**Addressing Modern Hazards in the Food Supply:**

**Ensuring the Safety of Fresh and Fresh-Cut Produce**

**Testimony of Caroline Smith DeWaal**

**Director of Food Safety**

**Center for Science in the Public Interest**

**before the**

**United States House of Representatives**

**Subcommittee on Horticulture and Organic Agriculture**

**Washington, DC**

**May 15, 2007**

My name is Caroline Smith DeWaal, and I am Director of Food Safety for
the Center for Science in the Public Interest (CSPI). CSPI is a
nonprofit health advocacy and education organization focused on food
safety, nutrition, and alcohol issues. CSPI is supported principally by
the 900,000 subscribers to its *Nutrition Action HealthLetter* and by
foundation grants. We accept no government or industry funding.

The Center for Disease Control and Prevention (CDC) estimates that 76
million Americans get sick, 325,000 are hospitalized, and 5,000 die from
foodborne hazards each year in the United States. According to CSPI's
database of 5,000 foodborne illness outbreaks, fruits and vegetables
caused 13 percent (639) of outbreaks with an identified food and
pathogen and nearly 21 percent (31,496) of the associated illnesses
between 1990 and 2004. Norovirus, *Salmonella* and *E. coli* 0157:H7
illnesses have been traced to a wide variety of produce, including
lettuce, salads, melons, sprouts, tomatoes, and many fruit- and
vegetable-containing dishes.[^1] In fact, foodborne illnesses from these
produce outbreaks surpassed those from all other foods, including beef,
chicken and seafood. Equally troubling is that the average size of these
outbreaks is larger than outbreaks from other foods, thus affecting more
people. It is time for Congress to take action to better ensure the
safety of our food supply and to protect Americans from these
preventable illnesses and deaths.

**Fall 2006 Produce Outbreaks**

A series of produce outbreaks in the fall of 2006 was a wake up call for
the public about the critical state of produce safety. Beginning in
August, a nationwide outbreak of *E. coli* 0157:H7 from bagged fresh
spinach sickened 205 and killed at least three.[^2] Then in late
September, *Salmonella* found in tomatoes sickened 183 restaurant
patrons in 21 states throughout the nation. *E. coli* O157:H7 appeared
in produce once more before the year's end when two separate incidents
of contaminated shredded iceberg lettuce sickened a total of 152
individuals at chain restaurants Taco Bell and Taco John.

While many produce outbreaks occurred prior to 2006, the spinach
outbreak provided the smoking gun that sourced the cause all the way to
the farm. The Food and Drug Administration (FDA) traced the exact strain
of the *E. coli* bacteria to a California spinach farm, finding it in
nearby manure piles, in a creek and even in a wild pig.[^3] These
findings definitively proved that the *E. coli* contamination that
sickened so many people started right on the farm.

**The Case for Produce Regulation**

While the produce outbreaks of fall 2006 have triggered a wake-up call
for produce safety, large-scale produce outbreaks are not a new
phenomenon in this country. Outbreaks from produce, both imported and
domestic, have resulted in deaths, illnesses, both mild and severe, and
great market disruptions. Domestic produce is largely unregulated, and
FDA has done little more than coax, request, and warn producers to
improve produce safety.

-   In February 2004, following fourteen outbreaks linked to lettuce and
    tomatoes, FDA sent a letter to firms that grow, pack, or ship fresh
    lettuce and/or fresh tomatoes asking them to review their current
    operations in light of the agency's guidance.[^4]

-   After seeing 18 outbreaks since 1995 involving *E. coli* 0157:H7 in
    lettuce, FDA sent another letter in November 2005 specifically to
    California lettuce firms outlining actions the industry should take
    in order to ensure lettuce safety.[^5]

-   At a June 2004 public meeting to discuss the proposed Produce Action
    Plan, Dr. Robert Gravani of Cornell University's Food Science
    Department reported that a Good Agricultural Practices Survey of
    Farm Workers in New York State showed that approximately 30 percent
    of producers were unaware of Good Agricultural Practices (GAPs) for
    their particular crop. The numbers show the need for a mandatory
    regulatory program for fresh produce and the same should go for
    fresh-cut produce.

