United States Government Accountability Office

Report to Congressional Committees

November 2017

FOOD SAFETY
FDA Continues to
Evaluate and
Respond to Business
Concerns about the
Produce Rule

GAO-18-85

 November 2017

FOOD SAFETY
FDA Continues to Evaluate and Respond to Business
Concerns about the Produce Rule
Highlights of GAO-18-85, a report to
congressional committees

Why GAO Did This Study

What GAO Found

Although the United States has one of
the safest food supplies in the world,
foodborne illness is a common public
health problem; some of this illness
can be linked to produce. For example,
in 2017, a Salmonella outbreak linked
to imported papayas sickened more
than 200 people in 23 states and killed
1. FDA’s produce rule, one of a
number of rules required by the FDA
Food Safety Modernization Act,
established the first enforceable
national food safety standards for
produce. The Agricultural Act of 2014
required that the produce rule include
“a plan to systematically…develop an
ongoing process to evaluate and
respond to business concerns” about
the rule and a provision for GAO to
report on FDA’s efforts 1 year after the
promulgation of the final rule and again
the following year. In November 2016,
GAO issued the first report.

Since GAO’s November 2016 report on the Food and Drug Administration’s
(FDA) 2015 produce rule, the agency has continued to use its Technical
Assistance Network (TAN) to evaluate and respond to questions and concerns
about the rule. GAO found that since the issuance of its 2016 report, which
contained data as of September 3, 2016, 2,665 more questions were submitted
to the TAN, 230 of which pertained to the produce rule, and of those 230
questions, 154 were submitted by businesses (see fig.).

In this follow-up report, GAO examined
(1) steps FDA has taken since GAO’s
2016 review to evaluate and respond
to business concerns regarding the
produce rule, (2) steps FDA has taken
to assess the effectiveness of its
efforts to evaluate and respond to
business concerns regarding the rule,
and (3) challenges FDA officials
reported facing in evaluating and
responding to business concerns
regarding the rule. GAO examined
TAN questions submitted by
businesses; interviewed FDA officials
and representatives from groups, such
as the Produce Safety Alliance,
working with FDA to implement the
rule; and interviewed representatives
from produce industry associations and
a farming organization.
GAO is not making any
recommendations.
View GAO-18-85. For more information,
contact Steve D. Morris at (202) 512-3841 or
morriss@gao.gov.

Questions Submitted to the Technical Assistance Network (TAN), September 4, 2016, through
June 30, 2017

a

The TAN also receives questions about other rules pertaining to the FDA Food Safety Modernization
Act, such as rules on imported food and the sanitary transportation of food.

b

Others include members of academia, consumers, and federal or state regulators.

Most produce rule-related TAN questions concerned agricultural water
standards, such as methods for testing water. In addition to the TAN, FDA has
taken other steps to evaluate and respond to business concerns, including
funding training for industry and visiting farms. FDA is also reviewing the rule’s
water standards and published a proposed rule in September 2017 to extend the
compliance dates associated with those standards in response to concerns.
FDA has begun collecting survey results on the web page used for submitting
TAN questions and continues to develop a survey to assess the timeliness and
quality of TAN responses. FDA also continued to develop metrics intended to
assess its overall efforts to evaluate and respond to business concerns, officials
reported. Produce industry representatives told GAO that FDA is open to hearing
questions and concerns, but businesses need more information to comply with
the rule and are awaiting FDA’s forthcoming guidance on parts of the rule.
FDA officials reported facing two challenges in evaluating and responding to
business concerns: identifying businesses subject to the rule and providing
consistent, region-specific information in response to concerns. Officials said that
the agency’s cooperative agreement with 43 states plays a key role in
addressing these challenges, as does the Produce Safety Network, a network of
region-based FDA food safety experts.
United States Government Accountability Office

 Contents

Letter

1
Background
FDA Has Continued to Take Steps to Evaluate and Respond to
Business Concerns and Is Reviewing the Produce Rule Water
Standards
FDA Has Collected Some Survey Results to Assess the
Effectiveness of the TAN and Has Continued to Develop
Metrics to Assess Outcomes of Its Other Mechanisms
FDA Officials Reported Facing Challenges Identifying Businesses
Subject to the Produce Rule and Providing Consistent and
Region-Specific Information in Their Responses
Agency Comments

4
7
17
20
21

Appendix I

FDA Outreach and Guidance Related to the Produce Rule

24

Appendix II

GAO Contact and Staff Acknowledgments

25

Related GAO Products

26

Tables
Table 1: Produce Safety Alliance (PSA) and Sprout Safety
Alliance (SSA) Trainings: Numbers of Courses and
Participants
Table 2: Food and Drug Administration (FDA) Outreach to
Produce Businesses, December 2016 through June 2017
Table 3: Published and Forthcoming Food and Drug
Administration (FDA) Produce Rule Guidance

