This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108]
[Page 199-209]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 108--EMERGENCY PERMIT CONTROL
Subpart A--General Provisions
Sec.
108.3 Definitions.
108.5 Determination of the need for a permit.
108.6 Revocation of determination of need for permit.
108.7 Issuance or denial of permit.
108.10 Suspension and reinstatement of permit.
108.12 Manufacturing, processing, or packing without a permit, or in
violation of a permit.
108.19 Establishment of requirements for exemption from section 404 of
the act.
Subpart B--Specific Requirements and Conditions for Exemption From or
Compliance With an Emergency Permit
108.25 Acidified foods.
108.35 Thermal processing of low-acid foods packaged in hermetically
sealed containers.
Authority: 21 U.S.C. 342, 344, 371.
Source: 42 FR 14334, Mar. 15, 1977, unless otherwise noted.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.3]
[Page 199-200]
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 A--General Provisions
Sec. 108.3 Definitions.
(a) The definitions contained in section 201 of the Federal Food,
Drug, and Cosmetic Act are applicable to such terms when used in this
part.
(b) Commissioner means the Commissioner of Food and Drugs.
(c) Act means the Federal Food, Drug, and Cosmetic Act, as amended.
(d) Permit means an emergency permit issued by the Commissioner
pursuant to section 404 of the act for such temporary period of time as
may be necessary to protect the public health.
(e) Manufacture, processing, or packing of food in any locality
means activities
[[Page 200]]
conducted in a single plant or establishment, a series of plants under a
single management, or all plants in an industry or region, by a
manufacturer, processor, or packer.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.5]
[Page 200]
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 A--General Provisions
Sec. 108.5 Determination of the need for a permit.
(a) Whenever the Commissioner determines after investigation that a
manufacturer, processor, or packer of a food for which a regulation has
been promulgated in subpart B of this part does not meet the mandatory
conditions and requirements established in such regulation, he shall
issue to such manufacturer, processor, or packer an order determining
that a permit shall be required before the food may be introduced or
delivered for introduction into interstate commerce by that person. The
order shall specify the mandatory conditions and requirements with which
there is a lack of compliance.
(1) The manufacturer, processor, or packer shall have 3 working days
after receipt of such order within which to file objections. Such
objections may be filed by telegram, telex, or any other mode of written
communication addressed to the Center for Food Safety and Applied
Nutrition, Food and Drug Administration (HFS-605), 5100 Paint Branch
Pkwy., College Park, MD 20740. If such objections are filed, the
determination is stayed pending a hearing to be held within 5 working
days after the filing of objections on the issues involved unless the
Commissioner determines that the objections raise no genuine and
substantial issue of fact to justify a hearing.
(2) If the Commissioner finds that there is an imminent hazard to
health, the order shall contain this finding and the reasons therefor,
and shall state that the determination of the need for a permit is
effective immediately pending an expedited hearing.
(b) A hearing under this section shall be conducted by the
Commissioner or his designee at a location agreed upon by the objector
and the Commissioner or, if such agreement cannot be reached, at a
location designated by the Commissioner. The manufacturer, processor, or
packer shall have the right to cross-examine the Food and Drug
Administration's witnesses and to present witnesses on his own behalf.
(c) Within 5 working days after the hearing, and based on the
evidence presented at the hearing, the Commissioner shall determine
whether a permit is required and shall so inform the manufacturer,
processor, or packer in writing, with the reasons for his decision.
(d) The Commissioner's determination of the need for a permit
constitutes final agency action from which appeal lies to the courts.
The Commissioner will not stay a determination of the need for a permit
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
[42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989;
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.6]
[Page 200]
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 A--General Provisions
Sec. 108.6 Revocation of determination of need for permit.
(a) A permit shall be required only during such temporary period as
is necessary to protect the public health.
(b) Whenever the Commissioner has reason to believe that a permit
holder is in compliance with the mandatory requirements and conditions
established in subpart B of this part and is likely to remain in
compliance, he shall, on his own initiative or on the application of the
permit holder, revoke both the determination of need for a permit and
the permit that had been issued. If denied, the applicant shall, upon
request, be afforded a hearing conducted in accordance with Sec. 108.5
(b) and (c) as soon as practicable. Such revocation is without prejudice
to the initiation of further permit proceedings with respect to the same
manufacturer, processor, or packer should later information again show
the need for a permit.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.7]
[Page 200-201]
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 A--General Provisions
Sec. 108.7 Issuance or denial of permit.
