FDA/IAS Brochure:  1985
 
 The FDA Importer's Guide Low-Acid Canned & Acidified Foods
 
Protecting Your Investment
 
Like many importers, you have probably invested a
considerable amount of money in your low-acid canned food
and acidified food imports. It makes good sense to protect
your investment and to import only safe, thermally processed
or properly acidified foods. Besides, that's the law.
Because only legal products are permitted into the United
States, it's necessary for you to know about the legal
requirements enforced by FDA. This pamphlet can help you. It
focuses on the necessity for processors of low-acid canned
foods and acidified foods to register their establishments
with FDA. These processors must also provide FDA with their
products' processes. The regulations which require
registration and process filing (Title 21 Code of Federal
Regulations (CFR) 108.25 and 108.35) also contain other
requirements.
 
Remember-an illegal import may be denied entry into the
United States, so stop a moment and make sure that
everything about your import food entry is in order.
 
                   A Question and Answer Guide
 
Registration of Manufacturers of Low-Acid Canned Food
and Acidified Foods
 
Q. What foreign food processing establishments must register
with FDA?
 
A. Each low-acid canned food and acidified food processing
establishment which ships products to the United States must
register with FDA. Make sure the processing establishment is
registered with FDA before importing its products.
   Upon receipt of a Food Canning Establishment
Registration Form (FDA-2541), FDA assigns each registered
processing establishment a Food Canning Establishment Number
(FCE #). This number helps FDA track the firm's registration
and processing records.
 
 
Q. How do I find out if the processing establishment is
registered?
 
A. Contact the processing establishment to verify FDA
establishment registration and to obtain the firm's Food
Canning Establishment Number (FCE #).
 
 
Q. Can I register the processing establishment?
 
A. FDA recommends that the processing establishment complete
the establishment registration form. In some cases, you may
register the processing establishment as the firm's
authorized representative. FDA requires a letter from the
processing establishment authorizing you to act as its
representative and to register the establishment. The letter
must be enclosed with the registration forms. Before
submitting the registration forms to FDA, have the
processing establishment authorize all registration
information.
 
Q. How can I tell if my imports are low-acid canned or
acidified products?
 
A. Low-acid canned foods are products like green beans,
mushrooms, and tuna fish. They are packaged in hermetically
sealed containers, have a pH greater than 4.6 and a water
activity greater than 0.85. Acidified foods are low-acid
foods to which acid is added to reduce the pH to 4.6 or
below. Some examples of acidified foods are pickles,
pimientos, and marinated artichokes. Acidified foods must
also have a water activity greater than 0.85 to be included
under the regulations.
   FDA recommends that you fully inform yourself of
the regulations for low-acid canned foods and acidified
foods. If you are unsure if the product is low-acid or
acidified, contact the processing establishment. It has the
technical information and should be able to tell you.
 
Q. How can I obtain information on the low-acid and
acidified regulations?
 
A. Contact the LACF Registration Coordinator, HFS-618,
Center for Food Safety and Applied Nutrition, 200 C St., SW,
Washington, DC 20204.
Q. If the processor is unable to determine if the products
are low-acid or acidified, can FDA provide assistance?
 
A. Yes, processors may ask for FDA's help by writing to:
FDA's Division of Enforcement, HFS-607, 200 C St., SW,
Washington, DC 20204. Send the name of the product (in
English), specific processing procedures, product pH and
water activity, and quantitative list of ingredients.
 
 
Filing Schedule Processes
 
Q. What is a scheduled process?
 
A. The process time and temperature, as well as any other
factors (e.g., drained weight, formulation, headspace, water
activity) critical to adequacy of the process, which has
been established by a competent process authority and which
is designed to achieve commercial sterility.
 
 
Q. For what low-acid canned food and acidified foods does
the food processing establishment have to file a scheduled
process?
 
A. Processors must file a separate scheduled process for
each product and product style, and for each container size
of all low-acid canned foods and acidified foods it intends
to export to the United States. This must be done before
shipping the products to the United States. The processor
must complete the necessary forms for each product and each
container type and size intended for shipment. The form used
depends upon the product's process. The processing
establishment can define the process and determine the
correct forms to use. The forms are: Form FDA-2541a (all
methods except low-acid aseptic) Form FDA-2541c (Low -acid
aseptic packaging systems)
 
Q. Does the scheduled process filing information have to be
on file with FDA before I import my product?
 
A. Yes, complete scheduled process filing information must
be on file with FDA before offering your products for import
into the United States. FDA food technologists technically
edit all process filing information for accuracy and
completeness. This important activity requires care. Because
of the many forms, it may take several weeks to complete
this edit.
 