12
24
24

Figures
Figure 1: Current Implementation Timeline for the Produce Rule
Figure 2: Produce Rule Questions Submitted to the Technical
Assistance Network (TAN), September 4, 2016, through
June 30, 2017
Figure 3: Examples of Questions about the Produce Rule
Submitted by Businesses to the Food and Drug
Administration’s Technical Assistance Network

Page i

6
8
10

GAO-18-85 FDA Produce Rule

 Figure 4: Implementation Timeline for the Produce Rule’s Current
and Proposed Agricultural Water Standards

15

Abbreviations
FDA
FSMA
PSA
SSA
TAN

Food and Drug Administration
FDA Food Safety Modernization Act
Produce Safety Alliance
Sprout Safety Alliance
Technical Assistance Network

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GAO-18-85 FDA Produce Rule

 Letter

441 G St. N.W.
Washington, DC 20548

November 27, 2017
Congressional Committees
Although the United States has one of the safest food supplies in the
world, foodborne illness is a common public health problem. Some of this
illness can be linked to produce. For example, beginning in the summer of
2017, a Salmonella outbreak linked to imported papayas sickened more
than 200 people in 23 states and killed 1, according to the Centers for
Disease Control and Prevention; in 2011, 147 people fell ill and 33 died
as a result of eating cantaloupes contaminated with Listeria. Other
produce-related outbreaks in recent years have involved cucumbers, hot
peppers, alfalfa sprouts, bean sprouts, and packaged salads. The Food
and Drug Administration (FDA), an agency within the Department of
Health and Human Services, is responsible for ensuring the safety of
produce, along with many other foods. Overall, FDA is responsible for
ensuring the safety of more than 80 percent of the U.S. food supply. 1
Because produce is often consumed raw, without processing to reduce or
eliminate contaminants, preventing contamination is key to ensuring safe
consumption. In January 2011, the FDA Food Safety Modernization Act
(FSMA) was signed into law, representing the largest expansion and
overhaul of U.S. food safety law since the 1930s. 2 FSMA, according to
FDA, marked a historic turning point by focusing on preventing rather
than reacting to foodborne illnesses. FSMA does so, in part, by requiring
FDA to promulgate new rules that, combined, provide a framework for
industry to implement preventive measures and for FDA to oversee
implementation. In response to FSMA, FDA developed seven
foundational rules; among them is the rule entitled Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption—also known as the produce rule. 3 This rule, which FDA
promulgated in November 2015, established the first enforceable national
1

FDA is responsible for ensuring that all domestic and imported foods—excluding meat,
poultry, catfish, and processed egg products—are safe, wholesome, sanitary, and
properly labeled.

2

Pub. L. No. 111-353, 124 Stat. 3885 (2011).

3

80 Fed. Reg. 74354 (codified at 21 C.F.R. pt. 112). Other rules required by FSMA that
have been promulgated include rules about preventive measures to ensure the safety of
human food, animal food, and imported foods; the sanitary transportation of food; and
protection against acts of intentional contamination.

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GAO-18-85 FDA Produce Rule

 standards for on-farm growing, harvesting, packing, and holding of
domestic and imported produce. 4 Among other things, the rule
established standards related to agricultural water quality; the use of soil
amendments, such as raw manure; the presence of domesticated and
wild animals; worker training, health, and hygiene; and sanitation of
equipment, tools, and buildings.
Some in the produce industry have raised questions and expressed
concerns about the produce rule standards, including questions about the
types of produce covered by the rule. Others have expressed concerns
about the costs necessary to comply with the rule, particularly for smaller
businesses. The Agricultural Act of 2014, also referred to as the 2014
Farm Bill, required that FDA ensure the final produce rule include “a plan
to systematically … develop an ongoing process to evaluate and respond
to business concerns.” 5
The act included a provision for GAO to report, 1 year after the
promulgation of the final produce rule and again the following year, on the
ongoing evaluation and response process. In November 2016, we issued
our first report. 6 We found that FDA developed an information
clearinghouse, called the Technical Assistance Network (TAN), to
evaluate and respond to questions and concerns from businesses
regarding implementation of the produce rule and other FSMA rules. In
addition to using the TAN to respond to questions, FDA uses TAN
questions to help inform the development of FSMA policy, guidance, and
training to help businesses understand and comply with the produce rule
and other FSMA rules. FDA officials told us the agency was developing a
survey, along with other metrics, to assess the effectiveness of the TAN.

