental rules apply:


Do you produce and sell honey?

If you answer yes, these departmental rules apply:


Montana Food Safety Law

Depending on what type of honey you plan to sell, to whom you plan to sell the honey, and where or how it is sold, you may be subject to rules under DPHHS and you may need a license to sell.

Find out more
Do you make cottage food products?

Please refer to this web page for a list of approved cottage food products.


Do you or another member of your supply chain grow, pack, or sell to a buyer who requires USDA GAP certification AND you are unable to obtain GAP certification on your own due to cost or uncertainty navigating the process?

Group GAP

The USDA has provided an opportunity for growers to work together on obtaining GAP certification. This may be an option for you to comply with this request.

Find out more

Mushroom GAP

If you answered yes and you only want to certify the food safety of mushrooms you are growing, the USDA does provide mushroom specific audits which may be attainable for you.

Find out more
Have you heard reference to or have you been asked to comply with the Perishable Ag. Commodities Act?

Perishable Ag. Commodities Act

PACA works with businesses who deal in fresh and frozen fruits and vegetables and need help enforcing a code of fair business practices, or need help resolving business disputes. This regulation has little to do with food safety, but it you may hear it referenced because the title sounds as if it could pertain to food safety.

Find out more
Are you a producer considering making a value added product which does not fall under cottage food rules?

Please refer to this web page for a list of approved cottage food products.


Montana Food Safety Law

You may be subject to regulations under DPHHS which cover Farmers Markets, Cottage Food Products, Mobile Food Establishments, Retail Food Establishments.

Find out more

Large Scale International

Private and Federal Food Safety Programs which meet the standards set by the Global Food Safety Initiative.

Buyers may request compliance with a specific private food safety protocol.

Find out more
Do you produce and sell juice products?


Click here to create a PDF with information in the topics you selected!



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Montana Produce Program (MTPP)


This program provides licenses to produce dealers in order to ensure the quality of fruits and vegetables distributed in Montana. Third party inspections are provided for grade and condition inspections on imported produce as well as grade and shipping point inspections on exported produce.

This program also provides produce dealer licenses to any of the following: Anyone who sells produce through wholesale marketing channels in Montana;
Anyone transporting produce from out of state for retail sale in Montana; and
Anyone retailing produce grown in the state when gross retail sales exceed $25,000 annually.

Montana Department of Agriculture Produce Rule Web Page

Department of Public Health and Human Services (DPHHS)


Each state is given the authority to write its own food regulations which coincide with and expand on any relevant federal regulations.

Montana regulations under DPHHS cover Farmers Markets, Cottage Food Products, Mobile Food Establishments, Retail Food Establishments. They also regulate the county sanitarians. It is important to be in touch with your county sanitarian if you are producing and selling any kind of value added food product. If you are altering a food product in any way, you may fall under retail food laws and should also be in touch with county or tribal sanitarians to find out if you are in compliance.

References:
Montana Code Chapter 50
DPHHS site with Cottage Foods FAQ, Honey FAQ, and Cottage Foods Brochure
Admin Rules of Montana list of cottage food

GAP - Good Agricultural Practices


The USDA Agricultural Marketing Service formally implemented the USDA Good Agricultural Practices and Good Handling Practices (GAP&GHP) audit verification program in 2002. This program is offered to the fruit and vegetable industry to verify an operation's efforts to minimize the risk of contamination of fresh fruits, vegetables, and nuts by microbial pathogens.

Steps to Compliance (Keep in mind GAP is entirely voluntary although some buyers may require it)

  1. 1. Complete a GAP food safety training.

  2. 2. Write and implement a Food Safety Plan.

  3. 3. Perform a self-audit with the GAP scoresheet.

  4. 4. (Optional) Complete an Internal Audit where a trained internal auditor reviews and scores your farm with you. The Ag. Development center closest to you should help find an internal auditor if you need one.

  5. 5. Request and complete a 3rd party auditor with a certified 3rd party USDA auditor - To find a 3rd party auditor see the ATTRA database.

  6. 6. Your operation and the crops you choose to certify will be listed on the USDA's public database as certified once you pass an audit.


