MINUTES OF CONSTITUENT OUTREACH MEETING

August 15, 2002

# Constituent Participants

Eli Briggs

National Rural Health Association

Glenda Christy

Conference on Food Protection

Barbara Reilly

National Customs Brokers and Freight Forwarders Association of America

Yvette Rose

Cargo Airline Association

Katherine Andrus

Air Transport Association

Julie S. Kimbro

American Mushroom Institute

Jonathan Bertera

Salt Institute

Ann Mileur Boeckman

Hogan & Hartson LLP

Friederich Wacker

German Embassy

Andrew Brecher

Capitol Associates representing National Nutritional Foods Association

Becky Smullin

Association of State and Territorial Health Officials

### FDA Participants 

Linda Arey Skladany, Senior Associate Commissioner

Patricia Kuntze, Office of the Commissioner (OC)

Jarilyn Dupont, OC

Patricia Alexander, Office of Regulatory Affairs (ORA)

Aleta Sindelar, Center for Veterinary Medicine (CVM)

Melissa Scales, Center for Food Safety and Applied Nutrition (CFSAN)

Marion Allen, CFSAN

Michelle Velasquez, CFSAN

Joe McCallion, ORA

Leslye Fraser, CFSAN

L. Robert Lake, CFSAN

Millie Barber, OC

Michael Herndon, OC

#### Presentation

Mr. Lake welcomed everyone and thanked them for coming.

Ms. Skladany gave an overview of FDA's response to the events of
September 11, 2001.

Ms. Fraser gave an overview of the food provisions in the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (the
Bioterrorism Act).

# Comments/Questions

Ms. Rose asked if outreach has been made to other aspects of the
transportation industry and which regulations are most likely to affect
the transportation industry.

-   Mr. Lake confirmed that there was an earlier meeting with the
    transportation industry.

-   Ms. Fraser said the provisions that would affect the transportation
    industry most directly was recordkeeping, although prior notice
    might affect it indirectly.

Ms. Andrus asked what records the transportation industry would be
required to keep, and asked FDA, if possible, to keep its recordkeeping
requirements consistent with those of other agencies.

-   Mr. Lake said the recordkeeping requirements FDA will require are
    still unclear at this point, and said it would be very helpful for
    the airline industry to notify FDA regarding the specific records
    the airline industry currently keeps.

-   Ms. Fraser said FDA already is conversing with other agencies. She
    is having weekly meetings with Customs. The recordkeeping workgroup
    is concentrating on what records industry should keep. The agency is
    considering a performance-based standard that specifies what
    information must be kept and that the information is readily
    accessible. If industry is keeping the same records under other
    regulatory requirements that meet the new regulation, it may not be
    required to do anything different. Because FDA will have to justify
    the cost/benefit balance, letting FDA know what records are kept now
    helps FDA adjust the cost/benefit analysis and determine regulatory
    options.

Ms. Andrus asked whether prior notice will be online.

-   Ms. Fraser said we don't necessarily intend to have prior notice
    online prior to October 12, 2003, but the first objective is to have
    something that works for both FDA and industry by October 12, 2003.

Ms. Andrus said the airline industry is subject to the regulatory
requirements of different agencies that may overlap with those of FDA.
She said industry would appreciate it if FDA could leverage its
requirements with those of the other agencies. Some of these agencies
include the United States Department of Agriculture (USDA) regarding
offloading of cargo and foot and mouth disease, Centers for Disease
Control and Prevention regarding bioterrorism issues and quarantine,
Department of Transportation regarding transport of dangerous goods, and
Transportation Security Administration (TSA) for security issues. She
said she doesn't know how agency organizations will be affected by the
Department of Homeland Security, but understands that FDA must continue
with its mandate regardless of outstanding issues with the organization
of the Department of Homeland Security.

-   Ms. Fraser encouraged Ms. Andrus to let FDA know what those
    overlapping requirements are, as FDA has not worked closely with the
    airline industry in the past. FDA especially would like to know what
    the airline industry already has in place as far as "one up, one
    down" as part of the recordkeeping process.

-   Ms. Andrus responded that she will be able to notify FDA regarding
    overlapping requirements for some agencies, but not TSA because of
    security issues.

-   Mr. Lake said FDA's focus is whether food is safe. Foot and mouth
    disease has a different focus because it concerns farm animals and
    doesn't affect humans. Other agencies' requirements might be
    different because their focus is different.

