BSE Inspection Training FD&C Act, CFRs and Evidence Development
(UNDER DEVELOPMENT)
STT CLASSROOM COURSE
SCHEDULE FOR FY07
RETAIL FOODS
FD108 TEMPORARY
FOOD ESTABLISHMENTS
Course Description: The
purpose of this introductory course is to outline the
key elements for conducting thorough application reviews
and inspections of temporary food establishments. Emphasis
will be placed on proper design and location of food
storage, preparation and serving operations and sanitary
facilities. Methods of instruction include lectures
with hands-on group exercises and discussion to reinforce
basic concepts.
Objectives: Upon completion of this
course, participants will be able to:
Apply the standards found in the “Pre-Operational
Guide for Temporary Food Establishments” to
perform reviews of applications from site coordinators
and vendors.
Conduct menu reviews.
Perform pre-operational and operational inspections
of temporary food establishments.
Target Audience: Federal, state and
local regulators conducting application reviews and
inspections of temporary food establishments.
Course Description: This introductory
course will consist of training on the Food code and
the public health rationale for the Code provisions
to prepare regulators for application of the Food Code
to “retail” food establishments. Topics
include management‘s duties and responsibilities,
employee health, food, equipment, water, plumbing, waste,
physical facilities, poisonous/toxic materials, compliance
and enforcement. Course subject matter can vary based
on local needs. Methods of instruction include lectures,
video, discussions and exercises.
Objectives: Upon completion of this
course, participants will be able to:
Evaluate a food establishment for compromises in
food safety based on the code, public health rationale
and science.
Discuss various means of corrective action.
Target Audience: Federal, state and
local regulators conducting inspections of retail food
establishments.
Prerequisite: N/A
CEU Credits: 1.8
Course Duration: 3 days
Enrollment is limited to 60 (Larger groups
may require modifying course delivery)
Course Description: The purpose of
this course is to provide a comprehensive overview of
the plan review process with an emphasis on equipment
and architectural design. The plan review process is
based on menu and food preparation procedures with the
end goal of reducing foodborne illnesses resulting from
poor facility design. Methods of instruction include
lectures with hands-on group exercises and discussion
to reinforce basic concepts.
Objectives: Upon completion of this
course, participants will be able to:
Demonstrate an ability to read blueprints
Apply requirements found in the Plan Review Guide
to identify health hazards and make corrective recommendations
related to ventilation, plumbing, finishing, lighting,
equipment and storage
Write stipulations and communicate hazards to facility
managers through applying the requirements found in
the Plan Review Guide
Target Audience: State and local regulatory
officials who are responsible for the plan review of
food service establishments, retail food stores, and
other food service operations. Course Level: Intermediate
to Advance.
Prerequisite: Must possess a working knowledge of the jurisdictions food code, risks associated with foodborne illnesses, and the necessary control measures.
Applying HACCP Principles to the Inspection
of Retail and Food Service Establishments
Course Description: This course is
designed to allow participants an opportunity to explore
the various ways that risk-based inspections can be
applied in retail and food service establishments. Topics
will include the “process approach” to HACCP,
applications of HACCP principles in routine inspection
work, and assessing active managerial control of risk
factors by operators through a HACCP system or other
established food safety systems.
While the process approach is new to many regulators,
it is better designed for use in retail and food
service settings than traditional HACCP approaches
because it eliminates lengthy flow charting and hazard
analysis for every type of food product.
Objectives: Upon completion of this
course, participants will be able to:
Identify possible hazards associated with retail
and food service operations and the control measures
available to prevent, reduce, or eliminate the risks
of these hazards.
Apply the “process approach” of HACCP
to routine inspections of retail and food service
operations.
Identify appropriate techniques and methods for
applying HACCP principles to inspections and offering
intervention strategies for controlling risks to operators
(those with and without HACCP Plans.)
Target Audience: Federal, state and
local regulators conducting inspections of retail food
establishments
Prerequisite: Students should have
some exposure to and understanding of the HACCP concepts.
They should have read and become familiar with the NACMCF
HACCP Principles and Application Guidelines: http://www.fsis.usda.gov/OPHS/NACMCF/past/JFP0998.pdf
Course Description: The course primarily focuses on
the sanitarian/inspector’s roles in the investigation
with insight to the other players on the team such
as the laboratory, nursing and epidemiology departments. Course
subject matter will vary based on local needs. Methods
of instruction include lectures, discussions and hands-on
problem solving exercises.
Objectives: Upon completion of this
course, participants will be able to:
With the aid of reference material, differentiate
various common foodborne pathogens in respect to
typical source, growth and destruction parameters,
incubation ranges, and disease symptoms.
Describe the concepts of surveillance and associations
of time, place and person.
Define a foodborne outbreak and describe the various
action levels that can lead up to a foodborne illness
investigation.
Assist with the environmental investigation:
Interview food service personnel
Conduct a food preparation review assessing
preparation procedures for opportunities of contamination,
growth, survival or death of foodborne pathogens.
Collect laboratory samples.
Assist in questionnaire development and implementation,
and state the purpose and difference between case
definitions and hypotheses.
Target Audience: Federal, state and
local regulators conducting or assisting with foodborne
illness investigations.
Prerequisite: Participants
should complete the ORA-U online foodborne illness
investigation courses prior to taking this face-to-face
course.
FD340 DIETARY SUPPLEMENTS (NEW course
currently under development)
Course Description: This course
is designed to prepare investigators to conduct inspections
of dietary supplement manufacturing operations. The
course will focus on current Good Manufacturing Practices
for manufacturers including personnel, control of facilities,
laboratory, quality control, product content and labeling,
and other requirements of the regulations. The
course content will include lectures, exercises, group
discussions, and review of dietary supplement
products.
Objectives: Upon completion
of the course, participants should be able to:
Recognize the requirements of the Dietary Supplement
cGMP regulations
Identify violations of the regulations that may
require regulatory action
Recommend corrective actions necessary to comply
with the cGMP regulations
Target Audience: Participants
will be limited to those field investigators who are
actively engaged in the inspection of dietary supplement
manufacturing, supervisors whose staff conduct
these inspections, or compliance officers who will
be actively reviewing cases.
Prerequisites: Participants
must read and be familiar with the Dietary Supplement
cGMP regulations including the preamble and background,
which will be provided to participants prior to attending
the course.
FD103
BASIC LOW ACID CANNED FOOD (Course Being Updated
for FY09)
FD202
ACIDIFIED FOODS
Course Description: This intermediate
to advanced course includes the following topics: acidified
food microbiology, overview of 21 CFR Parts 108.25 and
114 Acidified Food Regulations, FDA registration and
process filing, establishment of the acidification process,
critical control points in the acidification process,
documentation of process delivery, container integrity,
and assistance to the small manufacturer.
Objectives: Upon completion of this
course, participants will be able to:
Apply the principles and concepts of acidification
processes to different food products
Identify an acidified food product
Identify buffering capacity of food products when
dealing with acidification processes
Evaluate glass container closures and defects
Interpret the regulations (21 CFR 108, 114) to
determine if the firm is processing an acidified food
Target Audience: Sanitarians, investigators,
inspectors, extension agents and other regulators involved
in inspecting or advising the acidified food industry.
FD303 ADVANCED LACF (course being
updated for FY09) – no description
FD319
JUICE HACCP
Course Description: This course prepares
FDA investigators to conduct Juice HACCP Inspections
in their district. The course includes instruction on
the juice HACCP regulations, implementation of the HACCP
regulations into juice processors, and the pre-requisite
programs for juice HACCP (GMP’s, SSOP’s).
Students will attend all sessions and complete all workshops
and a post course assignment.
Objectives: Upon completion of this
course, participants will be able to:
Apply the seven (7) principles of HACCP into their
juice manufacturing inspections
Evaluate Juice HACCP plans for deviations and proper
critical control points
Prepare their own Hazard analysis and flow diagrams
for a juice manufacturing facility
Interpret the regulations (21 CFR 120) and apply
the regulations to their juice inspection
Target Audience: FDA Investigators
and State Inspectors, Supervisors, Compliance Officers,
responsible for conducting juice HACCP inspections at
juice manufacturing plants and those reviewing case
files pertaining to juice HACCP inspections.
Prerequisite: “Basics of HACCP”
series of online courses
Course Description: This course will
provide background information and a historical perspective
of the state contract auditing process. Classes will
include lectures and exercises that introduce draft
audits forms, as well as, instructions on how to prepare
for and conduct audits.
Objectives: At the conclusion of this
course, attendees will be able to:
Identify the procedures that are followed to conduct
audits of State inspectors, who conduct inspections
under FDA’s food contract
Apply the audit principles to identify and assess
issues encountered during the State contract inspections
Identify the responsibilities and roles of both
the auditor and the auditee
Target Audience: Federal and state
regulatory officials who are involved in the audits
of state contracts and who have had experience in either
oversight or joint inspection with state contractors.
Course Description: This course is
about the various types of thermal processing systems
used in the Grade A Milk program. The course covers
basic through highly advanced systems and the necessary
public health controls for each system. The course is
designed primarily for those who regulate the process.
Lectures, demonstrations, PowerPoint presentations,
case studies, and student presentations are used to
develop the understanding and skills necessary to evaluate
basic and complex pasteurization systems. Participants
using pasteurizer controllers and instrumentation and
perform hands-on practical sessions. When possible,
a processing plant field trip is integrated into the
training to demonstrate product flows and equipment
testing.
Objectives: Upon completion of this
course, participants will be able to:
Describe the function and installation requirements
for each component used in modern pasteurization systems
as stipulated in the course manual (Milk Pasteurization
Controls and Tests) and the current edition of the
Pasteurized Milk Ordinance.
Perform (in accordance with the course manual and
Appendix I of the PMO), all the tests required for
the various types of milk pasteurization systems.
Trace the product flow of pasteurization systems,
using practical exercises such as case studies, and
in-plant system evaluations, and be able to list and
describe the controls required for each component
Target Audience: Federal, state and
local regulators conducting inspections and testing
pasteurization systems of milk plants
Prerequisite: Attendance at FD372,
Milk Plant Sanitation and Inspection is recommended
but not mandatory
CEU Credits: pending
Course Duration: 4-5 days
Enrollment is limited to 40
FY08 Dates
Location
Registration Contact
FDA/ORA Trainer
04/07-11/08
Sturbridge, MA
Beth Altman
MA Food Protection Program
305 South Street
Jamaica Plain, NY 02130 Beth.altman@state.ma.us
614-983-6769
Course Description: This course was
developed to provide the participant with the knowledge
and skills necessary to evaluate and inspect the sanitary
status of milk plants, using the current applicable
sections of the current edition of the Pasteurization
Milk Ordinance, 3A Sanitary Standards, and other applicable
guidelines. Classroom discussions, exercises, audiovisuals
and milk plant field trips help provide the participant
with the following topic information: inspection techniques,
equipment and process control, identifying chemical,
biological and physical hazards, current quality assurance
concepts and milk processing sanitary procedures.
Objectives: Upon completion of this
course, participants will be able to:
Identify sanitation/public health violations in
a milk processing plant and debit them under the correct
PMO item using the current edition of the Milk Plant
Inspection Form.
List and effectively explain the public health
reason and administrative requirement for each “P”
item listed under the Pasteurized Milk Ordinance relative
to milk processing plant requirements.
Target Audience: Federal, state and
local regulators conducting inspections of milk plants
Prerequisite: N/A
CEU Credits: Pending
Course Duration: 4-5 days
Enrollment is limited to 40
FY08 Dates
Location
Registration Contact
FDA/ORA Trainer
03/10-14/08
Denver, CO
Michele Motsinger
CO Dept of Public Health & Envir
4300 Cherry Creek Drive S
Denver, CO 80246 Michele.motsinger@state.co.us
303-692-3647
FD373
STATE MILK LABORATORY EVALUATION OFFICERS WORKSHOP (LEO)
Course Description: This course is
designed for established and prospective State Laboratory
Evaluation Officers (LEO) who will be auditing Grade
A milk laboratories for accreditation under the criteria
established by the national Conference of Interstate
Milk Shippers (NCIMS) and specified in the Evaluation
of Milk Laboratories (EML) manual. This course covers
the accreditation requirements for the FDA/NCIMS Grade
A Milk Laboratory Program. Information covered includes
a review of FDA 2400 laboratory evaluation form, background
information on the program, practical application information
for auditing laboratories, and program changes. Classes
include lectures, presentations, and class participation
exercises.
Objectives: Upon completion of this
course, participants will be able to:
Recognize the procedures that are necessary to
conduct efficient and meaningful laboratory audits.
Recognize appropriate audit principles necessary
to assess compliance with the NCIMS Milk Laboratory
Program requirements.
Identify their responsibilities as State Milk LEO
and the responsibilities of others participating in
the NCIMS Milk Laboratory program.
Recall updates on significant changes that have
occurred in the NCIMS Milk Laboratory Program.