-   A qualitative study examining food safety practices used by Iowa
    produce growers was conducted by researchers from Iowa State
    University. Observational and in-depth interview techniques were
    used to assess current food safety practices at each operation.
    Producers were conscious of product safety, but levels of awareness
    about risk varied. Areas that needed improvement included improved
    hand washing facilities and practices; provision of employee
    training; and the development of cleaning and sanitizing protocols
    for both products and food contact surfaces.[^6]

**Imported Produce**

While it is important that we clean up our domestic produce industry, we
must also look to improving standards in the countries that export
produce to the U.S. as well. Americans seek a variety of fresh fruits
and vegetables year-round, and supplying this demand has greatly
increased the importation of produce from around the world. In fact,
one-quarter of our fruit, both fresh and frozen, is imported.[^7] A
troubling realization is that imported fruits and vegetables have caused
numerous large and sometimes deadly outbreaks.

Imports of berries, melons and even green onions, from areas with
substandard hygiene practices have sickened thousands of Americans in
the last ten years. In 1996 and 1997, thousands of people became ill in
both the U.S. and Canada from the parasite, *Cyclospora,* on raspberries
grown in Guatemala.[^8] Then in 1997, over 256 cases of Hepatitis A were
associated with the consumption of frozen strawberries imported from
Mexico and distributed through a U.S. Department of Agriculture (USDA)
school lunch program in several states.[^9]

Cantaloupe imported from Mexico caused three multistate outbreaks of
*Salmonella* serotype Poona infections in the spring of consecutive
years during 2000-2002. FDA traceback investigations of the cantaloupe
farms identified numerous hygiene failures including contaminated
irrigation and processing water and poor hygienic practices of
handlers.[^10] In the fall of 2003, raw green onions from Mexico spread
Hepatitis A to hundreds of people in four different states. In
Pennsylvania alone, 555 people became ill from Hepatitis A after eating
salsa with the contaminated green onions at a single restaurant.[^11]

Most of these outbreaks were traced to imported fruits and vegetables
that were grown or processed under substandard and unhygienic
conditions. In addition to imposing standards on domestic growers and
processors, FDA must ensure that the fruits and vegetables being
imported into our country are produced under equally rigorous standards.

**Consumer Confidence**

Consumer confidence in the safety of the food supply, and in FDA's
ability to protect consumers, has declined steadily in recent years.
According to the Coalition for a Stronger FDA, a Harris Poll showed that
consumer confidence in FDA plummeted by 25 percent in the last six
years, with 20 percent of that decline occurring between 2004 and 2006.
Those who thought FDA was doing an "excellent" or "good" job went from
61 percent in 2000 to 36 percent in 2006 while nearly 60 percent of
respondents ranked FDA as doing only a "poor" or "fair" job.

Consumers want to eat fresh vegetables and fruits and we love the
convenience of bagged salads that allow us to have a salad on the table
in few minutes. But consumer confidence in the safety of these bagged
products has certainly declined since the fall.[^12] A January 2007
survey by the Food Marketing Institute (FMI) reported declines in
consumer confidence in supermarket and restaurants foods.[^13] The
survey also reported that 38% of consumers stopped buying certain
products; 71% of these consumers stopped buying spinach and 16% stopped
buying lettuce. The spinach outbreak had as many fatalities as Jack in
the Box hamburger outbreak of 1992. It may prove to be a tipping point
for consumer confidence -- not only in FDA but in the food it regulates
-- unless the industry and the government act quickly to provide
solutions to the risks that are now so evident. Consumers want FDA to
put in place a regulatory system that will prevent these outbreaks from
occurring.

The American public wants safe food. A 2006 poll from the National
Center for Food Protection and Defense at the University of Minnesota
revealed that U.S. residents believe that for every \$1 spent to protect
against a terrorist attack from an aircraft, \$1.13 should be spent to
protect America's food supply.[^14] Unfortunately, these sentiments have
not translated into a budget reality.

