CFSAN 2004 Program Priorities
Letter from Center Director
Table of Contents
Dear Colleague, FDA Foods Community
I am pleased to share with you the FY 2004
Program Priorities for FDA's Center for Food Safety and Applied
Nutrition (CFSAN). This document lays out the Center's work product expectations
for the current fiscal year 2004 (October 1, 2003 through September 30,
2004), and is based on input we received from you (our stakeholders) as
well as input generated internally, with focus on the question: "Where
do we do the most good for consumers and the overall public health?" On
behalf of CFSAN, I thank you for your input and your continuing interest
in this process.
Our work plan is divided into four primary
sections:
- Assuring Food Safety and Security
- Improving Nutrition and Dietary Supplement Safety
- Assuring Food and Cosmetic Safety
- Assuring Food Safety: Crosscutting Areas
Last August, the Agency issued its Strategic
Action Plan, Protecting and Advancing America's Health: Responding to new
challenges and opportunities. CFSAN's work plan embraces the FDA Strategic
Action Plan and our work plan incorporates action items to implement those
goals and objectives.
Food Safety and security
remains a central theme in the Administration's public health agenda. Our
work plan is reflective of this continued focus. We will continue to concentrate
on the issuance of final rules for the four major areas of the Bioterrorism
Act of 2002 legislation and will continue our efforts to establish prevention
measures or "shields" for commodities and food products identified as a
high security concern.
This year's plan also reflects a commitment
to revitalize and bolster our nutrition program. Helping consumers improve
their nutrition is an increasingly urgent part of the FDA mission. Our efforts will focus
on improving the health of the public by empowering people in the many
choices they make every day that affect their health. We are working
harder than ever to make sure the information consumers receive is scientifically
valid and easily understood.
This is an ambitious and aggressive work
plan. Our plan includes 168 "A-list" goals. These are listed in bold-face type
in the document. Our goal is to complete at least 90 percent of these
"A-List" items by the end of the current fiscal year, September
30, 2004. Activities on the "B-list"
are those we plan to make significant progress on, but which we may not
complete before the end of the fiscal year. Many of these are multi-year
efforts that we anticipate placing on the "A-list" in subsequent years.
This work plan does not address our many
ongoing regulatory, enforcement, research and communication activities
as well as the myriad of unanticipated issues that also require a substantial
investment of CFSAN resources (e.g., responses to outbreaks of foodborne
illness). At mid-year, a progress review will be conducted and I will
provide you with a mid-year progress report that will include any needed
adjustments.
I cannot thank you, our
stakeholders, enough for your continuing support. I believe that working
together we can rise to the challenge of making sure Americans continue
to enjoy a safe and healthy food supply.
Sincerely,
Robert E. Brackett, Ph.D.
Director
Center for Food Safety and Applied Nutrition
Table of Contents
-
- Food Safety Implementing Regulations and Guidance
- Food Security: Emergency Preparedness
- Domestic Inspections
- Imports and Foreign Inspections
- Seafood Safety
- Fruits and Vegetables
- Egg Safety Action Plan
- Listeria
- Cooperative Programs
- Chemical Contaminants, Pesticides and Other Hazards
- Transmissable Spongiform Encephalopathies (TSEs)
- Game Meats
- Food Allergens
- Dairy Safety
- Education
-
- Nutrition, Health Claims and Labeling
- Dietary Supplements
-
- Food and Color Additives: Premarket Review
- Cosmetics
-
- Science Base
- International
- Food Biotechnology
- Internal Processes
- Focused, Economic-based Regulations
- EEO/Diversity Initiatives
- Management Initiatives
Part I
Assuring Food Safety and Security
Contents
Food Security/Food Safety Implementing Regulations and Guidance
Food Security: Emergency Preparedness
Domestic Inspections
Imports and Foreign Inspections
Seafood Safety
Fruits and Vegetables
Egg Safety Action Plan
Listeria
Cooperative Programs
Chemical Contaminants, Pesticides and Other Hazards
Transmissable Spongiform Encephalopathies (TSEs)
Game Meats
Food Allergens
Dairy Safety
Education
Priority Areas
Food Security/Food Safety Implementing Regulations and Guidance
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
Regulations |
1.1 |
1.1.1 |
Develop a final rule
for the establishment of food facility registration requirements
for all domestic and foreign facilities engaged in manufacturing,
processing, packing and holding of food. |
A |
1.1 |
1.1.2 |
Develop a final rule
for the establishment of prior notification requirements for
all imported food shipments. |
A |
1.1 |
1.1.3 |
Food Facility Registration Interim
Final Rule:reopen the comment period for 30 days, on a limited
set of issues, to ensure that those who comment on the interim
final would have had the benefit of outreach and education
efforts and experience with the systems, timeframes, and
data elements o the registration program prior to publication
of the Food Facility Registration Final Rule. |
A |
1.1 |
1.1.4 |
Prior Notice of Imported Food
Interim Final Rule:reopen
the comment period for 30 days to ensure that those who comment
on the interim final would have had the benefit of outreach
and education efforts and experience with the systems, timeframes,
and data elements of the prior notice system prior to publication
of the Prior Notice Final Rule. |
A |
1.1 |
1.1.5 |
Issue a final rule
for the establishment and maintenance of records to identify
immediate previous source and immediate subsequent recipient
of foods. |
A |
1.1 |
1.1.6 |
Issue a final rule
for the establishment of administrative detention requirements. |
A |
1.1 |
1.1.7 |
Issue a proposed rule on Serious Adverse Health
Consequences. |
A |
1.1 |
1.1.8 |
Conduct a satellite downlink and hold
a series of domestic and international outreach meetings to provide
information to our stakeholders about the two interim final rules
and the implementation of the registration, prior notice provisions
of the Bioterrorism Act of 2002. |
A
|
1.1 |
1.1.9 |
Issue Joint Food and Drug Administration (FDA)
and Customs and Border Protection (CBP) Plan for Increasing Integration
and Assessing the Coordination of Prior Notice Timeframes. |
A |
Guidance |
1.1 |
1.1.10 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue
for public comment Small Entity Compliance Guide on Registration
of Food Facilities. NOA published 12/12/03. |
A |
1.1 |
1.1.11 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue
for public comment Small Entity Compliance Guide on Prior Notice.
