CFSAN 2001 Program Priorities

"A" List

1. Conduct inspections of all domestic firms producing foods at "high risk" of microbiological contamination.
2. Refine the definition of "high-risk" foods, and develop and implement a program to ensure annual inspections in future years of all domestic firms that produce "high-risk" foods.
3. Continue to implement three-year strategy to enhance FDA audit and evaluation of State inspection programs.

"A" List

1. Conduct approximately 250 foreign inspections, with top priority to "high-risk" foods.
2. Implement the FDA and U.S. Customs Service joint Action Plan:

1. Publish guidance for field personnel to ensure that imported food is held in secure facilities until FDA has reviewed and released the shipments into domestic commerce.
2. Publish guidance for field personnel for determining which health and safety violations are sufficiently serious to require destruction of imported food.
3. Publish a proposed rule on the marking of refused food shipments.
4. Publish a proposed rule for the use of accredited laboratories for testing imported foods.
5. Publish guidance for field personnel on the imposition of civil money penalties, under Customs' authority, related to the importation of unsafe food.
3. International Outreach: Conduct two Regional Food Safety Workshops ("Roadshows") to provide information on key U.S. food safety initiatives (Asia and South Africa).

1. Initiate fourth year of inspections of domestic seafood processors, with a focused inspection and sampling emphasis on products in which pathogens and scombrotoxin are hazards that should be controlled, and where firms have not yet established adequate HACCP Plans. Implement enforcement strategies as appropriate.
2. Complete an evaluation of program performance through the second year, with an emphasis on the state of the industry, to assess whether the program is accomplishing its objectives and to identify where and how the program needs to be re-directed. Conduct re-evaluation through the third year once data are available.
3. Respond to citizen petition 98P-0504 requesting that FDA establish a performance standard for Vibrio vulnificus. Continue to work with the ISSC to create an effective control strategy for Vibrio vulnificus.
4. Publish the Vibrio parahaemolyticus risk assessment and work with the ISSC on control plan implementation.
5. Develop an overall public health strategy for methylmercury in commercial seafood, including a determination if the current consumer guidance should be revised.

1. Publish the final rule on HACCP for fruit and vegetable juices to improve their safety; and establish enforcement strategy for final rule.
2. In conjunction with ORA, continue the sampling assignment to analyze 1,000 domestic produce items for the presence of microbial pathogens.
3. Evaluate the information from the sampling assignment to analyze 1000 import produce samples for the presence of microbial pathogens and determine next steps.
4. In collaboration with JIFSAN, conduct two Regional Good Agricultural Practices Training Programs as train-the-trainer programs (Brazil and Trinidad and Tobago).
5. In conjunction with ORA, conduct follow-up inspections under the sprout guidance. Initiate enforcement action, as appropriate.
6. Produce a video on Good Agricultural Practices/Good Manufacturing Practices for fresh-cut produce, with help from the California Department of Health Services.

1. Publish final rule on egg labeling and refrigeration.
2. Work with States to implement egg label and refrigeration rule.
3. Conduct education campaign for egg label and refrigeration rule.
4. Publish proposed egg safety rule for farm and retail.
5. Solicit comments through public meetings on egg safety proposal.
6. Initiate Salmonella Enteritidis (SE) research plan.

1. Publish draft risk assessment on Listeria monocytogenes contamination in food.
2. Publish draft action plan to reduce Listeria monocytogenes contamination in food.
3. Solicit comments through public meeting on draft risk assessment and draft action plan.
4. Enhance consumer and health care professional information and education efforts, targeting at-risk populations.
5. Implement research program to provide Listeria monocytogenes control interventions, data and understanding.
6. Expand efforts to gather additional data through exposure assessment studies and regulatory product surveillance testing.

1. Distribute the senior citizen video and teaching program to area offices on aging, senior day care centers, local health departments, FDA field public affairs specialists, and USDA extension agents.
2. Distribute the secondary schools food safety curriculum for incorporation into the 2000-2001 school year curriculum and continue, in collaboration with the National Science Teachers association, the Teacher Enhancement Program.

