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FY99 Request
FY98
FY99 Enacted
FY2000 Request Delta from FY99 Enacted
Food Safety
(FSI)
43
101
87
7
79
Draft numbers
(agency enacted)
should
USDA
49
21
-28
bringing to
FDA
25
48
23
2125 million
CDC
5 ?
18
13
Plant Genom (Total)
40
55
40
55
(agency enacted)
USDA
5
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NSF
50
40
-10
ERI
(Total)
75
25
25
(agency enacted)
Ed
0
???????
???????
NSF
25
25
0
May.
Have is my capy of the Mou +
what little l know about the
FSI FY2000 request I'd like
to beemp it up to about $125 me ilem
Cill
2' ge he out of the office from
11:00 am on today, so please page
me if you , Me d to get in touch
Cilf
DRAFT September 14, 1998
MEMORANDUM OF UNDERSTANDING
Between The
FOOD SAFETY AND INSPECTION SERVICE
UNITED STATES DEPARTMENT OF AGRICULTURE
And The
FOOD AND DRUG ADMINISTRATION
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
I. PURPOSE
This agreement between the Food and Drug Administration, Department of Health and Human
Services (FDA) and the Food Safety and Inspection Service, United States Department of
Agriculture (FSIS), is intended to facilitate an exchange of information between the agencies
about establishments and operations that are subject to the jurisdiction of both agencies. This
exchange of information will permit more efficient use of both agencies' resources and will
contribute to improved public health protection.
II. BACKGROUND
In a May 1997 Report to the President entitled "Food Safety From Farm to Table - A National
Food-Safety Initiative," the agencies primarily responsible for food safety made several
recommendations to improve public health protection from foodborne illness. Several
recommendations also addressed the issues of increasing cooperation among agencies, ensuring
that the resources and experience of FDA and FSIS are used as efficiently as possible, and
avoiding duplication of efforts.
To advance the purposes of the President's Food Safety Initiative, FDA and FSIS have re-
evaluated a previous Memorandum of Understanding on coordination of inspectional efforts
signed by FSIS on July 14, 1983 and by FDA on July 25, 1983. The agencies have determined
that changes in inspectional activities, available resources, and food safety hazards necessitate
updating that agreement. Therefore, FDA and FSIS have entered into this Memorandum of
Understanding to address today's public health needs.
1
DRAFT September 14, 1998
III. STATUTORY AUTHORITIES
FSIS is responsible for implementing and enforcing the Federal Meat Inspection Act (21 U.S.C.
601, et seq.), the Poultry Products Inspection Act (21 U.S.C. 451, et seq.), and parts of the Egg
Products Inspection Act (21 U.S.C. 1031, et. seq.). In carrying out its responsibilities under
these acts, FSIS places inspectors in meat and poultry slaughterhouses and in meat, poultry, and
egg processing plants. FSIS also conducts inspections of warehouses, transporters, retail stores,
restaurants, and other places where meat, poultry, and egg products are handled and stored. In
addition, FSIS conducts voluntary inspections under the Agriculture Marketing Act (7 U.S.C.
1621, el seq.).
FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301, et sea.), the Public Health Service Act (42 U.S.C. 201, et. seq), the Fair
Packaging and Labeling Act (15 U.S.C. 1451 et. seq), and parts of the Egg Products Inspection
Act. In carrying out its responsibilities under these acts, FDA conducts inspections of
establishments that manufacture, process, pack, or hold foods, with the exception of certain
establishments that are regulated exclusively by FSIS. FDA also inspects vehicles and other
conveyances, such as boats, trains, and airplanes, in which foods are transported or held in
interstate commerce.
Nothing in this agreement shall lessen the responsibilities or authorities of FSIS or FDA under
their statutory authorities.
IV. SUBSTANCE OF AGREEMENT
1. List of District Level Contacts
The agencies agree to develop, maintain, and annually update a list of their districts and of
persons to contact at the district management level. Attached as Appendices A and B,
respectively, are the current lists of FDA and FSIS districts and contacts. In addition to the
annual updates to these lists, each district agrees to promptly inform its counterpart district of
any change in the contact person for that district. The agencies also agree to develop and
maintain a list of the district offices responsible for each state and territory. The current list is
attached as Appendix C. Each agency agrees to promptly inform the other agency of any
changes in the jurisdiction of district offices or in the field organization of the agency. These
lists are to be distributed to the district managers of both FSIS and FDA.
2. List of Dual Jurisdiction Establishments
The agencies agree to develop, maintain, and annually update a list of dual jurisdiction
establishments (hereinafter "DJEs"), that is, establishments that prepare, pack, hold, or otherwise
2
DRAFT September 14, 1998
handle both foods regulated by FSIS and foods regulated by FDA. This list is to be organized
by state and territory. The current list is attached as Appendix D and is to be distributed to the
district managers of both FSIS and FDA. When updating this list, each agency agrees to identify
all DJEs that have discontinued operations that are under its jurisdiction.
3. System of Communication
The district offices of each agency agree to promptly report to their counterpart district offices
certain findings, as set forth in paragraphs 5, 6, and 7, relating to DJEs. The district office
receiving the report agrees to respond with information regarding any planned or completed
follow-up action relating to the reported information District management of both agencies are
encouraged to initiate contact and to meet annually, or as frequently as necessary, to facilitate
the exchange of information about establishments and foods prepared, packed, held, or otherwise
handled by these establishments. The agencies agree to work together to develop, put in place,
and maintain a system of electronic communication at the district level to facilitate the exchange
of information about the DJEs.
4. Notification of Periodic Inspection
Each agency agrees to attempt to notify the appropriate contact identified in paragraph 1 of this
section prior to conducting an inspection of a DJE that is not under continuous FSIS inspection.
In addition, FDA agrees to attempt to notify the FSIS inspector prior to inspecting 2 DJE that is
under continuous inspection and to invite the FSIS inspector to accompany the FDA inspector on
the inspection.
5. Findings Involving DJEs That Are To Be Reported By Both Agencies
The district office of each agency is to notify its counterpart district office of the following
findings in a DJE:
a. Foods implicated in outbreaks of foodborne illness, injuries or adverse reactions.
b. Foods found to be contaminated or mislabeled such that there is a reasonable
probability that the use of or exposure to such products will cause serious adverse health
consequences. Hazards that constitute contamination or mislabeling covered under this
paragraph are attached as Appendix E.
C. A precessing condition or failure that is likely to results in food contamination leading
to outbreaks of foodborne illness, injuries, or adverse reactions.
d. Foods that have been recalled.
3
DRAFT September 14, 1998
e. Reports of tampering or threats of tampering.
f. A food handler diagnosed as having a communicable disease that is likely to result in
food contamination or outbreaks of foodborne illness (e.g., hepatitis).
6. Findings Involving DJEs That Are To Be Reported By FSIS to FDA
In addition to the findings in paragraph 5, the FSIS district office is to notify its counterpart
district office of FDA of the following finding in a DJE:
a. FSIS action to withhold the mark of inspection or to suspend or withdraw the grant of
inspection.
7. Findings Involving DJEs That Are To Be Reported By FDA to FSIS
In addition to the findings in paragraph 5, the FDA district office is to notify its counterpart
district office of FSIS of the following findings:
a. Any other processing condition in a DJE that could render foods bearing a USDA
mark of mandatory or voluntary inspection adulterated or mislabeled. Reports of FDA
enforcement actions associated with such conditions should be provided to FSIS.
b. Reason to believe that an FDA-regulated ingredients that would adulterate a meat,
poultry, or egg product if used in it has been sent to or received by an FSIS-regulated
establishment.
c. Convictions of a DJE, or any officer or key employee of a DJE, for any felony or more
than one misdemeanor involving the DJE or any food prepared, packed, held, or
otherwise handled in the DJE.
d. Convictions of an establishment preparing, packing, holding, or otherwise handling
both meat, poultry or egg products solely under state regulation and foods regulated by
FDA, or any officer or key employee of such an establishment, for any felony or more
than one misdemeanor involving the establishment or any food prepared, packed, held, or
otherwise handled in the establishment.
8. Follow-Up Action
a. The agency receiving notification of a finding listed in paragraphs 5, 6, or 7 agrees to
evaluate it and take appropriate action.
4
10/14/98
DRAFT September 14, 1998
b. For all reported findings listed in paragraphs 5, 6, or 7, the agency receiving the
notification agrees to track and use the information in program evaluation, work planning,
and consideration of whether action against the establishment is warranted.
C. The agency receiving the notification of a finding listed in paragraphs 5, 6, or 7 agrees
to respond to the notification within 30 days by communicating the disposition of the
notification to the notifying agency at the district management level, including, if
appropriate, any and all actions planned and taken by the agency receiving notification.
In addition, the agencies agree to explore the feasibility of granting each other access to
appropriate computer monitoring systems to permit interagency tracking of findings
listed in paragraphs 5, 6, or 7.
9. Information Sharing and Confidentiality
To promote increased cooperation and efficient use of enforcement resources, each agency agrees
to share documents and information for enforcement purposes upon request by the other agency,
to the extent permitted by applicable law. All non-public information shared between the two
agencies pursuant to this agreement is subject to all applicable limitations established by statute
or regulation on interagency sharing of information The current policies and procedures for
sharing such information are attached as Appendix F.
10. Training
The agencies agree to develop and provide appropriate training in the inspectional techniques and
processes of each agency as the agencies determine is necessary to implement this agreement
Putin
successfully. The agencies agree to develop and initiate the training as quickly as possible. The
previouse
district managers of both agencies are encouraged to evaluate training needs during annual
meetings, or as frequently as necessary, to determine whether additional training is warranted.
11. Joint Enforcement Activities
The agencies agree to establish a group to explore the feasibility of joint enforcement activities.
This group is to report its findings and recommendations by December 31, 1998 to the
Commissioner of FDA and the Administrator of FSIS.
12. Re-evaluation of the Agreement
The agencies agree to re-evaluate the effectiveness of this agreement after it has been in effect for
one year. The agencies also agree to explore the feasibility of expanding their cooperative
activities after one year, or sooner if the agencies agree that it is appropriate to do so.
5
DRAFT September 14, 1998
V. PERIOD OF AGREEMENT
The agencies agree to begin implementing this agreement within 30 days from execution by both
parties. This agreement will be effective indefinitely. It may be modified by mutual consent or
terminated by either party upon 30 days' written notice to the other.
VI. PREVIOUS AGREEMENTS
This agreement supersedes the Memorandum of Understanding on coordination of inspectional
efforts signed by FSIS on July 14, 1983 and by FDA on July 25, 1983. This MOU does not
modify any other existing agreements between USDA and FDA.
VII. NAME AND ADDRESS OF PARTICIPATING AGENCIES
Food Safety and Inspection Service
Food and Drug Administration
1400 Independence Ave., S.W.
5600 Fishers Lane
Washington, DC 20250-3700
Rockville, MD 20857
VIII. LIAISON OFFICERS
For FSIS:
For FDA:
John McCutcheon
Gary Pierce
Associate Deputy Administrator,
Director, Division of Emergency and
Office of Field Operations
Investigational Operations
Food Safety Inspection Service
Food and Drug Administration
1400 Independence Ave., S.W.
5600 Fishers Lane (HFC-130)
Washington, DC 20250-3700
Rockville, MD 20857
(202) 720-5190
(301) 827-5655
APPROVED AND ACCEPTED FOR
APPROVED AND ACCEPTED FOR
THE FOOD SAFETY INSPECTION
THE FOOD AND DRUG
SERVICE
ADMINISTRATION
By:
By:
Title: Administrator, FSIS
Title: Acting Commissioner. FDA
Date:
Date:
6
cc: JH, KR, JR, RP
4M1
AMERICAN
CC: CarenWilcox
MEAT
INSTITUTE
10/13/98
Serving The Industry Since 1906.
