# Presentation: 944302

## CFSAN

**Director, Center for Food Safety**
**and Applied Nutrition**
**April 28, 1999**

**CFSAN**
**Stakeholders Meeting**

## Topics for Discussion

**Senior CFSAN Team**
**“****Report Card” from Last Spring**
**Accomplishments**
**Budget – 1999 and 2000**

## Senior CFSAN Team

**Center Director**
**Deputy Center Director: ****Janice Oliver**
**Regulations and Policy: ****L. Robert Lake**
**FSI Director: ****Morris Potter, D.V.M.**
**Senior Science Advisor: ****Robert Buchanan, Ph.D.**
**Management Systems: ****Juanita Wills**

## “Report Card” from Last Spring

**Values/CFSAN PRIDE**
**FSI Top Priority**
**Set Priorities for Entire Foods Program**
**Need for Clear Accomplishments**

## Values

**P****ublic Health and Safety**
**R****espect**
**I****ntegrity**
**D****edication**
**E****xcellence**

## Food Safety Initiative

## Priorities

**With Presidential Initiatives, First it’s:**
**Food Safety,**
**Food Safety,**
**and**
**Food Safety**

## Vision

**Reduce incidence of foodborne illness**
**9,000 deaths and 6-33 million illnesses are ****TOO MANY**

## Highlights of First Year

**(FY98) Accomplishments**

**Laying a strong foundation**
**Seafood HACCP — Round 1**
**GAPs/GMPs Guidance**
**Juice HACCP/Labeling**
**Preventive measures for eggs (ANPR)**
**Antimicrobial Resistance (NARMS)**
**“****First Year Report”**

## Second Year (FY99) Goals:

**Target Highest Risk Areas**

**Imports — border and overseas**
**Gaps/GMPs roll-out**
**Seafood HACCP — Round 2**
**Juice HACCP — Final Rule**
**Prevention measures for eggs —NPRM**
**President’s Council on Food Safety**

## Priority Setting

## Priorities

**Next, we need to look across the**
**Foods Program and ask:**
**Where do we do the most good for consumers?**

## Goals

**Establish an open and participatory priority-setting process for FY99 and beyond**
**Develop a “blueprint” of priorities for FDA’s Foods Program for FY99 and beyond**

## Stakeholder Meeting

**June 24-25, 1998**
**23 oral presentations**
**15 written submissions**

## Twenty-Year History of CFSAN’s FTE Base

**10 years of steady decreases (FY78-87)**
**Increases targeted to**
**imported foods**
**seafood**
**NLEA**
**FSI**
**Even with increases, nearly a 20% reduction in base from FY78            (995 to 791)**

## Twenty-Year History of CFSAN’s FTE Base

**Excludes increases targeted to**
**imported foods**
**seafood**
**NLEA**
**FSI**
**Without target increases, a 33% reduction in base FTEs from FY78 (995 to 666)**

**Twenty-Year History of CFSAN’s FTE Base**

## Significant Legislation, 1978 – 1998

**	****1980****	****Infant Formula Act**
**	****1988****	****Pesticide Monitoring Improvement Act**
**	****1990****	****Nutrition Labeling and Education Act**
**	****1992****	****Dietary Supplement Act**
**	****1994****	****Dietary Supplement Health and Education Act**
**	****1996****	****Food Quality Protection Act**
**	****1997****	****FDA Modernization Act**

## Internal Process

**•****	****Program Office Priorities**
**•****	****Cross-Cutting Priorities**
**•****	****Synthesis into a Comprehensive Plan**

## Dr. Henney’s Priorities

*******	****•****	****FDAMA Implementation**
*******	****•****	****Science Base**
*******	****•****	****Food Safety**
**	****•****	****Blood Safety**
**	****•****	****Tobacco**

## 1999

**CFSAN Program Priorities**
**January 25, 1999**
**(Yellow Book)**

## FY99 Program Priorities

**FSI**
**Imports**
**HACCP**
**Produce**
**Additional Prevention Efforts**
**Surveillance and Outbreak Response**
**Research**
**Risk Assessment**
**Education**

## FY99 Program Priorities

**Major Program Areas**

**Premarket Review of Food Ingredients**
**Nutrition, Health Claims and Labeling**
**Dietary Supplements**
**Chemical and Other Contaminants**
**Cosmetics**

## FY99 Program Priorities

**Cross-Cutting Areas**

**Science Base**
**Federal–State–Local**
**International**
**Human Resources**

## Implementation

**“****A” List / “B” List**
**Monitoring the “Boulders”**
**4-month Reviews**

## Accomplishments

## Accomplishments

**Food Additives**
**Artificial Sweeteners**
**Postmarket Review of Olestra**
**Approval of Chlorine Dioxide**
**Expedited Review of Food Safety-Related Petitions**

## Accomplishments

**Health Claims/Food Labeling**
**Psyllium/Healthy Labeling**
**Authoritative Statement Guidance**
**Response to First Notifications (9 Claims)**
**Proposed Claim for Soy Protein**

## Accomplishments

**Dietary Supplements**
**Structure/Function Proposed Rule**
**Applicability of Authoritative Statements**
**“****Supplement Facts” Panel**