(a) After a determination and notification by the Commissioner in
accordance with the provisions of Sec. 108.5 that a manufacturer,
processor, or packer requires a permit, such manufacturer, processor, or
packer may not thereafter introduce or deliver for introduction into
interstate commerce any such food manufactured, processed, or
[[Page 201]]
packed by him unless he holds a permit issued by the Commissioner or
obtains advance written approval of the Food and Drug Administration
pursuant to Sec. 108.12(a).
(b) Any manufacturer, processor, or packer for whom the Commissioner
has made a determination that a permit is necessary may apply to the
Commissioner for the issuance of such a permit. The application shall
contain such data and information as is necessary to show that all
mandatory requirements and conditions for the manufacturer, processing
or packing of a food for which regulations are established in subpart B
of this part are met and, in particular, shall show that the deviations
specified in the Commissioner's determination of the need for a permit
have been corrected or suitable interim measures established. Within 10
working days after receipt of such application, (except that the
Commissioner may extend such time an additional 10 working days where
necessary), the Commissioner shall issue a permit, deny the permit, or
offer the applicant a hearing conducted in accordance with Sec. 108.5
(b) and (c) as to whether the permit should be issued. The Commissioner
shall issue such a permit to which shall be attached, in addition to the
mandatory requirements and conditions of subpart B of this part, any
additional requirements or conditions which may be necessary to protect
the public health if he finds that all mandatory requirements and
conditions of subpart B of this part are met or suitable interim
measures are established.
(c) Denial of a permit constitutes final agency action from which
appeal lies to the courts. The Commissioner will not stay such denial
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.10]
[Page 201]
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 A--General Provisions
Sec. 108.10 Suspension and reinstatement of permit.
(a) Whenever the Commissioner finds that a permit holder is not in
compliance with the mandatory requirements and conditions established by
the permit, he shall immediately suspend the permit and so inform the
permit holder, with the reasons for the suspension.
(b) Upon application for reinstatement of a permit, the Commissioner
shall, within 10 working days, reinstate the permit if he finds that the
person is in compliance with the mandatory requirements and conditions
established by the permit or deny the application.
(c) Any person whose permit has been suspended or whose application
for reinstatement has been denied may request a hearing. The hearing
shall be conducted by the Commissioner or his designee within 5 working
days of receipt of the request at a location agreed upon by the objector
and the Commissioner or, if an agreement cannot be reached, at a
location designated by the Commissioner. The permit holder shall have
the right to present witnesses on his own behalf and to cross-examine
the Food and Drug Administration's witnesses.
(d) Within 5 working days after the hearing, and based on the
evidence presented at the hearing, the Commissioner shall determine
whether the permit shall be reinstated and shall so inform the permit
holder, with the reasons for his decision.
(e) Denial of an application for reinstatement of a permit
constitutes final agency action from which appeal lies to the courts.
The Commisioner will not stay such denial pending court appeal except in
unusual circumstances, but will participate in expediting any such
appeal.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.12]
[Page 201-202]
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 A--General Provisions
Sec. 108.12 Manufacturing, processing, or packing without a permit, or in violation of a permit.
(a) A manufacturer, processor, or packer may continue at his own
risk to manufacture, process, or pack without a permit a food for which
the Commissioner has determined that a permit is required. All food so
manufactured, processed, or packed during such period without a permit
shall be retained by the manufacturer, processor, or packer and may not
be introduced or delivered for introduction into interstate commerce
without the advance written approval of the Food and Drug
Administration. Such approval may be granted only upon an adequate
showing that such food is free from microorganisms of public health
significance. The manufacturer, processor, or packer may
[[Page 202]]
provide to the Commissioner, for his consideration in making any such
determination, an evaluation of the potential public health significance
of such food by a competent authority in accordance with procedures
recognized as being adequate to detect any potential hazard to public
health. Within 20 working days after receipt of a written request for
such written approval the Food and Drug Administration shall either
issue such written approval or deny the request. If the request is
denied, the applicant shall, upon request, be afforded a prompt hearing
conducted in accordance with Sec. 108.5 (b) and (c).