J. Patrick Boyle
President and C.E.O
October 9. 1998
The Honorable Catherine E. Woteki, Ph.D.
Undersecretary for Food Safety
U.S. Department of Agriculture
14th St. and Independence Ave.. SW
Washington. DC 20250
Dear Secretary Worek:
AMI applauds your efforts and those of your federal colleagues on the President's
Council on Food Safety. We support your vision of a "seamless food safety system that uses
farm-to-table preventive strategies and integrated research, surveillance. inspection and
enforcement" to assure consumer safety and confidence.
Toward that end, AMI strongly urges the Council to take on as its first priority the
harmonization of food recall policies and procedures between the Food and Drug Administration
(FDA) and the Food Safety and Inspection Service (FSIS). As you can see from AMI's attached
comments on FSIS recall policies, major differences in food recall policies between these
agencies is the first problem that needs to be addressed. There is no better forum for resolving
these discrepancies, in our view, than the President's Council on Food Safety.
AMI pledges its support towards the Council's efforts to bring uniformity to federal food
recali policy. We look forward to working with you in this endeavor.
Sincerely,
J. Paugick Boyle
Attachment
Cc:
The Honorable Daniel Glickman
Secretary, U.S. Department of Agriculture
The Honorable Donna Shalala
Secretary, U.S. Department of Health of Human Services
James O'Hara. Deputy Assistant Secretary for Health, U.S. Department of Health and
Human Services
Thomas J. Billy, Administrator, Food Safety and Inspection Service, U.S. Department of
Agriculture
Post Office Box 3556, Washington, DC 20007 1700 North Moore Street, Arlington, VA 22209
Phone: 703/841-2400 Fax: 703/527-0938 Http://www.meatami.org
4M
AMERICAN
MEAT
INSTITUTE
Serving The Industry Since 1906.
J. Patrick Boyle
President and C.E.O
October 9. 1998
FSIS Docket Clerk
Food Safety and Inspection Service
U.S. Department of Agriculture
Room 102, Cotton Annex
300 12th Street SW
Washington, DC 20250-3700
Re:
Docket #98-029N
American Meat Institute Comments on
FSIS Recall Policy Working Group Recommendations
The American Meat Institute (AMI) is pleased to recommend ways to improve the
effectiveness and efficiency of meat and poultry product recalls. AMI strongly agrees
with the Working Group that companies should be responsible for conducting recalls,
including identifying affected product and, if necessary, notifying customers and/or
consumers. In this regard, AMI opposes efforts to give the Secretary of Agriculture new
statutory authority to mandate meat and poultry recalls. Instead, we believe the Food
Safety and Inspection Service (FSIS) should verify that companies have fulfilled
their recall responsibilities and, if they have not, FSIS should use its existing authorities
to prevent product from moving in commerce or seize product in the marketplace.
Within these parameters, there is much the industry and government can do to facilitate
the swift and complete removal from the market of any meat or poultry product believed
to present a public health hazard.
AMI is the national organization representing meat and poultry packers and
processors and their suppliers throughout North America Our members produce the
majority of meat and poultry products manufactured in the United States. AMI has been
active in federal government relations since its inception in 1906.
Post Office Box 3556, Washington, DC 20007 1700 North Moore Street, Arlington, VA 22209
Phone: 703/841-2400 Fax: 703/527-0938 Http://www.meatami.org
FSIS Docket Clerk
October 9, 1998
Page 2
In the past 92 years, we have helped hundreds of companies conduct product
recalls. Without exception. our experience is that companies want to retrieve recalled
products promptly, that they want to notify their own customers in a way that maintains
the best possible relationship, that they want to provide accurate information to all
affected parties and that they want to correct any problems which may have led to the
recall SO that it does not happen again. Finally, companies want to cooperate with FSIS
to ensure that both industry and government are working from the same base of facts and
toward the same goal.
Need for More Consistent Government Approach to Food Recalls
The agency's new focus on improving product recalls is helpful, but it does not go
far enough Federal food recall policy demands a broader approach. We have been
troubled by inconsistent FSIS and Food and Drug Administration (FDA) actions during
various food product recalls. To some limited degree this can be explained by the unique
circumstances of each recall. However, we believe this problem is caused by the absence
of uniform, consistent recall policies for both FSIS and FDA. Thus, the agency's current
Working Group activities are welcome, but insufficiently comprehensive.
Specifically, now is the time for the nation's food regulatory agencies to
devise a new, consistent approach to improving food recalls - not agency by agency,
but together, in a single, united effort through the President's Council on Food
Safety.
As Secretary Glickman stated August 25, the President ordered that "we move
toward a seamless government-wide strategy that cuts through bureaucratic barriers to
improving public health." We need such a seamless government-wide approach to food
product recalls, and the President's Council on Food Safety is the most appropriate entity
for devising such a uniform approach.
Our industry conducts on average approximately 40 recalls annually, each one
averaging approximately 270,000 pounds with an average recovery rate of 40 percent.
Most of these recalls are triggered by company findings. Just over 60 percent (average
22 per year) of meat and poultry recalls are ranked Class I by FSIS. In most cases, Class
1 recalls involve product which has not yet reached the consumer marketplace, thus in
most cases no press releases are issued by either the recalling company or FSIS
FDA-regulated food companies conduct on average 785 product recalls annually.
Most of these are triggered by company findings. Of these recalls, 34 percent (average
268 per year) are Class 1. FDA issues press releases on all Class I recalls where the
product is in consumer channels and publishes all classes of recall in FDA's Weekly
Enforcement Report.
FSIS Docket Clerk
October 9, 1998
Page 3
At present, there are numerous discrepancies between recall policies at FSIS and
FDA. Among the major differences is the level of recall oversight exerted by each
agency. A food company generally notifies FDA that the company is conducting a recall.
FDA then requests all relevant information. including any public notices, and suggests
modifications if necessary. FDA typically relies on companies to determine the scope of
a product recall and monitor and report on the progress of its recall to the agency. In this
way, FDA-regulated companies generally experience less pressure and intrusion from
FDA regulators that FSIS-regulated companies experience. In contrast, meat and poultry
companies generally notify FSIS that a problem has been found which may trigger a
recall. FSIS then begins to conduct its own problem solving exercise, requesting
documentation on product production, distribution, storage and sales. Companies
experience enormous pressure from FSIS to produce records and documents within
timeframes dictated by the agency on a case-by-case basis. This pressure can lead to
animosity, misunderstanding and incomplete or inaccurate information being
disseminated among regulators. Under these less than desirable circumstances, FSIS then
typically issues its own press release on Class I recalls to the public, even after the firm
has issued its own public notice
In general, FDA relies much more heavily on the industry to conduct, monitor and
report upon product recalls. In contrast, FSIS inserts itself into a company's recall
process and operates in an enforcement and compliance mode throughout the recall from
inception to completion. This discrepancy is illogical and counterproductive. There is no
reason to believe that FSIS-regulated products pose a greater threat to public health and
welfare than FDA-regulated products. Therefore, there is no compelling reason for FDA
and FSIS recall procedures to differ in any meaningful way.
Given the acknowledged resource discrepancies between FDA and FSIS, the
recall monitoring and oversight function is ripe for review by the President's Council on
Food Safety, with the hope that such a review would yield a more uniform approach to
food product recalls. In the meantime, we strongly recommend that FSIS take no further
action on modifying its current recall policy until such a review is completed.
Responses to FSIS Working Group Recommendations
Although it is premature to "reinvent" FSIS recall policies prior to an effort to
coordinate unified FDA/FSIS regulatory policy on recalls, AMI has some specific
responses to the Working Group's recommendations. What follows are the agency's
recommendations, with AMI's responses in italics.
1. The recalling establishment should be responsible for effecting the recall,
including identifying the product to be recalled. notifying customers and, if
product is already in commercial distribution, notifying the public. AMI agrees
completely.
FSIS Docket Clerk
October 9, 1998
Page 4
2. FSIS should ask each establishment to identify a recall contact person. AMI
suggests that each company should also identify a back-up recall contact person.
Through this person, FSIS should provide the establishment with as much
advance notice as possible that the FSIS Recall Committee will be meeting to
consider whether to request a recall of product shipped by the establishment. AMI
agrees completely.
3. FSIS should institute rulemaking to require that all entities that handle meat,
poultry or egg products include in their records information that will enable them
to trace all product from its entry into their facility to its shipment from the
facility to a specific customer. AMI agrees that those in the meat and poultry
production and distribution chain should be able to trace products to customers.
However, we disagree with a regulatory mandate: Instead, industrial good
manufacturing practices would address the need to trace product so that a
manufacturer can quickly recall IL The Working Group also recommended that
FSIS institute rulemaking to require that establishments have a written plan that
defines how they will conduct a recall should the need arise. AMI agrees that
plants should have written plans for recalling product. However, we disagree
with a regulatory mandate. Again, good manufacturing practices outlining
general principles of sound recall management would provide meaningful
guidance to the industry. No demonstrated need exists to regulate how a
company conducts a recall. In fact, every company that has effectively removed
product from distribution or sale has done 50 without a mandated recall plan
4. FSIS should prepare and issue guidance materials on a firm's responsibility in a
recall. These materials should advise firms to contact the Emergency Response
Division (ERD), Office of Public Health and Science (OPHS), or their District
Manager, to discuss a recall. They should also explain what FSIS would do if an
establishment refuses to recall and explain what are acceptable dispositions of
recalled product. FSIS should include in these guidance materials a model letter
establishments can use to notify consignees and subconsignees of a recall. AMI
agrees that guidance materials would be useful. Industry should collaborate with
FSIS to provide constructive model communications vehicles to establishments.
5. FSIS should create a Standard Operating Procedure to capture its procedures for
deciding whether to request a recall, and it should update its 1992 directive. It
should also address in the revised directive how FSIS will respond to a finding by
an outside laboratory of a pathogen in an inspected product. AMI generally
agrees. Standard operating procedures are used effectively in FDA recalls; FSIS
should develop similar procedures and abide by them. Caution should be
exercised before blindly accepting outside laboratory results without proper
verification of laboratory practices and confirmation of results to assure accuracy
6 FSIS should update the checklist that ERD faxes to establishments when it
notifies them that the Recall Committee plans to meet, so that the checklist fully
reflects the Agency's data needs. ERD should also work with the Technical
Service Center to develop more extensive work sheets to use in questioning a firm
about a possible recall. AMI strongly agrees.
10/14/95
FSIS Docket Clerk
October 9, 1998
Page 5
7. FSIS should expand the Recall Committee to include representatives from the
Technical Service Center, the relevant District Offices, and the Food Safety
Executive Management and Coordination Staff. A representative from CDC
should be included on the committee for matters that involve a pathogen, as well
as when an illness has been associated with a meat, poultry or egg product.
Members should be given as much time as possible to prepare for a Recall
Committee meeting. AMI strongly agrees. (This was originally part of the
Working Group's recommendation #2:) The Recall Committee should permit the
establishment to make a presentation to it about whether a recall is warranted if
the establishment wished to do so and is able to do $0 in a timely manner. AMI
strongly agrees.