Target Audience: State laboratory
evaluation officers or candidates who will be responsible
for auditing and accrediting milk laboratories, certified
industry supervisors (CIS) and analysts under the National
Conference of Interstate Milk Shippers (NCIMS) Grade
A Milk Laboratory Program.
Prerequisite: Course FD3104 (formerly
STT 300) “Laboratory Examination of Dairy Products”
or equivalent experience in the examination of dairy
products is recommended for acceptance in this workshop
CEU Credits: Pending
Course Duration: 4 days
Enrollment is limited to 30
FY08 Dates
Location
Registration Contact
FDA/ORA Trainer
03/10-14/08
Indianapolis, IN
Thomas Graham
MOFF Rm.417 HFS-450
6502 S Archer Road
Summit-Argo, IL 60501 Thomas.Graham@fda.hhs.gov
708-728-4114
Course Description: This course is
designed for technicians responsible for the microbiological
examination of dairy products. Emphasis is given to
those laboratory procedures that support the current
“Grade A Pasteurized Milk Ordinance”.
Objectives: Upon completion of this
course, participants will be able to:
Analyze official samples of milk for all required
microbiological and chemical tests in accordance with
the current edition of the Standard Methods for Evaluation
of Dairy Products
Perform analysis of milk and milk products, be
able to correctly interpret the data and correctly
record the results on the required applicable forms,
and
Employ standardized laboratory techniques in laboratory
analysis to insure uniformity both within and between
other official laboratories
Target Audience: Federal, state and
local regulators conducting examinations of dairy products
Prerequisite: The participant should
be currently employed as an analyst within an official
laboratory or within an officially designated laboratory
as defined in the current edition of the Pasteurized
Milk Ordinance with the responsibility of analyzing
milk samples for official purposes as required under
the National Conference for Interstate Milk Shippers
guidelines.
CEU Credits: Pending
Course Duration: 3 days
Enrollment is limited to 2
FY08 Dates
Location
Registration Contact
FDA/ORA Trainer
04/28-05/02/08
Indianapolis, IN
Thomas Graham
MOFF Rm417 HFS-450
6502 S Archer Road
Summit-Argo, IL 60501 Thomas.Graham@fda.hhs.gov
708-728-4114
Course Description: This course is
intended for those regulators who inspect Grad A Dairy
Fams under the NCIMS program. The course covers all
Pasteurized Milk Ordinance and Code sanitation/inspection
requirements for a Grade A operation. Training modules
include classroom discussion, exercises and dairy farm
field trips emphasizing the sanitary requirements, inspection
guidelines and methods to effectively evaluate compliance
with current Grade A Pasteurized Milk Ordinance requirements.
Objectives: Upon completion of this
course, participants will be able to:
Demonstrate through practical classroom and field
trip exercises, an acceptable level of inspection
competence and compliance with the dairy farm requirements
as provided in the appropriate items or the current
edition of the Pasteurized Milk Ordinance and identify
the violations on the current Dairy Farm Inspection
Form.
Demonstrate through written examination and class
exercises an acceptable level of confidence in determining
compliance with the current regulations and guidelines
relative to the storage and use of animal drugs
Evaluate individual water supply systems on dairy
farms and determine compliance with the ordinance
and EPA regulations
Target Audience: Federal, state and
local regulators conducting inspections of dairy farms
Prerequisite: Participants should
have at least one year of dairy farm inspection experience.
CEU Credits: Pending
Course Duration: 4-5 days
Enrollment is limited to 40
FY08 Dates
Location
Registration Contact
FDA/ORA Trainer
02/25-29/08
Baton Rouge, LA
Gary Cazaubon
LA Dept of Health & Hospitals
628 North 4th Street
Baton Rouge, LA 70821-4489
225-342-7655 GCazaubo@dahh.la.gov
FD376
NCIMS Dairy HACCP (not currently being
offered)
Course Description: This course is
for those regulators whose state agency desires to list
Grad A Milk plants on the IMS list under the optional
HACCP listing. It covers the listing process and includes
basic HACCCP principles with a dairy processing element.
Lectures, PowerPoint presentations, case studies, and
student presentations are used to develop the understanding
and skills necessary to audit an NCIMS HACCP system
with a level of certainty that protects public health
as adequately as the traditional inspection/rating/listing
system.
Objectives: Upon completion of this
course, participants (industry, state regulatory personnel
(SRP), state rating officers (SRO) and FDA Regional
Milk Specialists (RMS)) will be able to will be able
to:
Demonstrate knowledge of the seven principles of
HACCP and the major requirements of Appendix K - HACCP Program of the Grade "A" Pasteurization Milk Ordinance (PMO)
Through the application of audit observations, document
that the HACCP system is in compliance or non- compliance
with the requirements of the NCIMS Dairy HACCP program
using root cause analysis techniques.
Evaluate the compliance of a NCIMS Milk plant HACCP
system to include an evaluation of the completeness
and accuracy of milk plant HACCP system and the associated
records used to document product flow diagrams, product
hazard analyses, prerequisite programs, (including
implementation records and follow up) HACCP plans
and other NCIMS requirements.
Milk Plant Industry Representatives
Will be able demonstrate their ability to write
an effective and comprehensive root cause analysis
and corrective action plan.
State Regulatory Agency Representatives:
Will be able to evaluate records, “mock”
regulatory audit observations, and be able to successfully
complete the current version of the MILK PLANT
HACCP SYSTEM AUDIT REPORT and develop corrective
action time lines for HACCP system deficiencies.
State Milk Sanitation Rating Officers and
FDA Milk Specialists:
Will be able to evaluate records, “mock”
regulatory observations and successfully complete
the MILK PLANT HACCP SYSTEM AUDIT REPORT and
the NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW
REPORT
Target Audience: Federal and state
regulators and industry participants in the NCIMS Dairy
HACCP program. All federal, state regulatory personnel
and industry participants in the NCIMS Dairy HACCP program
are required to attend this course. FDA milk specialist
and state rating officers cannot be certified for HACCP
listings until they have successfully completed this
course.
Prerequisite: All attendees are expected
to have participated in a HACCP training offered by
industry, ORA U web based programs, or educational groups
with dairy manufacturing emphasis. SRP, SRO and RMS
shall have met the requirements for holding their current
regulatory positions.
FD471
ASEPTIC PROCESSING FOR MILK (not
currently being offered)
Course Description: This course focuses
on the principles and concepts of aseptic thermal processes.
This course will cover the advanced technology and techniques
involved with an aseptic system. It will focus o the
thermal process establishment, temperature distribution,
process documentation, advanced aseptic systems and
container technology. Instruction focuses on conducting
intensive inspections of aseptic milk operations for
compliance with the Food, Drug and Cosmetic Act, 21
CFR 108, 113 and 114 and other applicable regulations.
In addition to classroom lectures, the students will
be required to participate in a series of workshops
and exercises designed to reinforce their understanding
of the subject matter.
Objectives: Upon completion of this
course, participants will be able to:
Apply the principles and concepts of aseptic thermal
processing to assigned inspections both foreign and
domestic
Determine process deviations during record review
Calculate thermal processing values for aseptic
retort processing
Evaluate aseptic processing equipment
Target Audience: FDA and state regulatory
officials responsible for inspecting aseptic milk processing
plants
Prerequisite: Because of the advanced
nature of the material presented, only those individuals
dealing directly with advanced processing operations
should attend.
Course Description: Regulatory specialists,
industry representatives, dairy consultants, and other
authorities comprise the workshop instructional staff.
This course meets the National Conference on Interstate
Milk Shipments criteria for State Milk Rating Officers
certification. Course content is advanced and is designed
to meet specific needs of the State Milk Rating Officers.
Previous workshops have included the following topics:
aseptic systems, dry milk processing technology and
standards, computerized systems, process engineering,
milk laboratory issues, HACCP, NCIMS ratings issues
and conference changes.
Objectives: Upon completion of this
course, participants will be able to:
List and explain the current requirements and conference
changes relative to conducting both state and federal
ratings of NCIMS listed Grade A milk supplies
Demonstrate acceptable methods for collecting the
field and administrative information and be able to
accurately calculate Grade “A” Milk Sanitation
and Enforcement Ratings using current NCIMS guidelines,
including the “Procedures and Methods of Making
Ratings of Grade A Milk Supplies”
Target Audience: State Milk Rating
Officers conducting ratings of dairy farms and milk
processing plants under National Conference of Milk
Shippers guidelines and procedures
Prerequisite: Because of the advanced
nature of the material presented during this course,
only those individuals dealing directly with advanced
dairy processing operations should attend.
