[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.35]
[Page 210-214]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 108 EMERGENCY PERMIT CONTROL--Table of Contents
Subpart B Specific Requirements and Conditions for Exemption From or
Compliance With an Emergency Permit
Sec. 108.35 Thermal processing of low-acid foods packaged in hermetically
sealed containers.
(a) Inadequate or improper manufacture, processing, or packing of
thermally processed low-acid foods in hermetically sealed containers may
result in the distribution in interstate commerce of processed foods
that may be injurious to health. The harmful nature of such foods cannot
be adequately determined after these foods have entered into interstate
commerce. The Commissioner of Food and Drugs therefore finds that, in
order to protect the public health, it may be necessary to require any
commercial processor, in any establishment engaged in the manufacture,
processing, or packing of thermally processed low-acid foods in
hermetically sealed containers, to obtain and hold a temporary emergency
permit provided for under section 404 of the Federal Food, Drug, and
Cosmetic Act. Such a permit may be required whenever the Commissioner
finds, after investigation, that the commercial processor has failed to
fulfill all the requirements of this section, including registration and
the filing of process information, and the mandatory portions of part
113 of this chapter. These requirements are intended to ensure safe
manufacture, processing, and packing procedures and to permit the Food
and Drug Administration to verify that these procedures are being
followed. Such failure shall constitute a prima facie basis for the
immediate application of the emergency permit control provisions of
section 404 of the act to that establishment, pursuant to the procedures
established in subpart A of this part.
(b) The definitions in Sec. 113.3 of this chapter are applicable
when such terms are used in this section.
(c) Registration and process filing--(1) Registration. A commercial
processor when first engaging in the manufacture, processing, or packing
of thermally processed low-acid foods in hermetically sealed containers
in any state, as defined in section 201(a)(1) of the act, shall, not
later than 10 days after first so engaging, register with the Food and
Drug Administration on Form FDA 2541 (food canning establishment
registration) information including (but not limited to) his name,
principal place of business, the location of each establishment in which
such processing is carried on, the processing method in terms of the
type of processing equipment employed, and a list of the low-acid foods
so processed in each such establishment. These forms are available from
the LACF Registration Coordinator (HFS-618), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at any Food and Drug Administration
district office. The completed form shall be submitted to the LACF
Registration Coordinator (HFS-618), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park,
[[Page 211]]
MD 20740. Commercial processors presently so engaged shall register not
later than July 13, 1973. Commercial processors duly registered in
accordance with this section shall notify the Food and Drug
Administration not later than 90 days after such commercial processor
ceases or discontinues the manufacture, processing, or packing of
thermally processed foods in any establishment: Provided, That such
notification shall not be required as to the temporary cessation
necessitated by the seasonal character of the particular establishment's
production or caused by temporary conditions including but not limited
to strikes, lockouts, fire, or acts of God.
(2) Process filing. A commercial processor engaged in the thermal
processing of low-acid foods packaged in hermetically sealed containers
shall, not later than 60 days after registration and prior to the
packing of a new product, provide the Food and Drug Administration
information as to the scheduled processes including but not limited to
the processing method, type of retort or other thermal processing
equipment employed, minimum initial temperatures, times and temperatures
of processing, sterilizing value (Fo), or other equivalent scientific
evidence of process adequacy, critical control factors affecting heat
penetration, and source and date of the establishment of the process,
for each such low-acid food in each container size: Provided, That the
filing of such information does not constitute approval of the
information by the Food and Drug Administration, and that information
concerning processes and other data so filed shall be regarded as trade
secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This
information shall be submitted on the following forms as appropriate:
Form FDA 2541a (food canning establishment process filing for all
methods except aseptic), or Form FDA 2541c (food canning establishment
process filing for aseptic systems). These forms are available from the
LACF Registration Coordinator (HFS-618), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at any Food and Drug Administration
district office. The completed form(s) shall be submitted to the LACF
Registration Coordinator (HFS-618), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.
(i) If all the necessary information is not available for existing
products, the processor shall, at the time the existing information is
provided to the Food and Drug Administration request in writing an
extension of time for submission of such information, specifying what
additional information is to be supplied and the date by which it is to
be submitted. Within 30 working days after receipt of such request the
Food and Drug Administration shall either grant or deny such request in
writing.
(ii) If a packer intentionally makes a change in a previously filed
scheduled process by reducing the initial temperature or retort
temperature, reducing the time of processing, or changing the product
formulation, the container, or any other condition basic to the adequacy
of scheduled process, he shall prior to using such changed process
obtain substantiation by qualified scientific authority as to its
adequacy. Such substantiation may be obtained by telephone, telegram, or
other media, but must be promptly recorded, verified in writing by the
authority, and contained in the packer's files for review by the Food
and Drug Administration. Within 30 days after first use, the packer
shall submit to the Center for Food Safety and Applied Nutrition (HFS-
617), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740 a complete description of the modifications made and
utilized, together with a copy of his file record showing prior
substantiation by a qualified scientific authority as to the safety of
the changed process. Any intentional change of a previously filed
scheduled process or modification thereof in which the change consists
solely of a higher initial temperature, a higher retort temperature, or
a longer processing time, shall not be considered a change subject to
this paragraph, but if that modification is thereafter to be regularly
scheduled, the modified process shall be promptly
[[Page 212]]
filed as a scheduled process, accompanied by full information on the
specified forms as provided in this paragraph.
(iii) Many packers employ an ``operating'' process in which retort
operators are instructed to use retort temperatures and/or processing
times slightly in excess of those specified in the scheduled process as
a safety factor to compensate for minor fluctuations in temperature or
time to assure that the minimum times and temperatures in the scheduled
process are always met. This would not constitute a modification of the
scheduled process.
