BY LEANNE SKELTON, BIOLOGICAL SCIENCES SPECIALIST, 

AMS FRUIT AND VEGETABLE PROGRAM

The U.S. Department of Agriculture (USDA), Agricultural Marketing Service (AMS),

and the U.S. Food and Drug Administration (FDA) are separate federal agencies with

different missions. However, they share a robust working relationship when it comes

to the 2011 Food Safety Modernization Act (FSMA), which shifts the focus from responding to

food contamination after it occurs to preventing it in the first place.

Once these FSMA directives are finalized and enforced, farmers that grow, harvest, pack, and

ship fruits and vegetables will be regulated by the FDA. Since these are new federal regulations,

many growers may find themselves in unfamiliar territory on their own farms; but the USDA 

is prepared to help the growing community comply with the new regulations with its many 

programs and services.

BACKGROUND 

The Food Safety Modernization Act was passed by Congress and signed by President Obama

on January 4, 2011, and requires the FDA to draft the majority of the reports, studies, and regulations specified in the law. Two of the primary regulations or proposed rules drafted by the FDA

will impact fruit and vegetable growers and packers, depending on their location, the size of their

operation, farming activities, and agricultural practices used. 

The Produce Safety rule lays out food safety requirements for many of the farmers who grow

fruits and vegetables, while the Preventive Controls for Human Foods rule will affect businesses

that process and manufacture food for human consumption. Some farms both grow and process

food and will have to comply with the requirements of each category. Both rules have exemptions

for the smallest farms and businesses (with sales of under $500,000 annually). 

Draft regulations were published in the Federal Register on January 16, 2013, inviting the 

public to submit comments. The FDA then held public meetings across the nation to get more

comments and feedback. The agency also attended state and industry-sponsored listening sessions

and farm tours. 

The extended comment period closed in late November 2013 and the FDA then worked

through the arduous task of reviewing each and every comment. This included reviewing more

than 15,000 comments submitted for the proposed Produce Safety rule and several thousand 

comments for the Preventive Controls for Human Foods rule. 

Based on these comments, the FDA published supplemental proposals revising specific technical requirements in these two regulations and asked for additional public comment. 

This comment period closed on December 15, 2014, and the FDA has been reviewing the 

latest comments.

COMPLIANCE 

The Produce Safety rule is expected to become “final” or take effect in late December 2015

with an extended, staggered compliance timeline. The timeline will be based on the dollar value of

annual produce sales (over a rolling average of the three previous years) for farm businesses categorized as “very small,” “small,” and “all others,” and the compliance dates are proposed 

for December of 2019, 2018, and 2017, respectively. Each size category will have an additional

78 — Blueprints |Apr/May/Jun 2015

Partnering for Success

How the USDA is helping growers comply 

with the Food Safety Modernization Act

GOVERNMENT VIEWS

Key Elements

The USDA’s goal is to ensure that 

if a grower passes a GAP audit and 

is consistently implementing its own

food safety plan, then the FDA would

consider this farm in compliance 

with the Produce Safety regulation.

As the final rules are put in place for implementation of the Food Safety Modernization Act:

farmers that grow, harvest, pack, and 

ship fruits and vegetables will be 

regulated by the FDA

multiple rules from the Act may apply,

including Preventive Controls for

Human Foods and the Foreign Supplier

Verification Program 

Cooperative Extension specialists will 

be trained to help growers comply with

the new regulations.

To learn more about each key element, look

for the symbols throughout the article.
www.producebluebook.com Apr/May/Jun 2015 | Blueprints — 79

Government Views

two years to comply with certain water requirements (2021, 2020, and 2019, respectively).

In addition to the Produce Safety rule,

growers and packers may also be impacted by

one or more of the other prevention-oriented

FSMA regulations depending on the type of

operation and its location. These are the

aforementioned Preventive Controls for

Human Foods rule, Preventive Controls for

Animal Foods rule, and Foreign Supplier

Verification Program. 

Growers located outside the United States

who export food into our country must also

comply with the same regulations applicable to

their operations. Other FSMA regulations that

may impact various segments of the growing

community include Intentional Adulteration,

Sanitary Transportation, and Accredited ThirdParty Certifiers—but these regulations will

come into effect at a later date.

EDUCATION 

On many occasions, the FDA has stated the

need to “educate before we regulate.” For this

reason, the USDA is heavily involved in the

educational components of the FDA’s implementation strategy via the Produce Safety

Alliance and is involved to a lesser degree in the

activities of the Food Safety Preventive

Controls Alliance and the Sprouts Safety

Alliance.

The Produce Safety Alliance was established

in 2010 and will continue to at least 2017.

The Alliance is supported financially and relies

on staff from both the FDA and USDA represented on the Executive Committee. The standardized curriculum will be aimed at helping

growers better understand food safety implications and integrate practices into their farming

operations. This includes ensuring food 

safety and conservation practices can coexist

(sometimes referred to as “co-management”),

and helping farmers understand the specific

requirements of the Produce Safety regulations. 

Cooperative Extension specialists 

associated with the Land Grant University

System are likely to take on a primary role as

trainers working with farmers. There will

also be instructional events held across the

nation in farming communities, and growers

can meet the training requirement in the

Produce Safety rule by attending these workshops. Interest from agriculture consultant

firms, trade associations, and others looking

to become trainers for this curriculum is 

also expected. All are welcome to apply 

as trainers to the Produce Safety Alliance.

The USDA is committed to helping the

FDA understand the diversity of the nation’s

farming community and to assist growers and

packers, processors, and sprouts producers of all

sizes and production systems gain a better

understanding of how to comply with the

applicable regulations. Even growers excluded

or exempt from the FDA’s regulations can benefit—as some buyers may expect all of their

produce suppliers to meet the new FDA

requirements. For this reason, exempt 

farms may want to come into compliance to

maintain or gain access to these markets.

ASSISTANCE

The USDA’s personnel serve as technical

advisors on the produce safety and preventive

controls “operational teams” established by the

FDA to develop its implementation and compliance strategies. The USDA continues to

provide input to the FDA related to the Good

Agricultural Practices (GAP) program, the

USDA’s voluntary food safety certification program. This program continues to be a useful

tool for growers to demonstrate compliance

with FDA’s Guide to Minimize Microbial Food

Safety Hazards for Fresh Fruits and Vegetables.

Once the FDA’s Produce Safety rules are

final, there will be some modifications to the

USDA GAP program to ensure that USDA

GAP audits align with the new FDA regulations. Furthermore, the FDA has stated its

intent to leverage existing marketplace accountability measures that stakeholders (i.e., farmers

and packers) already have in place, such as one

of the USDA GAP programs (e.g., harmonized

GAP, generic GAP, mushroom GAP) or

Marketing Orders/Agreements that incorporate

food safety elements. 

In effect, the USDA’s goal is to ensure that

if a grower passes a GAP audit and is consistently implementing its own food safety plan,

then the FDA would consider this farm in

compliance with the Produce Safety regulation.

FEEDBACK 

As the implementation process continues,

the USDA will continue to provide feedback

on a variety of technical assistance approaches

being developed by the FDA. These efforts

include establishing a call or information center

to address real-time issues; transitioning FDA

field staff from generalists on all FDA-regulated

products (food, drugs, medical devices, etc.) to

specialists focusing on food; using research 

protocol framework documents aimed at 

supporting research on food safety practices

and standards for water quality and manure;

and updating or developing new guidance documents for GAP, small entity compliance, and

co-management, for example.

The role the USDA will play in helping

farmers comply with FSMA regulations is 

varied and robust. We look forward to continuing our engagement with the FDA on behalf

of our nation’s growers and packers of fruits

and vegetables.

Leanne Skelton is on staff in USDA’s

Agricultural Marketing Service Fruit and

Vegetable Program where she is responsible 

for maintaining a collaborative working 

relationship with the FDA on produce safety

and preventive controls issues. 

For more information on related topics, please see

the following articles in the Blue Book Online

Services Learning Center:

“Quality and Certification Go Hand in Hand” 

– April 2014

“Foreign Supplier Verification” 

– October 2014

Reprints available: phone 630-668-3500 or 

e-mail info@bluebookservices.com