STAKEHOLDERS MEETING: CONSUMER GROUPS

August 1, 2002

# Attendees from consumer groups

Gem Daus (Asian and Pacific Islander American Health Forum)

Adam Goldberg (Consumers Union)

Caroline Smith DeWaal (Center for Science in the Public Interest Health)

Larry White (AARP)

Laurie Haller (National Consumers League)

### FDA Attendees 

### Linda Arey Skladany, Senior Associate Commissioner for External Affairs

### Patricia Kuntze, Office of the Commissioner (OC)

### Jarilyn Dupont, OC

### Cynthia Leggett, Office of Regulatory Affairs (ORA)

### Mischelle Ledet, Center for Food Safety and Applied Nutrition (CFSAN)

### Alyson Saben, ORA

### May Dimasin Nelson, CFSAN

### Jo Anne Marrone, OC

### John Marzilli, ORA

### Patricia Alexander, ORA

### Marquita Steadman, CFSAN

### Beverly Corey, OC

### Virlie Walker, ORA

### Melissa Scales, CFSAN

### Denise Beavers, CFSAN

### Nega Beru, CFSAN

### Lou Carson, CFSAN

### Marion Allen, CFSAN

### Michelle Velasquez, CFSAN

### Glen Henderson, CFSAN 

### Joe Baca, CFSAN

### John Kvenberg, CFSAN

### Joe Levitt, CFSAN

### Leslye Fraser, CFSAN

### Catherine W. Carnevale, CFSAN

Ms. Skladaney gave a brief introduction and explained FDA's role in
responding to the events of September 11, 2001.

Mr. Levitt welcomed everyone and explained the format of the meeting:
Leslye Fraser will present an overview of the statute, then the
discussion would be opened up to the stakeholders' questions and
comments.

## Ms. Fraser presented an overview of the Bioterrorism Preparedness and Response Act, focusing particularly on the sections that require regulations.

### 

### Comments from stakeholders

Ms. DeWaal asked how FDA interpreted the statutory requirement of a
one-time registration with industry's burden of submitting timely
updates.

-   Ms. Fraser responded that FDA will need to define the term, "timely
    updates," in the regulation. She said the frequency of updates
    depends on the specificity of information required in the
    registration form, which is something FDA is considering.

Ms. DeWaal asked how FDA was proposing to deal with the timely update
requirement for facilities that were going out of business.

-   Ms. Fraser stated that although facilities going out of business
    were required to notify FDA as part of the timely update
    requirement, she acknowledged that notification may not be high on
    those facilities' priority list of things to do. She said the
    registration workgroup is exploring ways of keeping its list of
    registered facilities current, such as using states' information for
    verification purposes.

Ms. DeWaal asked Ms. Fraser to clarify whether registration numbers will
be accessible to the public.

-   Ms. Fraser stated that the statute expressly provides that
    registration numbers are not disclosable under the Freedom of
    Information Act (FOIA).

-   Ms. DeWaal followed up by saying that in New Zealand, companies post
    their registration numbers on the walls of their offices.

-   Ms. Fraser stated that the exemption from FOIA prevents the
    government from disclosing information.

> Mr. White stated that the statute requires facilities to list all of
> their trade names in their registration form. He asked whether this
> means each trade name will receive its own registration number, and if
> not, what happens when one brand goes out of business.

-   Ms. Fraser clarified that registration is by facility, not trade
    name or company. For example, if a facility originally registers
    three trade names and one brand goes out of business, the facility
    has a statutory obligation to update its registration to reflect
    that change. However, registration is by physical location, not
    product line.

-   Mr. White stated that his question was derived from dietary
    supplements, since the same product can be sold under many different
    brand names.

-   Mr. Levitt explained that registration is by building, not product.
    The new food registration authority is similar to drug registration,
    but contains less specificity. For example, Merck would be required
    to both register its facility and list its products under the drug
    registration requirements. For food registration, there is no
    requirement to list all products a facility produces.

> Ms. DeWaal inquired about how seasonal businesses, such as juice
> producers also having a retail outlet, would be affected by
> registration.

-   Mr. Levitt explained that this is an example of a "boundary area"
    that the registration workgroup is considering. Other "boundary
    areas" include farms that also have processing plants on-site. The
    question is whether to exempt this as a farm or regulate it as a
    processor.

-   Ms. DeWaal replied that it is important for the registration form to
    identify a company as a seasonal producer, so if FDA is unable to
    contact them at a specific time, FDA will know that the producer is
    closed only for the season, not permanently.

-   Mr. Levitt said to keep in mind that the statute is very specific
    about the kind of information the registration can require. Perhaps
    if confusion arises with respect to seasonal producers once the form
    is in place, FDA could require it as an optional part of the form.

-   Ms. DeWaal said the registration should include both mandatory and
    optional sections in order for FDA to obtain the information it
    needs in the event of a bioterrorist threat.

> Ms. DeWaal asked, regarding the recordkeeping access provision,
> whether records would have to include information involving hazard
> analysis critical control point (HACCP) plans.

-   Ms. Fraser stated that the recordkeeping access provision pertains
    to all records with certain exemptions, such as those relating to
    manufacturing and processing. FDA must demonstrate that it needs
    access to the records to assist it in determining whether a food is
    adulterated and presents a threat of serious adverse health
    consequences or death to humans or animals.

-   Mr. Levitt clarified that the legislation is not intended to limit
    the recordkeeping provisions already in place; if the requirements
    of seafood HACCP are broader than those of this legislation,
    industry's recordkeeping requirements remain the same.

-   Ms. DeWaal stated that she thought the bioterrorism legislation gave
    additional authority to FDA regarding access to records.

-   Mr. Levitt stated that the bioterrorism law gives FDA authority to
    require records involving purchasing and distribution for traceback
    purposes, also known as "one up, one down."

-   Ms. DeWaal asked if FDA will have access to HACCP records in a plant
    that does not process seafood. She suggested that FDA mandate
    labeling of a product's source in order to facilitate traceback.

-   Ms. Fraser suggested that Ms. DeWaal might be confusing access and
    traceback. She said that access to records involves records a
    company currently keeps. Traceback involves a new requirement that
    companies keep records of "one up, one down," to assist in
    traceback. She suggested that if other mechanisms are needed to
    assist FDA in traceback, stakeholders should submit those
    suggestions, but to keep the statutory requirements and limitations
    in mind.

-   Mr. Levitt stated that throughout the regulations process, there
    will be great scrutiny on FDA to ensure that the regulations remain
    within FDA's statutory boundaries.

> Mr. White remarked that a relationship exists between maintenance of
> records and certificates of analysis and asked if FDA saw this
> connection.

-   Mr. Levitt stated that records a company currently keeps are
    included in the recordkeeping access provision, but that there are
    triggers that prompt FDA's access to records. FDA does not have open
    access to these records.

> Ms. DeWaal stated that USDA recently ran into significant problems in
> the recall of ConAgra meat because the ID number on the label was lost
> through the chain of distribution. She said that based on the farm
> bill recently passed by Congress, a product's country of origin must
> be listed on its label. She suggested that labeling the food itself
> could assist in traceback. She stated that even unintentional
> contamination of food creates problems in traceback, let alone
> intentional contamination.

-   Ms. Fraser responded that this situation deals with establishment of
    records. She asked Ms. DeWaal how she would apply this suggestion of
    labeling to different kinds of foods. For example, Ms. DeWaal had
    mentioned meat. How would she suggest applying this to tomatoes?

-   Ms. DeWaal stated that, for example, raspberries can become
    contaminated quickly in a farm field and distributed quickly. The
    life-cycle of the contaminating parasite is quick. Another example
    is hepatitis A in strawberries.

-   Ms. Fraser said the important question her comment addresses is
    whether the records authority extends to labels.

> Ms. DeWaal asked what industry's concerns have been, and what does
> industry want, regarding import notification.

