FOOD
SAFETY STRATEGY (part 1)
January
7, 1999
USDA/
FSIS Hearing Clerk
300 12th Street, SW
Room 102 Cotton Annex
Washington, DC 20250
Re:
Docket No. 98-045N
FDA
Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Drive
Room 1-23
Rockville, MD 20857
Re:
Docket No. 97N-0074
S.T.O.P.,
Safe Tables Our Priority appreciates this opportunity to comment
on the federal government's strategic plan for food safety
policies. S.T.O.P. is a strong supporter of the President's
Food Safety Initiative. However, the organization continues
to assert that the best way to ensure efficient and effective
use of federal food safety resources is to create a single
federal food safety agency. The development of the President's
Food Safety Council contains some of the beneficial elements
of a single agency. With a strategic plan and greater inter-agency
cooperation, the federal food safety programs should become
more efficient and effective.
S.T.O.P.
is a nonprofit, grassroots organization consisting of victims
of foodborne illness, family, friends and concerned individuals
who recognize the threat pathogens pose in the U.S. food supply.
The organization was founded five years ago to prevent unnecessary
illness and loss of life from pathogenic foodborne illness.
Because S.T.O.P.'s members have been profoundly affected by
the weaknesses in the existing food safety programs, the organization
welcomes this opportunity to comment on the Food Safety Initiative's
strategic planning process and the plan.
I.
The Vision Statement
The
federal food safety system has been promoted by the government
as a consumer safety program. In his July 4, 2025 radio address
to the public the President said "I'm doing what I can
to protect our families from contaminated food." At S.T.O.P.'s
January 1998 anniversary memorial service, Secretary Glickman
told S.T.O.P. members "People look to their government
to protect them in ways that they cannot protect themselves.
That is why, as Secretary of Agriculture, there's nothing
I take more seriously than the safety of America's food."
Every
American citizen is a food consumer and a tax payer, and it
is the citizens' tax dollars that provide the funding for
the federal food safety system. The overarching goal and top
priority of the federal food safety system should be protection
of public health. A food safety system which operates on consumer
tax dollars and is promoted as operating for the consumer's
benefit should primarily address the consumer's concerns.
Since consumers pay for the system and the system has been
created primarily to protect consumers, the system's agenda
should be consumer driven. In section V of these comments,
S.T.O.P. recommends several steps the Council can take to
facilitate greater consumer participation in the food safety
strategic planning process.
conflicts
of interest
S.T.O.P.
is deeply concerned that the nation's food safety policies
are significantly weakened by food marketing and other issues
that are irrelevant to food safety. The Institute of Medicine
National Research Council report recognized conflicts of interests
as a problem within the current food safety system, "The
fact that some agencies have dual responsibilities (regulation
of the quality of food products while marketing them via promotional
activities) makes their actions more vulnerable to criticism
regarding possible conflicts of interest and may bias their
approach to food safety. (emphasis added)" A couple
of examples to demonstrate how marketing concerns have weakened
food safety policy follow:
- The
government has allowed recalling entities to approve press
releases informing the public about recalls.(1) During the
highly publicized Hudson Foods ground beef recall, the press
who knew about it took particular interest in the fact that
the agency had a practice of allowing the recalling establishment
to review agency press releases. An August 21, 2025 Wall
Street Journal article began with this statement, "Last
week, when the Agriculture Department announced what was
to become the largest beef recall ever, who was it that
cleared the press release? The answer: Hudson Foods Inc.,
the company responsible for producing the bacterial-tainted
ground beef that health officials have linked to an outbreak
of 16 food-poisoning cases in Colorado." Around the
time that this article was published, the Secretary of Agriculture
issued a memorandum to all sub cabinet officials and agency
administrators informing them the industry would no longer
be allowed to review agency press releases.(2) A year after
the Secretary changed the recall notification policy, the
FSIS working group on recalls recommended that USDA cede
responsibility for notifying the public of recalls to the
recalling entities. The working group noted in its recommendation
that FDA follows a policy where the recalling company writes
its own press release and is responsible for distributing
it to local press. Clearly the effectiveness of recall notification
has been tempered by food marketing concerns.(3)
- Although
the government's own consumer focus group research demonstrated
that consumers are more likely to adopt good food handling
practices when the risks, hazards, and prevalence of foodborne
pathogens is communicated, the government has continued
to promulgate consumer education messages that downplay
foodborne illness risks, hazards, and prevalence.(4)
Therefore
S.T.O.P. strongly urges that any reference to food marketing,
promotion, hunger, nutrition, or food affordability be removed
from the food safety council vision statement. The goal of
the council needs to remain clear and narrow to prevent conflicts
of interest that lead to weak, ineffective safety policies.
The purpose of the council creation was to address foodborne
illness. The Council's only goal should be preventing foodborne
illness and death.
roles
and responsibilities
S.T.O.P.
is also concerned about the last sentence in the vision statement:
food is safe because everyone understands and accepts their
responsibilities. The intent of this statement is unclear.
Our concern is raised by the traditional efforts of the government
and industry to shift responsibilities and blame for accidents
on other segments of the food safety continuum.
For
example, an incorrect extrapolation of CDC data has been widely
cited by the industry to blame consumers for over 90% of foodborne
illnesses. Although the CDC has circulated a memo explaining
that this figure is incorrect, the mythological statistic
is repeated to this day.(5) Instead of using surveillance
data to urge its members to be more vigilant in preventing
contamination, the National Meat Association has highlighted
incidents of E. coli O157:H7 in foods other than beef. The
association recently developed statistics to downplay the
well documented prevalence of the organism in ground beef.(6)
Presentations made before the Council at public meetings demonstrate
this very point. Many food industry representatives invested
a significant amount of time arguing about the validity of
the surveillance numbers instead of describing the actions
they will take to reduce food contamination.
In
an ideal world everyone would know what their responsibilities
are and assume them. But as policy makers should know all
too well, we do not live in an ideal world. Food safety laws
were created to address practices in food plants that compromised
public health. The meat inspection laws were created in response
to publication of The Jungle, an expose about the filthy
Chicago meat packing industry. Revision of antiquated meat
and poultry regulations didn't occur until a major outbreak
of E. coli O157:H7 significantly raised awareness about food
safety.
