Mad Cow Disease
FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness Gao ID: GAO-05-101 February 25, 2005More than 5 million cattle across Europe have been killed to stop the spread of bovine spongiform encephalopathy (BSE), commonly called mad cow disease. Found in 26 countries, including Canada and the United States, BSE is believed to spread through animal feed that contains protein from BSE-infected animals. Consuming meat from infected cattle has also been linked to the deaths of about 150 people worldwide. In 1997, the Food and Drug Administration (FDA) issued a feed-ban rule prohibiting certain animal protein (prohibited material) in feed for cattle and other ruminant animals. FDA and 38 states inspect firms in the feed industry to enforce this critical firewall against BSE. In 2002, GAO reported a number of weaknesses in FDA's enforcement of the feed ban and recommended corrective actions. This report looks at FDA's efforts since 2002 to ensure industry compliance with the feed ban and protect U.S. cattle.
FDA has made needed improvements to its management and oversight of the feed-ban rule in response to GAO's 2002 report, but program weaknesses continue to limit the effectiveness of the ban and place U.S. cattle at risk of spreading BSE. Improvements made include FDA establishing a uniform method of conducting compliance inspections and training FDA inspectors, as well as state inspectors who carry out inspections under agreements with FDA, on the new method. FDA also implemented new data-entry procedures that are designed to more reliably track feed-ban inspection results. Consequently, FDA has a better management tool for overseeing compliance with the feed-ban rule and a data system that better conforms to standard database management practices. However, various program weaknesses continue to undermine the nation's firewall against BSE. FDA acknowledges that there are more feed manufacturers and transporters, on-farm mixers, and other feed industry businesses that are subject to the feed ban than the approximately 14,800 firms inspected to date; however, it has no uniform approach for identifying additional firms. FDA has not reinspected approximately 2,800, or about 19 percent, of those businesses, in 5 or more years; several hundred are potentially high risk. FDA does not know whether those businesses now use prohibited material in their feed. FDA's feed-ban inspection guidance does not include instructions to routinely sample cattle feed to test for potentially prohibited material as part of the compliance inspection. Instead, it includes guidance for inspectors to visually examine facilities and equipment and review invoices and other documents. Feed intended for export is not required to carry a caution label "Do not feed to cattle or other ruminants," when the label would be required if the feed were sold domestically. Without that statement, feed containing prohibited material could be inadvertently or intentionally diverted back to U.S. cattle or given to foreign cattle. FDA has not always alerted USDA and states when it learned that cattle may have been given feed that contained prohibited material. This lapse has been occurring even though FDA's guidance calls for such communication. Although research suggests that cattle can get BSE from ingesting even a small amount of infected material, inspectors do not routinely inspect or review cleanout procedures for vehicles used to haul cattle feed.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-05-101, Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
This is the accessible text file for GAO report number GAO-05-101
entitled 'Mad Cow Disease: FDA's Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program
Effectiveness' which was released on March 15, 2005.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as part
of a longer term project to improve GAO products' accessibility. Every
attempt has been made to maintain the structural and data integrity of
the original printed product. Accessibility features, such as text
descriptions of tables, consecutively numbered footnotes placed at the
end of the file, and the text of agency comment letters, are provided
but may not exactly duplicate the presentation or format of the printed
version. The portable document format (PDF) file is an exact electronic
replica of the printed version. We welcome your feedback. Please E-mail
your comments regarding the contents or accessibility features of this
document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
Report to Congressional Requesters:
February 2005:
Mad Cow Disease:
FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-101]:
GAO Highlights:
Highlights of GAO-05-101, a report to congressional requesters:
Why GAO Did This Study:
More than 5 million cattle across Europe have been killed to stop the
spread of bovine spongiform encephalopathy (BSE), commonly called mad
cow disease. Found in 26 countries, including Canada and the United
States, BSE is believed to spread through animal feed that contains
protein from BSE-infected animals. Consuming meat from infected cattle
has also been linked to the deaths of about 150 people worldwide. In
1997, the Food and Drug Administration (FDA) issued a feed-ban rule
prohibiting certain animal protein (prohibited material) in feed for
cattle and other ruminant animals. FDA and 38 states inspect firms in
the feed industry to enforce this critical firewall against BSE. In
2002, GAO reported a number of weaknesses in FDA‘s enforcement of the
feed ban and recommended corrective actions. This report looks at FDA‘s
efforts since 2002 to ensure industry compliance with the feed ban and
protect U.S. cattle.
What GAO Found:
FDA has made needed improvements to its management and oversight of the
feed-ban rule in response to GAO‘s 2002 report, but program weaknesses
continue to limit the effectiveness of the ban and place U.S. cattle at
risk of spreading BSE. Improvements made include FDA establishing a
uniform method of conducting compliance inspections and training FDA
inspectors, as well as state inspectors who carry out inspections under
agreements with FDA, on the new method. FDA also implemented new data-
entry procedures that are designed to more reliably track feed-ban
inspection results. Consequently, FDA has a better management tool for
overseeing compliance with the feed-ban rule and a data system that
better conforms to standard database management practices. However,
various program weaknesses continue to undermine the nation‘s firewall
against BSE. For example:
* FDA acknowledges that there are more feed manufacturers and
transporters, on-farm mixers, and other feed industry businesses that
are subject to the feed ban than the approximately 14,800 firms
inspected to date; however, it has no uniform approach for identifying
additional firms.
* FDA has not reinspected approximately 2,800, or about 19 percent, of
those businesses, in 5 or more years; several hundred are potentially
high risk. FDA does not know whether those businesses now use
prohibited material in their feed.
* FDA‘s feed-ban inspection guidance does not include instructions to
routinely sample cattle feed to test for potentially prohibited
material as part of the compliance inspection. Instead, it includes
guidance for inspectors to visually examine facilities and equipment
and review invoices and other documents.
* Feed intended for export is not required to carry a caution label ’Do
not feed to cattle or other ruminants,“ when the label would be
required if the feed were sold domestically. Without that statement,
feed containing prohibited material could be inadvertently or
intentionally diverted back to U.S. cattle or given to foreign cattle.
* FDA has not always alerted USDA and states when it learned that
cattle may have been given feed that contained prohibited material.
This lapse has been occurring even though FDA‘s guidance calls for such
communication.
Although research suggests that cattle can get BSE from ingesting even
a small amount of infected material, inspectors do not routinely
inspect or review cleanout procedures for vehicles used to haul cattle
feed.
What GAO Recommends:
GAO recommends FDA, among other things, develop procedures for finding
additional firms subject to the feed-ban and using tests to augment
inspections. FDA said the study was thorough but disagreed on four of
nine recommendations. GAO continues to believe that, given the
discovery of BSE in North America and the oversight gaps described in
the report, the recommended actions are needed to protect U.S. cattle
from BSE.
www.gao.gov/cgi-bin/getrpt?GAO-05-101.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Robert A. Robinson at
(202) 512-3841 or robinsonr@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
FDA Has Taken Important Steps to Improve Implementation of the Feed
Ban:
Program Weaknesses Continue to Limit the Effectiveness of FDA's Animal
Feed Ban:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendixes:
Appendix I: Scope and Methodology:
Appendix II: GAO's Analysis of the Status of Actions on Recommendations
to FDA in Our January 2002 Report:
Appendix III: GAO's Summary of FDA's and USDA's Actions in Response to
the Two Cases of BSE Discovered in North America in 2003:
Appendix IV: Survey of State Agencies:
Appendix V: Chronology of FDA's Feed Ban and Proposed Rulemakings:
Appendix VI: Comments from the Food and Drug Administration:
GAO Comments:
Appendix VII: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Staff Acknowledgments:
Tables:
Table 1: Number of Firms Inspected by FDA and States for Compliance
with the Feed-Ban Rule, by Firm Type, Fiscal Year 2004:
Table 2: Number of Firms FDA Has Identified that Are Subject to the
Feed Ban, by Firm Type, as of the End of Fiscal Year 2004:
Abbreviations:
APHIS: Animal and Plant Health Inspection:
BSE: bovine spongiform encephalopathy:
DNA: deoxyribonucleic acid:
FACTS: Field Accomplishments and Compliance Tracking System:
FDA: Food and Drug Administration:
FSIS: Food Safety and Inspection Service:
PCR: polymerase chain reaction:
TSE: transmissible spongiform encephalopathy:
USDA: United States Department of Agriculture:
vCJD: variant Creutzfeldt-Jacob disease:
Letter February 25, 2005:
The Honorable Saxby Chambliss:
Chairman:
The Honorable Tom Harkin:
Ranking Member:
Committee on Agriculture, Nutrition, and Forestry:
United States Senate:
The Honorable Thad Cochran:
The Honorable Richard J. Durbin:
United States Senate:
Bovine spongiform encephalopathy (BSE), commonly known as mad cow
disease, is an always fatal neurodegenerative animal disease that has
been found in cattle in 26 countries since it was first identified in
the United Kingdom in 1986. In December 2003, the United States
discovered its first case of BSE in a cow in Washington State. The U.S.
Department of Agriculture (USDA) later determined that this cow was
imported from Canada. The agent believed to be responsible for BSE is a
malformed type of protein called a prion, found in certain tissue--
particularly brain and central nervous system tissue--of infected
animals. Cattle contract BSE by eating feed derived from the remains of
BSE-infected animals.[Footnote 1] In Europe, more than 5 million head
of cattle have been killed to thwart the spread of the disease.
Scientists also generally believe that a fatal disease in humans--knows
as variant Creutzfeldt-Jacob Disease (vCJD)--is linked to eating beef
contaminated with the malformed protein. Research suggests that vCJD is
difficult for humans to contract--about 150 people have died worldwide
from vCJD. Both diseases have long incubation periods during which they
are undetectable--2 to 8 years in cattle and possibly up to 30 years in
humans.
USDA is primarily responsible for detecting the disease in cattle, and
the Department of Health and Human Services' Food and Drug
Administration (FDA) is primarily responsible for preventing its
introduction and spread through animal feed. Both agencies recognize
the importance of preventing BSE from becoming established in the
United States--not only to protect the safety of the U.S. food supply
but also to protect the economic viability of the $70 billion U.S. beef
industry. With 95 million head of cattle, the United States is the
world's largest beef producer, exporting a record 2.6 billion pounds of
beef, valued at over $3.1 billion, in 2003. In January 2002, we
reported that the potential impact of even a small outbreak of BSE in
the United States could be economically devastating.[Footnote 2]
Indeed, between January and September 2004, the industry lost more than
80 percent of its export trade, or an estimated $2 billion, following
the discovery of the one BSE-infected animal in December 2003. Although
most countries stopped importing U.S. beef for some period of time,
domestic consumption did not drop. In fact, changing dietary trends
have led to increased U.S. beef consumption in the last several years.
The United States is in discussions with its major trading partners
about renewing U.S. beef imports.
To protect U.S. cattle and consumers, USDA and FDA have put in place
three primary firewalls. These include the following:
* Controls over imports. Since 1989, USDA has prohibited the
importation of live cattle and certain cattle products from countries
where BSE is known to exist. In 1992, FDA began identifying medical
products and other FDA-regulated foods and products derived from cattle
from countries with BSE. USDA and FDA, in cooperation with the
Department of Homeland Security's Customs and Border Protection, screen
shipments of such products.
* Animal surveillance. Since 1990, to detect BSE, USDA has been testing
brain tissue, primarily from cattle that exhibit neurological symptoms
and adult cattle that die from unknown causes, as well as from cattle
slaughtered for meat.
* Feed ban.[Footnote 3] In 1997, FDA banned the use of most proteins
derived from mammals in feed intended for cattle and other ruminants to
keep potentially infectious tissue out of cattle feed.[Footnote 4]
This report focuses on FDA's implementation and enforcement of the
animal feed-ban rule, which many industry and consumer groups consider
the most important firewall against the introduction and spread of BSE
in the United States.
Under the feed-ban rule, FDA requires firms to (1) label feed and feed
ingredients that contain or may contain most proteins from most mammals
(referred to hereafter as prohibited material) with a cautionary
statement that reads "Do not feed to cattle or other ruminants," (2)
have procedures to protect against commingling or cross-contamination
if they handle both prohibited and nonprohibited material for feed and
feed ingredients, and (3) maintain records so that feed and feed
ingredients that contain or may contain prohibited material can be
tracked from receipt through disposition.[Footnote 5] Firms that
transport both types of materials also must have procedures to prevent
commingling.
FDA's feed-ban rule applies to feed for cattle and other ruminants,
such as sheep and goats. The material prohibited for use in cattle feed
may continue to be used in pet food and in feed for poultry, swine,
horses, and other nonruminant animals.
The feed-ban rule designates a number of cattle-and other animal-
derived items as exempt from the ban, and hence allowable in cattle
feed. These exempt items include blood and blood products, plate waste,
gelatin, and milk and milk proteins.[Footnote 6] In addition, poultry
litter (a protein source comprised of poultry waste material, bedding,
and spilled feed) is allowed in cattle feed. FDA has published, but not
taken action on, several advance notices of proposed rulemaking for
revising the ban to, among other things, end most of the exemptions and
require that feed manufacturers and other such firms use dedicated
equipment for cattle feed.
To oversee compliance with the feed ban, inspectors from FDA and the 38
states that have contracts or agreements with FDA periodically inspect
firms, using FDA guidance and an inspection form that FDA developed to
document inspection results.[Footnote 7] Since 1997, FDA and states
have identified and inspected about 14,800 firms that are subject to
the feed-ban rule. The types of firms inspected include renderers,
protein blenders, feed mills, farms that mix their own feed, feed
transporters, pet food manufacturers, and other firms subject to the
feed-ban rule.[Footnote 8] In 2002, FDA began using a risk-based
priority approach to determine which firms to inspect annually. Under
this approach, FDA has designated firms that manufacture, blend, and
otherwise directly process with prohibited material as the highest risk
for potentially exposing U.S. cattle to BSE. Firms that do not process
with prohibited material are designated as lower risk. FDA had
designated about 570 firms as high risk in fiscal year 2004. FDA
assigns a list of high-risk firms for inspection to each of its
district offices and gives the district offices some discretion in
deciding which lower risk firms to inspect. FDA also negotiates with
states over the number of inspections that FDA will pay for under
contract. States conduct about 70 percent of feed-ban compliance
inspections. When FDA determines that firms are out of compliance, it
can issue warning letters, encourage firms to conduct voluntary
recalls, or seek court orders to seize feed or feed ingredients. FDA
district offices review inspection results for accuracy and enter
inspection information into FDA's central data system--the Field
Accomplishments and Compliance Tracking System (FACTS)--and
periodically post inspection results on FDA's Web site.
Our January 2002 report identified a number of weaknesses in federal
BSE prevention and detection efforts.[Footnote 9] Regarding the feed
ban, we reported that FDA had not promptly taken actions, such as
issuing warning letters or reinspecting firms that were out of
compliance, to enforce the feed ban and keep prohibited material out of
cattle feed. We also reported that FDA's data on inspections were so
severely flawed that the agency could not know the extent of industry
compliance. We made a number of recommendations to strengthen FDA's
enforcement of the feed ban and its oversight and monitoring of
compliance inspections.
As you requested, this report examines the effectiveness of the actions
FDA has taken, since our 2002 report, to ensure industry compliance
with the animal feed ban and protect U.S. cattle from BSE. In addition,
appendix III provides a chronology of FDA's and USDA's actions in
response to the two cases of BSE discovered in North America in 2003.
In conducting our work, we examined in detail 404 inspection reports
from fiscal years 2003 and 2004, which we randomly selected from FDA's
18 district offices responsible for inspections in the 50 states. We
interviewed FDA district officials in the 18 districts and observed FDA
and state investigators conduct 19 inspections in 12 states. The sites
were selected to cover a range of firm types and sizes in various
geographic locations with concentrations of cattle feeding operations,
including dairy cattle. We met with FDA headquarters' officials
responsible for procedures and actions taken to (1) oversee and enforce
the feed ban, (2) maintain the inspection data system, and (3) propose
and analyze regulatory decisions. We also surveyed state agency
officials in the 38 states that had contracts or agreements with FDA in
fiscal year 2004 regarding their inspection programs, testing of animal
feed and feed ingredients, and the training and guidance they received
from FDA. The state survey instrument and summary of responses appear
in appendix IV. Appendix I contains a detailed description of our scope
and methodology. We performed our work from October 2003 through
January 2005, in accordance with generally accepted government auditing
standards, which included an assessment of FDA's BSE program data
reliability and internal controls.
Results in Brief:
FDA has taken a number of important actions, as we recommended in our
2002 report, to improve its implementation of the feed ban. FDA
developed a uniform format for federal and state inspectors to document
inspection results, implemented a new data system that more reliably
tracks inspection results, and entered inspection results into the data
system in a more timely fashion. FDA also issued guidance and trained
its inspectors along with state inspectors on how to conduct BSE
inspections. However, we found the following weaknesses in FDA's
oversight and enforcement of the feed ban, which continue to limit the
effectiveness of this critical BSE firewall and could place U.S. cattle
at risk for BSE:
* FDA acknowledges that more firms are subject to the feed ban than the
nearly 14,800 that have been inspected to date, but it does not have
uniform procedures for identifying additional firms. Because these
firms have never been inspected, FDA has no assurance that they are in
compliance with the feed ban. FDA officials told us the agency has
asked Congress for more resources, which it plans to use, in part, to
support states' efforts to identify and inspect additional firms. We
observed one possible approach to help FDA identify additional firms
with existing resources: some inspectors wrote down the names of the
suppliers and customers of firms during inspections to check against
the inventory of active firms. Inspectors do not routinely note such
information, however, because FDA's guidance does not instruct them to
do so.
* We found that about 2,800 firms had not been reinspected since 1999
or earlier. While those early inspections indicated that most did not
process with prohibited material at that time, the firms could have
changed their practices over the last 5 years. Our analysis showed that
about two-thirds of those firms were farms that fed cattle and did not
feed other types of animals; FDA believes such farms are unlikely to
change their practices. However, about 400 firms were feed mills, which
FDA would consider at high risk of potentially exposing cattle to BSE
if they started to use prohibited material. Because firms are not
required to notify FDA if they change their operations and begin to
process feed using prohibited material, FDA would not target them for
annual inspection as high-risk firms.
* FDA's inspection guidance does not include routinely sampling feed
intended for cattle, in cases where such tests would be useful, to
augment the visual examination of facilities and equipment and review
of documents carried out during inspections. According to FDA, the
presence of exempt items, such as cattle blood, which are allowed in
cattle feed, would negate the value of the tests because the tests
cannot distinguish between prohibited material and these exempt items.
However, 18 of the 38 states that conduct BSE inspections under
agreement with FDA told us they take samples of feed during inspections
to test for animal material. State officials told us that tests could
confirm the presence of potentially prohibited material in cattle feed
at firms that assert they do not use exempt items. Tests would also be
useful to confirm the adequacy of procedures for cleaning equipment and
vehicles used for both cattle feed and feed with prohibited material.
However, FDA began testing bags of feed sold at retail stores and bulk
feed sold to cattle feedlots in August 2003. These samples were not
taken as part of the compliance inspections and were not selected
systematically. According to FDA officials, tests on some of these
samples indicated the presence of animal material and the agency was
investigating those test results at the completion of this report. We
plan to provide our analysis of FDA's collection, testing, and follow-
up of these samples later this year.
* FDA's regulations do not require the cautionary statement--"Do not
feed to cattle or other ruminants"--on feed or feed ingredients that
contain prohibited material if they are intended for export, although
that feed could be intentionally or inadvertently redirected back into
feed for U.S. cattle. In addition, the exported feed containing
prohibited material could be fed to cattle in other countries and meat
from those animals could subsequently be imported into the United
States. However, according to FDA officials, FDA cannot require feed
intended for export to carry the cautionary statement without a change
to the law that governs the export of food and feed.
* Although FDA has procedures for alerting USDA and states when it
discovers that cattle may have consumed feed that contains prohibited
material, FDA officials told us that they had never given such
notification, even though they had identified instances when prohibited
material had been used in cattle feed in the past. FDA said that
notification was not needed because BSE had not been discovered in a
cow born in the United States. However, FDA's position is inconsistent
with the purpose of the feed ban--to be a firewall for safeguarding
U.S. cattle from the introduction and spread of BSE. On one inspection
we observed, an inspector discovered that a firm's process had been
allowing prohibited material into cattle feed for nearly a year. The
firm voluntarily conducted a recall, but FDA did not alert USDA and the
state. FDA maintained that the recall was sufficient; however, USDA
officials told us that the department would have tracked the animals
that may have been fed contaminated feed and tested them for BSE when
slaughtered.
* FDA has not identified or inspected many transportation firms. In
addition, inspectors do not routinely review and document firms'
procedures for ensuring that the vehicles they use to haul cattle feed
are free of prohibited material. Routine review and documentation does
not occur in part because FDA's inspection form does not have specific
questions to capture that information. Eighty-two of the inspection
reports we examined were for renderers, protein blenders, feed mills,
and other firms that handled cattle feed and feed ingredients and also
processed with prohibited material. Inspectors documented vehicle clean-
cut procedures for only 11 of those 82 firms. Research suggests that
cattle can get BSE from ingesting even a small amount of infected
material--an amount that could be introduced in feed that was
transported in a poorly cleaned vehicle. FDA told us it has requested
resources to identify and inspect more transportation firms. However,
because thousands of trucks could transport cattle feed, we believe it
would be more effective to review and document cleanout procedures and
inspect vehicles as part of inspections at feed mills or other firms
that use the vehicles to haul their cattle feed or feed ingredients.
In addition to these weaknesses in the feed-ban firewall, we also
identified a related issue that needs to be addressed. FDA is reporting
information to Congress and the public on industry compliance without
providing a full and complete context for that information. That is,
FDA reported a 99 percent compliance rate in January 2004. While FDA
noted the rate was based on renderers, protein blenders, and feed mills
that process with prohibited material, it did not note that the rate
was based on inspections of only about 570 firms. Some industry
officials have cited that high rate of compliance as support for their
position that FDA does not need to strengthen the feed-ban rule.
Furthermore, FDA does not include all serious violations in its
calculations of compliance on its Web site because it reclassifies
firms as "in compliance" once they correct violations, regardless of
how long the problem may have existed. In addition, in 42 of the 404
inspection reports that we analyzed in depth, FDA had counted firms as
"in compliance" that lacked written procedures to prevent commingling
or cautionary statements on feed that contained prohibited material--
violations that can result in cattle being fed prohibited material.
Because of these concerns and the fact that FDA is still identifying
firms subject to the ban--as well as the fact that inspections are
largely paperwork reviews without tests to confirm compliance, and some
inspections are 5 or more years old--we do not believe that FDA has
enough information or enough current information to cite a rate of
compliance. Any compliance information FDA cites must be reported in
its complete context.
To further strengthen oversight and enforcement of the animal feed ban
and better protect U.S. cattle and American consumers, we are making
nine recommendations to the Commissioner of FDA, including that FDA
develop procedures for identifying additional firms subject to the ban;
ensure that it alerts USDA and states when inspectors discover that
feed with prohibited material may have been fed to cattle; and develop
guidance for inspectors to use tests to verify the safety of cattle
feed and confirm the adequacy of procedures for ridding equipment and
vehicles of prohibited material before using them for cattle feed.
In commenting on a draft of this report, FDA said we had conducted a
thorough and diligent study. However, FDA believes that the weaknesses
we identified are not sufficiently material to place U.S. cattle at
risk for BSE and that its risk-based inspection approach assures
adequate oversight of the feed-ban rule. We believe that the problems
described in this report are serious and that, given the fact that BSE
has been discovered in North American cattle, breaches in FDA's
oversight of the feed-ban rule place U.S. cattle at risk for BSE. FDA
generally disagreed with four of our nine recommendations. FDA did not
agree that, among other things, it should use tests as part of
compliance inspections, as we recommend, because current tests cannot
detect the prions that cause BSE. That is true. However, the existing
test can detect animal tissue, and FDA is using it to test samples of
bagged feed and feed sold at mills. We believe tests, in conjunction
with document review and visual examination carried out during
compliance inspections, will give FDA greater assurance that inspection
results are accurate. FDA also disagreed with our recommendation that
it require firms that process with prohibited material to notify FDA.
FDA believes it would need significant additional resources to
implement a notification program and said that its current approach of
working collaboratively with states gives FDA a good opportunity to
learn when firms change to using prohibited material. If there are not
significantly more high-risk firms than the approximately 570 firms FDA
already knows about, then the cost of implementing this recommendation
would be minimal. However, if the number of firms that process with
prohibited material is significantly larger, FDA needs to know that.
Appendix VI contains FDA's written comments and our detailed response.
Background:
BSE and vCJD belong to a family of diseases known as transmissible
spongiform encephalopathies (TSE). Other TSEs include scrapie in sheep
and goats, chronic wasting disease in deer and elk, feline spongiform
encephalopathy in domestic cats, and mink encephalopathy. Currently, no
therapies or vaccines exist to treat TSEs and a definitive diagnosis
can only be made from a post-mortem examination of the brain. The
infective agent that gives rise to TSEs is generally thought to be a
malformed type of protein, called a prion, which causes normal
molecules of the same type of protein in the brain to become malformed
and eventually results in death.[Footnote 10] Prions are neither
viruses nor bacteria and contain no genetic material--no
deoxyribonucleic acid (DNA). Prions cannot be readily destroyed by
conventional heat, irradiation, chemical disinfection, or sterilization
procedures.[Footnote 11] TSE prions have been found to accumulate in
central nervous system tissue--specifically the brain, spinal cord, and
eye--and have been found in other body tissues, such as the tonsils and
small intestines, of animals and humans. For BSE, the precise amount of
infective material needed to cause disease is unknown, but research
suggests that it is very small. According to scientific experts in the
European Commission, in careful feeding experiments, less than 1 gram
of infected brain tissue induced disease in all the recipient cattle.
The original source of BSE is not known with certainty. However, based
on available evidence, experts generally agree that the practice of
recycling the remains of diseased animals, specifically scrapie-
infected sheep, into feed for livestock, including cattle, was
responsible for the emergence and spread of BSE in the United Kingdom.
In 1986, BSE was first identified in the United Kingdom; and in 1988,
that government banned the practice of feeding ruminant-derived protein
to ruminants to thwart its spread. The number of new cases of BSE has
declined from a high in 1992 of 37,316 to a total of 764 new cases in
2004. BSE has been found in about 189,000 animals worldwide, most of
which (about 184,000) were discovered in the United Kingdom. The
remaining cases were discovered in 26 countries, including Canada and
the United States. Three nations--the United States, Oman, and the
Falkland Islands--have only detected the disease in imported animals.
The following are the number of reported cases, by region and/or
country: [Footnote 12]
* Europe. United Kingdom--184,045; the rest of Europe--5,107;
* North America. Canada--4; United States--1;
* Middle East. Oman--2; Israel--1;
* Asia-Pacific. Japan--14; and:
* South America. Falkland Islands--1.
In 1996, the United Kingdom reported the first case of the human
disease, vCJD. Scientists believe vCJD is linked to exposure to the BSE
prion, most likely through consuming beef and beef products infected
with BSE.[Footnote 13] While scientists and regulatory officials
believe that millions of people in the United Kingdom may have ingested
BSE-infected tissue, many also believe vCJD is difficult to contract.
As of December 1, 2003, 153 cases of vCJD had been reported worldwide,
with 143 of these cases in the United Kingdom. The Department of Health
and Human Services' Centers for Disease Control and Prevention, which
is responsible for surveillance of vCJD, reported that almost all of
the vCJD victims had multiple-year exposures in the United Kingdom
during the height of the outbreak of BSE-infected cattle--between 1980
and 1996. Most vCJD victims have been young--the average age at death
was 28--and half died within 13 months from the time they first showed
symptoms.
The first indigenous case of BSE in North America was discovered in
Canada in May 2003. (Canada's first infected cow, discovered in 1993,
had been imported from the United Kingdom.) A Canadian government
investigation concluded that the infected cow discovered in 2003 most
likely contracted the disease by consuming feed containing BSE-
contaminated ruminant material, probably before Canada imposed its feed
ban in 1997.[Footnote 14] Canadian authorities believe that BSE entered
the feed chain through slaughtered and rendered cattle imported from
the United Kingdom. In December 2003, an animal infected with BSE was
discovered in the United States. According to U.S. authorities, that
animal--a dairy cow in Washington State--had been part of a herd of 81
cattle imported from Canada in September 2001. Appendix III describes
FDA's and USDA's actions in response to the 2003 discoveries. In
January 2005, Canada discovered two more cases of BSE.
Following the discovery of the infected cow in the United States, U.S.
beef exports dropped precipitously. The United States is currently
engaged in discussions with its major trade partners to reestablish
beef exports. In October 2004, Japan, previously the largest importer
of U.S. beef, agreed in principle to resume imports of certain beef
products from cattle slaughtered at 20 months or younger; as of
February 11, 2005, the two countries were working out the details of
this agreement.
To detect potentially prohibited material in feed, FDA uses a test
called "feed microscopy," which is a visual examination of a sample
under a microscope for the presence of animal tissue, such as hair and
bone particles. According to FDA officials, when performed by an
experienced analyst, the species can sometimes be identified. FDA is
evaluating a more sensitive test called "polymerase chain reaction"
(PCR), which detects animal DNA and can distinguish ruminant DNA.
However, feed containing exempt items (e.g., milk and blood proteins)
derived from ruminants would test positive for ruminant DNA using PCR.
When inspectors find violations of the feed-ban rule, FDA can issue
warning letters, and firms may conduct voluntary feed recalls. FDA has
the authority to take immediate enforcement action, including seeking a
court order to seize feed products that violate the feed ban or
obtaining a court-ordered injunction ordering a firm to cease
operations. Of the 38 states we surveyed, 34 told us they have
authority to take action for violations of the feed ban. FDA directs
its districts to issue warning letters within 30 workdays--
approximately 45 calendar days after the inspection. Warning letters
give firms the opportunity to voluntarily take corrective action before
FDA initiates enforcement actions.
Under the risk-based priority inspection system that FDA adopted in
2002, FDA and states have focused inspection resources on the following
types of firms, which FDA has designated as high-risk for potentially
exposing cattle to BSE:
* renderers that accept dead ruminant animals and/or the waste
materials from beef slaughter facilities;
* feed mills that use prohibited material, which can include FDA-
licensed mills that handle certain new animal drugs for use in animal
feeds and nonlicensed mills that do not handle such animal drugs; and:
* protein blenders that use prohibited material.
Other firms subject to the feed ban include the following:
* firms that manufacture only pet food;
* firms that transport or distribute animal feed;
* firms that salvage animal feed or pet food; and:
* other firms that handle animal feed, including retailers, grocery
warehouses, and specialty food companies.
In addition to inspections of high-risk firms, FDA asks states to
perform a number of inspections at the lower risk firms under their
contracts or agreements with FDA. FDA also performs inspections of some
lower risk firms. Table 1 shows the number of firms inspected during
fiscal year 2004.
Table 1: Number of Firms Inspected by FDA and States for Compliance
with the Feed-Ban Rule, by Firm Type, Fiscal Year 2004:
Firm type: Renderers;
Number of firms: 195.
Firm type: Protein blenders;
Number of firms: 164.
Firm type: FDA-licensed feed mills;
Number of firms: 747.
Firm type: Nonlicensed feed mills;
Number of firms: 2,615.
Firm type: Others[A];
Number of firms: 2,285.
Total;
Number of firms: 6,006.
Source: GAO's analysis of FDA's online database.
Note: Since many firms engage in more than one activity (for example, a
feed mill may also be a protein blender), this analysis makes
assumptions about firms' primary activities to avoid counting firms in
more than one category.
[A] Other firm types include cattle feeders, transporters, pet food
manufacturers, and retail establishments.
[End of table]
Our 2002 report found that:
* FDA was not acting promptly to compel firms to keep prohibited
materials out of cattle feed and to label animal feed that cannot be
fed to cattle;
* FDA's data on feed inspections was so severely flawed that FDA did
not know the full extent of industry compliance;
* FDA had no clear enforcement strategy for firms that do not obey the
feed ban and did not know what enforcement actions states had taken;
and:
* FDA had been using inaccurate, incomplete, and unreliable data to
track and oversee feed-ban compliance.
A 2001 study by the Harvard Center for Risk Analysis noted that the
greatest risk of BSE exposure to cattle in the United States is through
mishandling, mislabeling, or contaminating cattle feed.[Footnote 15]
The study developed a simulation model for predicting the number of
infected animals that would result from the introduction of BSE into
the United States. Using this model, the Harvard study concluded that,
if 10 cattle infected with BSE were imported into the United States,
only three new cases of BSE would likely occur, on average, and that
BSE is virtually certain to be eliminated from the United States within
20 years following its introduction. According to the study, any new
cases of BSE would come primarily from industry's failure to comply
with the feed ban. A subsequent 2003 Harvard reassessment--following
the discovery of the BSE-infected cow in Canada that year--arrived at a
similar conclusion.[Footnote 16]
FDA Has Taken Important Steps to Improve Implementation of the Feed
Ban:
Since our January 2002 report, FDA has changed the way it collects,
tracks, and reports inspection data. In April 2002, FDA implemented a
uniform inspection form for federal and state inspectors to document
inspection results. Although FDA had an inspection form earlier,
inspectors were not always completing the required information, and
several states did not use FDA's form.