4
80 Fed. Reg. 74354, 74354. In the rule, FDA defines “produce,” in part, as any fruit or
vegetable, including mushrooms, sprouts, peanuts, tree nuts, and herbs. 80 Fed. Reg.
74354, 74551 (codified at 21 C.F.R § 112.3). Produce that is rarely consumed raw—such
as asparagus, potatoes, pumpkins, and sweet corn—is not covered by the rule. 80 Fed.
Reg. 74354, 74549 (codified at 21 C.F.R § 112.2(a)(1)). Businesses covered by the rule
are those averaging more than $25,000 in annual monetary value of produce sold during
the previous 3-year period, with certain exceptions. 80 Fed. Reg. 74354, 74552 (codified
at 21 C.F.R §§ 112.4, 112.5).
5

Pub. L. No. 113-79, §12311(a)(3), 128 Stat. 649, 992 (2014).

6

GAO, Food Safety: FDA’s Efforts to Evaluate and Respond to Business Concerns
Regarding the Produce Rule, GAO-17-98R (Washington, D.C.: Nov. 28, 2016).

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GAO-18-85 FDA Produce Rule

 This follow-up report examines (1) the steps FDA has taken since GAO’s
2016 review to evaluate and respond to business concerns regarding the
produce rule; 7 (2) the steps FDA has taken to assess the effectiveness of
its efforts to evaluate and respond to business concerns regarding the
rule; and (3) the challenges FDA officials reported facing in evaluating
and responding to business concerns regarding the rule.
To examine the steps FDA has taken since GAO’s 2016 review to
evaluate and respond to business concerns regarding the produce rule,
we reviewed information on FSMA and the produce rule on FDA’s
website; attended relevant food safety conferences, including the
Association of Food and Drug Officials conference in Houston, Texas;
interviewed FDA officials involved in implementation of the rule; and
obtained data from FDA on the number of questions submitted to the
TAN. To better understand the types of issues businesses were
communicating to FDA, we also examined the full text of questions and
concerns about the rule that businesses submitted to the TAN. We
classified the questions and concerns into categories based on the type
of question, such as requests for additional information or clarification
regarding the produce rule. We assessed the reliability of the TAN data
by interviewing agency officials knowledgeable about the data and
determined that the data were sufficiently reliable for our report. In
addition, we interviewed representatives from four organizations assisting
FDA with implementation of the rule and an official from one state
department of agriculture. 8 We also interviewed representatives from two
produce industry associations and a farming organization from the
northeastern United States. 9 We selected groups with large
memberships; those representing both large and small business; those
representing specific produce commodities, such as sprouts; those
involved with educating businesses on produce rule implementation; and
those representing different geographic locations across the United
States. The information we obtained from these interviews is not
7
We define “business concerns” as any concerns related to the produce rule raised by
businesses covered by the rule.
8
These organizations were the National Association of State Departments of Agriculture;
the Produce Safety Alliance; the Sprout Safety Alliance; and the Southern Center for
Training, Education, Extension, Outreach, and Technical Assistance to Enhance Produce
Safety. We also interviewed an official with the North Carolina Department of Agriculture
and Consumer Services.
9

We interviewed representatives from the Produce Marketing Association, United Fresh
Produce Association, and the New England Farmers Union.

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GAO-18-85 FDA Produce Rule

 generalizable to all produce industry associations, businesses, or others
affected by the produce rule, but it provides illustrative examples. To
examine the steps FDA has taken to assess the effectiveness of its
efforts to evaluate and respond to business concerns, we interviewed
FDA officials to learn about any ongoing or planned efforts. To examine
the challenges FDA faces in evaluating and responding to business
concerns, we interviewed FDA officials.
We conducted this performance audit from December 2016 to November
2017 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit to
obtain sufficient, appropriate evidence to provide a reasonable basis for
our findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our findings
and conclusions based on our audit objectives.

Background

This section provides an overview of the produce rule and describes how
FDA is partnering with states to implement the rule.

Overview of the Produce
Rule and Compliance
Dates

Produce is an important part of a healthy diet but is susceptible to
contamination from numerous sources, including agricultural water,
animal manure, equipment, and farm workers. The produce rule
established standards to help ensure the safe growing and handling of
produce. For example, the rule requires that businesses take steps to
ensure that agricultural water that comes into contact with produce is safe
and of adequate sanitary quality for its intended use. As part of this, the
rule established microbial water criteria to determine the presence of
generic E. coli, which is the most commonly used indicator of fecal
contamination, and referenced a testing method published by the
Environmental Protection Agency to test for the presence of generic E.
coli. 10 The rule also established standards specific to sprouts, which are
especially vulnerable to contamination because of the warm, moist, and
nutrient-rich conditions needed to grow them. In addition to the general
10

Generic E. coli is an indicator of fecal contamination because it is common in the
intestinal tract of food animals. While most E. coli are harmless, the intestinal tract is also
the primary pathway for contamination by pathogenic E. coli that can cause illness, such
as E. coli O157:H7. According to FDA documentation, indicator organisms, such as
generic E. coli have long been used in the United States to demonstrate the safety of
drinking water and adequacy of water treatment.