The
role of the government is ensuring that responsibilities for
public health and safety are assumed and carried out by the
food industry. Promotion of voluntary public health and safety
measures should not reduce or replace vigorous enforcement
of food safety laws and regulations. Consumers have little
access to food growing and processing areas. Taxpayers expect
the government to monitor on their behalf these often inaccessible
steps of the food chain. Secretary Glickman recognized this
in his remarks at the S.T.O.P. memorial service, "People
look to their government to protect them in ways that they
cannot protect themselves."
As
stated earlier, conflicts of interest mitigate food safety
policies. The public doesn't trust the industry to regulate
itself. The government has historically recognized that those
with an interest that may conflict with the laws adopted for
the public's good should be regulated to ensure that the public
is served and that commercial practices are conducted legally.
Consumers expect to have food safety laws enforced and they
expect a neutral, third party to be responsible for enforcing
these laws. Participants in a 1998 USDA sponsored focus group
said they trust government inspection to prevent contamination
of products before they reach the marketplace.(7)
Consumers
also expect to have a minimum standard of food safety enforced
consistently across the United States. Consumer attitudes
research conducted by Celinda Lake for Citizens for Sensible
Safeguards revealed that consumers expect to have the same
level of food safety wherever they are within the U.S. They
expect a cheeseburger purchased in Texas to be as safe as
one purchased in Maine.
Unfortunately,
there isn't a single food safety law enforced consistently
across the country. And state meat inspection programs have
demonstrated how local concerns can mitigate enforcement of
national food safety laws and place consumers at risk. In
an October 1998 Topeka Capital-Journal article, the Kansas
Secretary of Agriculture noted that the state inspectors had
difficulty enforcing federal laws in local plants "In
many situations, the inspectors live in the same community
as the people they regulated. They inspect people. They inspect
people's livelihood. These are tough decisions."(8) The
chair woman of the Kansas House Agriculture Committee explained
to the Topeka Capital-Journal that the state should retain
the costly state inspection program because it gives Kansas
the "home team" advantage.(9) The head of the Florida
state meat inspection program had a similar attitude, "We're
patient with small businesses...I would venture to say that
50% to 60% of these [processors] would go out of business
under federal inspection."(10)
The
Government should honestly convey to the public what it does
and does not do with regard to food safety. For instance,
if risk assessments and cost benefit analysis are going to
be used to determine the level of government oversight and
enforcement of food safety laws, the public should be told
what conditions are triggering oversight and enforcement.
In addition, the public should know what level of foodborne
illness and death the government is willing to ignore before
addressing weaknesses in the food safety laws and regulations.
accountability
Consumers
expect the government to provide a prevention based food safety
system that is verified to be effective. Just as publicly
traded companies must be held accountable to their stockholders,
the government should be held accountable to the public that
funds the its activities. S.T.O.P. encourages the President's
Food Safety Council to facilitate the creation of regular
evaluation reports that document food safety enforcement actions
and policy changes. These reports should be issued in conjunction
with national foodborne illness epidemiological data and assessments
of emerging foodborne pathogens. The USDA's Food Safety and
Inspection Service Quarterly Regulatory and Enforcement Reports
provide a good example of the type of evaluation document
that should be issued.
II.
Barriers and Gaps Impeding Food Safety Policies
S.T.O.P.
recognizes many of the food safety gaps the NAS committee
highlighted in its report. We agree that food safety efforts
are not adequately funded, that food safety laws should be
harmonized so that similar risks are addressed consistently
and effectively, that current surveillance efforts are not
sufficient, that additional food safety research is needed,
and that current consumer education efforts fail to change
behavior.
conflicts
of interest
As
previously noted, the vision statement itself includes a barrier
to improved execution and coordination of food safety policies:
marketing and promotion concerns verses public health concerns.
The NAS report also recognized the conflict of interest barrier
to more effective food safety policy.(11) The vision must
be confined to food safety issues in order be effective.
If
agricultural marketing and promotion issues remain as components
of the Council's purview, they will dilute the Council's food
safety work. To illustrate how food marketing concerns led
to reduced public health protection and to loss of consumer
confidence one can review the British BSE crisis. The United
Kingdom's Chief Medical Officer recently testified that his
statement regarding the safety of eating beef was altered
by the Ministry of Agriculture to downplay legitimate concerns
about product safety. Marketing concerns over-ruled public
health concerns.(12) When consumption of beef was linked to
CJDnv in the UK, public confidence in the government and the
industry plummeted. Demand for British beef diminished by
36%.(13)
fragmented
federal food safety program
The
current food safety system is fragmented across USDA, HHS,
EPA and DOC. At least six federal agencies have responsibility
for food safety: FDA, CDC, FSIS, ARS, CSREES, and EPA. In
addition, there are over 50 state and local public health
departments that monitor foodborne illnesses under diverse
regulations and laws. State and local public health departments
are also enforcing retail food safety under various statutes
and regulation. S.T.O.P. agrees with the NAS committee assessment
that "inconsistent, uneven and at times archaic food
statutes that inhibit use of science-based decision making
in activities related to food safety..." and that lack
of integration among federal agencies and among the federal
and state agencies is inhibiting the implementation and enforcement
of good food safety policies. (14)
There
are certain segments of the food safety chain that have been
virtually ignored, particularly the farm, the ranch, and product
in transit. Produce growing and processing, which is under
the jurisdiction of FDA, has not received adequate government
oversight. FDA conducts no inspections on farms except in
response to a foodborne illness. FDA and FSIS are still trying
to determine which agency is responsible for inspecting food
in transit. And although treatment and disposal of human sludge
is closely monitored by EPA and animal manure is frequently
a vehicle for pathogen contamination of produce, there are
no federal rules or regulations preventing the direct application
of pathogen harboring manure on human food crops. The present
food safety system does not extend from farm to table, it
ignores some of the most obvious contamination entry points
of the food chain.
inconsistent
enforcement and varying enforcement philosophies
Current
federal agency food statutes do not allow the consistent enforcement
of food safety policies. Different policies are applied by
varying agencies to foods posing similar risks. For example,
FSIS has a proactive inspection program to address meat and
poultry adulteration. All meat and poultry carcasses must
be inspected and approved by a federal inspector before entering
the market place. FDA has a passive inspection program. Seafood
establishments, which handle food with risks similar to those
of meat and poultry, are subject to approximately one inspection
per year. FSIS inspectors are in every meat and poultry plant
in the U.S. every day. FDA made a goal of inspecting all seafood
establishments in one year.(15)
Similar
food safety regulations for products that pose similar risks
are enforced in an inconsistent manner. For example, FDA and
FSIS have developed HACCP-based inspection for meat, poultry
and seafood. The FSIS HACCP regulation includes pathogen performance
standards, but the FDA HACCP regulation does not. FDA's regulatory
philosophy is dramatically different from that of FSIS. FDA
officials told the industry that the first seafood HACCP inspection
is conducted with the purpose of educating the industry while
FSIS's first year of large meat and poultry plant HACCP inspections
were conducted with the purpose of enforcing the law.
