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August 18, 2005
CFSAN 2005 Program Priorities
Accomplishments through June 2005
Letter from Center Director
Status Report. FY 2005, Through June 2005. Accomplished
(summary list).
Enclosure 1. Program Priorities and Accomplishments,
FY 2005, Through June 2005.
Enclosure 2. New Program Prioities, FY 2005.
Enclosure 3. Program Priority Modifications, FY
2005.
Enclosure 4. "Carryovers," Program Priorities,
FY 2005.
August 2005
Dear Colleague, FDA Foods Community:
I am pleased to report to you on the progress we are making
towards implementing CFSAN's FY 2005 Program
Priorities. We have made significant progress toward achieving our goal of
completing at least 90% of our "A-list" items by the end of the fiscal
year.
First, I would like to highlight
some of areas that we have accomplished thus far. As you know, since the
events of September 11, 2001, food safety and defense has remained a central
theme in the Administration's health agenda and CFSAN's workplan continues
to reflect
its commitment. On December 9, 2004, we published the "Maintenance of
Records" regulation implementing the third of the four provisions under the
Public Health Security and Bioterrorism Act of 2002 (the BT Act).
In our continued commitment to address the Nation's
obesity problem, we re-established the Obesity Working Group appropriately named
the "Obesity Working Group 2 (OWG 2)." Its goal is to implement
recommendations of the "Calories Count" Report prepared in FY 2004
by OWG 1.
In
the Dietary Supplement arena, we have developed a strategy to further implement
provisions of the Dietary Supplement Health and Education Act of 1994 as
outlined in FDA's Dietary Supplement Strategic Ten Year Plan.
Although FY 2005 has been a year of diminished resources, we continue to strive
to meet our projected goals. I also call your attention to the substantial
international leadership role that our Center's scientists have played in Codex
and other major global activities. We continue to make significant progress on
a broad range of our priority "ongoing:" activities such as domestic and
foreign
inspections, food safety/outbreak response, food defense-emergency
preparedness, food and color additive petition review, cosmetics and more.
About this "Progress Report:"
Enclosure #1: This workplan began with a total
of 123 "A-list" goals, and through June 30, we have completed 45 of these
A-list goals. Brief descriptions of these accomplishments are listed in enclosure
#1 of this document.
Enclosure #2: We are often tasked with responding
to unanticipated issues emerging throughout the year. This section (enclosure
#2)
lists "new" priority issues requiring CFSAN’s attention that
surfaced after publication of the FY 2005 Program Priorities Document.
Enclosure #3: Sometimes we have to revise goals
based on new information that we receive on the issue after publication of
the Program
Priorities Document. This section shows any modifications to goals to
accurately reflect our desired outcome.
Enclosure #4: We moved a number of A-list goals
to the B-list to give us the space we need to address and respond to the unanticipated
work affecting resources initially devoted to accomplishing our FY 2005 Program
Priorities. This section lists the A-list goals that we moved to the B-list.
In summary, we added eleven "new" A-list goals.
As a result of new information and emerging issues occurring after publication
of the FY 2005 Program Priorities Document, and resource availability, we moved
twenty-three goals from the A-list to the B-list bringing in our new total
of A-list goals to 111, to complete by the end of the year. Our overall goal
continues to be to complete at least 90% of the "A" List priorities by the
end of the fiscal year, September 30, 2005. So far we have completed 45 (41%)
of our program priority goals as of June 2005.
In closing, I believe we
are making excellent progress on our 2005 program priorities. I will provide
you with a final "Report Card" on our accomplishments in the fall. I welcome
any feedback you may have.
I thank all of you for your
continued support of FDA's foods program.
Sincerely,
Robert E. Brackett, Ph. D.
Director
Center for Food Safety and Applied Nutrition
Enclosures
FY 2005 Program Priority Status Report
Through June 2005
Accomplished
- Issued a Final Rule for the Maintenance of Records.
- Published Small Entities Compliance Guide for Maintenance of Records.
- Published Guidance for Administrative Detention.
- Completed Seafood HACCP Program Evaluation.
- Responded to the Environmental Working Group Petition on FDA's Methylmercury
Advisory.
- Published Proposed Rule for "in-lid" Labeling for Eggs.
- Held Public Meetings on the Proposed Egg Safety Rule.
- Convened Public Meeting on Sprout Safety.
- Published Guidance on Enforcement Discretion for Ozonation of Juice.
