CFSAN 2005 Program Priorities
Letter from Center Director
Table of Contents
Dear Colleague, FDA Foods Community
I am pleased to share with you the FY 2005 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 2005 (October
1, 2004 through September 30, 2005), and is based on comments we received from
you (our stakeholders) as well as comments 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 comments
and your continuing interest in this process.
Our work plan is divided into five primary sections:
- Ensuring Food Safety and Defense
- Improving Nutrition and Dietary Supplement Safety
- Ensuring Food/Color Additive and Cosmetic Safety
- Ensuring Food Safety: Crosscutting Areas
- Priority Ongoing Activities
Food Safety and Defense remains a central theme in the Administration's public
health agenda. Our work plan reflects 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 reflects the same commitment as last year to revitalize and
bolster our nutrition program. Helping consumers improve their nutrition is
an increasingly urgent part of the FDA mission. Our efforts continue to 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 committed to working
harder than ever to make sure the information consumers receive is scientifically
valid and easily understood.
This work plan was developed in recognition of the diminished food safety
budget yet still focusing on high priority areas that ensure the safety of
our foods. Our plan includes 123 "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, 2005. 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 year our priorities
contain a new category. This category is entitled "Priority Ongoing Activities" and
it is intended to illustrate some of the many high priority activities that
the Center performs on a regular basis in addition to those identified in our
A-list and B-list priorities.
Beyond these there are still many activities that our plan does not address
but that support our food safety mission. These include 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 Defense: Emergency Preparedness
- Imports
- 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
- Internal Processes
- Focused, Economic-based Regulations
- Management Initiatives
Part I
Ensuring Food Safety and Defense
Contents
Food Defense/Food Safety Implementing Regulations and Guidance
Food Defense: Emergency Preparedness
Imports
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 Defense/Food Safety Implementing Regulations and Guidance
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
Regulations |
1.1 |
1.1.1 |
Publish 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 |
Publish a final rule for the establishment of prior notification
requirements for all imported food shipments. |
A |
1.1 |
1.1.3 |
Publish a final rule for the establishment and maintenance
of records to identify immediate previous source and immediate
subsequent recipient of foods. |
A |
Guidance |
1.1 |
1.1.4 |
Publish FDA guidance procedures to access records under
the new regulation authorizing the establishment and maintenance
of records under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. |
A |
1.1 |
1.1.5 |
Publish Small Entity Compliance Guide for the establishment
and maintenance of records under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. |
A |
1.1 |
1.1.6 |
Issue Guidance for Administrative Detention under the Public
Health Security and Bioterrorism Preparedness and Response Act
of 2002. |
A |
1.1 |
1.1.7 |
Develop domestic and international plan and strategy for outreach
to stakeholders/industry regarding Bioterrorism rules, new regulatory requirements
and guidance. |
A |
Food Defense: Emergency Preparedness
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
Laboratory Preparedness |
1.2 |
1.2.1 |
Establish Laboratory Response Network (LRN) training assistance
with federal and state counterparts. |
B |
Imports
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.3 |
1.3.1 |
Publish final rule to set standards for the use of private
laboratories and for testing imported foods.
|
A |
1.3 |
1.3.2 |
Redesign import operations and establish processes and procedures
to ensure import enforcement resources are results oriented,
risk-based, and can be quickly redirected to meet emerging problems. |
A |
Seafood Safety
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.4 |
1.4.1 |
Publish analysis of all data gathered to date world-wide on
the good aquaculture practices project in preparation for the
drafting of guidance.
|
A
|
1.4 |
1.4.2 |
Publish final Vibrio parahaemolyticus risk assessment.
|
A
|
1.4 |
1.4.3 |
In cooperation with the Vibrio parahaemolyticus (Vp)
Subcommittee of the Interstate Shellfish Sanitation Conference,
develop a strategy to revise the interim control plan for the
control of Vp in raw molluscan shellfish, based on the findings
in the FDA Vp risk assessment.
|
A
|
1.4 |
1.4.4 |
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 |
1.4 |
1.4.5 |
Develop 4th edition of the Fish and Fishery Products
Hazards and Controls Guide. |
B |
1.4 |
1.4.6 |
Review and prepare response to 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 |
1.5 |
1.5.1 |
Publish a "White Paper" for Food Current Good Manufacturing
Practices (CGMPs). |
A
|
1.5 |
1.5.2 |
Issue draft guidance for fresh cut produce. |
A |
1.5 |
1.5.3 |
Hold a public meeting on sprout safety and initiate rulemaking
(ANPRM) for sprouts. |
A |
1.5 |
1.5.4 |
Evaluate testing protocol for the recovery of Salmonella in
sprout seeds. |
A |
1.5 |
1.5.5 |
Issue guidance on enforcement discretion for ozonation of
juice. |
A |
1.5 |
1.5.6 |
Provide assistance to California Department
of Health Services (CDHS) on production of the video on safe
juice processing. |
A |
1.5 |
1.5.7 |
Develop a unified Clostridium botulinum policy for the
wide variety of foods regulated by FDA. |
B |
1.5 |
1.5.8 |
Work with USDA, Animal Plant Health Inspection Service (APHIS)
and mango producers to institute practices to ensure safe handling
of mangoes. |
B |
1.5 |
1.5.9 |
Issue final fresh cut produce guidance. |
B |
1.5 |
1.5.10 |
Issue report on sprout assignment. |
B |
1.5 |
1.5.11 |
Issue assignment to sample mung beans intended for sprouting. |
B |
Egg Safety Action Plan
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.6 |
1.6.1 |
Publish proposal to permit "in-lid" labeling for the Safe
Handling Statement on shell eggs.