-   Mr. Levitt responded that the comments have not been "one size fits
    all." The most prevalent comments have been:

1.  People close to the border, such as Canada, want less time than 8
    hours for notification. Particularly regarding seafood, industry
    might be ready to cross the border within 2 hours of when the
    seafood is caught. Sitting around for 8 hours is not good for
    commerce.

2.  Industry involved with commerce commingled overseas is concerned
    with what level of specificity will be required in the notice,
    because their records do not always show this specificity.

-   Ms. Fraser also stated that some members of industry that ship
    containers to multiple ports are requesting more than five days of
    notice.

-   Ms. DeWaal stated that since industry knows when the containers will
    be arriving at the port, it should be able to give notice within
    five days. Imports have sophisticated information systems. Industry
    may say it can't give notice within 5 days but it can, based on the
    complexity of these systems. She urged FDA only to allow exemptions
    to the prior notice requirements with great specificity.

Ms. DeWaal inquired further regarding Mr. White's question on
certificates of analysis by asking who in the drug arena uses a
certificate of analysis.

-   Ms. Dupont stated that certificates of analysis are not used
    commonly in the drug arena either, and that the phrase has to be
    defined further in order to make it workable. She said certificates
    of analysis only are required in the food provisions in the Act
    under the import for export provision.

-   Ms. DeWaal stated that some food imported for the purpose of export
    is actually sold in the United States.

-   Ms. Dupont said food imported for the purpose of export must be
    exported or it will be destroyed.

-   Ms. DeWaal said FDA should keep in mind that concepts such as
    certificates of analysis, while not used widely now, could become
    widespread in the future. Therefore, it is important to clearly
    think through the implications of newly introduced concepts.

Ms. DeWaal invited FDA to ask the stakeholder groups any questions it
had regarding issues FDA is struggling with.

-   Mr. Levitt stated that one contentious area involves how to handle
    products commingled at different stages of production for the
    purposes of the "one up, one down" aspect of recordkeeping.

-   Ms. DeWaal stated that this issue opens up the potential for
    terrorist actions.

-   Mr. Levitt said a good example of this issue arose in the Starlink
    corn issue, where it was difficult to trace the corn back to its
    source. He said that the more a product is contained, the better for
    the consumer. He said the challenge is how to deal with a product
    that is commingled.

-   Ms. DeWaal said this commingling also has been an issue for USDA
    regarding fruits and vegetables. When problems arose with
    cantaloupes from Mexico, consumers began avoiding all cantaloupes
    because their labeling did not indicate their country of origin. She
    said such occurrences are not helpful to industry.

Mr. White asked, regarding the marking provision of the legislation,
whether all three standards Ms. Fraser had discussed in her presentation
had to be met in order to mark the product.

-   Ms. Fraser clarified by saying all three standards had to be met in
    order for the product to be considered misbranded.

-   Mr. White asked if there are any serious situations under which only
    two of the standards could be met.

-   Ms. Dupont said all three conditions have to be met for a product to
    be misbranded.

Ms. DeWaal urged FDA not to be too conservative in promulgating the
regulations. The issue at hand is protecting the public against
terrorism. It is vital to make sure FDA can respond adequately to a
threat. It is better for FDA to make sure now that it has the proper
tools to fight bioterrorism than to not be able to respond when a threat
arises.

Mr. White stated that the law makes it clear that FDA can give grants to
states for inspections. State inspections have had a checkered
background in conjunction with FDA. Will states operate under FDA's
authority? Will FDA grant resources to states if the states do not have
sufficient resources?

-   Mr. Marzilli stated that FDA is used to working with the states. FDA
    has offices in about 200 cities around the country. FDA's foods
    program works closely with the states. All states are not the same,
    as some have more resources than others. Need a balance between
    audit and contracts.

Ms. DeWaal asked for clarification on the difference between contracts
and partnerships.

-   Mr. Levitt said partnerships work with grants and contracts. State
    audits will apply even if there is a grants and contracts system.
    Consumers do not know or care if a contract or partnership is in
    place. At the present time, training is sometimes the major function
    of our state partnership. We train and communicate so we would all
    be at the same level.

Prepared by Melissa S. Scales