**SPARBOE COMPANIES** ![](media/image1.wmf){width="0.8479166666666667in"
height="0.7493055555555556in"}

35 East Fourth Street, P.O. Box 961 Telephone: (320) 693-2431

Litchfield, Minnesota 55355-0961 Fax: (320) 693-8594

April 20, 2000

Federal Drug Administration

Dockets Management Branch HFA-305

5630 Fishers Lane

Room 1061

Rockville, MD 20852

RE: Docket No. 00N-0504 (HFA-305)

Greetings:

The Sparboe Companies is pleased to comment on the President's Council
on Food Safety/Egg Safety Action Plan, hereafter referred to as the
Plan. The Sparboe Companies, headquartered in Litchfield, Minnesota is
among the largest producers of fresh shell table eggs in the United
States. We also rank among the largest producers of whole liquid egg
products in the United States. Our operations are located in Minnesota,
Iowa and Colorado. We also have several family farm egg producers on
contract with us throughout Minnesota and Iowa.

The three general questions inviting comments to the docket were:

1)  Does the Plan comprehensively cover the problem of SE in eggs and
    measure for reducing this hazard?

2)  What are the costs in implementing the risk reduction components?

3)  What training is needed?

These comments will respond to each of these general questions, detail
areas of the Plan that need more emphasis, and highlight those steps in
the Plan that do not contribute materially to the stated objectives.

Sparboe Companies considers food safety of paramount importance and
supports the goal of the President's Council to protect the public
health from all foodborne hazards through science-based objectives and
action steps. The Plan's strategic policies must continually ask if the
action steps will actually stop someone from getting ill.

Protecting the food supply is an ongoing challenge because, although the
risk associated with eating will never be eliminated, the hazards can be
minimized. Overall, the Plan is comprehensive. However, the Plan is over
ambitious and will not meet the objectives of the Plan for reasons
discussed herein.

Question No. 1. Does the Plan comprehensively cover the problem of SE in
eggs and measure for reducing this hazard?

Science-based objectives and action steps in any regulation must be
founded on accurate data

Any science-based objectives and action steps need to be truly rooted in
scientific data and accurate information so that there is valid
information for making informed decisions. [Broadening the participation
in quality assurance programs by establishing a national uniform program
of grading and inspection for all egg producers will assist with the
collection of accurate data and the further decline in the incidences of
SE related illnesses.]{.underline}

The Plan has numerous examples of misinformation and misunderstanding
which could lead to erroneous decisions. Even before the Plan's
introduction, numerous quality assurance programs developed by the egg
industry have contributed to a 48% decline in the rate of
culture-confirmed SE cases reported to the Centers for Disease Control
and Prevention (CDC) between the years of 1996 to 1999, and a 7% decline
between 1998 and 1999[^1]. In the 1999 National Animal Health Monitoring
Study[^2] it was reported that 56.1% of farm sites were conducting a
quality assurance program.

# Misinformation with misleading results

When President Clinton made his radio address on December 11, 1999, he
stated that there were 3.3 million infected eggs that could lead to
human illness. This risk is overstated. The figure 3.3 million is based
on the risk model of 1 egg in 20,000 or 0.005%. This percentage of the
nation's total egg production yields 3.3 million eggs, but the
President's advisors neglected to point out to the President that nearly
30% of all eggs are broken into liquid form and pasteurized. Overstating
the potential risk by 30% is a serious misstatement that has damaged the
reputation of the egg and thus the egg industry this past year.

The media coverage of the President's comments stated that foodborne
illness accounted for 76 million people becoming ill every year, 300,000
would be hospitalized and 5,000 reported deaths. It was
[not]{.underline} pointed out that this is a combined figure for all
foodborne illness, not just Salmonella or Salmonella Enteritidis
associated with eggs. We must take extreme care as both the Government
and the Industry are faced with making critical decisions based on
information. Accordingly, we need accurate information.

It is vital to recognize that the most important priority for any
Federal food safety strategic plan is credible information. Real, not
hypothetical, numbers need to be used in making decisions leading to
policy.