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GAO-18-85 FDA Produce Rule

 requirements of the produce rule, the rule also includes requirements for
businesses specifically related to preventing contamination of sprouts,
which have been associated with foodborne illness outbreaks. 11
The rule applies to businesses that grow, harvest, pack, or hold produce,
including produce that will be imported or offered for import, with some
exemptions based on the produce commodity and the size of a business.
For example, the rule does not apply to produce that is rarely consumed
raw, such as asparagus or black beans, and produce that is to be
consumed on the farm. 12 In addition, the rule does not apply to
businesses that have an average annual monetary value of $25,000 or
less of produce sold during the previous 3-year period.
FDA’s implementation of the produce rule will occur over several years.
According to the rule, compliance dates are phased in from 2017 through
2022 based on business size and other factors. 13 Compliance dates for
certain agricultural water standards and for sprouts differ from the
compliance dates for other provisions in the rule. 14 For example,
compliance for large businesses under certain agricultural water
standards with covered activities not involving sprouts is due in January
2020; compliance for small businesses under certain agricultural water
standards with covered activities not involving sprouts is due in January
2021; and compliance for very small businesses under certain agricultural
water standards with covered activities not involving sprouts is due in
January 2022. In 2019, FDA intends to start inspecting produce
11

80 Fed. Reg. 74354, 74561 (Nov. 27, 2015) (codified at 21 C.F.R §§ 112.141-112.150).
According to FDA, from 1996 to July 2016, there were 46 reported outbreaks in the United
States associated with sprouts that caused 2,474 illnesses, 187 hospitalizations, and 3
deaths.

12

Produce receiving commercial processing, such as refining produce into sugar or
distilling it into wine, that adequately reduces the presence of microorganisms of public
health significance is also eligible for exemption from the rule.

13

According to the produce rule, very small businesses are those averaging more than
$25,000 but no more than $250,000 in annual monetary value of produce sold during the
previous 3-year period; small businesses are those averaging more than $250,000 but no
more than $500,000 in annual monetary value of produce sold during the previous 3-year
period. All other businesses, which we refer to as “large businesses,” are those averaging
more than $500,000 in annual monetary value of produce sold during the previous 3-year
period.
14

These agricultural water standards include microbial water quality criteria, frequency of
testing of agricultural water, and corrective measures that must be taken if water does not
meet microbial quality criteria. 21 C.F.R. §§ 112.44, 112.45, 112.46(b)(i)(A).

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GAO-18-85 FDA Produce Rule

 businesses, other than those growing sprouts. At that time, FDA is to
assess compliance with the produce rule, with the exception of the
agricultural water standards, for all produce other than sprouts. 15 See fig.
1 for more information on implementation timelines.
Figure 1: Current Implementation Timeline for the Produce Rule

Note: According to the produce rule, very small businesses are those averaging more than $25,000
but no more than $250,000 in annual monetary value of produce sold during the previous 3-year
period; small businesses are those averaging more than $250,000 but no more than $500,000 in
annual monetary value of produce sold during the previous 3-year period. All other businesses, which
we refer to as “large businesses,” are those averaging more than $500,000 in annual monetary value
of produce sold during the previous 3-year period.
a
“Certain agricultural water standards” apply to all covered produce other than sprouts and do not
include all provisions of the rule that relate to agricultural water. See 80 Fed. Reg. 74354, 74461
(Nov. 27, 2015).

FDA-State Partnership in
Helping to Ensure
Compliance with the Rule

FSMA authorized and encouraged FDA to coordinate with states in
helping to ensure compliance with the produce rule. According to FDA
officials, developing a working relationship with states to implement the
rule is of critical importance because states may have an understanding
of farming practices as a result of their historically close relationship with
farms. To facilitate coordination with states, FDA established the State
Produce Implementation Cooperative Agreement Program. The program
15
FDA originally intended to begin inspections in January 2018. In September 2017, FDA
announced that it would start inspections 1 year later than originally planned to allow the
agency extra time to provide additional training and outreach to businesses.

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GAO-18-85 FDA Produce Rule

 is to provide funds to support a variety of state activities, including
educating and providing technical assistance to produce businesses, to
the 43 participating states. 16 Through the program, FDA obligated
approximately $22 million in 2016 to 42 states and approximately $31
million in 2017 to 43 states to help these states implement the rule.
In addition, in September 2014, FDA entered into a 5-year cooperative
agreement with the National Association of State Departments of
Agriculture—an organization representing state agriculture departments
in all 50 states and 4 U.S. territories. Under this cooperative agreement,
the association is working with FDA to support implementation of the
produce rule by, among other things, providing technical assistance to
states to help them implement their produce safety programs. FDA
renewed the cooperative agreement in 2016 with an expanded scope to
include states’ assistance with helping businesses understand what is
expected of them ahead of compliance dates.