- Assisted California Department of Health Services in Producing a Video
on Safe Juice Processing.
- Submitted to Congress the NACMCF Report on Refrigerated Ready-to-Eat
Foods.
- Published Results of the 2003 Survey of Foodborne Illness Risk Factors
in Retail Food Establishment.
- Published Expanded Exploratory Data on Acrylamide in Foods.
- Published Dioxin Analysis Results/Exposure Estimates.
- Published Expanded Exploratory Data on Furan in Food.
- Issued Perchlorate Survey.
- Published Proposed Rule for Arsenic in Bottled Water.
- Published Final Rule for Arsenic in Bottled Water.
- Published Final Generic "Channels of Trade" Guidance.
- Conducted Workshop on Exposure Assessment Methodologies of Food-borne
Chemicals.
- Published "Approaches to Establish Thresholds for Major Food Allergens
and Gluten in Foods" Report.
- Published Final Updated Federal Imported Milk Act CPG.
- Consolidated Consumer Education and Outreach Activities in CFSAN.
- Conducted Multicultural Listeria monocytogenes Food Safety Educational
Program.
- Established Obesity Working Group 2.
- Participated in the Keystone Forum.
- Published an ANPRM on Prominence of Calories on the Food Label.
- Published an ANPRM on Single Serving Size.
- Disseminated Public Information on the "2005 Dietary Guidelines for Americans."
- Held Public Meeting on 75-day Pre-notifications for New Dietary Ingredients.
- Developed a Strategy for Implementing DSHEA.
- Published Dietary Supplement Labeling Guidance for Industry.
- Published Final Guidance on AHA Labeling.
- Reviewed Social Science Research on Food Labeling and Weight Management.
- Conducted Cross-center Training on Adverse Event Management.
- Increased Consumer Knowledge for Trans fat, Saturated Fat, and Omega-3 Fatty Acids.
- Coordinated the FDA Review of Proposed SPS Measures.
- Chaired AFDO Export Certificates Working Group.
- Developed Database to Include All U.S. Federal International Technical Assistance Activities.
- Consolidated CFSAN Rulewriting Function.
- Published Proposed Rule on General Principles for Standards of Identity.
- Completed the FY 2005 Zero-based Budget Process.
- Completed CFSAN's Radioactive and Chemical Decommissioning Efforts in FB-8.
- Completed Occupancy of CFSAN's Adjunct Building: University Station.
- Implemented 1st Year Phase of the CFSAN Leadership Legacy Initiative.
Enclosure 1
FY 2005 Program Priorities
Accomplishments through June 2005
Food Security: Implementing New Legislation
- Publication of the Establishment and Maintenance of Records Final Rule:
On December 9, 2004, published in the Federal Register (69 FR 71561)
a final regulation entitled: "Establishment
and Maintenance of Records Under the Public Health Security and Bioterrorism
Preparedness and Response Act of
2002."
The final regulation
requires the establishment and maintenance of records by persons
who manufacture, process, pack, transport, distribute, receive, hold, or import
food
in the United States.
Final Rule on Establishment and Maintenance of Records (69 FR 71561)
- Establishment and Maintenance of Records Small Entity
Compliance Guide: Published a Small Entity Compliance Guide
as a booklet entitled: "What
You Need to Know About Establishment and Maintenance of Records".
This booklet informs domestic persons in the
U.S. who manufacture, process, pack, transport, distribute, receive, hold
or import food for humans or animals, and foreign
persons who transport food in the U.S., about a final regualtion
that establishes requirements regarding the establishment and maintenance of
records.
Spanish and French versions were published in May 2005.
What
You Need to Know About Establishment and Maintenance of Records (available
in PDF)
- Administrative Detention Guidance to Industry: Published guidance
entitled: "What
You Need to Know
About Administrative Detention of Foods ".
This guidance informs food manufacturers, processors, packers, transporters,
importers and exporters about expedited procedures for perishable foods as well
as procedures
describing how FDA will detain an article of food and the process for
appealing a detention order.
What You Need to Know
About Administrative Detention of Foods (available
in PDF, 305 Kb)
Seafood Safety
- Seafood HACCP: Completed an evaluation of program performance through
the sixth year, with an emphasis on
identifying factors that may be inhibiting improvements in compliance rates.