|
A |
1.6 |
1.6.2 |
Hold public meetings on the proposed egg safety rule.
|
A |
1.6 |
1.6.3 |
Develop Egg Safety final rule for publication in FY 2006.
|
A |
1.6 |
1.6.4 |
Develop and issue a field assignment for the inspection of egg
facilities. |
B |
Listeria
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.7 |
1.7.1 |
Submit to Congress a copy of the report for 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.
|
A |
1.7 |
1.7.2 |
Issue draft guidance advising processors on steps to reduce Listeria
monocytogenes (Lm) contamination in ready-to-eat
foods.
|
A |
1.7 |
1.7.3 |
In collaboration with FDA's Office of Regulatory Affairs
(ORA), perform targeted inspections of dairy products manufacturers
with an emphasis on raw milks, creams, butters and margarines,
soft unripened cheeses and fresh soft cheeses.
|
A |
1.7 |
1.7.4 |
Develop an action plan to address the large scale unlawful
importation of cheeses.
|
A |
1.7 |
1.7.5 |
Issue a field assignment regarding "gourmet" raw milk soft
cheeses.
|
A |
1.7 |
1.7.6 |
Respond to a Citizen petition (Docket No. 2003P-0574) to establish a regulatory limit of 100 colony forming units per gram for Listeria monocytogenes in foods that do not support the growth of the microorganism.
|
A |
1.7 |
1.7.7 |
Develop Listeria guidance specifically for the dairy industry. |
B |
1.7 |
1.7.8 |
Conduct a quantitative risk assessment (product pathway analysis)
for Listeria monocytogenes (Lm) in smoked seafood. |
B |
1.7 |
1.7.9 |
Work in conjunction with the Conference for Food Protection (CFP)
to evaluate the current Food Code provisions and ascertain the
need for modifications or additions to improve the control of Listeria
monocytogenes (Lm) at retail. |
B |
Cooperative Programs
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.8 |
1.8.1 |
Complete and publish the 2005 FDA Retail Food Code.
|
A |
1.8 |
1.8.2 |
Increase the number of state and local Retail Food Regulatory
Programs that are using risk-based inspection programs by 50%,
as measured by the Voluntary National Retail Food Regulatory
Program Standards.
|
A |
1.8
|
1.8.3 |
Increase the number of jurisdictions enrolled in the Voluntary
National Retail Food Regulatory Program Standards from 120 in
FY 2004 to 180.
|
A |
1.8 |
1.8.4 |
Complete and publish a report of the results of the 2003 survey
of Foodborne Illness Risk Factors in (retail-level) Food Establishments.
|
A |
1.8 |
1.8.5 |
Develop a strategy to engage our stakeholders in meeting
World Trade Organization (WTO) commitments that effect Cooperative
Programs' regulatory infrastructure.
|
A |
1.8 |
1.8.6 |
Draft 2005 PMO and ISSC Model Ordinances.
|
A |
Chemical Contaminants, Pesticides and Other Hazards
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.9 |
1.9.1 |
In conjunction with FDA's Office of Regulatory Affairs (ORA),
conduct survey of foods for perchlorate.
|
A |
1.9 |
1.9.2 |
Expand application of analytical methods for perchlorate to
additional high priority foods.
|
A |
1.9 |
1.9.3 |
Report to Congress on the findings of the perchlorate surveys
of food and bottled water.
|
A |
1.9 |
1.9.4 |
Issue proposed rule to revise the bottled water quality standards
for arsenic.
|
A |
1.9 |
1.9.5 |
Issue a final rule to revise the bottled water quality standards
for arsenic.
|
A |
1.9 |
1.9.6 |
Issue draft revised guidance for lead levels in candy.
|
A |
1.9 |
1.9.7 |
Issue revised final guidance for lead levels in candy.
|
A |
1.9 |
1.9.8 |
Develop action plan for furan in foods.
|
A |
1.9 |
1.9.9 |
In collaboration with ORA, conduct expanded survey for furan
in heat-processed foods and assess the effects of commonly employed
cooking methods on the levels of furan in selected foods.
|
A |
1.9 |
1.9.10 |
Issue final generic "channels of trade" guidance.
|
A |
1.9 |
1.9.11 |
Update the pesticides Compliance Policy Guide (CPG) to bring
it in line with Food Quality Protection Act (FQPA).
|
A |
1.9 |
1.9.12 |
Conduct workshop on exposure assessment methodologies and
practices in support of the World Health Organization/Food and
Agriculture Organization (WHO/FAO) project to update the principles
of risk assessment for chemicals in food.
|
A |
1.9 |
1.9.13 |
Develop analytical method for polybrominated diphenyl ethers and
initiate sampling in selected foods. |
B |
1.9 |
1.9.14 |
Develop policy for ethyl carbamate in food. |
B |
1.9 |
1.9.15 |
Develop an enhanced analytical method for methyl mercury.
