Remarks given by Linda Swacina, Deputy
Administrator, Food Safety and Inspection Service, at the Mexico
- U.S. Poultry Health and Trade Symposium, May 12, 2004, Mexico
View or download slides to accompany this speech (PDF Only)
(Slide 1) Good morning! It is a pleasure to be with you here in
beautiful Mexico City with its rich history and cultural attractions.
On behalf of the Food Safety and Inspection Service, I want to
thank the organizers of this symposium. This forum presents a wonderful
opportunity to continue dialogue and learn from each other how we
can further improve food safety across the common border between
our two countries, and around the world.
A Brief Background
Before I get into the heart of my discussion, let me provide you
some background about FSIS, as well as myself. I am the Deputy Administrator
of the U.S. Department of Agriculture's Food Safety and Inspection
Service, or FSIS as we call it.
(Slide 2) My role as Deputy Administrator of the Agency is to work
with Acting Administrator, Dr. Barbara J. Masters, who is a veterinarian
and our chief inspection official or central competent authority
as the position is commonly referred to in international negotiations.
We ensure that the programs and policies of the Agency are effectively
carried out on a daily basis to protect public health.
My connection to FSIS is a unique one. My father is a veterinarian
and worked for FSIS for 30 years, so I have a close and personal
relationship to the Agency and to the issue of food safety and public
health. I have witnessed many positive developments within FSIS,
especially several recently which I will talk about shortly.
A Brief Background of the Agency
(Slide 3) FSIS is the U.S. Department of Agriculture's public health
regulatory agency that protects consumers by ensuring that meat,
poultry and egg products are safe, wholesome, and accurately labeled.
(Slide 4) These products account for more than $120 billion in sales
- or approximately 1.4 trillion Mexican pesos, or about one-third
of all U.S. consumer spending on food.
(Slide 5) Looking at these products from another perspective,
each year we inspect 39 million cattle, 97 million swine, 3.5 million
sheep, and eight billion poultry before, and after, they are slaughtered.
Our inspectors also are responsible for inspecting 3.2 billion pounds
of liquid egg products, which eventually go into further processing
facilities that produce mayonnaise, ice cream, salad dressings,
etc. And finally, you will probably take particular attention to
this point, we re-inspect 3.8 billion pounds, or approximately 1.7
million metric tons, of imported meat, poultry and processed egg
products from 33 countries with inspection systems that are equivalent
to our own.
This enormous responsibility requires that we implement science-based
policies to protect public health. Our policies have already yielded
positive results for consumers. (Slide 6) Two weeks ago, the Centers
for Disease Control and Prevention (CDC) issued a report on the
incidence of infections from foodborne pathogens. The report noted
significant declines from 1996, the beginning of HACCP, to 2003
in illnesses caused by E. coli O157:H7 (down 42%), Salmonella
(down 17%), Campylobacter (down 28%) and Yersinia
(down 49%). (Slide 7) The CDC report also noted that illnesses caused
by Salmonella Typhimurium that are typically caused by
meat and poultry fell by 38% during this same period. Most significantly,
illnesses caused by E. coli 0157:H7 that are typically
associated with ground beef dropped by 36% between 2002 and 2003.
(Slide 8) Our measures to prevent E. coli O157:H7 contamination
in ground beef have also yielded an overall lower prevalence rate
of this pathogen. After beef plants were instructed to reassess
their HACCP plans to better address potential E. coli O157:H7
contamination, FSIS' scientifically trained personnel conducted
the first-ever comprehensive audits of 1,550 beef establishments'
HACCP plans. Sixty two percent of those plants made major improvements
based on these reassessments, and sixty percent added E. coli
O157:H7 as a pathogen likely to occur. As a result, we are seeing
a significant drop in the number of E. coli O157:H7 positive
samples in ground beef. In 2003, of the E. coli O157:H7
samples collected and analyzed, 0.30 percent tested positive, compared
to 0.78 percent in 2002. That's a 60% reduction and a definite improvement!
To see a significant drop in illnesses caused by this pathogen is
also something both industry and government can be proud of, and
consumers can reap the benefits of.
(Slide 9) For Salmonella, we issued new procedures to
control this pathogen more quickly. Instead of waiting for three
cycles of tests, the discovery of a second Salmonella positive
set now triggers a review of an establishment's HACCP plan. Due
to this process and other science-based initiatives, the rate of
Salmonella found in our regulatory testing program for
raw meat and poultry has dropped by 65% over the past six years
and by 16% compared with last year.
(Slide 10) And for Listeria monocytogenes, we have seen
similar decreases. Last June (2003), we issued a new rule for establishments
producing ready-to-eat products where Listeria monocytogenes
is a concern. Late last year, we released data that showed a 25
percent drop in the percentage of positive Listeria monocytogenes
samples from the year before and a 70% decline compared with years
prior to the implementation of HACCP.
Process for Evaluating Equivalence
These examples give you an idea of where we are headed with our
food safety system since our actions directly impact other nations
maintaining equivalency. (Slide 11) We (FSIS) are required by law
to evaluate a foreign country's inspection system before that nation
can export meat, poultry and egg products to the United States.