The
effectiveness of these enforcement philosophies is obvious.
FDA's goal was a 50% failure rate, but by mid-May 1998 the
failure rate was 70%.(16) USDA, on the other hand, took a
firm stance on HACCP compliance. Secretary Glickman made it
clear that the new inspection program at USDA would be fully
enforced from day one "Our new meat and poultry inspection
system will begin to take effect next week....And I want to
make one thing perfectly clear -- we will be watching. If
you're out there producing dirty product -- what we would
call a repeat violator,' from now on -- don't expect a thousand
chances to get it right."(17) USDA's strong stance was
evident in compliance results. In the first three quarters
of USDA HACCP implementation in large plants, the compliance
rate was 92%.(18)
inconsistent
state and local laws, regulations, and enforcement
Inconsistent
state food safety programs also impede the formation of a
seamless, national food safety program. Some states have adopted
laws or maintained policies that counter food safety efforts.
For example, agricultural disparagement laws are cited by
some public health department officials as a barrier to releasing
foodborne illness or outbreak information. The FSIS working
group on recall report reveals that in three out of five E.
coli O157:H7 retail contamination and recall incidents, state
agencies chose not to notify the public of the contamination
or recall.(19)
Another
state food law that counters food safety is the permissive
sale of dangerous food products. Most states have banned the
sale of raw milk, which has been repeatedly linked to E. coli
O157:H7 illnesses; but a few continue to allow the sale of
this very risky and hazardous product.
Retail
food safety is a very important link in the food chain --
often the last link before food is consumed.(20) Yet retail
food inspection is governed by state and local entities that
enforce a patchwork of different food safety statutes and
regulations. FDA's model inspection Food Code has been cherry
picked to reflect the agribusiness biases within each state
or locality. S.T.O.P. doubts it will ever be universally and
wholly adopted and enforced without stronger federal incentives
for states and localities to do so.
State
meat and poultry inspection enforcement demonstrates the very
regulatory attitudes which cause consumer concern about local
enforcement. Although state regulators are supposed to enforce
federal standards, this is often not the case. There is a
bias at the state and local level to not impede local businesses.
This attitude leads to lenient inspection and enforcement
of regulations. A quote from the executive director of the
Kansas Meat Processors Association regarding Kansas state
inspection demonstrates this point: "Things the state
has not checked us on in 30 years, the federal does. ...It's
like living in two different worlds."(21) The Wall Street
Journal documented this disparity in a story about Florida's
meat inspection program.(22) Even some in the food industry
have recognized the difference. During a discussion of USDA's
National Advisory Committee for Meat and Poultry Inspection,
David Theno of Foodmaker remarked, "My experience in
reviewing some of these state facilities, and I've looked
at them before in terms of local supply and things, is that
there is some disparity...I've seen disparity in what I would
call a federal plan and a state plan."(23)
inconsistent
foodborne illness surveillance and response
Surveillance
of foodborne illnesses is uneven. FoodNet cites make a horse
shoe around the upper rim of the nation: California (part
of state), Oregon, Minnesota, New York (part of state), Connecticut,
Maryland (part of state), and Georgia (part of state). FoodNet
has no to very little data on illnesses in the Southwest and
Midwest sections of the U.S.
Surveillance
of foodborne illness is mostly dependent upon a passive, inconsistent
volunteer reporting system. The patchwork of state foodborne
illness reporting policies degrade the quality of national
statistical data. All states are not reporting the same diseases
to CDC. While some states monitor E. coli O157:H7 illness,
some do not. At this time, Pennsylvania, Wisconsin, Virginia
and Hawaii are not E. coli O157:H7 reporting states.(24)
The
statistics gathered are based on voluntary compliance to reporting
laws. Although it is frequently acknowledged that physicians
often do not report illnesses to public health agencies, we
are unaware of any adoption of incentive or disincentive programs
to facilitate reporting. S.T.O.P. is concerned that the government
is fostering more dependence on risk assessment while continuing
to ignore the barriers to collecting more reliable data.
Public
health department policies and capacities vary state by state.
Some states count individual illness cases while others only
count illnesses associated with outbreaks. Some states have
the capacity to conduct PFGE or DNA finger printing of foodborne
pathogens while others do not. At this time only 14 states
and New York City are participating in PulseNet. Some states
reserve PFGE testing for cases arising from particular circumstances.
Many S.T.O.P. victim members expressed anger when they learned
that their state was part of PulseNet, but the public health
department did not employ this technology during the investigation
of their illness.
Responses
to foodborne illnesses vary in accordance with local and state
laws. S.T.O.P. frequently hears victim complaints about local
public health department handling of illness cases. Most often,
victims complain that state health departments did not aggressively
pursue the source of contamination. Frequently, state health
departments do not investigate individual cases of illness.
They reserve their resources for outbreaks. Even in cases
where the source was investigated and the food vehicle identified,
victims were shocked to learn that no measures were taken
to alert the public to the problem so that others would be
informed of the risk and seek necessary medical attention.
In many cases the responsible party was not penalized in any
way for causing harm to the public.
Those
who have suffered from contamination often are not treated
like customers by state and local public health departments.
Frequently, they are told very little about the foodborne
illness investigation, if there even is an investigation.
Sometimes the cause of illness or death is not disclosed to
the victim or the victim's family. S.T.O.P. has at least two
members from unrelated illness incidents who learned the cause
of their childrens' deaths by listening to news broadcasts
on the radio.