1. Reconsider definition of potentially hazardous food, based on scientifically valid criteria, at the retail level.
2. Develop comprehensive guidance for the food industry on how to conduct effective food recalls.
3. Coordinate and conduct a Spice Pathogen Reduction Treatment Validation Pilot Study with three firms, develop and initiate use of FDA Validation Reviewer's Guide and develop a compliance policy guide (CPG) for spice reconditioning validation.

1. Develop a plan to revise and update OASIS entry criteria.
2. Implement action plan with steps to ensure confidence in the Canadian Food Inspection Authority system covering pathogens in produce and pesticide chemicals in produce.
3. Amend 21 CFR 1.90 to allow discretion to release import samples prior to completion of analysis. Develop and implement standard operating procedures implementing change in 21 CFR 1.90.

1. Make progress with Canada and the National Marine Fisheries Service, and States as appropriate, regarding optimum seafood HACCP inspection frequency.
2. Initiate project to improve existing guidance to the fishing industry that harvest scombroid species on proper onboard handling and to educate the industry on how to comply with that guidance.
3. Initiate project to develop good aquacultural practices to ensure that aquaculture waters are not a source of pathogens or other contaminants.
4. Develop the 3rd edition of the FDA guidelines for seafood HACCP, the "Fish and Fishery Products Hazards and Controls Guide."
5. Evaluate the results of the parasite survey on human illnesses to determine whether it provides sufficient documentation of the need for HACCP controls for this hazard for certain species, or whether additional information is needed.

1. *  Develop draft of the 1^st edition of the FDA Hazards and Controls Guide for Juice.
2. *  Develop a guidance document for fresh cut produce to advise producers of steps they should take to reduce microbial hazards common to fresh cut processing.
3. As a follow-up to the Costa Rica Survey, develop an international model program for surveying fruit and vegetable producer agricultural practices and consumer food safety knowledge, attitudes and behaviors.
4. Develop a proposed regulation and enforcement strategy for sprouts.
5. Initiate a follow-up import produce survey of 300 samples focused on fruits and vegetables found to be contaminated with microbial pathogens.
6. Develop training modules for juice HACCP and a video on safe juice processing.

1. *  Develop and submit for public comment, industry guidance to reduce Listeria monocytogenes contamination at processor and retail levels.
2. Conduct projects with retail establishments to pilot Listeria monocytogenes control measures.

1. Continue to develop and promote food safety campaigns in collaboration with the Partnership for Food Safety Education, through support of National Food Safety Education Month and grass-root efforts conducted at the local level by FDA public affairs specialists.
2. Conduct focus group research on the use of the term "fresh" on food labels or labeling to refer to food products processed using new technologies to ensure safe food.
3. Explore costs and methods for developing a low literacy pictorial food safety training program for food service workers.
4. Conduct Collaborative Exchange meetings, as follow-ups to meetings held in FY2000 with Mexico, Chile and Canada.

1. Update and implement the 3-year Research Plan, including intramural and extramural research, to ensure critical needed food safety research related to foodborne pathogens and other high priority issues are conducted.
2. Support activities in the Joint Institute for Food Safety Research (JIFSR).

1. *  Develop a proposed rule consistent with the Food Code for Interstate Travel Program conveyances and support facilities.
2. Track Model Food Code adoption through AFDO survey of state, local and tribal jurisdictions and increase the adoption to at least 28 states.

1. Revisit policy for dealing with imported Grade A dairy products.
2. Improve the drug residues in milk monitoring programs (NDRMMP and M-a-86).

1. *  Explore tools available under the Public Health Service Act to reduce foodborne illness.
2. Continue to develop data sharing systems, e.g., eLexnet and Virusnet, through interagency and state efforts.

1. Complete "Salmonella Enteritidis Traceback Investigation Protocol."
2. In collaboration with ORA, and state and local governments, continue to provide support for the National Food Safety System Outbreak Coordination Workgroup Project to finalize guidelines for improving coordination and communication of multi-state foodborne outbreak investigations.

