**SUPPORTING STATEMENT**

**Regulations Under the Federal Import Milk Act (21 CFR Part 1210)**

**OMB No. 0910-0212 - Extension**

A. **JUSTIFICATION**

1\. **Necessity for the Information Collection**

> All milk and cream imported into the fifty States and the District of
> Columbia is subject to the requirements of the Federal Import Milk Act
> of 1927 (FIMA) (21 U.S.C. 141-149) (Attachment A). Under the
> regulations implementing FIMA (21 CFR Part 1210) (Attachment B), milk
> or cream may be imported into the United States only by the holder of
> a valid import milk permit. Before such permit is issued: (1) cows
> must be physically examined and found healthy; (2) if the milk or
> cream is imported raw, all cows must pass a tuberculin test; (3) the
> dairy farm and each plant in which the milk or cream is processed or
> handled must be inspected and found to meet certain sanitary
> requirements; (4) bacterial counts of the milk 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 50° F. In
> addition, the regulations in Part 1210 require that dairy farmers and
> plants maintain pasteurization records (§ 1210.15) and that each
> container of milk or cream imported into the United States bear a tag
> with the product type, permit number, and shipper's name and address
> (§ 1210.22).
>
> We are requesting OMB approval for the following reporting and
> recordkeeping requirements contained in the following citations which
> are needed to assure the conformance with FIMA:
>
> **21 CFR 1210.11 - Reporting - Sanitary Inspection of Dairy Farms**
>
> Requires reports on the sanitary conditions of dairy farms producing
> milk and/or cream to be shipped to the U.S. to determine the sanitary
> conditions of the facility, equipment and processing/milking
> procedures.
>
> **21 CFR 1210.12 - Reporting - Physical Examination of Cows**
>
> Requires reports on physical examination of herds producing milk/cream
> to be shipped into the U.S. to aid in determining whether or not such
> herds are in a healthy condition.
>
> **21 CFR 1210.13 - Reporting - Tuberculin Tests of Cattle**
>
> Requires the reporting of tuberculin testing of all herds producing
> milk/cream to be shipped into the U.S. to aid in determining whether
> or not the herds are free of tuberculosis.
>
> **21 CFR 1210.14 - Reporting - Sanitary Inspection of Plants**
>
> Requires the reporting on the sanitary conditions of plants handling
> milk/cream to be shipped into the U.S. to determine the sanitary
> condition of such plants and of their facility, equipment and
> procedures.
>
> **21 CFR 1210.20 - Reporting - Application for Permit**
>
> Requires that an application for a permit to ship or transport milk or
> cream into the United States be made by the actual shipper on forms
> prescribed by the Secretary.
>
> **21 CFR 1210.22 - Disclosure - Form of Tag**
>
> Requires that each container of milk or cream shipped or transported
> into the United States be tagged with the permit number, type of
> product, and shipper's name and address. **(Language approval only.)**
>
> **21 CFR 1210.23 - Reporting - Permits Granted on Certificates**
>
> Permits a statement signed by an accredited official saying that
> copies of reports attached are based on the necessary inspections and
> examination performed under the supervision of that official.
>
> **21 CFR 1210.15 - Recordkeeping - Pasteurization, Equipment/Methods**
>
> Requires pasteurization of milk products at proper time and
> temperature using proper equipment. Requires recordkeeping to include
> pasteurization/processing charts properly recorded, initialed,
> numbered, and dated by authorized official and requires retention of
> the charts for two years.
>
> We are also requesting OMB approval for the following forms which are
> used in collecting the information (Attachment C):
>
> Form FDA 1815 - Certificate/Transmittal for an Application (21 CFR
> 1210.23)
>
> Form FDA 1993 - Application for Permit to Ship or Transport Milk and
> /or Cream into the U.S. (21 CFR 1210.20)
>
> Form FDA 1994 - Report of Tuberculin Tests of Cattle (21 CFR 1210.13)
>
> Form FDA 1995 - Report of Physical Examination of Cows (21 CFR
> 1210.12)

Form FDA 1996 - Dairy Farm Sanitary Report (21 CFR 1210.11)

Form FDA 1997 - Score Card for Sanitary Inspection of Milk Plants (21
CFR 1210.14)

2\. **How, By whom, and for What Purpose the Information is Used**

> The information would be used by the Food and Drug Administration
> (FDA) to determine whether a permit to import milk and/or cream into
> the United States should be granted.