|
B |
1.9 |
1.9.16 |
Develop draft guidance levels for methanol in alcoholic beverages. |
B |
1.9 |
1.9.17 |
Develop draft lead action levels for foods based on levels adopted
by Codex. |
B |
1.9 |
1.9.18 |
Develop a revised action level for aflatoxin in peanuts. |
B |
1.9 |
1.9.19 |
Develop draft action level for the mycotoxin, deoxynivalenol,
in wheat products such as wheat flour. |
B |
Transmissible Spongiform Encephalopathies (TSEs)
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.10 |
1.10.1 |
Publish final rule on Bovine Spongiform Encephalopathy (BSE)
recordkeeping.
|
A |
1.10 |
1.10.2 |
Finalize Interim Final Rule for Bovine Spongiform Encephalopathy
(BSE).
|
A |
1.10 |
1.10.3 |
Complete Bovine Spongiform Encephalopathy (BSE) risk assessment.
|
A |
Game Meat
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.11 |
1.11.1 |
Identify manufacturers or processors of game meats and game
meat products and then develop an inspection and sampling plan
to evaluate compliance with applicable laws.
|
A |
Food Allergens
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.12 |
1.12.1 |
Implement the provisions of the Food Allergen Labeling and
Consumer Protection Act of 2004, including training, guidance
and outreach activities to: 1) assist industry and 2) provide
the appropriate information to FDA field staff. |
A
|
1.12 |
1.12.2 |
Obtain expert consultation on gluten-free labeling in response
to the Food Allergen Labeling and Consumer Protection Act of
2004. |
A
|
1.12
|
1.12.3 |
Develop for publication in FY 2006 a proposed rule for gluten-free labeling in response to
the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
|
A
|
1.12
|
1.12.4 |
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
|
1.12 |
1.12.5 |
Issue draft guidance on the use of test kits to detect the
presence of peanut protein for regulatory purposes. |
A
|
1.12 |
1.12.6 |
Complete an Association of Official Analytical Chemists (AOAC)
interlab study for immunochemical peanut protein test kits following
the AOAC-harmonized validation protocol. |
A |
1.12 |
1.12.7 |
Initiate Association of Official Analytical Chemists (AOAC)
performance and harmonized validation of egg and milk test kits. |
A |
1.12 |
1.12.8 |
Issue allergen Compliance Program and implement enforcement
strategy. |
A |
1.12 |
1.12.9 |
Issue report on allergen inspections. |
A |
1.12 |
1.12.10 |
Develop a comprehensive food allergen strategy to address considerations
such as cross-contamination problems. |
B |
Dairy Safety
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.13 |
1.13.1 |
Complete the evaluation of the science of raw milk cheeses.
(60 day aging).
|
A |
1.13 |
1.13.2 |
Issue revised draft dairy based Compliance Policy Guides (CPG)
to reflect current practices and remove outdated CPGs.
|
A |
1.13 |
1.13.3 |
Issue final updated Federal Import Milk Act (FIMA) Compliance
Policy Guide (CPG).
|
A |
1.13 |
1.13.4 |
Develop draft guidance on performance standards and validation
of new technologies for pasteurization based on the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF) advice. |
B |
1.13 |
1.13.5 |
Evaluate the science and develop specific options for Vitamins
A & D supplementation of dairy products. |
B |
1.13 |
1.13.6 |
In collaboration with FDA's Office of Regional Operations (ORO)
and FDA's Center for Veterinary Medicine (CVM), validate the method
to be used for the new National Drug Residue Milk compliance Program
(NDRMCP). |
B |
1.13 |
1.13.7 |
In conjunction with FDA's Center for Veterinary Medicine (CVM),
develop a statistically-based comprehensive national plan for the
monitoring of milk for the presence of animal drug residues. |
B |
1.13 |
1.13.8 |
Validate the test kits commercially available for the detection
of aflatoxin in milk. |
B |
Education
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
1.14 |
1.14.1 |
Consolidate CFSAN consumer education and outreach activities
to enhance efficiencies and coordination of public messages.
|
A |
1.14 |
1.14.2 |
Carry out a consumer education campaign on the safe handling
of produce.
|
A |
1.14 |
1.14.3 |
Develop new and promote existing food label education materials
particularly those pertaining to healthy weight management and
healthy lifestyles.
|
A |
1.14 |
1.14.4 |
Prepare and distribute "Moms to Be" educational program for
pregnant women to health care providers.
|
A |
1.14 |
1.14.5 |
Prepare and distribute "Moms to Be" educational program in
Spanish.
|
A |
1.14 |
1.14.6 |
Carry out a multicultural food safety initiative educational
program for pregnant women through Hispanic media and community-based
public health specialists in high density Spanish-speaking areas
on the risk of Listeria monocytogenes (Lm) in cheeses.
|
A |
Part II
Improving Nutrition and Dietary Supplement Safety
Contents
Nutrition, Health Claims and Labeling
Dietary Supplements
Priority Areas
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 Obesity Working Group 2 (OWG2),
chaired by the Director of CFSAN, to maintain the momentum of
the Obesity Working Group (OWG) and to make sure the objectives
in the "Calories Count" report are implemented and revised as
necessary on related issues such as:.
- Continuing involvement in Keystone Center-led national policy
dialogue initiative to address aspects of the obesity problem.
