FST 640 - Food Regulations
Winter 2007

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

Randal McKay, Esq. Ross Laboratories, Columbus, OH. 614-624-3688.

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

Required 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. 2^nd 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. –  Dr. McKay

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. Case History Study -- Infant Formula Act.

2. The Scope of the Federal Food, Drug and Cosmetic Act. The Statute, Its Breadth and Depth – Dr. McKay

a. Foods
b. Drugs
c. Cosmetics
d. Medical Devices
e. Biologics

3. The Nature, Structure and Function of the Food and Drug Administration – Guest Lecturers (USDA and FDA)

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 – Dr. Pascall

a. Ingredients
b. Current GMP
c. HACCP

d. Impact of the Homeland Security/bioterrorism laws.

Midterm Examination

5. Food Labeling – Dr. Pascall

a. NLEA
b. Promotion
c. Advertising

6. Prohibited Acts and Penalties – Dr. Pascall

a. Adulteration
b. Misbranding
c. Misrepresentation

7. Compliance and Investigation and Enforcement – Drs. Pascall and McKay

a. Notice of Inspection
b. Inspection
c. 483 Observations
d. Warning Letters
e. Seizures
f. Recalls
g. Prosecution
h. Consent Agreements

8. Plant tours – Drs. Pascall and McKay

a. Observation of food safety issues in a real world environment.

b. Simulated FDA inspection of a food processing operation.

9. Class discussions of plant tours and tour report due – Drs. Pascall and McKay.

Plant Tour Assignment:
The class would visit one food processing facility. The class would observe the systems in place for compliance with FDA/USDA CGMP, labeling and HACCP regulations. The class would be divided into groups of approximately five students. Each group would select one aspect of food safety relating to the plant visit, discuss this topic and each student writes a report.

The food safety topics to be selected are:

A. FDA inspector’s 483 report of the plant visit.
B. The company’s guidelines for preparation of a FDA/USDA visit.
C. The company’s recall policy
D. The company’s HACCP plan.

The final report must be typed, space and a half and should contain from 5 to 10 pages. This report will be due on March 7^th 2006.

Grading:

Mid-Term                100

Final                        100

Plant tour assign.     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.

Ohio State University

FST 640

FOOD REGULATIONS