3\. **Use of Improved Information Technology**

> The major portion of the annual burden for this information collection
> is associated with Form FDA 1996, Dairy Farm Sanitary Report. This
> form is completed by a sanitarian on-site in rural areas. Under these
> circumstances, electronic data entry would most likely increase the
> burden rather than reduce the burden. However, industry is
> increasingly turning to the use of automatic production facilities.
> Any use of improved technology appropriate to satisfy FDA regulation
> is acceptable.

4\. **Identification of Duplication and Similar Information Already
Available**

> The information collected in fulfilling the statutory requirements for
> applying for a permit to import under FIMA is unique to the dairy
> herds which are the source of the milk and the plants in which the
> product is pasteurized. Because FDA is the only Federal agency with
> the authority to issue permits to import milk under FIMA, there is no
> likelihood of duplication by other Federal agencies.

5\. **Impact on Small Business**

> Small firms may also apply for a permit. The forms to be completed are
> simple, consisting of check boxes and short narrative responses. FDA
> will assist small firms with these requirements thus minimizing the
> burden.

6\. **Consequences of Less Frequent Information Collection**

> Under FIMA and our implementing regulations, submission of the
> required information and approval of the information after review by
> FDA is a condition precedent to the issuance of a permit. . Therefore,
> if the information is not submitted, FDA cannot issue a permit to the
> importing party, and the milk and/or cream offered for import would be
> denied entry into the United States.

7\. **Explain Any Special Circumstances to the Information Collection**

> None of the requirements are inconsistent with the guidelines in 5 CFR
> 1320.5.

8\. **Outside Consultation and Results from the 60-day Comment Period**

> On \_Thursday, May 31, 2005 (70 FR 30951), FDA published a 60-day
> notice in the Federal Register soliciting public comment as required
> under the PRA of 1995 (Attachment D).

In the **Federal Register** of May 31, 2005 (70 FR 30951), FDA published
a 60-day notice requesting public comment on the reporting and record
keeping requirements contained in FDA regulations at part 1210 (21 CFR
part 1210) implementing the Federal Import Milk Act of 1927 (FIMA) (21
U.S.C. 141-149) .  FDA received one letter in response, which contained
several comments and suggestions. These suggestions and FDA's responses
follow.

The comment stated that the collection of information in forms FDA 1815,
FDA 1993, FDA 1994, FDA 1995, FDA 1996 and FDA 1997 is necessary and
that most of these forms provide practical information. However, the
comment requested a number of changes to the forms. First, the comment
suggested that certification of tuberculosis-free status in Form FDA
1815 and Form FDA 1994 should be done in a manner consistent with the
U.S. Department of Agriculture's Animal Plant Health and Inspection
Service (APHIS) guidelines entitled "Bovine Tuberculosis Eradication
Uniform Methods and Rules" (APHIS 91-45-011). Another comment suggested
that that Form FDA 1815 and Form FDA 1995 include a requirement that the
submitter certify that the dairy cows are free from brucellosis and that
the certification of brucellosis-free status should be done in a manner
consistent with the APHIS guidelines published in the document entitled,
"Brucellosis Eradication: Uniform Methods and Rules" (APHIS 91-45-013).

FDA agrees that, where possible, federal agencies should act in a
consistent manner. However, FDA declines to make the suggested changes
to its forms because such changes are not necessary. The two referenced
documents are published by APHIS as part of its national animal disease
eradication efforts undertaken by the National Center for Animal Health
Programs pursuant to the statutory authority provided by the Animal
Health Protection Act (7 U.S.C. 8301-8320). These are domestic programs
in the United States which are designed to address the general health
status of U.S. domestic cattle. Under the statutory authority provided
by FIMA, FDA regulates all foreign-produced milk and cream imported into
the United States. FIMA requires certification of the general health of
the animal, which certification is obtained by FDA on Form FDA 1995.
Although the two statutory authorities may differ, the practices
presented in the APHIS documents already are being followed by FDA. FDA
considers the status of the brucellosis and tuberculosis control
programs in the country offering milk for importation into the United
States and bases its acceptance decision on that status.