- Engaging and maintaining active dialogue on obesity issues
with interested stakeholders.
|
A |
2.1 |
2.1.1 |
b. Publish proposed rule for carbohydrate nutrient
content claims.
|
A |
2.1 |
2.1.1 |
c. Publish an Advance Notice of Proposed Rulemaking
(ANPRM) for the terms used in relation to carbohydrate content
of foods, e.g., "net" and "effective."
|
A |
2.1 |
2.1.1 |
d. Publish final rule on sodium provisions for
the implied nutrient content claim "healthy."
|
A |
2.1 |
2.1.1 |
e. Publish an Advance Notice of Proposed Rulemaking
(ANPRM) to solicit public comment on how to give more prominence
to calories on the food label, e.g., 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 |
f. Publish an Advance Notice of Proposed Rulemaking
(ANPRM) 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 |
g. Publish draft guidance on the evidence-based
ranking system for health claims and qualified health claims.
|
A |
2.1 |
2.1.1 |
h. Publish an Advance Notice of Proposed Rulemaking
(ANPRM) to solicit comments on updating Daily Values in
nutrition labeling.
|
A |
2.1.2 Enhance Consumer Health Information for Better
Nutrition |
2.1 |
2.1.2 |
a. Provide consumer studies research and economic
data to help develop principles for use of the word "net" in
relation to carbohydrate content.
|
A |
2.1 |
2.1.2 |
b. Review comments on the Advance Notice of Proposed
Rulemaking (ANPRM) and develop proposed rule to regulate
qualified health claims.
|
A |
2.1 |
2.1.2 |
c. Review comments received on the proposed rule providing
for more flexibility in the use of health/nutrient content claims
in response to citizens' petitions (Docket nos. 94P-0390 and 95P-0241). |
B |
2.1 |
2.1.2 |
d. Develop strategy to initiate rulemaking on claims for
whole grains. |
B |
2.1.3 Protecting and Promoting Public Health
with Agency Initiated Actions
|
2.1 |
2.1.3 |
a. Develop strategy to address claims and disclosure/footnote
statements on trans fat based on comments to July
11, 2003 Advance Notice of Proposed Rulemaking (ANPRM).
|
A |
2.1 |
2.1.3 |
b. Publish a proposed rule to amend 21 CFR 190.6
relative to description of new dietary ingredients.
|
A |
2.1 |
2.1.3 |
c. Publish proposed rule to revise, as appropriate,
existing regulation that requires irradiated food to be labeled.
|
A |
2.1.4 Improve Efficiency/Responsiveness
|
2.1 |
2.1.4 |
a. Develop a final rule to update nutrient
values for the voluntary nutrition labeling program. |
B |
2.1 |
2.1.4 |
b. Develop data collection instrument for the Food Label
and Package Survey (FLAPS). |
B |
2.1.5 Infant Formula and Medical Foods |
2.1 |
2.1.5 |
Publish a final rule for infant formula Good Manufacturing
Practice (GMP) and quality factors.
|
A |
Dietary Supplements
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
2.2.1 Protecting and Promoting Public Health with Agency Initiated
Actions |
2.2 |
2.2.1 |
a. Publish a final rule for dietary supplement
Good Manufacturing Practice (GMP).
|
A |
2.2.2 Improve Efficiency/Responsiveness
|
2.2 |
2.2.2 |
a. Hold a public meeting to address industry
submissions of 75-day pre-notifications for new dietary ingredients.
|
A |
2.2 |
2.2.2 |
b. Publish final rule on "per day" labeling for
dietary supplements.
|
A |
2.2 |
2.2.2 |
c. Develop strategy for the implementation of
the Dietary Supplement Health and Education Act of 1994 (DSHEA).
|
A |
Part III
Ensuring Food/Color Additive and Cosmetic Safety
Contents
Food and Color Additives: Premarket Review
Cosmetics
Priority Areas
Food and Color Additives: Premarket Review
|
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
3.1.1 Protecting and Promoting Public Health with Agency Initiated
Actions
|
3.1 |
3.1.1 |
a. Make available draft updated chemistry guidance
for recycled plastics.
|
A
|
3.1 |
3.1.1 |
b. Issue final guidance concerning the early food safety
evaluation of new plant proteins produced by bioengineered plants
intended for food use that may be present in the food supply,
but that have themselves not completed all regulatory steps for
marketing. |
A
|
3.1 |
3.1.1 |
c. Develop a proposed rule to adopt the specifications in
the most recent edition of the Food Chemicals Codex as appropriate. |
B
|
3.1 |
3.1.1 |
d. Develop a proposed rule to extend exclusion from Environmental
Assessments to additional categories of Agency action on food and
color additives. |
B
|
3.1 |
3.1.1 |
e. Develop a final rule to amend 21 CFR 178.1010, as a result
of the Food Quality Protection Act (FQPA), to accommodate partial
transfer of this regulation to the Environmental Protection Agency
(EPA). |
B |
3.1 |
3.1.1 |
f. Develop guidance for packaging used when irradiating
foods. |
B |
3.1.2 Improve Efficiency/Responsiveness |
3.1 |
3.1.2 |
a. Publish a draft Compliance Policy Guide (CPG)
for chloropropanols. |
A |
3.1 |
3.1.2 |
b. Develop a final rule for the GRAS Notification Program. |
B |
3.1 |
3.1.2 |
c. Develop final guidance on the use of antibiotic resistance
genes in bioengineered plant foods. |
B |
3.1
|
3.1.2 |
d. Develop E-guidance for the electronic submission of food
and color additive petitions. |
B
|
3.1 |
3.1.2 |
e. Develop E-guidance for the food contact substance notification
program. |
B |
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. Publish final Alpha Hydroxy Acids (AHA) guidance
on labeling of AHA-containing products.
