The
Ohio State University
Department of Food Science and Technology
Instructors:
Melvin Pascall, Ph.D. 225 Parker Hall. 614-292-0287.
Email: pascall.1@osu.edu
Office hours:
M & W 1-3pm. (Dr. Pascall)
Credits: 3
Class time:
Tu, Th 5:00 - 6:30pm.
Classroom:
118 Parker Food Science
Prerequisites:
FST 401 or permission of lecturer
T.A:
Lizanel Feliciano. 230
Parker Hall.
Email: feliciano.16@buckeyemail.osu.edu
Optional Text:
Federal, Food Drug and Cosmetic Act as amended, and Related Laws. U.S.
Government Printing Office, Washington, D.C. (Available on the web and on
reserve)
Health Law: Federal Regulation of Drugs, Biologics, Medical
Devices, Food and Dietary Supplements. 2nd Ed. 2004. Roseann
Termini. Forti Publications.
Recommended (Available on the web):
Code of Federal Regulations, Title 21, Parts 1-99, Parts 100-169 and Parts
170-199. (http://vm.cfsan.fda.gov/~dms/opa-toc.html)
Objectives:
Students completing FST 640 should:
·
Be familiar with the Code of Federal
Regulations and be able to determine which regulations are applicable to a
given food product.
·
Be able to identify the laws and regulations
that pertain to a given processes and to design the process so that these
regulations are met.
·
Be able to identify the laws regarding the
use of ingredients and additives required for the production of a product
and be able to formulate a product in compliance with these regulations.
·
Be able to recommend a HACCP plan for a
product that will comply with the appropriate regulations for that type of
product.
·
Be able to design a nutritional and content
label that complies with the NLEA and other appropriate regulations for a
given class of products.
·
Be able to review an advertising plan to
ensure that it is in compliance with the appropriate regulations regarding
product labeling and representation.
·
Be able to understand the relationship
between food laws and food safety.
Course Outline:
1. History and Evolution of Modern Food Laws and regulations. –
a. In the beginning...
b. Federal Food, Drug and Cosmetic Act
c. Federal Meat Inspection and
Poultry Products Act
d. Fair Packaging and Labeling Act
e. Federal
Trade Commission Act
f. Infant
Formula Act
2. The Scope
of the Federal Food, Drug and Cosmetic Act. The Statute, Its Breadth and
Depth –
a. Foods
b. Drugs
c. Cosmetics
3. The
Nature, Structure and Function of the USDA and the Food and Drug
Administration
a. Federal Agency
b.
District Offices and Residue Posts
c. Safe-Guarding the Food Supply
d.
Importance of Consumer Complaints
e. Crisis Management
4. Food Safety
a. Ingredients
b.
Current GMP
c. Food Modernization
Act 2011
d. HACCP
e. Impact of the
Homeland Security/bioterrorism laws.
5.
Food Labeling
a. NLEA
b. Promotion
c. Advertising
6. Prohibited Acts and Penalties
a. Adulteration
b.
Misbranding
c. Misrepresentation
7. Compliance and Investigation
and Enforcement
a. Notice of Inspection
b. Inspection
c. 483 Observations
d. Warning Letters
e. Seizures
f. Recalls
g. Prosecution
h. Consent Agreements
8.
Observation of food safety issues in a real world environment
a. Class discussion of
term paper topics
b. Class presentations
9.
Summary of class discussions and term paper due
Term Paper
Assignment:
The class would
divided into groups of approximately four students. Each group would be
given one topic on an aspect of food safety. The group should meet at
their convenience, discuss this topic and each student must write a report
(term paper).
Examples of food
safety topics are:
A. Summarize three FDA
inspector’s 483 reports produced during 2009-2011 (found on FDA’s website).
B. The company’s guidelines for preparation of a FDA/USDA visit.
C.
Discuss three recent recalls (During the year 2010-2011).
D. Discuss the
reasons why FDA adapted the juice and seafood HACCP plan.
E. Discuss the
main features of the Food Safety Modernization Act 2011.
E. More
topics will be given during the class.
The final term paper
must be: typed, single
spaced, 12 point (Times New Roman font), 1 inch
margin and should contain from 3 to 5 pages. It should contain a
cover-page with your name, class title and the topic of your paper. This
cover-page is not counted as one of the 3 to 5 pages. This report will
be due on March 6, 2012.