Victims
have little recourse when health departments do not respond
appropriately to their cases. There is no higher body to which
they may appeal that will re-evaluate the situation in time
to conduct a meaningful investigation. It is a widely held
belief that the CDC is the nation's public health department
and that they have jurisdiction over state health departments.
Most S.T.O.P. victims learned the hard way that CDC may only
investigate illness incidents when state agencies invite their
participation.
Some
states alert the public of food recalls by issuing press releases
that include the brand name of the contaminated food and its
source. As mentioned in the preceding section, other states
choose not to release retail recall information to the public.
The first child to die in the 1993 Jack in the Box outbreak
resided in the same county as the restaurant chain's parent
company. The family was not informed of the actual cause of
death, no effort was made to alert the public to potential
additional cases, and no effort was made to investigate whether
the contaminated product was distributed to other retailers.
Several weeks later, at least three more children died, at
least 195 people (mostly children) were hospitalized with
HUS, and over 700 people suffered illness from tainted Jack
in the Box burgers sold in four states.(25)
inconsistent
and inaccurate consumer education information
The
NAS report noted that consumer education "often fails
to influence behavior."(26) S.T.O.P. asserts that most
industry and government consumer food safety education has
been conducted in an ineffective manner. Although the government's
own consumer research has indicated that consumers will adopt
food safety precautions in response to illness reports, the
government and industry have repeatedly disseminated messages
that downplay food risks, food hazards and pathogen prevalence.
S.T.O.P. suspects the reluctance to include honest communication
of foodborne illness risks, hazards and prevalence stems from
the conflict of food marketing and food safety roles within
the federal government.
The
government's own pathogen baseline tests indicate that Salmonella
and Campylobacter are rampant in the food supply. USDA's ground
chicken survey detected Salmonella in 44.6% and Campylobacter
in 59.8% of the samples taken. (27) USDA's ground turkey survey
found Salmonella in 49.9% and Campylobacter in 25.4% of the
samples taken.(28) This information was gleaned through research
funded by taxpayer dollars to further their interest. At the
very least, this information should be used in consumer education
campaigns to convince consumers that they should handle food
properly every time they cook or eat. It is in the public's
best interest to know the prevalence of pathogens in the food
supply. S.T.O.P. believes consumers would be more likely to
use good handling practices if they understood that approximately
half of the ground poultry products they purchase are contaminated
with organisms that cause foodborne illness.
At
this time, FSIS presents information about E. coli O157:H7
by stating: "E. coli O157:H7 is a potentially deadly
pathogen that can cause bloody diarrhea and dehydration. The
very young, the elderly, and persons with compromised immune
systems are the most susceptible to foodborne illness. E.
coli O157:H7 bacteria have been implicated in several recent
outbreaks of foodborne illness across the United States."
S.T.O.P. E. coli O157:H7 victims have experienced liver failure,
heart attacks, seizures, blindness, paralysis, brain damage,
kidney failure, and death. Approximately one out of five E.
coli O157:H7 victims requires hospitalization. The government's
information downplays the negative outcome of E. coli O157:H7
by emphasizing bloody diarrhea and dehydration and noting
that E. coli O157:H7 is "potentially deadly." The
serious ramifications of E. coli O157:H7 are limited to a
couple of adverbs in this statement. More Americans would
be motivated to implement recommended food safety precautions
if they understood that one out of five E. coli O157:H7 victims
require hospitalization and that some victims suffer severe
and permanent health consequences.
The
government's message doesn't explain to the public that individuals
susceptible to illness include pregnant women, people using
antibiotics, alcoholics, and people using antacids. In emphasizing
susceptible populations, however, the government shouldn't
imply that healthy adults can't contract severe cases of E.
coli O157:H7 illness and die. Although E. coli O157:H7 and
other foodborne illnesses most often strike children, S.T.O.P.
is composed of numerous adult E. coli O157:H7, Listeria, Campylobacter,
and Salmonella victims.
At
the very least, education messages conveyed to consumers should
be accurate. We are disappointed that advice to cook hamburgers
until "no longer pink" (i.e. brown) is still distributed
to consumers. The government's own studies have proven that
a significant portion of ground beef prematurely browns when
cooked at low temperatures.(29) Approximately one out of every
ten hamburgers cooked in the U.S. will turn brown before reaching
160 degrees F. The only advice consumers should receive regarding
cooking ground beef is: cook it until it reaches 160 degrees
F.
focus
efforts on the pathogens
In
order for the government to address food safety, it must shift
its focus to microorganisms that cause human illness and it
must have a means of comparing the effectiveness of one pathogen
control system to another. The government should be doing
more to detect pathogens in food. FSIS meat and poultry HACCP
should incorporate Campylobacter performance standards as
soon as possible. FDA Seafood HACCP should incorporate pathogen
testing. FDA's juice program should include a random sampling
program for E. coli O157:H7 similar to the FSIS E. coli O157:H7
random sampling plan for ground beef. Pathogen testing verifies
that food safety systems are working and facilitates voluntary
industry testing. The FSIS random sampling program for beef
significantly increased E. coli O157:H7 positives from a high
of four positives in one year to 14 positives in FY98 when
it shifted its focus to plants that are not actively testing
for this pathogen.
More
reliable and rapid pathogen tests need to be developed. Quantitative
tests for food pathogens need to be developed to move towards
an infectious dose based performance standard. Rapid tests
are needed to achieve results before product is released into
the market place.
Good
decisions are made upon good information. Speed and accuracy
are key to epidemiological investigations and recalls. The
improvement of test accuracy and sensitivity will lead to
quicker and more confident decision making in cases that indicate
a potential public health threat.
Microbial
baselines should be established for risky foods. Baselines
provide objective and meaningful information with which food
safety systems can be evaluated. Each segment of the food
safety chain and each oversight area needs baselines. For
example, state inspection programs should have baselines for
each state inspected product. Baselines of a particular food
should reflect pathogen loads at the producer, processing,
distribution, retail, and consumer levels. Without baselines,
it will be difficult to gauge which programs are effective
and what segments of the food safety chain require greater
attention. As baselines and quantitative tests are developed,
more pathogen performance standards should be adopted. Pathogen
standards should be set slightly below the infectious dose
for the most vulnerable population.
industry
accountability and anonymous food
No
unlabeled food should be sold within the United States. Anonymous
food interferes with effective trace back in cases of foodborne
illness and effective recall of contaminated product. Allowing
un-branded food in the market place does nothing to instill
one important government food safety objective: getting the
industry to take responsibility for food safety.