**A Roadmap to Recovery**

Fresh fruits and vegetables are at the center of a healthy diet, so it
is critical that steps are taken to improve their safety. FDA should
consider emergency regulations requiring all fruit and vegetable
producers and processors to focus on the hazards associated with their
products and have written plans in place to identify where contamination
is likely to occur and how to address it. This approach is appropriate
for both large and small growers and processors. It targets resources to
critical areas and reduces risk by using prevention. The FDA should
adopt mandatory hazard control programs for farms and fruit and
vegetable processors. These programs should address all major sources of
contamination, including the following areas:

***Manure:*** The grower must manage the application of manure to ensure
that it does not contribute to the contamination of crops, including
limitations on the crops where and the times when it may be applied.

***Water:*** Growers and producers should ensure that the water supply
used for irrigation and in food processing plants is suitable for its
intended use. Growers should assess the microbial and chemical quality
of the water used in primary production.[^15]

***Hygiene:*** Growers and processors should ensure that employees have
close access to bathrooms and that handwashing facilities are visible to
supervisors. Employees with direct and indirect access to the production
areas should be trained in preventive controls that will help to
eliminate or minimize contamination of produce.

***Sanitation:*** Processors should establish mandatory standard
operating procedures for sanitation, including cleaning procedures for
equipment, storage areas, air systems, and water storage areas.

***Traceback:*** Processors should mark packaging to ensure easy
traceback when fruits and vegetables are implicated in an outbreak.
Package markings should be specific enough to extend all the way back to
the farm/farms of origin.

Adoption of mandatory regulatory requirements is the best way to ensure
that growers and others in the produce supply chain address the risks
inherent in the production of fresh produce. FDA should also regularly
conduct random inspections of farm fields and facilities that process
produce, prioritizing by size and risk potential. Where states or third
party auditors are being used, FDA should oversee audits and exercise
more rigorous enforcement actions, including product seizure and
criminal sanctions whenever adulterated products are sold.

**FDA's Budget Problems**

Unfortunately the solution to cleaning up the produce industry is not as
simple as imposing regulations. Steps taken by industry players, such as
the Western Growers Association, are important first steps because FDA
currently lacks the funding and authority to act on its own. But FDA
alone is empowered to enforce uniform standards across growers in all
states and importing countries.

Last fall's produce outbreaks are just the latest symptom of an agency
that is overwhelmed by responsibility, but lacks the staff and resources
to function effectively. The agency responds to crisis after crisis
rather than preventing them. Current FDA funding shortfalls have reached
a critical level and budget cuts have left the agency with fewer
inspectors, even as their workload continues to increase. In fact, since
1972 inspections conducted by the FDA declined 81 percent. Since 2003,
the number of FDA field staff dropped by 12 percent and between 2003 and
2006, there was a 47 percent drop in federal inspections.[^16]

In 2006, FDA's food program had a funding shortfall of \$135 million,
which an FDA budget official described as equivalent to a 24 percent
budget cut.[^17] This means that many other parts of the agency's
responsibilities are just not getting attention -- things like obesity,
dietary supplements, and oversight of new food technologies. In
addition, funding shortfalls do not allow the FDA to develop more modern
testing technologies and leave the U.S. at a competitive disadvantage
compared to other developed countries.

Equally important is the fact that the federal agencies' food safety
expenditures are disproportionate to the risk posed by the foods they
regulate. USDA regulates 20 percent of the food supply, which causes 27
percent of outbreaks, yet its food safety appropriations are double that
given to FDA.[^18] This means that while USDA has the resources to
inspect meat and poultry plants daily, the FDA inspects food facilities
it regulates on average just once every five to ten years.

The Bush Administration's 2008 budget proposal brings no relief to the
ailing agency. The recent budget proposal gives USDA \$104 million in
new money for food safety.[^19] The FDA, which regulates 80 percent of
the food supply, including produce, will only get \$10.6 million in new
food safety money.[^20] It is a food safety budget that defies logic.

Foodborne illness outbreaks related to fresh produce are a major public
health problem. Prevention, early detection, and control measures must
be in place at every step of fresh produce production to help minimize
food safety risks. Voluntary guidelines are not an effective public
health response to address the food safety problems related to fruits
and vegetables. And while FDA can likely cobble together the authority
it needs to regulate on the farm from existing statutes, there is no
clear mandate from Congress that ensures food safety oversight all the
way from the farm to the table. Food safety is critically important to
consumers' health and to the health of the industries that produce food;
yet, it is governed by laws that are 100 years old. It is time to
modernize food safety.