Ms. Andrus asked how inspections of recordkeeping will be implemented
and whether FDA's inspection authority will be limited.

-   Ms. Fraser said FDA's authority will be limited to that given by the
    statute, which authorizes access to records needed to determine if
    food is adulterated and presents a threat of serious adverse health
    consequences or death to humans or animals.

Mr. Wacker asked if there is any way for FDA to harmonize its provisions
with those of the Food Safety and Inspection Service (FSIS) under USDA.

-   Mr. Lake responded that FDA has a lot of interaction with FSIS;
    however, the system in place for inspection of imported meat and
    poultry is more stringent than this law. Congress also chose to make
    the Bioterrorism Act clear that the present regulations would not
    affect what USDA does, nor does it give FDA authority over meat and
    poultry. He said it is best to look at USDA as a separate system
    already in place, and view the Bioterrorism Act as an effort to step
    up oversight of other foods.

Ms. Rose said timing is an issue for her business. Transporters tend not
to know about a shipment until it is ready for them to transport. As a
result, timing is an issue for recordkeeping.

-   Mr. Lake responded that any information regarding how the airline
    industry operates as it relates to transport would be helpful. He
    said FDA recognizes differences between different modes of
    transportation and wants to account for those variations.

Ms. Andrus said her association represents both cargo and
passenger/cargo planes. This makes her industry different regarding
recordkeeping because it does not pertain just to cargo. She will
provide FDA with background information, although she does not know how
the rulemaking process will unfold.

Mr. Wacker said section 306 of the Bioterrorism Act gives the Secretary
access to certain records, such as those related to processing and
distribution. He asked whether these provisions apply to foreign
facilities.

-   Mr. Lake answered that this provision is new to both domestic and
    foreign facilities. He said to keep in mind that a threshold
    standard needs to be met before FDA can look at records. The most
    common time FDA would use this authority is in an outbreak, in which
    FDA would be trying to get to the source of a problem. The first
    process is to trace back to the source, then to trace forward to
    find other contaminated shipments in order to prevent other
    outbreaks.

## Mr. Wacker asked whether FDA would do the inspections of the foreign facilities or whether it would use the foreign authorities.

-   Mr. Lake responded that FDA would use both its own inspectors and
    those of the foreign government. Traceability has gotten a lot of
    attention lately. He was recently at a meeting in Switzerland, in
    which someone presented a paper on this topic to serve for
    discussion. The paper talks about "one up, one back" in terms of
    records to keep.

-   Mr. Wacker said the German government is in favor of traceability.
    The only concern is about letting a foreign government have access
    to the records of foreign facility.

-   Mr. Lake said he understood, and that of lot of it depends on
    confidence. The problem needs to be identified and prevented from
    getting to consumers as quickly as possible. The idea is that in
    order to achieve that end, we need a foreign government to help us
    and we need to help them.

Ms. Andrus asked for clarification regarding the scope of the
Bioterrorism Act: she said although the act has the word "bioterrorism"
in it, the Act does not seem limited to biological agents or intentional
acts.

-   Mr. Lake answered that, yes, even broken glass is within the purview
    of FDA.

-   Ms. Dupont said the Bioterrorism Act covers all kinds of agents.

Ms. Andrus said her understanding is that food served on airlines would
be covered. How does this apply to airline kitchens?

-   Mr. Lake said FDA directly regulates different aspects of airline
    food service, including caterers, and even has staff who inspect
    Boeing's airline kitchen designs.

-   Ms. Fraser added that Ms. Andrus' question concerns a "boundary
    issue." The question is whether flight kitchens are processors or
    retailers? The registration workgroup is dealing with this issue.

Ms. Eli asked if FDA has considered outreach to small businesses in
rural areas.

-   Ms. Skladany said her office is looking into that issue. She says
    FDA is planning to hold meetings around the country during the
    comment period, and would like to hold at least one video
    teleconference.

Ms. Reilly said her association represents custom brokers. They meet
every couple of weeks. She wondered if the group could meet with FDA and
find out more about FDA's outreach efforts.

-   Ms. Skladany said yes, that could be arranged. She said she hopes
    trade associations are our allies in this endeavor. She said the
    Bioterrorism Act has provided us with a unique opportunity, because
    everyone has same goal of ensuring food safety and security.