[Federal Register Volume 65, Number 125 (Wednesday, June 28, 2000)]
[Notices]
[Pages 39912-39914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1296]


Final Guidance: Importation of Pasteurized Milk Ordinance (PMO) 
Defined Dairy Products (M-I-00-4); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance document entitled ``Importation of PMO 
Defined Dairy Products (M-I-00-4)''. This guidance provides information 
that States can use to respond to inquiries regarding the importation 
of ``Grade A'' dairy products from other countries.

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

[[Page 39913]]

Persons who wish to submit electronic comments should go to FDA's home 
page at www.fda.gov, select ``Dockets,'' and follow the instructions. 
Submit written requests for single copies of the guidance entitled 
``Importation of PMO Defined Dairy Products (M-I-00-4)'' to Charlotte 
Epps, Milk Safety Branch (HFS-625), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204. Send one self-addressed adhesive label to assist that office in 
processing your requests. See section III of this document for 
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Joseph M. Smucker, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-205-8178, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is the Federal agency with 
responsibility under the Federal Food, Drug, and Cosmetic Act for the 
safety of the United States' dairy products. In the case of those dairy 
products regulated by the States under the Grade ``A'' milk safety 
program, one way FDA has chosen to fulfill this charge is by providing 
technical assistance to State regulators under the authority of various 
sections of the U.S. Public Health Service Act.
    The National Conference on Interstate Milk Shipments (NCIMS) is a 
voluntary coalition of regulators from U.S. States and one U.S. 
commonwealth. These regulators have banded together in this 
organization to ensure the safety of Grade ``A'' milk and milk products 
shipped in interstate commerce and to minimize duplicate regulatory 
restrictions on these products if they are produced according to this 
group's stringent public health standards.
    As the need arises, FDA provides information to the States in the 
NCIMS and others interested in production and processing of Grade ``A'' 
milk and milk products.
    Under the procedures of the NCIMS, administrative and other 
miscellaneous information is transmitted to FDA regional staff and 
through them to State agencies in the form of a memorandum of 
information (M-I). Several M-I's are issued each year; M-I-00-4 is this 
type of memorandum. It is being provided to transmit an FDA opinion. 
This opinion clarifies that the food protective measures provided under 
the NCIMS system are an important part of the U.S.'s appropriate level 
of protection for Grade ``A'' dairy products. This guidance also 
describes three options that both FDA and the NCIMS have accepted to 
ensure that the public health effect of these food protective measures 
is not circumvented when these dairy products are imported.
    This level 2 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). This guidance 
document represents the agency's current thinking on the subject and 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, 
regulation or both.
    What follows is a verbatim copy of this memorandum.

``M-I-00-4''

    April 11, 2000

    To: All Regional Food and Drug Directors Attn: Regional Milk 
Specialists

    From: Milk Safety Branch (HFS-626)
    Subject: Importation of PMO Defined Dairy Products

    This memorandum provides guidance that States can use to respond 
to inquiries regarding the importation of ``Grade A'' dairy products 
from other countries. This guidance document represents the agency's 
current thinking on this subject and 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, regulation or 
both.

I. Background Information

    International trade agreements to which the United States is 
signatory allow countries to establish measures to ensure safety of 
food within their countries. The measures, however, must be applied 
in a manner so that they do not arbitrarily discriminate between 
products from different countries or treat domestic products more 
favorably than imported products without justification.
    The World Trade Organization's (WTO) Agreement on the 
Application of Sanitary and Phytosanitary Measures (SPS Agreement) 
also obligates the over 160 member countries to consider the 
``equivalence'' of another country's food protection measures if an 
exporting country requests such consideration. The determination of 
equivalence is made by the importing country based on whether the 
exporting country's measures meet the level of protection deemed 
appropriate by the importing country, as provided by its own 
measures. Because the WTO agreements only went into effect in 1995, 
the concept of equivalence is only now beginning to be utilized in 
international trade. Nevertheless, Article 4. Equivalence of the SPS 
Agreement exists as an obligation for all WTO Member governments.
    The system of controls used to provide the U.S.'s appropriate 
level of protection for ``Grade A'' dairy products is described in 
the current edition of the ``Grade A Pasteurized Milk Ordinance'' 
(PMO) and related documents. Since the early 1950's, States and FDA 
using a system of ratings and check ratings have verified the level 
of protection provided by the PMO in domestic (interstate) commerce. 
The requirements for these ratings and check ratings are specified 
in the current edition of the ``Procedures Governing the Cooperative 
State-Public Health Service/Food and Drug Administration Program of 
the National Conference on Interstate Milk Shipments'' (Procedures).
    In a 1977 Memorandum of Understanding (MOU) with the National 
Conference on Interstate Milk Shipments (NCIMS), FDA accepted the 
standards, requirements and procedures of the NCIMS to manage the 
public health risks associated with ``Grade A'' milk and milk 
products. FDA considers this NCIMS milk safety program to be 
adequate for the protection of the health and safety of the 
consumer.