Given this responsibility, I want to focus the rest of my discussion
on the processes required for exporting to the United States.
Sanitary and Phytosanitary Measures Agreement
(Slide 12) The Sanitary and Phytosanitary Agreement (SPS) is an
agreement that sets out the basic rules to ensure food safety, and
animal and plant health standards for international trade. The agreement
allows countries to set their own standards, but it also stipulates
that any regulations must be based on science. Food safety equivalence
judgments are based on the provisions of the SPS Agreement, and
the United States is bound as a signatory.
(Slide 13) I want to highlight a very important point regarding
equivalence that is summarized from Article 4.1 of the SPS Agreement.
It states that:
"Members shall accept the sanitary
measures of other members as equivalent, even if these measures differ from their own
if the exporting member objectively demonstrates
that its measures achieve the importing member's appropriate level of sanitary
(Slide 14) This means that an exporting country has the burden
to demonstrate equivalence. And an importing country has the right
to decide if a foreign inspection system is either:
- Inadequate to achieve the appropriate level of protection;
- Unable to demonstrate equivalence adequately.
(Slide 15) Since the United States signed the SPS Agreement, FSIS
has made several changes in its laws and regulations to comply.
First, we amended our regulations to reflect the terminology "equivalent to" as the standard of eligibility. Second, our regulations now
set forth the criteria for evaluating foreign systems. And finally,
each criterion constitutes a sanitary measure as defined in the
(Slide 16) One of the most important terms cited within the SPS
Agreement is "sanitary measure." Some examples
of sanitary measures might include:
- End product criteria;
- A specific sampling procedure;
- A testing, inspection or certification procedure; or
- A packaging and labeling requirement directly related to food
These sanitary measures must be based on scientific
principles and applied in a non-arbitrary, non-discriminatory manner.
In addition, they need to be based on an assessment of the risk
from a food safety hazard.
(Slide 17) Another important term in the SPS Agreement is the
"appropriate level of protection." This means the
SPS Agreement affirms the right of each government to choose its
own level of protection. Exporting countries may employ measures
that differ from those used by importing countries, provided that
they obtain the same level of protection established by the importing
(Slide 18) For example, we require generic E. coli testing
as a sanitary measure to determine adequate process control during
the slaughter of animals. A nation that exports to the United States
might decide either to:
- Adopt the U.S. requirements, or
- Use another microorganism to determine whether the slaughter
process is under control.
The SPS Agreement also directs FSIS in how to make equivalence
decisions. The decision-making process requires a cooperative effort
between both the importing and the exporting countries. For instance,
the importing country, in this case the United States, must notify
the 33 countries that export to the United States of any changes
in U.S. regulations.
In another example, when the United States implemented HACCP and
Salmonella testing requirements, we notified all countries
(eligible to export to the United States) and asked them to provide
us with documentation on the implementation of those requirements.
(Slide 19) On the other hand, the 33 countries that are eligible
to export can ask FSIS to explain our appropriate level of protection
and how the HACCP and Salmonella testing requirements are
relevant. Once we provide an explanation, the exporting country
can either implement those requirements or develop a case for implementing
different requirements. If a country chooses to implement a different
requirement, then FSIS will review the documentation from the exporting
country and make a decision. (Slide 20) FSIS will then decide to
do one of three things:
- Determine whether the different sanitary measure is equivalent
to the HACCP and Salmonella testing requirements;
- Request more information; or
- Reject the different sanitary measure.
How FSIS Determines Equivalence under the SPS Agreement
FSIS' Office of International Affairs
(Slide 21) Equivalence decisions under the SPS Agreement are handled
by FSIS' Office of International Affairs (OIA). This office is headed
by Ms. Karen Stuck, Assistant Administrator. Ms. Stuck has been
with the Agency for more than 20 years and thus has extensive experience
in food safety issues.
FSIS-OIA is the only government office in the U.S. federal government
that makes these equivalence decisions each day. The decisions are
made by a staff of analysts and scientists specially trained in
(Slide 22) FSIS-OIA makes two different kinds of equivalence determinations.
The first is the initial equivalence determination. This
process starts when a country wants to begin exporting to the United
States. The second is the on-going equivalence determination.
FSIS-OIA uses this process to decide whether a country continues
to maintain an equivalent inspection program.
The Initial Equivalence Determination
First, let's look at how we make initial equivalence decisions.
(Slide 23) We use a multi-step process to determine whether another
country's food regulatory system is equivalent to our own. Any country
can apply for eligibility to export meat, poultry or egg products
to the United States. The process usually begins with a letter from
a central competent authority within another country's government
asking for approval to export its products for sale in the United
States. We then respond with copies of our laws, FSIS regulations,
and other documents that set forth meat, poultry and egg product
regulatory policy, as well as questionnaires designed to collect
detailed information about the country's food regulatory system.
Usually, it takes several months for countries to complete the
application package we send, but we provide as much advice and guidance
as possible to other governments concerning any portion of the process.