Based on FDA's historical compliance classification system, approximately
91% of firms were in compliance through the sixth year of the Seafood HACCP
Program. This is a significant increase over the 85% compliance rate of 2001. FDA
intends to continue to prioritize all manufacturers of high risk fishery products,
particularly processors of scombroid species and cooked ready-to-eat products,
for annual inspection and to complete an evaluation of firms that need a HACCP
plan but still do not have one and determine what follow up action is needed
to ensure compliance on this issue.
- Environmental Working Group Information Quality Appeal: In May 2005,
responded to the Environmental Working Group's (EWG) appeal to their Information
Quality Act Request for Correction of the FDA Seafood Advisory Entitled: "What
You Need to Know About Mercury in Fish and Shellfish."
Egg Safety Action Plan
- Egg Safety - In-lid Labeling: On May 5, 2005, published in the Federal
Register (70 FR 23813) a
proposed rule entitled: "Food
Labeling:
Safe Handling Statements: Labeling of Shell Eggs." This notice proposes
to amend the Agency's food labeling regulations to permit the egg industry to
place the safe handling statement for shell eggs on the inside lid of egg
cartons if the statement "Keep Refrigerated" appears on the principal display
panel (PDP) or information panel.
Federal
Register (70 FR 23813)
- Egg Safety Public Meetings: On September 22, 2004, published in the Federal
Register (69 FR 56823) a proposed rule for egg safety national standards.
To solicit public comment on the proposed rule, FDA held three public meetings.
These
meetings were held on October 28, 2004, College Park, MD; November 9, 2004,
Chicago IL and November 16, 2004, Los Angeles CA.
A transcript of the proceedings
from these public meetings, as well as all information and data submitted
voluntarily to FDA during the public meetings, will become part of the
administrative record.
Egg Safety
Fruits and Vegetables
- Public Meeting on Sprout Safety: On May 17, 2005, FDA held a public
meeting to elicit information on the current science related
to foodborne illness associated with the consumption of sprouts. In October
2004, FDA released a produce safety
action plan entitled "Produce Safety from Production to Consumption: 2004
Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption"
(Produce Action Plan). One item in the Produce Action Plan is to initiate
rulemaking to minimize foodborne illness associated with the consumption of
sprouted seeds.
Sprout Safety Public Meeting
- Guidance on Enforcement Discretion for Ozonation of Juice: Issued
guidance for industry entitled "Recommendations to Processors of Apple Juice or Cider on the
Use of Ozone for Pathogen Reduction Purposes." This guidance addresses the use of ozone to
treat apple juice to meet the pathogen reduction requirements of 21 CFR Part
120 "Hazard Analysis and Critical Control Point (HACCP) Systems" (the juice HACCP
regulation) and 21 CFR 101.17(g) "Juices that have not been specifically processed to
prevent, reduce, or eliminate the presence of pathogens" (the juice labeling regulation).
The guidance notes that FDA is currently unaware of any validated treatments for juice using
ozone.
Recommendations to Processors of Apple Juice or
Cider on the Use of Ozone for Pathogen Reduction Purposes
- Safe Juice Processing Video: In November 2004, FDA/CFSAN provided
technical assistance to the California Department of Health Services, Food
and Drug Branch, in cooperation with the Centers
for Disease Control & Prevention, university researchers, and industry representatives,
in the development of an educational video to assist the industry in producing
safer juice.
Safer Processing of Juice video
Listeria
- NACMCF Report on Ready-to-Eat Foods: House Report 108-193 of the Agriculture
Rural Development, Food and Drug Administration and Related Agencies 2004 Appropriations
Language directed FDA to provide the Appropriations Committee a copy of the
report by the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF) advising on the necessary scientific parameters for establishing safety-based
us-by-date labels for refrigerated ready-to-eat foods to help reduce the incidence
of foodborne listeriosis.
National
Advisory Committee on Microbiological Criteria for Foods (NACMCF) (available
in PDF,
313 Kb)
Cooperative Programs
- 2003 Survey of
Foodborne Illness Risk Factors in (retail-level) Food Establishments:
The report of the results of the 2003 data collection of foodborne
illness risk
factors in retail-level food establishments was released on September 14, 2004 via CFSAN web posting.
Q&A's related to the report were also developed and made
available in January 2005 and serve to provide the reader with a better
understanding of the
report
and its contents.
FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)
Chemical Contaminants, Pesticides and Other Hazards
- Acrylamide in Food: In June 2005, published on the CFSAN Website expanded
exploratory data on acrylamide in food. This is part of FDA’s continued
efforts to investigate how acrylamide is formed in food, seek to identify ways
to reduce acrylamide levels, and study the human health risk of consuming acrylamide
in food.