FDA has also issued feed-ban inspection guidance and appointed BSE
coordinators in each of its district offices to review inspection forms
for completeness.[Footnote 17] The district BSE coordinators told us
that FDA has trained inspectors on using the inspection form and
carrying out inspections. Although most states reported that this
training was sufficient, a few told us that they had not received
training since the late 1990s or were not able to attend training
because of state budget constraints. However, in commenting on a draft
of the report, FDA officials said that the agency always offers to
provide training to states, when requested.
Regarding the data deficiencies we reported in 2002, FDA implemented a
newly designed feed-ban database and data entry procedures in its Field
Accomplishment and Compliance Tracking System (FACTS) in April 2002.
According to our analysis, this new approach and data system are
designed to more reliably track feed-ban inspection results. As a
result, FDA has a better management tool for overseeing compliance with
the feed-ban rule and a data system that better conforms to standard
database management practices. Specifically, FDA's new approach makes
the following improvements:
* All firms have unique identifiers. Inspection records in FDA's data
system--including those that were previously missing unique
identifiers--now have them, according to our data reliability analysis.
Before the new approach, about 45 percent of FDA's feed inspection
records lacked information to identify individual firms. As a result,
the earlier data could not be used to reliably determine the number of
firms inspected, compliance trends over time, or the inspection history
of an individual firm. These problems should not occur with FDA's new
system.
* Information is substantially complete and accurate. FDA has corrected
information problems we had identified in our 2002 report, according to
our data reliability analysis of the inspections conducted since April
15, 2002. The new FACTS database contains edit checks to detect any
incomplete or inaccurate data. Furthermore, FDA's current feed-ban
inspection guidance directs district BSE coordinators or their
designees to review BSE inspection forms for completeness and accuracy.
Previously, headquarters staff had entered the data received from
district offices and did not have sufficient knowledge to detect
irregularities in the data they were entering. In addition, states that
have contracts or agreements with FDA are now using the same inspection
forms as FDA. Previously, several states used state-developed forms,
which did not always provide comparable information.
* Data are more timely. Since April 15, 2002, about 95 percent of
inspections with serious violations have been entered into the FACTS
database within 45 days of the inspection date, according to our
analysis. This rate of entry is a significant improvement over the
timeliness of entry rates we reported in 2002. At that time, we found
that some inspections were entered into FDA's database 2 or more years
after the date of inspection. For such inspections, FDA could not
accurately report on firms' compliance with the feed ban and could not
clarify inconsistent or conflicting information, or obtain answers to
missing information--situations that FDA's new approach should help
avoid.
As a result of these improvements, FDA is able to present more reliable
feed ban inspection information on its Web site for the approximately
10,000 firms inspected since April 15, 2002, or about two-thirds of the
approximately 14,800 firms inspected since 1997. Appendix II provides a
detailed description of actions FDA has taken on the recommendations in
our 2002 report.
Program Weaknesses Continue to Limit the Effectiveness of FDA's Animal
Feed Ban:
While FDA has made many improvements to its oversight and enforcement
of the feed ban in response to our 2002 report recommendations, we
found a number of oversight weaknesses that limit the effectiveness of
the ban and could place U.S. cattle at risk for BSE. Specifically, we
found that FDA does not:
* have a uniform procedure to identify all firms subject to the feed
ban,
* require firms to notify FDA if they process with prohibited material,
* routinely use tests to verify compliance with the feed ban,
* alert USDA or states when cattle may have been fed with feed
containing prohibited material, and:
* adequately overseeing the procedures for cleaning vehicles that haul
cattle feed.
Furthermore, we found that cautionary statements are not required on
feed or feed ingredients intended for export that contain prohibited
materials. In addition, FDA has not been reporting BSE inspection
results to Congress and the public in a full and complete context.
FDA Does Not Have Uniform Procedures to Identify Additional Firms
Subject to the Feed-Ban Rule:
When the feed ban took effect in 1997, FDA first focused on identifying
as many firms as possible that were subject to the ban. As of September
30, 2004, FDA officials had identified approximately 14,800 firms that
are subject to the feed ban (see table 2). That is about 4,200 more
firms than the 10,576 firms FDA had identified approximately 3 years
earlier. FDA officials acknowledge that the agency has not identified
all firms subject to the feed-ban rule.
Table 2: Number of Firms FDA Has Identified that Are Subject to the
Feed Ban, by Firm Type, as of the End of Fiscal Year 2004:
Firm type: Renderers;
Number of firms: 249.
Firm type: Protein blenders;
Number of firms: 281.
Firm type: FDA-licensed feed mills;
Number of firms: 1,061.
Firm type: Nonlicensed feed mills;
Number of firms: 4,922.
Firm type: Others[A];
Number of firms: 8,252.
Total;
Number of firms: 14,765.
Source: GAO analysis of FDA's online database.
Note: Since many firms engage in more than one activity (for example, a
feed mill may also be a protein blender), this analysis makes
assumptions about firms' primary activities to avoid counting firms in
more than one category.
[A] Other firm types include cattle feeders, transporters, pet food
manufacturers and retailers.
[End of table]
FDA has identified firms by reviewing:
* its list of firms that manufacture feed that contains certain new
animal drugs; FDA knew about these firms because it requires them to be
licensed and because it has certain regulatory responsibility over
these firms.
* a list of the firms or individuals that USDA has identified as
violating USDA's and FDA's requirements with respect to chemical and
drug residues in animals slaughtered for human consumption.[Footnote 18]
* lists of firms that states identified. For example, 27 of the 38
states we surveyed register renderers, 28 register protein blenders,
and 34 register feed mills that FDA has not licensed, and provide this
information to FDA during meetings to set up annual inspection plans.
* membership lists of industry associations, such as the National
Renderers Association.
In addition, FDA officials told us that FDA districts have used
multiple approaches, including looking through telephone books to
identify the names of additional firms. However, FDA has not developed
a systematic approach for identifying additional firms subject to the
feed ban. For example, FDA does not have an approach for identifying
additional nonlicensed feed mills in states that do not provide that
information. FDA also acknowledged that it has identified only a small
percentage of the thousands of transportation firms that may haul
cattle feed. Moreover, in commenting on a draft of this report, FDA
told us that there are an estimated 1 million businesses (e.g., dairy
farms feedlots, and other facilities) that feed cattle and other
animals. FDA also told us that it does not consider farms that mix
their own feed or feed cattle as well as other animals as low risk.
However, FDA does not have a strategy for ensuring that this industry
sector is in compliance with the feed-ban rule.
We observed one approach for expanding the number of firms subject to
the feed ban: some FDA and state inspectors we accompanied on firm
inspections wrote down the names of the firm's suppliers and customers
during the inspection and checked these names against FDA's inventory
of firms to help identify additional firms. According to officials in
one district where we observed this practice, they inspect these
additional firms as resources allow. However, FDA does not have
guidance for inspectors to do this routinely, and we observed other
inspectors who did not record the names of firms' suppliers and
customers. The approach we observed was one that may be largely applied
with existing resources. Congress provided FDA with an additional $8.3
million in the fiscal year 2005 budget, which FDA officials told us
would be used, in part, to funds states' efforts to identify and
inspect additional firms.[Footnote 19]
FDA Does Not Require Firms to Notify the Agency if They Process with
Prohibited Material:
Under FDA's risk-based inspection system, FDA's goal is to annually
inspect all renderers, feed mills, and protein blenders that process
with prohibited material--about 570 firms--and to inspect a number of
other firms that FDA considers lower risk. The number of other firms
varies according to the inspection resources available. As previously
stated, in total, FDA and states inspected 6,006 firms in fiscal year
2004. However, once FDA has inspected a firm and determined that it
does not process with prohibited materials, FDA may not reinspect that
firm for many years. In the interim, FDA does not know whether the firm
has changed operations and now processes prohibited materials because
it does not require firms that do so to notify the agency. FDA and
state agencies only learn of a change in operations if they inspect the
firms. Without a requirement to notify FDA, these firms are not
annually inspected to monitor for compliance with the feed ban, as are
other high-risk firms.
We found that 2,833 or about 19 percent, of these firms FDA has
identified as subject to the feed-ban rule have not been reinspected in
5 or more years. These firms include:
* 1,224 farms that fed ruminant animals;
* 846 farms that mixed their own feed;
* 377 feed mills; and:
* 386 other types of firms, such as distributors and retailers.
According to FDA officials, of these four types of firms that have not
been reinspected, about 2,100 or two-thirds are farms, which FDA
believes are not likely to change their practices. However, feed mills,
which account for about 400 of the firms, would be classified as high
risk if they process with prohibited material.
FDA officials also believe that the number of firms processing with
prohibited material is declining and that in all likelihood firms that
have not been inspected for a number of years would not change their
practices and start doing so. As FDA pointed out, firms may decrease
their use of prohibited material because of the requirement that they
maintain records sufficient to track all receipt, processing, and
distribution of that material. Nonetheless, some firms that did not use
prohibited material when they were last inspected may begin to use that
material in processing their feed.
FDA officials told us that they have considered options for identifying
firms that process feed with prohibited material, including requiring
those firms to be licensed. The officials noted, however, that some
firms may not comply with a notification requirement; thus, FDA would
still not know about all high-risk firms, and it would incur the
additional costs of overseeing the notification requirement.
FDA Does Not Routinely Sample Feed and Feed Ingredients during
Inspections for Analysis to Verify Compliance with the Feed Ban:
While FDA inspection procedures include guidance for reviewing firm
documents and procedures, examining their invoices, and inspecting
facilities and equipment, they do not include guidance on when samples
should be taken and tested. For example, the feed-ban inspection
guidance does not instruct inspectors to routinely sample cattle feed
to verify firms' claims that they do not use prohibited materials or
exempt ingredients, or to ensure that firms' cleanout and flushing
procedures to prevent commingling are followed and are effective.
We recognize that the usefulness of testing is limited at firms that
use exempt items--cattle and other ruminant blood, milk proteins,
poultry litter, and plate waste--as ingredients in cattle feed. FDA
officials told us that they did not want to routinely test samples at
firms during inspections because the tests would likely have many false
positives as a result of the exemptions. Consequently, officials
believed testing would not use resources wisely.
However, in 9 of the 19 inspections we observed, inspectors could have
used tests to verify feed-ban compliance because the firms claimed they
did not use any animal-derived exempt items. Even in these instances,
where tests would be beneficial, inspectors did not sample the feed.
For instance, inspectors did not take samples to confirm the adequacy
of cleanout procedures at firms that use nondedicated production
facilities to manufacture cattle feed but do not use any exempt
materials. FDA's feed-ban inspection guidance allows inspectors to draw
samples at their discretion, but FDA officials told us that inspectors
rely on their judgment of whether the cleanout procedures appear to be
adequate and rarely use testing to verify their assessment. FDA
officials did not give us a clear reason why they would not advise
testing in situations where tests would be useful to help confirm
compliance.
Some states have also done significant testing that FDA could use to
verify compliance with the feed ban but do not provide their test
results to FDA, although that information could give FDA a more
complete picture of feed ban compliance. In response to our survey, 18
of the 38 states that have agreements with FDA to conduct feed-ban
inspections told us they had collected and tested over 1,500 feed
samples during 2003.[Footnote 20] For example, according to a North
Carolina Department of Agriculture official, the state collected and
tested 738 samples; and, according to a Kansas Department of
Agriculture official, the state collected and tested 94 samples. In
these states, if the tests find what appears to be prohibited material,
the states followed up with the firms to determine what ingredients
they used. According to the officials, no contaminated cattle feed was
found. In California, which collected and tested about 100 samples,
officials found tests to be useful for demonstrating to cattle feed
manufacturers the difficulties of cleaning equipment that has been used
for prohibited material. FDA and state agency officials told us that
most California feed firms have switched to using dedicated equipment
for cattle feed. Eleven of the 18 states share test results with FDA,
but FDA does not use these results to verify industry compliance with
the feed ban.
In August 2003, FDA instructed its districts to begin testing finished
feed and feed ingredients, such as bags of feed sold at retail stores
and bulk feed sold to cattle feedlots. These tests were not taken in
conjunction with feed-ban compliance inspections. FDA inspectors took
660 samples nationwide. The samples were submitted to FDA regional
laboratories for analysis, where analysts used feed microscopy.
Although in its instructions to districts for the collection effort,
FDA called the tests "a method to monitor for compliance with" the feed
ban, FDA officials told us that the test results could not be the sole
basis for enforcement action at individual firms because microscopic
analysis cannot distinguish prohibited bone and tissue from exempted
material. Nonetheless, the officials also told us the testing gives FDA
further assurance of industry's compliance with feed ban.
Because FDA did not use an approach that allows it to generalize the
results, the test results cannot be used as assurance of industry
compliance. In fact, because FDA did not provide instructions on how to
randomly select firms for sampling and how to take a random sample of
feed at the firms, the results cannot even help confirm compliance by
the stores, feedlots, and other firms where the samples were taken. In
initiating this effort without a sampling plan, FDA wasted its already
limited inspection resources. FDA has committed resources to collect
and analyze 900 additional samples in fiscal year 2005. With the same
resources, FDA could have developed a sample design that would have
allowed it to generalize the test results to industry.
FDA officials told us the agency would have to conduct an investigation
to determine whether an enforcement action was warranted. FDA provided
us some information on test results for the 660 samples that were taken
and analyzed. The data showed 145 potential violations, including 8
that FDA's laboratories originally classified as serious. About one-
third of the 145 samples with potential violations were of cattle feed.
Several of those samples had evidence of mammalian matter. Without more
information, we could not determine whether the cattle feed contained
exempt items or prohibited material. As of February 2005, FDA was in
the process of gathering the information we requested from its district
offices on the results of its investigation of the 145 potential
violations and what, if any, enforcement actions were taken based on
the tests and follow-up investigations. We plan to provide our analysis
of FDA's collection, testing, and follow-up of these samples later this
year.
The Cautionary Statement Is Not Required on Feed Intended for Export:
Animal feed and feed ingredients containing prohibited material
(including material from rendered cattle) are not required to be
labeled with the cautionary statement, "Do not feed to cattle or other
ruminants," when that material is intended for export. Shipping
containers for such material, however, must be labeled that they are
for export only; and, if prohibited material is put back into domestic
commerce, the containers must be relabeled with the cautionary
statement.
Not placing the warning label on exported feed poses a potential risk
to U.S. and foreign cattle and consumers from two perspectives. First,
feed with prohibited materials could be intentionally or inadvertently
redirected into feed for U.S. cattle if firms fail to add the
cautionary label to the product that they had initially intended to
export. Second, exported feed containing prohibited material could
mistakenly be fed to cattle that are subsequently imported into the
United States or whose meat and other products are imported into the
United States.
We observed one situation where a problem could occur because a
cautionary statement was not on an exported product. One firm we
visited processed fishmeal, which is normally considered a safe
ingredient for cattle feed. However, this plant processed the fishmeal
on the same equipment it used for prohibited materials. If it were sold
domestically, the fishmeal would have to be labeled with the cautionary
statement because it is potentially contaminated with prohibited
materials. However, the product was shipped to overseas customers
without the cautionary statement. Because the fishmeal was not labeled,
and fishmeal would not be expected to contain prohibited material,
customers could unwittingly mix the fishmeal with other ingredients for
their cattle. The FDA inspector did not document in the inspection
report which countries were sent the fishmeal. When we asked FDA
officials about this situation, they were concerned only about whether
feed intended for export was actually being diverted to domestic
cattle, a situation that they believed was unlikely to occur because
FDA rules prohibit it. However, according to the report by the
international panel of experts on BSE convened by USDA, the United
States has an obligation to act responsibly toward its global neighbors
when exporting feed and feed ingredients.
FDA officials told us that FDA cannot require the cautionary statement
on feed intended for export without a change to the Federal Food, Drug,
and Cosmetic Act.[Footnote 21] Under that act, animal feed intended for
export only cannot be deemed to be adulterated or misbranded if it (1)
meets the foreign purchasers specifications, (2) is not in conflict
with laws of the country to which it is intended for export, (3) is
labeled on the outside of the shipping package that it is intended for
export, and (4) is not sold or offered for sale in domestic commerce.