Q. Can the importer file the scheduled process information?
 
A. FDA recommends that the processing establishment complete
all the necessary filing forms. Completion of these forms
requires knowledge of thermal processing requirements and of
the scientific data relating to heat resistance of food
spoilage bacteria.
   In some cases, you may wish to file process
information as the processing establishment's authorized
representative. FDA requires a letter from the processing
establishment authorizing you to act as its representative
and to file this information. The letter must be enclosed
with the process filing forms. Before submitting the forms
to FDA, please authorize all process filing informaion. The
technical nature of the process filing information, and the
actual location of the processing establishment away frorn
your office, make this communication very important.
 
 
Q. The processing establishment told me they filed a process
with FDA for the protuct I intended to import. Why has the
shipment been detained?
 
A. FDA food technologists examine each process filing for
possible incorrect or incomplete filed process information.
Because of the serious nature of questionable, incomplete,
or incorrectly filed processes, the forms will be returned
to the firm for clarification and/or completion. Until the
returned forms are found to be complete, they are not
considered on file with FDA.
 
 
Q. Will I receive a certificate from FDA for the scheduled
process I have filed with FDA?
 
A. No, FDA does not certify processes. It is the
responsibility of the food processor to obtain scheduled
processes established by a competent processing authority
and to assure that the filed processes are followed.
 
Q. Are there other requirements for low-acid canned foods
and acidified foods besides establishment registration and
process filing?
 
A. Yes, imported low-acid canned foods and acidified foods
are subject to all of the requirements under the Federal
Food, Drug, and Cosmetic Act and the Fair Packaging and
Labeling Act. These laws require that foods be safe, clean,
and wholesome, and that labeling be honest and informative.
  The processing of low-acid canned foods must comply with the
requirements of the Good Manufacturing Practice regulations
(21 CFR Part 113). The processing of acidified foods must
comply with the requirements of the Good Manufacturing
Practice regulations (21 CFR Part 114).
 
 
Help To Prevent Delays
 
   Be sure to contact the nearest FDA office listed on the next
page to obtain information about filing form FDA-701 or
Customs Form 3461 before the shipment arrives at the port of
entry. Since form FDA-701 will contain important
information about your imports, care should be taken to
correctly complete all areas. The special care taken to
complete this form may help prevent delays at the port of
entry. Pay particular attention to these special items on
form FDA-701 (numbers indicate areas on form).
 
 
1. FDA District Office
List the appropriate FDA office.
 
2. Country of Origin
The country of the LACF processor.
 
3. Consignee (Name & Address)
The buyer (recipient) of goods.
 
4. Importer (Name & Address)
The negotiator between the consignee and the processor of goods.
 
5. Manufacturer (Name & Address)
The LACF processing establishment registered with FDA. This is not
the distributor, who does not manufacture the food product.
 
6. Food Canning Establishment Number (FCE #).
List the FCE # beside the manufacturer's name and address in
Block 5. FDA assigns this number upon the processing
establishment's registration. If several processors'products are
contained in the shipment, indicate in Block 7 the FCE # which
corresponds with the appropriate product. The FCE # can be obtained
from the processing establishments.
 
7. General Description of Shipment
The number of product pieces and cartons in a shipment. List
the product and the container dimensions of each item. The product
name should be the same as the product name on the process filing
form. lf the manufacturer is not listed in Block 5, delineate the
FCE # beside each product.
 
These Publications May Help You Prevent Import Product Delays
 
Procedures for Importing Foods into the United States
Information including a flow chart listing United States
food import procedures, and ways to prevent delays at the
port of entry.
 
Requirements for Establishment Registration, Thermal Process
Filing, and Good Manufacturing Practice for Low-Acid Canned
Foods and Acidified Foods
Reprint of regulations in Title 21, Code of Federal Regulations,
Parts 108, 113 and 114
 
 
FDA's Catalog of Information Materials for the Food and
Cosmetic Industries
Lists publications, audiovisuals, and displays currently
available to assist industry in complying with the laws.
Tells how to obtain the following:
- Food, Drug, and Cosmetic Act
- Fair Packaging and Labeling Act
- Title 21 Code of Federal Regulations (paperback books containing
  all of FDA's regulations
- Subscriptions to the Federal Register (contains new FDA
  regulations as published)
 
 
Requirements of Laws and Regulations Enforced by the U.S.
Food and Drug Administration
Discusses such topics as sanitation requirements, low-acid
canned foods registration, fishery products, and required
label statements. This informative booklet may be purchased
from National Technical Information Service, order
#PB93-177244. Telephone (703) 487-4650 for availability and
price (major credit cards accepted).
 
Requests for Single Copies of These Publications and
Specific Inquiries (in writing, with details, please) to:
 
Industry Activities Staff
Center for Food Safety and Applied Nutrition/FDA
200 C Street, SW
Washington, DC 20204
 
FDA/Industry Affairs Staff Brochure:  1985
HHS Publication No. (FDA) 85-2145