All pages should be numbered.
The body of the paper
should be arranged according to the following: 1. Introduction (a brief
description of the topic and its relevance to food safety, quality and/or
fair trade); 2. Discussion (the main body of the paper – it should include a
detail discussion of the subject matter, including references that must be
cited at the end of the paper); 3. Summary (a brief bullet-point summary of
the main points of the paper); 4. References (a list of the references cited
in the body of the paper – this should include the authors, year published,
page number and journal, book, website, etc. where the citation could be
found).
The term paper will be
graded accordingly:
1.
Paper format (correct
margins, font, pages, etc.) 10 points
2.
Introduction
15 points
3.
Body of paper
60 points
4.
Summary
10 points
5.
References
5 points
Total
100 points
Grading:
Points
Class attendance and participation 10
Quiz 20
Class presentations 20
First mid-term 60
Second mid-term 90
Term paper 100
Grading Scale
A: 93% 300-280 C+: 77% 239-230
A: 90% 279-270 C: 73% 229-220
B+: 87% 269-260 C-: 70% 219-210
B: 83% 259-250 D+: 67% 209-200
B-: 80% 249-240 D: 63% 199-190
E: <63% Below 189
Academic
Misconduct:
This course requires group participation and
cooperation. The project will be a group report and as such will require
working together. You are expected to marshal all the resources you can
towards solving your problem and thus, consultation with others is expected
and this will not constitute academic misconduct. Plagiarism and
falsification of information will be dealt with following the academic
misconduct rules of The Ohio State University.
Disability
Services:
If you need an
accommodation based on impact of a disability, you should contact the
instructor to arrange an appointment as soon as possible. At the
appointment we can discuss the course format, anticipate your needs and
explore potential accommodations. We rely on the Office for Disability
Service for assistance in verifying the need for accommodations and
developing accommodation strategies. If you have not previously
contacted the Office for Disability Services, we encourage you to do so.
FST 640 FOOD REGULATIONS
|
Date 2012 |
Topic |
|
|
Wk1. History & Evolution of
Modern Food Laws & Regs |
|
1/3 TU |
Introduction to Food Law |
|
1/5 TH |
Introduction to Food Law; Federal Food Drug
& Cosmetic Act |
|
WK2.
History & Evolution of Modern Food Laws & Regs |
|
|
1/10 TU |
Federal Meat Inspection & Poultry Products
Act; Fair Packaging & Labeling Act ; Federal Trade Commission
Act |
|
1/12 TH |
Infant Formula Act; Roles and
Responsibilities |
|
WK3. Scope of the Food Drug & Cosmetic
Act (Quiz) |
|
|
1/17 TU |
Foods, Drugs and Cosmetics |
|
1/19 TH |
Safe-Guarding the Food Supply; Importance
of Consumer Complaints; |
|
WK4. The Nature, Structure and Function
of the FDA & USDA |
|
|
1/24 TU |
Federal Agency, District Offices and
Residue Posts |
|
1/26 TH |
USDA and meat inspection |
|
WK5. Food Safety |
|
|
1/31 TU |
Ingredients; Current GMP |
|
2/2 TH |
Midterm Examination |
|
WK6. Food Safety |
|
|
2/7 TU |
HACCP; |
|
2/9 TH |
2011 Food Modernization Act; Homeland
Security Act |
|
WK7. Food Labeling |
|
|
2/14 TU |
NLEA – labeling |
|
2/16 TH |
Promotion; Advertising; Misbranding;
Misrepresentation |
|
WK8. Prohibited Acts and Penalties
(Quiz) |
|
|
2/21 TU |
Adulteration |
|
2/23 TH |
Notice of inspection; Inspection; 483
observations – term paper topics to be given out |
|
WK9. Compliance, Investigation and
Enforcement & Plant Tour |
|
|
2/28 TU |
Warning letters;
Seizures; Prosecution; Consent agreements |
|
3/1 TH |
Second Midterm
Examination |
|
Wk10. Class Summary |
|
|
3/6 TU |
Oral Presentations –
term paper due |
|
3/8 TH |
Oral Presentations; Review and graded term
paper given out |
|
3/15 TH |
Make up Examination |