|
A |
3.2 |
3.2.1 |
b. Develop Color Additive Lakes Preliminary Regulatory Impact
Analysis (PRIA) for public comment analysis of economic impact
of proposed rule for permanently listing color additive lakes. |
B |
3.2 |
3.2.1 |
c. Develop Color Additive Lakes final rule permanently listing
color additive lakes through FDA. |
B |
3.2 |
3.2.1 |
d. Support National Toxicology Program/National Center for
Toxicological Research (NTP/NCTR) photocarcinogenicity testing
of glycolic acid andsalicylic acid. |
B |
3.2.2 Improve Efficiency/Responsiveness
|
3.2 |
3.2.2 |
a. Develop a cosmetic labeling strategy for amending
21 CFR 701.3 (c)(2) concerning outdated sources for naming cosmetic
ingredients.
|
A |
3.2 |
3.2.2 |
b. Develop Cosmetic Handbook for Industry as Level 1 and
Level 2 guidance documents. |
B |
3.2.3 Enforcement/Compliance
|
3.2 |
3.2.3 |
a. Respond to citizen petition proposing that
FDA take immediate action to cease the unlawful distribution
of misbranded, adulterated, and unlabeled cosmetics (Docket No.
2004P-0266/CP 1). |
A
|
3.2
|
3.2.3 |
b. Develop draft guidance pertaining to 21 CFR section 740.10
warnings for products formulated with ingredients that lack adequate
safety substantiation. |
B
|
3.2 |
3.2.3 |
c. Perform preliminary investigations in the development
of test protocols to determine the safety of tattoo inks. |
B |
3.2 |
3.2.3 |
d. Develop a strategy for assessing potential public health
concerns associated with tattoo inks. |
B |
3.2 |
3.2.3 |
e. 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 |
3.2.3 |
f. Develop a proposed rule concerning the use of hormones
such as progesterone and pregnenolone in cosmetic products. |
B
|
3.2 |
3.2.3 |
g. In conjunction with the National Toxicology Program (NTP),
develop a protocol to assess absorption of titanium dioxide utilizing
nanotechnology. |
B
|
3.2 |
3.2.3 |
h. Conduct a human exposure estimate for selected phthalates
present in cosmetic products. |
B
|
3.2 |
3.2.3 |
i. Conduct annual internal control review of Color Certification
Program procedures. 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 CFSAN's
Office of Cosmetics and Colors Color Certification Program. |
B
|
Part IV
Ensuring
Food Safety: Crosscutting Areas
Contents
Science Base
International
Internal Processes
Focused, Economic-based Regulations
Management Initiatives
Science Base
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.1 |
4.1.1 |
Pilot the development of core competencies for scientific
and regulatory professionals in two CFSAN program offices.
|
A
|
4.1 |
4.1.2 |
Administer a task order to Association of Official Analytical
Chemists (AOAC) to conduct a "blue ribbon" scientific panel to
recommend the "best practices" for the validation of microbiological
methods.
|
A |
4.1 |
4.1.3 |
Prepare three risk profile documents: Hepatitis A virus, Norovirus,
and Listeria monocytogenes in produce.
|
A |
4.1 |
4.1.4 |
Conduct a program review of research on dietary supplements
and develop a strategic plan for research.
|
A |
4.1 |
4.1.5 |
Host a meeting of academic research institutions to discuss
CFSAN research needs and potential mechanisms for enhancing the
interaction of the Center with its academic partners.
|
A |
4.1 |
4.1.6 |
Collect consumer data on current infant feeding practices,
in conjunction with the Centers for Disease Control and Prevention
(CDC), FDA's Office of Women's Health, the National Institutes
of Health (NIH), and the Health Resources and Services Administration
(HRSA).
|
A |
4.1 |
4.1.7 |
Review social science research on connections between food
labeling and weight management.
|
A |
4.1 |
4.1.8 |
Implement a food safety intervention strategy to track progress
toward the attainment of the public health food safety goals.
|
A |
4.1
|
4.1.9 |
In conjunction with the CFSAN Adverse Events Reporting System (CAERS),
work with partners and their studies (Slone Epidemiology Survey, Behavioral
Risk Factor Study, and the National Emergency Injury Surveillance Study) to
collect and analyze adverse event data obtained from these studies.
|
A |
4.1 |
4.1.10 |
Implement cross-center training program for new hires using
a clinical and epidemiology training module based on real adverse
event data analyses from FDA.
|
A |
4.1 |
4.1.11 |
Increase consumer knowledge by 40% for trans fat, by
10% for saturated fat, and by 10% for omega-3 fatty acids based
on the completion of the Food Safety Survey in FY 2004 and 2007.
|
A |
4.1 |
4.1.12 |
Develop a white paper for the foods and food technology Critical
Path Initiative.
|
A |
4.1 |
4.1.13 |
Improve CFSAN's workplanning process so that it includes incorporation
of risk-based priorities, best practices, and development of
a multi-factorial risk model for both domestic and import operations.