Exploratory data on acrylamide in Food
- Dioxin Analysis Results/Exposure Estimates: In June 2005, published
on the CFSAN Web site "FDA
Analysis of Food and Feed for Dioxin-like Compounds (DLC)." This
analysis was completed as part of specific goals for FDA's Dioxin Monitoring
Program to obtain baseline data for DLC levels in food and animal
feed ingredients susceptible to DLC contamination and to determine opportunities
for DLC reduction by identifying contamination sources that can be eliminated
or significantly reduced.
Dioxin Analysis Results/Exposure Estimates
- Furan in Food: In June 2005, published on the CFSAN Web site expanded
exploratory data on furan in food. FDA is now posting furan data that were collected through November 18, 2004. Data are presented in chronological order with data collected between June 10, 2004 and November 18, 2004. FDA is presenting these data to inform the public of FDA's progress and to help stimulate research into the formation of furan in food. The results reflect furan levels detected in samples of individual food products.
Exploratory Data on Furan in Food
Data through November 18, 2004
- Survey of Foods for Perchlorate:
In February 2005, in conjunction with FDA's Office of Regulatory Affairs
(ORA), issued an expanded survey assignment to determine perchlorate levels in
450 samples of various domestic and imported foods. The first phase of the assignment
called for collection and analysis of 240 food samples that include fresh fruits
and vegetables, fruit juices, and grain products. The second phase of the assignment
called for collection and analysis of additional samples of fresh fruits and
vegetables, fruit juices, and grain products and seafood.
- Proposed Rule for Arsenic in Bottled Water: On December 2, 2004,
published in the Federal Register (69 FR 70082) a proposed rule to amend FDA's
bottled water quality standard regulations by revising the existing allowable
level for the contaminant arsenic. This notice proposes to ensure that the
minimum quality of bottled water, as affected by arsenic, remains comparable
with the quality of public drinking water that meets the Environmental Protection
Agency's (EPA's) standards.
Federal Register (69 FR 70082)
- Final Rule for Arsenic in Bottled Water: On June 9, 2005, published in the Federal Register (70 FR 33694) a final regulation for arsenic levels in bottled water. The final regulation requires manufacturers to monitor their finished bottled water products for arsenic at least once each year and to monitor their source water for arsenic as often as necessary, but at least once every year.
Federal Register (70 FR 33694)
- Final Generic "Channels of Trade" Guidance: On May 18
2005, published in the Federal Register (70 FR 28544) guidance for
industry entitled "Channels of Trade Policy for Commodities with Residues
of Pesticide Chemicals for which Tolerances have been Revoked, Suspended,
or Modified by the Environmental Protection Agency Pursuant to Dietary Risk
Considerations." This guidance
presents FDA's general policy for implementing the channels of trade provision
in the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996, for food containing residues of pesticide chemicals,
for which tolerances have been revoked, suspended, or modified pursuant to
dietary risk considerations.
Channels of Trade Policy for Commodities with Residues
of Pesticide Chemicals for which Tolerances have been Revoked, Suspended,
or Modified by the Environmental Protection Agency Pursuant to Dietary Risk
Considerations
- Foodborne Chemicals Workshop: On May 2-6, 2005, CFSAN, in conjunction with JIFSAN, co-sponsored a workshop, in Annapolis, Maryland, on methodologies for assessing and estimating exposure of food-borne chemicals. The workshop was convened to update the principles and practices of exposure assessment for chemicals in food. The end product of the workshop was a draft report that will undergo further revisions and then publish under the auspices of the WHO/FAO.
Food Allergens
- Approaches to Establish Thresholds for Major Food Allergens and for Gluten
in Food: On June 17, 2005, announced in the Federal
Register (70 FR 35258) the availability of a draft report entitled:
" Approaches to Establish Thresholds for Major Food Allergens and for
Gluten in Food."
The draft report, prepared by an interdisciplinary group of scientists
from CFSAN, was prepared to facilitate the further development of CFSAN's
policy for food allergens, including the Center's implementation of the
Food Allergen labeling and Consumer Protection Act of 2004 (FALCPA).
Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food
Dairy Safety
- Federal Imported Milk Act CPG: On April 13, 2005, announced in the
Federal Register (70 FR 19489) the availability of a compliance
policy guide entitled: "Sec.
560.400 - Imported Milk and Cream - Federal
Import Milk Act (CPG 7119.05)." The CPG provides guidance on the applicability
of the Federal Import Milk Act (FIMA) to imported milk and cream.