NOA published 12/12/03. |
A |
1.1 |
1.1.12 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue
for public comment Compliance Policy Guide Sec. 110.310 – Prior
Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. NOA published 12/15/03. |
A |
1.1
|
1.1.13 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue
for public comment Guidance for Industry: Questions and Answers
on the Interim Final Rule on Prior Notice of Imported Foods. NOA
published 12/16/03. |
A |
1.1 |
1.1.14 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue Compliance
Policy Guide Sec. 110.300-Registration of Food Facilities under
the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002. NOA published 12/19/03. |
A |
1.1 |
1.1.15 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue
Guidance on food safety and security for the retail food sector.
NOA published 12/17/03. |
A |
1.1 |
1.1.16 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue
security guidance for Cosmetics. NOA published 12/17/03. |
A |
1.1 |
1.1.17 |
To implement
authorities under the Bioterrorism Act (P.L. 107-188) in effect
as of July 2002, issue for public comment, industry and field
staff guidance, as necessary. |
A |
1.1 |
1.1.18 |
Develop and issue a
Good Importer Practices (GIPs) draft guidance focusing on food
importers to enhance compliance with new Bioterrorism regulations,
relevant receiving, handling, or processing requirements, and
data declaration for risk-based entry data processing by FDA
systems. |
B |
IT Systems
|
1.1 |
1.1.19 |
Design and build, in conjunction with FDA's Office of Regulatory Affairs (ORA), the electronic system to support prior notification requirements for all imported food shipments as a requirement of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. |
A |
Food Security: Emergency Preparedness
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
Laboratory Preparedness |
1.2 |
1.2.1 |
Provide support to the FDA Office of Regulatory
Affairs in the establishment and operation of the Food Emergency
Response Network, including the articulation of interim methods,
the development and delivery of training modules, the establishment
and integration of laboratory communication systems and protocols,
the integration with agency crisis management procedures, establishment
of methods validation systems, and the establishment of proficiency
programs for microbiological, chemical, and radiological detection
methods. Enhance the preparedness of CFSAN laboratories that
are part of the FERN and/or LRN. |
A |
1.2 |
1.2.2 |
Conduct food threat
assessment evaluations. |
A |
1.2 |
1.2.3 |
Conduct intramural and extramural
research to determine threat agent characteristics in foods
and dose response for humans. |
A |
1.2 |
1.2.4 |
Acquire and communicate to the appropriate
sector leads scientific information needed to consider and
implement options for establishing prevention measures or shields
for food identified as a high security concern. |
A |
1.2 |
1.2.5 |
Conduct intramural
and extramural research on prevention strategies. |
A |
1.2 |
1.2.6 |
Validate and develop methods for
use in foods and prioritize according to FDA food threat assessment. |
A |
1.2 |
1.2.7 |
Provide proficiency test samples during FY
2004 to FDA food testing laboratories to evaluate analyst proficiency
in testing for organisms of food security and safety concern. |
A |
Response Capability |
1.2 |
1.2.8 |
Participate in emergency response exercises. |
A |
1.2 |
1.2.9 |
(FDA) Provide Emergency
Response training in critical areas essential to CFSAN's reparation
for and response to potential acts of terrorism against the
food supply. |
A |
1.2 |
1.2.10 |
(FDA) Provide training
on the Bioterrorism Rules. |
A |
1.2 |
1.2.11 |
Enhance coordination of food security andcounter-terrorism issues with federal, state, andlocal governments and other organizations, through full participation in the Interagency Food Working Group (IFWG) and sub groups. |
A |
Safety Upgrades |
1.2 |
1.2.12 |
Initiate upgrade
of NCFST to BSL3. |
A |
1.2 |
1.2.13 |
As a counter-terrorism
activity, continue build out of BSL3 facility at MOD
I. |
A |
Domestic Inspections
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.3 |
1.3.1 |
Inspect 95% of all domestic firms that produce "high-risk" foods. |
A |
1.3 |
1.3.2 |
Evaluate results of FY 2003 "high-risk" inspections.
Make recommendations on improvements. |
A |
Imports and Foreign Inspections
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.4 |
1.4.1 |
Perform
60,000 physical exams and conduct sample analyses on products
with suspect histories. |
A
|
1.4 |
1.4.2 |
Contingent
upon resources, conduct 180 foreign inspections. |
A
|
1.4 |
1.4.3 |
Complete
the evaluation and classification of foreign firm inspections. |
A
|
1.4 |
1.4.4 |
Publish
a proposed rule to set standards for the use of private laboratories
and for testing imported foods. |
A
|
Seafood Safety
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.5 |
1.5.1 |
Report to Congress on seafood HACCP
temperature requirements for imported seafood products and
any planned or ongoing FDA research projects on the effectiveness
of new technologies to control hazards due to improper temperature. |
A
|
1.5 |
1.5.2 |
Report to Congress on sampling frequency
and violation rates for imported shrimp, and its efforts to
ensure that any shrimp that test positive for chloramphenicol
will not be subsequently consumed. |
A
|
1.5 |
1.5.3 |
Develop a revised draft of the consumer advisory on methylmercury
in commercial seafood based on the recommendations from the Food
Advisory Committee. |
A
|
1.5 |
1.5.4 |
Complete an evaluation of program
performance through the sixth year, with an emphasis on identifying
factors that may be inhibiting improvements in compliance rates,
in order to assess whether the program is accomplishing its
objectives and to identify where and how the program needs
to be re-directed. |
A |
1.5 |
1.5.5 |
Continue to work with the ISSC to implement a control strategy
for Vibrio vulnificus in raw oysters. |
A |
1.5 |
1.5.6 |
Publish final Vibrio parahaemolyticus risk assessment. |
A |
1.5 |
1.5.7 |
Conclude the study of optimum seafood-based inspection frequency. |
B |
1.5 |
1.5.8 |
Prepare analysis of all data gathered to date world-wide on the
good aquaculture practices project to determine their adequacy
for the drafting of guidance. |
B |
1.5 |
1.5.9 |
Prepare final FDA report on comparability of North American and
European shellfish programs. |
B |
1.5 |
1.5.10 |
Publish guidance on the use of common or usual names for fish
