[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]