0212 SS Part A 2015

Regulations Under The Federal Import Milk Act
OMB Control No. 0910-0212
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
Under the Federal Import Milk Act (FIMA) (21 U.S.C. 141–149), milk or cream may be
imported into the United States only by the holder of a valid import milk permit (21 U.S.C. 141).
Before such permit is issued by the Food and Drug Administration (FDA): (1) all cows from
which import milk or cream is produced must be physically examined and found healthy; (2) if
the milk or cream is imported raw, all such 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 (21 U.S.C. 142). Regulations in part 1210 (21 CFR part
1210) implement the provisions of FIMA.
We request OMB approval of the following reporting and recordkeeping requirements:
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 United States 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
United States 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 United States 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 United States to determine the sanitary conditions.
21 CFR 1210.15 - Recordkeeping - Pasteurization, Equipment/Methods
Requires pasteurization of milk products at proper time and temperature using proper equipment,

and associated recordkeeping to include pasteurization/processing charts properly recorded,
initialed, numbered, and dated by authorized official and requires retention of the charts for two
years.
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 – Third Party 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.
We are also requesting OMB approval for the following forms which are used in collecting the
information:
Form FDA 1815 Form FDA 1993 Form FDA 1994 Form FDA 1995 Form FDA 1996 Form FDA 1997 -

Certificate/Transmittal for an Application (21 CFR 1210.23)
Application for Permit to Ship or Transport Milk and /or Cream into the
United States (21 CFR 1210.20)
Report of Tuberculin Tests of Cattle (21 CFR 1210.13)
Report of Physical Examination of Cows (21 CFR 1210.12)
Dairy Farm Sanitary Report (21 CFR 1210.11)
Score Card for Sanitary Inspection of Milk Plants (21 CFR 1210.14)

2. Purpose and Use of the Information Collection
The information is 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 and Burden Reduction
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 our regulations is acceptable.
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We estimate that about twenty-five percent (25%) of the reports will be submitted electronically in
the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
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, duplication by other Federal agencies is unlikely.
5. Impact on Small Businesses or Other Small Entities
We estimate that fifty percent (50%) of respondents are small businesses. Small firms may also
apply for a permit. The forms to be completed are simple, consisting of check boxes and short
narrative responses. We will assist small firms with these requirements thus minimizing the burden.
We aid small businesses in complying with our requirements through our Regional Small Business
Representatives and through our scientific and administrative staffs. We have provided a Small
Business Guide on our website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. Under FIMA and our implementing regulations, submission of
the required information and approval of the information after our review is a condition precedent to
the issuance of a permit. Therefore, if the information is not submitted, we 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. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in the
Federal Register of March 25, 2015 (80 FR 15794). No comments were received in response to the
notice.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.

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10. Assurance of Confidentiality Provided to Respondents
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. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: The respondents include foreign dairy farms and plants engaged in
transporting milk and/or cream into the United States. Respondents are from the private sector (forprofit businesses).
12a. Annualized Hour Burden Estimate
We Estimate he burden of this collection of information as follows:
Table 1.—Estimated Annual Reporting Burden1
21 CFR
Section

Form No.

No. of
Respondents

1210.11

FDA 1996/Sanitary
inspection of dairy farms
FDA 1995/Physical
examination of cows
FDA 1994/Tuberculin
test
FDA 1997/Sanitary
inspections of plants
FDA 1993/Application
for permit
FDA 1815/Permits
granted on certificates

1210.12
1210.13
1210.14
1210.20
1210.23

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No. of
Responses
per
Respondent
200

Total
Annual
Responses
400

1

1

1

1

1

1

2

1

2

2

1

2

2

1

2

Average
Burden
per
Response
1.5

Total
Hour
s

0.5
(30 mins)
0.5
(30 mins)
2.0

0.5

0.5
(30 mins)
0.5
(30 mins)

Total
1

600

0.5
4.0
1.0
1.0
607.0

There are no capital costs or operating and maintenance costs associated with this collection of information.

12a. Annualized Hour Burden Estimate
Table 2 – Estimated Annual Recordkeeping Burden1
21 CFR
Section

No. of
Recordkeepers

No. of Records per
Recordkeeper

1210.15

2

1

1

Total Annual
Records
2

Average Burden
per Recordkeeping
0.05

Total
Hours
0.10

There are no capital costs or operating and maintenance costs associated with this collection of information.

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The estimated number of respondents and hours per response are based on our experience with the
import milk permit program and the average number of import milk permit holders over the past
three years. We estimate that two respondents will submit approximately 200 Form FDA 1996
reports annually, for a total of 400 responses. FDA estimates the reporting burden to be 1.5 hours
per response, for a total burden of 600 hours.
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.
Because we have not received any Forms FDA 1994 and 1995 in the last three years, the agency
estimates no more than one will be submitted annually. We estimate the reporting burden for each
to be 0.5 hours per response for a total burden reporting burden of 0.5 hours each.
We estimate that two respondents will submit one Form FDA 1997 report annually, for a total of
two responses. We estimate the reporting burden to be 2.0 hours per response, for a total burden of
4 hours. We estimate that two respondents will submit one Form FDA 1993 report annually, for a
total of two responses. We estimate the reporting burden to be 0.5 hours per response, for a total
burden of 1 hour. We estimate that two respondents will submit one Form FDA 1815 report
annually, for a total of two responses. We estimate the reporting burden to be 0.5 hours per
response, for a total burden of 1 hour.
With regard to records maintenance, we estimate that approximately two recordkeepers will spend
0.05 hours annually maintaining the additional pasteurization records required by § 1210.15, for a
total of 0.10 hours annually.
No burden has been estimated for the tagging requirement in § 1210.22 because the information on
the tag is either supplied by us (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 subject to
review by the Office of Management and Budget under the Paperwork Reduction Act. 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 business activities.
12b. Annualized Cost Burden Estimate
We estimate the annualized burden hour cost to a respondent for completion and submission of the
required forms to be approximately $56,354. FDA estimates a respondent’s average wage to be that
of a Federal government employee at the GS-13/Step-3 rate for the Washington-Baltimore locality
pay area for the year 2015, which makes the annual wage cost for completion and submission
approximately $28,176.94 (607 hours x $46.42 per hour). To account for overhead, this cost is
increased by 100 percent, making the total estimated burden hour cost to the respondent $56,353.88,
rounded to $56,354.
13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers
There are no capital, start-up, operating, or maintenance costs associated with this collection. Many
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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 respondents also comply
with many of ours, mitigating cost burden. This applies particularly to tuberculosis testing and
physical examination of herds, which are required by the government of New Zealand.
14. Annualized Cost to Federal Government
We estimate that the staffing burden 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 rate of $46.42 per hour, the GS13/Step-3 rate for the Washington-Baltimore locality pay area for the year 2015 (160 hours x
$46.42 per hour = $7,427.20). 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 $46.42 per hour, the GS-13/Step-3 rate for the Washington-Baltimore locality pay
area for the year 2015 (16 hours x $46.42 per hour = $742.72). Thus, the total cost is $8,169.92
($7,427.20 + $742.72). To account for overhead, this cost is increased by 100 percent, making the
total estimated annual cost to the Federal Government $16,339.84, rounded to $16,340.
15. Explanation for Program Changes or Adjustments
The hour burden is unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
The information obtained from this data collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
No approval is requested.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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