in order to provide clarification on this subject and to consolidate
information from various sources. |
B |
1.5 |
1.5.11 |
Continue project to improve existing guidance on proper on-board
handling to the fishing industry that harvest scombroid species,
and to educate industry. |
B |
1.5 |
1.5.12 |
Review petition from the Center for Science in the Public Interest
requesting that FDA establish a microbial testing program for hazards
in seafood products. |
B |
Fruits and Vegetables
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.6 |
1.6.1 |
Assist the government of Mexico to develop a certification program
for cantaloupes intended for export to US. |
A |
1.6 |
1.6.2 |
Finalize the 1st edition of the Juice Hazards and Controls
Guide. |
A |
1.6 |
1.6.3 |
Issue draft guidance for fresh cut produce. |
A |
1.6 |
1.6.4 |
Prepare final report on modernizing the food Good Manufacturing Practices
(GMPs). |
A |
1.6 |
1.6.5 |
Solicit public input on how to modernize FDA's Food Current Good
Manufacturing Practices cGMPs. |
A |
1.6 |
1.6.6 |
Conduct international Good Agricultural Practices (GAP) outreach
in conjunction with the Joint Institute for Food Safety and Applied Nutrition
(JIFSAN). |
A |
1.6 |
1.6.7 |
Develop strategy for addressing outbreaks caused by pathogens in
produce. |
A |
1.6 |
1.6.8 |
Develop a more sensitive Salmonella detection methodology for cantaloupe. |
B |
1.6 |
1.6.9 |
Issue final guidance for fresh cut produce. |
B |
1.6 |
1.6.10 |
Work with relevant trade associations to develop GAPs and GMPs for cantaloupes. |
B |
1.6 |
1.6.11 |
Publish report of the 1999 and 2000 sprout assignment. |
B |
1.6 |
1.6.12 |
Provide assistance to the California Department of Health Services on
production of the video on safe juice processing. |
B |
1.6 |
1.6.13 |
Amend sprouts guidance regarding mung bean irrigation water sampling
and use of kits. |
B |
1.6 |
1.6.14 |
Issue assignment to sample imported mung beans. |
B |
1.6 |
1.6.15 |
Work with APHIS and mango producers to ensure safe handling of mangoes. |
B |
Egg Safety Action Plan
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.7 |
1.7.1 |
Issue proposed egg safety rule to
further reduce human illnesses from Salmonella Enteritidis. |
A |
1.7 |
1.7.2 |
Publish proposal to permit "in-lid" labeling for the Safe Handling
Statement on shell eggs. |
A |
1.7 |
1.7.3 |
Hold public meetings on the proposed egg safety
rule once it is issued. |
B |
1.7 |
1.7.4 |
In collaboration with the Office of Crisis Management
(OCM), develop a draft Salmonella Enteritidis (SE) Traceback
Investigation Protocol. |
B |
Listeria
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.8 |
1.8.1 |
Publish for comment citizen petition
to amend 21 CFR Part 109 to establish a regulatory limit for Listeria monocytogenes in
foods that do not support its growth. |
A |
1.8 |
1.8.2 |
Submit to Congress a copy of the report
from the National Advisory Committee on Microbiological Criteria
for Foods (NACMCF) on the necessary scientific parameters for
establishing safety-based use by dates for refrigerated ready-to-eat-foods
to help reduce the incidence of foodborne listeriosis, when the
report becomes available in 2004. |
B |
1.8 |
1.8.3 |
Issue draft guidance advising processors
on steps to reduce Listeria monocytogenes contamination
in ready-to-eat foods. |
B |
1.8 |
1.8.4 |
Issue a field assignment regarding "gourmet"
raw milk soft cheeses. |
B |
1.8 |
1.8.5 |
Develop Listeria guidance specifically for the dairy industry. |
B |
1.8 |
1.8.6 |
Perform targeted inspections of dairy products manufactures with
an emphasis on those that produce pasteurized and raw milks, creams,
butters and margarines, soft unripened cheeses and fresh soft cheeses. |
B |
1.8 |
1.8.7 |
Develop an action plan to address the unlawful importation of
cheeses. |
B |
1.8 |
1.8.8 |
Work with the states to eliminate the production and sale of unlawful
raw milk cheeses. |
B |
1.8 |
1.8.9 |
Operate a pilot program involving the smoked fish industry to
determine the effectiveness and feasibility of implementing Listeria control
strategies within smoked fish processing operations. |
B |
Cooperative Programs
1.9 |
1.9.1 |
In conjunction with CFSAN's Office
of Compliance and FDA/ORA, achieve adoption of the Food Code
in 43 states representing 83% of US population. |
A |
1.9 |
1.9.2 |
Increase the number of state and
local Retail Food Regulatory Programs that are utilizing risk-based
inspection programs by 50%, as measured by the Voluntary National
Retail Food Regulatory Program Standards. |
A |
1.9 |
1.9.3 |
Work with stakeholders to institute a
process to develop and present training for States to implement
the NCIMS Grade "A" voluntary HACCP alternative to the
traditional Grade "A" regulatory system. |
B |
1.9 |
1.9.4 |
Institute processes that improve the Shellfish and Grade A Milk
Programs by establishing internal consensus-based mechanisms including
Steering Committee participation with other internal partners. |
B |
1.9 |
1.9.5 |
Develop operational plans for the National
Milk Safety Team and the National Shellfish Safety Team that
identifies strategic goals and performance measures for the Teams. |
B |
1.9 |
1.9.6 |
Increase uniformity in regulations governing
the retail segment of the food industry by: increasing the number
of jurisdictions enrolled in the Voluntary Program Standards
from 120 in FY 2003 to 180. |
B |
1.9 |
1.9.7 |
Develop strategic plan/best model for
administering the Interstate Travel Program and infrastructure
to implement. |
B |
Chemical Contaminants, Pesticides and Other Hazards
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.10 |
1.10.1 |
Continue to analyze selected Total Diet Survey
samples and to collect and analyze selected samples for acrylamide. |
A |
1.10 |
1.10.2 |
Issue final Compliance Policy Guide on radionuclides in foods
to update existing levels and to add radionuclides. |
A |
1.10 |
1.10.3 |
Collect and analyze 8,000 food samples to maintain current
level of monitoring for pesticides and chemical contaminants. |
A |
1.10 |
1.10.4 |
Continue implementing FDA's strategy, on dioxin-like compounds,
including monitoring, method development and identifying opportunities
to reduce exposure. |
A |
1.10 |
1.10.5 |
Issue a proposal to revise the bottled water quality standards
for arsenic. |
A |
1.10 |
1.10.6 |
Complete analytical method development for detection of Perchlorate
in selected products. |
A |
1.10 |
1.10.7 |
Perchlorate: conduct exploratory survey of foods particularly