CEU Credits: Pending
Course Duration: 4 days
Enrollment is limited to 40
FY08 Dates
Location
Registration Contact
FDA/ORA Trainer
12/10-14, 2007
Columbia, MD
Ted Elkin
MD Dept of Hlth & Mental Hygiene
6 St. Paul St. Ste 1301
410-767-8430 telkins@dhmh.state.md.us
Course Description: This course is
designed for federal and state milk rating and regulatory
personnel. The course content is generally “tailored”
to meet the specific needs of the sponsoring state and
region. Key topics may include aseptic systems, ESL
and HHST systems, computer controls, packaging and filling
technology, and advanced CIP systems.
Objectives: Upon completion of this
course, participants will be able to:
Evaluate compliance through classroom exercises
or in-plant evaluations of advanced milk pasteurization/processing
systems including but not limited to HHST, UP, and
Aseptic Processing and Packaging systems.
Describe the controls necessary for both direct
and indirect heating systems used in the pasteurization
of milk products.
Describe the required tests applicable to advanced
systems including direct and indirect heating systems.
Calculate minimum holding tube lengths using the
tables provided in the current edition of the Pasteurized
Milk Ordinance.
Target Audience: Federal, state and
local regulators conducing inspections of milk processing
plants utilizing advanced milk pasteurization processing
systems.
Prerequisite: Because of the advanced
nature of the material presented during this course,
only those individuals dealing directly with advanced
dairy processing operations should attend.
CEU Credits: Pending
Course Duration: 4 days
Enrollment is limited to 40
FY08 Dates
Location
Registration Contact
FDA/ORA Trainer
05/19-23/08
Reynoldsburg, OH
Charles Twining
Ohio Dept of Ag, Dairy Div.
8995 East Main Street
Reynoldsburg, OH 43068
614-466-5550 twining@mail.agri.state.oh.us
Course Description: This course is
designed for state and local government shellfish program
personnel with minimal knowledge in shellfish sanitation.
The course will cover the public health aspects of shellfish
plant inspections. Specific topics covered in the course
include the introduction to the National Shellfish Sanitation
Program (NSSP), shellfish biology, plant premises, plant
interior, water supply, plumbing, cross-connections,
equipment and utensils, non-food contact surfaces, and
records. This course is a perquisite to FD241, Shellfish
State Standardization Officer.
Objectives: Upon completion of this
course, participants will be able to:
Apply consistent interpretation and application
of the NSSP requirements
List and discuss the basic equipment used in a processing
plant
Recognize and determine the various biological entities
or function of shellfish biology applicable to sanitation
and associated public health
Target Audience: Federal, state and
local regulators conducting inspections of shellfish
plants
Course Description: This is the final
course in the series required for qualification as a
State Shellfish Standardization Officer under the National
Shellfish Sanitation Program. The course teaches the
uniform application of the requirements of the NSSP
Model Ordinance, and helps prepare the candidate for
the field component of the standardization process.
There is a brief review of HACCP principles as applied
to shellfish processing plants; discussion of model
sanitation standard operating procedures (SSOPs) and
associated records; explanation of the requirements
of the Model Ordinance from the requirements; and methods
and forms for the review of the required records. Inspection
and recording techniques are discussed.
Individuals seeking certification are required to pass
a final exam with a minimum score of 70%. Certification
as a State Standardization Officer is dependent upon
satisfactory completion of this course and the field
component of the standardization process. The field
standardization component is not part of this course.
Methods of instruction used include course manuals,
supplementary handouts, case examples, question/answer
and discussion sessions, lecture, and audio-visual aids.
*Note: The State Standardization Officers
who are currently certified have fulfilled the Basic
Shellfish Sanitation course requirement.
Objectives: Upon completion of this
course, participants will be able to:
Apply the HACCP Principles to the NSSP requirements
Identify the sanitation requirements
Identify additional Model Ordinance requirements
Target Audience: Regulators who are
seeking qualification as State Shellfish Standardization
Officers under the National Shellfish Sanitation Program.
Prerequisite: Satisfactory completion
of each of the following courses:
Course Description: The purpose of
this course is to teach applied methods of shoreline
survey requirements and concepts. This course will familiarize
the student with basic concepts of sanitation for shellfish
growing and harvest areas. Methods of instruction include
workshops, problem solving, case examples, and discussions.
The specific subject matter will vary based on local
needs. Examples of topics include: NSSP basic concepts
and requirements, sanitary practices for commercial
shellfish harvesters, biology of shellfish as related
to public health, shellfish pollution, sampling, reporting,
and record keeping requirements.
A scientific calculator is required to participate
fully and take the examination.
