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1994 FDLI Update 3 (1994)

handle is hein.journals/fdliup1994 and id is 1 raw text is: A
The Food and Drug Law Institute
UPDATE
V

Regulation

-   Education

March   1994                                                Route to: Q           Q         Q

Message from the Chairman
By Alfred A. Piergallini, Ger-
ber Products Company
It is my pleasure as Chair-
man of The Food and Drug
Law Institute to report on what
I see as FDLI's direction next
year. The Institute has had tre-
mendous success during the
last several years in the areas
of conferences, publications
and our other educational pro-
grams. These activities not
only have provided leadership in enhancing the understanding of
food and drug issues, but also have created a much more finan-
cially strong FDLI.
Our objectives during the next 12 months are built on these
successes. For example, this year we will hold, in conjunction with
FDA, several additional satellite video conferences in the medical
device field. The satellite video conferences conducted this past
year have been very well received by all those involved. I person-
ally hope that we can encourage FDA to join with us in similar sat-
ellite video conferences in other food and drug fields in the
coming year, as these conferences offer a unique opportunity for a
timely dialogue on some of the most important issues of the day.
I also want to extend to related fields our historical success
in increasing the awareness and understanding, at law schools, of
food and drug laws. For example, we are currently working on a
drug law curriculum to be offered to pharmacy law professors. I
hope we are able to continue to increase the awareness of the
food and drug legal and regulatory environment to other areas
including the food science, nutrition and biomedical fields.
I look forward to FDLI's activities in the next year as the activi-
ties provide yet another step to better understanding the framework
and policies impacting all of the Institute's constituencies. A

Seafood Hazard Critical Control
Points (HACCP)
An interview with L. Robert
Lake, Center for Food Safety
and Applied Nutrition
Hazard Analysis Critical
Control Points (HACCP) is a
system  designed  to  ensure
food safety. HACCP involves
first identifying and then modi-
fying the critical points in food
preparation at which the great-  /
est risks of hazards are present.
Currently the FDA is working
to require that all seafood industries employ the HACCP system.
The FDA feels that with HACCP, national safety assurance in sea-
food will be granted. Consequently, consumer concerns will
diminish in knowing that a standardized safety procedure has been
applied to all seafood. The proposed regulation for the seafood
HACCP was published in the January 28, 1994 Federal Register.
The following is an interview with Bob Lake, Senior Associate
Director, FDA's Center for Food Safety and Applied Nutrition. He
gave Update his insights on the important issues concerning HACCP.
Q. When was the concept of HACCP introduced?
A. Historically speaking, the notion of HACCP dates back
quite a long time. HACCP was first developed in association
with NASA in the early efforts of men in space. The need for
safe food in space was apparent and HACCP was introduced as
a means to satisfy this requirement. Since then, the idea has
evolved and spread to other areas in the food industry. Now the
FDA is working to try to mandate that HACCP procedures be
continued on page 3

2 Message from the President
3 New Mammography Program at FDA
7 History of a Food and Drug Lawyer: Alan Kaplan

In This Issue
10 New Members
13 Food and Drug Law Journal
13 Food and Drug Law Report

14 People On The Move
14 Job Exchange
1 6 Conference Calendar

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