from areas where water sources are believed to be contaminated
with Perchlorate. |
A |
1.10 |
1.10.8 |
Continue to collect and analyze samples
of honey and seafood for the presence of chloramphenicol. |
A |
1.10 |
1.10.9 |
Issue communication on lead levels in candy. |
A |
1.10 |
1.10.10 |
Issue assignment to monitor lead in imported candy. |
A |
1.10 |
1.10.11 |
Develop analytical method for polybrominated diphenyl ethers in
selected foods. |
B |
1.10 |
1.10.12 |
Update the pesticides CPG to bring it in line with FQPA. |
B |
1.10 |
1.10.13 |
Develop policy for ethyl carbamate in food. |
B |
1.10 |
1.10.14 |
Develop for the Internet the FDA Pesticide Monitoring data and
summary information as required by the Pesticide Monitoring Improvement
Act. |
B |
1.10 |
1.10.15 |
Unify clostridium botulinum policy for the wide variety of foods
regulated by FDA. |
B |
1.10 |
1.10.16 |
Issue draft guidance levels for methanol in alcoholic beverages. |
B |
1.10 |
1.10.17 |
Issue draft lead action levels for foods based on levels adopted
by Codex. |
B |
1.10 |
1.10.18 |
Revise action level for aflatoxin in peanuts. |
B |
1.10 |
1.10.19 |
Conduct workshop on exposure assessment
methodologies and practices in support of the WHO/FAO project to
update the principles of risk assessment for chemicals in food. |
B |
1.10 |
1.10.20 |
Issue final generic "channels of trade"
guidance. |
B |
Transmissible Spongiform Encephalopathies (TSEs)
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.11 |
1.11.1 |
Publish BSE regulation, paralleling USDA's regulation, banning
use of bovine specified risk materials, nonambulatory disabled
and dead cattle, and mechanically separated (beef) in CFSAN-regulated
products. |
A |
1.11 |
1.11.2 |
Initiate a BSE risk assessment. |
A |
1.11 |
1.11.3 |
Determine potential of CWD infected cervids as a human health
risk through collaboration with IFT/Harvard. |
B |
Game Meat
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.12 |
1.12.1 |
Identify manufacturers or processors of game meats and game meat
products and then develop an inspection and sampling plan to evaluate
sanitation practices. |
B |
Food Allergens
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.13 |
1.13.1 |
Continue consumer and industry outreach to increase awareness
of the presence of allergens in food and address the need for
better reporting of allergen adverse events. |
A
|
1.13 |
1.13.2 |
Complete an Association of Official Analytical Chemist (AOAC)
interlab study for immunochemical peanut protein test kits following
the AOAC harmonized validation protocol. |
A
|
1.13 |
1.13.3 |
Issue draft guidance to the field on the use of test kits to
detect the presence of peanut protein. |
A
|
1.13 |
1.13.4 |
Publish a proposed rule to require the declaration
of carmine/cochineal extract, a color additive, on the ingredient
statement of food, drug, and cosmetic products containing it. |
A
|
1.13 |
1.13.5 |
Develop proposed rule for the labeling of the most common allergens. |
B
|
1.13 |
1.13.6 |
Develop
a "Basic Food Allergen" training module (computerized) for ORA
University to enhance and improve the Agency's knowledge base. |
B
|
1.13 |
1.13.7 |
Develop a comprehensive food allergen strategy to address considerations
such as cross-contamination problems (not including bioengineered
foods). |
B |
Dairy Safety
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.14 |
1.14.1 |
Publish draft updated Federal Import Milk Act (FIMA) Compliance
Policy Guide. |
A |
1.14 |
1.14.2 |
Complete the evaluation of the science and safety of raw milk
cheeses (60-day aging). |
B |
1.14 |
1.14.3 |
In collaboration with the Office of Regulatory Affairs and the
Center of Veterinary Medicine, facilitate the implementation of
the new National Drug Residue Milk Compliance Program (NDRMCP). |
B |
1.14 |
1.14.4 |
Evaluate the science and specific options for Vitamins A & D
supplementation of Grade A dairy products. |
B |
1.14 |
1.14.5 |
Develop guidance for the pasteurization alternatives of section
403(h)(3) [Farm Security and Rural Investment Act of 2002]. |
B |
1.14 |
1.14.6 |
Revise dairy-based CPGs to reflect current practices and remove
outdated CPGs. |
B |
1.14 |
1.14.7 |
Continue to work toward completion of equivalence determinations
with the EU. |
B |
Education
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.15 |
1.15.1 |
Develop training manual for health
educators to teach food safety to pregnant women and women
who may become pregnant, in particular safe food handling and
education about the risks of methyl mercury in seafood and
Listeria monocytogenes in refrigerated foods. |
A |
1.15 |
1.15.2 |
Develop and distribute Seafood Safety Education Materials. |
A |
1.15 |
1.15.3 |
In conjunction with Radio Unica, provide an education and outreach
program on food safety to the Hispanic community through participation
in the Radio Unica Health Fair Initiative. |
A |
1.15 |
1.15.4 |
Complete a review of the preventive controls that industry
may take to reduce the risk for an intentional act of terrorism
or contamination using the US food supply for high
risk and medium risk food commodity/agent combinations. |
A |
1.15 |
1.15.5 |
Conduct a Food Advisory Committee meeting to present an update
on how FDA has responded to their July 2002 recommendations for
revising the methylmercury advisory. |
A |
1.15 |
1.15.6 |
Develop the Food Safety and Security Health Professionals Program. |
A |
Part II
Improving Nutrition and Dietary Supplement Safety
Contents
Nutrition, Health Claims and Labeling
Dietary Supplements
Priority Area
Nutrition, Health Claims and Labeling
|
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
2.1.1 Preventing Obesity through Better Nutrition |
|
2.1 |
2.1.1 |
a. Establish
Agency-wide Obesity Working Group (OWG) chaired by the FDA
Deputy Commissioner and vice-chaired by CFSAN Director, to
address obesity through development of new and innovative ways
to help consumers lead healthier lives through better nutrition. |
A
|
2.1 |
2.1.1 |
b. Issue
report within six months to the Commissioner outlining strategy
for developing and implementing goals of the working group. |
A |
2.1 |
2.1.1 |
c. Obesity
Message: Develop and begin testing consumer messages tied to
"calories count" focus. |
A |
Food Labeling |
2.1 |
2.1.1 |
d. Publish
a Advance Notice of Proposed Rulemaking to solicit public comment
on how to give more prominence to calories on the food label,
i.e., increasing the font size for calories, including a percent
Daily Value (%DV) column for total calories, and eliminating