(Slide 24) When we receive the completed application, we conduct
an initial document analysis to compare that country's inspection
system sanitary measures with the ones we apply in the United States.
If there is any further information we need, then we work collaboratively
with the country's food regulatory officials to get the necessary
information to finish our initial evaluation.
(Slide 25) After reviewing the entire application, we decide whether
that country's food regulatory system meets all U.S. import requirements
in an equivalent manner to our own and if it provides the same level
of public health protection attained domestically. If we determine
that both of these objectives are met, then we send a multidisciplinary
team of experts to that country to conduct an on-site audit of its
entire meat, poultry or egg product regulatory system. We verify
that the country has satisfactorily implemented all laws, regulations,
and other inspection or certification requirements cited in the
(Slide 26) After the on-site audit has been successfully completed,
we publish a proposed regulation in the Federal Register
to add the country to our list of eligible importers. There is a
period of time in which we must collect public comments to this
proposed regulation to help us make a final decision on whether
the country can be eligible to export to the United States.
(Slide 27) What I would like to point out here is that we do not
conduct food inspections in another country, nor do we certify individual
establishments for export to the United States. After we determine
that a country has an equivalent food regulatory system, we rely
on that system to meet our public health requirements.
Any establishment that desires to export to the United States must
apply to their own central competent authority, and that country's
chief inspection official must certify to FSIS a list of all establishments
that meet our import requirements. This process is quite different
from the one used by the U.S. Department of Health and Human Services'
Food and Drug Administration, which looks at individual companies
to determine whether they can export to the United States.
On-going Equivalence Determination
(Slide 28) Countries that are eligible to export to the United
States must continuously demonstrate that they remain equivalent.
FSIS-OIA utilizes three methods to make ongoing equivalence decisions.
(Slide 29) The first step in the on-going equivalence process
is called the document analysis. We are especially concerned with
government regulatory oversight, as well as verification and enforcement
procedures. Therefore, we review documents that describe the country's
fundamental laws, regulations, policies, food production requirements,
regulatory oversight, verification and enforcement requirements.
(Slide 30) The second step is the system audit. This is where we
send one or more of our auditors to the country to assess the inspection
system in daily operation, particularly with respect to implementation
of any new requirements we have put forth. We audit each country
that exports to the United States at least once each year, and we
focus on process control and government oversight.
After an audit plan is developed, an FSIS auditor will examine
records pertaining to a country's oversight of establishments and
laboratories. The auditor will also select a representative number
of establishments for actual on-site review. After the audit is
complete, the auditor holds an exit conference with inspection officials
where the audit findings are discussed.
After an FSIS auditor returns to the United States, an audit report
is prepared. We send a final draft audit report to a country for
review. A nation has 60 days to comment on the findings, and these
findings are then included as an addendum to the final audit report.
FSIS-OIA often holds conference calls with the country's inspection
officials and/or takes an enforcement action, if necessary. The
final audit is then posted on FSIS' Web site.
(Slide 31) The third step of the on-going equivalence process is
called port-of-entry reinspection. This involves reinspection of
randomly selected samples at the port of entry. These samples are
selected by an automated centralized computer database. Furthermore,
the samples selected are performance-based, enabling compliance
histories to be continuously updated based on test results. All
shipments are checked for damage, accurate labeling, proper certification,
and for general condition.
Meeting Export Requirements
(Slide 32) The thoroughness of our import inspection procedures
is matched by our commitment to ensure that only the safest products
are exported from the United States. Because of FSIS' centralized
inspection program, we rely heavily on our inspection force to assure
that plants are producing the safest possible products both domestically
and for export. Our internal assurances come from a multi-tiered
system which consists of our front line inspectors, an inspector-in-charge,
and visits by circuit supervisors. In addition, the inspection force
continually verifies the eligibility of exports from the United
States by consulting with the FSIS Library of Export Requirements.
The Library is on-line, on FSIS' Web site, and it provides current
complete information for both exporters and FSIS inspectors for
more than 100 countries.
Closing - The Global Farm-to-Table Chain
(Slide 33) With a global food supply, we are all interdependent
on each other's actions. The farm-to-table chain that we historically
visualized as being confined within one nation's borders is becoming
more of a complex and integrated global network.
This is the reason why when we carry out our meat, poultry and
egg products inspection, as well as other food safety activities,
we work with all of our domestic and international partners. We
need to make sure that we are seeking the highest levels of food
safety standards possible - standards that are based on sound science.
(Slide 34) Hopefully, you have gained a better understanding of
our food safety system and how we determine equivalence under the
SPS Agreement. I want to reiterate the importance of government
oversight and enforcement of food safety systems, as well as laboratory
sampling. These are matters we take very seriously
when we conduct audits of other nation's systems.
Mexico is a dear and close ally of ours, and we are working very
closely together to ensure both food safety systems are based on
science and protect all our consumers. Food safety is vital for
free trade. We still have work to do - government to government
to industry. But when we focus on utilizing science as our common
ally to improve food safety and public health, we will get it done.
Thank you for your attention, and I would be happy to answer any
questions you might have.