FDA Did Not Alert USDA or State Regulatory Authorities When It Learned
That Cattle Feed Containing Prohibited Material Was Marketed:
When an FDA district office learns that ruminant animals may have been
fed contaminated feed, the feed-ban inspection guidance directs the
district office to oversee efforts to appropriately dispose of the
contaminated feed and to ensure that the animals that had consumed this
feed are not slaughtered for human food or other animal feed. The
guidance also advises FDA to consider coordination with USDA and the
affected states.
While FDA districts have monitored voluntary recalls of feed that did
not comply with the feed ban, they had not been alerting USDA or state
departments of agriculture when they learned that such feed had been
given to cattle and other ruminants--in some cases for an extensive
period of time. FDA district and headquarters officials responsible for
the feed-ban program were not aware that the guidance instructed FDA to
alert USDA and states.
In our observations at inspections and our review of inspection
records, we found the following instances in which FDA did not alert
USDA or state authorities or take further action.[Footnote 22]
* A producer of cattle, hogs, and goats had inadvertently fed salvaged
pet food containing prohibited materials to goats, which are
ruminants.[Footnote 23] We observed the mislabeled feed in a March 2004
inspection. The feed mill that manufactured and sold the feed had not
labeled the salvaged pet food with the required cautionary statement
"Do not feed to cattle or other ruminants." Shortly after this
discovery, the firm recalled the misbranded feed. In April 2004, a
state feed inspector found out about the misfed animals from the feed
mill, not from FDA, and alerted his state program managers. The state
contacted FDA, and after determining that FDA did not intend to take
action beyond issuing a warning letter, the state seized and destroyed
the animals in May 2004 under state authority to prevent the meat from
entering the food supply. FDA did not alert the state or USDA and did
not issue the warning letter to the feed mill until June 2004.
* A feed mill had inadvertently contaminated cattle feed with
prohibited material. The firm had made a mistake in designing and
placing equipment in the manufacturing process, which allowed spilled
feed containing prohibited material to become commingled with
ingredients used to make cattle feed. We observed this problem during
an April 2004 inspection. FDA issued a warning letter in June 2004
demanding that the firm correct the violations; the firm also conducted
a voluntary recall of the feed in June. Because the mill operated with
this flawed system for about 1 year before the discovery, potentially
contaminated feed was marketed and sold for cattle feed for that period
of time. FDA did not contact USDA or state authorities to alert them
that cattle had consumed the feed.
* A feed mill did not clean mixing equipment and transportation
vehicles used for processing and transporting feed containing
prohibited and nonprohibited materials. The firm also failed to
properly label feed containing prohibited materials with the required
cautionary statement and did not maintain sufficient records for
tracking the sale of cattle feed to its customers, as FDA requires. We
identified these problems during our review of inspection reports. The
inspection occurred in March 2003. The firm corrected the violations
and recalled all cattle feed that had not yet been consumed in March
2003. FDA issued a warning letter to the firm in May 2003 and took no
further action.
When we discussed these findings with FDA headquarters officials, they
told us they were not familiar with the guidance recommending this
communication. As a result, FDA, USDA, and state authorities had not
assessed the health risk to humans and the animals that may have
ingested that feed and may not have taken sufficient action to prevent
those cattle and other ruminants from entering the human food or animal
feed supply. The FDA officials said they had not considered
coordinating with USDA and state officials but that USDA and the states
were notified of the recalls because the recalls are posted on the FDA
Web site. However, we found that the posted recall notices do not
include information on whether, or for how long, cattle or other
ruminants had been given the contaminated feed. Furthermore, FDA
officials asserted that no action was needed beyond a recall in these
incidents because BSE has not been discovered in a cow born in the
United States. According to the officials, the meat would not make
people ill and the feed would not make cattle ill. Before this report
was issued, these same FDA officials told us that in the future, FDA
will alert USDA and states when cattle may have consumed prohibited
feed. USDA officials told us that they were not aware of these three
incidents. They said that, had they known, USDA would have tracked the
animals and tested them for BSE when they were slaughtered.
FDA Has Limited Assurance That Vehicles Used to Haul Cattle Feed Comply
with the Feed Ban:
According to FDA's feed-ban rule, transportation firms that haul
prohibited material and use the vehicles to haul feed or feed
ingredients for cattle must have and use procedures to prevent
commingling or cross-contamination. The procedures must provide for
cleaning out the vehicles or other adequate preventative measures.
Research suggests that cattle can get BSE from ingesting even a small
amount of infected material--an amount that could be introduced in feed
that was transported in a poorly cleaned vehicle. As part of an
inspection of transportation firms, inspectors review the adequacy of
these procedures, but the inspection form does not prompt them to do so
during inspections of other types of firms. The following two problems
impede the effectiveness of FDA's current procedures:
* FDA has not identified and does not inspect many transportation
firms. According to FDA officials and transportation data, thousands of
independent truckers, large and small trucking companies, and rail
companies may carry cattle feed and feed ingredients. FDA officials
told us that it would be virtually impossible to identify and inspect
all of these firms, given its limited resources. However, FDA agrees
that transportation compliance is important. In commenting on a draft
of this report, the agency noted that it is planning to increase
oversight of transportation firms based on FDA's assessment of
compliance and risk in this industry sector.
* Inspecting transportation firms at their home base would not ensure
that the required procedures are being used and that the nearly 200,000
large trucks that haul animal feed would be clean at the time they
picked up cattle feed, in part, because vehicles that carry prohibited
material may also carry cattle feed and other loads in succession
before returning to their home base. For example, at an inspection of
one high-risk protein blender, we observed an FDA inspector talking
with an independent trucker who had dropped off a load of cattle feed
ingredients, was picking up prohibited materials at the protein
blender, and was scheduled later to pick up a load of corn, which could
be used in cattle feed. The trucker explained that if he saw anything
in the truck between loads, he would climb in and sweep the material
out with a broom; if he did not see anything, he did not sweep out the
truck between loads. The trucker also said it would be extremely
difficult to find washout facilities to clean the truck between loads
while on the road.
Consequently, we believe that it would be more effective to require FDA
and state inspectors to review and document procedures that feed mills
and other firms use to ensure that the vehicles they use to haul cattle
feed and feed ingredients are free of prohibited material as part of
their inspections at feed mills and other firms. During our
observations of inspections, we found that some FDA and state
inspectors were already doing so. However, our observations and
analysis of inspection reports showed that the inspectors did not
routinely do so and did not uniformly report on the adequacy of the
firms' procedures for preventing the introduction of prohibited
material. We believe that inspectors were overlooking the adequacy of
firm's procedures to ensure the safe transport of cattle feed because
the BSE inspection form does not have any questions to capture that
information. Specifically, 82 of the 404 inspection reports we reviewed
were for renderers, protein blenders, feed mills, and other firms that
processed with prohibited material and handled cattle feed and feed
ingredients. We found that inspectors had documented the required
cleanout procedures for transportation equipment at only 11 of these 82
firms. Without requiring inspectors to uniformly review and document
vehicle cleaning procedures, FDA has insufficient assurance that the
vehicles are safe to carry cattle feed and feed ingredients.[Footnote
24]
FDA Does Not Fully Report BSE Inspection Results:
In January 2004, FDA's Deputy Commissioner testified that inspectors
"at least annually, targeted BSE inspections of 100 percent of known
renderers, protein blenders, and feed mills processing" with prohibited
material. He testified that compliance by those firms was "estimated to
be better than 99 percent." Subsequently, some industry officials
claimed that overall compliance with the feed ban is nearly 100 percent
and used that figure to support their claim that the feed ban does not
need to be strengthened. However, as noted earlier, those groups are
comprised of about 570 firms--approximately 4 percent of the firms in
FDA's inventory.
In addition, FDA periodically publishes compliance information on its
Web site for all industry segments. This information has also been used
to cite high industry compliance. However, FDA and industry do not have
a basis for citing a compliance rate for a segment of firms subject to
the feed ban or industrywide because there are too many unknowns.
Specifically, FDA does not know the status of compliance for firms
that:
* have never been inspected,
* have not been reinspected in 5 or more years, and:
* may have started to process with prohibited materials since their
last inspection.
Furthermore, as we previously discussed, because FDA does not routinely
sample feed to confirm compliance, inspection results are largely based
on a review of paper documents and a visual inspection. All these
concerns apply to compliance information FDA reports to Congress and
the public on its Web site.
Additionally, our analysis of inspection reports also disclosed that
FDA was not including all serious violations in its calculation of the
compliance rate because it reclassified firms as "in compliance" once
they correct violations, regardless of how long the problem may have
existed.
Finally, we found that FDA has classified 42 firms as having less
serious violations that it counted as "in compliance" with the feed
ban. Inspectors reported that 18 of these firms failed to include a
cautionary statement on feed containing prohibited materials. Although
FDA's feed-ban inspection guidance designates the lack of a cautionary
statement as a serious violation, and lack of such a statement should
result in the feed being deemed misbranded under the Federal Food,
Drug, and Cosmetic Act, FDA excluded the violations at these firms from
its calculation of the compliance rate. Inspectors also reported that
the remaining 24 firms had procedures for preventing commingling but
did not have these procedures in writing. FDA's guidance designates the
lack of written procedures as a less serious violation, but we believe
these violations should be classified as serious. Without written
procedures, FDA has no assurance that the firms consistently take the
necessary steps to prevent commingling. FDA officials told us that the
guidance is advisory and therefore gives the agency the discretion to
reclassify the violations based on its review.
Conclusions:
Diligent FDA oversight and enforcement of the feed ban is essential,
not only because of the potential threat to public health but also
because of the economic impact on the cattle and beef industry; this
impact was clearly demonstrated by the sharp drop in U.S. beef exports
after one infected cow was discovered in 2003. The ongoing discussions
and agreements to reopen beef export markets could be derailed if more
cattle were discovered with BSE.
FDA has taken positive steps since our 2002 report. Today FDA can say
with greater confidence that it has more timely and reliable inspection
data. Also, the risk-based system FDA has adopted to target inspection
resources on high-risk firms will increase the likelihood that firms
inspected annually will remain in compliance with the feed ban.
FDA's processes, however, still have considerable room for improvement.
FDA does not have uniform procedures for identifying additional firms
that are subject to the ban but have never been inspected or for
learning about firms that change their practices and begin to handle
prohibited material. Furthermore, because inspectors are not using
tests optimally--to help confirm, when appropriate, that cattle feed,
production equipment, and transportation vehicles are free of
prohibited material--FDA is limiting its ability to assure that firms
are in compliance with the feed ban and that cattle feed is safe.
Additionally, FDA is not taking advantage of state test results to
provide greater assurance that industry is adhering to the feed ban and
is not using its own program for sampling finished feed and feed
ingredients in a manner that will allow it to project test results.
Moreover, the lack of a requirement for warning labels on feed and feed
ingredients intended for export that contain prohibited material,
creates opportunities for having the material fed to domestic or
foreign cattle, either intentionally or inadvertently. As the
international group of BSE experts convened by USDA pointed out, the
United States has an obligation to act responsibly toward its global
neighbors when exporting feed and feed ingredients.
Especially troubling was our discovery that FDA did not alert USDA and
state authorities when it became aware that cattle had been given feed
that contained prohibited material. FDA, and its key partner, USDA,
together provide critical firewalls that the federal government has in
place to protect U.S. cattle and consumers. In addition, the lack of
notification was contrary to FDA's own guidance and FDA's inaction
prevented USDA and states from being able to make an informed decision
on how to respond to the discovery that cattle had consumed prohibited
material.
Given these weaknesses and the fact that FDA does not include all
violations in its estimates, we believe FDA is overstating industry's
compliance with the animal feed ban and understating the potential risk
of BSE for U.S. cattle in its reports to Congress and the American
people. Despite the problems in FDA's calculation, some in the feed
industry claim that overall compliance with the feed ban is nearly 100
percent--a claim that FDA's compliance information does not support.
Recommendations for Executive Action:
To further strengthen oversight and enforcement of the animal feed ban
and better protect U.S. cattle and American consumers, we recommend
that the Commissioner of FDA take the following nine actions:
* Develop uniform procedures for identifying additional firms subject
to the feed ban.
* Require firms that process with prohibited material to notify FDA. If
FDA believes it does not have the necessary statutory authority, it
should seek that authority from Congress.
* Develop guidance for inspectors to systematically use tests to verify
the safety of cattle feed and to confirm the adequacy of firms'
procedures for ridding equipment and vehicles of prohibited material
before they are used for processing or transporting cattle feed or feed
ingredients.
* Collect feed test results from states that sample feed to help verify
compliance with the feed ban.
* Develop a sample design for FDA's inspectors to use for sampling
finished feed and feed ingredients that will allow FDA to more
accurately generalize about compliance with the feed ban from the test
results.
* Seek authority from Congress to require the cautionary statement on
feed and feed ingredients that are intended for export and that contain
prohibited material.
* Ensure that USDA and states are alerted when inspectors discover that
feed or feed ingredients with prohibited material may have been fed to
cattle.
* Modify the BSE inspection form to include questions inspectors can
use to document whether firms that process or handle cattle feed or
feed ingredients have procedures to ensure the cleanliness of vehicles
they use to transport cattle feed and feed ingredients.
* Ensure that inspection results are reported in a complete and
accurate context.
Agency Comments and Our Evaluation:
We provided FDA with a draft of this report for review and comment. FDA
stated that our report was thorough and that it recognized the
enhancements FDA has put in place in its feed-ban program. However, FDA
said the report did not identify material weaknesses to support our
position that oversight weaknesses limit FDA's program effectiveness
and place U.S. cattle at risk of spreading BSE. FDA believes that its
current risk-based inspection approach is adequate to protect U.S.
cattle. According to FDA, given the wide variety of firms subject to
the feed ban and its resource limitations, it "is obligated to set
priorities for inspecting a meaningful subpopulation of these regulated
firms." We recognize that FDA has made many improvements, including
adopting a risk-based approach for inspections, that have substantially
improved its oversight of the feed-ban rule. However, our report
identifies significant problems in FDA's oversight that continue to
place cattle at risk for BSE. The importance of a strictly enforced
feed ban is heightened now that BSE has been found in North American
cattle. As Harvard and the international panel of experts pointed out,
the feed ban is the most important fire wall against the spread of BSE.
Given the problems we identified and the significance of a well
enforced feed ban, it is important that FDA improves its feed ban
oversight and optimizes its use of resources.
In addition, FDA does not agree with our criticism of its compliance
reporting. FDA believes that it provides the inspection results in a
transparent, complete, and accurate context. FDA notes that the BSE
inspection data posted on its Web site "allows the user to analyze the
data, in a multitude of ways, to provide their own contextual
reference." Our concern is precisely that the data are being analyzed
and interpreted in an erroneous context. Specifically, when FDA and
industry used those data to assert a 99 percent compliance rate with
the feed ban, they took that information out of context. While FDA's
calculation of compliance by a subset of regulated industries may in
fact be quite high, FDA's data are not sufficient to make that
projection to all regulated industries. In addition, FDA does not know
the status of compliance for firms that have never been inspected or
have not been reinspected in years. Nor does it know if previously
inspected firms have started using prohibited material. Furthermore,
because FDA reclassifies firms from "out-of-compliance" to "in-
compliance" on its Web site when the firms correct violations, the
information posted on that Web site does not tell the user when serious
and/or long-standing violations have occurred. Lastly, inspection
results are largely based on a review of paper documents and a visual
inspection, with little or no feed testing. Given these data concerns
and compliance unknowns, FDA's data should not be used to project
industry compliance; and, anytime those data are cited, they should be
reported in a complete and accurate context.
Regarding the nine recommendations we make in the report, FDA did not
take issue with the need for five and generally disagreed with four.
Although FDA noted implementation concerns, it did not take issue on
the need for (1) developing uniform procedures for identifying firms
subject to the feed ban, (2) collecting test results from the states
that sample feed, (3) including a cautionary statement on feed and feed
ingredients intended for export, (4) notifying USDA and states when
feed or feed ingredients containing prohibited material may have been
fed to cattle, and (5) modifying the inspection form to include
questions to better oversee the cleanliness of vehicles used to
transport cattle feed or feed ingredients.
FDA disagreed with our recommendation that it require firms that
process with prohibited material to notify the agency. FDA believes
that it is already getting information on changes to firms' practices
from states and that requiring an additional notification process would
be costly to implement. However, FDA acknowledged that it has generally
not identified high-risk feed salvagers and farms that mix their own
feed or those that feed cattle as well as other animals. The cost of
the notification program will depend on the requirements FDA puts in
place. In developing the program, FDA could target the notification to
firms that pose a potentially high risk for exposing cattle feed to
prohibited material. We believe that FDA should know which firms are
high risk and that industry self-reporting is a mechanism that would
help the agency identify those firms and help it ensure compliance with
the feed ban.
