**Compliance Policy Guide**

**Guidance for FDA Staff**

Sec. 560.400 - Imported Milk and Cream -- Federal Import Milk Act (CPG
7119.05)

***DRAFT GUIDANCE***

**This guidance document is being distributed for comment purposes
only.**

Comments and suggestions regarding this draft document should be
submitted within 30 days of publication in the [Federal
Register]{.underline} of the notice announcing the availability of the
draft guidance. Submit comments 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 the docket
number listed in the notice of availability that publishes in the
[Federal Register]{.underline}.

For questions regarding this draft document contact:

Esther Lazar

Division of Dairy and Egg Safety

Office of Plant and Dairy Foods

Center for Food Safety and Applied Nutrition

Food and Drug Administration

Phone: 301-436-1485

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Food Safety and Applied Nutrition**

**\[Date\]**

**\[Category\]**

**Compliance Policy Guide**

**Guidance for FDA Staff**

Sec. 560.400 - Imported Milk and Cream -- Federal Import Milk Act (CPG
7119.05)

*Additional copies are available from:*

*Division of Compliance Policy HFC-230*

*Office of Enforcement*

*Office of Regulatory Affairs*

*Food and Drug Administration*

*5600 Fishers Lane*

*Rockville, MD 20857*

*Send two self-addressed adhesive labels to assist that office*

*in processing your request or fax your request to*

*240-632-6861*

*Copies available on-line at*

http://www.fda.gov/ora/compliance_ref/cpg/default.htm

**TABLE OF CONTENTS**

**I. INTRODUCTION
..........................................................................
4**

**II. backgrounD
............................................................................
4**

**III. DISCUSSION
.................................................................................5**

**A. Definitions
\..........................................................................5
B. Application of the FIMA
......................................................5**

**IV. Regulatory action guidance
\................................................6**

**V. Specimen charge
......................................................................6**

**Compliance Policy Guide**

**Imported Milk and Cream -- Federal Import Milk Act**

This draft Compliance Policy Guide, when final, will represent the Food
and Drug Administration\'s (FDA\'s) 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. You can use an alternative approach
if the approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach, contact
the FDA staff responsible for implementing this guidance at the number
listed on the title page of this guidance.

**Sec. 560.400 Imported Milk and Cream -- \*Federal\* Import Milk Act**

> **(CPG 7119.05)**

**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 draft 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). 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 or 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]{.underline} 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 on the Internet at
<http://vm.cfsan.fda.gov/~lrd/fr000628.html> and
<http://www.cfsan.fda.gov/~ear/mi-00-4.html>, respectively.

FDA published a notice in the [Federal Register]{.underline} 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. 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 Milk, Fortified Milk, Flavored Milk,
> Concentrated Milk, Evaporated Milk, Sweetened Condensed Milk, 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\. 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 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
District 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 FIMA.

**V. SPECIMEN CHARGE:**

The article of \[milk\] \[cream\] does not have 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: \[insert date\]