the listing for calories from fat. |
A |
2.1 |
2.1.1 |
e. Publish
a Advance Notice of Proposed Rulemaking to solicit comment
on (1) whether to require food packages that can reasonably
be consumed at one eating occasion to declare the whole package
as a single serving, (2) which, if any, Reference Amounts Customarily
Consumed (RACCS) of food categories need to be updated, and
(3) whether to provide for comparative claims for smaller portions
of identical foods. |
A |
2.1 |
2.1.1 |
f. Develop
principles for use of the term "net" in relation to the carbohydrate
content of foods. |
B |
2.1 |
2.1.1 |
g. Develop
an Advance Notice of Proposed Rulemaking to solicit comments
on whether to allow a health claim such as "Diets low in calories
may reduce the risk of obesity, which is associated with diabetes,
heart disease, and certain cancers" on certain foods that meet
FDA's definition of "reduced" or "low" calorie. |
B |
Enforcement |
2.1 |
2.1.1 |
h. FTC/FDA:
in conjunction with the Federal Trade Commission (FTC), increase
enforcement against weight loss products having false or misleading
claims. |
A |
2.1 |
2.1.1 |
i. Issue
letter to manufacturers regarding inaccurate serving sizes
and, as appropriate, issue letters concerning specific products. |
A |
Restaurants |
2.1 |
2.1.1 |
j. Participate
with the Office of the Commissioner in working with a third-party
facilitator to develop options for providing voluntary standardized,
simple and understandable nutrition (including calorie) information
at point-of purchase in a restaurant setting; enlist restaurants
to participate in pilot program to use options developed and
evaluate program results at appropriate intervals. |
A |
Education |
2.1 |
2.1.1 |
k. Participate
with the Office of the Commissioner in working with a third-party
facilitator to develop approaches including partnerships for
educating consumers, particularly adolescents, about obesity. |
A |
2.1.2 Enhance Consumer Health Information for Better Nutrition |
2.1 |
2.1.2 |
a. Publish ANPRM to request comment on the regulatory strategy
for qualified health claims. |
A
|
2.1 |
2.1.2 |
b. Conduct and analyze consumer research to help ensure that
qualified health claim messages in the labeling of foods and
dietary supplements employ the most effective wording so that
the messages are not misleading to consumers. |
A
|
2.1 |
2.1.2 |
c. Publish proposed rule to regulate qualified health claims. |
A
|
2.1 |
2.1.2 |
d. Reopen
comment period on the proposed rule providing for more flexibility
in the use of health/nutrient content claims in response to
citizens' petitions (Docket nos. 4P-0390 and 95P-0241). |
A
|
2.1.3 Review of Industry Submissions/Statutory
Requirements |
2.1 |
2.1.3 |
a. Review
nutrient content/ health claim notifications and petitions within
statutory timeframe. |
A
|
2.1 |
2.1.3 |
b. Review
premarket notifications for new infant formulas within statutory
timeframe. |
A |
2.1 |
2.1.3 |
c. Develop
a final rule for infant formula GMPs and quality factors. |
B |
2.1 |
2.1.3 |
d. Develop
proposed rule to revise, as appropriate, existing regulation that
requires irradiated food to be labeled. |
B |
2.1.4 Protecting and Promoting Public Health with Agency Initiated
Actions |
2.1 |
2.1.4 |
a. Promote trans fat
education and outreach. |
A
|
2.1
|
2.1.4 |
b. Extend
for 60 days the comment period for the advance notice of proposed
rulemaking for the Trans Fatty Acids in Nutrition Labeling. |
A
|
2.1 |
2.1.4 |
c. Develop
final rule on sodium provisions for the implied nutrient content
claim "healthy." |
B |
2.1 |
2.1.4 |
d. Develop
strategy to address claims and disclosure/footnote statements on trans fat
based on comments to July 11, 2003, ANPRM. |
B |
2.1 |
2.1.4 |
e. Integrate
data on caffeine content of conventional foods and dietary supplements
to estimate total exposure and develop a policy on caffeine labeling. |
B |
2.1.5 Improve Efficiency/Responsiveness |
2.1 |
2.1.5 |
a. Develop
proposed rule for nutrient content claims that are the subject
of health claims. |
B |
2.1 |
2.1.5 |
b. Review
the Institute of Medicine/National Academy of Sciences (IOM/NAS)
report on methodology to be used to update reference values used
in nutrition labeling and principles for discretionary fortification
of foods based on new Dietary Reference Intake values and develop
strategy for updating Daily Values in nutrition labeling. |
B |
2.1 |
2.1.5 |
c. Develop
final rule to update nutrient values for the voluntary nutrition
labeling program. |
B |
2.1.6 Enforcement/Compliance |
2.1 |
2.1.6 |
a. Conduct
enforcement activities related to inappropriate labeling of conventional
foods. |
A |
Dietary Supplements
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
2.2.1 Requirements Statutory/Congressional
Requirements |
2.2 |
2.2.1 |
a. Review
premarket (75-day) notifications for new dietary ingredients
within statutory timeframe. |
A
|
2.2 |
2.2.1 |
b. Review
30-day postmarket notifications for supplement claims in a timely
manner. |
A
|
2.2 |
2.2.1 |
c. Develop
proposal to amend 21 CFR 190.6 relative to description of new dietary
ingredients. |
B |
2.2.2 Protecting and Promoting Public Health
with Agency Initiated Actions |
2.2 |
2.2.2 |
a. Publish
a final rule for dietary supplement GMPs. |
A
|
2.2 |
2.2.2 |
b. Continue
to develop standard operating procedures (SOPs) to enhance timely
identification and clinical assessment of dietary supplement
adverse events and coordinate these efforts with the Centers
for Disease Control and Prevention (CDC) and the National Institutes
of Health (NIH) in their respective capacities. |
B |
2.2 |
2.2.2 |
c. Continue
to develop mechanisms to enhance timely clinical assessment of
dietary supplement adverse event investigations. |
B |
2.2.3 Improve Efficiency/Responsiveness |
2.2 |
2.2.3 |
a. Develop
guidance for industry on submissions of 75-day pre-notifications
for new dietary ingredients. |
A |
2.2 |
2.2.3 |
b. Publish
guidance on substantiation of structure/ function claims for
dietary supplements. |
A
|
2.2
|
2.2.3 |
c. Publish
a final rule declaring dietary supplements containing ephedrine
alkaloids adulterated under the FD&C Act. |
A
|
2.2 |
2.2.3 |
d. Complete
Dietary Supplement Labeling Guide and post on the CFSAN Web site. |
B |
2.2 |
2.2.3 |
e. Publish
final rule on "per day" labeling for dietary supplements. |
B |
2.2.4 Enforcement/Compliance |
2.2 |
2.2.4 |
a. Continue
to identify dietary supplement ingredients/products that raise
safety problems, and take appropriate enforcement actions. |
A
|
2.2 |