It
is widely acknowledged that foodborne illnesses are rarely
traced to their source. The sources of even the most wide
spread and publicized illnesses (Jack in the Box and Hudson
Foods) were never definitively determined. Between 1982 and
1996, 139 outbreaks linked to ground beef were reported to
CDC. For fourteen years, there were an average of approximately
10 ground beef outbreaks per year. Only one outbreak has ever
been linked to the farm or ranch.(30) Without accountability,
the food industry can easily evade responsibility for food
products served to millions of Americans.
All
food products should be labeled with a brand name, farm of
origin, and subsequent processing information. The UK has
recently adopted a nation-wide bovine tracking system, one
Colorado meat company has a bar code system that tracks food
products from the individual animal to the final product,
and FDA requires origin labels on mulluscan shellfish to identify
the harvester, date of harvest, and location of harvest.(31)
Recalls
of un-branded foods are less effective. The lack of food labeling
prevents consumers and retailers from identifying recalled
food. Recalled un-branded foods are more likely to remain
on grocery store shelves and consumer pantries, and therefore
are more likely to lead to increased injuries and fatalities.
biased
food advisory committees
Currently,
the federal government relies upon advisory committees to
elicit comments on various food safety proposals, but frequently
the committee composition is unbalanced. Although the consumer
community has nominated candidates, the influential National
Advisory Committee for Microbial Criteria for Foods has no
consumer representation. The National Advisory Committee on
Meat and Poultry Inspection has three consumer and seven industry
representatives. To obtain well rounded counsel that reflects
the input of all constituencies, membership on federal advisory
committees should be balanced.
Further,
there are no requirements for advisory committee participants
to disclose information that would demonstrate a potential
conflict of interest, such as receipt of food industry research
funding, investment holdings in agribusinesses, or receipt
of food industry consulting fees. The FDA requires researchers
who test drugs and medical devices to disclose financial ties
to the manufacturers. Major medical journals such as the New
England Journal of Medicine and schools such as the Johns
Hopkins School of Medicine have adopted conflict of interest
policies. Members of government advisory committees significantly
influence federal food safety policy. The public and the government
should know whether those officially influencing national
food safety policy are doing so with any temptation to recommend
what is in the best interest of themselves or their employer.
lack
of accountability to the public
Currently
there isn't an adequate feedback mechanism for the food safety
agencies' customers to assess the government's performance.
While companies, trade associations and unions often utilize
formal opportunities to evaluate agency performance, average
citizens rarely read the Federal Register. S.T.O.P. urges
the federal government to re-examine its processes for soliciting
comments on food safety policies from the public.
S.T.O.P.
suggests that President Food Safety Council public meetings
regarding food safety priorities be held after business hours
or on weekends. If the public meetings must be held on a weekday,
it should be a Friday. Members of the public taking time from
work to participate would be more likely to fly to a meeting
on a Friday to get a cheaper Saturday stay-over ticket. The
meetings should be set well in advance, perhaps with an identified
day and month each year, such as the first Friday in March.
As
mentioned in a preceding section of this document, S.T.O.P.
recommends that the government issue at least an annual report
presenting information about federal enforcement and regulatory
actions pertaining to food safety. This report should be released
in conjunction with latest epidemiological information on
foodborne illnesses and pathogen emergence.
government
commitment
Every
federal employee at each food safety agency must understand
and support the nation's food safety mission. The messages
and policies developed at the top need to be delivered and
enacted throughout the agencies' ranks. S.T.O.P. was very
concerned to learn that a year after the Hudson Foods outbreak
and recall, a year after the Wall Street Journal publicized
USDA's policy of allowing recalling industries the opportunity
to review press releases regarding their own recalls, and
a year after the Secretary of Agriculture sent a memo to agency
staff informing them that no industry review of further recall
press releases would take place, the FSIS' own working group
on recalls formally recommended that the recalling entities
be solely responsible for issuing press releases about the
recall. Clearly the Administration's food safety philosophy
has not been grasped deeper within the agency. S.T.O.P. suspects,
again, that the duel and opposing marketing and inspecting
responsibilities of the departments are the root of the problem.
Information
must flow down from the administration and up from the field.
Those enforcing the laws and regulations should have the opportunity
to provide feedback to the agencies. S.T.O.P. recommends that
food safety agencies, as a part of their suggested yearly
evaluation, hold a focus group with a randomly selected portion
of the field work force to discuss ways in which the agency
can improve regulations and their implementation.
lack
of food safety administrators
There
are few people who posses both public health and food science
credentials. Government research and scholarship programs
should encourage the development of experts with both of these
credentials. The lack of overlap between these two disciplines
is evident in the hamburger cooking consumer education campaign.
Public health experts have collected data correlating consumption
of hamburger based on the assumption that pink hamburgers
are uncooked and brown hamburgers are cooked. Food scientists
have demonstrated that pink hamburgers are frequently cooked
thoroughly and brown hamburgers frequently are not thoroughly
cooked. If the two disciplines were more intermingled, both
disciplines could work more effectively and efficiently.
III.
Changes Needed to Meet Vision Statement Goals
A.
Government Agencies
1.
Federal
- There
needs to be an independent, single food safety agency.
- Federal
food safety agencies should not only require conflict of
interest disclosure for advisory committee members, but
also require that the research on which government policies
are based be limited to articles published in scientific
journals with financial disclosure or conflict of interest
policies. To develop sound food safety policies, the government
should rely upon unbiased data. In order to determine whether
study results my be biased, one should rely on information
published in journals with disclosure requirements.
- A
single agency, preferably the CDC, should compile foodborne
illness and outbreak information on an ongoing bases. This
information should be shared with food safety agencies and
the public in a timely manner. Outbreak and illness information
should be broken down by pathogen and food type. This information
should be available on agency web sites and it should be
distributed to interested constituents through a "Constituent
Update" type publication. The agencies should distribute
the food type organized information to industries and industry
trade associations that produce food linked to particular
pathogens. This list should also be distributed to agency
employees.