**Modernizing the Law: The Safe Food Act**

Following September 11, 2001, Congress enacted the Bioterrorism Act of
2002 but left the most frequent traveler across U.S. borders ---
imported food --- under the supervision of a fragmented system of food
regulation. According to the National Academy of Sciences, "\[a\]t least
a dozen federal agencies implementing more than 35 statutes make up the
federal part of the food safety system."[^21]

In response to the problems identified by the National Academy of
Sciences, Government Accountability Office, and other agencies, several
Members of Congress have introduced legislation---the Safe Food
Act---that would modernize the outdated inspection system and give clear
authority for on-farm programs. The new system would rely on
preventative control systems implemented by the industry and performance
standards monitored and enforced by the government.

In a post-September 11 world, with risks of bioterrorism and natural
hazards such as *E. coli* O157:H7, the U.S. food safety system has
become an issue of national security. The existing regulatory framework
is simply insufficient to handle these challenges. The Safe Food Act was
introduced February 15, 2007 by Senator Richard Durbin (D-IL) and
Representative Rosa DeLauro (D, CT-3^rd^) as a solution to the myriad of
problems in the food system. The Act would streamline food safety at the
federal level by consolidating food programs at the FDA, USDA, EPA, and
several other key food agencies into a new, independent, unified,
science-based Food Safety Administration. In addition, the Safe Food Act
would create new authorities to address the development of preventative
processing controls, sanitation standards, performance standards for
contaminants, adequate recordkeeping to monitor compliance, and a
sampling program to ensure that the process controls are effective.[^22]

The key to creating a modern food safety system is to implement
science-based programs to prevent contamination. The Safe Food Act calls
for the implementation of science-based process controls to ensure that
food contamination is minimized throughout the production process. The
bill would require all food establishments to implement appropriate
measures to control and reduce the levels of harmful contaminants in
food and meet performance standards for harmful pathogens.  The bill
builds upon existing Hazard Analysis of Critical Control Points (HACCP)
programs, a prevention-based food safety system, but would not limit the
agency administrator to rely solely on this program.

In addition, the Safe Food Act would create a system of risk-based
inspection, "determined by the type of food handled and the type of
processing to which the food is subjected."[^23] Food establishments
would receive a rating of between one and five, based on public health
considerations and strong scientific evidence, to determine the
frequency and timing of inspections. The risk-based inspection program
would continue the "carcass-by-carcass" inspections by government
employees at slaughterhouses and perform daily inspections of high-risk
products. All facilities now regulated by the FDA would be inspected at
least annually, with many inspected much more often. This system of
risk-based inspection would allow for the best use of government
resources while still providing safety checks along the entire
"farm-to-fork" continuum.

Consumption of imported foods continues to rise exponentially, and the
Safe Food Act recognizes and addresses this important component of our
food supply.[^24] Due to limited resources, the FDA currently inspects
only about one percent of food entering the U.S., and does little to
evaluate foreign food safety systems or inspect foreign plants.[^25] The
Safe Food Act would give the Food Safety Administration the authority to
evaluate and certify a country's food safety program to ensure that it
is "at least equivalent to the food safety program in the United
States."[^26] The Administration would have the authority to audit the
certified countries and would ensure continued compliance at least every
five years.[^27] The proposed law also requires routine inspections of
foreign food imports to ensure that the food is safe and properly
labeled. Under the Safe Food Act, foods would no longer have an "open
visa" to enter the U.S. without inspection or regulation.

The Safe Food Act further mandates the establishment of a national
system for "tracing food and food producing animals from point of origin
to retail sale."[^28] The Act would allow companies to issue voluntary
recalls should their product be deemed unsafe, but also grants authority
for the Food Safety Administration to issue a mandatory recall if the
company fails to do so. This will ensure quicker removal of contaminated
products from the market and increase consumer confidence in the food
supply.

Because our understanding of foodborne illness is constantly evolving,
the Safe Food Act recognizes the importance of outbreak investigations
and scientific research to improve the safety of the food supply. The
legislation would require the CDC and state health departments to share
outbreak investigation information with the Food Safety Administration.
The bill also would give the Food Safety Administration the
responsibility to maintain an "epidemiological system dedicated to
food-borne illness identification, outbreaks, and containment."[^29]
Detailed food attribution data is critical for risk assessments and also
for the identification of emerging foodborne pathogens that could
endanger the public.