2.2.4 |
b. Continue
efforts in conjunction with the Federal Trade Commission, to
take action against unsubstantiated claims on dietary supplements. |
A |
2.2 |
2.2.4 |
c. Conduct
surveillance activities pertaining to pesticides/contaminants in
dietary supplement products. |
B |
Part III
Assuring Food & Cosmetic Safety
General
Contents
Food and Color Additives: Premarket Review
Cosmetics
Priority Area
Food and Color Additives: Premarket Review
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
3.1.1 Review of Industry Submissions/Statutory Requirements |
3.1 |
3.1.1 |
a. For the petition receipt cohort of FY 2003, complete within
360 days of filing, the safety evaluation of at least two of
three of those food and color additive petitions that qualify
for expedited review. |
A |
3.1 |
3.1.1 |
b. For the petition receipt cohort of FY 2003, complete within
360 days of filing, the safety evaluation of 70% of those food
and color additive petitions that do not qualify for expedited
review. |
A |
3.1 |
3.1.1 |
c. Complete
CFSAN evaluation of biotechnology final consultations within
180 days. |
A |
3.1 |
3.1.1 |
d. Complete
processing of 80% of GRAS notifications (GRNs) within 180 days. |
A |
3.1 |
3.1.1 |
e. Complete
review of premarket notifications for food contact substances
within the statutory time limit (120 days). |
A |
3.1.2 Protecting and Promoting Public Health with Agency Initiated
Actions |
3.1 |
3.1.2 |
a. Increase
enforcement actions for dietary supplement type ingredients in
conventional foods whose use is neither approved under section
409 nor generally recognized as safe. |
A
|
3.1 |
3.1.2 |
b. Develop
documents to adopt the specifications in the most recent edition
of the Food Chemicals Codex into regulations as appropriate. |
B |
3.1 |
3.1.2 |
c. Make
available updated chemistry guidance for recycled plastics. |
B |
3.1 |
3.1.2 |
d. Continue
to interact with stakeholders proactively by encouraging prefiling
consultations for new submissions. |
A |
3.1 |
3.1.2 |
e. Develop
a Federal Register proposal extending exclusion from Environmental
Assessments to additional categories of Agency action on food and
color additives. |
B |
3.1 |
3.1.2 |
f. Amend
21 CFR section 178.1010, as a result of the Food Quality Protection
Act, to accommodate partial transfer of this regulation to EPA. |
B |
3.1 |
3.1.2 |
g. Develop
guidance for packaging used when irradiating foods. |
B |
3.1 |
3.1.2 |
h. Continue
to monitor the use of bromates in baked goods. |
B |
3.1 |
3.1.2 |
i. Continue
to make additional final revised Redbook Chapters available on
the FDA website. |
B |
3.1.3 Improve Efficiency/Responsiveness |
3.1 |
3.1.3 |
a. Make
publicly available 5 study review templates on the Internet to
facilitate the evaluation of toxicology/safety data submitted
in food and color additive petitions and in food contact notifications. |
A |
3.1 |
3.1.3 |
b. Develop
guidance for the electronic submission of food and color additive
petitions. |
B |
3.1 |
3.1.3 |
c. Develop
E-guidance document for the food contact substance notification
program. |
B |
3.1 |
3.1.3 |
d. Develop
a final rule for the GRAS notice program. |
B |
3.1 |
3.1.3 |
e. Develop
E-guidance document that would accompany the GRAS notification
program final rule. |
B |
3.1.4 Enforcement/Compliance |
3.1 |
3.1.4 |
Publish a draft Compliance Policy Guide (CPG)
for chloropropanols. |
A |
Cosmetics
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
3.2.1 Protecting and Promoting Public Health
with Agency Initiated Actions |
3.2 |
3.2.1 |
a. Certified
Color Additives: Continue to analyze all batches of color additives
and determine certification status (certify or refuse to certify)
within an average of 5 working days. |
A
|
3.2 |
3.2.1 |
b. Alpha
Hydroxy Acids (AHA): Publish final guidance on labeling of AHA
containing products. |
A |
3.2 |
3.2.1 |
c. Color
Additive Lakes (PRIA): Publish, for public comment, analysis of
economic impact of proposed rule. |
B |
3.2 |
3.2.1 |
d. Color
Additive Lakes: Develop a final rule permanently listing color
additive lakes through FDA. |
B |
3.2 |
3.2.1 |
e. Cosmetic
Product Safety: Support NTP/NCTR photocarcinogenicity testing
of glycolic acid and salicylic acid. |
B |
3.2.2 Congressional Reports/Directives |
3.2 |
3.2.2 |
Report to Congress on steps that
will be taken to ensure that there will not be any future excessive
fluctuations in the cost of the color certification program. |
A |
3.2.3 Improve Efficiency/Responsiveness |
3.2 |
3.2.3 |
a. Develop
electronic tracking and filing system, Oracle based, to improve
workflow, document tracking, and ease sharing of documents
and information with the Office of Cosmetics and Colors. |
A
|
3.2 |
3.2.3 |
b. Cosmetic Labeling: Develop a strategy for amending 701.3
(c)(2) to update sources for naming cosmetic ingredients. |
A |
3.2 |
3.2.3 |
c. Develop
Cosmetic Handbook for Industry as Level 1 and Level 2 guidance
documents. |
B |
3.2.4 Enforcement/Compliance |
3.2 |
3.2.4 |
a. Develop
an analytical method for the determination of phthalates in cosmetic
products. |
A
|
3.2 |
3.2.4 |
b. Conduct
a survey of products to determine the contribution of phthalates
to human exposure. |
A
|
3.2 |
3.2.4 |
c. Sampling
survey: Conduct annual internal control review of its procedures
for the Color Certification Program. To meet this need, the districts
are to collect survey (investigational) samples of certified colors
(21 CFR Parts 74 and 82) for subsequent analysis and verification
by OCAC's Color Certification Program. |
B |
3.2 |
3.2.4 |
d. Develop
draft guidance for issuance of 21 CFR section 740.10 warnings for
products formulated with ingredients that lack adequate safety
substantiation. |
B |
3.2 |
3.2.4 |
e. Tattoo inks:
Perform preliminary investigations in the development of test protocols
to determine the safety of tattoo inks. Develop a strategy for
assessing potential public health concerns associated with tattoo
inks. |
B |
3.2 |
3.2.4 |
f. Guidance
for Cosmetic Labeling: Develop a plan to establish criteria for
cosmetic claims, implement the Inter-Center agreement concerning
cosmetic products making drug claims through review of labeling,
and conduct regulatory follow-up. |
B |
3.2 |
3.2.4 |
g. Re-propose
use of progesterone and pregnenolone in cosmetics to evaluate claims
and quantities of hormones allowable in cosmetic products. |
B |
3.2 |
3.2.4 |
h. Nanotechnology:
In conjunction with the NTP, develop a protocol to assess absorption
of titanium dioxide. |
B |
Part IV
Assuring
Food Safety: Crosscutting Areas