FDA also disagreed with our recommendation to systematically use tests
in conjunction with compliance inspections. While we recognize the
limitations of current test methodologies, we believe that tests are
useful. In fact, states and FDA are currently using these tests on
feed. Our recommendation speaks to systematically using these tests
where appropriate, to augment inspections, which are largely
observation and paperwork reviews. We expanded the recommendation to
recognize that FDA may validate other tests in the future.
With respect to our recommendation that FDA develop a sample design for
testing finished feed and feed ingredients, FDA disagreed with the need
for a sample design that will allow it to more accurately generalize
about compliance. FDA stated that tests alone cannot serve as a basis
to generalize compliance. We agree that tests that indicate potential
violations need to be confirmed, because of the limitations of the
current tests. However, FDA is using the test results to identify
potential problems, and it tested 660 samples in 2003/2004 and plans to
test 900 samples this year. The point of our recommendation is that any
testing activity of this magnitude should have a sampling plan.
Finally, FDA believes that it already reports inspection results in a
complete and accurate context, as we recommend. We disagree. As noted
above, given the data concerns and compliance unknowns raised in this
report, FDA's data should not be used to project industry compliance.
Anytime those data are cited, they should be reported in a complete and
accurate context. FDA also provided technical comments, which we have
incorporated into this report, as appropriate. FDA's written comments
and our responses are in appendix VI.
We also provided USDA with a draft of appendix III, which summarizes
FDA's and USDA's actions in response to the 2003 discovery of BSE in
North America, for review and comment. USDA had no comments on the
draft appendix.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution of it until 30
days from the date of this letter. We will then send copies to
interested congressional committees; the Secretary of Health and Human
Services; the Secretary of Agriculture; the Director, Office of
Management and Budget; and other interested parties. We will make
copies available to others on request. In addition, the report will be
available at no charge on GAO's Web site at [Hyperlink,
http://www.gao.gov].
If you or your staffs have any questions about this report, please call
me at (202) 512-3841. Key contributors to this report are listed in
appendix VII.
Signed by:
Robert A. Robinson:
Managing Director, Natural Resources and Environment:
[End of section]
Appendixes:
Appendix I: Scope and Methodology:
As discussed below, to assess the effectiveness of the Food and Drug
Administration's (FDA) actions to ensure industry compliance with the
feed ban and protect U.S. cattle from bovine spongiform encephalopathy
(BSE), we (1) analyzed 404 inspection reports for BSE inspections
performed during fiscal year 2003 and 2004; (2) observed 19 inspections
in 12 states that were conducted by either FDA or state inspectors; (3)
assessed the reliability of FDA's feed-ban inspection database; (4)
interviewed officials at FDA headquarters and district offices, state
agencies, and industry associations, as well as reviewed documents
provided by these officials concerning oversight of the animal feed
ban; and (5) surveyed state agency officials in 38 states.
To assess FDA's oversight, we analyzed BSE inspection records to
identify types of firms inspected; types of material processed
(prohibited, nonprohibited, or both); oversight of transportation
equipment; violations identified during inspections (if applicable);
and final inspection classifications. We randomly selected 413
inspection reports from the universe of BSE feed inspections conducted
during fiscal year 2003 and fiscal year 2004 (up to February 7, 2004).
For each of the 18 FDA districts, responsible for inspections in the 50
states, we randomly selected inspection reports from one state (most
FDA district offices cover more than one state). We included all of the
314 high-risk firms that process prohibited materials for the 18
selected states. In addition, we randomly selected 12 other firms that
process with prohibited materials; 68 firms that distribute prohibited
materials; and 19 firms that do not process or distribute prohibited
materials. We examined only 404 of the 413 inspection reports because 9
of the report files that we requested were still open-case files at the
time of our review.
To evaluate the inspection process, we accompanied inspectors on 19 BSE
inspections of firms in 12 states covered by the feed ban. The sites
were selected to cover a range of firm types and sizes in various
geographic locations with concentrations of cattle feeding operations,
including dairy cattle. The 19 inspections included renderers, protein
blenders, feed mills, farms with ruminants and other animals, and pet
food manufacturers. Seven of these firms processed or handled only
prohibited material, and the remaining 12 processed or handled both
types of material. On 12 of the inspections, we accompanied FDA
inspectors, and on 7 we accompanied state inspectors.
To assess the reliability of the data FDA uses when reporting industry
compliance, we analyzed the agency's database for inspections conducted
on or after April 15, 2002, when FDA implemented its newly designed
feed-ban database.[Footnote 25] Specifically, we analyzed the 9,230
inspection records in this database, as of February 7, 2004. To
complete the reliability assessment, we (1) reviewed existing
documentation related to the data sources; (2) electronically tested
the data to identify obvious problems with completeness, accuracy, or
timeliness of data entry; and (3) interviewed knowledgeable agency
officials about the data. We determined that the data were sufficiently
reliable for purposes of this report.
We interviewed officials or reviewed documents at FDA headquarters and
at the 18 FDA district offices that are responsible for overseeing and
enforcing the feed ban in the 50 states, maintaining the inspection
database system, and proposing and analyzing regulatory decisions. In
the 18 district offices, we used a structured interview to uniformly
gather information on various issues, such as methods used to identify
the universe of firms subject to the feed ban; the process for
selecting firms for inspection; training programs for FDA and state
inspectors; feed-ban inspection guidance and procedures; the processes
for reviewing inspection results, classifying findings, and determining
what, if any, enforcement action should be taken; and oversight of
contracts and agreements with state agencies that perform BSE
inspections. We received information and documentation on FDA's
oversight and enforcement of the feed ban from the following specific
FDA units: Center for Veterinary Medicine, Office of Management, Office
of Surveillance and Compliance; Office of Regulatory Affair's Office of
Regional Operations; Center for Food Safety and Applied Nutrition's
Office of the Director; and Office of the Chief Counsel. We reviewed
various FDA program documents, including the BSE/Ruminant Feed Ban
Inspections Compliance Program Guidance; BSE feed inspection form;
advance notices of proposed rulemakings to strengthen the feed ban,
including public comments; and the reports on the feed samples
collected and tested. We also interviewed state agency officials and
reviewed documents from the California Department of Food and
Agriculture; the Departments of Agriculture of Georgia, Illinois,
Kansas, Missouri, North Carolina, and Pennsylvania; and the Texas Feed
and Fertilizer Control Service. Lastly, we interviewed officials and
reviewed documents from the American Feed Industry Association, the
Association of American Feed Control Officials, the National Renderers
Association, the Association of Analytical Communities, and the Harvard
Center for Risk Analysis.
To understand the role that states play in the feed inspection program,
we surveyed state officials in the 38 states that have contracts or
other agreements with FDA to perform feed-ban compliance inspections
and report the inspection results to FDA.[Footnote 26] The survey
included questions about the states' inspection programs, testing of
animal feed ingredients, and FDA's training and guidance for feed-ban
inspections and enforcement. Before implementing our survey, we
pretested the questionnaire with state agriculture officials in five
states. During these pretests, we interviewed the respondents to ensure
that (1) questions were clear and unambiguous, (2) terms were precise,
and (3) the survey did not place an undue burden on the staff
completing it. We received completed questionnaires from all 38 states
surveyed. The state information presented in this report is based on
information obtained from this survey and interviews with state
officials.
We performed our work from October 2003 through January 2005, in
accordance with generally accepted government auditing standards, which
included an assessment of data reliability and internal controls.
[End of section]
Appendix II: GAO's Analysis of the Status of Actions on Recommendations
to FDA in Our January 2002 Report:
In order to strengthen oversight and enforcement of the animal feed
ban, we recommended that the Secretary of Health and Human Services
direct the Commissioner of FDA to take the following actions:
Recommendation: Develop a strategy, working with the states, to ensure
that the information FDA needs to oversee compliance is collected and
that all firms-subject to the feed ban are identified and inspected in
a timely manner;
Status of actions taken: FDA (1) developed a new BSE inspection form
that provides guidance to FDA and state feed- ban inspectors on how to
uniformly and completely document firm's operations and assess
compliance, (2) designated a BSE program coordinator in each district
office who is responsible for ensuring that inspection reports are
accurate and completed timely, and (3) provided training for FDA and
state inspectors on conducting and documenting BSE inspections; FDA
has not developed a uniform strategy to identify all firms subject to
the feed ban or to ensure that all firms are inspected in a timely
manner.
Recommendation: Ensure that, as contractors modify the inspection
database, they incorporate commonly accepted data management and
verification procedures so that the inspection data can be useful as a
management and reporting tool;
Status of actions taken: FDA implemented a newly designed BSE feed-ban
database and data-entry procedures designed to more reliably track feed-
ban inspection results. The new database, a module of FDA's Field
Accomplishment and Compliance Tracking System, contains commonly
recognized database management and verification procedures, such as
unique identifiers for each inspected firm and edit checks to help
ensure that data entered is complete and valid.
Recommendation: Develop an enforcement strategy with criteria for
actions to address firms that violate the ban and time frames for
reinspections to confirm that firms have taken appropriate corrective
actions;
Status of actions taken: FDA issued feed-ban inspection guidance to FDA
and state inspectors and program managers for determining compliance
with the animal feed ban and to help ensure that BSE feed inspections
and enforcement actions are conducted in a uniform manner and are of
high quality.
Recommendation: Track enforcement actions taken by states;
Status of actions taken: FDA does not plan to track enforcement actions
taken by states, as we had recommended. Officials told us that FDA and
state enforcement actions would not be comparable because state
standards for initiating an action may not be equivalent to FDA
standards. As a result, FDA believed that the information would be
misleading if presented collectively.
In order to strengthen inspections of imported products that could pose
a risk of BSE, we recommended that the Secretaries of Health and Human
Services and of Agriculture, in consultation with the Commissioner of
Customs:
Recommendation: Develop a coordinated strategy, including identifying
resource needs;
Status of actions taken: FDA hired more than 655 additional food
security personnel and increased its port-of-entry food examinations,
including imported animal feed that could pose a risk of BSE; As part
of the prior notice requirement of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, FDA and the U.S.
Customs and Border Protection announced that they have integrated their
information systems, which allows FDA staff to more efficiently
evaluate and process each import entry; FDA and U.S. Customs and Border
Protection signed a memorandum of understanding under which FDA
commissions Customs officers in ports and other locations to conduct,
on FDA's behalf, investigations and examinations of imported food,
including animal feed. Currently, FDA has commissioned over 8,000
Customs officers.
To further help consumers identify foods and other products that may
contain central nervous system tissue, we recommended that the
Secretary of Health and Human Services:
Recommendation: Consider whether the products it regulates, including
food, cosmetics, and over-the-counter drugs, should be labeled to
advise consumers that the products may contain central nervous system
tissue;
Status of actions taken: FDA does not intend to label these products,
as we recommended. Officials told us that that the decision to label
products has to be based on science and if the presence of central
nervous system tissue poses a human risk, then it should not be allowed
as an ingredient in the product; FDA issued an interim final rule in
July 2004 that prohibits the use of certain cattle material, including
central nervous system tissue from nonambulatory cattle, in human food,
including dietary supplements, and cosmetics.
Source: GAO analysis of FDA documents.
[End of table]
[End of section]
Appendix III: GAO's Summary of FDA's and USDA's Actions in Response to
the Two Cases of BSE Discovered in North America in 2003:
Date: May 20, 2003;
FDA: Canadian government reported that a single cow from Alberta had
tested positive for BSE. FDA began working with USDA, other federal
agencies, and Canadian officials to gather additional information about
this cow, including its location, previous ownership, and records about
its feed;
USDA: USDA temporarily halted imports of live ruminant animals and most
ruminant products from Canada.
Date: May 26, 2003;
FDA: FDA learned from the Canadian government that rendered material
from the BSE-infected cow may have been used to manufacture pet food,
some of which was shipped to the United States. FDA notified the U.S.
pet food firm that received the feed ingredients and the firm requested
that customers who may have purchased the suspect product hold it for
pickup by the distributor.
Date: August 8, 2003;
USDA: USDA announced it would allow certain ruminant products from
Canada to enter the United States under permit. These include boneless
beef from cattle under 30 months of age and boneless veal from calves
that were 36 weeks of age or younger.
Date: October 31, 2003;
USDA: USDA announced a proposed rule, published on November 2003, to
allow the importation of certain low-risk, live ruminant animals and
ruminant products from Canada; USDA released the results of the second
Harvard BSE risk assessment. The study found that even if infected
animals or ruminant feed material entered the United States from
Canada, the risk of BSE spreading within the U.S. herd is low.
Date: December 9, 2003;
USDA: USDA collected samples from a nonambulatory cow and diverted all
potentially high-risk material (central nervous system tissue) from the
human food supply and into the animal rendering process.
Date: December 22, 2003;
USDA: USDA laboratory test results are "preliminary positive" for BSE.
Date: December 23, 2003;
FDA: USDA's Animal and Plant Health Inspection Service (APHIS) notified
FDA's Office of Crisis Management that a "presumptive positive" finding
of BSE in the Washington cow; FDA activated its Emergency Operations
Center and began to implement its BSE Emergency Response Plan. FDA
headquarters and district office staff participated in a teleconference
with APHIS and Washington State officials to ensure a coordinated
response to the incident;
USDA: USDA announced a "presumptive positive" finding of BSE; USDA sent
a sample from the infected animal to a world reference laboratory in
the United Kingdom for final confirmatory testing; APHIS quarantined
the cattle herd where the BSE-infected cow last resided and began an
epidemiological investigation; USDA's Food Safety and Inspection
Service (FSIS) initiated a recall of the over 10,000 pounds of meat
from the group of 20 cattle slaughtered on December 9.
Date: December 24, 2003;
FDA: FDA dispatched several teams of investigators to find any FDA-
regulated products that were or could have been made from the infected
cow, including animal feed.
Date: December 25, 2003;
USDA: The world reference laboratory in the United Kingdom confirms
USDA's BSE diagnosis.
Date: December 27, 2003;
FDA: FDA announced that an estimated 2,000 tons of feed that could
contain potentially infectious material from the BSE-infected cow was
found before any of it was used to manufacture animal feed. According
to FDA, the feed was disposed of in a landfill in accordance with
federal, state, and local regulations;
USDA: USDA's investigation with Canadian officials indicated that the
BSE-infected cow was likely imported from Canada in 2001 and was about
6½ years old.
Date: December 28, 2003;
USDA: USDA identified 73 other cattle that were imported from Canada in
the same shipment with the BSE-infected cow; USDA determined that the
recalled meat products had been distributed to Alaska, California,
Guam, Hawaii, Idaho, Montana, Nevada, Oregon and Washington.
Date: December 31, 2003;
USDA: USDA appointed an international team of scientific experts to
review its BSE investigation and make recommendations following the
completion of the epidemiological investigation.
Date: January 6, 2004;
USDA: USDA's and Canada's chief veterinary officers held a joint press
conference to announce that DNA evidence indicated--with a high degree
of certainty--that the BSE-positive cow found in Washington State
originated from a dairy farm in Alberta, Canada.
Date: January 12, 2004;
USDA: FSIS issued an interim final rule, effective January 12, 2004,
that, among other things, prohibited the use of brain, skull, spinal
cord, and other specified tissues of cattle 30 months or older for
human food, and required that all nonambulatory animals presented for
slaughter be condemned. FSIS also gave notice that it would no longer
pass and give a mark of inspection to carcasses and cattle parts
selected by APHIS until the sample is determined to be negative.
Date: January 26, 2004;
FDA: FDA announced that it would be issuing interim final rules to
strengthen existing BSE firewalls, including banning a wide range of
cattle material from human food, dietary supplements, and cosmetics,
and strengthening the 1997 feed ban through an extended list of banned
feeding and manufacturing practices.
Date: February 9, 2004;
USDA: USDA completed its investigation of the Washington State BSE
case.
Date: June 1, 2004;
USDA: Following the international scientific review panel's
recommendation, USDA began an enhanced BSE surveillance program
targeting cattle from highest-risk populations, as well as a random
sampling of animals from the aged cattle population.
Date: July 14, 2004;
FDA: FDA requested information and public comment on additional
measures that are being considered for strengthening the 1997 feed ban.
FDA requested this information because the international scientific
review panel convened by the Secretary of Agriculture recommended
broader measures than FDA had previously announced it would be issuing
as part of an interim final rule, such as banning all mammalian and
poultry protein from ruminant feed; FDA issued an interim final rule
that prohibits certain cattle material from human food, dietary
supplements, and cosmetics;
USDA: USDA asks for public comment on additional preventative actions
that are being considered concerning BSE, such as implementation of a
national animal identification program.