Objectives: Upon completion of this
course, participants will be able to:
Apply methods of shoreline survey requirements
and concepts
Identify the basic concepts of sanitation for shellfish
growing and harvest areas
Identify the diseases associated with shellfish
consumption and biology
Target Audience: Federal, state, and
local regulators conducting inspections of shellfish
growing areas.
Course Description: Consistent with
the second objective of the 2004 FDA Produce Safety
Action Plan, this course provides training to promote
consistency of investigations and the identification
of potential sources of contamination focusing at the
farm and packing operations.
The primary goal of the Produce Farm Investigations
course is to provide inspectors and investigations with
the most up-to-date information on practices and conditions
associated with the primary production, packing, and
further processing of fresh produce as they may relate
to the risk (or reduced risk) of microbial contamination.
The course will include observations from recent inspections
and outbreak investigations, as well as covering investigational
techniques and reporting.
The course will be presented in a classroom environment,
with both classroom and field instruction and study.
A final assessment will be administered for completion
of the course. The final assessment will be used to
evaluate both the effectiveness of training presented
and the student’s grasp of the material covered.
Objectives: Upon completion of this
course participants will be able to:
Gain the knowledge and skills to conduct effective
and efficient produce farm investigations that are
consistent with the agency’s mission and policies
to provide safe produce to the public.
Apply current Good Agricultural Practices (GAPs)
and Good Manufacturing Practices (GMPs) during investigations
(including ample collections) to effectively and consistently
identify and assess potential sources of contamination
of fresh product at the farming and packing operation
level.
Report investigation activities and finding in
a complete, clear and timely fashion.
Target Audience: FDA field investigators
and analysts as well as inspectors from states which
grow, harvest, and/or pack fresh produce and conduct
farm investigations as a result of complaints, positive
laboratory findings, foodborne illness and/or tracebacks
of implicated product back to the farm.
Course Description: The course is
designed for regulatory program personnel who are involved
with tissue residue violations, and participants will
acquire skills and knowledge in gathering, developing,
and documenting evidence during investigations. Topics
with livestock, dairy and poultry will include investigational
techniques, regulations, polices, residue sources, extra
label use of veterinary drugs, and include production
and marketing practices of animal derived foods.
Objectives: Upon completion of this
course, participants will be able to:
Identify appropriate investigative and data gathering
techniques for conducting on-farm investigations of
violative tissue residues.
Identify the documentation required for the development
of a successful enforcement action.
Recognize animal diseases, types of drugs used
to treat these diseases, animal management practices
for the various food-animal production classes, the
causes of drug residues, and the development and implementation
of prevention strategies
Target Audience: Federal and state
regulators (investigators, inspectors, and compliance
officers) conducting tissue residue investigations
Course Description: This
course will train new system users on all aspects of
data entry, queries, and reports. RVIS responsibilities
for District Program Monitors will be clearly identified
and explained. The course will update current District
Program Monitors and their back-ups on RVIS enhancements
under ORACLE 6i as well as the use of new reports and
queries.
Objectives: At the completion
of the course, students will be able to:
Access Food Safety and Inspection Service-reported
violator information from the Residue Violation Information
System
Identify patterns of egregious violations
Add Federal/State inspectional information
Target Audience: Residue Program
Monitors and their designated back-ups.
Course Description: This course is
designed for regulatory program personnel who are actively
involved in medicated feed programs. Participants will
acquire skills and knowledge in medicated feed GMP’s,
critical control points pertaining to the manufacturing
of quality medicated feeds, and proper reporting of
significant deviations from GMP’s during medicated
feed inspections. Also included will be discussions
of the BSE regulation and inspection requirements.
Objectives: Upon completion of this
course, participants will be able to:
Differentiate between the regulations that apply
to FDA-licensed medicated feed mills and those regulations
that apply to unlicensed feed mills.
Determine when drug assays are required.
Develop the knowledge of record-keeping requirements
that apply to medicated feed mills.
Identify recent developments in the medicated feed
arena.
Target Audience: Federal, state and
local regulators conducting inspections of medicated
feeds
Prerequisite: Participants should
be actively involved in at least “basic/non-medicated”
feed mill inspections
Course Description: This course is
intended to instruct field investigators on the laws,
regulations and policies pertaining to compounding of
animal drugs and the Animal Drug Use Clarification Act
related to the extra-label drug use in animals.
