MEMORANDUM OF MEETING

Date: Tuesday, July 30, 2002

Place: Food and Drug Administration (FDA), Center for Food Safety and
Applied Nutrition (CFSAN), Harvey W. Wiley Federal Building, College
Park, MD

Participants: See attached list

Subject: Bioterrorism constituent briefing for food industry and
importers

This meeting was one in a series of briefings that FDA held with various
stakeholder groups to inform stakeholders about the food provisions in
Title III of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 ("the Bioterrorism Act") and to solicit comment
from stakeholders about the proposed regulations FDA is developing to
implement the legislation.

Joseph A. Levitt, CFSAN's Director, and Linda A. Skladany, Senior
Associate Commissioner for the Office of External Relations, opened the
meeting with a welcome and introduction of all participants. Leslye M.
Fraser, CFSAN's Associate Director for Regulations, provided an overview
of the Bioterrorism Act that closely followed the overview provided in
the Dear Colleague letter issued by Mr. Levitt on July 17, 2002. Ms.
Fraser also described in detail the four provisions in the Bioterrorism
Act requiring regulations that CFSAN will be developing: 1) registration
of food facilities, 2) establishment and maintenance of records, 3)
prior notice, and 4) administrative detention.

Mr. Levitt then explained the process for submitting written comments
for each of the four proposed regulations. Participants were encouraged
to submit comments by August 30, 2002, to the dockets established for
each of the proposed regulations (docket numbers are listed in the July
17^th^ Dear Colleague letter). Participants also were asked to submit
supporting data for their comments, as appropriate. Mr. Levitt explained
that comments received by this date would be considered in the
development of the proposed rules. Comments received after this date
will be considered as comments to the notice of proposed rulemaking. Mr.
Levitt acknowledged that the August 30^th^ date was short notice, but
explained that FDA had ambitious deadlines in order to meet the
statutory deadline of December 12, 2003. Although the administrative
detention provision does not have a statutory deadline, all four
regulations are being kept on the same timeline in order to conserve
resources (e.g., conduct public meetings on all regulations at the same
time).

The following were the major questions and points made during this
outreach meeting (please note that the questions and statements have
been paraphrased and are not exact quotes):

-   [Michael McGuffin, American Herbal Products
    Association]{.underline}, asked: How should the exception for
    retailers in the registration provision be interpreted?

> Ms. Fraser: This is one of the questions we have posed to our Office
> of Chief Counsel.
>
> Mr. Levitt: Do you have any ideas on this?
>
> Mr. McGuffin: No solution right now, but it needs to be clarified at
> an early stage, e.g., as a question in the proposed rule.

-   [Donna Garren, United Fresh Fruit & Vegetable
    Association]{.underline}, asked: What is the definition of "farm"
    and "in-field packing"?

Ms. Fraser: We still are at the stage where we are working on defining
terms. Do you have any ideas? When submitting comments, e.g., regarding
exemptions, commenters should consider the relevant statutory language.

> Mr. Levitt: It is important to give suggestions with specificity even
> if your ideas still are preliminary.

-   [Ray Glowaky, Chocolate Manufacturers Association]{.underline},
    asked: Does a raw agricultural commodity facility fall under the
    definition of a facility that must register? Mr. Glowaky gave the
    example of a facility that imports cocoa beans for processing; the
    cocoa beans are not consumed as food in its current state because
    further processing still needs to be done on them.

Ms. Fraser: We do not have an answer right now. We still are dealing
with these kinds of questions.

-   [Ken Klippen, United Egg Producers Association]{.underline}, asked:
    Could FDA elaborate on the establishment definitions, and the
    determination of the immediate previous source and the immediate
    subsequent recipient of food (1 up, 1 down) in the recordkeeping
    provision?

Ms. Fraser: You are mixing up recordkeeping and registration. The
registration provision requires timely updates of name, address, and
food category if those are part of the registraton (categories that are
helpful to us and to the registrant). The 1 up, 1 down requirement will
enable the agency to do a traceback. The agency is looking at the
cost-benefit trade-off and current business practices to help us
determine the scope of the 1 up, 1 down provision.

> Mr. Levitt: It is a good idea to piggyback on existing practices and
> systems. Information you can provide, such as like explanations of
> current practices, is very useful to us.