Current Status

    FDA and the NCIMS have identified and mutually accepted three 
options which are consistent with NCIMS ``Procedures'' and which 
will allow States to receive PMO defined ``Grade A'' products 
produced outside of the United States.
    These options are:
    1. A dairy firm outside of the United States could contract with 
any current NCIMS member's regulatory/rating agency to provide the 
''Grade A'' milk safety program in total. This would include the 
regulatory licensing, dairy farm and milk plant inspection and 
sampling, pasteurization equipment testing, laboratory certification 
and rating/NCIMS listing certification. To use this option the firm 
would be required to abide by all applicable NCIMS regulatory and 
rating requirements and the regulatory/rating agency would have to 
agree to treat the firm as if it were located within its 
jurisdiction for all purposes, including inspection and enforcement. 
Ratings of the firm would be check-rated by FDA.
    2. The importing country, or a political subdivision thereof, 
may become a full member of the NCIMS subject to all NCIMS rules and 
enjoying all privileges of a U.S. State. This would require, among 
other things, that the milk regulatory agency(ies) of the importing 
countries adopt and enforce rules and regulations which are the same 
as those required in the United States and abide by all applicable 
NCIMS regulatory and rating requirements. Their ratings would be 
check-rated by FDA in the same way as State ratings. FDA would 
certify their rating, sampling surveillance and laboratory 
evaluation officers.
    3. FDA can evaluate the importing country's system of assuring 
the safety of dairy products and compare the effect of that system 
with the effect of the United States system on the safety of dairy 
products produced domestically. The NCIMS has adopted a procedure to 
accept FDA findings of equivalence and to allow NCIMS member States 
to accept products produced within the scope of such a finding.

Emerging International Issue

    As trade barriers are removed and trade between countries 
increases, there are more frequent requests to allow the importation 
of ``Grade A'' defined products that originate in

[[Page 39914]]

other countries. The most common concern is how an adequate level of 
safety can be verified.
    Under current Federal law and regulation, FDA can only take 
action on imported food products based on a violation of the Federal 
Food, Drug, and Cosmetic Act (FFDCA). Importation of milk products 
without adhering to any of the three options described above, is 
NOT, in and of itself, a violation of the FFDCA.\1\
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    \1\ Milk or cream may also need a permit under the provisions of 
the Federal Import Milk Act.
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    Based on the 1977 MOU, milk protection measures in the United 
States have been set by the combined efforts of FDA and the States 
under the NCIMS milk safety program.
    Under this program the States must adopt as law and enforce the 
provisions of the PMO as specified in the ``Procedures''. Their 
collective actions are intended to insure that milk marketed in the 
United States meets the U.S. appropriate level of protection.
    FDA works with the States to verify that the U.S. level of 
protection is met under authority of the Public Health Service Act 
(42 U.S.C.). Under this act FDA has a broad mandate to assist States 
technically and to evaluate their performance under the 
``Procedures''. However, current regulations promulgated under this 
act do not provide an adequate base for direct FDA enforcement of 
the PMO.
    If the U.S. level of protection, as currently met by consistent 
State enforcement of the PMO, is to continue to be met, it must be 
accomplished by States continuing to collectively require this level 
of protection.
    Under U.S. trade agreements products imported from another 
country must be treated by States and by FDA, no less favorably than 
those products imported from another State.
    The three options in this memorandum can be used by States to 
assure that the same level of safety for ``Grade A'' defined 
products is achieved for products produced in other countries.
    In order for the agency to function within the provisions of the 
MOU and fulfill its food safety responsibility, FDA will note, in 
State program evaluations, if a State is not requiring the NCIMS 
``Grade A'' level of protection in interstate or international 
commerce.
    If after a reasonable opportunity to correct this situation, a 
State still does not provide their citizens with this level of 
protection, FDA may declare that the State is not in substantial 
compliance under the ``Procedures * * *''
    Copies of this memorandum are enclosed for your distribution to 
District Milk Specialists, State milk regulatory agencies, State 
Laboratory Evaluation Officers and State Milk Rating Officers in 
your region. This memorandum is also available on the FDA Prime 
Connection Computer bulletin board system (Internet address: http://www.cfsan.fda.gov), and should be widely distributed to 
representatives of the dairy industry and other interested parties. 
/S/''

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the guidance entitled 
``Importation of PMO Defined Dairy Products (M-I-00-4)'' at any time. 
Two copies of written comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the guidance and written and electronic comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain copies of the 
guidance entitled ``Importation of PMO Defined Dairy Products (M-I-00-
4)'' at http://www.cfsan.fda.gov.

    Dated: June 19, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-16292 Filed 6-28-00; 8:45 am]
BILLING CODE 4160-01-F