The MMWR of February 4, 2000 provides the number of outbreaks and number
of deaths attributed to Salmonella Enteritidis infection associated with
eating raw or undercooked eggs. The deaths reported during that 14-year
period was 79 (less than 6 per year . . . nowhere near the 5,000 deaths
reported), of which 64 or 81% occurred in health-care facilities. The
MMWR of March 17, 2000, also shows a decline in illnesses attributed to
SE. The information about the majority of deaths occurring in
health-care facilities were not included in the Plan, with the net
effect that major newspapers and other forms of media attributed the
5,000 deaths annually to eating SE-contaminated eggs. Any loss of life
is unacceptable. However, risk communication must be accurate to prevent
the continued disparaging of any commodity. Greater efforts need to be
directed toward accurate risk communication.

# Cited epidemiology must be current and accurate

In reporting the rate of isolation of SE from infected humans, the Plan
cited the years from 1976-1994 to acknowledge an increase in the rate
from 0.5 to 3.9 per 100,000 population. It also reported regional trends
for the years 1990-1994, indicating a decrease in the Northeast with
increases elsewhere. This is correct information for that time period.
However, this information is misleading as the more current information
from CDC shows [a decline in every region]{.underline} of the country.
The MMWR reported from 1996-1998, the rate of culture-confirmed SE cases
reported declined from 3.6 to 2.2 per 100,000. Every effort should be
made in reporting accurate and up-to-date epidemiology information so
that action steps can be solidly based.

[Industry demographics must be accurate]{.underline}

# Every egg producer must be included in the plan

In reporting the demographics of the US egg industry, the Plan noted the
estimated value of layers at nearly \$1 billion. In 1999 the value of
the laying flock would be more accurately reported at \$1 per bird. With
an average flock size nationwide of 269 million layers, this would have
yielded a value of less than one-third of the reported value in the
Plan. Additionally, the demographics represented the egg industry as
5,000 producers with 3,000 or more hens and another 65,000 farms having
less than 3,000 egg-laying hens. The USDA, in cooperation with the
American Egg Board collects the most current statistics on the number of
egg-producing farms with 3,000 or more hens showing this total at less
than 700 farms.

The actual number of farms is, therefore, only 14% of the number
referenced in the Plan.

Accurate industry demographics are imperative for accurate
decision-making. Because the Plan will exclude farms with 3,000 or fewer
layer hens and because it is reported that these farms can produce up to
three-quarters of a million eggs annually for each farm, the potential
exists for millions of eggs to be produced each year by farms excluded
by the Plan. This creates a significant opportunity for potential
foodborne disease problems with a large number of eggs entering the
marketplace without any quality assurance surveillance. The grading and
inspection program must be uniform and apply to every egg-producing farm
in the country irrespective of the number of laying chickens on that
farm.

# What is the Risk?

Are eggs less safe than other protein-rich foods? This is the
implication in the FDA's proposed safe handling label. The President's
Council on Egg Safety has identified egg safety as one component of this
public health issue that warrants immediate federal, interagency action.
The risk assessment has been determined by the SE Risk Assessment Final
Report prepared by the Food Safety and Inspection Service as one
SE-contaminated egg from the production of 20,000 eggs[^3]. The risk
assessment is 0.005% which is several orders of magnitude lower than
most animal products. Statistically, the likelihood of becoming ill from
a contaminated egg is once in 84 years. This risk is very, very low. The
Plan's action steps in developing labeling for egg cartons must be
adjusted from its proposed discriminatory message. United Egg Producers
(UEP and others) has suggested that the Partnership for Food Safety
Education's *Fight Bac!* Campaign will further educate consumers in the
proper way to handle all foods rather than wan against eating such
products. Sparboe Companies supports such a campaign.

# Importance of educating consumers demands immediate implementation

A broadly based policy is more likely to be effective in
decreasing/controlling egg-associated SE illnesses than a policy
directed solely at one stage of the farm-to-table continuum. In the Plan
the burdens of immediacy are placed on the egg industry through a
comprehensive testing program (Section 1.1.1) while federal
responsibilities provide for more generous timelines.

