FST 640 - Food Regulations
Winter 2012

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;
 Crisis Management, Recalls

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