8. The Director of ERD, OPHS, should be delegated the authority to decide whether
to request Class II and Class III recalls. AMI agrees. However, it should be made
clear who is authorized to decide on Class I recalls.
9. FSIS should expand the role of compliance officers (Compliance and
Investigations Division, Office of Field Operations) in a recall to include actions
before and during, as well as after, the Recall Committee's deliberations.
Compliance officers should be dispatched to the establishment as soon as a
possible need for a recall is identified. Compliance officers should be available at
the establishment to answer the Recall Committee's questions and to resolve
issues while the Recall Committee deliberates. They also should verify the
records relied upon by the establishment. AMI strongly disagrees. Compliance
officers should have more clearly defined responsibilities in recall situations;
however, their responsibilities should be limited to monitoring company recall
activities outside the official establishment. In-plant inspection personnel should
be charged with monitoring plant activities.
10. Except when the source of a problem is apparent at the recalling establishment,
FSIS should regularly trace product back one level from the recalling entity.
However, a more extensive traceback, even to the producer of the animals that
were the source of the product involved, may be appropriate in some
circumstances. AMI agrees.
11. FSIS should continue to defer, if possible, to State and local agencies in recalls
involving retail-prepared product. AMI strongly disagrees. All who process and
distribute meat, poultry and egg products should be subject to Federal recall
oversight.
FSIS Docket Clerk
October 9, 1998
Page 6
12. FSIS should issue a press release if it will advance the purpose of the recall - to
remove product that there is reason to believe is adulterated or misbranded from
commerce. For all other recalls, FSIS should notify the public by making the
Recall Notification Report available through constituent communications and on
the Agency's website. AMI has major concerns. Since food companies are
responsible for recalling products. it is they who should issue press releases 10 the
public in cases where recalled product is available in the consumer marketplace.
FSIS should issue press releases only when the recalling company fails to issue its
own press release. FSIS press releases should be written according to clearly
defined and standardized guidelines, such as ominent information about how to
contact the recalling company, no listing of the recalling company's customers
and no use of dramatic terms such as "deadly," or "fatal." If FSIS issues a press
release instead of the recalling company. FSIS should review the proposed press
release with the recalling company to ensure its accuracy, and should provide the
release to the company immediately prior to releasing it to the public. The Recall
Notification Report should be used to notify essential government personnel and
should be modified to include more detailed information about whom to contact at
the recalling company for specific types of information (i.e., a contact for retail
customers, for consumer questions, for state health departments, for media) The
Report should not list the recalling company's customers. It should be posted on
the FSIS website only after the recalling company has notified its customers
Finally, in today's technology dependent society, the issuing of a press release is
often not enough to respond to the many questions from consumers, customers,
state health officials and others. Thus, we believe both industry and FSIS should
work together to identify practical means of making appropriate recall
information available through other channels - i.e., websites, pre-recorded phone
messages, toll-free hotlines, etc. In this way, both industry and government can
facilitate the most important element of any recall: prompt, accurate availability
of information to those who need to know. AMI looks forward to working with
FSIS in this area
13. FSIS should use the Recall Notification Report, which is prepared by the Media
Communications Office, to provide early notification about a recall to State and
local agencies, and to all FSIS Deputy Administrators and District Offices. AMI
has major concerns. Recent experience shows that this Report does not provide
adequate useful information about the recalling company, making it very difficult
for the company to respond to an avalanche of questions that emerge from the
Agency's distribution list. (See suggestions above) The Agency should provide
the recalling company a copy of the Report immediately prior to its distribution
50 the company can be prepared to respond appropriately. A distribution list
should also be provided 10 the recalling company. Finally, FSIS should never
include on this Report any customer list of the recalling company.
14. FSIS should maintain and improve its communications about recalls with the
FDA, CDC and other Federal agencies. AMI strongly agrees. In fact, FSIS
should adopt revised recall procedures that more closely mirror those used by
FDA.
FSIS Docket Clerk
October 9, 1998
Page 7
15. District Offices should be responsible for recalls of imported product by official
import establishments that are located in their districts. AMI disagrees. FSIS
headquarters should be responsible for recalls of imported products in order to
protect a uniform approach to recalls.
16. After a recall, the establishment should be responsible for determining the
disposition of the recovered product, subject to FSIS verification FSIS must
determine whether the fact that the establishment shipped adulterated product
evidences a HACCP system failure that would justify enforcement action against
the establishment. AMI generally agrees. However, shipping adulterated product
that resulted from an unforeseen hazard or a hazard that cannot be controlled
under best available practices to a zero tolerance performance standard should
not result in a determination of a HACCP system failure.
17. FSIS should regularly assess whether a recall provides evidence of a need to
change Agency policies, and whether the Agencies recall procedures worked
effectively and efficiently in the recall. AMI agrees. Further, AMI believes FSIS
and industry should regularly consult on the most effective means by which
industry and government can cooperate when recalling products - especially
Class I recalls where public health is most threatened Since a recall is ultimately
a company's responsibility, it would benefit both the private and public sectors to
share observations, recommendations and experiences in order to improve
continuously the speed and efficiency of recall operations.
The industry and government commitment to HACCP demonstrates our mutual
desire to prevent health hazards in foods. We must work continuously to improve our
prevention systems. One net result of such improvement will be, we believe, a
reduction in the number of food safety-related product recalls. But even if only a
handful of recalls were to be necessary in the meat and poultry industry each year,
each of those recalls is extremely important and should be handled quickly,
professionally and with accurate information. Toward this end, AMI pledges its
participation to the President's Council on Food Safety and to FSIS, as you work to
define a uniform approach to food product recalls.
Sincerely,
J. Patrick Boyle
PRESIDENTS
w
FOOD SAFETY
INITIATIVE
USDA
FY 2000 BUDGET
October 20, 1998
UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY INITIATIVE
(Dollars in Thousands)
1999
2000
Change 2000
1998
1999
Vatoed
1999
Department Allowance from
Approp.
Budget
Bill
Omnibus
Allowance
1999 Budget
A. EARLY WARNING SYSTEM FOR PUBLIC HEALTH SURVEILLANCE
1. Enhance/Expand active foodborne disease surveillance program
Economic Research Service (ERS)
$32
$285
$282
$285
0
Food Safety and Inspection Service (FSIS)
1,500
1,500
1,500
1,500
0
DEPARTMENT SUBTOTAL, A
1,532
1,785
1,782
1,785
0
9. RISK ASSESSMENT
1. Establish a Risk Assessment Consortium
Cooperative State Research, Education, and Extension Service (CSREES)
0
962
1,612
962
0
Economic Research Service (ERS)
33
686
236
686
0
Office of the Chief Economist (OCE)
3
3
3
3
0
2. Develop better data and modeling techniques to assess exposure to microbial and
chemical contaminants, including animal drug residues, through the food supply
Agricultural Research Service (ARS)
4,498
4,818
4,818
7,218
$2,400
Cooperative State Research, Education, and Extension Service (CSREES)
150
1,000
1,000
1,000
0
Food Safety and Inspection Service (FSIS)
0
0
0
0
0
2,500
National Agricultural Statistical Service (NASS)
0
0
0
2,500
Office of the Chief Economist (OCE)
51
149
149
149
0
3. Develop dose-response essessment models (also called hezard characterization) for
use in risk assessment
Food Safety and Inspection Service (FSIS)
0
0
0
1,000
1,000
Office of the Chief Economist (OCE)
6
6
6
6
0
4. Identify control measures for reducing foodborne Illness losses In
agricultural production and processing.
Food Safety and Inspection Service (FSIS)
0
1,000
1,000
1,000
o
AGENCY SUBTOTAL, B (ARS)
4,498
4,818
4,818
7,218
2,400
AGENCY SUBTOTAL, B (CSREES)
150
1,962
2,612
1,962
0
AGENCY SUBTOTAL, B (ERS)
33
686
236
686
0
AGENCY SUBTOTAL, B (FSIS)
0
1,000
1,000
2,000
1,000
AGENCY SUBTOTAL, 8 (NASS)
0
0
0
2,500
2,500
AGENCY SUBTOTAL, B (OCE)
60
158
158
158
0
DEPARTMENT SUBTOTAL, B
4,741
8,624
6,824
14,524
5,900
UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY INITIATIVE (Continued)
(Dollars In Thousands)
1999
2000
Change 2000
1998
1999
Vetoed
1999
Department Allowance from
Approp.
Budget
Bill
Omnibus
Allowance
1999 Budget
C. BIOSCIENCE RESEARCH
1. Improved detection methods
Agricultural Research Service (ARS)
11,115
12,815
11,697
12,815
0
Cooperative State Research, Education, and Extension Service (CSREES)
1,260
2,258
3,108
2,653
395
2. Understanding antimicrobial resistance
Agricultural Research Service (ARS)
508
808
608
2,308
1,500
Cooperative State Research, Education, and Extension Service (CSREES)
500
740
1,240
740
0
3. Understanding antibiotic drug resistence
Agricultural Research Service (ARS)
92
892
492
2,692
1,800
Cooperative State Research, Education, and Extension Service (CSREES)
0
0
0
395
395
4. Prevention techniques: pathogen control, reduction, and elimination
Agricultural Research Service (ARS)
29,710
38,810
34,290
43,030
4,220
Cooperative State Research, Education, and Extension Service (CSREES)
3,810
5,940
8,940
6,599
659
5. Food hendling, distribution, and storage
Agricultural Research Service (ARS)
8,926
10,676
10,126
10,856
180
Cooperative State Research, Education, and Extension Service (CSREES)
680
1,500
1,500
1,764
264
6. Test samples of fruits and vegetables for microbial pathogens
Agricultural Marketing Service (AMS)
0
6,257
0
6,257
0
AGENCY SUBTOTAL, C (AMS)
0
6,257
0
6,257
0
AGENCY SUBTOTAL, C (ARS)
50,351
64,001
57,413
71,701
7,700
AGENCY SUBTOTAL, C (CSREES)
6,250
10,438
14,788
12,151
1,713
DEPARTMENT SUBTOTAL, C
56,601
80,696
72,201
90,109
9,413
UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY INITIATIVE (Continued)
(Dollars in Thousands)
1999
2000
Change 2000
1998
1999
Vetoed
1999
Department Allowance from
Approp.