Objective 8 provides for the education of individuals using
science-based materials. This must be a high priority item with a more
aggressive action step. Based on data from the Centers for Disease
Control and Prevention (CDC), most SE outbreaks occur in commercial
venues. The Plan under the subheading Egg-Handling Practices provides
the basis for the urgency in the immediate implementation of
science-based educational material by stating, "the presence of SE
bacteria in a raw egg, alone, does not guarantee illness upon
consumption." Thus, control measures directed against egg contamination
per se are not critical for control of SE illnesses in humans. If one
applies the HACCP approach to the whole food chain, the only real
critical control point is at the handling and food preparation point.
Focus on this point, as an alternative to the strategies the Plan offers
of either diversion or pasteurization, will significantly and with more
certainty and lower cost, reduce the incidence of SE illness in humans.
However, the likelihood of developing SE infection increases when the
egg is not handled safely by permitting the bacteria to multiply and a
greater number of bacteria to be ingested with the food. In 1997,
seventy-one percent of the SE outbreaks were in food service or
institutional settings. Clearly, food service establishments need
additional education on how to store and prepare food. The sooner this
is developed, the sooner we will reap the rewards of meaningful
reductions in the incidence of Salmonella associated with eggs and other
foods.

We can and must work together on educating consumers. Without a clearly
focused timeline on this vitally important step of educating the
consumers and handlers we are undermining the efforts of the Plan.
Although not the only line of defense, educating the consumer in proper
food handling and preparation is the final line of defense.

# Flaws in the objectives and action steps of 

[the Egg Safety Action Plan]{.underline}

**The Overarching goal** calls for the elimination of SE illnesses
associated with the consumption of eggs by 2010. The Plan has set an
interim goal of a 50% reduction in egg associated SE illnesses by 2005.
These are surely commendable goals. However, is there a consensus among
epidemiologists that complete elimination of Salmonella is possible? In
the Plan it states, "Salmonella of various serotypes are commonly found
in the digestive tracts of animals and frequently contaminate our
environment." Salmonella is also found in domestic animals, insects,
lizards, amphibians, fish, wild mammals and wild birds. If Salmonella is
commonly found in the digestive tracts of animals and these other
sources, how can any amount of effort totally eliminate it? To establish
a goal that will not succeed is to plan to fail. It will only result in
further damaging consequences and reduce the credibility of both egg
industry and the Government.

**Objective 1** calls for the reduction of the number of SE-containing
eggs marketed to the consumer. In subsection 1 of the nationwide SE
reduction program it details a rigorous testing program and diversion of
eggs to pasteurization upon discover of a positive. Is this diversion
the result of a positive SE test? This is an important factor as other
vectors can contribute to the presence of SE in the environment. For
example, science has shown that mice may be carriers with each fecal
pellet possibly containing 25,000 SE organisms. One mouse may deposit
100 pellets in a single night. Testing can help verify that a good
quality assurance program is working and that should be the goal rather
than **testing** be the goal. We can control rodents, but we cannot
eliminate them. The egg industry in the United States does not and
cannot operate in a vacuum.

Section 1.2 establishes a HACCP-based system for shell processing with
the specifics being founded in quality assurance programs. This action
step should precede Section 1.1.1 on environmental testing. Testing
should be the validation of the effectiveness of a quality assurance
program. You cannot "test" your way to safety, but you can manage those
hazards that will reduce the incidence of Salmonella associated with
eggs through a good quality assurance program.

Question No. 2. What are the costs in implementing the risk reduction
components?

# Economic Impact of Testing

Basically, the Plan is an attempt to first control, and then eliminate
SE in eggs and egg products. As referenced, it is our position that SE
infections in humans can be controlled better (completely) and in a more
cost efficient manner at the food preparation level rather than on the
farm. The fact is, SE eradication on the farm is not necessary for
effective control of SE infections in humans.

If a flock tests positive for SE, the measures that need to be
implemented to divert those eggs to pasteurization and/or make the flock
SE negative will cost the producer significantly.

It is difficult to place a number on the cost associated with a positive
SE test result. However, if a flock tests positive for SE, sooner or
later the economics will force the producer to attempt to make it SE
negative. This cannot be achieved without depopulation of the farm. If
the Plan is truly comprehensive (arguably the Plan is), depopulation of
one positive barn on a complex cannot be expected to eliminate SE from
the entire complex. Thus, the whole complex will have to be considered
SE positive, all eggs will have to be diverted, and depopulation of the
whole complex will be necessary. Even with that, there is no guarantee
that you can repopulate without another positive test result which, as
you can see, leads to a "catch 22" and could result in having to
continue to divert eggs while you start the cycle all over again. Do you
understand the implications?

Under a serious Plan, once a flock tests positive for SE, it is
considered positive for life. Thus, eggs are diverted for life. It
cannot be argued that a SE positive flock can suddenly become an SE
negative flock. We should not propose a Plan that ignores this and call
it serious. Again, we suggest that the most cost effective method to
control SE infections in humans is at the food preparation link in the
food chain and not, as the Plan emphasizes, at the farm level.

For instance, if 81% of the SE related deaths reported occurred in the
"at risk" populace (see Page 3, supra) it would be much easier, cheaper
and more effective if control measures are directed toward food handling
and preparation to these at risk individuals rather than at the farm
environment. Indeed, alternative pasteurized products available to the
populace as a whole, and mandatory use of pasteurized egg products in
elementary schools and nursing homes would reduce the incidence of SE
illnesses tremendously and create much less of an economic hardship to
egg producers.

One can argue with and tweak the numbers to support a vast array of all
kinds of costs in implementing the Plan and the risk reductions
associated therewith. However, one thing is certain: the [economic
impact of the egg industry of following the protocols of testing under
the Plan to their logical conclusions would be significant. The
economics of SE eradication would be huge.]{.underline}

**Question No. 3: What training is needed?**

# Inconsistent Enforcement

Objective 1.1.8 specifies the training of an inspection force.
Implementation of inspection services would be conducted through the
state agencies. The President's Council on Food Safety sought in its
risk management goals the identification of gaps in the food safety
system. The egg industry in general, and Sparboe Companies in
particular, is supportive of focused and comprehensive objectives that
will reduce the rate of foodborne disease, but the Plan is producing
more gaps in its organizational structure by its plans to train State
agencies to provide oversight and enforcement. The development of an
organizational structure for enforcing egg safety programs through
training fifty State agencies will create more and larger
inconsistencies and pave the way for wider gaps in the current food
safety system. The Plan is setting itself up for failure unless the
organizational structure can be verified and enforced by a Federal
system that has proven results in consistent enforcement. Because the
USDA Agricultural Marketing Service and USDA Animal & Plant Health
Inspection Service; both of which have written agreements to audit UEP's
5-Star Quality Assurance Program with already trained USDA employees,
the Sparboe Companies would support an organizational structure of
enforcing of egg safety standards through those entities.

AMS in cooperation with the National Egg Regulatory Officials currently
utilize a work force representing 50% of USDA's AMS workforce who
already have experience in processing, sanitation inspection,
refrigeration enforcement, monitoring quality assurance plans, enforcing
the Egg Products Inspection Act and determining the quality of eggs
through hand candling. This proven track record for enforcing consistent
grading standards through the AMS voluntary shell egg grading service
demonstrates the degree of effective communication necessary between
industry and government to achieve success. To develop a training
program through State agencies is not a good utilization of taxpayer
funds when a proven system is already in place. This would duplicate
what is already done daily. This recommendation is the most efficient,
most effective and the least expensive in achieving this objective.

**[HACCP, Vaccines and New Technologies]{.underline}**

Objective 1.2 establishes a HACCP-based system for shell egg processing.
The Sparboe Companies is supportive of policies and procedures that are
HACCP-like in their implementation. Reductions in the incidence of
Salmonella have resulted from HACCP-like quality assurance programs and
public health surveillance systems. To see the rate of disease decrease
four years in a row is heartening to agencies, egg producers and
consumers. The Sparboe Companies is optimistic about continuing this
trend as it further develops stringent quality assurance plans.
Practical techniques that are economically feasible, such as the use of
vaccines for controlling Salmonella, are eagerly sought by the Sparboe
Companies. Every effort should be made to facilitate the sharing of
technologies that will contribute to a decrease in a foodborne disease.
The egg industry and private vaccine manufacturers have submitted data
and information on the use of vaccines in preventing the shed of SE
organisms in the egg to the Food and Drug Administration with no
response. European countries have added the use of vaccines in effective
SE control programs. The interagency coordination necessitates that this
lack of response be addressed and corrected so that transfer of
technology be facilitated.

**[Labeling should educate consumers, not frighten them]{.underline}**

Objective 1.4 notes the finalization and implementation of refrigeration
and labeling regulations for eggs from processor to consumer. The
Sparboe Companies supports providing safe handling labels that reflect
science-based education of consumers into proper food handling and
preparation. What is the rationale for the development of the FDA
proposed safe handling label that uses language substantially more
alarmist than the language required by the FSIS for labeling meat and
poultry?