Resources:
USDA Page on GAP
Food Safety Plan Writing Resources
National Center for Appropriate Technology Instructional Videos on USDA GAP Internal Audit Process

Group GAP


Group GAP allows a group of producers to work collectively toward GAP certification under the central management of one entity. This could be a distribution hub, a business development group, a farm incubator organization or another centralized entity. All of the farms in a group will conduct an internal audit with a certified internal auditor who may be affiliated with the central entity. A portion of the group will have a 3rd party USDA GAP audit. If all of the farms audited by the USDA pass, the group is considered to have been certified. This may provide the benefit of sharing information as well as costs associated with implementing food safety and conducting audits.

Considerations:



USDA GAP Audit Scoresheet [PDF]
Wallace Center Case Study of GroupGAP

Tomato GAP


USDA AMS Specialty Crops Inspection (SCI) Division provides oversight for commodity specific audits performed to satisfy the requirements of the California Tomato Growers Cooperative. These voluntary, independent audits of produce suppliers are performed throughout the production and supply chain.

The tomato industry initiated the Food Safety Programs and Auditing Protocol for the Fresh Tomato Supply Chain in October 2008, with the goal of harmonizing food safety audit standards for the fresh tomato supply chain.

Tomato Food Safety Audit Protocol

Mushroom GAP


The USDA-Agriculture Marketing Service Specialty Crops Inspection (SCI) Division provides oversight for commodity specific audits performed to satisfy the requirements of the mushroom industry. These voluntary, independent audits of produce suppliers are performed throughout the production and supply chain.

Commodity specific guidance for this audit program was provided by the American Mushroom Institute and Penn State University contained in the "Industry-Wide Food Safety Standards for Fresh Mushroom Growing, Harvesting, and Shipping." If you are a mushroom producer, it would be good to look at these standards, even though you likely will not be required to comply at a small scale.

USDA Mushroom GAP

Harmonized GAP


Harmonized GAP is the food safety system developed by the USDA after their GAP program. Harmonized GAP uses a more detailed scoring system and because it evolved from the GAP program, some buyers may feel it is a higher standard and may request compliance.

USDA, Agricultural Marketing Service, Specialty Crops Program, Specialty Crops Inspection (SCI) Division Audit Programs offers voluntary independent audits of produce suppliers throughout the production and supply chain.

Previously, there were two standards used for Produce GAPs Harmonized Food Safety Standard Audits: the "Field Operations and Harvesting Harmonized Food Safety Standard" and the "Post-harvest Operations Harmonized Food Safety Standard." The official versions of these standards are posted on the United Fresh Produce GAPs Harmonization Initiative website. The USDA has combined the two United Fresh standards into a new standard and started using this standard on May 1, 2018.

USDA has also developed a standard for Harmonized GAP Plus+ [PDF], an audit program that will be submitted to the Global Food Safety Initiative (GFSI) to be considered equivalent to the GFSI standard.

Perishable Agricultural Commodities Act


PACA protects businesses dealing in fresh and frozen fruits and vegetables by establishing and enforcing a code of fair business practices and by helping companies resolve business disputes.

FSMA Produce Rule


The federal government passed the Food Safety Modernization Act in 2010. The Produce Rule is a baseline set by the Food and Drug Administration to establish national standards for food safety for farms and is currently the only mandatory federal regulation farms must comply with. Compliance is mandatory unless you meet one of the exemptions which are based upon total sales levels and the location of your customers.

Steps to Compliance (Compliance levels are mandatory based on sales level)

Produce Safety Alliance
The FDA partnered with Cornell University to develop and provide the Produce Safety Alliance (PSA) curriculum. This curriculum trains producers on aspects of the produce safety rule. The PSA website is also a good resource for updates to the Produce Rule.

Compliance in Montana
Compliance inspections for farms in Montana that are not exempt from the rule will be performed by MT Dpt. of Ag. personnel, not by the FDA. These inspections will begin in 2019.