-   [Robert Garfield, American Frozen Food Institute]{.underline},
    commented further on the 1 up, 1 down issue: There may be cases
    where a manufacturer has many suppliers and the food becomes
    commingled before packaging. For example, a company may have many
    suppliers of green beans; all the beans are commingled before they
    are processed and packaged. It would be difficult to keep track of
    the immediate previous source of all suppliers when the food is
    commingled. His proposed solution is for the recordkeeping
    regulation to allow for maximum flexibility and to not require the
    manufacturer to track with too much specificity. For example, the
    manufacturer can supply FDA the names of the 5 suppliers (or 30-40
    farmers) who contributed to the final product.

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-   [John Bode, Cheese Importers Association of America]{.underline},
    asked: Will the marking and records protection provision be included
    in guidance? These items were not mentioned as being addressed in
    the 4 proposed regulations.

Ms. Fraser: The agency is deciding which provisions need guidance
documents. The guidance documents that we issue will be issued according
to the agency's Good Guidance Practices, e.g., via notice and comment.

> Mr. Levitt: We are assembling people to address these areas and these
> areas will get the proper attention.
>
> Jarilyn Dupont, FDA: In regard to the marking provision, the agency
> previously had published a proposed rule about marking, but we had to
> pull it back when the Bioterrorism Act was signed because the proposed
> rule differed from the marking provisions in the Bioterrorism Act. We
> probably will issue a guidance for the new marking provision, and then
> issue a regulation later.
>
> Mr. Bode: How come there was no mention of the limitation on records
> access in the overview?
>
> Ms. Fraser: Mr. Bode is correct. The statute gives the agency
> authority to access records if they will assist the Secretary in
> determining whether an article of food is adulterated and presents a
> threat of serious health consequences or death to humans or animals.
>
> Mr. Bode: Does sign-off authority to access records rest solely with
> the Secretary?

Ms. Fraser: The agency is looking closely at this limitation and will
determine whether guidance is needed.

-   [Tom O'Connor, National Grain and Feed Association]{.underline},
    asked: Does section 307, prior notice, require the importer to
    provide information on the foreign grower? Knowing the grower is
    impossible unless one goes through extensive efforts. What kind of
    effort is FDA looking for to determine the identification of the
    grower? Is a good faith effort sufficient?

Mr. Levitt: This is a similar issue raised by Bob Garfield, i.e., when
ingredients are received as a group and you do not have a system to
identify where each sub-group came from because commingling occurred
during course of business. Do you have a suggestion as to how to cope
with this problem?

> Mr. O'Connor: It is impossible to do identification with a bulk
> processor; it is not commercially feasible.
>
> Mr. Levitt: Please submit comments with specific suggestions.

-   [Michael McGuffin, American Herbal Products
    Association]{.underline}, asked: Does the Bioterrorism Act provide
    sufficient resources for FDA to carry out its charge?

Mr. Levitt: Congress did provide supplemental appropriations, which was
a substantial increase for the FDA budget. That increase is relative,
but it is a historic amount.

-   [John Bode, Cheese Importers Association of America]{.underline},
    asked: What is the status of the improvements to OASIS?

Mr. Levitt: The registration and prior notice regulations involve
significant IT components, e.g. electronic submissions. We will need to
be able to handle these IT issues and OASIS is part of that. The Office
of Regulatory Affairs was already in the process of enhancing OASIS.

> Deborah Ralston, FDA: We are always in the process of enhancing OASIS.
> The challenge will be how best to use these older systems to comply
> with the new requirements. We recognize that a lot of work needs to be
> done.
>
> Mr. Bode: Will plans for enhancements be made available?
>
> Ms. Ralston: Maybe.

-   [Robert Garfield, American Frozen Food Institute]{.underline},
    asked: Will large manufacturers be able to register plants through
    the central corporation?

Mr. Levitt: Do you think that would mean, for example, 1 or 10
registration numbers?

> Mr. Garfield: FDA probably would need 10 registration numbers. FDA
> still should make it easy to do.
>
> Mr. Garfield: Can trade associations help smaller processors with
> registration?
>
> Mr. Levitt: Should third parties be able to help? This is another
> boundary issue we need to determine.

-   [Justin LeBlanc, National Fisheries Institute]{.underline}, asked:
    The provision in prior notice that requires no less than 8 hours
    notice will not apply if FDA comes up with a different regulation,
    right?

