Principles of Food Sanitation

Sanitation laws and regulations and guidelines

Since thousands of laws, regulations, and
guidelines are currently in effect to control
the production, processing, and preparation
of food in the United States, it would be
impossible to address all of these rules in this
book. Thus, it is not the intent of this chap-
ter or this book to emphasize the specific
details of food processing, or preparation,
regulations. Only the major agencies involved
with food safety and their primary respon-
sibilities are discussed. The reader should
consult regulations available from various
jurisdictions to determine specific require-
ments for the food operation and area where
it is located. It is inappropriate to discuss
regulatory requirements for cities and coun-
tries because they have designated govern-
mental entities with their own food safety
criteria (Bauman, 1991), which often differ
from one area to another and can change
periodically.
Sanitation requirements developed by leg-
islative bodies and regulatory agencies in
response to public demands are detailed
in laws and regulations. They are not static
but change in response to sanitation, pub-
lic health, and new scientific and technical
information regarding biological, chemical,
and physical hazards and other important
issues brought to public attention.
Lawsare passed by legislators and must be
signed by the chief executive. After a law has
been passed, the agency responsible for its
enforcement prepares regulationsdesigned to
implement the intention of the law or the
act. Regulations are developed to cover a wide
range of requirements and are more specific
and detailed than are laws. Regulations for
food provide standards for building design,
equipment design, commodities, tolerances
for chemical or other food additives, sanitary
practices and qualifications, labeling require-

ments, and training for positions that require

certification.

Regulation development is a multistep

process. For example, in the federal process,

the relevant agency prepares the proposed

regulation, which is then published as a pro-

posed rule in the Federal Register. The Federal

Registeris the official daily publication for

rules, proposed rules, and notices of federal

agencies and organizations as well as execu-

tive orders and other presidential documents.

Accompanying the proposal is information

related to background. Any comments, sug-

gestions, or recommendations are to be

directed to the agency, usually within 60 days

after proposal publication, although time

extensions are frequently provided. The regu-

lation is published in final form after com-

ments on the proposal have been reviewed,

with another statement of how the comments

were handled and specifying effective dates

for compliance. This statement suggests that

comments on matters not previously consid-

ered in the regulations may be submitted for

further review. Amendments may be initiated

by any individual, organization, other govern-

ment office, or by the agency itself. A petition

is necessary, with appropriate documents that

justify the request.

There are two types of regulations:sub-

stantive and advisory. Substantive regula-

tions are more important because they have

the power of law. Advisory regulations are

intended to serve as guidelines. Sanitation

regulations are substantive because food

must be made safe for the public. In regula-

tions, the use of the word shall means a

requirement, whereas shouldimplies a rec-

ommendation. Several regulations impor-

tant to sanitation by various governmental

agencies will now be addressed.

Food and Drug Administration Regulations

The FDA, responsible for enforcing the

Food, Drug, and Cosmetic Act, as well as

Sanitation and the Food Industry 9