- Consumers
expect to have consistent food safety laws and regulations
across the nation. The federal government should encourage
that state and local agencies adopt minimum, consistent
food safety requirements (such as the Food Code), remove
obstructive state and local food safety laws and regulations
(such as agricultural disparagement laws), and provide a
minimum standard of public health protection (such as PFGE
testing capacity in each state) by providing positive and
negative incentives to meet these minimum standards. For
example, the federal funds for state agriculture inspection
programs should only be granted in states that adopt the
Food Code, remove agricultural disparagement laws, require
reporting of all foodborne illnesses tracked by the CDC,
outlaw the sale of raw milk, and meet or demonstrate the
will to meet the minimum standards within the CDC public
health department core capacity document (this document
outlines the minimum standards state and local public health
departments should adopt). State agencies seeking federal
dollars should provide four items to the federal government:
an annual report on food safety enforcement (similar to
the quarterly inspection enforcement reports prepared at
USDA), copies of all consumer generated agency evaluations,
the state's microbial baseline studies for state inspected
products (should cover the same microorganisms tracked by
the federal government under their inspection of these products),
and annual foodborne illness surveillance information for
the state.
- Federal
agencies need to harmonize their work. All of the food safety
programs should address similar food risks in a consistent
manner. For example, an adulterant recognized by FDA should
be recognized as an adulterant at FSIS. FDA should have
a proactive seafood HACCP inspection program similar to
FSIS' meat and poultry HACCP inspection program. The FDA
HACCP program should include microbial testing and pathogen
performance standards as the FSIS HACCP program does.
- The
federal agencies should have jurisdiction at the farm and
distribution levels. An agency should take responsibility
for manure control and develop regulations to ensure that
only pathogen free manure is applied to food crops.
- If
the government is striving to improve its performance, it
needs to ask those it serves to evaluate their work. To
facilitate meaningful public comment, the government should
follow up with a random sample of individuals that it has
served (such as consumer hot line callers or illness victims)
and ask these consumers to evaluate the government's handling
of their cases.
- The
federal food safety agencies should require brand and origin
labeling for all consumer food products.
- FDA
food establishments should be required to register with
the government. The agency currently doesn't have a list
of all of the entities that it is responsible for inspecting.
- Federal
agencies should incorporate more microbial testing and performance
standards into their inspection programs. Microbial baseline
studies should be ongoing. Once quantitative pathogen tests
are developed, pathogen standards should be set slightly
below the infectious dose for the most vulnerable populations.
- The
federal government should ensure that its food safety education
messages are consistent and accurate. Risks, hazards and
pathogen prevalence should be presented in a forthright
manner to facilitate more widespread adoption of good handling
practices.
- The
federal government should conduct an assessment of industry
compliance with food safety laws and regulations. This assessment
should determine the average deviation from food safety
laws and regulations. The information gathered would be
useful in determining performance standards and developing
regulations.
2.
State and Local
- State
food safety enforcers should be under the jurisdiction of
public health departments rather than state departments
of agriculture. This would limit the influence of food marketing
concerns on food safety policy decisions.
- To
increase the probability that local agencies are addressing
consumer issues, state and local agencies should institute
food safety advisory committees that include balanced representation
from the industry, public health professionals, and consumers.
- States
should also require conflict of interest and financial disclosure
for food safety advisory committee members. States should
recognize research that is conducted by researchers in institutions
that have conflict of interest policies or is published
in scientific journals with conflict of interest and financial
disclosure policies.
- State
rules and regulations should be consistent with federal
food safety rules and regulations. For example, all state
meat and poultry inspectors should be enforcing FSIS HACCP
regulations in large state inspected plants. All states
should adopt the Food Code in its entirety.
- States
conducting parallel inspection programs should have food
by food baseline studies for all microorganisms monitored
by the federal government. For example, state meat and poultry
inspection agencies should collect Campylobacter baseline
information in the same manner and at the same time of year
that FSIS collects this data for meat and poultry. This
would make the state and federal data comparable and allow
for the evaluation of the performance of each system in
contrast to the other.
- State
agencies should have consumer comment feed-back loops incorporated
into their food safety work. The agencies should have regular
consumer evaluations.
- The
state and local governments should ensure that their food
safety education messages are consistent and accurate. Food
risks and hazards and pathogen prevalence should be presented
in a forthright manner.
- The
state food safety agencies should conduct a risk assessment
study on industry compliance with state food safety laws
and regulations. The study should control factors that may
affect performance, such as number of employees or seasonal
work. This assessment should determine the average deviation
from food safety laws and regulations for the business types
studied. The information gathered would be useful in developing
state based performance standards and regulations.
- The
CDC should have the authority to be involved in every illness
and outbreak investigation in which the illness victim requests
their assistance.
B.
Industry
- The
industry should share microbial and consumer complaint data
with regulating agencies.
- Industry
trade associations should share illness and outbreak data
with their members. Data should be used to educate members
about the risks in products they produce or process.
- Food
industries should be marketing food safety. Competition
based on safety will increase safety overall. In order for
market forces to work, all products should bear brand name
and origin information.
- The
industry should focus its attention on its own food safety
problems. Instead of shifting blame for foodborne illnesses
on other segments of the food safety continuum, the industry
should address the weaknesses within its own area of responsibility.
For instance, instead of arguing that consumers are responsible
for foodborne illness and embarking on consumer food safety
education efforts that downplay risks, hazards, and pathogen
prevalence, the industry should work to effectively educate
and train its own personnel and to ensure that food handling
practices are employed every time food is handled under
their care. It is not enough to educate employees about
safe handling practices, businesses must ensure that management
requires the application of safe handling practices. Trade
associations should be teaching their members HACCP, informing
members of risks associated with their food products, and
sharing the latest relevant scientific advances for pathogen
detection and control.
C.
Public Health Professionals
- Public
health officials should agree on minimum standards that
state and local public health agencies should meet to run
effective programs. This is underway through the CDC's core
capacity effort. Once core capacity standards are achieved,
public health officials should encourage their adoption
in each state.
- Public
health departments need to incorporate consumer evaluation
into their programs.
- Public
health officials need to provide the public with food safety
information that will prevent illnesses and deaths. For
example, agencies should issue press releases regarding
outbreaks and recalls likely to affect state residents.