Date: September 30, 2004; FDA: FDA announced the availability of
industry guidance "Use of Material from BSE-Positive Cattle in Animal
Feed."
Source: GAO analysis of FDA and USDA documents.
[End of table]
[End of section]
Appendix IV: Survey of State Agencies:
[See PDF for image]
[End of figure]
[End of section]
Appendix V Chronology of FDA's Feed Ban and Proposed Rulemakings:
August 4, 1997:
FDA feed ban took effect, prohibiting certain materials in ruminant
feed to prevent the establishment and spread of BSE if it were to
appear in U.S. cattle herds. FDA took this action because it had been
an industry practice to feed proteins to ruminant animals that could
transmit the infective agent that causes BSE. Additionally, research in
the United Kingdom suggested that variant Creutzfeldt-Jacob Disease
(vCJD) in humans is linked to eating cattle infected with BSE. The feed
ban requires that firms, with some exceptions, take the following
actions:
* label feed and feed ingredients that contain most proteins from
mammals (prohibited material) with a cautionary statement "Do not feed
to cattle or other ruminants,"
* have procedures to protect against commingling or cross-contamination
if they handle both prohibited and nonprohibited feed and feed
ingredients by using either equipment dedicated exclusively to feed or
ingredients intended for cattle or using cleanout procedures or other
adequate means to prevent carryover, and:
* maintain records so that feed and feed ingredients that contain or
may contain prohibited material can be tracked from receipt through
disposition.
According to FDA's rules, firms that transport both types of materials
must also follow these procedures. Additionally, prohibited materials
may be used in pet food and in feed for poultry, swine, horses, and
other nonruminant animals. Lastly, FDA designated a number of cattle-
and other animal-derived items as exempt from the ban--and hence,
allowable in cattle feed. These items include blood and blood products,
plate waste, gelatin, milk and milk protein, and any product whose only
mammalian protein consists entirely of protein from pigs and horses.
FDA has also not regulated the use of poultry litter in feed.
October 30, 2001:
FDA held a public hearing to solicit information and views regarding
ways in which the current feed ban and its enforcement might be
improved or to determine if any new objectives should be considered.
FDA took this action because BSE had spread beyond the United Kingdom
to most countries in western and central Europe and Japan. FDA asked
for responses to 17 questions, including the following:
* Should FDA require dedicated facilities for the production of animal
feed containing mammalian protein?
* Should FDA require dedicated transportation of animal feed containing
mammalian protein?
* Should FDA license renderers and other firms engaged in the
production of animal feed containing mammalian proteins?
* Should FDA revoke or change any of the current exemptions in the
current rule?
* Should FDA require pet food to contain the cautionary statement?
* Should FDA extend the recordkeeping requirement beyond 1 year?
* Should FDA request authority to assess civil monetary penalties?
November 6, 2002:
FDA published an advanced notice of proposed rulemaking announcing that
it was considering revising the feed ban and asking the public to
comment on certain possible modifications. FDA explained that shortly
after its October 2001 public hearing, USDA released a report by the
Harvard Center for Risk Analysis on the findings of a major, 3-year
initiative to develop a risk assessment model and assess the risk of
BSE in the United States. The model concluded that the risk to U.S.
cattle and to consumers from BSE is very low, but certain new control
measures could reduce that small risk even further. Therefore, based on
comments received at the public hearing and the findings of the Harvard
Study, FDA asked for public comment on various ways that the BSE feed
ban could be strengthened, including the following questions:
* Should tissues that are known to be at higher risk for harboring the
infective agent for BSE, such as brain and spinal cord from ruminants 2
years of age or older be excluded from all rendered products?
* How extensive is the use of poultry litter in cattle feed, what is
the level of feed spillage in poultry litter, and what would be the
impacts resulting from banning poultry litter in ruminant feed?
* Should pet food for retail sale carry the cautionary statement "Do
not feed to cattle or other ruminants?"
* Are there practical ways, other than dedicated facilities, for firms
to demonstrate that the level of carryover of prohibited material in a
feed mill could not transmit BSE to cattle or other ruminants? If so,
what is the safe level of carryover of prohibited material and what is
the scientific rationale for establishing this safe level?
* To what extent is plate waste used in ruminant feed and what would be
the impacts from excluding this material from ruminant feed?
January 26, 2004:
FDA announced that it would be issuing interim final rules to
strengthen existing BSE firewalls, including banning a wide range of
cattle material from human food, dietary supplements, and cosmetics,
and strengthening the 1997 feed ban through an extended list of banned
feeding and manufacturing practices.
July 14, 2004:
FDA, with USDA, announced that the agencies are considering additional
measures to protect the public from the health risk associated with BSE
and to prevent the spread of the disease in U.S. cattle and are asking
for public comment. The agencies are considering additional safeguards
based on the recommendations of a panel of international experts
convened by the Secretary of Agriculture to review the U.S. regulatory
response following the finding of a BSE-positive cow in Washington
State in December 2003. In addition to some of the measures FDA had
planned to take in an interim final rule, the international panel
recommended broader measures, such as banning all mammalian and poultry
protein from ruminant feed. Since these recommendations would require
significant changes in current feed manufacturing practices and could
make some previously announced proposals unnecessary, FDA requested
additional information and public comment on the panel recommendations
and other measures, including the following:
* What information is available to support or refute the assertion that
removing tissues that are known to be at higher risk for harboring the
BSE infective agent, such as brain and spinal cord tissue, from all
animal feed is necessary to effectively reduce the risks of cross-
contamination of ruminant feed or of misfeeding on the farm?
* If FDA prohibits high-risk tissues from all animal feed, would there
be a need to require dedicated facilities, equipment, storage, and
transportation?
* What information is available to support banning all mammalian and
poultry meat and bone meal from ruminant feed?
* If FDA prohibits high-risk tissues from all animal feed, what
information is available to support banning all mammalian and poultry
meat and bone meal from ruminant feed?
* Can high-risk tissues be effectively removed from dead stock and
nonambulatory cattle so that the remaining material can be used in
animal feed, or is it necessary to prohibit the entire carcass from use
in all animal feed?
* Do FDA's existing authorities under the Federal Food, Drug, and
Cosmetic Act and under the Public Health Service Act provide a legal
basis to ban the use of high-risk cattle tissues and other cattle
material in nonruminant animal feed, given that such materials have not
been shown to pose a direct risk to these animals?
FDA also issued an interim final rule on July 14, 2004, to prohibit
certain cattle materials in FDA-regulated food, including dietary
supplements, and cosmetics, to minimize potential human exposure to the
BSE infective agent. Specifically, FDA prohibited use of the brain,
skull, spinal cord, and other specified tissues of cattle that are 30
months or older; small intestine and tonsils of all cattle; material
from nonambulatory disabled cattle or cattle not inspected and passed
for human consumption; and beef that is mechanically separated from
bones. FDA took this action in response to the finding of a BSE-
positive cow in Washington State in December 2003 and to conform with
an interim final rule issued by USDA in January 2004 declaring these
materials unfit for human consumption.
[End of section]
Appendix VI: Comments from the Food and Drug Administration:
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Food and Drug Administration:
Rockville MD 20857:
January 13, 2005:
Robert A. Robinson:
Managing Director, Natural Resources and Environment:
Natural Resources and Environment Team:
United States Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Mr. Robinson:
Please find the enclosed comments from the Food and Drug Administration
on the GAO draft report entitled, MAD COW DISEASE, FDA's Management of
the Feed Ban Has Improved But Oversight Weaknesses Continue to Limit
Program Effectiveness, GAO-05-101). The agency provided technical
comments directly to your staff.
We appreciate the opportunity to review and comment on this draft
report before its publication as well as the opportunity to work with
your staff in developing this report.
Sincerely,
Signed by:
Lester M. Crawford, D.V.M., Ph.D
Acting Commissioner of Food and Drugs:
Enclosure:
General Comments by the Department of Health and Human Services' Food
and Drun Administration on the Government Accountability Office's Draft
Report, MAD COW DISEASE: FDA's Management of the Feed Ban Has Improved
But Oversight Weaknesses Continue to Limit Program Effectiveness, (GAO-
05-101):
The Food and Drug Administration (FDA) appreciates the opportunity to
review and comment on the Government Accountability Office's (GAO)
draft report. While GAO has raised a few areas to further strengthen
the feed ban program, FDA does not believe that material weaknesses
were identified that support GAO's position that "various oversight
weaknesses continue to limit program effectiveness of the ban and place
U.S. cattle at risk of spreading BSE."
FDA commends GAO for conducting such a thorough and diligent study on
such an important program and we appreciate the recognition of the
enhancements put into place as we have expanded our activities. We note
that this work was conducted in October 2003 through November 2004, and
involved visits to 17 of 19 FDA district offices, visits to many states
conducting inspections under the ruminant feed ban, a significant
review of our data systems and multiple meetings with headquarters
personnel. A considerable amount of FDA resource time has been devoted
to responding to the information requests of this GAO study. While FDA
has endeavored to provide both timely and complete responses, we note
that FDA field offices alone expended approximately 1500 hours
nationwide to provide the 413 inspection reports and to respond to
questions from GAO during their visits. This does not include the
ongoing information collection requested by GAO after the exit
conference, of follow-up information on approximately two hundred feed
samples.
FDA's ruminant feed ban regulation, our implementation of which uses a
risk-based approach, potentially involves a wide variety of firms
involved in the animal feed industry. Every firm that manufactures,
transports, distributes or sells animal feed or feed ingredients for
any animal species is subject to inspection under the FDA ruminant feed
ban compliance program, regardless of whether prohibited material is
utilized. Even swine and poultry farms that mix their own feed and
grocery stores that sell pet food are potentially subject to inspection
under this rule. All operations feeding ruminants, such as dairy and
beef cattle, are also subject to the rule. In consideration of the
limited resources for inspecting this large population of firms, FDA is
obligated to set priorities for inspecting a meaningful subpopulation
of these regulated firms.
FDA provides inspection priority direction to FDA and state
investigators through publication of an inspection priority document as
part of the BSE/Ruminant Feed Inspection Compliance Program guidance
document. The highest priority for inspection is directed towards firms
that are manufacturing or processing animal feeds or feed ingredients
that contain prohibited material. This industry segment, which includes
renderers, protein blenders, and feed mills, represents the most
important industry segment to ensure that ruminant feeds do not contain
prohibited material. This industry group is inspected on an annual
basis.
Generally, firms outside of these segments collectively have a lower
priority for inspection since the operations of the firms in the high
priority segment of the industry pose the greatest risk of resulting in
contaminated feed. Other segments, such as cattle feeders, are of
interest to the FDA, but there are estimated to be over one million
ruminant feeders in the U.S. While FDA does not have the resources to
fully inspect certain industry segments, the agency continues to
develop and utilize educational tools to compliment inspections and to
promote voluntary compliance in these large industry segments. FDA will
additionally implement inspectional initiatives to increase its
presence in some of these less inspected segments, such as transporters
and animal feed salvagers, based on our assessment of compliance and
risk in these industry sectors.
We also do not agree with the assertion by GAO concerning the format
with which FDA summarizes ruminant feed ban reporting of inspection
results. FDA has provided a degree of transparency related to these
inspections that is unprecedented, compared to any other inspection
program. All data related to BSE inspections are posted on an Internet
site that is available to Congress, industry and the public. FDA took
this action because of the visibility of this inspection program and
because of the recognition that one of the best tools to obtain
compliance with the feed ban was public disclosure of our findings.
While GAO may disagree with the context provided by any summary
documents, our web site allows the user to analyze the data, in a
multitude of ways, to provide their own contextual reference.
RECOMMENDATIONS FOR EXECUTIVE ACTION:
To further strengthen oversight and enforcement of the animal feed ban
and to better protect U.S. cattle and American consumers, we recommend
that the Secretary of Health and Human Services direct the Commissioner
of FDA to take the following 9 actions:
1) Develop uniform procedures for identifying all firms subject to the
feed ban.
FDA Comment:
FDA has already identified the merits of using a consistent procedure
for identifying additional firms subject to its jurisdiction and has
revised the Investigational Operations Manual (IOM).
As noted in the report, FDA acknowledges that more firms are subject to
the feed ban than the over 14,800 that have been inspected to date.
However, FDA's current inspectional strategy has been to focus on
renderers, protein blenders, and feed mills, which we believe are the
primary means of controlling feed and feed ingredients that may contain
prohibited material. FDA believes that it has uniform procedures for
identifying and inspecting these higher risk firms and that we have
been successful in covering this inventory. The survey data collected
by GAO from the states supports that, to a great extent, this inventory
of firms has been both identified and inspected.
The issue that GAO raises in the draft report is related only to the
lower risk firms that are purchasing feed ingredients from one of the
higher risk establishments. FDA does not have the resources to inspect
all ruminant feeders, transporters/haulers of feed, feed retailers and
feed distributors that may be subject to this regulation. This total
inventory is massive and for most of these firms there is either no
commercial handling of prohibited material since they are handling only
packaged product (like pet food), or there is limited manipulation of
the product that would allow for contamination. Therefore, the FDA
approach has been to selectively inspect sample firms in this lower
risk category to assess their level of compliance with the regulations,
and to assist in determining additional educational efforts that may be
needed. FDA has inspected all firm types in these lower risk industry
segments and continues to expand the number of inspections conducted
both by FDA and the states in these lower risk categories. When FDA
identifies a specific segment that may need additional inspectional
coverage, the agency will issue specific assignments to broaden our
coverage. This is the situation with the transporters/haulers and pet
food salvagers for which the FDA's Center for Veterinary Medicine (CVM)
is currently drafting an assignment to FDA's field operations.
GAO identified a process used by some FDA investigators, on some of the
observed inspections, to help FDA identify additional firms. This
process entails investigators writing down the names of the suppliers
and customers of firms during inspections to check against the
inventory of active firms. While there is value to GAO's suggestion,
the recording of the supplier and customer names and later checking
them against an inventory of active firms after all inspections would
take additional resource time and is not resource neutral as suggested
by GAO. The current BSE inspection module is 7.5 hours. Such inventory
improvement would utilize time that would have to be diverted from
conducting additional inspections. Nevertheless, FDA has already
identified the merits of consistently using this approach. Earlier this
year, as part of FDA's ongoing improvements in our security awareness
program, we recently changed our 2005 Investigations Operations Manual
(IOM) regarding the standard narrative report. IOM Chapter 593.03,
Individual Narrative Headings, has been revised to advise the FDA
Investigator to verify, during the initial inspection, distribution
patterns for the firm's products, raw materials, and components to
firms which warehouse or further process products which may be subject
to FDA regulations. The 2005 IOM revision also reminds FDA District
Offices that any new information should be incorporated into their
Official Establishment Inventory (OEI) improvement activities. Lastly,
this revised section also provides a cross-reference to the necessary
section of the IOM that describes how to add firms to a District OEI.
Once the 2005 IOM has been finalized, ORA will alert Districts through
our various mechanisms to this change, which affects all ORA Inspection
programs, including the BSE Inspection Program. We will also discuss
this recommendation with the Field Veterinary Committee for
incorporation into the next Compliance Program Guidance revision of the
BSE Inspection program.
2) Require that firms that process with prohibited material notify FDA.
If FDA believes it does not have legislative authority to require this,
it should seek that authority from the Congress.
FDA Comment:
FDA's current regulations do not require that firms handling prohibited
material notify FDA and the Federal Food, Drug, and Cosmetic Act
(FFDCA) does not currently require such notification. If such a
notification program were implemented, FDA would need significant
additional resources to develop the notification regulation, develop
collection and monitoring tools, collect the information, monitor the
information and compliance with the requirement, and conduct follow-
ups. FDA believes that our current approach of working collaboratively
with our state counterparts does give us a good opportunity to keep
abreast of changes firms may make in the use of prohibited material and
to use our resources to focus on high risk firms. We continue to
enhance our working relationships with our state counterparts to
facilitate the exchange of such information.
In support of identifying all firms of higher risk, FDA has already
initiated the process of reviewing records for food facilities that
have registered with FDA under section 415 of the FFDCA, and
determining whether there are any facilities that may potentially
handle prohibited material that have registered but that we have not
previously inspected. Under section 415 of the FFDCA, facilities that
manufacture, process, pack, or hold food for consumption in the United
States must register with FDA. When the facility registers, it must
indicate if it manufactures, processes, or packs certain categories of
food. The facility may voluntarily indicate if it manufactures,
processes, or packs other categories of food. All categories of animal
food are among those that facilities may voluntarily report to FDA.
While the registration system has certain limitations, including an
exemption for farms that process feed for their own animals, we believe
that the registration information could still lead us to identify
additional facilities that handle prohibited material.