> Ms. Fraser: Yes.
>
> Mr. LeBlanc: For fresh seafood, one may not know species, catch, and
> volume until the end of production for that day.
>
> Mr. LeBlanc: Leslye Fraser gave an excellent summary of the
> Bioterrorism Act. Can Leslye provide copies of the Powerpoint
> presentation slides to a wider audience, like their members?
>
> Ms. Fraser: Most of the information presented in the slides is
> available in the stakeholder letter.
>
> Mr. Levitt: The same slideshow will be shown at all the briefings.

-   [Annette Dickenson, Council for Responsible Nutrition]{.underline},
    asked: Are CFSAN's standard operating procedures (SOPs) that are
    being used to develop these regulations available to the public?

> Ms. Fraser: No, these SOPs are internal works in progress. The SOPs do
> not really impact external parties; it is a step-by-step process for
> how the Center develops regulations and ensure all the right internal
> parties are involved at the appropriate stages.
>
> Mr. Levitt: The SOPs are based on the principle of doing lots of
> thinking before doing lots of writing. They are meant to introduce
> more discipline in the process---paper light, but thought heavy. The
> aim is to identify the of issues up front so that the writing process
> is more straightforward.

-   [Rick Jarman, National Food Processors Association]{.underline},
    asked: Given the schedule, is there a process in place for meeting
    more in depth with FDA?

Mr. Levitt: We will be holding outreach meetings this week. There is an
open docket for all four regulations. The industry coalition has special
workgroups in place---if the coalition wants to meet with FDA, they
should contact us, as needed.

Mr. Bode: The industry workgroups would like to meet with FDA.

Ms. Skladany: I will facilitate these meetings within the bounds of the
APA and the Federal Advisory Committee Act.

END OF MEETING

Attachment: Attendee list

Prepared by: May Dimasin Nelson, HFS-024; 08-08-02

> **BT Constituent Briefing for Industry, Importers**
>
> **and Dietary Supplement**
>
> **Tuesday, July 30, 2002**
>
> **10:00am -- 12:00pm**

## 

# Attendees

1\. Dave Dexter (Snack Food Association)

2\. E. Linwood Tipton (International Dairy Foods Association)

3\. Ken Klippen (United Egg Producers Association)

4\. Bonny Weinstein (American Association of Exporters & Importers)

5\. Rick Jarman (National Food Processors Association)

6\. Donna Garren (United Fresh Fruit & Vegetable Association)

7\. Al Yamada (Fresh Produce Association of the Americas)

8\. Kathy Means (Produce Marketing Association)

9\. Robert Garfield/ Mike Gill (American Frozen Food Institute)

10\. Lee Sanders (American Bakers Association)

11\. Stuart Pape (Grocery Manufacturers of America)

12\. Justin LeBlanc (National Fisheries Institute)

13\. Stephen Payne (Pet Food Institute)

14\. Annette Dickenson (Council for Responsible Nutrition)

15\. Tom Donegan (The Cosmetic, Toiletry and Fragrance Association)

16\. Bob Bauer (Association of Food Industries, Inc.)

17\. John Bode (Cheese Importers Association of America)

18\. Tom O\'Connor (National Grain and Feed Association)

19\. Michael McGuffin (American Herbal Products Association)

20\. Richard Silverman (Hogan & Hartson)

21\. Ray Glowaky (Chocolate Manufacturers Association)

22\. Allison Bodor (National Confectioners Association)

23\. Kelly Johnston (National Food Processors Association)

24\. Robert Maxwell (National Association of Beverage Importers)

### FDA 

1\. Linda Arey Skladany, Senior Associate Commissioner for External
Affairs

2\. Patricia Kuntze, Office of Commissioner (OC)

3\. Jarilyn Dupont, OC

4\. Deborah Ralston, Office of Regulatory Affairs (ORA)

5\. Cynthia Leggett, ORA

6\. Mischelle Ledet, CFSAN

7\. Alyson Saben, ORA

8\. May Dimasin Nelson, CFSAN

9\. Melissa Scales, CFSAN

10\. Mary Ayling, CFSAN

11\. Denise Beavers, CFSAN

12\. Nega Beru, CFSAN

13\. Lou Carson, CFSAN

14\. Marion Allen, CFSAN

15\. Michelle Velasquez, CFSAN

16\. Bernice Friedlander, CFSAN

17\. Joe Baca, CFSAN

18\. John Kvenberg, CFSAN

19\. Joe Levitt, CFSAN

18\. Janice Oliver, CFSAN

19\. Leslye Fraser, CFSAN

20\. Catherine W. Carnevale, CFSAN

##### Prepared by: MVAllen/Mvelasquez:HFS-32:07-31-02