- Canning
FOOD
SAFETY, FISHERIES, FRUITS AND VEGETABLES AND MEAT AND POULTRY
* FDA Food Canning
Regulations
The FDA Office of Management Programs seeks public comments by
April 8, 2005 on the paperwork and regulatory burdens associated
with the extension of an Information Collection Request, titled
"Food Canning Establishment Registration, Process Filing, and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers," OMB Control Number
0910-0037 - In seeking public comments on the ICR, FDA notes that
" ... Under the Federal Food, Drug, and Cosmetic Act ... FDA is
authorized to prevent the interstate distribution of food products
that may be injurious to health or that are otherwise adulterated,
as defined in section 402 of the act ... Under the
authority granted to FDA by section
404 of the act ... FDA regulations require registration of food
processing establishments, filing of process or other data, and
maintenance of processing and production records for acidified
foods and thermally processed low-acid foods in hermetically
sealed containers. These requirements are intended to ensure safe
manufacturing, processing, and packing procedures and to permit
FDA to verify that these procedures are being followed. Improperly
processed low-acid foods present life-threatening hazards if
contaminated with foodborne microorganisms, especially Clostridium
botulinum. The spores of C. botulinum must be destroyed or
inhibited to avoid production of the deadly toxin that causes
botulism.
This is accomplished with good
manufacturing procedures, which must include the use of adequate
heat processes or other means of preservation. To protect the
public health, FDA regulations require that each firm that
manufactures, processes, or packs acidified foods or thermally
processed low-acid foods in hermetically sealed containers for
introduction into interstate commerce register the establishment
with FDA using Form FDA 2541 (Sec. Sec.
108.25(c)(1) and 108.35(c)(2) (21 CFR 108.25(c)(1) and
108.35(c)(2))).
In addition to registering the plant,
each firm is required to provide data on the processes used to
produce these foods, using Form FDA 2541a for all methods except
aseptic processing, or Form FDA 2541c for aseptic processing of
low-acid foods in hermetically sealed containers (Sec. Sec.
108.25(c)(2) and 108.35(c)(2)). Plant registration and
process filing may be accomplished simultaneously. Process data
must be filed prior to packing any new product, and operating
processes and procedures must be posted near the processing
equipment or made available to the operator (Sec.
113.87(a) (21 CFR 113.87(a)). Regulations in parts 108,
113, and 114 (21 CFR part 114) require firms to maintain records
showing adherence to the substantive requirements of the
regulations.
These records must be made available
to FDA on request. Firms are also required to document corrective
actions when process controls and procedures do not fall within
specified limits (Sec. Sec. 113.89, 114.89,
and 114.100(c)); to report any instance of potential
health-endangering spoilage, process deviation, or contamination
with microorganisms where any lot of the food has entered
distribution in commerce (Sec. Sec. 108.25(d) and 108.35(d) and
(e)); and to develop and keep on file plans for recalling products
that may endanger the public health (Sec. Sec.
108.25(e) and 108.35(f)). To permit lots to be traced after
distribution, acidified foods and thermally processed low-acid
foods in hermetically sealed containers must be marked with an
identifying code (Sec. Sec. 113.60(c)
(thermally processed foods) and 114.80(b) (acidified foods)) ..."
A paper copy of the ICR is available
from Peggy Robbins at 301 827 1223
FDA February 7 Federal Register:
http://a257.g.akamaitech.net/7/257/2422/
01jan20051800/edocket.access.gpo.gov/2005/05-2297.htm
http://a257.g.akamaitech.net/7/257/2422/
01jan20051800/edocket.access.gpo.gov/2005/05-2297.htm
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