Budget
Bill
Omnibus
Allowance
1999 Budget
INSPECTIONS
1. Enhanced Federal-State inspection partnerships
Food Safety and Inspection Service (FSIS)
565
6,412
5,796
8,778
366
2. Expand training and technical assistance to countries exporting produce to U.S.
Foreign Agricultural Service (FAS)
0
0
0
1,000
1,000
AGENCY SUBTOTAL, D (FAS)
0
0
0
1,000
1,000
AGENCY SUBTOTAL, D (FSIS)
565
8,412
5,796
8,778
366
DEPARTMENT SUBTOTAL, D
565
8,412
5,796
9,778
1,366
EDUCATION
1. Improve consumer education
Cooperative State Research, Education, and Extension Service (CSREES)
1,115
3,461
1,645
3,725
264
Economic Research Service (ERS)
420
420
420
420
0
Food Safety and Inspection Service (FSIS)
0
500
500
720
220
Office of the Chief Economist (OCE)
2B
28
28
28
0
2. Improve retail, food service, and institutional education
Cooperative State Research, Education, and Extension Service (CSREES)
900
2,799
1,330
3,194
395
Office of the Chief Economist (OCE)
10
10
10
10
0
Food and Nutrition Service (FHS)
0
2,000
2,000
2,000
0
3. Improve veterinary and producer education
Cooperative State Research, Education, and Extension Service (CSREES)
350
1,105
525
1,368
263
Food Safety and Inspection Service (FSIS)
0
2,000
2,000
2,000
0
AGENCY SUBTOTAL, E (CSREES)
2,365
7,365
3,500
8,287
922
AGENCY SUBTOTAL, E (ERS)
420
420
420
420
o
AGENCY SUBTOTAL, E (FNS)
0
2,000
2,000
2,000
0
AGENCY SUBTOTAL, E (FSIS)
0
2,500
2,500
2,720
220
AGENCY SUBTOTAL, E (OCE)
38
38
38
38
0
DEPARTMENT SUBTOTAL, E
2,823
12,323
8,458
13,465
1,142
UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY INITIATIVE (Continued)
(Dollars In Thousands)
1999
2000
Change 2000
1998
1999
Vetoed
1999
Department Allowance from
Approp-
Budget
Bill
Omnibus
Allowance
1999 Budget
F. ENERGENCY OUTBREAK RESPONSE COORDINATION
1. District Epidemiology Officers
0
0
0
1,450
1,450
Food Safety and Inspection Service (FSIS)
UNITED STATES DEPARTMENT OF AGRICULTURE
21-Oct-98
FOOD SAFETY INITIATIVE
(Dollars in Thousands)
1999
2000
Change 2000
1998
1999
Vetoed
1999
Department Allowence from
Approp.
Budget
Bill
Omnibus
Allowance
1999 Budget
AMS
0
$6,257
0
$2,831
$6,257
0
ARS
$54,849
68,819
862,231
67,219
78,919
$10,100
CSREES
8,765
19,765
20,900
24,765
22,400
2,635
1,391
938
938
1,391
0
ERS
485
0
0
0
0
1,000
1,000
FAS
FNS
0
2,000
2,000
2,000
2,000
0
FSIS
2,065
13,412
10,796
18,532
16,448
3,036
0
0
0
0
2,500
2,500
NASS
98
196
196
196
196
0
DCE
TOTAL, USDA
66,262
111,840
97,061
116,481
131,111
19,271
President's Food Safety Initiative -- FY 2000 Budget
USDA
AGRICULTURAL RESEARCH SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Risk Assessment:
Data Modelling Techniques ($000)
$4,498
$4,818
$7,218
$2,400
Risk Assessment: Data Modelling Techniques
Hazard Analysis and Critical Control Point (HACCP) programs need to be supported
by quantitative risk assessment to understand the potential for each step in the farm-to
table chain to either enhance or reduce the risk of illness. Risk assessment will help
determine which steps are critical, what degree of control the step must provide, and
the critical control points for each step. An expert system and specific, appropriate
quantitative data is required to accomplish risk assessments. Quantitative
microbiological data is needed to carry out the mathematical computations and to
develop and validate predictive microbiology models which are a necessary
component of these risk assessments.
Risk assessment modelling supported by the 2000 budget will evaluate the effects of
various on-farm production practices, processing systems, and transportation systems
on the contamination of food-producing animals, including cattle, swine and poultry, as
they are presented for slaughter. The proposed research will result in improved
information for the animal industry to base decisions on production practices that will
result in fewer pathogens in food animals being presented for slaughter. This
research will be closely coordinated with the regulatory responsibilities and research
needs of the Food Safety and Inspection Service, in particular their Animal Production
Food Safety activities, and with the Food and Drug Administration through the Risk
Assessment Consortium.
The 2000 budget request extends risk assessment modelling to include the production
or pre-harvest phase. Previous modelling has addressed only the data needs of post-
harvest operations. Other research has obtained data and developed models on
normal contamination levels in raw food ingredients, food composition parameters (pH,
water activity and processing operations) to calculate the temperature profile of a beef
roast being cooked in an oven. This information has begun providing the basis for a
workable expert system for food microbiologists in the industry and regulatory
agencies to use without extensive software training. This post-harvest modelling
activity must continue, but it must also be extended to pre-harvest to develop data for
use in assessing risk in predictive microbiological models which will describe the
USDA
Page 1
President's Food Safety Initiative -- FY 2000 Budget
effects of various production practices, processing, and transportation systems on the
behavior and subsequent contamination of poultry, beef, and swine as they are
presented for slaughter.
FY 2000 Activities:
Develop a system that will contain data banks with models for the growth rates,
lag times, survival, thermal inactivation, and radiation inactivation as appropriate
for additional pathogens. For post-harvest operations, it will contain information
on normal contamination levels in raw food ingredients and food composition
parameters (pH, water activity and processing). For pre-harvest operations it will
contain data describing risk of various food animal production and transportation
practices and interventions.
Gather data on the incidence and number of pathogens on food producing
animals at various critical stages in production and management systems. With
this data the research will develop predictive models for the risk of transmission of
zoonotic pathogens through farm management systems to the presentation of the
animals for slaughter. In addition to production practices, microbiological and
animal behavioral data on various systems used for transporting swine will be
generated and evaluated in relation to the subsequent contamination of the
animals at slaughter. The research will also develop predictive models for the risk
of transmission of zoonotic, parasites through farm management systems, animal
manure, and water run off.
USDA
Page 2
President's Food Safety Initiative -- FY 2000 Budget
USDA
NATIONAL AGRICULTURAL STATISTICS SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Risk Assessment:
Fruits And Vegetables Food Safety
$0
$0
$2,500
$2,500
Survey ($000)
Risk Assessment: Data Modelling Techniques
On October 2, 1997, the President announced a plan to further ensure the safety of
the Nation's food supply. The main objective of the Initiative to Ensure the Safety of
Imported and Domestic Fruits and Vegetables is to ensure food safety in the
production and processing of domestic and imported fruits and vegetables.
As a result of this initiative, USDA, the Food and Drug Administration (FDA), the
Environmental Protection Agency (EPA), and representatives from the fruit and
vegetable industries recommended that National Agricultural Statistics Service (NASS)
be responsible for conducting a survey of fruit and vegetable growers and
packinghouses handling practices with regard to food safety. A primary use of these
data would be to establish a baseline of agricultural practices related to microbial food
safety and to provide a benchmark to measure future industry changes. Survey data
reported by producers would inform domestic and international data users on U.S.
grower food safety practices. The survey information would also be used by FDA and
USDA to target specific industry educational outreach programs to increase fruit and
vegetable industry awareness on microbial food safety. Economic data collected
would be the basis for cost/benefit analyses for food safety related agricultural
practices.
This initiative supports the Research, Education, and Economics Mission Area Goal 2,
A Safe and Secure Food and Fiber System, by providing accurate and timely
statistical data which can be used to establish a baseline for agricultural practices as
they relate to microbial food safety issues for fruits and vegetables.
FY 2000 Activities:
Design survey materials and plans based on a 1999 pilot study to be conducted in
California and New York. These two pilot States were chosen based on distinct
differences in crops grown, growing conditions, and agricultural practices.
USDA
Page 3
President's Food Safety Initiative -- FY 2000 Budget
Conduct a statistical survey of approximately 10,000 fruit and vegetable growers,
as well as fruit and vegetable packinghouses, to establish a baseline for good
agricultural practices as they relate to microbial food safety issues. The survey
would be conducted in major fruit and vegetable States which account for nearly
85 percent of the Nation's acreage. The survey would consist of core questions
covering water, manure management, facility sanitation, worker sanitation and
hygiene, and transportation practices. The survey would also include questions
related to specific practices and the related cost data to allow the calculation of
associated cost/benefit analyses.
USDA
Page 4
President's Food Safety Initiative - FY 2000 Budget
USDA
FOOD SAFETY AND INSPECTION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Risk Assessment:
Dose-Response Assessment Models ($000)
$0
$0
$1,000
$1,000
Risk Assessment: Dose Response Assessment Models
The Food Safety and Inspection Service's (FSIS) goal is to reduce the incidence of
foodborne illness by 25 percent. Up to 5 million illnesses are estimated to occur
annually with up to 4,500 related deaths. To reduce illness and death from foodborne
illness, FSIS, in cooperation with other agencies, and industry, must identify hazards
and reduce the risk of regulated products becoming contaminated with bacterial
pathogens, such as Salmonella enteritidis, E. coli O157:H7, and Campylobacter.
In order to make FSIS policies and programs risk-based, it is important to estimate
human health consequences of hazards in meat, poultry, and egg products. It is
equally important to know how hazards entering the food chain can be controlled and
how these controls affect the human health outcome. A quantitative risk assessment
is the best way to estimate foodborne illnesses associated with USDA regulated
products and to identify and evaluate the most effective strategies to prevent them.
Microbial risk assessors require better information about the number. of bacteria that it
takes to make a person ill. This dose-response information is critical for risk
assessments and is needed to strengthen current estimates of risk, rather than relying
on existing dose-response information.
Risk assessment requires dedicated resources and rapid response to illness
investigations while the implicated food is available and patient recall is accurate.
This is only possible at the most local level within the State. FSIS is proposing
cooperative agreements with five States to collect food specimens during
investigations of foodborne disease to help determine the occurrence, distribution, and
level of contamination associated with illness. This collaborative effort will also
strengthen FSIS relations with State health departments, and improve information
sharing and rapid responses when problems do occur.
USDA
Page 5
President's Food Safety Initiative -- FY 2000 Budget
FY 2000 Activities:
Enter into cooperative agreements with five States to collect food specimens
during investigations of foodborne disease epidemics. Information at the local
level is necessary to accurately determine the exposure to pathogens in suspect
foods. These specimens will be sent to FSIS laboratories to isolate, identify and
enumerate pathogens. FSIS will use this information to support selection of
appropriate dose-response model forms that will be used to assist the agency in
policy decisions. Potential applications include determining acceptable pathogen
levels on/in regulated meat, poultry, and egg products.
USDA
Page 6
President's Food Safety Initiative -- FY 2000 Budget
USDA
COOPERATIVE STATE RESEARCH, EDUCATION AND EXTENSION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Improved Detection Methods ($000)
$1,260
$2,258
$2,653
$395
Bioscience Research: Improved Detection Methods
Continued outbreaks of food-borne illness due to a variety of pathogens of fecal origin
in various foods (ground beef, poultry, eggs, and fresh fruits and vegetables) have
sustained a high level of awareness among the public about the issue of food safety.
Changes, such as the implementation of Hazard Analysis and Critical Control Point
(HACCP) systems in meat and poultry plants by FSIS and the Guidance Document
on Production Practices for Fresh Fruits and Vegetables by the Federal Drug
Administration (FDA), have enhanced the awareness of the potential role of
production practices in contamination of various food products.
This awareness means that food animal and fruit and vegetable producers must be
more involved in reducing the opportunity for contamination by pathogens of fecal
origin, whether from domestic or wild animal species or human beings. In order to
accomplish better control of these pathogens, their presence needs to be detected in
a variety of sample matrices. The tests must be rapid, accurate, and usable in field
settings. The Cooperative State Research, Education and Extension Service
(CSREES) and its partners in the land-grant universities are well positioned, through
their interactions with the production community and other segments of the food
system, to conduct the applied research and related educational programs to
implement these improved detection systems.
Improved detection methodologies. will enable producers, processors, and others in
the food system to monitor various food products in a more effective manner. It will
also enable regulatory officials to have an improved monitoring system for the impact
of HACCP implementation throughout the food system. Outcomes of this program
can include sampling of animals under different management strategies and at time of
shipment for slaughter, as well as monitoring of microbial contamination of carcasses
following the slaughter process. In the fruits and vegetables sector, similar sampling
will inform us about the benefits of specific interventions and the economic benefits to
be derived. Cooperation on this program would occur with FSIS through their Animal
Production Food Safety Unit. It should be noted that improved detection systems
may give an initial impression of an increase in microbial contamination due to their
increased efficiency in detecting microorganisms.
USDA
Page 7
President's Food Safety Initiative -- FY 2000 Budget
Research efforts on detection methods in the 1998 and 1999 programs have been
focused on improving the accuracy and sensitivity of various kinds of tests. The
program in 2000 will direct its focus to refining testing methods now being developed
to make them more user friendly and able to be used in field testing situations where
rapid results are a major concern.
FY 2000 Activities:
Improved detection methods for the most prevalent pathogens by making them
more adaptable for quick, on-site testing of products, and more able to identify
specific pathogens, rather than simply indicating presence of fecal contamination.
Develop better sampling strategies that minimize incorrect results due to sampling
errors in order make testing methods more effective.
USDA
Page 8
President's Food Safety Initiative - FY 2000 Budget
USDA
AGRICULTURAL RESEARCH SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Understanding Antimicrobial
Resistance ($000)
$508
$808
$2,308
$1,500
Bioscience Research: Understanding Antimicrobial Resistance
Food has been preserved for many years using traditional preservation technologies,
including heat or cold, low pH, high salt content, and disinfectants. Since these
technologies kill or otherwise control bacterial growth, bacteria may become resistant
to them just as they do to the much newer antibiotics.
To preserve the effectiveness of traditional preservation technologies, a greater
understanding of how and why resistance may develop to these technologies, as well
as an understanding of the relationship of this resistance to antibiotic resistance. New
ways to apply existing pathogen prevention technologies or new intervention
technologies that are more effective and sustainable in mitigating pathogen presence
must be developed.
The 2000 budget request will extend the present Agricultural Research Service (ARS)
research in antimicrobial resistance, which has thus far focused primarily on acid
resistance, to include additional traditional preservation technologies. It will also
include the relationship of this resistance to other methods of pathogen control, and it
will develop new pathogen prevention/intervention technologies where necessary.
The budget increase will for the first time provide for establishment of new culture
collections of resistant and non-resistant bacterial and fungal food pathogens. This
research will be closely coordinated with the research and regulatory programs
including the Food and Drug Administration and the Food Safety and Inspection
Service.
USDA
Page 9
President's Food Safety Initiative - FY 2000 Budget
FY 2000 Activities:
Define physiological and/or genetic mechanisms that microbes utilize to become
resistant to traditional food safety barriers such as heat or cold, low pH, low water
activity and disinfectants. ARS will use this information to develop
prevention/intervention pathogen control strategies which delay or prevent the
acquisition of resistance, which would compromise the safety of food products
which have relied on these control techniques. Acid susceptibility is important
when fermentation is used to preserve both animal and plant based foods.
Establish culture collections of resistant and non-resistant bacterial and fungal
pathogens. These resources will be used to develop molecular characterization
methods to facilitate (1) the identification of the resistant bacterial pathogens
detected in food products, and (2) the tracing of these organisms to their source
(e.g. environment, manure, water, animal feed).
USDA
Page 10
President's Food Safety Initiative -- FY 2000 Budget
USDA
AGRICULTURAL RESEARCH SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Understanding Antibiotic Drug
Resistance ($000)
$92
$892
$2,692
$1,800
Bioscience Research: Understanding Antibiotic Drug Resistance
The effectiveness of antibiotic drugs for both human and animal use is compromised
by the development of antibiotic resistance in drugs used for treatment, in many
cases to only one pathogen, but also in increasing frequency to multiple drugs such
as with Salmonella typhimurium DT 104. The resistance of pathogens to antibiotics,
particularly the DT 104 pattern of resistance in Salmonella sp. to multiple antibiotics
has been increasingly recognized by the public health and medical communities and
antibiotic use in animals is identified as a contributing factor. In a few cases only one
drug is available for successful treatment of diseases caused by certain pathogens.
Antibiotic resistance is an important factor that must be controlled in both animal
health and the use of animals and their products as foods. Research is needed to
develop the knowledge to prevent the development of this antibiotic drug resistance.
The development of resistant human pathogenic bacteria is closely associated with
the use of antimicrobial agents in human medicine, but it is also likely that food
producing animals are sources or vectors of resistant bacteria that may be transmitted
directly or indirectly to humans. To maintain the effectiveness of antibiotics in the
therapy of life-threatening human disease, effective strategies must be devised to
prevent both the emergence and the maintenance in food producing animals of
pathogenic and non-pathogenic antibiotic resistant bacteria.
A major impediment to determining the effect of antibiotic use in food animals on
human health risk is the complexity of the food-animal drug treatment and subsequent
food processing and handling. The 2000 budget request will support research that
will lead to a better understanding of how the use of antibiotics in food-producing
animals increases the risk of emergence of microorganisms that are resistant to
specific antibiotics, and how the emergence of resistance in bacteria in animals that
received antibiotics is related to the concentrations of the drugs to which the bacteria
are exposed and also to the duration of treatment or exposure. Efforts will also be
undertaken to establish whether an increase in resistance detection is due to the use
of antibiotics in food animals or to the perpetuation of resistant species in food
animals, the environment, or other reservoirs.
USDA
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President's Food Safety Initiative -- FY 2000 Budget
The budget increase will provide for research to determine the concentration, length
of use, and other selective factors or conditions favoring the acquisition and
dissemination of resistance genes among pathogens and nonpathogens, particularly
in relation to poultry, cattle and swine. As necessary, the Agricultural Research
Service (ARS) will conduct prospective ecological studies that better define sources of
resistant bacteria in the environment, and determine if increase of morbidity and
mortality sometimes associated with antibiotic resistant organisms are due to genetic
factors for increased virulence accompanying the bacterial resistance genes.
Current research activities of ARS support both the interagency National Antimicrobial
Susceptibility Monitoring Program, which prospectively monitors changes in antibiotic
susceptibilities of zoonotic pathogens, and a small program which is determining the
basis for multiple antibiotic resistance factors associated with DT 104. The budget
request will extend the present ARS research program, which has focused primarily
on Salmonella, to include additional pathogens and it will include development of new
pathogen prevention/intervention technologies. Research will be closely coordinated
with the research and regulatory programs and responsibilities of the Food and Drug
Administration, the Food Safety and Inspection Service, and the Centers for Disease
Control and Prevention.
FY 2000 Activities:
Determine the concentration, length of use, and other selective factors or
conditions favoring the acquisition and dissemination of resistance genes among
pathogens and non-pathogens in food producing animals. Basic information will
be developed using chemostat model systems, on the time and dose dependency
of various antibiotics which favor the emergence of resistant organisms in the
gastrointestinal, tract of food animals species.
Develop technologies and controls, including competitive exclusion, that will
prolong the usefulness of antibiotics for both human and animal use, and prevent
food products of animal origin from being carriers of resistant organisms.
USDA
Page 12
President's Food Safety Initiative -- FY 2000 Budget
USDA
COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Understanding Antibiotic Drug
Resistance ($000)
$0
$0
$395
$395
Bioscience Research: Understanding Antibiotic Drug Resistance
Continued outbreaks of foodborne illness due to a variety of pathogens of fecal origin
in various foods (ground beef, poultry, eggs, and fresh fruits and vegetables) have
sustained a high level of awareness among the public about the issue of food safety.
Changes, such as the implementation of Hazard Analysis and Critical Control Point
(HACCP) systems in meat and poultry plants by the Food Safety and Inspection
Service (FSIS) and the Guidance Document on Production Practices for Fresh Fruits
and Vegetables by the Food and Drug Administrtion (FDA), have enhanced the
awareness of the potential role of production practices in contamination of various
food products.
The increasing problem with bacterial isolates that exhibit resistance to one or more
antibiotics has caused significant concern because of the difficulty of treating any
human that becomes infected with such an organism. This emphasis has increased
the need for much more research on management practices that will reduce the
prevalence of pathogens, e.g., Salmonella, E. coli, and Campylobacter as well as
provide resources for educating producers on the implementation of such practices.
Through grant awards to experienced research groups with a significant background
in mechanisms of drug resistance, the Cooperative State Research, Education, and
Extension Service (CSREES) can cause rapid changes in our knowledge base and
immediately translate these findings into educational programs that can be delivered
through the Cooperative Extension System and the land grant universities. Projects
which combine research activities and extension programs in a single project are
most likely to have the desired impact and will ensure the needed linkage between
research outcomes and their application by producers. Cooperation on this program
would occur with FSIS through their Animal Production Food Safety Unit and, through
an Inter Agency Working Group, all efforts are also coordinated with FDA. Outcomes
will be measured by monitoring the antibiotic resistance patterns of bacterial isolates
from a variety of sources, both animal and human. The primary source of information
about the isolates will come from on-going surveillance programs being operated by
FDA and FSIS.
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President's Food Safety Initiative -- FY 2000 Budget
This area of research has not been given major support during 1998 and 1999.
Therefore, the research effort in 2000 will represent a new emphasis on this
increasingly important topic in public health.
FY 2000 Activities:
Determine the process by which antibiotic resistance may develop in bacteria and
how that resistance may be transferred among different bacterial populations.
Determine the effectiveness of best management practices interventions in the
production setting related to control of antibiotic usage in food. This knowledge will
also be used to as a basis to develop educational programs for producers.
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President's Food Safety Initiative -- FY 2000 Budget
USDA
AGRICULTURAL RESEARCH SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Prevention Techniques: Pathogen
Control, Reduction, and Elimination
($000)
$29,710
$38,810
$43,030
$4,220
Bioscience Research: Prevention Techniques - Pathogen Control, Reduction,
and Elimination
Exposure and infection of animals by zoonotic pathogens during production, which is
accentuated by the increasing animal density of present day livestock operations, is a
major source of the contamination in meat-based foods. These pathogens may also
contaminate fruits and vegetables produced for human consumption fertilized with
animal manure. Effective handling systems for animal manures will help break the
cycle of enteric infections with human pathogens in food producing animals and will
also help assure that pathogens from these animal manures do not contaminate
drinking and food processing waters and are not available to contaminate fruits and
vegetables. Manure handling systems are needed to assure effective inactivation,
including identification of sources and reservoirs on the on-farm and in the
environment, development of pathogen reduction processes suitable to farm size and
manure production levels, and reduction of farm level transport, dissemination, and
vectoring of pathogens. Because many fruits and vegetables are eaten raw without
cooking, it is critical we develop post-harvest technologies that suppress or control
zoonotic pathogens, while not destroying freshness and other quality attributes, to
help assure the safety of fruits and vegetables.
The proposed research provided by this budget request will address interventions
which can be utilized throughout the farm-to-table continuum to assure safety of both
meat, poultry, fruits, and vegetables. The budget request provides for the first time
for investigations into the control of pathogens in animal manure. Effective methods
to handle and treat poultry, swine and cattle manure during production will prevent
transmission of pathogens to agricultural lands and to crops used for human food,
and will help prevent possible distribution of pathogens to crops or other animals from
surface runoff and irrigation waters. Where appropriate the research will investigate
wild animals and other vectors as potential sources of contamination of animal
wastes.
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President's Food Safety Initiative -- FY 2000 Budget
The request will provide for extension and expansion of the present Agricultural
Research Service (ARS) research with fruits and vegetables to permit greater in depth
investigation of the ecology of food bome pathogens, including their environmental
sources. Traditional and non-traditional methods of inhibiting pathogens of fruits and
vegetables will be optimized, to include both outer and inner surfaces as appropriate.
Both chemical and physical control techniques and strategies, including irradiation,
radio frequency radiation, steam pasteurization, and competitive exclusion will be
investigated. The effects of phytochemical and environmental conditions on growth
and survival of E. coli O157:H7, Salmonella, and Campylobacter on the surface of
fruits and vegetables will be quantified, particularly in relationship to biofilm
development.
The active and passive manure treatments or composting techniques developed will
reliably, predictably and consistently reduce or eliminate pathogens in manure, and
thus prevent their transmission to food products of both plant and animal origin.
These techniques, coupled with technologies to control zoonotic pathogens on fruits
and vegetables will increase consumer confidence in the safety of their food supply
and promote the consumption of a healthful diet. This research will be closely
coordinated with the research and regulatory programs and responsibilities of the
Food and Drug Administration and the Food Safety and Inspection Service.
FY 2000 Activities:
Design effective control programs for zoonotic bacteria and parasites. This
proposed preharvest research will develop practical and economical pathogen
reduction processes for manure from food producing animals. Different processes
are needed and will be developed for each major type of animal production facility,
and the processes will be suitable to farm size and manure production levels and
have well-defined process parameters.
Determine how bacteria and fungi normally present on plants influence the growth
and survivability of human pathogens that may be present. Data will be
developed on the characteristics of fruits and vegetables associated with high
quality products that resist growth of pathogens.
Develop technologies to control pathogens on fruits and vegetables, including
proper handling procedures, rinses, and other procedures to reduce pathogen
population on fresh cut produce.
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President's Food Safety Initiative -- FY 2000 Budget
USDA
COOPERATIVE RESEARCH, EDUCATION, AND EXTENSION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Prevention Techniques: Pathogen
Control, Reduction, and Elimination
($000)
$3,810
$5,940
$6,599
$659
Bioscience Research: Prevention Techniques - Pathogen Control, Reduction,
and Elimination
Continued outbreaks of food-borne illness due to a variety of pathogens of fecal origin
in various foods (ground beef, poultry, eggs, and fresh fruits and vegetables) have
sustained a high level of awareness among the public about the issue of food safety.
Changes, such as the implementation of Hazard Analysis and Critical Control Point
(HACCP) systems in meat and poultry establishments by the Food Safety and
Inspection Service (FSIS) and the Guidance Document on Production Practices for
Fresh Fruits and Vegetables by the Food and Drug Administration (FDA), have
enhanced the awareness of the potential role of production practices in contamination
of various food products. Food animal and fruit and vegetable producers must be
much more involved in reducing the opportunity for contamination by pathogens of
fecal origin, whether from domestic or wild animal species or human beings. This
emphasis has brought more attention to management practices that will reduce the
prevalence of pathogens, e.g., Salmonella, E. coli, and Campylobacter, as well as
provide resources for educating producers on the implementation of such practices.
The Cooperative State Research, Education, and Extension Service (CSREES) can
facilitate rapid changes in our knowledge base by funding established research
groups and immediately translate these findings into educational programs that can
be delivered through the Cooperative Extension System and the land-grant
universities. Outcomes of this program can include sampling of animals under
different management strategies and at time of shipment for slaughter, as well as
monitoring of microbial contamination of carcasses following the slaughter process. In
the fruits and vegetables sector, similar sampling will inform us about the benefits of
specific interventions and the economic benefits to be derived. Cooperation on this
program would occur with FSIS through their Animal Production Food Safety Unit.
We are already working cooperatively, including CSREES serving as the funding and
management agent for FSIS activities on implementation of improved management
practices in livestock production. Similarly, we have a close working relationship with
FDA in developing applied research and educational programs in support of their new
Guidance Document for fruit and vegetable growers.
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President's Food Safety Initiative -- FY 2000 Budget
In the 1998 and 1999 budgets, we are focusing the research component on
developing epidemiologic information about several of the most prevalent pathogens
(E. coli, Salmonella, Campylobacter), which can then be used as the basis for the
proposed activities in 2000. The education program has been more directly focused
on the consumer and food handler sectors and, while that will continue, added funds
(see Safe Food Handling Education section) will permit the addition of more program
efforts directed to the production segment of the food chain. In this manner, we
intend to be successful in preventing the contamination of the food products in the
first instance, rather than trying to impose decontamination procedures later in the
process.
FY 2000 Activities
Conduct epidemiologic studies to determine risk factors in the production unit that
are related to the presence of specific organisms in the digestive tract of animals
and the subsequent shedding of these organisms in the feces.
Evaluate the management practices, which are determined to be most effective in
initial experiments, through monitored field experiments and facilitate the transfer of
these new methodologies through demonstration or extension efforts.
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President's Food Safety Initiative -- FY 2000 Budget
USDA
AGRICULTURAL RESEARCH SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Food Handling, Distribution, and
Storage ($000)
$8,926
$10,676
$10,856
$180
Bioscience Research: Food Handling, Distribution, and Storage
Food products spend long hours in storage and being transported over long distances
before they arrive at the consumer's plate. Temperature control is often not
adequate, and pathogen growth results. Adequate information is not available on the
conditions under which food products may be transported and handled and how this
handling influences their acquiring contaminants and the possible growth of these
contaminants that may occur. Research is needed to develop methods and
technology to minimize those conditions and therefore the likelihood of such
contamination developing.
The 2000 budget supports Agricultural Research Service research projects to develop
enhanced procedures and products to be used during food handling, distribution and
storage. These treatments, primarily for fruits and vegetables, will include rinses and
other procedures to reduce pathogen populations and eliminate cross-contamination.
The proposed research will result in decreased pathogen growth particularly for fruits
and vegetables, as these food products are handled, distributed and stored. Thus
fewer pathogens will contaminate fruits and vegetables that come to the table of
American consumers. This research will be closely coordinated with the research and
regulatory programs and responsibilities of the Food and Drug Administration.
FY 2000 Activities:
Investigate the ecology of foodbome pathogens during handling, distribution and
storage, including their environmental sources.
Determine if inhibitors of normal surface flora can effect some control of pathogen
growth.
Investigate proper handling procedures and the efficacy of rinses and other
procedures to reduce pathogen populations on fresh cut produce during handling,
distribution, and storage.
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President's Food Safety Initiative - FY 2000 Budget
USDA
COOPERATIVE RESEARCH, EDUCATION, AND EXTENSION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Bioscience Research:
Food Handling. Distribution, and
Storage ($000)
$680
$1,500
$1,764
$264
Bioscience Research: Food Handling, Distribution, and Storage
Continued outbreaks of foodborne illness due to a variety of pathogens of fecal origin
in various foods (ground beef, poultry, eggs, and fresh fruits and vegetables) have
sustained a high level of awareness among the public about the issue of food safety.
While progress has been made in improving the processing sector, the transport and
storage sector of the food system has received much less attention. Now, processors
are requesting help in ensuring that products which are known to be free of microbial
contamination after the processing stage, are maintained in a similar high quality
status during the subsequent movement of products into the hands of the consumer.
The Cooperative State Research, Education, and Extension Service (CSREES) and
its partners in the land-grant universities are well positioned to conduct the applied
research and the related educational programs to effect the needed changes in
transport, handling, and storage practices.
Through grant awards to experienced research groups with a significant background
in such work, CSREES can cause rapid changes in our knowledge base and
immediately translate these findings into educational programs that can be delivered
through the Cooperative Extension System and the land grant universities. Projects
which combine research activities and extension programs in a single project are
most likely to have the desired impact and will ensure the needed linkage between
research outcomes (knowledge of control strategies) and their application as a result
of well-planned educational programs. Close working relationships will be maintained
with regulatory agencies to monitor the progress of this program and gain feedback
on needed changes in the direction or focus of the program. Microbial status of
various food items can be determined prior to, and after, movement of the product
from producer/processor and consumer.
With the 2000 funds, more attention will be directed to issues of how to maintain
close monitoring of conditions during shipping via various kinds of remote sensor
technology. Funding in 1998 and 1999 focused on methods to detect contamination
at specific times rather than establishing continuous monitoring of conditions.
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10/26/98
20:32
President's Food Safety Initiative - FY 2000 Budget
FY 2000 Activities:
Extend studies on contamination of food products to the distribution and storage
phase of the food system to ensure that safe and wholesome products are not
rendered unsafe due to poor storage or handling practices.
Evaluate the management practices, which are determined to be most effective in
initial experiments, through monitored field experiments and facilitate the transfer of
these new methodologies through demonstration or extension efforts.
USDA
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President's Food Safety Initiative - FY 2000 Budget
USDA
FOOD SAFETY AND INSPECTION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Inspections:
Enhanced Federal-State Inspection
Partnerships ($000)
$565
$8,412
$8,778
$366
Inspections: Enhanced Federal-State Inspection Partnerships
All federally and State inspected establishments must operate under the provisions of
the Hazard Analysis and Critical Control Point (HACCP) final rule by January 25,
2000. This includes some 6,000 establishments under Federal inspection and more
than 2,000 under State inspection. To achieve a seamless national inspection
program covering all establishments, FSIS is proposing legislation that would provide
for State meat and poultry inspection programs to enforce Federal meat and poultry
inspection laws and regulations within their States. State inspected product that is
inspected under Federal HACCP requirements would then be permitted to move in
interstate commerce, rather than intrastate commerce only. To assure compliance
with Federal requirements and improve consumer confidence in the national food
supply, FSIS must conduct pathogen testing on State inspected product and validate
the capability of State laboratory programs to conduct other critical microbial testing.
FSIS is currently working to assure that State programs implement HACCP
requirements that are "at least equal to" the Federal program. The legislative
proposal on interstate shipment of State inspected meat and poultry products will
increase the cooperative relationship with States by providing for a one-year transition
period from enforcing "at least equal to" requirements to enforcing Federal laws and
regulations. The transition to Federal requirements will increase the ability of very
small establishments to compete in the marketplace and ensure the viability of State
meat and poultry inspection programs.
In 2000, the State inspection programs will be the focus of HACCP implementation
efforts. The $2.4 million included in the 2000 budget for assisting the States with
pathogen testing and laboratory validation will build on 1999 efforts to assist the
States in preparing for HACCP implementation. One-time special assistance of
$2.0 million to the States for 1999 will include: (1) implementation of the Field
Automation Information Management (FAIM) project to provide States FSIS off-the-
shelf inspection automation infrastructure that will accommodate HACCP
requirements; (2) laboratory equipment for pathogen detection required by the
HACCP final rule; and (3) HACCP training for State inspectors. These efforts are
intended to assist State programs in implementing HACCP requirements that are
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President's Food Safety Initiative -- FY 2000 Budget
"at least equal to" Federal requirements. Working to assure that State inspection
programs are "at least equal to" Federal requirements will facilitate the transition to a
seamless national inspection system and interstate shipment of State inspected
product. For 2000, FSIS is proposing legislation to permit State inspected product to
move in interstate commerce. To assure compliance with Federal requirements and
improve consumer confidence in the national food supply, FSIS must conduct
pathogen testing on State inspected product.
FY 2000 Activities:
Conduct pathogen testing on 56,000 samples of State inspected meat and poultry
products in FSIS laboratories to determine the compliance of some 2,000 State
inspected establishments with pathogen reduction performance standards.
Conduct comprehensive reviews and audits of 20 State laboratories as well as
private laboratories used by State programs.
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President's Food Safety Initiative - FY 2000 Budget
USDA
FOREIGN AGRICULTURAL SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Inspections:
Training and Technical Assistance to
Countries Exporting Produce to the
U.S. ($000)
$0
$0
$1,000
$1,000
Inspections: Training and Technical Assistance to Countries Exporting
Produce to the U.S.
Following recent foodborne illness outbreaks associated with raspberries from
Guatemala and the alleged association with Mexican strawberries, US consumers
have become more vocal and have expressed concern about the safety of imported
food products, particularly those products regulated by the Food and Drug
Administration (FDA). Congressional action (H.R. 3052) has been initiated mandating
that FDA increase inspection and compliance activities, particularly in foreign markets
supplying food products to the United States.
Several agencies within USDA, including the Foreign Agricultural Service (FAS), have
been working closely with FDA to improve food safety under the President's Food
Safety Initiative. FAS, in particular, has been directly involved in implementing the
Presidential Directive of October 2, 1997, to Ensure the Safety of Imported and
Domestic Fruits and Vegetables. In accordance with the 90-day Fresh Produce
Status Report, FAS will facilitate visits of FDA investigators and scientists to visit
foreign operations to ascertain the source of problems that may pose a safety hazard
in produce imported into the United States. In addition, FAS is to facilitate the
development of international research, education and training programs. FAS meets
bi-weekly with FDA staff to coordinate this effort.
FAS did not have a specific budget allocation to support this initiative in 1998 or for
1999. Activities to date have been limited to facilitating FDA visits to Guatemala and
Mexico and organizing international briefings and seminars on the President's Food
Safety Initiative. Given that 40-50 different countries export produce to the United
States, the impact of expanded FDA in-country inspections on FAS field office
operations will increase dramatically as FDA moves to fully implement the initiative.
FDA at present has no plans for posting FDA investigators or scientists in U.S.
Embassies and will draw on FAS field staff to support their in-country activities as
appropriate.
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President's Food Safety Initiative - FY 2000 Budget
FY 2000 Activities:
Facilitate the collection of data, report on good agricultural production and
manufacturing practices within the food sector, and support FDA field staff visits,
primarily in Latin America and Asia.
Negotiate equivalency understandings with foreign governments.
Conduct international risk assessment workshops and other training activities to
facilitate understanding of the risks associated with microbial contamination on food
and the control measures needed to reduce incidence of foodborne illness. These
activities will be self-initiated or done in cooperation with the International Institute
for Cooperation in Agriculture, the Food and Agriculture Organization, and/or the
World Health Organization as appropriate.
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President's Food Safety Initiative -- FY 2000 Budget
USDA
COOPERATIVE RESEARCH, EDUCATION, AND EXTENSION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Safe Food Handling Education:
Consumer Education ($000)
$1,115
$3,461
$3,725
$264
Safe Food Handling Education: Consumer Education
Many Americans continue to fall victim to foodborne illness in the United States. As a
result, there is a need for an increased effort to fully integrate food safety research
and education to inform the public about preventive measures. Increased levels of
funding will be imperative for the Cooperative State Research, Education, and
Extension Service (CSREES) to strengthen existing links between food safety
research and education, and to establish new links that mobilize the vast resources of
the land-grant universities and other public institutions. CSREES is in a unique
position, because of its partnership with the land-grant universities, to fully integrate
food safety research and education in a way that attracts broad support and
addresses complex issues with economic, social, and health consequences.
There continue to be areas of unmet needs in food safety education targeted to
consumers. Research results that identify sources of contamination, bacterial
reservoirs, and new prevention methods will need to be communicated to consumers.
Public education and outreach programs that focus on the adoption of recommended
food handling practices resulting from research need to be developed. Furthermore,
there are targeted populations who are at an increased risk for developing foodborne
illnesses (older Americans, pregnant or nursing mothers, young children, the
chronically ill, the immune-suppressed). These are "hard to reach" populations for
whom education and training about proper food selection, preparation, storage, and
handling is crucial.
Funding increases in 2000 will provide the impetus needed to ensure that relevant
research results are interpreted and translated to all consumers, but particularly those
at increased risk for developing food borne illness. In 1998, funds were used to
develop educational programs and resources targeting high-risk or under served
populations. Increased funding would ensure that vulnerable populations receive
critical information necessary to make informed decisions about food safety.
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President's Food Safety Initiative - FY 2000 Budget
FY 2000 Activities:
Increase efforts to integrate research and education in food safety through
technology transfer and through the development of educational programs that
focus on the adoption of recommended food handling practices consistent with the
current knowledge base.
Develop educational programs for consumers that focus on the role of the
consumer in ensuring and improving the safety of the nation's food supply.
Increase efforts to develop education and outreach programs that target high-risk,
under-served populations who are at in increased risk for developing food borne
illnesses.
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President's Food Safety Initiative -- FY 2000 Budget
USDA
FOOD SAFETY AND INSPECTION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Safe Food Handling Education:
Consumer Education ($000)
$0
$500
$720
$220
Safe Food Handling Education: Consumer Education
Safe food handling is an increasingly major issue with U.S. consumers and spans all
ages from pre-school aged children to senior citizens. To address concerns
expressed by consumers about food safety, the Food Safety and Inspection Service
(FSIS) is taking a major role in educating the public about how to handle domestically
produced and imported food more safely.
FSIS needs to ensure that it is meeting the public's demand for food safety education,
that educational materials are consistent with current research findings, and that the
Meat and Poultry Hotline is fully accessible to the public. From 1996 to 1997, Hotline
calls increased by more than 22 percent to 138,120. Call volume has also been high
in 1998 due to power outages associated with "El Nino". In addition to maintaining
the Hotline, examples of current efforts in food safety education include FSIS support
for the Public/Private Partnership in the "Fight BAC!" campaign and working
cooperatively with FDA to distribute an educator's package for Food Safety Education
Month. FSIS also produces and distributes the "Food Safety Educator", which is a
vehicle for sharing information from FSIS, the Food and Drug Administration (FDA)
and the Cooperative Research, Education, and Extension Service (CSREES), and
supports the National Agricultural Library database on food safety education with
FDA. For 1999, FSIS estimates that it will reach 158 million people with food safety
information.
The 1999 initiatives include updating and strengthening safe food handling messages,
improving dissemination of existing educational information to school children, and
developing a visual graphic depicting basic safe food handling principles primarily for
children and youth. In 2000 FSIS will build on these efforts to reach an estimated
170 million adults and children, in cooperation with State and local governments, FDA
and CSREES. The 2000 initiatives will expand outreach efforts and include food-
handling messages in educational materials that reflect the latest research findings.
Also, FSIS will procure the necessary equipment and services to increase the call
capacity of the Meat and Poultry Hotline, which will accommodate the estimated
increase in the number of calls that are expected to be received.
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President's Food Safety Initiative -- FY 2000 Budget
FY 2000 Activities:
Develop, produce, and distribute materials for cooking, vocational and public
schools, and community leaders that focus on the third quadrant of the "Fight
BAC!" educational graphic "Cook to Proper Temperatures.".
Produce and distribute radio public service announcements addressing safe food
handling practices.
Provide Cooperative Extension agents across the Nation a packet of safe food
handling education materials that can be used by family and consumer science
teachers.
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President's Food Safety Initiative -- FY 2000 Budget
USDA
COOPERATIVE RESEARCH, EDUCATION, AND EXTENSION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Safe Food Handling Education:
Retail, Food Service, an Institutional
Education ($000)
$900
$2,779
$3,194
$395
Safe Food Handling Education: Retail, Food Service, an Institutional Education
Recent outbreaks of food-borne illness have heightened public sensitivity about food
safety, including the safety of fresh fruits and vegetables. In recent years, a new
Hazard Analysis and Critical Control Points (HACCP) based method for inspecting
meat and poultry products has addressed some concerns about E. coli O157:H7. To
address the issue of produce safety, the President's Fruit and Vegetable Initiative will
target producers and growers of domestic and imported produce. Good Management
Practices are being developed and adapted for the fruit and vegetable industry that
will significantly expand the need for education and outreach programs focusing on
preventing microbial contamination during growing, harvesting, processing, and
transportation of fresh produce.
There has been consistent progress made toward providing HACCP education and
training to large retailers through the various retail organizations. However, there are
several under-served groups for whom HACCP education and training is critical. For
example, there is a large unmet need for HACCP and food safety training and
education for very small retailers who are often not participating members of major
retail organizations. CSREES will need to develop methods to identify and target this
under-served group, and to provide them with critically needed HACCP education and
training consistent with new HACCP regulations. In addition, there is a need to
increase the focus on developing and implementing training and education programs
for growers and producers of fresh fruits and vegetables. These programs will need
to be based on established good manufacturing practices and they will require a
collaborative effort across all Federal agencies with a role in ensuring the safety of
the food supply.
In 1998, funds were used develop food safety training and education programs for
retail and commercial food service establishments. Additional funds are needed to
expand HACCP education and training to under-served groups, such as very small
retailers not currently affiliated with trade organizations. Additional funds are also
necessary to build an education and outreach component that addresses the needs of
growers and producers of fresh fruits and vegetables.
USDA
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President's Food Safety Initiative -- FY 2000 Budget
FY 2000 Activities:
Develop educational programs that focus on providing HACCP education and
training for very small retailers.
Increase efforts to provide food safety education and training to key segments of
the retail market, including food transportation and food distribution sectors.
USDA
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President's Food Safety Initiative - FY 2000 Budget
USDA
COOPERATIVE RESEARCH, EDUCATION, AND EXTENSION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Safe Food Handling Education:
Veterinary and Producer ($000)
$350
$1,105
$1,368
$263
Safe Food Handling Education: Veterinary and Producer Education
Continued outbreaks of food-bome illness due to a variety of pathogens of fecal origin
in various foods (ground beef, poultry, eggs, and fresh fruits and vegetables) have
sustained a high level of awareness among the public about the issue of food safety.
Changes such as the implementation of Hazard Analysis and Critical Control Point
(HACCP) systems in meat and poultry plants by the Food Safety and Inspection
Service (FSIS) and the Guidance Document on Production Practices for Fresh Fruits
and Vegetables by the Food and Drug Administration (FDA) have enhanced the
awareness of the role of production practices in contamination of various food
products.
The awareness of food safety issues means that food animal and fruit and vegetable
producers and their consultants must be much more involved in reducing the
opportunity for contamination with pathogens of fecal origin, whether from domestic or
wild animal species or human beings. This emphasis has increased the need for
more research on management practices that will reduce the prevalence of
pathogens, e.g., Salmonella, E. coli, and Campylobacter, and has also given marked
impetus to the efforts to provide resources for educating producers and veterinarians
on the implementation of such practices. The Cooperative State Research,
Education, and Extension Service (CSREES) and its partners in the land-grant
universities are well positioned through their interactions with the production
community, to conduct the applied research and, via the extension system and
production consultants, the related educational programs to effect the needed
changes in on-farm practices.
Initial efforts will focus on developing educational programs for veterinarians and
livestock producers to cause a reduction in the incidence of human pathogens present
within the livestock production system. In this manner, we expect to reduce the
shedding of such pathogens in the feces of animals and reduce the likelihood that
food products, whether animal or plant derived, are contaminate with these
organisms. Outcome measurements will include monitoring of animals going to
slaughter for presence of foodborne pathogens prior and following implementation of
management systems due to educational programs. Similarly, outcomes for
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President's Food Safety Initiative -- FY 2000 Budget
educational programs for fruit and vegetable growers about best production practices
can include implementation of these practices and impact on contamination levels of
harvested crops.
For 2000, the program would begin to focus on the producer of fruits and vegetables.
Currently, pilot programs are being conducted on how to proceed with educational
programs for food animal producers and these would then be more fully implemented
in 2000. The fruit and vegetable sector would have an increased level of training
programs in 2000 as compared to the anticipated efforts in 1999.
FY 2000 Activities:
Develop educational programs for veterinarians on how to function as auditors or
certifiers of Best Management Practices (BMP's) for livestock production units.
Develop educational programs and provide them to producers on the management
systems needed to reduce or eliminated specific pathogens that can cause human
illness through contamination of food products.
Increase efforts in educating fruit and vegetable growers on how to minimize
contamination of their crops and be in compliance with the proposed guidance
document from FDA.
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President's Food Safety Initiative - FY 2000 Budget
USDA
FOOD SAFETY AND INSPECTION SERVICE
1998
1999
2000
Proposed
Actual
Budget
Proposal
Increase
Emergency Outbreak Response
Coordination:
District Epidemiology Officers ($000)
$0
$0
$1,450
$1,450
Emergency Outbreak Response Coordination: District Epidemiology Officers
To further reduce illness and death from foodborne disease, improved detection of
foodborne illness outbreaks is needed, as well as stronger capability to appropriately
handle an increasing number of product recalls. This calls for increasing the
presence and scientific expertise of field epidemiologists who conduct recalls and
coordinate with the States in investigating outbreaks. The Food Safety and Inspection
Service (FSIS) has determined that the 8 existing field epidemiology personnel are
insufficient to cover this workload, which grew by 25 percent from 40 recalls in 1996
to 50 recalls in 1997.
The request is needed to increase the number and preparedness of the Agency's field
epidemiologists. An additional 10 field epidemiologists, along with the current 8,
would serve as District Epidemiology Officers (DEO) to cover all 18 inspection
districts. The increased number of DEO's will provide FSIS with expertise to respond
effectively in unexpected crises. DEO's will be in regular contact with State health
and agriculture departments and will assist in foodborne outbreak investigations. This
will require specialized education to acquire microbiological investigative skills, as well
as instruments for complicated analytical work and mobile communication devices.
Mobility among the States, FSIS headquarters, and the Centers for Disease Control
and Prevention (CDC) will also be necessary to achieve the level of preparedness
that will significantly improve the FSIS response to foodborne illness.
FSIS expects to expand ongoing coordination with States and the Food and Drug
Administration to facilitate mutually beneficial exchanges of laboratory and technical
expertise. This effort will further assist Federal, State and local integration in support
of a seamless national food safety program. DEO's will also participate in the
Foodborne Outbreak Response Coordinating Group (FORCG), which is a combined
State and Federal effort.
USDA
Page 34
President's Food Safety Initiative as FY 2000 Budget
FY 2000 Activities:
Increase the number of District Epidemiology Officers by 10 for a total of
18 epidemiologists.
Conduct investigations associated with product recalls.
Investigate foodborne illness outbreaks in cooperation with other Federal and
State public officials.
Promote food safety during production by working with farmers and others to
reduce the risk of future contamination.
Page 35
USDA
FAX COVER SHEET
USDA
OFFICE OF THE UNDER SECRETARY
FOR FOOD SAFETY
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DATE: FEB12
NUMBER OF PAGES including cover: $5
TO:
CLIFF GABRIEL
FAX NUMBER:
486 6027
FROM:
CATHERINE E. WOTEKI, UNDER SECRETARY
KRISTIE D. KELM
CAREN A. WILCOX, DEPUTY UNDER SECRETARY
JOYCE E. SMITH
COMMENTS:
THIS IS THE BEST we
HAVE- USED ON LAVACH.
THESE FIGURES (15t 3 paper VS lost paye)
2017 necessanly go together due to they
$33million we pot as "effort" -
Telephone (202) 720-0350/51 Fax (202)690-0820
1400 Independence Avenue, SW - Room 227-E
Washington, D.C. 20250
PRESIDENT'S FOOD SAFETY INITIATIVE
FY 2000 PROPOSAL
2000
Proposed
1997
1998
1999
Proposal
Increase
ACTIVITY
Dollars in Thousands
SURVEILLANCE:
USDA:
Food Safety and Inspection Service
$1,000
$1,500
$1,500
$1,500
$0
Economic Research Service
32
32
282
285
3
Subtotal, USDA
1,032
1,532
1,782
1,785
3
HHS:
Food and Drug Administration
737
3,897
3,897
10,297
6,400
Centers for Disease Control and
Prevention
4,500
14,500
19,000
29,000
10,000
Subtotal, HHS
5,237
18,397
22,897
39,297
16,400
Subtotal, Surveillance
6,269
19,929
24,679
41,082
16,403
COORDINATION:
USDA:
Food Safety and Inspection Service
0
0
0
500
500
HHS:
Food and Drug Administration
7,173
7,723
7,723
7,723
0
Subtotal, Coordination
7,173
7,723
7,723
8,223
500
INSPECTIONS:
USDA:
Food Safety and Inspection Service
0
565
10,113
12,513
2,400
HHS:
Food and Drug Administration
73,244
81,114
105.614
122,514
16,900
Subtotal, Inspections
73,244
81,679
115,727
135,027
19,300
2000
Proposed
1997
1998
1999
Proposal
Increase
ACTIVITY (Cont.)
Dollars in Thousands
RISK ASSESSMENT:
USDA:
Agricultural Research Service
5,461
4,498
4,909
7,309
2,400
Cooperative State Research,
Education, and Extension Service
145
150
2,612
3,702
1,090
Food Safety and Inspection Service
0
0
3,260
3,260
0
Economic Research Service
33
33
236
686
450
National Agricultural Statistics Service
0
0
0
2,500
2,500
Office of the Chief Economist
62
60
158
158
0
Subtotal, USDA
5,701
4,741
11,175
17,615
6,440
HHS:
Food and Drug Administration
2,589
6,539
6,539
7,039
500
Subtotal, Risk Assessment
8,290
11,280
17,714
24,654
6,940
EDUCATION:
USDA:
Cooperative State Research.
Education, and Extension Service
2,365
2,365
7.365
8,287
922
Food Safety and Inspection Service
0
0
3,659
3,659
0
Food And Nutrition Service
0
0
2,000
2.000
0
Office of the Chief Economist
27
38
38
38
0
Economic Research Service
420
420
420
420
0
Subtotal, USDA
2,812
2,823
13,482
14,404
922
HHS:
Food and Drug Administration
4,800
6,870
6,870
8,370
1,500
Centers for Disease Control and
Prevention
0
0
476
476
0
Subtotal, HHS
4,800
6,870
7,346
8,846
1,500
Subtotal, Education
7,612
9,693
20,828
23,250
2,422
RESEARCH:
USDA:
Agricultural Research Service
44,165
50,351
64,959
74,279
9 320
Cooperative State Research,
Education, and Extension Service
3,724
6,250
14,788
23,799
9,011
Agricultural Marketing Service
0
0
112
6,297
6185
Subtotal, USDA
47,910
56,601
79,859
104,375
24,516
HHS:
Food and Drug Administration
20,793
27,193
27,693
32,393
4700
Subtotal, Research
58,703
83,794
107,552
136,768
29.216
TOTAL, INITIATIVE
171,291
214,098
294.223
369,004
74.781
PRESIDENT'S FOOD SAFETY INITIATIVE
FY 2000 PROPOSAL
Increase
2000
Over
1997
1998
1999
Proposal
1999
TOTAL INITIATIVE
Dollars in Thousands
USDA:
Agricultural Research Service
$49,647
$54,849
$69,868
$61,588
$11,720
Cooperative State Research,
Education, and Extension Service
6,234
8,765
24,765
35,788
11,023
Agricultural Marketing Service
0
0
112
6,297
6,185
Food Safety and Inspection Service
1,000
2,065
18,532
21,432
2,800
Economic Research Service
485
485
938
1,391
453
Office of the Chief Economist
89
98
196
196
0
National Agricultural Statistics
0
0
0
2,500
2,500
Service
0
0
2,000
2,000
0
Food and Consumer Service
57,455
66,262
116,411
151,192
34,781
Subtotal, USDA
HHS:
Food and Drug Administration
109,336
133,336
158,335
188,336
30,000
Centers for Disease Control and
Prevention
4,500
14,500
19,476
29,476
10,000
Subtotal, HHS
113,836
147,836
177,812
217,812
40,000
TOTAL, INITIATIVE
171,291
214,098
294,223
369.004
74,781
FOOD SAFETY ACTIVITIES
(Dollars in Millions)
1999
2000
Change from
2000
Change from
1998
1999
1998
Budget
1999
Food Safety Initiative:
USDA:
ARS
54.8
69.9
15.0
81.6
11.7
CSREES
8.8
24.8
16.0
35.8
11.0
AMS
0.0
0.1
0.1
6.3
6.2
PSIS
2.1
18.5
16.5
21.4
2.9
ERS
0.5
0.9
0.5
1.4
0.5
OCE
0.1
0.2
0,1
0,2
0.0
FNS
0.0
2.0
2.0
2.0
0.0
NASS
0.0
0.0
0.0
1.5
1.5
Subtotal, USDA
66.3
116.4
50.1
150.2
33.8
HHS:
FDA
133.3
158.3
25.0
108.3
30.0
CDC:
14.5
19.5
5.0
29.5
10.0
Subtotal, Has
147.8
177.0
30.0
217.8
40.0
Total, FSI
214.1
294.2
80.1
368.0
73.E
Food Safety and Inspection
Service (Wet FSI) :
587.2
598.5
11.3
631.6
33.1
TOTAL, Food Safety Activities
801.3
892.8
91.5
999.6
106.9
RECAP:
Food Safety Activities:
USDA
ARS
54.2
69.9
15.0
81.6
11.7
CSREES
$.8
24.8
16.0
35.8
11.0
AMS
0.0
0.1
0.1
6.3
6.2
FSIS
589.3
617.1
27.8
653.0
36.0
ERS
0.5
0.9
0.5
1.4
0.5
OCE
0.1
0.2
0.1
0.2
0.0
FNS
0.0
2.0
2.0
7.0
0.0
NASS
0.0
0.0
0.0
1.5
1.5
Subcotal, USDA
693.5
725.0
61.5
781.0
66.9
PHS:
FDA
133.3
158.3
25.0
188.3
30.0
cre.
14.5
19.5
5.0
29.5
10.0
Subcotal. HHS
167.8
177.0
30.0
217.8
40.0
TOTAL, Food Safery Activities
801.3
892.8
91.5
999.6
106.9