|
A |
4.1 |
4.1.14 |
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 |
4.1 |
4.1.15 |
Provide risk analysis training and education to CFSAN staff and
managers. |
B |
4.1 |
4.1.16 |
Expand the microbiological proficiency testing program in support
of the Food Emergency Response Network (FERN) and the Laboratory
Response Network (LRN). |
B |
International
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.2 |
4.2.1 |
Coordinate the FDA review (scientific and technical analysis)
of proposed foreign Sanitary and Phytosanitary (SPS) measures
notified to World Trade Organization (WTO) under the SPS Agreement. |
A |
4.2 |
4.2.2 |
In accordance with Association of Food and Drug Officials'
(AFDO) charge for 2004-2005, chair working group composed of
industry, states and federal agencies to:
- Harmonize state export certificates
- Encourage at least 80% of the states to develop
export certificate websites
- Test harmonized export certificates with other
country governments
- Request information on export certificate requirements
of importing countries through FAS foreign agriculture
posts
- Complete work to enable U.S. export
certificate website to go "live".
|
A |
4.2 |
4.2.3 |
Collaborate with USDA to develop a combined database ("metadatabase")
to include all U.S. federal international technical
assistance activities, to be accessible to all participating
federal agencies. |
A |
4.2 |
4.2.4 |
Prepare final FDA report on comparability of North American and
European shellfish programs. |
B |
Internal Processes
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.3 |
4.3.1 |
Consolidate CFSAN rulewriting function within the Office of
Regulations and Policy of the Center for Food Safety and Applied
Nutrition. |
A
|
4.3 |
4.3.2 |
Institute an outreach program that will inform regulatory
authorities and industry of the requirements of the Low Acid
Canned Food/Acidified Food (LACF/AF) regulations. |
A |
4.3 |
4.3.3 |
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
hazards within versus outside of a firm's control; addressing
risk estimate and characterization of the hazard(s); and determining
the consequences to the public health as a result of agency action
vs. inaction). |
A |
4.3 |
4.3.4 |
Finalize the CFSAN evaluation procedure under the Agency's
risk management umbrella targeting specific problem areas such
as dietary supplements, sprouts and "for cause" firms, including
firms with recall problems. |
A |
4.3 |
4.3.5 |
Publish proposed rule/direct rule to revise 21 CFR 113.40
to permit use of alternative temperature-indicating devices,
as well as mercury-in-glass thermometers. |
A |
4.3 |
4.3.6 |
Modify selected CFSAN Compliance Programs, EIR formats and
the IOM so that during domestic inspections investigators examine,
report, and track counterfeit imported products, returns of imported
products, rejected imported products, and complaint files concerning
imported products. |
A |
Focused, Economic-based Regulations
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.4 |
4.4.1 |
Publish proposed rule on general principles for standards
of identity in collaboration with USDA.
|
A |
4.4 |
4.4.2 |
Publish proposed rule to amend definition of "milk" in cheese
standards (21 CFR 133) to provide for use of fluid ultra-filtered
milk.
|
A |
4.4 |
4.4.3 |
Publish an Advance Notice of Proposed Rulemaking (ANPRM) to
seek comments on amending standards of identity for parmesan
cheese (21 CFR 165) and frozen desserts (21 CFR 135).
|
A |
4.4 |
4.4.4 |
Develop proposed rule to amend the standard of identity for yogurt. |
B |
Management Initiatives
Strategy |
Sub Strategy |
Goal Description |
Priority Level |
4.5 |
4.5.1 |
Complete the FY 2005 zero based budget process which
includes identifying priority funding needs and all essential
costs associated with the foods program and continue an on-going
review throughout the year.
|
A |
4.5 |
4.5.2 |
Complete CFSAN's radioactive and chemical decommissioning efforts
in Federal Building 8. |
A |
4.5 |
4.5.3 |
Complete the occupancy of CFSAN's adjunct building: University
Station, ensuring that all systems and laboratories are fully functional. |
A |
4.5 |
4.5.4 |
Implement 1st year phase of the CFSAN Leadership
Legacy Initiative across the Center.
|
A |
4.5 |
4.5.5 |
Provide training and other educational and developmental offerings
to clerical and administrative support staff to prepare them
for changes in work functions associated with the ongoing A-76
process.
|
A |
Part V
Priority Ongoing Activities
Food Defense: Emergency Preparedness
- Complete the annual food defense section of the FDA counterterrorism
research report to Congress.
- Continue to conduct intramural and extramural research to determine
threat agent characteristics in foods.
- Continue to conduct intramural and extramural research to determine
threat agent dose response in humans.
- Continue to conduct intramural and extramural research to determine
threat agent prevention strategies.
- Continue interagency microbial forensics research efforts with
the Department of Homeland Security.
- Establish laboratory proficiency by providing testing samples
to the Food Emergency Response Network (FERN) food testing laboratories
to evaluate
analyst proficiency in testing for biological agents of food defense
and safety concern.
- Participate in emergency response exercises.
- Continue to support the establishment of Food Emergency Response
Network (FERN) and enhance the interface between FDA and the Nationwide
Laboratory Response Network (LRN) and utilize e-Lexnet for data exchange.
Food Safety/Outbreaks Response:
- Rapidly respond to emergency/outbreaks and issues and contact
stakeholders as needed.
- Continue to utilize CDC PulseNet in outbreak investigations.
Domestic Inspections:
- In conjunction with ORA, inspect 95% of estimated 7,200 high-risk
domestic establishments.
- Continue to evaluate results of "high-risk" plant and dairy food inspections.
Make recommendations on whether the program is accomplishing its objective
and identify where and how the program needs to be improved.
Foreign Inspections:
- In conjunction with ORA (contingent upon resources), conduct an estimated
255 foreign inspections.
- In conjunction with ORA, perform 60,000 physical exams and conduct
sample analyses on products with suspect histories.
- In conjunction with ORA, complete the evaluation and classification
of foreign firms inspections.
