CPG Sec 560.400 Imported Milk and Cream - Federal Import Milk Act

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

CPG 560.400 Imported Milk and Cream -
Federal Import Milk Act
Comments and suggestions regarding this Compliance Policy Guide (CPG) should be
submitted to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with docket number 2004D-0453.
For questions regarding this CPG contact:
*Division of Dairy, Egg and Meat Safety*
*Office of Food Safety*
Center for Food Safety and Applied Nutrition
Food and Drug Administration
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition
TABLE OF CONTENTS
I. 	INTRODUCTION
II. 	BACKGROUND
III. 	DISCUSSION
A. 	Definitions
B. 	Application of the FIMA
IV. 	REGULATORY ACTION GUIDANCE
V. 	SPECIMEN CHARGE
This guidance document represents the Food and Drug Administration's (FDA) current thinking
on this topic. It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public. An alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.
I. INTRODUCTION:

*The purpose of this document is to provide guidance regarding which imported dairy products
require a permit under the Federal Import Milk Act.
FDA's guidance documents, including this Compliance Policy Guide, do not establish legally
enforceable responsibilities. Instead, guidance documents describe the agency's current thinking
on a topic and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in agency guidance documents means that
something is suggested or recommended, but not required.
II. BACKGROUND:
The Federal Import Milk Act (FIMA) was passed by Congress in 1927 to "regulate the
importation of milk and cream into the United States for the purpose of promoting the dairy
industry of the United States and protecting the public health" (Public Law 69-625, codified as
21 U.S.C. 141-149). Under the FIMA, only the holder of a valid import milk permit may "ship or
transport" milk or cream into the United States. The FIMA defines "United States" as "the fifty
States and the District of Columbia" (21 U.S.C. 149). Therefore, the FIMA's permit requirement
does not apply to milk and cream that is shipped to jurisdictions other than a State or the District
of Columbia (e.g., United States Trust Territories and Protectorates).
Under the FIMA, FDA issues import permits, which expire in 1 year. Prior to such permit being
issued, the FIMA requires that: (1) all cows must be physically examined and found healthy
within 1 year previous to the time of importation; (2) if the milk or cream is raw when imported,
all cows must pass a tuberculin test within 1 year previous to the time of importation; (3) the
dairy farm and each plant in which the milk or cream is processed or handled must be inspected
and must meet certain sanitary requirements; (4) bacterial counts of raw milk, raw cream,
pasteurized milk, and pasteurized cream at the time of importation must not exceed specified
limits; and (5) the temperature of the milk or cream at time of importation must not exceed 50º F
(10º C) (21 U.S.C. 142). Regulations under the FIMA are found in 21 CFR Part 1210. Requests
for permit applications may be made to the Food and Drug Administration, Office of Plant and
Dairy Foods, Division of Dairy and Egg Safety, HFS-367, 5100 Paint Branch Parkway, College
Park, MD 20740.
Section 148 of the FIMA provides that nothing in the FIMA shall be construed "to affect the
powers of any State, or political subdivision thereof, to regulate the shipment of milk or cream
into, or the handling, sale, or other disposition of milk or cream in, such State or political
subdivision" after it has been lawfully imported under a FIMA permit. In addition, FDA and the
states participate in a cooperative program, known as the Interstate Milk Shippers Program, to
ensure the safety of Grade "A" milk and milk products. For more details regarding how this
program relates to the importation of milk, refer to the Federal Register Notice of June 28, 2000
(65 FR 39912-39914) and to "Final Guidance: Importation of Pasteurized Milk Ordinance

(PMO) Defined Dairy Products (M-I-00-4)." These documents are available at the U.S.
Government Publishing Office.
FDA published a notice in the Federal Register of March 22, 1968 (33 FR 4881) announcing its
determination, based on an opinion from the Department of Justice, that imported milk products
in hermetically sealed cans, so processed by heat as to prevent spoilage, are not subject to the
provisions of the FIMA. Similarly, FDA intends to consider sweetened condensed milk and
evaporated milk as not subject to the provisions of the FIMA. Sweetened condensed milk is
required by 21 CFR 131.120 to contain a quantity of nutritive carbohydrate sweetener sufficient
to prevent spoilage, and evaporated milk is required by 21 CFR 131.130 to be sealed in a
container and so processed by heat as to prevent spoilage. In addition, FDA has viewed the literal
language of the FIMA as applicable only to milk and cream and not to products predominately
comprised of milk and cream. Furthermore, FDA has applied the FIMA to imported milk and
cream whether intended for use as human or animal food, and whether intended for direct
consumption or manufacture into other foods.
III. DISCUSSION:
A. Definitions:
The following definitions apply to this guidance:
The term "milk" refers to milk from domesticated (dairy) cows (genus Bos).
The term "United States" refers to the fifty States and the District of Columbia.
B. Application of the FIMA:
1. 	FDA intends to consider the following dairy products as subject to the FIMA's permit
requirement for importation:
i. 	Milk, Lowfat Milk, Skim or Nonfat Milk, Fortified Milk, Flavored Milk,
Concentrated Milk, and Ultra Filtered Milk.
ii. 	Cream, Half-And-Half, Heavy Cream, Light Cream, and Light Whipping Cream.
2. 	FDA intends to consider the following dairy products as not subject to the FIMA's permit
requirement for importation:
i. 	Sour Cream, Cultured Milk, Acidified Milk, Yogurt, Cheese, Ice Cream, and
Eggnog.
ii. 	Sweetened Condensed Milk, Evaporated Milk, Dried Milk, Nonfat Dry Milk,
Nonfat Dry Milk fortified with vitamins A and D, and other dehydrated milk
products.

iii. 	Any of the dairy products for which a permit is otherwise required (see III.B.1.) if
they have been processed and packaged in hermetically sealed containers so as to
be commercially sterile in accordance with the requirements of 21 CFR 108.35
and 113.
3. 	The importation of milk and/or cream into the United States Trust Territories and
Protectorates does not require a permit under the FIMA because these jurisdictions are
not within the FIMA's definition of "United States." FDA intends to consider any
subsequent distribution of milk or cream from United States Trust Territories and
Protectorates to the United States or the District of Columbia as importation into the
United States requiring a permit under the FIMA. Regardless of whether a permit is
required, dairy products must comply with the applicable provisions of the Federal Food,
Drug, and Cosmetic Act, Public Health Service Act, and implementing regulations.
IV. REGULATORY ACTION GUIDANCE:
The following represent criteria for direct reference detention by ORA Field Offices:
Milk or cream or other dairy product identified in III.B.1. that is offered for importation and is
not accompanied by a valid import milk permit, as required by the FIMA.
V. SPECIMEN CHARGE:
The article of [milk] [cream] is not accompanied by a valid import milk permit, as required by
the Federal Import Milk Act (21 U.S.C. 141-149).
Note: Import detention and refusal documents must reference the FIMA as the authority for
detention and refusal. Section 801(a) of the Federal Food, Drug, and Cosmetic Act should not be
cited for this violation.*
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 04/05
Updated: 05/12/05