Contents
Science Base
International
Food Biotechnology
Internal Processes
Focused, Economic-based Regulations
EEO/Diversity Initiatives
Management Initiatives
Priority Area
Science Base
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.1 |
4.1.1 |
Evaluate foodborne illness risk factors
in conjunction with the FDA National Retail Food Team to establish
public health food safety goals (Food Safety Program Assessment
Rating Tool Goal), and track progress toward those goals. |
A |
4.1 |
4.1.2 |
Provide training
on methods of risk analysis for foods. |
A |
4.1 |
4.1.3 |
Human
Subject Protection: Working with the Agency and the Department,
enhance the protection of human subjects in clinical and other
research related to CFSAN-regulated products. |
A
|
4.1 |
4.1.4 |
Re-engineer the CFSAN Laboratory Quality Assurance System. |
A
|
4.1 |
4.1.5 |
Continue the cooperative research agreement between CFSAN/FDA
and the University of Mississippi's National Natural Products Research Center. |
A
|
4.1 |
4.1.6 |
Enhance CFSAN's science base and
interaction with the academic community through "Centers of
Excellence" - host a meeting to present research needs and
coordinate activities amongst the existing Center of Excellence
(NCFST, JIFSAN, NCNPR) and other academic counterparts and
stakeholder groups. |
A |
4.1 |
4.1.7 |
Plan the FY-05 Food Safety Survey. |
A |
4.1 |
4.1.8 |
Conduct a Program Effectiveness Conference
in conjunction with CDC and a brief report to evaluate mechanisms
and methods to measure the degree of food related risks. |
A |
4.1 |
4.1.9 |
Conduct survey data on consumer understanding
of the relationships between heart disease risk and consumption
of trans, saturated and omega 3 fatty acids to provide a baseline
for measuring long-term changes in consumer understanding. |
A |
4.1 |
4.1.10 |
Establish leveraging activities with
the Department of Homeland Security to develop methods for
strain attribution of foodborne pathogens. |
A |
4.1 |
4.1.11 |
Collect consumer data on current Infant
Feeding Practices and, in conjunction with CDC, FDA's Office
of Women's Health, NIH, and HRSA, evaluate HHS Breastfeeding
Awareness Campaign. (FY 04-05) |
B |
4.1 |
4.1.2 |
Develop clinical and epidemiology training
modules based on real adverse event data analyses from FDA work
for new hires. |
B |
4.1 |
4.1.13 |
Implement 1st phase of the Learning Management System. |
B |
4.1 |
4.1.14 |
Coordinate CFSAN Leadership Training Program. |
B |
4.1 |
4.1.15 |
Implement key recommendations of CFSAN's assessment of the JIFSAN
Program. |
B |
International
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.2 |
4.2.1 |
Codex Committees and Working Groups: Participate in and assure FDA/CFSAN visibility in the Codex committees, ad-hoc task forces, related drafting and working groups, and scientific advisory committees meeting in FY 2003 that are of relevance to FDA/CFSAN. High priority attention to the following: |
|
Commission Session: | 1. Codex Commission Alimentarius Commission | A |
Cross-cutting General Subject Committees: |
2. Nutrition and Foods for Special Dietary Uses | A |
3. Food Import and Export Inspections and Certifications Systems | A |
4. Food Hygiene | A |
5. Methods of Analysis and Sampling | A |
6. Fish and Fishery Products | A |
7. Food Additives and Contaminants | A |
8. General Principles (19th Session) | A |
9. Food Labeling | A |
10. Milk and Milk Products | A |
11. General Principles (20th Session) | A |
Trilateral U.S./Canada/Mexican Activities: | 12. Technical Working Group for Food Labeling, Packaging and Standards.
| A |
4.2 |
4.2.2 |
Participate in United States trade negotiations to draft the
sanitary and phytosanitary articles of the agriculture chapters
of the Central American Free Trade Agreement (CAFTA), Morocco,
Andean Community, Australia, Bahrain, Dominican Republic, Panama,
Southern African Customs Union (SACU, Sri Lanka, and Thailand
FTAs to ensure public health protections are maintained and
FDA's regulatory authority not compromised in each FTA. Includes
working on SPS trade-related issues of products under FDA jurisdiction. |
A |
4.2 |
4.2.3 |
Export Certificates: Work with States, other federal agencies,
and industry to increase transparency of U.S. systems for issuance
of food export certificates. Continue to lead the Association
of Food and Drug Officials (AFDO) Export Certificate Working Group. |
B |
4.2 |
4.2.4 |
Move OCO databases of Technical Assistance Events/People and International
Travel into CFSAN shared files to provide search access to CFSAN
staff. |
B |
4.2 |
4.2.5 |
Develop FDA descriptors for the State/Federal Food Export Certificates
Website. |
B |
4.2 |
4.2.6 |
Improve the safety of food, drug and cosmetic imports through
the development of international harmonized standards, participation
in the development and implementation of trade agreements, and
provision of effective international technical assistance. |
B |
4.2 |
4.2.7 |
Participate in United States trade negotiations to draft the sanitary
and phytosanitary articles of agriculture chapter in the Free Trade
Area of the Americas (FTAA) to ensure the American consumer's public
health remains protected and FDA's regulatory authority not compromised
in the final FTAA. The FTAA of 34 countries spanning the entire
Western Hemisphere is projected to be completed by the end of 2005. |
B |
Food Biotechnology
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.3 |
4.3.1 |
Enhance the information provided to the public in FDA's evaluation
of foods derived from bioengineered plants. |
A
|
4.3 |
4.3.2 |
Convene a public meeting of the food Biotechnology Subcommittee
of the Food Advisory Committee to discuss current Agency activities
in food biotechnology. |
A
|
4.3 |
4.3.3 |
Develop
guidance concerning the potential presence of unintended varieties
of bioengineered plant foods that may be present in the food
supply, but that have themselves not completed all regulatory
steps for marketing. |
A |
4.3 |
4.3.4 |
Work with appropriate FDA components and other U.S. Government
agencies to develop a strategy to ensure that materials derived
from non-food use bioengineered plants, such as pharmaceutical
or industrial-use crops, do not adulterate the food supply. |
B
|
4.3 |
4.3.5 |
Publish final guidance for voluntary labeling of foods that have
or have not been developed using bioengineering. |
B |
4.3 |
4.3.6 |
Develop draft guidance on assessing allergenicity in relation
to bioengineered food. |
B |
4.3 |
4.3.7 |
Develop guidance on the use of antibiotic resistance genes in