3) Develop guidance for inspectors to systematically use feed
microscopy and/or polymerase chain reaction (PCR) to verify the safety
of cattle feed and to confirm the adequacy of firms' procedures for
ridding equipment and vehicles of prohibited material before they are
used for cattle feed or feed ingredients.
FDA Comment:
Since no test currently exists for the detection of the infectious
prion agent that causes BSE in feed, analysis of feed is not by itself
a means of verifying the safety of cattle feed. Additionally, feed
microscopy and/or PCR are not adequate methods to make compliance
decisions based on test results alone about the presence of prohibited
material with respect to the ruminant feed ban rule. The feed
microscopy method has limitations and the rule has exemptions. Feed
microscopy generally can only detect the presence of mammalian tissue,
through the identification of either bone or hair. In certain
situations, feed microscopy can only detect the presence of animal
tissue when blood is detected. The present ruminant feed ban allows for
certain exemptions to the mammalian protein prohibition. Exempted
materials include pure porcine meat and bone meal, blood (from any
animal species, including ruminants), gelatin, and milk protein.
Further, there is no prohibition on the use of non-mammalian proteins
(e.g., poultry meal). The detection of certain non-specific materials,
such as bone or muscle, may be the result of exempt ingredients, such
as ruminant blood meal, pure porcine meat and bone meal, or poultry
meal. PCR has similar limitations since the test cannot differentiate
between prohibited material ingredients and certain ruminant-
containing exempt ingredients, such as ruminant blood, ruminant milk
products, and plate waste. Since feed microscopy and PCR cannot
differentiate prohibited material from other acceptable materials, the
analytical results cannot be used to verify the presence [or absence]
of prohibited material, nor used for confirming the adequacy of clean-
out measures.
On August 18, 2003, FDA/CVM issued a sampling assignment to the FDA
field staff for the collection of 600 domestic samples [increased to
900 samples for the current fiscal year]. The characteristics of the
ruminant feed ban sampling assignment are unique when compared to other
FDA sampling programs. Other programs are more simply based on
methodology that can definitively detect the presence of the
objectionable contaminant or pathogen. Further, the nature of the
contaminants in some of the other programs allow for the establishment
of tolerance levels. The mere detection of a pathogen or some of these
contaminants, possibly with respect to an established tolerance, is
sufficient to result in the finding of a violation in these other
programs. In contrast to these other programs, analytical findings
alone under the ruminant feed ban program cannot establish the
occurrence of a violation to the rule. As the ruminant feed ban
assignment notes, positive analytical findings necessitates follow-up
evaluations in determining whether the findings were indeed the result
of ruminant feed ban violations.
The fairly recent implementation of this unique ruminant feed ban
sampling program has involved efforts to educate laboratory personnel
as to the limitations of the methodology, and the approach in
categorizing the lab results. Laboratory personnel have been educated
through conference calls, training, and individual telephone
conversations in classifying these samples. Further, field
investigators have been instructed that regulatory action should not be
taken on the basis of sample analysis alone. (See the Enforcement and
Regulatory follow-up sections in the BSE/Ruminant Feed Ban Inspections
Compliance Program Guidance and the Domestic Feed Sampling Assignment,
respectively.) In the next fiscal year, FDA intends to provide
additional guidance to describe the variety of situations where animal,
mammal and/or ruminant tissue may be present in an animal feed or feed
ingredients. Through an analysis of the experience derived from the
first year of the sampling assignment, FDA will revise overall sampling
instructions in the sampling assignment, with these sampling procedures
eventually being incorporated into the BSE/Ruminant Feed Ban
Inspections Compliance Program guidance document.
4) Collect feed test results from states that sample feed to help
verify compliance with the feed ban.
2002 GAO BSE Study:
Recommendation to track enforcement actions taken by states.
2002 FDA Comment:
FDA thanks the GAO for this recommendation. FDA needs to more fully
evaluate the impact of this recommendation. FDA does not have the
authority to require that all states track and report to FDA
enforcement actions taken. Currently, state laws differ on what
inspection and enforcement authorities each state has and the ability
of each state to provide such information to FDA. We do strongly
support the concept of voluntarily sharing inspection and enforcement
actions taken by FDA and our state partners. This was one of the
primary motivators for our quarterly FDA-State regulator BSE meetings
to provide a forum to share such potentially confidential information.
2004 GAO BSE Study:
Recommendation to collect feed test results from states that sample
feed to help verify compliance with the feed ban.
FDA Comment:
We have included the comment from GAO's 2002 recommendation on tracking
enforcement actions by states as these two recommendations present some
of the same difficulties for the agency. First is the fact that each
state agency may enforce different state laws and regulations regarding
feed manufacturers and these laws and regulations may not be the same
as the federal rules. The collection of enforcement actions and sample
results could, therefore, actually confuse the enforcement and
compliance national picture rather than enhance it. Second, concerning
both enforcement and collection of samples, until FDA and the states
have developed a standard for sampling procedures, analytical
techniques, and enforcement strategies, the shared data would be
considered skewed and potentially misleading. While enforcement could
be equalized through adoption of equivalent regulations by the states,
FDA would have to evaluate each state enforcement program through our
audits, which would require field inspection resources. Accepting
sample results would also require not only the use of equivalent
testing protocols, e.g. using acceptable ELISA test kits, but also may
involve the evaluation of the laboratory and laboratory personnel.
Performing this type of evaluation would require resources currently
not available to FDA. With the current test and with the implementation
of the very sensitive PCR test, the test could be positive for exempt
ingredients or for non-ruminant material such as mice, rats, etc.
To enhance our sampling/analytical aspects of this program, FDA is
incorporating collection of samples under the Feed Manufacturing/BSE
state contracts. States will submit these samples to FDA laboratories
to support FDA's own efforts in surveying the animal feed industry. FDA
is also considering expanding, as funding permits, the Electronic
Laboratory Exchange Network (eLEXNET) to include animal feeds. eLexnet
is a nationwide laboratory data network that allows member laboratories
the ability to detect, compare and communicate findings. Also with
proper funding, FDA will add the state contract feed manufacturer
programs into eSAF (electronic state access to FACTS) in FY05/06. Once
the programming is funded and completed, the states will be able to
enter their contract data (or other inspections) into the system and
both FDA and the state will be able to review all the entered
inspections for that particular state. This will improve the timeliness
of information collected by states during feed establishment
inspections.
5) Develop a sample design for FDA's inspectors to use for sampling
finished feed and feed ingredients that will allow FDA to more
accurately generalize about compliance with the feed ban from the test
results.
FDA Comment:
Sampling of finished feed and feed ingredients cannot serve as a basis
to generalize compliance with the feed ban. As explained in the above
responses, the current tests available and in use today are not
definitive for prohibited material. Feed microscopy has limitations,
including that it can demonstrate animal tissue and can sometimes
determine if the tissue is mammalian, but cannot distinguish between
prohibited mammalian protein, non-prohibited protein, and exempt
mammalian protein. The test being used today [feed microscopy] provides
information that there may be a potential problem. The only way to
determine compliance with the feed ban is to conduct an inspection of
the firm. The feed sampling assignment is designed to be an additional
way to review products in the marketplace. Finding a positive result
from feed microscopy provides information for us to conduct targeted
follow-up inspections but does not by itself prove the presence of
prohibited material and a violation of the ruminant feed ban.
The August 18, 2003 domestic assignment directs ORA Field personnel to
routinely sample and analyze feed to verify compliance with the feed
ban. (See excerpt below.)
Samplinq Information:
A. Sample Selection:
Products should be selected for sampling using the following criteria:
1. Animal feed, feed ingredients, and other animal feed products as
identified in Attachment B to this assignment.
2. Products intended for ruminant animals. These products should be
given the highest priority for collection. At least one half (1/2) of
the samples should be selected from these products if possible.
3. Animal feed, feed ingredients, and other animal feed products that
are labeled as containing animal protein but do not bear the caution
statement "Do not feed to cattle or other ruminants" on the label.
4. Animal feed, feed ingredients, and other animal feed products that
do not list mammalian protein in the product name or ingredient list.
5. Each sample should represent a different source, processor, or
manufacturer if possible.
Attachment B:
Products/ Product Codes Covered by this Assignment:
69 - Medicated Animal Feeds:
69[][][][][]All Products:
70 - Non-Medicated Animal Feeds:
70[][][][][] All Products:
71 - By-product for Animal Food:
71 [] [] [] [] [] All Products:
6) Seek authority from the Congress to require the cautionary statement
on feed or feed ingredients that are intended for export and that
contain prohibited material. In the meantime, FDA should encourage
firms to include such cautionary statement on these exports.
FDA Comment:
The Federal Food, Drug, and Cosmetic Act currently does not include a
provision that directly requires feed or feed ingredients intended for
export to bear the cautionary statement. We note that, if FDA
determined that it would be appropriate for the agency to adopt a
policy encouraging exporting firms to voluntarily include a cautionary
statement on feed labels, the agency would first need to determine
whether such a policy must be issued under FDA's Good Guidance Practice
regulations at 21 CFR 10.115. Under those regulations, a guidance
document is a document that includes the agency's "interpretation of or
policy on a regulatory issue." For the most part, FDA focuses its
policies on matters under its regulatory authority. In addition, before
FDA could adopt a policy to encourage the use of the cautionary
statement on exports, it would need to determine that such a statement
would not be inconsistent with the laws of other countries in light of
the requirement in section 801 (e) of the Federal Food, Drug, and
Cosmetic Act that the product is not in conflict with the laws of the
country to which it is intended for export.
FDA has a comprehensive program that reviews the entry of all feed
commodities that either are ingredients or may end up as ingredients in
ruminant feed. FDA detains animal feeds or feed ingredients that
contain ingredients of animal origin and that are imported from
countries identified as having BSE or being at risk for having BSE.
This system does not rely upon other countries to enforce FDA labeling
requirements for feed with prohibited material. Other countries have
similar programs to refuse entry to imported products that pose a risk
of BSE. Each country thus assumes responsibility for enforcing its own
laws with respect to BSE.
Even if FDA were to require products for export that contain prohibited
material to include the cautionary statement, this statement might not
make the product acceptable to the importing country and may conflict
with the country's own label requirements. FDA refuses import of
products into the U.S. with such material from BSE risk countries
regardless of whether they have such a warning because of the risk of
diversion.
Currently FDA's guidance for exports, as excerpted below, focuses on
clearly labeling the product for export and providing guidance on
material that may be brought back into the U.S.
PRODUCTS FOR EXPORT:
* Prohibited protein product destined for export should be marked "FOR
EXPORT ONLY" on the shipping containers if appropriate and on documents
accompanying the shipment. No other labeling would be required for
purposes of this regulation but there may be additional labeling
requirements for the country of destination.
* Any prohibited protein product destined for export which is diverted
back to domestic commerce for any reason (salvage, quality, etc.), will
be subject to all of the requirements of the regulation. This will
include the requirement to label the product with the cautionary
statement "Do not feed to cattle or other ruminants."
* Responsibility for these prohibited protein products rests with the
owner of the goods (holder of the title to the goods). The owner is
responsible for assuring that they are not diverted back to domestic
commerce unless they meet the requirements of the regulation, including
use of the cautionary labeling statement.
7) Ensure that procedures for alerting USDA and states are followed
when inspectors discover that feed or feed ingredients with prohibited
material may have been fed to cattle.
FDA Comment:
FDA has and continues to coordinate closely with USDA and state
officials on issues related to BSE. FDA has notified both States and
USDA when the agency assessment was that their involvement was
important from a public health perspective. Nevertheless, FDA accepts
the GAO recommendation and will consider notifying USDA to allow full
information to be exchanged with USDA whenever there has been a recall
in which prohibited material from domestic or from an imported source
may have been used as an ingredient in feed, or as feed for ruminants.
The GAO draft report states that "...although FDA has procedures for
alerting USDA and states when it discovers that cattle may have
consumed feed that contains prohibited material, FDA officials told us
that they have never given such notification even though they have
identified the prohibited material being used in cattle feed in the
past. FDA said that notification is not needed because BSE has not been
discovered in a cow born in the United States...."
The section referenced by GAO is found in the FDA compliance program
guidance entitled BSE/Ruminant Feed Ban Inspections, and pertains to
recalls. It provides "generic" scenarios that could be encountered by
field personnel and suggests appropriate courses of action. The purpose
of this information is to provide guidance to assure similar recall
situations will be handled in a consistent manner, and to reduce the
burden on FDA of having to re-evaluate situations that present the same
variables. This compliance program guidance is not intended to cover
all situations, and any new or novel scenarios will require review and
evaluation by CVM. The guidance to contact USDA is found in the second
scenario on "prohibited material from domestic or from an imported
source is used as an ingredient in feed, or as feed to ruminants" and
is cited below U.S. manufacturer of non-ruminant animal feeds uses
prohibited material from a domestic source, or from an imported source,
and that feed is fed to ruminants either as a supplement (i.e., dairy
cow supplement), by mistake, or unknowingly due to inadequate
flushing/cleaning of equipment.
(1) Classification: Class II:
(2) Reason: The ruminant feed or feed ingredient contains prohibited
material, with or without a caution statement.
(3) Action:
* Production/Distribution: Pending results of the investigation.
* Publicity: Press should be issued immediately by the responsible firm
and/or FDA in accordance with established policy for Class I recalls.
Publication in the FDA Enforcement Report once the recall action has
been classified.
* Recall: Pursue voluntary recall to the retail level by the
responsible firm, or seek FDA requested recall.
Depth: Retail level;
Notification: 100%;
Effectiveness Checks: Level A, 100% verification of notification and
appropriate response;
Audit Checks: Level B (25%) to direct consignees (distributors/
retailers). Level B (25%) to retail accounts of audited distributors.
Inspection: GMP inspection is indicated to review production controls,
scope of possible adulteration, extent of time such practices have been
ongoing, and to obtain necessary recall information.
State Involvement: Advise State counterparts of the situation and
enlist their assistance in monitoring.
Animal Control: Assess control over the disposition of ruminant animals
fed the prohibited protein so as to prevent their slaughter for human
food or other animal feed. Coordination with States and USDA/FSIS
should be considered. Consult with CVM regarding coordination and
regulatory approach of animal disposition.
Disposition of recalled/ held product: Oversee appropriate disposition
of feed and status of animals that have been fed the feed. Determine if
relabeling feed with the warning label is an option.
FDA believes that it has followed this guidance and considered
notification of USDA. While it is true that FDA has not notified USDA
of every incident when animal feed was recalled and potentially fed to
ruminants, FDA does consider the need to notify USDA based on our
assessment of the facts in each unique situation. In each case FDA
looks into the source of the prohibited material (imported or domestic
source), what species of ruminant is it being fed to 10 (cattle or
other species not known to acquire natural infection by the agent of
BSE), the potential level of contamination with prohibited material in
the feed, as well as the level of evidence available to determine if
ruminant animals may have actually consumed any prohibited material.
Again, FDA will continue to coordinate closely with USDA and state
officials on all issues related to BSE.
8) Modify the BSE inspection form to include questions inspectors can
use to document whether firms that process or handle cattle feed or
feed ingredients have procedures to ensure the cleanliness of vehicles
they use to transport that cattle feed and feed ingredients.
FDA Comment:
FDA has attempted to limit the number of changes to avoid having
multiple versions of the reporting tool in use as well as to enhance
the quality of the data. However, we will consider whether modifying
the reporting tool would be appropriate. We would emphasize that the
checklist is an inspection reporting tool, not the guidance for the
inspection. As a reporting tool, it reflects the overall results of the
inspection but does not capture every item that is inspected, reviewed,
or evaluated during the inspection. The Compliance Program provides
comprehensive instructions to the inspectors about inspection methods,
areas to look at, records to review, and questions to ask. The
following are two excerpts from the Compliance Program which
specifically include review of transport conveyances.
Firms Avoiding Commingling with Adequate Clean-out Procedures - If the
same equipment is shared for both products containing prohibited
material and products containing only non-prohibited material, describe
the clean-out procedures. Clean-out can consist of physical cleaning
(e.g. vacuuming, sweeping, washing), flushing, sequencing, or other
means, either alone or in combination with separation measures, that
are adequate to prevent carryover of prohibited material into runs that
are intended to be free of prohibited material. Clean-out procedures
should be used on all equipment and conveyances (e.g. trucks, rail
cars) that handle both prohibited material and non-prohibited material.
Feed Storage. [This section is included in the information on
inspection of ruminant feeders]
Feed storage, particularly in operations where both ruminant and non-
ruminant species are being fed, should be examined. If ruminant feeds
and non-ruminant feeds are stored in the same location, the
investigator should note the procedures used for ensuring that ruminant
animals are not fed non-ruminant feeds and should take photographs or
draw diagrams of feed bins and equipment. In particular, investigators
should note whether Feed bins are labeled to identify ruminant and non-
ruminant feed. (This is not required by 21 CFR §589.2000 but will help
the investigator determine whether ruminants have been fed non-ruminant
feed.)