FDA Has Continued
to Take Steps to
Evaluate and
Respond to Business
Concerns and Is
Reviewing the
Produce Rule Water
Standards

Since we last reported on the produce rule, FDA has continued to use its
information clearinghouse, the TAN, to take steps to evaluate and
respond to questions and concerns from businesses and other
stakeholders regarding the produce rule. FDA has also taken other steps,
including funding training for industry, conducting visits to farms, and
publishing guidance, to evaluate and respond to concerns. In addition,
FDA is reviewing the produce rule agricultural water standards and in
September 2017 published a proposed rule to extend compliance dates
associated with those standards.

16

FDA officials said they will rely on inspectors from 40 of the 43 states participating in the
program to inspect businesses within their jurisdictions. The remaining 3 states in the
program did not apply for program funding to support inspection and enforcement
activities. For these 3 states, as well as other states not participating in the program,
officials told us FDA will conduct inspections. FDA officials also told us that states can
apply to participate in the program at any time.

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GAO-18-85 FDA Produce Rule

 FDA Continues to
Evaluate and Respond to
Business Concerns
through Its Information
Clearinghouse

FDA has continued to use the TAN to evaluate and respond to questions
and concerns from businesses and other stakeholders regarding all of the
FSMA rules, including the produce rule. Since our last report, we found
that FDA received 2,665 additional questions submitted to the TAN from
September 4, 2016, through June 30, 2017. 17 Of those 2,665 additional
questions, 230 questions (about 9 percent) pertained to the produce
rule. 18 Of those 230 questions, 154 questions (about 67 percent) came
from individuals who self-identified as belonging to “business/industry.” 19
(See fig. 2.)

Figure 2: Produce Rule Questions Submitted to the Technical Assistance Network (TAN), September 4, 2016, through June 30,
2017

17

In our last report, we examined data on TAN questions received by FDA from
September 10, 2015, when the TAN began operating, through September 3, 2016. We
found that FDA received 2,626 TAN questions during that period. See GAO-17-98R. FDA
received a total of 5,291 TAN questions from September 10, 2015, through June 30, 2017.

18

Other questions submitted to the TAN included those pertaining to the other FSMA
rules, such as the rules on human food, animal food, imported food, and the sanitary
transportation of food.

19

FDA reported the total number of TAN questions received from individuals who selfidentified as belonging to “business/industry” was from both domestic and foreign
businesses.

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GAO-18-85 FDA Produce Rule

 a

The TAN also receives questions about other rules pertaining to the FDA Food Safety Modernization
Act, such as rules on human food, animal food, imported food, and the sanitary transportation of food.

b

Others include members of academia, consumers, and federal or state regulators.

We reviewed the full text of questions about the produce rule that were
submitted to the TAN by those who identified themselves as belonging to
business/industry. We reviewed all such questions submitted since
September 10, 2015, when the TAN first began operating, through March
31, 2017, the date of the most recently available information when we
conducted our audit work (321 total questions). Questions spanned a
variety of topics related to the rule, with the most commonly asked
questions pertaining to the rule’s agricultural water standards. For
example, some businesses submitted questions to clarify whether a
specific water testing method they intended to use was acceptable. Other
commonly asked questions related to the types of produce covered by the
rule and whether a particular business was subject to the produce rule or
a related FSMA rule known as the preventive controls for human food
rule, which mandates new food safety requirements for food facilities,
such as food processing businesses. For example, one business owner
who grows almonds and also processes them submitted a question about
whether the business is subject to the produce rule or the preventive
controls rule. In addition, we found that most submissions (281 questions,
or 88 percent) contained requests for additional information or clarification
from FDA about implementing the produce rule. 20 Examples of questions
about the produce rule that were submitted by businesses are shown in
figure 3.

20

Among the remaining 12 percent of submissions, some (about 5 percent) voiced
concerns about or suggested revisions to the produce rule. Other submissions (about 5
percent) neither requested additional information nor expressed a concern about the rule.
For example, these included solicitations from businesses seeking to assist FDA with
implementing the produce rule. We did not categorize 10 questions (about 3 percent),
including those that were unintelligible or duplicates of other questions. Percentages do
not sum to 100 percent due to rounding.