"A" List

1. Application Review Goals:

1. For the petition receipt cohort of FY 2000, complete within 360 days of filing, the safety evaluation of 80-90% of those food and color additive petitions that qualify for expedited review.
2. For the petition receipt cohort of FY 2000, complete within 360 days of filing, the safety evaluation of 50-60% of those food and color additive petitions that do not qualify for expedited review.
3. Reduce by 50% the number of pending food and color additive petitions that were more than 1 year overdue on 10/1/2000.
4. Complete CFSAN evaluation of 66% of the biotechnology final consultations received in FY2000, within 180 days.
5. Complete processing of 80% of GRAS notifications in the receipt cohort of FY2000, within 180 days.
6. Complete review of premarket notifications for food contact substances within statutory time limits (120 days).

2. Process Enhancements for Application Review:

1. Complete the reorganization of the Office of Premarket Approval to help meet new, more stringent performance standards.
2. Formalize procedures for prefiling consultation for new petitions; begin conducting the consultations according to the new procedures.
3. Create "review templates" to make the internal review of toxicology data in petitions more efficient.

3. Food Contact Substances (FCS) -- Notification Processing:

1. Publish Federal Register final rule on food contact substance notification.

2. Publish final FCS guidance documents for administrative, toxicology and chemistry.

4. Reports to Congress:

1. Submit a report to Congress on use of FY2000 additional funds earmarked to accelerate the rate of review of direct and color additive petitions, including those with food safety benefits.

2. Submit an annual report to the appropriations committees of the House of Representatives and the Senate that provides an estimate of the costs of carrying out the premarket notification program.

"B" List

1. *  Develop final rule for the GRAS Notice Program.
2. *  Develop a strategy for regulating the use of bromates in baked goods; respond to the pending citizen petition on bromates.
3. Complete the chloropropanols risk assessment, and as appropriate, develop policies and field assignments to ensure appropriate maximum levels in specific foods.
4. Publish on the World Wide Web four newly revised Redbook chapters.
5. Develop a Federal Register proposal extending exclusion from Environmental Assessments to additional categories of agency action on food and color additives.
6. Develop draft guidance on the preparation of Environmental Assessments or claims of categorical exclusion.
7. Develop a Federal Register proposal to codify pre-filing consultation procedures.

"A" List

1. Regulation/Guidance

1. Publish final regulation for trans fatty acid labeling.
2. Publish proposal on the sodium proviso of the implied nutrient content claim 'healthy.'
3. Conduct focus group research and gather other relevant information on food irradiation labeling approaches.
4. Review premarket notifications for new infant formulas within statutory timeframe.
5. Review and take appropriate timely actions in response to nutrient content/health claim notifications and petitions.

2. Enforcement/Procedures

1. Take enforcement actions to ensure product safety, define boundaries among product categories, and prevent misleading claims including medical foods and infant formula as well as conventional foods
2. Establish and implement a strategy for ensuring that dietary supplement ingredients, when added to conventional foods, are lawful.

3. Research/Science Base

1. Conduct Year 2000 Food Label and Package Survey (FLAPS).

4. Reports to Congress

1. Submit a report to Congress on the adoption of a health claim relating consumption of omega-3 fatty acids to reduced risk of coronary artery disease.
2. Submit a report to Congress on the status of the proposed regulation on food irradiation labeling.

"B" List

1. Regulations/Guidance

1. *  Develop final rule on infant formula good manufacturing practices and quality factors, and develop appropriate implementation and enforcement strategies.
2. *  Develop proposed rule on food irradiation labeling approaches.
3. *  Prepare final rule on health claim relating sterol/stanol esters to reduced risk of heart disease.
4. Develop proposed rule to update raw produce and fish values for voluntary nutrition labeling program.
5. Develop proposed rule providing for nutrient content claims for substances that are the subject of health claims.
6. Develop final rule providing for more flexibility in the use of health/ nutrient content claims in response to citizen petitions 94P-0390 and 95P-0241.
7. Continue to develop a strategy regarding an appropriate scientific and regulatory framework for structure/function claims on conventional foods, including a definition for "nutritive value."
8. Develop guidance for evaluating ingredients new to infant formula.

2. Enforcement Procedures

1. Implement procedures to streamline case development process and increase use of warning letters.

3. Research/Science Base/Monitoring/Policy Development

1. Evaluate issues related to caffeine labeling on foods.
2. Evaluate comments related to "added sugars" in nutrition labeling and claims.
3. Conduct scientific workshop on soy safety issues.
4. Develop research plan for banked human breast milk.
5. Complete methods development for fatty acid content of infant formula.

"A" List

1. Regulations/Guidance

1. Publish dietary supplement GMP proposed rule and conduct outreach program.
2. Complete health claim evaluations for three diet/disease relationships begun in FY 2000: antioxidants and cancer; vitamin B and vascular disease; and vitamin E and heart disease.
3. Continue to review premarket (75-day) notifications for new dietary ingredients within the statutory timeframe.

2. Enforcement/Outreach

1. Continue to identify highest priority safety issues and initiate appropriate enforcement actions against unsafe, adulterated, or misbranded dietary supplement products and ingredients.
2. Establish a system for making adverse event reports (AERs) promptly available to manufacturers that includes the timely redaction of confidential information.
3. Establish strategy for dietary supplements that contain ephedrine alkaloids based on March 2000 release of AER's and related material and August 2000 public meeting/public comments.
4. Complete Dietary Supplement Labeling Guide.

3. Research/Science Base

1. Work with National Academy of Sciences' (NAS) Institute of Medicine (IOM) to review dietary supplement safety.
2. Develop mechanisms to expedite dietary supplement adverse event investigations and enhance timely clinical assessment of dietary supplement adverse event reports.
3. Review analytical methods for isoflavones in soy.
4. Complete and disseminate dietary supplement research plan.

4. Reports to Congress

1. Submit a report to Congress summarizing the total funding spent in FY 2000 to access the safety of dietary supplements, including related costs required to meet the legal statutory burden under DSHEA.
2. Submit a report to Congress on the dollar cost to implement the Dietary Supplement Strategic Plan.
3. Submit a report to Congress on implementation of the decision in the United States Court of Appeals for the District of Columbia Circuit Court in Pearson v. Shalala regarding dietary supplement health claims.

"B" List

1. Regulations/Guidance

1. Develop guidance or regulation on safety information/material fact labeling for dietary supplements.
2. Develop approach for ensuring inclusion of appropriate safety information within 75-day notifications.
3. Evaluate experience in evaluating health claims under the October 6, 2000 Interim Strategy to determine appropriate framework for long-term approach.
4. Develop final rule on 'per day' labeling for dietary supplements.
5. Collaborate across Agency to complete guidance document on structure/function final rule. (CDER Lead)
6. Collaborate across Agency to publish proposal for labeling dietary supplements for women who are or may become pregnant. (CDER Lead)

2. Enforcement/Outreach

1. Continue to review the 30-day postmarket notifications for structure/function claims in a timely manner.
2. Clarify policy and enforcement strategy for the definition of "represented as a conventional food" (e.g., beverages).
3. Develop dietary supplement consumer information document on topic of product category boundaries.
4. Enhance and improve the dietary supplement website and create a "list serve" for dietary supplement topics.
5. Prepare regulatory guidebook for industry.

3. Research/Science Base

1. In conjunction with NAS/IOM, investigate criteria and options for evaluating emerging science relative to dietary supplements.
2. Develop analytical methods for conjugated linoleic acids (CLA).
3. Implement a 'Dietary Supplement Analytical Methods Working Group' for safety issues.

"A" List

1. Mycotoxins:

1. Issue final patulin guidance.
2. Prepare field assignment to determine consistency of patulin levels with the guidance, following issuance of final guidance¹.
3. Issue final fumonisins guidance document.
4. Prepare a field assignment to determine consistency of fumonisin levels with FDA guidance guidance, following issuance of final guidance¹.

2. Dioxins: Develop & begin implementation of a strategy to expand dioxin surveillance.
3. Pesticides:

1. Finalize "channels of trade" guidance for industry on foods containing methyl parathion residues.
2. Provide support to EPA in the regulation of StarLink corn.

