FDA's mandate to ensure the safety of
the nation's food supply is derived principally from the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.).
Under the act, FDA has authority to ensure that all foods in
interstate commerce, or that have been shipped in interstate
commerce, are not contaminated or otherwise adulterated, are
produced and held under sanitary conditions, and are not misbranded
or deceptively packaged. Under 21 U.S.C. 371, the act authorizes
the agency to promulgate regulations for its efficient enforcement.
The agency also has authority under the Public Health Service Act
(42 U.S.C. 264) to promulgate and enforce regulations to prevent
the introduction, transmission or spread of communicable diseases
from one State, territory or possession to another, or from outside
the United States into this country. The "Hazard Analysis and
Critical Control Point (HACCP); Procedures for the Safe and
Sanitary Processing and Importing of Juice" regulations establish
Part 120 of Title 21 of The Code of Federal Regulations, which
requires the use of (HACCP) methods by processors of fruit and
vegetable juices. HACCP is a system of preventive controls, which
was advocated by President Clinton in his remarks on Food Safety
Regulations on October 2, 1997. The rationale in establishing a
HACCP system of preventive controls is to design and check the
process so that the final product is not contaminated - not test
for contamination after it may have taken place. Under HACCP,
processors of fruit and vegetable juices establish and follow a
pre-planned sequence of operations and observations (the HACCP
plan) designed to avoid one or more specific food hazards, and
thereby ensure that their products are safe, wholesome, and not
adulterated; in compliance with section 402 of the act (21 U.S.C.
342). The foundation of a HACCP system is the use of current good
manufacturing processes (CGMPs) and prerequisite program standard
operating procedures (SOPs). The hazard analysis and HACCP plan
builds on this foundation. By design, the HACCP method relies
heavily on monitoring the critical control points established in
the HACCP plan, and periodically recording the conditions at
control points during the processing operations leading to the
finished product. These recorded observations are necessary to
verify adherence to the established control conditions during the
critical processing operations, and thereby demonstrate that the
finished food is safe. Information development and record keeping
are essential parts of any HACCP system. The information collection
requirements of these regulations are narrowly tailored to focus on
the development of appropriate controls and documenting those
aspects of processing that are critical to food safety. Through
these regulations, FDA is implementing its authority under 21
U.S.C. 342(a)(4). The information development and record keeping
requirements of these regulations are likewise an implementation of
21 U.S.C. 342(a)(4). Under the authority of section 704 of the act
(21 U.S.C. 374), FDA periodically inspects the facilities of, and
collects samples from, domestic food processors to determine
whether food is prepared, processed, and packaged in compliance
with the adulteration (section 402), (21 U.S.C. 342 (a)(3) and
(a)(4)), misbranding, and other provisions of the act. FDA also
inspects and samples foods imported to the U.S. under the authority
of section 801 of the act (21 U.S.C. 381). Compliance of foods with
the act and its derivative regulations can often be established
only by costly and statistically imperfect sampling and laboratory
testing of finished products for physical, chemical, or microbial
adulterants. HACCP procedures can largely eliminate the need for
extensive testing of finished products. HACCP procedures yield
products that are known, with a high degree of confidence, to be
free of the hazards controlled by the plan.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0466 42 USC 264 7-10-2007.doc
Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice