Department of Health and Human Services

Food and Drug Administration

Office of International Programs

Embassy Briefing

Public Health Security and Bioterrorism Preparedness and Response Act of
2002

Hubert Humphrey Building

200 Independence Avenue, S.W.

Conference Room 800

Tuesday, August 13, 2002

1:30pm -- 3:45pm

**MEETING MINUTES**

Welcome and Introductions\...\...\...\...\...\...\...\..... Murray
Lumpkin, M.D.

> Senior Associate Commissioner for International Activities and
> Strategic Initiatives

Linda Arey Skladany, Esq.

Senior Associate Commissioner

Office of External Relations

Dr. Murray (Mac) Lumpkin opened the briefing by explaining that since
FDA assures the safety of 80% of the food supply, we are also
responsible for protecting it from bioterrorism activities. He stressed
that FDA needs to hear from its constituents, especially from the
embassies, to incorporate their ideas into the proposed regulations that
will be issued in December 2002. At that time, it will not be final, but
will be open for comment, not just from Americans but from all of our
stakeholders. Suggestions should be addressed to Dockets: 02N-0275
through 0278.

Linda Skladany elaborated on FDA's activities after September 11, 2001,
including the recent hiring of 600 additional employees to monitor food
imports.

Foods Statutory Provisions

Next Steps and Timelines\...\...\...\...\...\...\...\...\..... Leslye M.
Fraser, Esq.

> Associate Director for Regulations /CFSAN Office of Regulations and
> Policy

Presentation outlining the information contained in the AStakeholders
letter@ dated July 17, 2002, from Joseph A. Levitt to the FDA Foods
Community \[www.cfsan.fda.gov/\~dms/sec-ltr.html\]

# 

Leslye Fraser announced that comments from the first few stakeholder
meetings on the bioterrorism regulations have been included in the
respective dockets. She followed with a detailed power point
presentation of the new legislation. The FDA's goal is to publish final
regulations by October 12, 2003.

### Discussion

## **General:**

**Indonesia** (Wong) -- How does the federal-state relationship work
here, because states can be more or less enthusiastic?

Jarilyn Dupont/OC: *State officials may be deputized by FDA to help---it
depends. When this happens State officials must act under Federal rules
and regulations. However, States also have authority to enforce their
own rules and regulations. ORA has had quite a bit of dialogue with the
states.*

Is border-crossing an FDA issue*?*

Jarilyn Dupont/OC*: Yes, borders are FDA-monitored along with Customs,
and state authorities come into play about one foot over the line.*

**UK** (Hughes) -- What is the role of APHIS/USDA in the process?

Leslye Fraser/CFSAN: *This new authority is directed to the FDA and
APHIS has no role with respect to what rules we have to promulgate. Many
agencies are now moving toward bigger and better systems that eventually
we would like to be able to tie into but they are not on the fast track
that we are on. We are looking at and trying to build on existing
systems.*

Is relabeling still OK?

Leslye Fraser/CFSAN: *Yes. These are new authorities that do not take
away existing authorities.*

**New Zealand** (Frost) -- Will the registration information be open to
all*?*

Leslye Fraser/CFSAN: *No, we are precluded from disclosure.*

**Pakistan** (Qayyum) -- Will you use U.S. Embassies abroad to
disseminate and gather information?

Leslye Fraser/CFSAN: *We recognize that our outreach effort is critical.
We do not want importers being detained at the border because of failure
to know about registration. We are working through issues now of how to
effectively communicate this information broadly and we appreciate your
suggestions on how to communicate broadly.*

**EU** (Coutsouradis) -- Are you planning to do an analysis of the
impact of these regulations on trade?

Leslye Fraser/CFSAN: *Yes, we are required under specific treaties to be
aware of and look at the impacts on all implications of the
implementation of the statute. Joe Levitt would say, "What is the worst
and what is the best that could happen?" Your thoughts on possible
negative trade effects are welcome.*

**Indonesia** (Wong)Under the marking provision, will you allow it to be
shipped to another country?

Jarilyn Dupont/OC: *This statute does not change existing authorities.
It depends---it could be destroyed by Customs if a dangerous threat or
it could be shipped to another country. But once released, we can't stop
it, even if it is marked from being shipped to another country. It would
be up to that country*.

**Australia** (Corrigan) \-- Will you increase compliance inspections?

Leslye Fraser/CFSAN: *With 600 new employees, FDA still is looking at
how we will deal with the prior notice:Customs interface.*

**Netherlands** (Bootsma) -- Will you screen drugs*?*

Leslye Fraser/CFSAN: *Yes, there are separate provisions for drugs.*

**Japan** (Sato) -- Is this the first major change by FDA since 9/11. It
seems that FDA has been stricter since then.

Leslye Fraser/CFSAN: *There may have been other existing regulations
having nothing to do with 9-11 that are being enforced. This is the
first initiative for us post 9-11.*

What do we mean by "animals" when we say "serious adverse health
consequences or death to humans or animals"?

Leslye Fraser/CFSAN: *FDA has the authority to regulate animal feed.
Foods intended for humans or animals that present that threat are
implicated.*

**Pakistan** (Qayyum) -- To avoid trade interruption, I suggest you have
a dialogue with foreign exporters.

***303 (Detention):***

**UK** (Hughes) \-- If perishables are detained and subsequently found
to be OK, but they are spoiled by then, will there be compensation?

Leslye Fraser/CFSAN: *The question of who bears the responsibility and
costs in this situation is being looked at by OCC*.

**Ireland** (O'Donoghue) -- Will exporters be told what kind of evidence
has been lodged against their shipment that has been detained, so they
can respond?

Leslye Fraser/CFSAN: *It will be handled by due process of the law and
may depend on whose tip it is (eg. FBI or CIA). National security issues
will need to be considered. What is credible evidence will need to be
determined*.

**Netherlands** (Hamid) -- What are your thoughts on the expediting
provision for perishables?

Leslye Fraser/CFSAN: *We might take the nature of the food into account
or simply have a faster time line for all perishable food.*

**Argentina** (Molina) *--* What if a food is adulterated later by
someone other than the registered facility? Who is responsible? *\[safe
packaging issue?\]*

***305 (Registration):***

**France** (Buy) -- On December 12, 2003 will all companies have to be
registered, or will they have some grace period?

Leslye Fraser/CFSAN: *All must be registered by Dec. 12, 2003 if they
intend to export anything into the U.S. on that day. That is why we will
publish the regulations in the Federal Register by October 12, to give
you time. If we publish on 10/12/03, and the effective date is 12/12/03,
we hope to be set-up to receive early registrations. On paper
registrations, your duty may be met once you mail your registration, not
when you get your receipt.*

**Netherlands** (Hamid) Are you really going to be able to register
every facility in two months?

Leslye Fraser/CFSAN: *Our IT people say it is feasible.*

**Ireland** (O'Donoghue) -- Will the registration information be
evaluated---that might slow it down?

Leslye Fraser/CFSAN: *No, we envision that you will fill out a form on
the Internet and automatically receive your registration number by
return email. We still are figuring out how to keep the registration
information up-to-date.*

Is there authority to revoke registrations?

Leslye Fraser/CFSAN: W*e are looking at the statute. If you do not send
the "timely" updates, it is a prohibited act.*

## **New Zealand** (Frost) -- How will this new registration interact with shellfish, LACF and other registration systems? Isn't it going to be duplicative? Is the list of registered facilities available to the public?

## Leslye Fraser/CFSAN: One of the challenges on the prohibition of disclosing the registration numbers may require everyone to re-register to be able to give them new confidential numbers. We will try to decrease the information burden and are looking to see if we can link existing information together. I am not sure we can feasibly do this by October 12; we may be better off starting from scratch and getting good data. There are concerns that current systems have inaccuracies and we may be better off starting from scratch. We are balancing not being repetitive with getting accurate information. 

**Bangladesh** (Ahsan) \-- The companies that are supposed to register
may have many products. Do they register by each product?

Leslye Fraser/CFSAN: *No, just by facility, but we may include a place
to check off product categories on the form.*

**Mexico** (Cruz) -- A company may have a US-based distributor, clients,
warehousers, etc. What kind of U.S. agent are you talking about*?*

Leslye Fraser/CFSAN: *We don't have a clear idea yet. We are looking at
existing regulations on drug registration. All thoughts are welcome.*

**Argentina** (Molina) -- Is the importer an acceptable agent? A
packager of honey after it is collected from a group of bee keepers? Or
the labeler or warehouser? Leslye Fraser/CFSAN: W*e need to define the
agent.*

**Denmark** (Fabry) -- What if the registration form hasn't reached the
database? Leslye Fraser/CFSAN: *The owner, operator or agent of the
facility bears the burden of making sure the registration goes through
in a timely manner. The registration number may be part of the prior
notice. Who would see it? We are looking at how the paper registration
system would work. There is a greater risk in mailing it. How we notify
ports in a timely fashion is another issue we are working through.*

**Australia** (Corrigan) -- SPS health certification through the
exporting country's government includes a facility registration number,
so we have captured that information to some extent already. It seems
that here you are trying to work directly with the facilities instead of
through the competent authorities of our countries. Could the
governments be responsible for the registration?

Leslye Fraser/CFSAN: *There are not certification systems for all foods
in all countries. The statute requires facilities to register with FDA.*

**Brazil** (Donner) *--* What is a foreign facility required to
register, just FDA-regulated food?

Leslye Fraser/CFSAN: Y*es, but that includes food for humans and feed
for animals.*

Are all foreign facilities that manufacture, process, pack, etc.
required to register? Leslye Fraser/CFSAN: *The definition of foreign
facility is limited to exports without further processing or packing
outside the U.S. The facility (owner, operator or agent in charge) has
to register. We have to define who these people are. The facility doing
the last major activity is the one responsible for registering.*

**Argentina** (Molina) -- Following up on Australia's comment, FSIS has
registration---will it be the same for other food products? We are
concerned about the impact on trade.

Leslye Fraser/CFSAN: *We are looking at other systems.*

***306 (Record Keeping):***

**Mexico** (Cruz) -- When does the record keeping become effective?

Leslye Fraser/CFSAN: *Once the regulations take effect. There is no
default provision in the statute for this one. The regulation will say
how long the records are to be kept. We are taking comment on record
retention periods.*

**Denmark** (Fabry) *--* Will you require that the information be kept
at the facility or at FDA, because our suppliers can change quickly?

Leslye Fraser/CSAN: *Submission of the information to FDA is not
required. We are interested in what the current practices are for record
keeping. The records will be required to be "readily accessible" which
will be defined in the regulation. We are looking for input.*

***307 (Prior Notice):***

**Canada** (Matthiesen) -- What computer in the sky is going to receive
this information? Is FDA looking at Customs ITDS and the OASIS systems?

Leslye Fraser/CFSAN: *Yes. We are looking at what information we
currently receive in OASIS and at Customs and what we can build on. We
are looking at what additional IT capabilities we need.*

**Bangladesh** \-- What is the role of Customs?

Leslye Fraser/CFSAN: *The prior notice statute requires us to work with
Customs. We receive the notice, decide if the import needs to be
inspected, ask Customs to detain it, and send in our inspectors.*

**France** (Buy) -- Why is the prior notice period so short?

Leslye Fraser/CFSAN: W*e don't know why those time frames were chosen by
Congress. Perhaps to shorten the time for potential mischief?*

Number range CHAPTERRecorded by:

Denise R. Beavers

Regulatory Counsel

Office of Regulations and Policy

Center for Food Safety and Applied Nutrition

Food and Drug Administration