"B" List

1. Mycotoxins:

1. Aflaxtoxin/Peanuts - Develop draft guidance to harmonize US level with Codex guidance level of 15 ppb.
2. Develop a fumonisins risk assessment.

2. Bottled Water

1. *  Develop proposal to adopt EPA's regulation for disinfection byproducts in public drinking water as a quality standard.
2. Develop proposal to revise quality standards for arsenic.
3. Develop reproposal on coliform standard.
4. Develop proposal to respond to EPA's Interim Enhanced Surface Water Treatment Rule.

3. Pesticides

1. Implement methyl parathion assignment to determine compliance with EPA tolerance revocation for raw agricultural commodities.
2. Update the pesticide CPG to bring it in line with FQPA and changes in pesticide programs and policy over the past few years.
3. Validate the new EPA enhanced sensitivity method and begin analyzing food samples for organophosphate pesticides to assist the EPA in doing risk assessments.
4. Issue, as appropriate, "channels of trade" guidance documents when EPA revokes tolerances.
5. Develop a compliance program component to assess pesticides in botanicals.
6. Publish on the Internet FDA Pesticide Monitoring data and summary information as required by the Pesticide Monitoring Improvement Act.

4. Filth Associated with Public Health

1. Develop fly fact sheets for field identification of disease carrying flies.
2. Develop draft CPGs on revised filth strategy for: (1) interpretation of filth, and (2) guidelines for levels in processing plants and warehouses.
3. Develop draft CPG on flies in hen houses for egg production.

5. Ackee: Issue assignment to monitor hypoglycin levels in canned ackee.

"A" List

1. Cosmetic Ingredient Safety

1. Alpha Hydroxy Acids (AHA): Publish draft guidance on labeling of AHA containing products.
2. Diethanolamine (DEA): Complete evaluation of DEA risk assessment and develop risk management approaches; initiate implementation of risk management decisions.

2. Cosmetic Enforcement and Surveillance

1. Prepare MOU with CDER that allows the Office of Cosmetics and Colors to manage enforcement actions for cosmetic products that do not contain active drug ingredients but whose label or labeling contains structure/function or disease claims.
2. Publish draft guidance for issuance of § 740.10 warnings for products formulated with ingredients that lack adequate safety substantiation.

3. Voluntary Cosmetic Registration Program (VCRP): Implement the WEB-based, interactive registration system, as follows:

1. Beta test, and selectively bring on line, the WEB-based, interactive registration system.
2. Post support documents (e.g. catalogue of ingredients registered in the VCRP) on the cosmetics WEB site.
3. Implement selected VCRP participation incentives.

4. Certified Color Additives

1. Analyze all batches of color additives and determine certification status (certify or refuse to certify) within an average of 5 working days.

"B" List

1. *  Color Additive Lakes: Prepare final rule permanently listing color additive lakes.
2. Cosmetic Product Safety: Support NTP/NCTR photocarcinogenicity testing of glycolic acid and salicylic acid.
3. Cosmetic Labeling: (a) Develop proposal to amend §701.3(c)(2) to update sources for naming cosmetic ingredients; (b) Develop guidance for issuance of General Industry Letters and Untitled Letters for cosmetic products with labeling violations.
4. Consumer and Industry Assistance:

1. Develop Federal Register notice for issuance of Cosmetics Handbook for Industry. Post the Handbook on the Cosmetics web site and make copies available to requestors.
2. Complete preparation of a draft Cosmetics Labeling Manual.
3. Initiate preparation of a draft Cosmetics Handbook for Consumers.
4. Continue updating and enhancing cosmetics WEB page.

5. International Harmonization: Continue support of EU-US bilateral program and the Cosmetics Harmonization and International Cooperation (CHIC) initiative.
6. Color Additive Certification: (a) update written methods used in certification of color additives; (b) Evaluate the impurities in FD&C Red No.40 and determine whether additional specifications are necessary.

"A" List

Continue a multifaceted program of action and information sharing to ensure the relocation of CFSAN personnel, associated laboratory and office space, and programs from the Metropolitan D.C. area to the College Park campus and the Muirkirk Road campus starting in the Fall of 2001.

1. Conduct an intensive information-sharing program to keep CFSAN personnel informed on the status of the project, the programs in place to plan the move, and the details for the actual move.
2. Continue to work in partnership with NTEU to identify options and negotiate agreements to ensure adequate lab and office space for all CFSAN employees.
3. Pursue a planned approach to successfully obtain further funding to occupy the College Park building, adjunct building, and the MOD I/BRF facility and to expand College Park in the future.
4. Continue task group efforts responsible for planning the detailed projects necessary to move CFSAN personnel into new facilities, augmented by the relocation planning and management consultants:
1. Provide information technology (cabling, phones, and network services) to College Park, adjunct building and MOD I/BRF.
2. Plan and implement a library facility at College Park with an integrated library system.
3. Institute a standard records management scheme for all file collections within CFSAN and implement standard filing practices and equipment for College Park buildings.
4. Conduct a phased cleanup of all files, offices, laboratories and storage rooms in FB-8 and Vermont Avenue.
5. Purchase and install all new office workstations for personnel at College Park buildings. Obtain necessary waivers and approvals.
6. Obtain furnishings for public spaces and conference rooms.
7. Prepare for the orderly move of all the laboratories in FB-8 to College Park, the adjunct building, MOD I/BRF.
8. Establish new contracts to meet the service and support needs of College Park, the adjunct building, MOD I/BRF.
9. Work with move consultants, task group chairs and moving coordinators, to develop the order of move, the roles and responsibilities of all concerned, and the statement of work for the actual physical movers.
10. Develop detailed plans and proceed, in a phased effort, to decommission FB-8.

"A" List

1. Establish CFSAN Staff College and implement key "core training" activities.
2. Implement new Food Advisory Committee structure – A "parent" committee in addition to four subcommittees: dietary supplements; food additives and ingredients; contaminants and natural toxicants; and food biotechnology.
3. Implement collaborative research program for botanical dietary supplements with the University of Mississippi National Center for Natural Products Research and NCTR.
4. Submit official application for AAALAC accreditation of CFSAN's animal care and use program.
5. Develop a 3-Year Plan for research conducted at or by personnel from the new Office of Applied Research and Safety Assessment (OARSA).

"B" List

1. Implementation of new manuscript approval/tracking system.
2. Implementation of Center-wide training on laboratory accreditation, as part of the overall Agency effort on laboratory accreditation, for evaluation of regulatory samples.
3. Acquire training for supervisors and managers in peer review systems used to evaluate CFSAN scientists.
4. Develop process for in-house validation of analytical methods proposed for regulatory purposes.
5. Support domestic/international risk analysis efforts:
1. Expand JIFSAN Program for Risk Analysis Clearinghouse.
2. Support FAO/WHO in the establishment of an international expert consultative body for microbial risk assessment.
3. Provide experts to JECFA to conduct risk assessments for preparation of international standards.
6. Develop detailed implementation plan, including information technology systems, for the new Research Project Management framework.

"A" List

1. Codex Committees and Working Groups: Participate in and raise visibility in the 17 Codex committees, ad hoc task forces, and related drafting and working groups and scientific advisory committees (i.e., JECFA) meeting in FY 2001 that are of relevance to the FDA.
2. WHO Food Safety Strategic Planning: Building on the May 2000 WHO Resolution on Food Safety, provide resources to enable global participation in WHO strategic planning of programs on food safety, including food safety initiatives of WHO Regional Offices.
3. NAFTA TWGs: Participate in Technical Working Groups (TWGs) with Canada and Mexico.

"B" List

1. *  Equivalence Criteria: Obtain clearance of FDA document through other federal agencies with vested involvement in U.S. equivalence criteria. Publish a Federal Register notice conveying FDA's criteria for evaluating foreign food safety systems to determine their equivalence to that of the U.S.
2. Export Certificates: Achieve progress in defining the needs of exporters for food export certificates and approaches to issuing them, including current and future demands on the agency for issuing such certificates. Discuss and review with states, industry, trade agencies, consumer groups and other stakeholders. Assure consistency of international guidance regarding export certificates with U.S. practices.
3. Equivalence Evaluations: Continue to evaluate equivalence of foreign country dairy and seafood systems.
4. Shellfish: Initiate shellfish equivalence, comparing North American shellfish safety programs to European shellfish programs.
5. Proposal to Consider Adoption of Codex Standards: Review responses to initial ANPR (1997) and prepare initial Federal Register document containing: 1) FDA proposed policy for consideration of Codex standards, guidelines, and recommendations, and 2) proposal to amend existing rules for adoption of Codex standards.
6. Food and Cosmetic Information Line: Develop Spanish Language Option for CFSAN's Food and Cosmetic Information Line to ensure that Spanish-speaking callers will have access to more consumer information on food safety.

"A" List

1. Biotechnology:
1. Publish biotechnology notification proposal.
2. Publish draft guidance for voluntary labeling of foods that have or have not been developed using bioengineering.
3. Develop draft guidance for industry on how to assess genetically engineered food products for allergenicity, for presentation to the Food Advisory Committee¹.
4. Submit a report to Congress on the current state of Federally funded research and development in predictive methodology for assessment of genetically engineered food products for allergenicity.
2. Food Allergens:
1. Develop a strategy for exploring clearer labeling of food allergens on the food label, emphasizing the eight major foods that are allergens, and including a public workshop meeting.
2. 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.
3. Issue a field allergen inspection guide and training for FDA Field Offices.
4. Publish a draft food allergen Compliance Policy Guide concerning manufacturing and labeling practices.
3. Adverse Event Reporting: Present proposed model for a centralized adverse event reporting system within CFSAN.

"A" List

1. Bioterrorism: Finalize, with ORA, a bioterrorism plan to address intentional chemical and biological contamination of foods and water associated with food production.

"B" List

1. Regulations Process: Further evaluate the CFSAN regulations development and review process in order to make additional refinements in quality and efficiency and to then make further recommendations for improvement.
2. Compliance/Enforcement: Improve CFSAN's compliance and enforcement program activities.
3. CFSAN Field Relations: Continue activities initiated in FY2000 to strengthen relations between CFSAN and ORA in the areas of budget and workplan, compliance and enforcement, and laboratories.

"A" List

1. Publish proposed regulation on standard of identity for crabs/names for crabs.

"B" List

1. *  Develop a final rule to establish a food standard for white chocolate.
2. Develop proposed regulation on standard of fill for tuna.
3. Develop proposed regulation for standard of identity for scallops.
4. Collaborate with USDA on food standards proposal.

"A" List

1. National Treasury Employees Union (NTEU) – Continue to work with NTEU and the Partnership Committee to fully implement the NTEU Collective Bargaining Unit Agreement.
2. Administrative Services – Continue to implement steps to improve the provision of administrative support services within the Center.
3. Recruitment and Hiring
1. Implement the FY2001 Recruitment Plan and develop and implement a CFSAN personnel- tracking system that will allow for quick identification of qualified applicants.
2. Complete hiring initiative for the food additive premarket review program as a result of the additional funds in the FY2000 budget allocation.
4. Career Development – Develop phase two of the Individual Development Plan (IDP) program for professional and career development of professional, administrative and scientific staff.
5. New Employee Training –
1. Develop two new courses for integration into Part IV – Core Training of the CFSAN Employee Orientation Program.
2. Implement web-based training for new hires in conjunction with the CFSAN Staff College.
6. Hispanic Initiative – In accordance with Executive Order 13171, develop and implement program to enhance retention of Hispanic employees and recruitment of qualified Hispanic applicants.

"B" List

1. Integrated Financial Management System Enhancement – Continue the integration of the automated financial management system and further develop additional financial reports.
2. Quality of Worklife – Continue to provide mechanisms for improved communication and quality of worklife. In particular, emphasis will be placed on contract/recruitment of a part time fitness coordinator.
3. Information Technology – Continue implementation of the Agency Information Systems Architecture (ISA) with migration of database applications to Oracle and the completion of the ISA standard desktops throughout the Center. Move toward replacing paper-based transactions with secure electronic Web based transactions within a common Agency infrastructure. Prepare for the move to College Park.