## Accomplishments

**Federal–State Collaboration**
**Food Code**
**National Integration Meetings**
**ISSC/Florida Shellfish Safety**

## Budget

## FY99 Budget Increases for FDA

**Food Safety Initiative****	****$25.00 M**
**Other Food/Cosmetics****	****3.25 M**
**Medical Device****	****1.50 M**
**Generic Drugs****	****1.00 M**

## FY99 Food Safety Initiative

**ORA****	****$14.2 M**
**CFSAN****	****9.0 M**
**CVM****	****1.3 M**
**NCTR****	****.5 M**
**	****	****$25.0 M**

## FY99 Budget

**Other Food/Cosmetic Increases**

**Cosmetics****	****$1.5 M****	****(CFSAN)**
**	****	****1.0 M****	****(Field)**
**Food Contact ****	****.5 M****	****	****	**
**Substances****	**
**Seafood****	****.25 M**
**	****	****3.25 M**

## History of CFSAN’s FTE Base

**10 years of steady decreases (FY78-87)**
**Increases targeted to**
**imported foods**
**seafood**
**NLEA**
**FSI**
**cosmetics**
**indirect additives**
**Even with increases, 18% reduction in base from FY78 ****	****  (995 to 815)**

## History of CFSAN’s FTE Base

**Excludes increases targeted to**
**imported foods**
**seafood**
**NLEA**
**FSI**
**indirect additives**
**Without target increases, a 34% reduction in base FTEs from FY78 (995 to 652)**

**History of CFSAN’s FTE Base**

## FY2000 Budget

**Proposed increase of $216 M (18%) for FDA above FY99 appropriation**
**If enacted, it will be the largest one-year increase in resources in the Agency’s history**

## “The President’s budget request for FY2000 begins a fundamental rebuilding of this agency and its science base...”

**Donna Shalala**
**Secretary of Health and Human Services**
**Before the House Agriculture Appropriations Subcommittee **
**February 23, 1999**

## FY2000 Budget

**Main FDA Funding Requests**

**	**_**Total**_
**Injury Reporting****	****$15.3 M**
**Product Safety Assurance****	****$52.2 M**
**Premarket Application Review****	****$28.0 M**
**Food Safety Initiative ****	****$30.0 M**
**Youth Tobacco Prevention****	****$34.0 M**
**Bioterrorism****	****$13.4 M**

## “ Food safety is a compelling public health issue and is a critical responsibility of my department...the requested new funds will reduce a persistent hazard...”

**Donna Shalala**
**Secretary of Health and Human Services**
**Before the House Agriculture Appropriations Subcommittee **
**February 23, 1999**

## FY2000 Budget

**Total Foods Program Increases**

**FSI****	****$****	****30.0 M**
**Food and Color Additives****	****$****	****11.4 M**
**(includes $10.0 M in proposed new user fees)**
**Injury Reporting****	****$****	****2.5 M**
**College Park****	****$****	****4.6 M**
**Seafood Inspection****	****$****	****15.7 M****	**
**(contingent on transfer of program **
**from National Marine Fisheries Services)**
**Total Program Increases****	****$****	****64.2 M**

## FY2000 Budget — FSI

**Inspectional Capability**
**Once a year for high risk, beginning in 2001**
**Foreign inspections will double**
**More tests to give inspectors the “tools”**

## FY2000 Budget — FSI

**Outbreak Response**
**Rapid Response Team for more outbreaks**
**Lab capability for more outbreaks**
**Two Field labs linked to PulseNet**

## FY2000 Budget — FSI

**Retail and Food Service**
**Training to implement Food Code**

**Antimicrobial Resistance**
**Improve and expand National Antimicrobial Resistance Monitoring System (NARMS)**

## FY2000 Budget — Injury Reporting

**$2.5 Million for CFSAN**
**Dietary Supplements, Food Ingredients, Cosmetics**

## FY2000 Budget — Food Additives

**$1.4 M****	****Appropriated Funds**
**  ****6.0 M****	****Review Fees – Food ****	****	****	****	****Contact Substances**
**  ****4.0 M****	****Review Fees – Direct ****	****	****	****	****Food and Color Additives**
**  ****$ 11.4 M**

## Challenges

## Challenges

**1)****	****Identify real public health issues and ensure they are being addressed properly**
**2)****	****Establish clear priorities and stick to them**
**3)****	****Match expectations with resource availability**
**4)****	****Enhance effective 2-way communication with stakeholders**

## Enhanced Communications

**www.cfsan.gov**
**Information Center**
**Special Mailings**
**Stakeholder Meetings**

## Stakeholder Input

**	****June 24-25, 1998****	****Priority-Setting/FDAMA**
**	****January 22, 1999****	****Cosmetics Program Restoration**
**	****February 19, 1999****	****WHO Proposed Scheduling of Ephedrine**
**	****March 12, 1999****	****Notifications for Food Contact Substances**
**	****April 28, 1999****	****Agency-wide Stakeholder Video-Conference – CFSAN in Chicago**
**	****May 11, 1999****	****Health Claims Based on Authoritative Statements**
**	****June 8, 1999****	**** Overall Strategy for Dietary Supplements**

## Last Spring:

**“****It’s a great time to be in the foods business!”**

## Today:

**“****It’s ****STILL**** a great time to be in the foods business!”**

## “And Getting Better All the Time!”