Compounding of animal drugs has increased exponentially
in the last few years. Certain compounding practices
undermine the animal drug approval process, and present
unknown and potentially hazardous risk to animal and
human health. Animal drug compounding is addressed in
various laws, regulations, and policies. In order to
adequately assess violations of concern, investigators
need to understand the laws, regulations and policy
that distinguish animal from human drug compounding.
Extra-label drug use practices may especially result
in violative food animal tissue residues. Investigators
need to understand under what circumstances extra-label
drug use can or cannot be utilized in veterinary medicine.
Objectives: Upon completion of this
course, participants will be able to:
Describe the regulations and guidance documents
that address the proper use of animal drugs, the compounding
of drugs for use in animals, and the extra label use
of drugs in animals.
Recognize appropriate investigative and data gathering
techniques for conducting investigations of compounding
pharmacies, veterinarians and food animal producers.
Correctly complete the documentation required for
the development of a successful enforcement action.
Target Audience: This course is intended for state, local and FDA field investigators who inspect animal drug compounding pharmacies and veterinarian extra label drug use in the practice of veterinary medicine in food producing animals.
Prerequisite: Participants should
have previous experience on inspections involving animal
drugs.
Course Description: This course will
provide background information and a historical perspective
of the state contract auditing process for BSE and/or
Medicated Feed Mill inspections. Classes will include
lectures and exercises that introduce draft audits forms,
as well as, instruction on how to prepare for and conduct
audits.
Objectives: Upon completion of this
course, participants will be able to:
Identify procedures that are followed to conduct
efficient and meaningful audits of State inspectors
and/or a program audit under FDA’s BSE/Medicated
Feed Mill contracts.
Apply audit principles to identify and assess areas
for improvement observed during the state contract
inspection.
Define the responsibilities and roles of both the
auditor and the auditee.
Target Audience: FDA co-project officers,
Consumer Safety Officers (i.e. investigators), and/or
state personnel who will have the lead in auditing state
inspectors and/or the program under state BSE/Medicated
Feed Mill inspection contracts. Courses are scheduled
by their primary audience as related to the audit: state
personnel or FDA personnel.
FDA Consumer Safety Officers, who routinely work with
FDA’s state BSE/Medicated Feed Mill contract audit
program should attend the course held in Rockville,
MD.
Course Description: This course is
intended to instruct state and FDA field investigators
on how to conduct and record inspections under the ruminant
feed ban regulation, 21 CFR 589.2000
Bovine Spongiform Encephalopathy (BSE) is the bovine
form of a group of uniformly fatal neurological diseases
known as Transmissible Spongiform Encephalopathies (TSEs).
BSE appears to be spread through the feeding of infected
material to cattle. BSE is a public health issue for
the U.S. This disease has been linked to the human TSE
known as variant Creutzfeldt-Jakob Disease (vCJD), presumably
through people consuming ruminant tissues infected with
the BSE agent. In addition, BSE has had a devastating
economic effect on the livestock industry in countries
where it has been identified or suspected.
On August 4, 1997, the “Animal Proteins Prohibited
From Use In Animal Feeds” regulation, 21 CFR §589.2000,
became effective. This regulation is designed to prevent
the establishment and amplification of BSE through animal
feed, by prohibiting the use of certain proteins derived
from mammalian tissue in the feeding of ruminant animals.
This regulation affects renderers, protein blenders,
commercial animal feed manufacturers, distributors (including
retailers), transporters of animal feed and feed ingredients,
on-farm animal feed mixers, and ruminant feeders. Based
on the acute need to control the entry and spread of
this disease, the Agency has set a goal of full compliance
with the regulation.
Objectives: Upon completion of this
course, participants will be able to:
Recognize the inspection basics of Compliance Program
Guidance 7371.009, “BSE/Ruminant Feed Ban Inspections”
relating to:
prohibited materials not to be used in ruminant
feeds
definitions of renderer/transporter/distributor/feed
manufacturer and ruminant feeder.
major inspectional questions to ask. Does the
firm:
receive / process prohibited material?
handle prohibited material?
label feed with prohibited material with
proper cautionary statements?
conduct the required recordkeeping?
avoid commingling of prohibited materials
with non prohibited materials?
Accurately complete the FDA checklist, “Report
of Inspection for Compliance with 21 CFR 589.2000,
based on informational scenarios provided by the instructors.
Target Audience: Federal, state and
local regulators conducting inspections of firms subject
to the ruminant feed ban regulation as outlined in 21
CFR 589.2000.
Prerequisite: Participants should
have previous experience on conducting inspections under
the ruminant feed ban regulation.