Sec.
560.400 - Imported Milk and Cream - Federal
Import Milk Act (CPG 7119.05)
Education
- Consolidation of CFSAN's Consumer and Outreach Activities:
On January 14, 2005, CFSAN announced the formation of the new Office of Food
Safety, Defense, and Outreach (OFSDO), which consolidates the Center's
outreach and education activities. OFSDO now serves as the overall Center lead
responsible for coordinating, developing, and delivering high-quality outreach
and education products to our stakeholders (e.g., consumers, industry, health
professionals, and other regulatory authorities). This organizational change
is designed to improve the quality, quantity, and timeliness of CFSAN outreach
and education.
CFSAN announced the formation of the new Office of Food
Safety, Defense, and Outreach (OFSDO)
- Listeria Education Program: In FY2005, CFSAN
carried out 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 in cheeses.
Nutrition Health Claims and Labeling
- Establish FDA's Obesity Working Group (OWG2): Established the Obesity
Working Group 2 to carryout the short-term and long-term recommendations for
dealing with the Nation's obesity problem set forth by OWG 1 in FY 2004.
A detailed matrix of the status of the OWG 1 Report recommendations has been
maintained and updated periodically and shared with appropriate CFSAN staff
and FDA senior management.
- Keystone Forum: Participated, along with representatives
of academia, industry and government, in the first plenary session of the "Keystone
Forum on Away-From Home Foods: Opportunities for Preventing Weight Gain and
Obesity " on April 26-27, 2005 in Washington, D.C. The
2-day forum session focused on building a shared understanding of the market
and nutritional aspects of away-from-home foods, as well as opportunities
to begin to identify potential avenues for action.
The next meeting of the Keystone
Forum was scheduled for July 21-22, 2005, and it focused on aspects of
consumer behavior, consumer-oriented nutrition information, nutrition
education, and marketing communication (commercial and social).
- Prominence of Calories: On April 4, 2005, published in the
Federal Register (70 FR 17008) an
advance notice of proposed rulemaking (ANPRM) entitled "Food
Labeling: Prominence of Calories." The purpose of the ANPRM is to request comment
on whether to amend certain provisions of the Agency's nutrition labeling regulations
to give more prominence to calories on
food labels. The ANPRM was issued response to recommendations of the
Obesity Working Group 1 (OWG 1), which was created by the Commissioner of Food
and Drugs to develop an action plan to address the Nation's obesity problems.
Federal Register (70 FR 17008)
- Serving Size: On April 4, 2005, published in the Federal Resister
(70 FR 17010) an
advance notice of proposed rulemaking (ANPRM) entitled: "Food Labeling:
Serving Sizes of Products that can Reasonably be Consumed At One Eating
Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for
Recommending Smaller Portion Sizes." The purpose of the ANPRM is to request
comment on whether to amend certain provisions of the Agency's nutrition labeling
regulations
concerning serving size. FDA is
issuing this ANPRM in response to recommendations of the Obesity Working Group
1 (OWG 1), which was created by the Commissioner of FDA to develop an action
plan
to address the Nation's obesity problem.
Federal Resister (70 FR 17010)
- Dietary Guidelines: Participated in the review and dissemination
of public information on the "2005 Dietary Guidelines for Americans."
Dietary Supplements
- Premarket Notification Program for New Dietary Ingredients - Public Meeting: On
November 15, 2004, held a public meeting about the premarket
notification program for New Dietary Ingredients (NDIs). FDA solicited comments
from industry, consumers, and other interested members of the public concerning
the content and format requirements for NDI notifications made under the Federal
Food, Drug, and Cosmetic Act (the Act).
- Dietary Supplements: Strategy for the Further Implementation and Enforcement
of the
Dietary Supplement Health and Education Act of 1994 (DSHEA):
On November 9, 2004, announced in the Federal Register (69 FR 64957) the availability
of the strategy for the further implementation of DSHEA. The strategy sets forth
a series of specific, integrated research and regulatory measures, including
guidance, regulations, and science-based compliance and enforcement mechanisms.
By implementing these measures, CFSAN hopes to improve the transparency, predictability,
and consistency of both its scientific evaluations of dietary supplement products
and ingredient safety, and of its regulatory actions to protect consumers against
unsafe dietary supplements and dietary supplements making unauthorized, false
or misleading claims. CFSAN expects that this improved transparency will help
engage stakeholders in developing further measures to implement DSHEA.