Seafood Safety:
- Continue to work with the ISSC to implement a control strategy for Vibrio
vulnificus in raw oysters.
- Continue to revise as appropriate existing guidance on proper on-board
handling of seafood to the fishing industry that harvests scombroid species,
and provide ongoing educational programs for the seafood industry.
- Continue to evaluate seafood industry Hazard Assessment Critical Control
Point (HACCP) performance.
- Continue to develop and maintain seafood case precedent system to
capture those unique aspects of cases that amplify or clarify policy regarding
hazards
or controls.
- Implement the second year of a three year extramural research project
on: (a) whether there are types of Modified Atmosphere Packaging (MAP)
that are not likely to produce a hazard, depending upon how permeable they
are
to oxygen; and (b) whether there are qualities of the fish, e.g., fat content,
that make a species more or less likely to form toxin in MAP.
- Continue to consolidate and array all data on chemical contaminants
in seafood.
- Continue to review Fish Naming Criteria and update as necessary.
Fresh Fruits and Vegetables:
- Begin implementation of the Produce Safety Action Plan.
- Collect and analyze produce samples in collaboration with ORA.
- Work with relevant trade association s to develop GAPs and GMPs for
selected commodities,such as tomatoes, cantaloupes, and green onions.
- Continue to conduct international Good Agricultural Practices (GAP)
outreach in conjunction with the Joint Institute for Food Safety and Applied
Nutrition (JIFSAN).
Listeria:
- Work with the states to reduce the production and sale of unlawful raw
milk cheeses.
Cooperative Programs
- Continue to increase the adoption of the Food code within the U.S.
and its Terroritories.
- Through the FDA National Steering Committees for Grade A Milk and Molluscan
Shellfish, develop strategic goals for a risk-based focus for the benefit
of the National Program and our regulatory partners.
- Maintain up-to-date science-based information in the Pasteurized Milk
Ordinance through the efforts of the 2005 National Conference of Interstate
Milk Shippers (NCIMS) and effect implementation of the provisions nationwide.
- Maintain up-to-date science-based information in the Interstate Sanitation
Shellfish Conference (ISSC) Model Ordinance through the efforts of
the ISSC Conferences and effect implementation of the provisions nationwide.
Chemical Contaminants, Pesticides and Other Hazards
- In conjunction with ORA, continue to analyze selected Total Diet Study
samples and to collect and analyze selected samples for acrylamide.
- In conjunction with ORA, continue to collect and analyze 8,000 food samples
for pesticides and chemical contaminants.
- Continue implementation of acrylamide action plan.
- Continue implementing FDA's dioxin and Polychlorinated Biphenyl (PCB)
strategy, including monitoring, methods development, identifying opportunities
to reduce exposure.
- Develop for the Internet the FDA Pesticide Monitoring data and summary
information as required by the Pesticide Monitoring Improvement Act
(PMIA).
- In conjunction with ORA, continue to collect and analyze samples of honey
and seafood for the presence of chloramphenicol.
Food Allergens:
- Continue consumer and industry outreach for food allergens.
- Evaluate data from food allergen inspections.
Education:
- Continue to respond to consumer inquires via the hotline (1-888-SAFEFOOD).
- Continue education campaign for at-risk populations about methylmercury
in fish and shellfish.
- Enhance consumer awareness about FDA food safety advice through media
placements and exhibits.
- Continue to enhance consumer awareness about FDA food safety advice through
Spanish language media placements.
- Continue to distribute food safety educational materials in Spanish at
health fairs targeting major Hispanic populations.
- Continue to distribute brochures in Spanish on the safe handling of produce.
Preventing Obesity through Better Nutrition:
- Conduct additional research to develop "Calories Count" measures.
Enhance Consumer Health Information for Better Nutrition:
- Conduct enforcement activities related to violative labeling of conventional
foods.
Infant Formula:
- Continue to review premarket notifications for new infant formulas within
statutory timeframe.
Review of Health Claims:
- Continue to review nutrient content/health claim notifications and petitions
within statutory timeframes.
Dietary Supplements:
- Continue to review premarket (75-day) notifications for new dietary ingredients
within statutory timeframe.
- Continue to review 30-day postmarket notifications for supplement claims
in a timely manner.
- Continue to develop educational materials that provide plain language
information on dietary supplements to improve public understanding
of these products.
- Continue to identify dietary supplement ingredients/products that raise
safety problems, and take appropriate enforcement action.
- Continue efforts, in conjunction with the Federal Trade Commission, to
take action against unsubstantiated claims on dietary supplements.
Food and Color Additives: Premarket Review
- Continue to review food and color additive petitions within the established
time frame.
- Continue to review biotechnology final consultations within the established
time frame.
- Continue to review GRAS notifications (GRNs) within the established time
frame.
- Continue to review premarket notifications for food contact substances
within the established time frame.
- Continue CFSAN Bio-research monitoring program (GLP inspections).
- Continue monitoring the use of bromates in baked goods. (formerly 3.1.2.h)
- Continue enforcement activity for dietary supplement type ingredients
in conventional foods whose use is neither approved under section 409
nor generally recognized as safe.
- Continue applied research to develop analytical methodology for monitoring
and enforcement of food additive regulations.
- Continue to develop and validate analytical methods for detecting and
quantifying substances in dietary supplements and conventional foods.
- Continue to develop and expand The Food Additive Regulatory Management
(FARM) System to provide external stakeholder access to the electronic
submission process and to increase internal reviewer's access to data
to expedite the review process.
Cosmetics
- Continue to analyze all batches of color additives and determine certification
status (certify or refuse to certify) within an average of 5 working days.
Science Base
- The Human Subjects Protection Committee (HSPC) and the Research Involving
Human Subjects Committee (RIHSC) Liaison Committee will continue
oversight for all CFSAN investigators conducting research involving human
subjects. HSPC
and RIHSC Liaison standard operating procedures are currently in
place and are being implemented by CFSAN.
- Continue to update and enhance the Bacteriological Analytical Manual
(BAM), including validation of the BAM methods.
- Continue to collect and evaluate data for the annual Food Safety Survey.
- Provide training and educational offerings to increase the Center's emergency
preparedness and enhance emergency response, particularly in the
area of food defense: scientific and laboratory-based courses, emergency
response exercises, emergency preparedness and continuity of operations,
regulations
and guidance.
- Continue to enhance and conduct training and education program for supervisors
and team leaders.
- Continue to support, facilitate and coordinate the establishment and/or
enhancement of academic partnerships including existing Centers of
Excellence [National Center for Food Safety and Technology (NCFST), the
Joint Institute
for Food Safety and Applied Nutrition (JIFSAN), the National Center
for Natural Products Research (NCNPR)] and future partners.
- Continue to conduct research to develop new analytical methods or investigate
know analytical methods for detecting and identifying microbial pathogens,
chemical contaminants, and toxins in foods and cosmetics that can be
potentially harmful to the public health.
International
- Continue FDA leadership in Codex. Ensure adequate participation in Codex
committees, ad-hoc task forces, and working groups meeting in FY 2005 that
are of relevance to FDA/CFSAN.
- Codex Alimentarius Commission
- General Principles (2 meetings
- Food Hygiene
- Food Additives and Contaminants
- Food Import and Export Inspection and Certification Systems
- Nutrition and Foods for Special Dietary Uses
- Methods of Analysis and Sampling
- Food Labeling
- Pesticide Residues
|
- North America and the Southwest Pacific
- Fish and Fishery Products
- Fats and Oils
- Foods Derived from Modern Biotechnology (work comprises involvement
to re-establish Task Force and determine new work items).
- Juice and Juice Products
- Milk and Milk Products
|
- Continue to represent FDA in U.S. Delegations to committees involved
in implementing and interpreting existing trade agreements on sanitary
and phytosanitary measures (e.g., World Trade Organization (WTO), Sanitary
and Phytosanitary (SPS) Agreement, and Central American Free Trade
Agreement (CAFTA), U.S./Chile SPS Agreement).
- Continue to represent FDA in multilateral and bilateral negotiations
on the SPS sections of trade agreements (e.g., Andean countries, Thailand).
- Continue to notify World Trade Organization (WTO), Sanitary and Phytosanitary
(SPS) and Technical Barriers to Trade (TBT) Committees, through U.S.
contact points, of all FDA proposed rules affecting trade of food and cosmetics,
in accordance with WTO obligations on transparency.
- Continue to issue Certificates for Export to U.S. food and cosmetic producers
and exporters as necessary to satisfy the requests of foreign governments
for U.S. attestation that the particular products are produced and
marketed in the United States in general conformity with U.S. requirements.
Internal Processes
- Continue to provide mathematical and statistical support to high priority
initiatives and regulations.
- Continue to review and revise the CFSAN Adverse Events Reporting Systems
(CAERS) to better track adverse events for CFSAN-regulated products.
- Continue cooperative research agreement between CFSAN/FDA and University
of Mississippi's National Center for Natural Products Research (NCNPR).
- Continue to conduct outreach activities to both internal FDA and external
stakeholders to provide information access and training by maintaining,
modifying, and/or expanding CFSAN's Office of Compliance intranet web
site to further strengthen its usefulness as a primary source of assistance
and information for field stakeholders operating on behalf of the Center
for Food Safety and Applied Nutrition.
- Continue to expand Low Acid Canned Food (LACF) and Acidified Food (AF)
web-based firm registration and process filing to the rest of domestic
firms and initiate roll-out of the web-based system for foreign firms.
- Provide additional training to CFSAN staff and managers on protection
of human subjects in research.
- Continue to enhance the Interstate Travel Program (ITP).
- Continue to issue Temporary Marketing Permits (TMP) for the interstate
shipment of experimental packs of food varying from requirements
of standards of identity, in accordance with 21 CFR 130.17.
- In conjunction with the FDA Office of Regulatory Affairs (ORA), continue
to develop and deliver State and Federal (web based) curricula for:
- Certification of Cooperative Programs Specialists and state and
local regulators.
- Low Acid Canned Foods (LACF) leveraging activities.
- Listeria control implementation for manufacturers and retail/food
service operators
- Food Allergen control strategies.
- National Conference on Interstate Milk Shipments (NCIMS) Grade "A" voluntary
HACCP alternative to the traditional Grade "A" regulatory system for
state regulatory agencies.
Management Initiatives
- Continue to develop and refine, 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.
- Continue implementation of initiatives associated with the President's
Management Agenda within the 5 core areas identified in the Agenda.
- Continue to work with National Treasury Employees Union (NTEU)
and the Cooperation Committee to fully implement the NTEU Collective
Bargaining Agreement.
- Continue focus group research and interviews to support the CFSAN Leadership
Legacy Training Program.