Consumer messages should be unbiased and accurate.
- State
public health officials should provide foodborne illness
victims with all relevant information regarding their illnesses
and the investigation of their illnesses.
- State
public health agencies should quickly and aggressively pursue
the cause of every foodborne illness brought to their attention.
D.
Consumers
- Consumers
should read warning labels on foods and take necessary precautions.
- Consumers
should read and follow safe handling instructions on foods.
- Consumer
organizations should inform consumers about foodborne hazards,
risks and pathogen prevalence.
- Consumer
organizations should educate the public about steps they
may take to reduce the likelihood of contracting illness.
E.
Congress
- Congress
should grant USDA and FDA mandatory recall authority.
- Congress
should grant USDA and FDA the authority to assess civil
fines and penalties on violators of food safety laws.
- Congress
should give FDA the authority to inspect imported food in
a manner similar to USDA import inspection.
- Congress
should grant USDA and FDA the authority to regulate farming
and animal husbandry practices that are demonstrated to
influence food safety.
- Congress
should give food workers whistle blower protection.
- Congress
should provide food safety agencies with adequate funding
to meet consumer expectations of the food safety agencies.
- Congress
should prevent members with financial interests in agribusiness
from serving on agriculture-related committees.
IV.
Short-term and Long-term Goals
A.
Short-term
- Require
brand and origin labeling on all consumer food packages.
- Develop
and implement manure control regulations.
- Require
FDA regulated establishments to register with FDA. Registration
should also include a small processing fee towards maintenance
of the FDA registration database and document management.
- Federal
and state governments should embark on baseline studies
for foodborne pathogens in risky foods, such as Campylobacter
in meat and poultry.
- The
federal government should begin implementing a state food
safety funding incentive program. The obstacles to effective
food safety systems and the core elements of state food
safety programs should be determined.
- The
federal and state agencies should incorporate feed back
mechanisms in their food safety programs to elicit consumer
evaluations, particularly from foodborne illness victims.
- Federal
and state agencies should revise consumer education messages
to incorporate accurate information that facilitates adoption
of good handling practices. These messages should inform
the consumer of illness ramifications and provide information
that allows the consumer to determine the level of risk
products poses to him or her.
- Federal
and state agencies should adopt conflict of interest and
financial disclosure policies for research and advisory
committee participation.
- FoodNet
sites should be expanded to cover the Southwest and Midwest.
- Federal
and state agencies should provide foodborne illness statistics
and pathogen emergence information to industry and trade
association representatives.
- A
federal agency, preferably the CDC, should develop a foodborne
illness outbreak and illness cases list that is continually
compiled and regularly disseminated. This list should incorporate
information gathered on foodborne illnesses in each state.
- Research
rapid and quantitative pathogen tests.
- Establish
criteria for evaluating and approving consumer pathogen
interventions such as produce washes.
- Conduct
assessments of industry compliance with food safety laws
and regulations.
B.
Long-term
- Establish
a single food safety agency.
- Harmonize
food safety laws and regulations.
- Conduct
research needed to detect pathogens such as Hepatitis A
and Cyclospora in foods.
- Acquire
mandatory recall authority, farm and ranch regulatory jurisdiction
and the authority to assess civil fines and penalties.
- Develop
performance standards for additional pathogens.
- Provide
whistleblower protection for plant employees.
- Facilitate
the development of public health/food science experts.
V.
Improving Public Involvement in Development of Government
Food Safety Policy Making
There
should be more outreach to consumers in order to elicit their
participation in rule making and public meetings. S.T.O.P.
recommends that public meeting and proposed rules be distributed
to interested parties in a weekly "Constituent Update,"
such as the one prepared and distributed via fax by FSIS.
This update is more user friendly because it is short and
written in plain language. It could also be distributed to
a greater number of consumers through email. It would be best
if all food safety related government announcements
were combined in a single, weekly "Constituent Update"
type document.
To
increase public participation in meetings, they should be
held when average consumers can attend. So far President Food
Safety Council public meetings have been scheduled during
business hours, which are most convenient for full time lobbyists
and trade association representatives. We recommend that the
Council hold public meetings on weekends or after business
working hours.
Government
food safety agencies should follow up with consumers who have
filed complaints with the agencies or with illness victims
to get their feedback on the agency's handling of their concerns.
Constituent feedback is often gathered for other government
programs. For example, many state WIC departments regularly
poll their constituency to assess whether WIC benefit recipients
have suggestions for improving the system.
Public
meetings should be announced at least two months in advance
to give consumer constituents enough time to plan participation.
It would be best if meetings were held regularly and scheduled
on a fixed date. For example, the Food Safety Council could
establish a yearly public meeting for consumer input during
the first Friday of a specified month.
The
federal government could create a consumer advisory panel
to provide the consumer's perspective on issues raised by
the committee. Participation in the panel should be voluntary,
but any travel expenses related to participation should be
paid for by the government. This panel could also be used
by the various agencies with responsibility for food safety
-- HHS, USDA, and EPA -- to elicit consumer input.
The
federal government should increase consumer participation
in meetings by encouraging participation through conference
calling. For example, FSIS held a National Advisory Committee
for Meat and Poultry Inspection in which many members who
couldn't travel to the meeting participated via conference
call. Some observers also participated through conference
call. This is a good way to include the many consumer constituents
who would like to be involved in policy development, but cannot
afford to travel, cannot travel due to a medical condition,
cannot hire child care on the meeting date, or cannot take
time off from work to participate.
--------------------------------------
- There
is very good evidence to support the need for an unbiased
party to present recall information to the public. Food
industry attorney Phil Olsson noted in an April 27, 2025
Food Drug Law Institute conference on product recalls that
companies have a vested interest in distributing as few
press releases as possible. He also noted that establishments
should regard writing a recall press release as an opportunity
to put their spin on the issue. Olsson made a point of telling
attendees that FSIS no longer allowed establishments to
review the agency's recall press releases. Allison Beers,
"Recalls Present Tough Decisions for Food Companies,"
Food Chemical News, May 4, 1998, page 19.
- Allison
Beers, "Recalls Present Tough Decisions for Food Companies,"
Food Chemical News, May 4, 1998, page 19.