(b) Except as provided in paragraph (a) of this section, no
manufacturer, processor, or packer may introduce or deliver for
introduction into interstate commerce without a permit or in violation
of a permit a food for which the Commissioner has determined that a
permit is required. Where a manufacturer, processor, or packer utilizes
a consolidation warehouse or other storage facility under his control,
interstate shipment of any such food from the point of production to
that warehouse or storage facility shall not violate this paragraph,
provided that no further introduction or delivery for introduction into
interstate commerce is made from that consolidated warehouse or storage
facility except as provided in paragraph (a) of this section.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.19]
[Page 202]
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 A--General Provisions
Sec. 108.19 Establishment of requirements for exemption from section 404 of the act.
(a) Whenever the Commissioner finds after investigation that the
distribution in interstate commerce of any class of food may, by reason
of contamination with microorganisms during the manufacture, processing,
or packing thereof in any locality, be injurious to health, and that
such injurious nature cannot be adequately determined after such
articles have entered interstate commerce, he shall promulgate
regulations in Subpart B of this part establishing requirements and
conditions governing the manufacture, processing, or packing of the food
necessary to protect the public health. Such regulations may be proposed
by the Commissioner on his own initiative or in response to a petition
from any interested person pursuant to part 10 of this chapter.
(b) A manufacturer, processor, or packer of a food for which a
regulation has been promulgated in subpart B of this part shall be
exempt from the requirement for a permit only if he meets all of the
mandatory requirements and conditions established in that regulation.
[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.25]
[Page 202-205]
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. 108.25 Acidified foods.
(a) Inadequate or improper manufacture, processing, or packing of
acidified foods 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, to protect the public health, it may be necessary
to require any commericial processor, in any establishment engaged in
the manufacture, processing, or packing of acidified foods, 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 filing of process information, and
the mandatory portions of Secs. 114.10, 114.80(a) (1) and (2), and (b),
114.83, 114.89, and 114.100 (b), (c), and (d) of this chapter as they
relate to acidified foods. These requirements are intended to ensure
safe manufacturing, processing, and packing processes and to permit the
Food and Drug Administration to verify that these processes are being
followed. Failure to meet these requirements shall constitute a prima
facie basis for the immediate application of the emergency permit
control provisions of section 404 of the act
[[Page 203]]
to that establishment, under the procedures established in subpart A of
this part.
(b) The definitions in Sec. 114.3 of this chapter are applicable
when those terms are used in this section.
(c)(1) Registration. A commercial processor, when first engaging in
the manufacture, processing, or packing of acidified foods in any State,
as defined in section 201(a)(1) of the act, shall, not later than 10
days after first so engaging, register and file with the Food and Drug
Administration on Form FDA 2541 (food canning establishment
registration) information including, but not limited to, the name of the
establishment, principal place of business, the location of each
establishment in which that processing is carried on, the processing
method in terms of acidity and pH control, and a list of foods so
processed in each 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 Center for Food
Safety and Applied Nutrition (HFS-565), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Commercial processors
presently so engaged shall register within 120 days after the effective
date of this regulation. Foreign processors shall register within 120
days after the effective date of this regulation or before any offering
of foods for import into the United States, whichever is later.
Commercial processors duly registered under this section shall notify
the Food and Drug Administration not later than 90 days after the
commercial processor ceases or discontinues the manufacture, processing,
or packing of the foods in any establishment, except that this
notification shall not be required for temporary cessations due to the
seasonal character of an establishment's production or by temporary
conditions including, but not limited to, labor disputes, fire, or acts
of God.
(2) Process filing. A commercial processor engaged in the processing
of acidified foods shall, not later than 60 days after registration, and
before packing any new product, provide the Food and Drug Administration
information on the scheduled processes including, as necessary,
conditions for heat processing and control of pH, salt, sugar, and
preservative levels and source and date of the establishment of the
process, for each acidified food in each container size. Filing of this
information does not constitute approval of the information by the Food
and Drug Administration, and 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 form FDA 2541a (food canning establishment process filing form for
all methods except aseptic). 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 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, MD
20740.