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GAO-18-85 FDA Produce Rule

 Figure 3: Examples of Questions about the Produce Rule Submitted by Businesses
to the Food and Drug Administration’s Technical Assistance Network

According to FDA data, as of June 2017, the agency had responded to
about 84 percent (312) of the 372 questions specifically about the
produce rule submitted by businesses to the TAN since it began
operating. The agency’s median response time to these questions was 48
business days. As of June 2017, FDA had responded to 81 percent
(4,307) of all 5,291 questions submitted to the TAN, with a median
response time of 16 business days. Officials we interviewed said that
FDA’s longer median response time for produce rule questions submitted
by businesses was because the agency needed additional time to
address several unique produce rule questions that were not considered
during the rulemaking process.
To understand produce businesses’ concerns in detail, FDA officials said
they track questions submitted to the TAN. For example, these officials
said they track the number of questions requesting more information
about implementing the standards in the produce rule. These officials said

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GAO-18-85 FDA Produce Rule

 that FDA is using these data to inform the development of resources to
help businesses comply with the rule. For example, the officials told us
that they are developing a set of commonly asked TAN questions about
the produce rule that businesses can examine on FDA’s website prior to
submitting their questions to the TAN. FDA has already published similar
commonly asked TAN questions for some of the other FSMA rules.
Representatives we interviewed from two industry associations said that
such a list of questions would be helpful as businesses work to comply
with the produce rule.

FDA Has Taken Other
Steps to Evaluate and
Respond to Business
Concerns, Including
Funding Training for
Industry and Conducting
Visits to Farms

Since we last reported on the produce rule, FDA has taken steps in
addition to the TAN to evaluate and respond to business concerns
regarding the produce rule.
Training: FDA has funded partnerships to deliver training to help produce
businesses meet the new requirements under the produce rule.
•

The Produce Safety Alliance (PSA)—a collaboration involving Cornell
University, FDA, and the U.S. Department of Agriculture—has
developed a standardized national training curriculum about the
produce rule and has conducted training sessions for more than 6,100
industry participants in the United States and foreign countries. In
addition to serving an educational role, PSA training sessions help
FDA evaluate and respond to business concerns. For example, FDA
officials told us the agency uses questions submitted to the TAN to
inform PSA course content, thereby helping to ensure that the training
sessions address the most commonly asked questions. In addition,
FDA officials and PSA representatives we interviewed said that PSA
trainers are able to respond to questions from industry participants
during the training sessions. These representatives said that they
forward questions that PSA trainers are not able to answer during
training sessions to FDA using the TAN and through regular meetings
with FDA officials. One PSA trainer we interviewed said that face-toface interactions with businesses at training sessions are the major
way her organization hears about business questions and concerns.

•

The Sprout Safety Alliance (SSA) is a collaboration between the
Illinois Institute of Technology and FDA to enhance the sprout
industry’s understanding of the produce rule. SSA has developed a
training curriculum to help businesses comply with produce rule
standards related to sprout production. SSA has conducted training
courses for over 100 industry participants in the United States and
Canada. According to an SSA representative, SSA has addressed

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GAO-18-85 FDA Produce Rule

 questions and concerns from sprout industry participants during
trainings. This representative also said SSA communicates with FDA
about questions SSA trainers are unable to answer.
Table 1 provides information about trainings provided by PSA and SSA.
Table 1: Produce Safety Alliance (PSA) and Sprout Safety Alliance (SSA) Trainings:
Numbers of Courses and Participants
Number of
Training courses (within the United States)
States hosting training courses
Industry participants

PSA

SSA

222

12

39

6

6,131

102

Source: PSA and SSA data.   GAO-18-85

Note: PSA data are from September 13, 2016, through September 14, 2017; SSA data are from
August 30, 2016, through June 28, 2017. Both PSA and SSA have also conducted training courses
outside the United States. The number of industry participants includes those outside the United
States, such as from Mexico and Canada.

Educational Farm Visits: FDA officials participated in educational farm
visits in 2016 and 2017 across the United States. According to FDA
officials we interviewed, these visits were intended to broaden FDA’s
knowledge of industry practices on these farms and were not for
compliance or inspection purposes. FDA officials said they learned about
a variety of industry concerns during these visits, including industry’s
concerns with the water standards under the produce rule. FDA
conducted these visits in a number of states, including Alaska, Arizona,
California, Colorado, Georgia, Maine, Maryland, Nevada, New Mexico,
Oregon, Texas, Vermont, Washington, Wisconsin, and the U.S. Virgin
Islands, according to agency officials.
Outreach to Produce Industry Associations: According to FDA
officials, the agency performs outreach to various produce industry
associations to educate businesses about the produce rule, answer
questions, and learn about produce business concerns. For example,
FDA officials said that, since we last reported on the produce rule, they
have attended industry conferences and held outreach meetings with
produce industry associations and they learned about specific concerns,
such as businesses’ need for additional training on the produce rule and
for information on how to identify materials that are suitable to properly
sanitize surfaces with which produce comes into contact.