- For
example, a June 29, 2025 Costco press release about a recall
of E. coli O157:H7 contaminated meat reads as if it were
crafted to specifically contradict the agency's findings
justifying the recall: "Costco has an extensive testing
program to help minimize any possible risk from E. coli
0157:H7 in beef sold at our warehouse stores. Our internal
tests and those of independent certified laboratories detected
no contamination in this meat..." USDA tested Costco
beef taken from the same batch eaten by an illness victim
and found traces of E. coli 0157:H7. A woman was hospitalized
after consuming contaminated Costco beef. One who read the
Costco press release would be unlikely to conclude that
eating the product could lead to hospitalization. Under
the "consumer remedy" section of the press release
Costco stated, "Consumers can ensure the safety of
ground beef by cooking it to an internal temperature of
160 degrees Fahrenheit." There was no mention of the
fact that handling the raw product could lead to illness
or death.
- "Most
participants agreed that media messages reporting serious
illness might convince them that thermometer use is necessary."
(p. 18) "One theme that ran through most groups was
the fear of contracting a serious disease from eating undercooked
meat or poultry. Informing the public through public awareness
campaigns that describe and explain outbreaks of foodborne
illness was thought to be a powerful motivator for behavior
change." Patrick Koeppl, "Final Report: Focus
Groups on Barriers that Limit Consumers' Use of Thermometers
when Cooking Meat and Poultry Products," January 1998,
pages 4, 23, 18, 42, and 44.
- "Recently,
a statement was made, purportedly quoting CDC data, that
'the food processing industry is involved in less than 10%
of reported foodborne disease outbreaks of known origin...'
The statement is a gross misinterpretation of data in a
paper by Bean and Griffin in the Journal of Food Protection
in 1990." Memorandum to the record from the Acting
Chief, Foodborne and Diarrheal Diseases Branch, Division
of Bacterial and Mycotic Diseases, NICD, July 21, 1995.
- National
Meat Association "USDA Reports on Foodborne Illness,"
Lean Trimmings, March 17, 1997. National Meat Association,
"Assessing e. coli O157:H7 in Ground Beef," Herd
on the Hill, November 2, 1998. National Meat Association
"E. coli O157:H7 -- the Odds," Lean Trimmings,
November 30, 1998.
- Patrick
Koeppl, "Final Report: Focus Groups on Barriers that
Limit Consumers' Use of Thermometers when Cooking Meat and
Poultry Products," January 1998, pages 14, 26, and
42.
- Christie
Applehanz, "Ag Boss Trying to Rescue State's Meat Program,'"
Topeka Capital-Journal, September 20, 2025
- Christie
Applehanz, "State Hopes Meat Program Gets a 'Well Done,'"
Topeka Capital-Journal, October 4, 1998.
- Pat
Beall, "Consumer Groups Decry State Meat Inspection,"
Wall Street Journal (Florida Journal), July 17, 1996.
- Committee
to Ensure Safe Food from Production to Consumption, "Ensuring
Safe Food: From Production to Consumption," Institute
of Medicine National Research Council, National Academy
Press, Washington, DC 1998, page 8.
- "Former
CMO 'Did Not Approve Safe Beef Message," PA News,
October 30, 1998.
- Peter
Cunliffe, "BSE Crisis 'Cost Nearly #1B in First Year,"
PA News, March 13, 1998.
- Committee
to Ensure Safe Food from Production to Consumption, "Ensuring
Safe Food: From Production to Consumption," Institute
of Medicine National Research Council, National Academy
Press, Washington, DC 1998, page 9.
- Adrienne
Dern, "Food Safety Initiative Programs Targeted for
Launching in 1999, Food Chemical News, June 15, 1998,
page 7.
- Natalie
Pargas, "FDA's Kraemer Identifies Four Major Research
Areas for Seafood HACCP Implementation," Food Chemical
News, July 13, 1998, page 8.
- Secretary
Dan Glickman, remarks at the 5th Anniversary of the Pacific
Northwest Outbreak, Chicago, IL, Release No. 0022.98, January
18, 1998.
- USDA,
"Food Safety and Inspection Service Quarterly Regulatory
and Enforcement Report," July 1, 2025 to September
30, 1998, page 1.
- USDA,
FSIS, "Improving Recalls at the Food Safety and Inspection
Service: Report of the Recall Policy Working Group,"
1998, page 40.
- According
the ERS, 56% of Americans eat away from home each day. L.
Borrud, C. Wilkinson Enns, and S. Mickle, "What we
Eat in America: USDA Surveys Food Consumption Changes,"
Food Review, September-December 1996, page 18
- Christie
Applehanz, "State Hopes Meat Program Gets a 'Well Done,'"
Topeka Capital-Journal, October 4, 1998.
- Pat
Beall, "Consumer Groups Decry State Meat Inspection,"
Wall Street Journal (Florida Journal), July 17, 1996.
- USDA
transcript of the National Advisory Committee for Meat and
Poultry Inspection, Docket No. 97-044N, Washington, DC,
September 10, 1997, page 196.
- Table
II Provisional cases of selected notifiable diseases, United
States weeks ending November 7, 1998, and November 1, 2025
(44th Week)," MMWR, November 13, 1998.
- Jean
Buzby et. al, "Bacterial Foodborne Disease: Medical
Costs & Productivity Losses," ERS, Report No. 741,
August 1996, page 29.
- Committee
to Ensure Safe Food from Production to Consumption, "Ensuring
Safe Food: From Production to Consumption," Institute
of Medicine National Research Council, National Academy
Press, Washington, DC 1998, page 9.
- USDA,
FSIS, "Nationwide Raw Ground Chicken Microbiological
Survey," May 1996.
- USDA,
FSIS, "Nationwide Raw Ground Turkey Microbiological
Survey," May 1996.
- D.
Soderberg and M. Hoffman, "An FSIS/ARS Study: Premature
Browning of Cooked Ground Beef," August 10, 1998.
- Gregory
L. Armstrong, Jill Hollingsworth, and J. Glenn Morris, "Emerging
Foodborne Pathogens: Escherichia coli O157:H7 as a Model
of Entry of a New Pathogen into the Food Supply of the Developed
World," Epidemiologic Reviews, Vol. 18, No.
1, 1996, page 37.
- FDA,
"1997 Food Code," sections 3-202.17, 3-202.18,
and 3-602.11.
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