Bulk feeds for ruminants are separated from non-ruminant feeds for
preventing mix-up, commingling and/or cross-contamination (This is not
required by 21 CFR Section 589.2000 but will help the investigator
determine whether ruminants have been fed non-ruminant feed.)
Transportation and feed equipment handling both ruminant and non-
ruminant feeds is either separate or adequately cleaned (See Section
(2)(c)).
9) Ensure that inspection results are reported in a complete and
accurate context.
FDA Comment:
FDA believes that it has reported inspection results in a complete and
accurate context.
GAO states that FDA has reported that industry is 99 percent in
compliance with the feed ban. GAO further states that they do not
believe that FDA has enough information or enough current information
to cite a rate of compliance. GAO also notes that FDA has not inspected
the universe of firms subject to the ban, many inspections are five or
more years old, and inspections are largely paperwork review with very
little testing to confirm compliance.
We do not agree with GAO's conclusion that FDA is reporting data that
is incomplete and not accurate. FDA has made tremendous efforts, and at
great cost, to have every inspection posted on FDA's Internet site.
This extraordinary level of transparency, which is unique to this
program, allows Congress, Industry and the public to view the
inspection results, virtually at the same time as it is entered into
the agency's FACTS system. The data is available to be searched and
sorted by any number of variables to allow the user to ascertain their
own perspective on the data. Additionally, FDA publishes CVM Updates on
"Ruminant Feed (BSE) Enforcement Activities." These updates have been
published on a periodic basis since January 10, 2001. These reports
identify inspection results by type of industry using the standard FDA
inspection classification criteria. At FDA's exit conference with GAO,
GAO advised that these updates were an accurate and complete depiction
of BSE inspection results.
While we understand GAO's perception with regard to the one line
synopsis of overall inspection results as having a confusing message,
this confusion is not due to a lack of candor on the part of the
agency. We also do not agree that our "inspections are largely
paperwork review with very little testing to confirm compliance." Our
BSE inspections are thorough assessments where the inspector spends a
considerable amount of their inspection time on the plant floor judging
the firm's compliance with the feed ban regulation. Furthermore, review
of paperwork, including records of feed ingredient receipt and lists of
feed ingredients, are one component of our inspections and are crucial
to FDA enforcement of the feed ban. FDA believes that its current
regulatory approach, of assuring compliance of FDA's feed rule by the
major suppliers and users of cattle feed, is the most effective
approach in making sure the public health is protected.
The following are GAO's comments on the Food and Drug Administration's
letter dated January 13, 2005.
GAO Comments:
1. We believe the report identifies numerous oversight weaknesses that
continue to limit program effectiveness and place cattle at risk. The
purpose of the feed ban firewall is to prevent the exposure and spread
of BSE. A well enforced feed ban is even more critical now that BSE has
been discovered in cattle in North America. As shown in our report, FDA
does not know the compliance status or risks posed by firms it has not
identified, inspected or reinspected for many years. FDA acknowledged
that many more firms are subject to the feed ban than have been
inspected to date but said the agency must set priorities for the
number and types of firms it can identify and inspect with limited
inspection resources. We agree with FDA's use of a risk-based
inspection approach; however, FDA acknowledges the need to increase
inspections of certain industry segments, such as transporters and
animal feed salvagers. Moreover, for firms that FDA inspects, it does
not routinely sample feed to verify whether the operating procedures
observed by its inspectors are actually preventing prohibited materials
from contaminating cattle feed. Our recommendations are aimed at
ensuring that FDA has a strategy for maximizing the effectiveness of
its limited inspection resources, targeting inspections, and using feed
tests to minimize the risk of cattle being fed prohibited material.
2. Our concern is precisely that the data are being analyzed and
interpreted in an erroneous context. Specifically, when FDA and
industry used those data to assert a 99 percent compliance rate with
the feed ban, they took that information out of context. While industry
compliance may in fact be quite high for firms FDA has inspected
recently, FDA's data are not sufficient to project compliance
industrywide. FDA does not know the status of compliance for firms that
have never been inspected or have not been reinspected in years. In
addition, compliance history is lost--firms that had serious and long-
standing violations are classified as "in-compliance" once FDA
determines that the problems are corrected. FDA is not reporting that
the firms were ever out of compliance or the length of time that the
feed ban was violated. Lastly, inspection results are largely based on
a review of paper documents and a visual inspection, with little or no
feed testing. Given these data concerns and compliance unknowns, we
believe that FDA's data should not be used to project industry
compliance and, anytime those data are cited, they should be reported
in a complete and accurate context.
3. FDA agrees that there are industry sectors (such as transporter and
animal feed salvagers) that need to be assessed to determine their
potential risk to U.S. cattle. In fact, FDA acknowledges that there are
millions of firms potentially subject to the feed-ban rule. At the same
time, FDA implies that it has identified all high-risk firms. FDA has
no basis for that assertion. The example we suggest in this report is
one way of identifying additional firms that we observed during our
review. FDA identified other approaches that its districts used to
identify other firms. We believe that any approaches FDA identifies as
useful should be applied uniformly across all FDA districts. We
included information in the report on how FDA plans to use the $8.3
million it received in the 2005 budget. We also revised the report to
include FDA's estimate of the number of firms that feed cattle and
other ruminants and revised the recommendation in recognition that it
may be impossible for FDA to identify all firms subject to the feed-ban
rule.
4. FDA suggests that requiring notification would take significant
resources. The cost of the notification program will depend on the
requirements FDA puts in place. In developing the program, FDA could
target the notification to firms that pose potentially high-risk for
exposing cattle feed to prohibited material. According to FDA, of the
14,800 firms it has inspected, about 570 renderers, protein blenders,
and feed mills comprise the high-risk firms subject to notification
because they manufacture or process prohibited material. While we
believe there may be more firms that fall into this group, it should
not be a significantly larger number. If it is significantly larger,
that is something FDA needs to know. Furthermore, requiring industry to
self-report is another mechanism that would help FDA identify firms and
oversee compliance. Finally, FDA has registration requirements in place
for medicated feed firms and for food facilities, and could draw on its
experience with those programs for developing a notification program
for firms subject to the feed-ban rule.[Footnote 27] Because firms can
change their practices over time, we believe it is important that firms
notify FDA whenever such changes occur.
5. While we agree that the current test methods have certain
limitations, we believe that testing can be a valuable tool for helping
FDA oversee compliance with the feed ban. FDA maintains that, because
the current test methods cannot differentiate prohibited material from
exempt material, they cannot be used to verify the presence or absence
of prohibited material or to confirm the adequacy of cleanout measures.
However, states told us that they are using tests for these purposes.
Moreover, FDA is currently testing finished feed and using the test
results, together with follow-up inspections, to determine whether the
feed ban had been violated. We believe tests would help inspectors who
now rely on only paperwork review and visual examination to determine
the adequacy of cleanout procedures. Tests would also be useful for
vegetable-based cattle feed, where detecting the presence of animal
protein would indicate a violation. We revised the recommendation to
recognize that FDA may elect to use other test methods in addition to
feed microscopy and polymerase chain reaction (PCR). With respect to
FDA's sampling of finished feed, the 660 samples FDA tested were not
collected during feed-ban compliance inspections. We plan to report
later this year on FDA's sampling of finished feed.
6. We agree that FDA's current test methodology will not allow it to
use test results alone to verify feed-ban violations. However, testing
combined with follow-up inspections would allow FDA to be in a better
position to generalize about compliance with the feed-ban rule if FDA
developed a random sample methodology for inspectors to use for
sampling finished feed and feed ingredients. (Also see comment 5.)
7. After clarifying FDA's comment with an attorney in FDA's Office of
the Chief Counsel, we revised the report and the recommendation to
delete references that FDA should encourage firms to include a
cautionary statement on feed exports that may contain prohibited
material. We believe that it would be more prudent for FDA to focus its
efforts on obtaining statutory authority to require that the cautionary
statement be used on such exports.
8. We revised the recommendation to clarify that FDA should be alerting
USDA and the affected states whenever inspectors discover that cattle
may have consumed feed with prohibited material.
9. Based on the inspections we observed and the 404 inspection reports
that we reviewed in detail, we believe that inspector activities during
feed-ban compliance inspections are driven by the checklist
items/questions on the BSE inspection form. Therefore, we believe the
checklist should include specific questions to prompt inspectors to
examine vehicles and firms' cleanout procedures on every inspection.
10. As noted in the report, FDA believes that it provides the
inspection results in a transparent, compete, and accurate context. FDA
notes that the BSE inspection data posted on its Web site "allows the
user to analyze the data, in a multitude of ways, to provide their own
contextual reference." Our concern is precisely that the data are being
analyzed and interpreted in an erroneous context. Specifically, when
FDA and industry used those data to assert a 99 percent compliance rate
with the feed ban, they took that information out of context. While
FDA's calculation of compliance by a subset of regulated industries may
in fact be quite high, FDA's data are not sufficient to make that
projection for all regulated industries because of the many problems we
cite in the report. Specifically, FDA does not know the status of
compliance for firms that have never been inspected or those that have
not been reinspected in years. FDA also does not know if a firm that it
previously inspected and classified as low-risk has started using
prohibited material; and FDA reclassifies a firm in the database from
"out-of-compliance" to "in-compliance" when it corrects a violation--
even when the violation was serious and long-standing. Lastly,
inspection results are largely based on a review of paper documents and
a visual inspection, with little or no feed testing. Given these data
concerns and compliance unknowns, FDA's data should not be used to
project industry compliance and, anytime those data are cited, they
should be reported in a complete and accurate context.
[End of section]
Appendix VII: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Robert A. Robinson, (202) 512-3841;
Erin Lansburgh, (202) 512-3017:
Staff Acknowledgments:
In addition to the individuals named above, Vincent Balloon, Jim
Dishmon, Natalie Herzog, Lynn Musser and John C. Smith made key
contributions. Other contributors included George Quinn, Carol
Herrnstadt Shulman, Joan Vogel and Amy Webbink.
(360391):
FOOTNOTES
[1] It is a common nutritional practice to add protein (derived from
animals or plants) to speed animal growth.
[2] GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other
Regulatory Areas Would Strengthen U.S. Prevention Efforts, GAO-02-183
(Washington, D.C.: Jan. 25, 2002).
[3] 21 C.F.R. §589.2000.
[4] Ruminants are animals with four-chambered stomachs, including, but
not limited to, cattle, buffalo, sheep, goats, deer, elk, and antelope.
For the purpose of this report, unless stated otherwise the term
"cattle" refers to cattle and all other ruminant animals and the term
"cattle feed" refers to feed for cattle and other ruminant animals.
[5] The feed-ban rule is based on FDA's authority to regulate food
additives. See 21 U.S.C. §§ 321, 348.
[6] Plate waste is discarded meat and other food from institutions,
restaurants, and other dining facilities, which is collected by
processors, recooked to eliminate bacteria, and used in animal feed as
a protein source. Gelatin is made from boiling animal bones, cartilage,
tendons, and skin.
[7] FDA is responsible for inspections in the 12 states that do not
have contracts or agreements with FDA to conduct inspections.
[8] Renderers process animals unfit for human consumption and waste
material (carcasses and meat scraps) from slaughterhouses and
processors into a protein for animal feed. Protein blenders mix
rendered proteins into feed ingredients.
[9] GAO-02-183.
[10] The prion hypothesis is widely, although not universally,
accepted. Some scientists believe a virus or other conventional agent,
as yet undetected, gives rise to TSEs.
[11] Under certain laboratory conditions, high temperature, pressure,
and caustic chemicals have been shown to deactivate prions.
[12] These data are as of February 1, 2005, for Canada and as of
December 2004 for all other regions/countries.
[13] Researchers also believe that one probable case of vCJD reported
in the United Kingdom was the result of a blood transfusion from an
infected donor.
[14] Canada implemented its feed ban on the same day that the United
States implemented its feed ban.
[15] Evaluation of the Potential for Bovine Spongiform Encephalopathy
in the United States, Harvard Center for Risk Analysis, Harvard School
of Public Health and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University, Nov. 26, 2001.
[16] Evaluation of the Potential Spread of BSE in Cattle and Possible
Human Exposure Following Introduction of Infectivity into the United
States from Canada, Harvard Center for Risk Analysis, Harvard School of
Public Health, Oct. 31, 2003.
[17] FDA's feed-ban inspection guidance, called the BSE/Ruminant Feed
Ban Inspections Compliance Program Guidance, was issued on October 21,
2003.
[18] USDA discovers these violations in tests and visual examinations
at meatpacking plants.
[19] FDA officials said this funding would be used for additional state
and federal inspections, inspector training, industry outreach, and to
improve FDA's ability to respond to problems found during BSE
inspections.
[20] States reported on a 12-month time period, which could have been
the calendar year, federal fiscal year, or state fiscal year.
[21] An attorney with FDA's Office of the Chief Counsel said that FDA
could require a cautionary statement only if the absence of such a
statement would cause the feed to be in conflict with the laws of the
importing country. See 21 U.S.C. § 381.
[22] USDA's Animal and Plant Health Inspection Service has the
authority to seize and destroy cattle and compensate producers for the
cattle.
[23] Salvaged pet food containing prohibited materials must be labeled
with the cautionary statement.
[24] These steps take on added importance, given the Department of
Transportation's recent proposed rule under the Sanitary Food
Transportation Act. In the preamble to the proposed rule, the
department stated that it, along with USDA and FDA, had concluded that
the expertise for ensuring the safety of the food supply, including
transportation, lies with USDA and FDA and that implementation of a
food transportation safety program under the Department of
Transportation would be unnecessarily duplicative. The proposed rule
would incorporate USDA and FDA guidance on the transportation of food.
69 Fed. Reg. 76423 (Dec. 21, 2004).
[25] Previously, we reported that FDA has been using inaccurate,
incomplete, and unreliable data to track and oversee feed ban
compliance (GAO-02-183).
[26] At the time of our review, the following states did not have a
contract or partnership agreement with FDA to perform and report BSE
inspections to the agency: Alaska, Connecticut, Delaware, Hawaii,
Louisiana, Maine, Massachusetts, Mississippi, New Hampshire, Rhode
Island, South Carolina, and Wyoming.
[27] The registration requirement for food facilities is provided for
in the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, Pub. L. No. 107-188; 116 Stat. 594 (2002).
GAO's Mission:
The Government Accountability Office, the investigative arm of
Congress, exists to support Congress in meeting its constitutional
responsibilities and to help improve the performance and accountability
of the federal government for the American people. GAO examines the use
of public funds; evaluates federal programs and policies; and provides
analyses, recommendations, and other assistance to help Congress make
informed oversight, policy, and funding decisions. GAO's commitment to
good government is reflected in its core values of accountability,
integrity, and reliability.
Obtaining Copies of GAO Reports and Testimony:
The fastest and easiest way to obtain copies of GAO documents at no
cost is through the Internet. GAO's Web site ( www.gao.gov ) contains
abstracts and full-text files of current reports and testimony and an
expanding archive of older products. The Web site features a search
engine to help you locate documents using key words and phrases. You
can print these documents in their entirety, including charts and other
graphics.
Each day, GAO issues a list of newly released reports, testimony, and
correspondence. GAO posts this list, known as "Today's Reports," on its
Web site daily. The list contains links to the full-text document
files. To have GAO e-mail this list to you every afternoon, go to
www.gao.gov and select "Subscribe to e-mail alerts" under the "Order
GAO Products" heading.
Order by Mail or Phone:
The first copy of each printed report is free. Additional copies are $2
each. A check or money order should be made out to the Superintendent
of Documents. GAO also accepts VISA and Mastercard. Orders for 100 or
more copies mailed to a single address are discounted 25 percent.
Orders should be sent to:
U.S. Government Accountability Office
441 G Street NW, Room LM
Washington, D.C. 20548:
To order by Phone:
Voice: (202) 512-6000:
TDD: (202) 512-2537:
Fax: (202) 512-6061:
To Report Fraud, Waste, and Abuse in Federal Programs:
Contact:
Web site: www.gao.gov/fraudnet/fraudnet.htm
E-mail: fraudnet@gao.gov
Automated answering system: (800) 424-5454 or (202) 512-7470:
Public Affairs:
Jeff Nelligan, managing director,
NelliganJ@gao.gov
(202) 512-4800
U.S. Government Accountability Office,
441 G Street NW, Room 7149
Washington, D.C. 20548:
