FST 640 - Food Regulations
Winter 2010

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

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. 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. – 

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 – Guest Lecturer (USDA)

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. HACCP

d. Impact of the Homeland Security/bioterrorism laws.

Midterm Examination

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 – Guest Lecturer (FDA)

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

Second Midterm Examination

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.

Examples of food safety topics are:

A. Summarize three FDA inspector’s 483 reports produced during 2008 (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 2008-2009).
D. Discuss the reasons why FDA adapted the juice and seafood HACCP plan.
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 11, 2010.

Grading:

Quiz                       10

Mid-Term                 90

Second mid-term     100

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.

The H1N1 or ILI pandemic flu:

This threat has prompted us to look at our preparations for “Continuity of Instruction”, or our ability to offer courses or provide course material in the event of any emergency, including the flu. More will be discussed during the class in the event the issue comes up.

FST 640 FOOD REGULATIONS