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GAO-18-85 FDA Produce Rule

 On-farm Readiness Reviews: According to agency officials, these are
voluntary reviews during which state inspectors and educators,
accompanied by FDA officials, review businesses’ progress toward
meeting the produce rule standards to promote compliance with the rule.
States and FDA piloted the program in 2016 and, according to agency
officials, they plan to roll out the full program in late 2017 or early 2018. 21
In addition to helping businesses comply with the rule, FDA officials said
these reviews have helped the agency learn about businesses’ questions
and concerns. For example, officials said they learned during these
reviews that some businesses needed additional information regarding
water testing methods under the rule, including information on the number
of water samples to be collected and the locations of testing laboratories.
Produce Safety Network: Recognizing regional differences in growing
practices, FDA established the Produce Safety Network in 2017 to
address the unique needs of produce businesses in various parts of the
country, according to agency officials. This network was established, in
part, to respond to business questions and concerns, according to FDA
officials. The network is made up of FDA produce safety experts and
specialized investigators based in different parts of the country who help
evaluate and respond to questions from businesses, state regulators, and
other stakeholders in their regions, according to agency officials. For
example, according to FDA officials, these produce safety experts learned
about business questions regarding FDA’s list of produce the agency
considers rarely consumed raw and not subject to the produce rule. In
response to these concerns, the network developed a fact sheet outlining
FDA’s rationale for developing the list.
Guidance: According to FDA officials, the agency has been working on
guidance to assist businesses in complying with the produce rule. FDA
officials said guidance allows FDA to respond to questions and concerns
related to the rule. For example, in January 2017, FDA published draft
guidance on sprout-specific requirements under the rule. 22 FDA officials
told us they conducted outreach to sprout businesses before releasing
this guidance to let businesses know why the guidance was issued and
21

FDA completed five pilot on-farm readiness reviews in Florida, Michigan, New Jersey,
North Carolina, and Vermont in 2017, according to FDA.
22

Food and Drug Administration, Compliance with and Recommendations for
Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout Operations: Guidance for Industry
(Washington, D.C.: 2017).

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 that it was available for public comment. In developing the guidance, FDA
also took into account public comments made during the rulemaking
process, according to FDA officials. An SSA representative we
interviewed confirmed this, saying that the draft guidance was responsive
to comments made by sprout businesses during rulemaking that asked
FDA to include specific examples of how businesses were to comply with
requirements. This representative said the draft guidance contained
relevant examples. In addition, in early September 2017, FDA published
guidance to help small businesses comply with the produce rule. 23 The
guidance provides small businesses with information about who must
comply with the rule, training required, and which businesses are eligible
for qualified exemptions from the rule, among other things. See appendix
I for a list of published and forthcoming FDA produce rule guidance.

FDA Is Reviewing the
Produce Rule Water
Standards in Response to
Business Concerns and Is
Proposing to Extend
Compliance Dates

FDA announced in March 2017 that it would conduct a review of the
agricultural water standards under the produce rule and, in September
2017, the agency published a proposed rule in the Federal Register that
would extend the compliance dates for the water standards by an
additional 2 years from the original compliance dates, depending on
business size, for produce other than sprouts (see fig. 4). 24

23

Food and Drug Administration, Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption: What You Need to Know About the FDA
Regulation-Small Entity Compliance Guide: Guidance for Industry-Small Entity
Compliance Guide (Washington, D.C.: 2017). FDA prepared the guidance in accordance
with the Small Business Regulatory Enforcement Fairness Act of 1996. Pub. L. No. 104121, Tit. II, § 212, 110 Stat. 857, 858.

24

FDA proposed to extend the compliance dates to January 26, 2022, for large
businesses and to January 26, 2023, and January 26, 2024, for small and very small
businesses, respectively. The proposed rule would also simplify the compliance
framework to give all of the water requirements a 4-year delay in the compliance dates.
Currently, the produce rule includes a delay of 2 years in the compliance dates for certain
agricultural water requirements, but for other water requirements there is no delay. On
September 13, 2017, FDA established a 60-day public comment period for the proposed
changes. FDA stated that sprouts remain subject to the applicable agricultural water
requirements under the original compliance dates. 82 Fed. Reg. 42963, 42965. (Sept. 13,
2017).

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 Figure 4: Implementation Timeline for the Produce Rule’s Current and Proposed Agricultural Water Standards

a

”Certain agricultural water standards” apply to all covered produce other than sprouts and do not
include all provisions of the rule that relate to agricultural water. See 80 Fed. Reg. 74354, 74461
(Nov. 27, 2015).

b

According to FDA, the proposed rule would also simplify the compliance framework to give all of the
water requirements a 4-year delay compared to compliance dates for other requirements under the
rule. Currently, the produce rule includes a delay of 2 years in the compliance dates for certain
agricultural water requirements, but for other water requirements there is no delay.

According to FDA, its review of the water standards is an effort to simplify
the standards and make them easier for businesses to comply with. FDA
also said that it would use the extended compliance period to work with
produce businesses as it considers the best approach to respond to their
concerns about the standards. The extended compliance period will also
allow FDA to provide additional outreach and training.
FDA officials we interviewed said that their decision to review the water
standards and extend compliance dates was in response to industry
concerns. They also said that they learned about these concerns through
some of the steps they have taken, which we identify in this report. For
example, FDA officials said they heard numerous questions and concerns
from businesses about the water standards during educational farm visits.
Also, as we note above, questions about the water standards were the
most common produce rule-related questions submitted to the TAN.
According to representatives we interviewed from two industry
associations, some businesses did not fully understand the water
standards because, among other things, they said the standards do not
provide a clear definition of “agricultural water,” leaving some businesses
uncertain about what water sources and water uses are subject to the

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GAO-18-85 FDA Produce Rule

 rule. In addition, according to documentation from an industry meeting
with FDA, some businesses have expressed concerns about costs
associated with the new water testing requirements. Some businesses
have also expressed concerns that the water testing method described in
the standards has not traditionally been used by industry and that finding
laboratories that use this method will be difficult. The standards allow for
the use of alternative testing methods, but some businesses have
expressed concerns that FDA has not specified these alternative testing
methods, thereby leaving businesses uncertain about what methods will
be acceptable to FDA. 25 Along with its announcement of a review of the
water standards, in September 2017, FDA announced a list of eight water
testing methods it determined to be equivalent to the method described in
the standards. According to FDA officials, the list was established in
response to business concerns, and the agency will add to this list as
additional equivalent methods are identified.
FDA officials we interviewed did not provide specific details or a timeline
for the agency’s review of the water standards. These officials said the
agency is considering adding clarifying information on the standards in
forthcoming guidance and, if necessary, making changes to the standards
themselves by revising the produce rule. In addition, officials said they
plan on hosting a water summit in early 2018 with stakeholders and
technical experts.

25

See Center for Produce Safety, Report on Agricultural Water Testing Methods
Colloquium (Irvine, CA: IDS Decision Sciences, April 6 and 7, 2017).

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GAO-18-85 FDA Produce Rule

 We are sending copies of this report to the appropriate congressional
committees, the Secretary of Health and Human Services, and other
interested parties. In addition, the report is available at no charge on the
GAO website at http://www.gao.gov.
If you or your staff have any questions about this report, please contact
me at (202) 512-3841 or morriss@gao.gov. Contact points for our Offices
of Congressional Relations and Public Affairs may be found on the last
page of this report. Key contributors to this report are listed in appendix II.

Steve D. Morris
Director, Natural Resources and Environment

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GAO-18-85 FDA Produce Rule

 Appendix I: FDA Outreach and Guidance
Related to the Produce Rule
Appendix I: FDA Outreach and Guidance
Related to the Produce Rule

Table 2: Food and Drug Administration (FDA) Outreach to Produce Businesses, December 2016 through June 2017
Type of outreach

Date(s)

Location of outreach
activity

Produce rule standard(s)
addressed (water
testing, soil, etc.)

FDA meeting with Produce Industry
Coalition

Multiple

College Park, MD

Various aspects of the
produce rule

Farm Visits by Produce Safety Network

Multiple

Texas, Oregon, California
(Salinas Valley), Alaska,
Wisconsin, Arizona, U.S.
Virgin Islands

Various aspects of the
produce rule

FDA meeting with International Sprout
Growers Association

December 15, 2016

College Park, MD

Sprouts

FDA meeting with National Onion
Association

February 13, 2017

College Park, MD

Various aspects of the
produce rule

Sprout Safety Alliance webinar by FDA
staff on Draft Sprout Guidance to
implement produce rule

March 6, 2017

Webinar

Sprouts

FDA meeting with Almond Board of
California

June 2, 2017

Conference call

Written assurances

FDA meeting with California Leafy
Greens Marketing Association

June 6, 2017

College Park, MD

All

FDA meeting with Almond Board of
California

June 7, 2017

College Park, MD

Scope

FDA meeting with National Sustainable
Agriculture Coalition

June 9, 2017

Silver Spring, MD

Various aspects of the
produce rule

College Park, MD

Various aspects of the
produce rule

FDA meeting with California Wine Grape June 21, 2017
Growers
Source: FDA.   GAO-18-85

Table 3: Published and Forthcoming Food and Drug Administration (FDA) Produce Rule Guidance
FDA guidance documents
Produce rule topic covered by guidance

Actual or anticipated publication date

Draft Guidance on Sprout Production

January 2017

Produce Rule Small Entity Compliance Guide

September 2017

Produce Rule Draft Compliance & Implementation Guidance
(excluding agricultural water)

January 2018

Draft Updated Good Agricultural Practices

2020

Region- and commodity- specific guidance documents

As necessary

Draft Packinghouse Guidance

As necessary

Source: FDA.   GAO-18-85

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