(3) Process adherence and information--(i) Scheduling. A commercial
processor engaged in processing acidified foods in any registered
establishment shall process each food in conformity with at least the
scheduled processes filed under paragraph (c)(2) of this section.
(ii) Process and pH information availability. When requested by the
Food and Drug Administration in writing, a commercial processor engaged
in the processing of acidified foods shall provide the Food and Drug
Administration with any process and procedure information that the Food
and Drug Administration deems necessary to determine the adequacy of the
process. Furnishing of this information does not constitute approval by
the Food and Drug Administration of the content of the information
filed, and the information concerning processes and other data so
furnished shall be considered trade secrets within the meaning of 21
U.S.C. 331(j) and 18 U.S.C. 1905 (to the
[[Page 204]]
extent that they qualify under those provisions).
(d) A commercial processor engaged in the processing of acidified
foods shall promptly report to the Food and Drug Administration any
instance of spoilage, process deviation, or contamination with
microorganisms, the nature of which has potential health-endangering
significance, where any lot of such food has in whole or in part entered
distribution in commerce.
(e) A commercial processor engaged in the processing of acidified
foods shall prepare and maintain files on a current procedure for use
for products under the processor's control, which that processor will
ask the distributor to follow, including plans for recalling products
that may be injurious to health; for identifying, collecting,
warehousing, and controlling products; for determining the effectiveness
of recalls; for notifying the Food and Drug Administration of any
recalls; and for implementing recall programs.
(f) All plant personnel involved in acidification, pH control, heat
treatment, or other critical factors of the operation shall be under the
operating supervision of a person who has attended a school approved by
the Commissioner for giving instruction in food-handling techniques,
food protection principles, personal hygiene, plant sanitation
practices, pH controls, and critical factors in acidification, and who
has satisfactorily completed the prescribed course of instruction. The
Commissioner will consider students who have satisfactorily completed
the required portions of the courses presented under Sec. 108.35 and
part 113 of this chapter before March 16, 1979, as having satisfactorily
completed the prescribed course of instruction under this section and
part 114 of this chapter. The Commissioner will not withhold approval of
any school qualified to give such instruction.
(g) A commercial processor engaged in the processing of acidified
foods shall prepare, review, and retain at the processing plant or other
reasonably accessible location for a period of 3 years from the date of
manufacture, all records of processing, deviations in processing, pH,
and other records specified in part 114 of this chapter. Upon written
demand during the course of a factory inspection under 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 that employee of these records to verify the pH and the
adequacy of processing.
(h) 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 Food Safety and 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.)).
(i) Wherever the Commissioner finds that any State regulates the
commercial processing of acidified foods under effective regulations
specifying at least the requirements of part 114 of this chapter, the
Commissioner shall issue a notice stating that compliance with such
State regulations shall constitute compliance with this section, if the
State through its regulatory agency or each processor of acidified foods
in the State files with the Food and Drug Administration the
registration information and the processing information prescribed in
paragraph (c) of this section.
(j) Imports: (1) This section applies to any foreign commercial
processor engaged in the processing of acidified foods and offering
those 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, under section 801
of the act, to any acidified 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 acidified food so refused admission shall not be admitted
until the Commissioner determines that the commercial processor offering
the food
[[Page 205]]
for import has complied with the requirements of this section and that
the food is not injurious to health. To assist the Commissioner in
making this determination, a duly authorized employee of the Food and
Drug Administration shall be permitted to inspect the commercial
processor's manufacturing, processing, and packing facilities.
(k) The following information submitted to the Food and Drug
Administration under this section is not available for public disclosure
unless it has been previously disclosed to the public as defined in
Sec. 20.81 of this chapter or it relates to a product or ingredient that
has been abandoned and no longer represents a trade secret or
confidential commercial or financial information as defined in
Sec. 20.61 of this chapter:
(1) Manufacturing methods or processes, including quality control
information.
(2) Production, sales, distribution, and similar information, except
that any compilation of the information aggregated and prepared in a way
that does not reveal information which is not available for public
disclosure under this provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
[44 FR 16207, Mar. 16, 1979, as amended at 54 FR 24891, June 12, 1989;
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.35]
[Page 205-209]
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 206]]
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
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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,
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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
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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]