The sterner warning proposed by FDA and the use of additional
inflammatory adjectives and other wording not required for meat and
poultry may have the effect of implying to consumers that eggs are less
safe than meat and poultry.

**[Funding]{.underline}**

No mention is made in the Plan as to how this program is to be funded.
Will the egg industry find itself in a position of enforcing an unfunded
mandate? To be consistent with every inspection program calling for
Salmonella-testing presently enforced by federal statute; public funds
are used to pay the cost of inspection. To segregate the egg industry
from every other inspection program by insisting on an unfunded mandate
is discriminatory. Whatever program is enforced by federal regulatory
authority, it should embrace the consistent practice of public funding.
To do otherwise would be construed a tax, be discriminatory, and would
further contribute to the consolidations and further decline in the
number of farms already taking place in the egg industry.

The egg industry is supportive of indemnifying egg producers who must
divert their eggs to a breaker. The level of indemnity would be based on
the market value during the time of diversion less what the egg producer
receives from the breaker for those eggs to be pasteurized.

**[Answers to Specifically Numbered Questions Posed in the Federal
Register Notice]{.underline}**

4.) Are the following appropriate and adequate components for a
nationwide SE reduction program: Bio-security, SE-negative feed, chicks
from SE-monitored breeders, flock health monitoring program, cleaning
and disinfection of houses, rodent/pest control, monitored water supply?
Yes, these components are important in the validation procedure but not
sufficient to control or eliminate SE. However, cleaning and
disinfecting, for example, is not practical for producers in colder
climates during the winter months. Therefore, although appropriate, it
may not be practical. Providing SE negative feed would be highly cost
prohibitive. Again, many of these components would be cost prohibitive
as control components under the Plan and, therefore, can only act as a
monitoring component which, by the time a positive test result is
obtained, will only lead to the vicious diversion and depopulation cycle
referenced earlier.

Many quality assurance programs presently in operation call for these
components. An additional provision should be comprehensive training in
the program addressing the implementation of each segment on a
consistent basis, nationwide.

5.) How effective do you think each component would be? Which
component(s) do you think will provide the most risk reduction? Each
component is a link in the chain for preventing the introduction of
*Salmonella* into the egg laying complex. We believe the best risk
reduction component is emphasis on the food preparation and "at risk"
populace consumption. The components listed are adequate for monitoring
the effectiveness of quality assurance programs but actually do little
to reduce/eliminate the risks of SE illnesses.

6.) Is environmental testing an appropriate verification step to ensure
that the risk reduction plan is working? In the event an environmental
test proves positive, additional testing would occur, as specified in
the UEP 5-Star Quality Assurance Program. Sparboe's follows the UEP
5-Start Quality Assurance Program. Environmental testing is an
appropriate step in determining whether the program is working and thus
monitors the risk of reduction but does not effectively control such.

7.) In the event that an environmental sample for SE is positive, what,
if any, additional steps should a producer be required to take with the
positive flock/house and with the next flock that will be placed in that
house? Two series of steps are recommended; one calling for the use of
vaccines and the other if vaccines are not used. If vaccines are used,
and the environmental tests are SE positive, then extra cleaning and
disinfecting procedures (formaldehyde) should begin immediately upon
depopulation. The replacement flock would be vaccinated with an approved
live or killed SE vaccine prior to the onset of lay. Next, environmental
testing of the facilities would be conducted at 30 weeks of age and
again, if and, when the flock is molted. Environmental testing of molted
flocks should be tested once hens have been returned to production. If
environmental tests are positive, then eggs must be diverted to
pasteurization until egg tests of 480 egg samples have indicated a
negative test. Environmental testing will be conducted 6-10 weeks prior
to depopulation.

8.) Where vaccines have been used, is there a correlation between
vaccine use and reduction of SE in eggs? Yes. \[See answer to number 7
above.\]

9.) In the event eggs from an SE-positive layer flock are diverted from
the table egg market, what measures should be implemented to ensure
those eggs are pasteurized? Any eggs diverted to the breakers will be
pasteurized. Loads destined for the breakers are tagged so that any
loads determined to be positive will be identifiable and will be
pasteurized. This requires uniform enforcement by the USDA.

10.) In the event eggs from an SE-positive layer flock are diverted to
the production of liquid, frozen, or dried egg products, should the eggs
be handled or processed differently? *No. Salmonella* is heat sensitive
so the process of pasteurization will kill the pathogens.

11.) Do customer specifications exist that prohibit the processing of
SE-positive eggs for egg products? There exist some breaking facilities
that may not accept SE-positive eggs for pasteurization even though the
heat process kills the pathogens. This would cause serious consequences
for those egg producers who are in a position where they must divert
their production to the breakers due to the identification of
*Salmonella*-positives. Diverting those eggs to a landfill may also
require a moisture-absorbing additive prior to acceptance at a landfill.
The losses for a producer in this predicament is substantial.

The series of questions relating to specific costs for various
components in the quality assurance programs were answered during the
public meetings in differing areas of the country. These costs are
significant.

15.) Are there any methods by which a packer/processor can determine how
old eggs are when they are received? No. While we may not be able to
determine the exact day each egg is laid, AMS has been operating a
grading service that serves as a barometer of both age and quality of
shell eggs. Also, nest run eggs are more commonly graded than farm
packed if those eggs are destined for the table egg market. Those eggs
would commonly have lot numbers which could help ascertain how old the
eggs are when graded.

16.) When packing shell eggs for the consumer, will the use of only new
primary packing materials increase marketing costs? Only new material is
used when packing shell eggs for the consumer.

17.) Are the proposed components of the national standards for packing
and processing of shell eggs and egg products appropriate and adequate
to reduce the risk associated with SE? No. The Plan is comprehensive
enough as it relates to these areas but emphasis at the packing and
processing stages is misplaced. For example, the Plan indicates that
research should be conducted on the practice of repackaging and
re-selling of eggs that have been returned unsold from grocery stores.
We should not study the practice. [We should ban the
practice!]{.underline}

The Plan should also provide stronger incentives to implement the
promising vaccination programs. For example, if a human illness outbreak
should warrant an FDA traceback to the farm, then those layer houses
using a vaccination program as a component of the total Quality
Assurance Program would be exempt from environmental tests and only egg
tests would be conducted. The Plan requires much more testing than is
necessary. Diversion of eggs should only occur if *Salmonella* is
determined in egg samples. Afterall, it is the eggs that are sold to the
consumer and hence that is the ultimate product to be sampled as is true
in other commodities such as meat and poultry. The Plan does not address
the ongoing practice of egg centrifugation at restaurants and bakeries
in those States that have not banned the process or the machinery. This
process of centrifugation at the bakeries and restaurants must be
prohibited to stop the commingling of the shell's surface with the
internal contents of the egg.

The remainder of the questions in the Federal Register notice call for
answers that would vary from farm operation to farm operation.

## Conclusion

The Sparboe Companies considers food safety of paramount importance and
supports the reasonable goals outlined in the Plan aimed at protecting
the public health. The Plan is meant to be a salmonella enteriditis
control program, not a salmonella enteriditis monitoring program. The
very core of the Plan's problem is that, on the farm SE control is
extremely difficult, is uncertain, is not cost effective and is
basically a failed approach.

Whereas we agree that we need to attack the problem at each link in the
food chain, not enough emphasis is being placed upon those areas where
control is less difficult, more certain, more cost effective and a
proven approach in controlling SE illnesses.

Therefore, with the suggested strategies listed herein, together with
informed input from other stakeholders the Plan effects, we believe a
workable [and]{.underline} reasonable Plan can be arrived at and put
into operation.

Thank you for the opportunity to present these comments. Please call
with any questions.

Sincerely,

John W. Mueller Gregrey J. Murch Radivoje Spasojevic

Legal Counsel Vice President, Operations D.V.M., M.S., Ph.D., A.C.P.V.

JWM/rm

**Butler, Jennie C**

**From:** Nita Nurmi \[Nita@sparboe.com\]

**Sent:** Thursday, April 20, 2000 4:54 PM

**To:** \'FDADockets@oc.fda.gov\'

![](media/image2.wmf)

[^1]: CDC Mortality and Morbidity Weekly Report, February 17, 2000.

[^2]: USDA/APHIS/US National Animal Health Monitoring System.

[^3]: FSIS Salmonella Enteriditis Risk Assessment, Shell Eggs and Egg
    Products, June 12, 1998.