(3) Process adherence and information. (i) A commercial processor
engaged in the thermal processing of low-acid foods packaged in
hermetically sealed containers in any registered establishment shall
process each low-acid food in each container size in conformity with at
least the scheduled processes and modifications filed pursuant to
paragraph (c)(2) of this section.
(ii) Process information availability: When requested by the Food
and Drug Administration in writing, a commercial processor engaged in
thermal processing of low-acid foods packaged in hermetically sealed
containers shall provide the Food and Drug Administration with any
information concerning processes and procedures which is deemed
necessary by the Food and Drug Administration to determine the adequacy
of the process: Provided, That the furnishing of such information does
not constitute approval of the information by the Food and Drug
Administration, and that the information concerning processes and other
data so furnished shall be regarded as trade secrets within the meaning
of 21 U.S.C. 331(j) and 18 U.S.C. 1905.
(d) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall promptly
report to the Food and Drug Administration any instance of spoilage or
process deviation the nature of which indicates potential health
significance where any lot of such food has in whole or in part entered
distribution.
(e) A commercial processor engaged in thermal processing of low-acid
foods packaged in hermetically sealed containers shall promptly report
to the Food and Drug Administration any instance wherein any lot of such
food, which may be injurious to health by reason of contamination with
microorganisms, has in whole or in part entered distribution.
(f) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall have
prepared and in his files a current procedure which he will use for
products under his control and which he will ask his distributor to
follow, including plans for effecting recalls of any product that may be
injurious to health; for identifying, collecting, warehousing, and
controlling the product; for determining the effectiveness of such
recall; for notifying the Food and Drug Administration of any such
recall; and for implementing such recall program.
(g) All operators of retorts, thermal processing systems, aseptic
processing and packaging systems, or other thermal processing systems,
and container closure inspectors shall be under the operating
supervision of a person who has attended a school approved by the
Commissioner for giving instruction in retort operations, aseptic
processing and packaging systems operations or other thermal processing
systems operations, and container closure inspections, and has
satisfactorily completed the prescribed course of instruction: Provided,
That this requirement shall not apply in the State of California as
listed in paragraph (j) of this section. The Commissioner will not
withhold approval of any school qualified to give such instruction.
(h) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall prepare,
review, and retain at the processing plant for a period of not less than
one year, and at the processing plant or other reasonably accessible
location for an additional two years, all records of processing,
deviations in processing, container closure inspections, and other
records specified in part 113 of this chapter. If during the first year
of the three-year record retention period the processing plant is closed
for a prolonged period between seasonal packs,
[[Page 213]]
the records may be transferred to some other reasonably accessible
location at the end of the seasonal pack. Upon written demand during the
course of a factory inspection pursuant to section 704 of the act by a
duly authorized employee of the Food and Drug Administration, a
commercial processor shall permit the inspection and copying by such
employee of these records to verify the adequacy of processing, the
integrity of container closures, and the coding of the products.
(i) This section shall not apply to the commercial processing of any
food processed under the continuous inspection of the meat and poultry
inspection program of the Animal and Plant Health Inspection Service of
the Department of Agriculture under the Federal Meat Inspection Act (34
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat.
791 (21 U.S.C. 451 et seq.)).
(j) Compliance with State regulations: (1) Wherever the Commissioner
finds that any State regulates the commercial thermal processing of low-
acid foods in accordance with effective regulations specifying at least
the requirements of part 113 of this chapter, he shall issue a notice
stating that compliance with such State regulations shall constitute
compliance with part 113 of this chapter. However, the provisions of
this section shall remain applicable to the commercial processing of
low-acid foods in any such State, except that, either the State through
its regulatory agency or each processor of low-acid foods in such State
shall file with the Center for Food Safety and Applied Nutrition the
registration information and the processing information prescribed in
paragraph (c) of this section.
(2) The Commissioner finds that the regulations adopted by the State
of California under the laws relating to cannery inspections governing
thermal processing of low-acid foods packaged in hermetically sealed
containers satisfy the requirements of part 113 of this chapter.
Accordingly, processors, who under the laws relating to cannery
inspections are licensed by the State of California and who comply with
such state regulations, shall be deemed to comply with the requirements
of part 113 of this chapter.
(k) Imports: (1) This section shall apply to any foreign commercial
processor engaged in the thermal processing of low-acid foods packaged
in hermetically sealed containers and offering such foods for import
into the United States except that, in lieu of providing for the
issuance of an emergency permit under paragraph (a) of this section, the
Commissioner will request the Secretary of the Treasury to refuse
admission into the United States, pursuant to section 801 of the act, of
any such low-acid foods which the Commissioner determines, after
investigation, may result in the distribution in interstate commerce of
processed foods that may be injurious to health as set forth in
paragraph (a) of this section.
(2) Any such food refused admission shall not be admitted until such
time as the Commissioner may determine that the commercial processor
offering the food for import is in compliance with the requirements and
conditions of this section and that such food is not injurious to
health. For the purpose of making such determination, the Commissioner
reserves the right for a duly authorized employee of the Food and Drug
Administration to inspect the commercial processor's manufacturing,
processing, and packing facilities.
(l) The following data and information submitted to the Food and
Drug Administration pursuant to this section are not available for
public disclosure unless they have been previously disclosed to the
public as defined in Sec. 20.81 of this chapter or they relate to a
product or ingredient that has been abandoned and they no longer
represent a trade secret or confidential commercial or financial
information as defined in Sec. 20.81 of this chapter:
(1) Manufacturing methods or processes, including quality control
information.
(2) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
[[Page 214]]
provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
54 FR 24891, June 12, 1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov.
6, 2001]
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