- Dietary Supplement Labeling Guide: On April 2005, published on the
CFSAN Web site guidance for industry entitled: "A
Dietary Supplement Labeling Guide." This guide was prepared to help
assure that dietary supplements sold in the U.S. are properly labeled. This
guide
applies
to dietary supplements produced domestically as well as those produced in foreign
countries.
A
Dietary Supplement Labeling Guide
Cosmetics
- Alpha Hydroxy Acids Guidance: On January 10, 2005,
announced in the Federal Register (70
FR 1721) the availability of a guidance document entitled:" Guidance
for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha
Hydroxy
Acids as Ingredients." The guidance recommends content for a labeling
statement for cosmetic products containing alpha hydroxy acids (AHAs) as
ingredients. This action was prompted by a citizen petition filed by the
Cosmetic, Toiletry, and Fragrance Association, which requested that FDA issue
a regulation establishing labeling requirements relating to sun protection with
use of cosmetic products containing AHAs.
Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients
Science Base
- Social Science Research on Connections between Food Labeling and Weight
Management: In April 2005, prepared a summary that reports weighted
frequencies based on the FY 2004 Health and Diet Survey (HDS) Supplement
that assessed consumer's knowledge and understanding of carbohydrates, diets based on limiting
carbohydrates, and carbohydrate claims in the marketplace (e.g., net carbs).
- Adverse Event Data Management at FDA: On June 18, 2005,
implemented cross-center training program
for new hires using a clinical and epidemiology training module based on real
adverse event data analyses from FDA. Participants comprised staff from all
FDA centers.
- Consumer Knowledge of Trans fats, Saturated fats and Omega-3 fats:
In an effort to inform consumers about how much trans fat, saturated
fats and Omega-3 fats are in the foods that we eat and the risk posed by eating
too much of these
fats and acids, CFSAN has begun an effort to 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 FY 2004 and FY 2007 Health and Diet
Survey (HDS). During FY 2005, CFSAN collected, compiled and analyzed baseline
data begun in FY 2004 for these fats and acids. The 2004 Health and Diet
Survey Supplement surveyed consumer awareness of fatty acids (saturated, trans,
and omega-3) and their knowledge of the link between fatty acid consumption and
risk for coronary heart disease.
International
- SPS Agreement: In FY 2005, CFSAN staff coordinated FDA scientific
and technical review of 98 proposed foreign Sanitary and Phytosanitary (SPS)
measures relating to FDA's food and feed safety jurisdictional areas that were notified by Member
Countries to World Trade Organization (WTO) under the SPS Agreement. CFSAN drafted U.S. comments on 40 of these notifications, i.e., those that warranted
comment (as of 4/29/05). The comments were subjected to interagency
collaboration and sent to the U.S. Enquiry Point for submission to
the appropriate foreign government. CFSAN anticipates an additional 75
notifications to be reviewed with comments by the end of FY 2005.
- AFDO Working Group Activity: In accordance with the Association of Food and Drug Officials'
(AFDO) charge for 2004-2005, chaired a working group composed of industry,
states and federal agencies and:
- Published a harmonized model system for state food export certificates;
- Encouraged at least 80% of the states to develop export
certificate websites and capture the updated links on the website;
- Tested the harmonized state export certificates for
acceptability by other country governments;
- Requested information on export certificate requirements
of importing countries through a new Food and Agricultural Import
Regulations and Standards (FAIRS) Report from USDA-FAS posts abroad, to
be posted and updated annually on the website beginning September 2005; and
- Completed work to enable U.S. export certificate website
to go "live."
- International Technical Assistance Activities: CFSAN collaborated
with USDA to develop a combined database ("metadatabase") to include
all U.S. federal international technical assistance activities. CFSAN created
a vehicle to make this information
more
accessible to diverse federal agencies participating in SPS-related technical
assistance, through a new feature "Technical Assistance/Trade Capacity Building
Issues" in the SPS/TBT Weekly News.
Internal Processes
- CFSAN Regulations Writing Consolidation: CFSAN has implemented several
changes toward the consolidation of its regulations writing function within
the Center. In late FY 2004, the responsibility of the regulation writing function
and managing of the CFSAN process for planning, developing, and clearing regulations
was delegated to CFSAN's Office of Regulation and Policy (ORP). In FY
2005, in an effort to promote efficiency and effectiveness in the regulations
development operations, CFSAN's Economics Team and its Consumer Studies Team
formerly
located in CFSAN's Office of Scientific Analysis and Support were
moved to ORP. These two staffs report to a newly created position of Associate
Director for Social Sciences within ORP.
Realignment of the Economics Team and the Consumer Studies Team to ORP, as well as creation of the new
Associate Director for Social Sciences is not only another step toward streamlining Center operations, it
also will enhance the Center's ability to complete high quality rulemakings in a timely fashion. In
subsequent years, CFSAN will perform a review to determine if the Center has improved this function.
Focused Economic-based Regulations
- FDA/FSIS Standards of Identity (General Principles):
On May 20, 2005, published in the Federal
Register (70 FR 29214) a proposed rule entitled: "Food Standards;
General Principles and Food Standards." This is a joint proposal between the
Food Safety and Inspection Service (FSIS) under the U.S. Department of Agriculture
(USDA) and the Food and Drug Administration (FDA).
The FDA and FSIS are proposing to
establish a set of general principles for food standards. The proposed general
principles will establish the criteria that the agencies will use in
considering whether a petition to establish, revise, or eliminate a food
standard will be the basis for a proposed rule. In addition, each agency may propose
to establish, revise, or eliminate a food standard on its own initiative or may
propose revisions to a food standard in addition to those a petitioner has
requested. These proposed general principles are the agencies' first step in
instituting a process to modernize its standards of identity (and any
accompanying standards of quality and fill of container) and standards of
composition. Federal Resister (70 FR 29214)
Management Initiatives
- Zero-based Budget Process (ZBB): This
was the first year that CFSAN relied on zero based budgeting to ensure
that financial resources required to meet the Center's needs are allocated in
an economic and efficient manner. The result of this process was much
additional savings with reduced funding. We were able to limit each Office to
75% of their previous funding levels and the Offices managed to allocate their
funds to meet their needs. The biggest change we accomplished by adopting ZBB
was that we were able to identify program areas within each Office and make
funding recommendations based on program needs.
- Decommissioning Federal Building 8 (FB-8): The chemical and
radioactive decommissioning of FB-8 is complete. CFSAN has submitted the final
report, called the Final Status Survey, to the Nuclear Regulatory Commission
(NRC). On June 6, 2005, the NRC officially released the FB-8 facility for unrestricted
use. CFSAN has completed all of its obligations to the FB-8 decommissioning
project.
- CFSAN's Adjunct Building: University Station: In the fall of 2004,
completed construction and occupancy of a second building called "University
Station," located next door to the Harvey Wiley Building. This marks
the end of a significant milestone in the relocation of nearly all CFSAN headquarters
staff to a single location. The building is fully furnished and all laboratories
are operational.
- 1st Year Phase of the CFSAN Leadership Legacy Initiative:
In FY 2005, CFSAN initiated
the application process for two leadership development opportunities targeted
for career/career conditional, full-time CFSAN employees who have demonstrated
leadership potential and who are currently in non-supervisory positions. The
first opportunity will be for selected employees to perform a one-year detail
with the Office of the Center Director on the Executive Operations Staff
(EOS). The second opportunity will be for selected employees to participate in
CFSAN's newly established "Leaders Developing Leaders (LDL)" Program. The
launch of these two opportunities represents a key step in shifting to a more
intentional, systematic and Center-focused approach to the development of
CFSAN's future leaders.
Enclosure 2
FY 2005 Program Priorities
"New Priorities"
The following eleven new goals emerged as a high priority after publication
of the FY 2005 Program Priorities Document. These goals are all targeted for
completion
before
the end of FY 2005.
- In cooperation with the Interstate Shellfish Sanitation Conference, reassess
the appropriateness of the method of calculating the level of illness
reduction for Vibrio vulnificus in raw Gulf Coast oysters,
especially the number of illness reporting states included in the
calculation, and recommend changes for Conference adoption as appropriate.
- Hold Public Meeting on the Risk Assessment on Vibrio parahaemolyticus in Raw Oysters.
- Conduct outreach to consumers, industry and state regulators regarding untreated cider or juice not processed under HACCP.
- Disseminate Public Information on the "2005 Dietary Guidelines for Americans."
- Respond to Environmental Working Group on Methylmercury.
- Publish Expanded Exploratory Data on Acrylamide.
- Publish Expanded Exploratory Data on Furan in Food.
- Publish Data on Dioxins.
- Publish Dietary Supplement Labeling Guidance for Industry.
- Begin to incorporate the recommendations and outcomes of the Interstate Shellfish Sanitation Conference (ISSC) and incorporate, as appropriate, changes into the National Shellfish Sanitation Program (NSSP) Model Ordinance.
- Begin to incorporate the recommendations and outcomes of the National
Conference on Interstate Milk Shipments (NCIMS) and incorporate, as appropriate,
changes into the Pasteurized Milk Ordinance (PMO).
Enclosure 3
FY 2005 Program Priorities
"Modifications"
The following goals have been revised as a result of new information after issuance
of our Program Priorities Document. The following goal has been revised.
Revised A-list Goals
|
1. |
Original Wording: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.
Revised Wording:1.4.1 - Submit for publication papers based on data
collected world-wide in preparation for drafting guidance on seafood Good
Aquaculture Practices. |
2. |
Original Wording:1.5.3 - Hold a public meeting
on sprout safety and initiate rulemaking (ANPRM) for sprouts.
Revised Wording:1.5.3 - Hold a public meeting on sprout safety and
evaluate outcome of the meeting. |
3. |
Original Wording:1.12.9 - Issue report on
allergen inspections.
Revised Wording:.12.9 - Complete report on allergen inspections. |
4. |
Original Wording:1.12.6 - Complete an Association
of Official Analytical Chemist (AOAC) interlab study for immunochemical peanut
protein test kits following the AOAC harmonized validation protocol.
Revised Wording:1.12.6 - Initiate an Association of Official Analytical
Chemist (AOAC) interlab study for immunochemical peanut protein test kits
following the AOAC harmonized validation protocol. |
5. |
Original Wording:1.13.2 - Issue revised
dairy based CPGs to reflect current practices and remove outdated CPGs.
Revised Wording:1.13.2 - Develop draft dairy based CPGs to reflect
current practices and remove outdated CPGs. |
6. |
Original Wording:1.8.6 - Draft and Publish
2005 PMO and ISSC Model Ordinances
Revised Wording:1.8.6 - Begin to incorporate the recommendations
and outcomes of the Interstate Shellfish Sanitation Conference (ISSC) and
incorporate, as appropriate, changes into the National Shellfish Sanitation
Program (NSSP) Model Ordinance.
1.8.7 - Begin to incorporate the recommendations and outcomes of the National
Conference on Interstate Milk Shipments (NCIMS) and incorporate, as appropriate,
changes into the Pasteurized Milk Ordinance (PMO).
|
Enclosure 4
FY 2005 Program Priorities:
"Deletions from the A-list"
Due to the additional high priority activities that emerged
after the publication of the FY 2005 "Priorities Document, " and resource
availability
we
have moved the
following goals to the "B-list " for the remainder of FY 2005. This means
FDA
will continue to work on these goals as time permits, but we will not expect
final action this fiscal year. These goals will be evaluated for inclusion the
A-list
in our FY 2006 Program Priorities Document.
"Moved to B-list "
- Publish final rule to set standards for the use of
private laboratories and for testing imported foods.
- Issue draft guidance advising processors on steps to reduce Listeria monocytogenes (Lm) contamination in ready-to-eat foods.
- Issue a field assignment regarding "gourmet" raw milk soft cheeses.
- 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.
- Issue revised final guidance for lead levels in candy.
- Update the pesticides Compliance Policy Guide (CPG) to bring it in line with Food Quality Protection Act (FQPA).
- Publish final rule on BSE recordkeeping.
- Finalize Interim Final Rule for Bovine Spongiform Encephalopathy (BSE).
- Issue allergen compliance program and implement enforcement strategy.
- Complete evaluation of the science of raw milk cheeses. (60 day aging).
- Publish an Advance Notice of Proposed Rulemaking (ANPRM) to solicit comments on updating Daily Values in nutrition labeling.
- Publish draft guidance on the evidence-based ranking system for health claims and qualified health claims.
- Publish a proposed rule to amend 21 CFR 190.6 relative to description of new dietary ingredients.
- Publish proposed rule to revise, as appropriate, existing regulation
that requires irradiated food to be labeled.
- Publish a final rule for infant formula Good Manufacturing Practice (GMP) and quality factors.
- 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.
- Conduct a program review of research on dietary supplements and develop a strategic plan for research.
- 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.
- 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.
- 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.
- 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
hazard(s) and determining the consequences to the public health as a result
of agency action vs. inaction.
- 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.
- 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, and complaint files concerning imported products.