bioengineered plant foods. |
B |
Internal Processes
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.4 |
4.4.1 |
CFSAN Adverse Events
Reporting System CAERS): Implement CAERS enhancements to improve
tracking of dietary supplements and food and cosmetics adverse
events. |
A
|
4.4 |
4.4.2 |
Identify a partner or data source
to obtain exposure and other missing data on OTC drugs, dietary
supplements, and devices used at home. |
A |
4.4 |
4.4.3 |
Provide timely customer service, information
and regulatory support to ORA field offices, including expanding
this effort through the Office of Compliance's intranet site. |
A |
4.4 |
4.4.4 |
Governmentwide Paperwork Elimination Act (GPEA):
Implement electronic submission and e-signature capability via
the internet to meet GPEA requirements to allow for industry
submission of Low Acid Canned Foods. |
A |
4.4 |
4.4.5 |
Work planning: Implement
CFSAN's risk management framework which includes incorporation
of risk based priorities, best practices, and development of
a multi-factorial risk model for both domestic and import operations. |
A |
4.4 |
4.4.6 |
Inspections: Identify
common factors and a system to assist CFSAN in prioritizing
and choosing sites/systems for inspection, including the establishment
of a process for conducting statistically based audits of areas
not identified as high risk as a means to ensure that the Agency
is targeting appropriate sites for inspection and compliance/enforcement
activities. |
A |
4.4 |
4.4.7 |
Compliance/Enforcement:
Establish a process by which CFSAN will set compliance priorities
by conducting a series of annual assessments that identify
the internal and external hazards a regulated firm faces (e.g.,
those within versus outside of a firm's control); addressing
risk estimate and characterization of the hazards); and determining
the consequences to the public health as a result of Agency
action vs. inaction. |
A |
4.4 |
4.4.8 |
Establish policies
and procedures that enhance the use of a tiered approach to
foreign food inspections based upon risk for foods so that
the amount/type of oversight (e.g., full inspections, abbreviated
or focused inspections, evaluations of GMP documents, etc.)
is proportional to the degree of risk. Process should be designed
to promote development and maintenance of a flexible and risk-based
stratified list of foreign facilities requiring inspection
to maximize efficient use of foreign inspection resources. |
A |
4.4 |
4.4.9 |
Begin to modify CFSAN
Compliance Programs, EIR foremast and the IOM so that during
domestic inspections inspectors examine, report, and track
counterfeit imported products, returns of imported products,
rejected imported products, and complaint files concerning
imported products. |
A |
4.4 |
4.4.10 |
Evaluate FY 2002 and FY 2003 review times by CFSAN staff on legal
action reviews and recommend actions for CFSAN implementation
to improve efficiency and effectiveness for meeting Agency time
frames. |
B |
4.4 |
4.4.11 |
Implement the enhanced Center's correspondence
control process that was developed in FY 2003 to improve the
internal coordination of information to ensure orderly, timely,
and coordinated responses to internal and external communications. |
B |
4.4 |
4.4.12 |
CFSAN will report to Congress any modifications,
on any proposed consolidation efforts to CAERS with detail information
on the impact to the system prior to these modifications being
made. |
B |
Economic based Regulations
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.5 |
4.5.1 |
Submit a report to Congress within 120 days of the close of the comment
period of the ANPRM on standard of identity for Yogurt. |
A
|
4.5 |
4.5.2 |
Report to Congress, quarterly, on the status
of petitions regarding the use of ultrafiltered milk, casein,
or milk protein concentrates in standardized dairy products. |
A |
4.5 |
4.5.3 |
Publish proposed rule on general principles
for standards of identity in collaboration with USDA. |
A
|
4.5 |
4.5.4 |
Develop proposed
rule to amend definition for "milk" in cheese standards to provide
for use of fluid ultra-filtered milk. |
B |
4.5 |
4.5.5 |
Develop advance notices of proposed rulemakings
to seek comments on amending standards of identity for parmesan
cheese and frozen desserts. |
B |
4.5 |
4.5.6 |
Develop response to petition requesting
a common or usual name for soymilk. |
B |
EEO/Diversity Initiatives
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.6 |
4.6.1 |
"Affirmative Employment Program": Implement
strategies in accordance with (1) Executive Order 11478
which mandates that equal employment opportunity be an integral
part of every aspect of personnel policy and practice in the
recruitment, hiring and retention of minorities, women and people
with disabilities and (2) the Civil Service Reform Act of 1978
which mandates that the nations' workforce reflect the diversity
of the nation as a whole. |
A |
Management Initiatives
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.7 |
4.7.1 |
Complete
the FY 2004 budget review, identifying priority funding needs
and all essential costs associated with the foods program and
continue an on-going review throughout the year. |
A
|
4.7 |
4.7.2 |
Continue
CFSAN's radioactive and chemical decommissioning efforts in Federal Building 8. |
A |
4.7 |
4.7.3 |
Manage
and plan the occupancy of CFSAN's adjunct building: University
Station. |
A |
4.7 |
4.7.4 |
Realign
CFSAN's Office of Management Systems' Organizational structure
and functions to reflect the establishment of an FDA Office of
Shared Services. |
A |
4.7 |
4.7.5 |
Establish
service level agreements and new modalities for working with
the Office of Shared Services to establish and deliver the best
possible service to the CFSAN User community. |
A |
4.7 |
4.7.6 |
Continue
to develop and implement programs and policies to ensure full
security over select agents used within CFSAN. |
A |
4.7 |
4.7.7 |
The
President's Management Agenda: Continue implementation of initiatives
associated with the President's Management Agenda within the
5 core areas identified in the Agenda. |
A |
4.7 |
4.7.8 |
NTEU:
Continue to work with NTEU and the Cooperation Committee to fully
implement the NTEU Collective Bargaining Agreement. |
A |
4.7 |
4.7.9 |
Leadership Legacy:
- Complete
work and issue report of Steering Committee and Task Forces.
- Establish
Senior Leadership Board.
- Implement
Leadership Legacy initiative across CFSAN.
|
A |
4.7 |
4.7.10 |
Develop a new system for budgeting research projects. |
B |