Another comment stated that Form FDA 1996 and Form FDA 1997 do not
provide practical information and should be made consistent with Form
FDA 2359a, which, the comment states, is "utilized to ensure milk
sanitation standards are met at the farm level."

FDA disagrees that Form FDA 1996, "Dairy Farm Sanitation Report," and
Form FDA 1997, "Score Card for Sanitary Inspection of Milk Plants," do
not provide practical information. The information collected on these
two forms is used by the agency in determining whether the imported milk
or cream offered for import meet FIMA's requirements for sanitary
inspections of dairy farms and plants (21 U.S.C. 142). FDA also
disagrees that the two forms should be made consistent with Form FDA
2359a because that form is used domestically for inspection of
facilities producing Grade "A" milk products. FDA does not use it for
inspections of facilities producing manufacturing-grade milk
domestically. Thus, it would be inappropriate for FDA to use it for
inspection of foreign facilities manufacturing non-Grade "A" milk
products.

The comment also opposed electronic submission of the forms and
suggested that several changes should be made to the requirements of
FIMA and the agency's related Compliance Policy Guide. These comments
are outside the scope of the four collection of information topics on
which the notice solicits comments and, thus, will not be addressed
here.

> We consult from time to time with the Australian Embassy and various
> Australian officials regarding the requirements of the Import Milk Act
> and its regulations. Our contacts in the United States are:
>
> Dr. Andrew Cupit
>
> Australian Embassy - Washington
>
> 1601 Massachusetts Ave,
>
> Washington DC, 20036
>
> Recent inquiries and responses to request for permits under FIMA have
> been received from the Murray Goulburn Co-op Co. Ltd., Maffra and
> Leongatha, Victoria and Warrnambool Cheese & Butter Factory in
> Allansford, Victoria, Australia

9\. **Payment to Respondents**

> This information collection does not provide for payment or gifts to
> respondents.

10\. **Confidentiality of Information**

> The information and data collected do not concern any method or
> processing which is entitled to protection as a trade secret nor is it
> concerned with matters that are commonly considered private or
> sensitive in nature. No assurance of confidentiality is given.

11\. **Sensitive Questions**

> This information collection does not involve any questions of a
> sensitive nature.

12\. **Respondent Hour Burden and Annualized Burden Hour Costs
Estimates**

> [Burden Hours]{.underline}.
>
> FDA estimates the burden of this collection of information as follows:

  --------------------------------------------------------------------------------------
  Estimated Annual                                                              
  Reporting Burden                                                              
  ------------------ --------- ------------- ----------- ----------- ---------- --------
  Form No.           21 CFR    No. of        Annual      Total       Hours per  Total
                     Section   Respondents   Frequency   Annual      Response   Hours
                                             per         Responses              
                                             Response                           

  FDA 1815/Permits   1210.23   8             1           8           0.5        4.0
  granted on                                                                    
  certificates                                                                  

  FDA                1210.20   8             1           8           0.5        4.0
  1993/Application                                                              
  of permit                                                                     

  FDA                1210.13   1             1           1           0.5        0.5
  1994/Tuberculin                                                               
  test                                                                          

  FDA 1995/Physical  1210.12   1             1           1           0.5        0.5
  examination of                                                                
  cows                                                                          

  FDA 1996/Sanitary  1210.11   8             200         1600        1.5        2400
  inspection of                                                                 
  dairy farms                                                                   

  FDA 1997/Sanitary  1210.14   8             1           8           2 .0       16.0
  inspections of                                                                
  plants                                                                        

  Totals                                                                        2425.0
  --------------------------------------------------------------------------------------