The Safe Food Act would create a single food agency with the necessary
authority to fulfill its mission to put safe food on America's tables.
The Administration could detain imported food and recall tainted food
from the market. It would provide the necessary authority to penalize
persons or organizations for violating food safety laws, allowing both
civil and criminal penalties, and also provide whistleblower protection
for individuals who disclose food safety violations.

The Safe Food Act would work to prevent foodborne illness and
bioterrorism without grand schemes or an inflated budget. Instead, it
ensures a strong national program, outbreak surveillance, and effective,
honest public communication. The food industry remains the first line of
defense, but the Act recognizes that effective industry programs require
government monitoring and oversight.

U.S. food safety laws are more than a century old and were not designed
to deal with modern issues such as bioterrorism, antibiotic resistance,
or tainted produce. The September 11, 2001 terrorist attacks
demonstrated the need for enhanced national security, and the recent
produce outbreaks serve as a reminder that much more must be done to
protect the food supply. The Safe Food Act draws from these
recommendations and creates a program that puts public health at the
forefront of food safety in America.

[^1]: Center for Science in the Public Interest, *Outbreak Alert!*
    (Revised and updated -- 2006). This database of foodborne illness
    outbreaks is maintained by CSPI. It contains 15 years of data, from
    1990--2004. Outbreaks are classified by both food vehicle and
    disease-causing agent. Food is classified by which agency regulates
    the product. During the years 1990 -- 2004, there were 3,323
    foodborne illness outbreaks from FDA-regulated foods (e.g. seafood,
    produce, eggs, milk); USDA regulated-foods (e.g. beef, poultry,
    pork) caused 1,344 outbreaks.

[^2]: FDA News. "FDA Finalizes Report on 2006 Spinach Outbreak" March
    23, 2007. \<http://www.fda.gov/bbs/topics/NEWS/2007/NEW01593.html\>

[^3]: ProMED-mail. E. coli O157, spinach -- USA (multistate)(20).
    ProMED-mail 2006; 27 October: 20061027.3067. February 23, 2007.
    \<http://www.promedmail.org\>

[^4]: FDA, CFSAN (2004). *Letter to Firms that Grow, Pack, or Ship Fresh
    Lettuce and Fresh Tomatoes.* Feb. 5, 2004. March 5, 2007.
    \<http://www.cfsan.fda.gov/\~dms/prodltr.html\>.

[^5]: FDA, CFSAN (2005). *Letter to California Firms that Grow, Pack,
    Process, or Ship Fresh and Fresh-cut Lettuce*. November 4, 2005.
    March 5, 2007. \<http://www.cfsan.fda.gov/\~dms/prodltr2.html\>.

[^6]: J Ellis, et al. (2005). "Assessing On-farm Food Handling Practices
    of Iowa-grown Produce and Eggs in Regard to Food Safety." *Food
    Protection Trends,* 25(10): 758-61.

[^7]: Bridges, A. "Imported food rarely inspected." *Washington Post*.
    April 16, 2007.

[^8]: J Hoffman *et al* (1996). "Update: Outbreaks of *Cyclospora
    cayetanensis* Infection -- United States and Canada, 1996." July 19,
    1996. *MMWR* 45(28): 611-612.

[^9]: Centers for Disease Control (1997). "Hepatitis A Associated with
    Consumption of Frozen Strawberries---Michigan, March 1997." *MMWR*.
    46(13): 288-295.

[^10]: SM Anderson *et al.* (2002) "Multistate Outbreaks of *Salmonella*
    serotype Poona Infections Association with Eating Cantaloupe from
    Mexico---United States and Canada, 2000-2002." November 22, 2002.
    *MMWR*, 51(46);1044-1047.

[^11]: V Dato *et al.* (2003) "Hepatitis A Outbreak Associated with
    Green Onions at a Restaurant---Monaca, Pennsylvania, 2003." *MMWR,*
    52(47): 1155-1157.

[^12]: In November 2006, the Food Policy Institute at Rutgers University
    conducted a telephone survey of 1,200 adults to assess consumer
    attitudes on bagged leafy greens. The survey found that consumers
    were confused over which products were recalled and that some
    consumers were hesitant to resume consumption of bagged leafy
    greens. Cutie, Cara Ph.D., et al, *Public Response to the
    Contaminated Spinach Recall of 2006.* Food Policy Institute, Rutgers
    University. (February 5, 2007).

[^13]: Food Marketing Institute. "FMI Consumer Trends 2007: Confidence
    in Food Safety Down, Energy Costs Changing How People Shop." *News
    Release.* May 7, 2007*.
    \<*http://fmi.org/media/mediatext.cfm?id=873\>

[^14]: Stinton TF, et al. "How Should America's Anti-Terrorism Budget Be
    Allocated? Findings from a National Survey of Attitudes of U.S.
    Residents about Terrorism." The Food Industry Center, University of
    Minnesota. March 2006.

[^15]: United Nations Codex Alimentarius Commission (2003). *Codex Code
    of Hygienic Practice for Fresh Fruits and Vegetables. Section
    3.2.1.1.* November 15, 2006.
    \<http://www.codexalimentarius.net/download/standards/10200/cxp_053e.pdf\>See
    also: Beuchat LR (1998). "Surface decontamination of fruits and
    vegetables eaten raw: A review." *Food Safety Issues*. World Health
    Organization.

[^16]: Waxman, Henry. *Fact Sheet: Weaknesses in FDA's Food Safety
    System*. Representative Henry Waxman. (October 30, 2006); Andrew
    Bridges, Seth Borenstein, "AP Investigation: Food Safety Inspections
    Lanquish," Associated Press, February 29, 2007.

[^17]: Frank Claunts, Office of Management, Food and Drug
    Administration, FDA: Financial realities, at 14. (Aug. 10, 2006,
    updated Aug. 17, 2006).

[^18]: Center for Science in the Public Interest, *Outbreak Alert!*
    (Revised and updated -- 2006).

[^19]: United States Department of Agriculture. *FY08 Budget Summary and
    Annual Performance Plan.*
    \<http://www.obpa.usda.gov/budsum/fy08budsum.pdf\>

[^20]: Food and Drug Administration. *Summary of FDA's FY 2008 Budget.*
    \<http://www.fda.gov/oc/oms/ofm/budget/2008/summary.html\>

[^21]: Institute of Medicine, National Research Council. *Ensuring Safe
    Food from Production to Consumption*. (Washington, DC: National
    Academy Press, 1998)

[^22]: United States. Congress. House of Representatives. 110^th^
    Congress, 1^st^ Session. *H.R. 1148, The Safe Food Act of 2007.*
    \[introduced in the House of Representatives 16 February 2007\].
    110^th^ Congress. Congressional Bills, GPO Access. \<
    http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h1148ih.txt.pdf\>

[^23]: Congresswoman Rosa L. DeLauro.
    \<http://www.house.gov/delauro/safe_food_act_109.html\>

[^24]: Jerardo, Alberto. *The Import Share of U.S.-Consumed Food
    Continues To Rise*. United States Department of Agriculture.
    FAU-66-01 (July 2002)
    \<http://usda.mannlib.cornell.edu/usda/ers/FAU/2000s/2002/FAU-07-03-2002_Special_Report.pdf\>

[^25]: General Accounting Office (GAO), Food Safety. *Overview of Food
    Safety and Inspection Service and Food and Drug Administration
    Expenditures* (GAO/T-RCED-00-300T). (September 20, 2000) (statement
    of Lawrence J. Dyckman, Director, Food and Agriculture Issues,
    Resources, Community, and Economic Development Division, GAO).
    \<http://www.gao.gov/archive/2000/rc00300t.pdf\>

[^26]: United States. Congress. House of Representatives. 110^th^
    Congress, 1^st^ Session. *H.R. 1148, The Safe Food Act of 2007.*
    \[introduced in the House of Representatives 16 February 2007\].
    110^th^ Congress. Congressional Bills, GPO Access. \<
    http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h1148ih.txt.pdf\>

[^27]: *id.*

[^28]: *id*

[^29]: *id*