OFRR
Farms who wish to prepare for these inspections can participate in a confidential "On Farm Readiness Review" or OFRR. The OFRR is meant to help the farmer understand their level of readiness and is not intended to be an audit with any disciplinary actions. Although the structure and content are different, the OFRR is similar to the USDA internal audit in that it's a somewhat less formal way to have another set of trained eyes take a look at an operation's food safety system without the stress of an official audit or inspection. Contact the Montana Department of Ag. Food Safety Coordinator to request to be put on the list of farms receiving free OFRR's.

See the FDA website on the produce rule for more information.

HACCP


HACCP is a management system provided by the FDA in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

Specifically, the FDA has created HACCP for the following industries: Dairy Grade A Voluntary, Juice, Retail and Food Service, Seafood.

The recent Food Safety Modernization Act Preventive Controls Rule is the most recent piece of legislation which contains Hazard Analysis and applicable to domestic and foreign food facilities. The Preventive Controls Rule contains a similar hazard analysis called Process Control as well as the following additional categories of consideration: Supply Chain Program, Allergen Program, and Sanitation Control.

FSMA Preventive Controls


This rule, which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards. Key requirements include updates to the Current Good Manufacturing Practices (CGMPs) and a food safety plan.

Compliance dates are staggered, based on the size of the business, with separate dates for the requirements of the supply chain program. Training, education, and technical assistance are available for those covered by this rule.

Generally, domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, and Cosmetic Act (see below) must comply with the requirements for risk-based preventive controls mandated by FSMA as well as the modernized CGMPs of this rule (unless an exemption applies). It is important to note that applicability of the CGMPs is not dependent upon whether a facility is required to register.

Section 415 of FD&C (Section 350d. Of federal code)
Registration of food facilities
An entity shall submit a registration contact information and the general food category of any food manufactured, processed, packed, or held at such facility. The registration shall contain an assurance that the Secretary will be permitted to inspect such facility. The registrant shall notify the Secretary in a timely manner of changes to such information.

FD&C


FD&C is especially relevant to producers who are exempt from FSMA and any other rules. Producers are still required to sell unadulterated and correctly labeled goods.

The FD&C is written in the US code under Title 21 of US Code: Food and Drugs

Passed in 1938, the FD&C gives authority to the FDA to regulate the safety of food, drugs and cosmetics. The FD&C also make it illegal to produce or sell adulterated or mislabeled food products in commerce.

Title 21, of the US Code covers the following categories pertaining to food: Adulterated or misbranded foods or drugs; teas; filled milk; animals, meats and meat and dairy products; federal food, drug and cosmetic act; poultry and poultry products inspection; meat inspection; egg products inspection; pesticide monitoring improvements; food safety; food safety modernization.

Large Scale International


Over the last few years, large U.S. retailers and food service companies have pushed for auditing schemes that are universally accepted worldwide. This drive for standardization of audit schemes created the Global Food Safety Initiative (GFSI), a push for auditing companies to benchmark their schemes against the GFSI standards and compliance requirements of food producers.

GFSI

The Global Food Safety Initiative brings together key actors of the food industry to collaboratively drive continuous improvement in food safety management systems around the world.

Primus
According to Primus, the most recent Primus program, PrimusGFS v3, will be aligned with relevant FSMA regulations, benchmarked to GFSI version 7.1, and released at the PrimusGFS.com webpage after achieving official GFSI recognition.

Safe Quality Food Institute (SQF)
According to SQF, their program is recognized by the Global Food Safety Initiative (GFSI) and links primary production certification to food manufacturing, distribution and agent/broker management certification. SQF is administered by the Food Marketing Institute (FMI). SQF is reportedly the only scheme to integrate a quality component as well as food safety into their program.

BRC Global Standards
According to BRC, the company helps build confidence in the supply chain. Their standards for food safety, packaging and packaging materials, storage and distribution, consumer products, agents and brokers, and retail help provide assurance to customers that their products are safe, legal and of high quality.

The USDA has also submitted an audit program to GFSI:

USDA Harmonized GAP Plus+
The USDA has developed a standard for Harmonized GAP Plus+, an audit program that will be submitted to the Global Food Safety Initiative (GFSI) for technical equivalence. Audits to the new standard will be performed using the new GFSI GAP Plus+ Checklist beginning May 1, 2018.