  ------------------------------------------------------------------------------------
  Estimated Annual                                                            
  Recordkeeping                                                               
  Burden                                                                      
  ------------------ --------------- --------------- --------- -------------- --------
  21 CFR Section     No. of          Annual          Total     Hours per      Total
                     Recordkeepers   Frequency of    Annual    Recordkeeper   Hours
                                     Recordkeeping   Records                  

  21 CFR 1210.15     8               1               8         .05            0.40
  ------------------------------------------------------------------------------------

> The estimated number of import milk permit applications and hours per
> response are based on the number of current permit holders and the
> number of inquiries that FDA has received regarding requests for
> applications in the past 3 years. The information collected and
> reported to FDA by the respondent is provided on six (6) different
> established forms which are listed individually above with estimated
> completion time on each form. It is estimated that the eight (8)
> respondents will submit approximately 200 Form FDA 1996 reports
> annually.
>
> No burden has been estimated for the tagging requirement in § 1210.22
> because the information on the tag is either supplied by FDA (permit
> number) or is disclosed to third parties as a usual and customary part
> of the shipper\'s normal business activities (type of product,
> shipper\'s name and address). Under 5 CFR 1320.3(c)(2), the public
> disclosure of information originally supplied by the Federal
> government to the recipient for the purpose of disclosure to the
> public is not a collection of information. Under 5 CFR 1320.3(b)(2)),
> the time, effort, and financial resources necessary to comply with a
> collection of information are excluded from the burden estimate if the
> reporting, recordkeeping, or disclosure activities needed to comply
> are usual and customary because they would occur in the normal course
> of activities.
>
> Low burden has been estimated for Forms FDA 1994 and 1995 because they
> are not used often. The Secretary of Health and Human Services has the
> discretion to allow Form FDA 1815, a duly certified statement signed
> by an accredited official of a foreign government, to be submitted in
> lieu of Forms FDA 1994 and 1995. To date, Form FDA 1815 has been
> submitted in lieu of these forms.
>
> [Estimated Annualized Cost for the Burden Hours]{.underline}.
>
> . The estimated annualized cost to respondents for the hour burden for
> this collection of information is 2425 total annual burden hours x
> \$29/hour = \$70,325. To account for overhead, this cost is increased
> by 100 percent, making the total estimated burden hour cost to the
> respondent \$140,650.

13\. **Total Annual Cost Burden to Respondents**

> There are no capital costs or operating and maintenance costs
> associated with this collection. Many of the requirements of FDA's
> regulations are also regulatory requirements of the country in which
> the firm is located. By complying with their own country's regulations
> they also comply with many of ours, mitigating the cost burden. This
> particularly applies to tuberculosis testing and physical examination
> of herds, which are required by the government of New Zealand.

14\. **Annualized Cost to the Federal Government**

> FDA estimates that the staffing burden currently assigned to review
> and respond to the current level of applications for a permit to
> import milk and/or cream to this country is 160 hours at a GS-12 level
> (160 hours x \$29/hour = \$4,640). Additional reviews at the Division,
> office/center and Associate Commissioner levels are estimated by
> program specialists to take an additional 16 hours at an aggregate
> rate of \$32/hour (16 hours x \$32/hour = \$512). Thus, the total cost
> is \$5,152 (\$4,640 + \$512). To account for overhead, this cost is
> increased by 100 percent, making the total estimated annual cost to
> the Federal Government \$10,304.

15\. **Explanation of Change in Items 13 and 14**

> The total estimated burden hours increased by one hour, as a result of
> the addition of a half burden hour for each of two forms (Forms FDA
> 1994 and 1995) previously estimated to have a zero hour burden, for
> the reasons discussed above. The increase in the total annual cost
> burden to the respondent is due to an increase in salary of the
> respondent's preparer and the addition of overhead costs. The increase
> in the annual cost burden to the Federal Government is due to an
> increase in salary of the reviewer and the addition of overhead costs.

16\. **Statistical Reporting**

> No comprehensive tabulation of the data is planned.

17\. **Display of Expiration Date on the Information Collection**

> No approval requested.

18\. **Exception to Certification Statement**

No exceptions requested.

B. **Collections of Information Employing Statistical Methods**

> This collection of information does not employ statistical methods.