Regulations Under the Federal Import Milk Act
SUPPORTING STATEMENT
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: (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). FDA’s regulations in part 1210 (21 CFR part 1210) implement the provisions of FIMA.
We request OMB approval of 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:
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. 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
FDA regulation is acceptable.
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, there is
no likelihood of duplication by other Federal agencies.
5. Impact
on Small Businesses or Other Small Entities
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 Collecting the Information Less Frequently
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. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
None
of the requirements are inconsistent with the guidelines in 5 CFR
1320.5.
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of August 25, 2008 (73 FR
50031). No comments were received.
9. Explanation
of Any Payment or Gift to Respondents
This
information collection does not provide for payment or gifts to
respondents.
11. Justification
for Sensitive
Questions
This
information collection does not involve any questions of a sensitive
nature.
12. Estimates
of Annualized Burden Hours and Costs
FDA
estimates the burden of this collection of information as follows:
21 CFR Section |
Form No. |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
1210.11 |
FDA 1996/Sanitary inspection of dairy farms |
8 |
200 |
1,600 |
1.5 |
2,400 |
1210.12 |
FDA 1995/Physical examination of cows |
1 |
1 |
1 |
0.5 |
1 |
1210.13 |
FDA 1994/Tuberculin test |
1 |
1 |
1 |
0.5 |
1 |
1210.14 |
FDA 1997/Sanitary inspections of plants |
8 |
1 |
8 |
2.0 |
16.0 |
1210.20 |
FDA 1993/Application for permit |
8 |
1 |
8 |
0.5 |
4.0 |
1210.23 |
FDA 1815/Permits granted on certificates |
8 |
1 |
8 |
0.5 |
4.0 |
Total |
|
|
|
|
|
2,426.0 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
21 CFR Section |
No. of Recordkeepers |
Annual Frequency per Recordkeeping |
Total Annual Records |
Hours per Record |
Total Hours |
1210.15 |
8 |
1 |
8 |
0.05 |
0.40 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of respondents and hours per response are based on FDA’s experience with the import milk permit program and the average number of import milk permit holders over the past three years. FDA estimates that eight respondents will submit approximately 200 Form FDA 1996 reports annually, for a total of 1,600 responses. FDA estimates the reporting burden to be 1.5 hours per response, for a total burden of 2,400 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 FDA has not received any Forms FDA 1994 and 1995 in the last three years, the agency estimates no more than one will be submitted annually. FDA estimates the reporting burden for each to be 0.5 hours per response for a total burden reporting burden of 0.5 hours each.
FDA estimates that eight respondents will submit one Form FDA 1997 report annually, for a total of eight responses. FDA estimates the reporting burden to be 2.0 hours per response, for a total burden of 16 hours. FDA estimates that eight respondents will submit one Form FDA 1993 report annually, for a total of eight responses. FDA estimates the reporting burden to be 0.5 hours per response, for a total burden of 4 hours. FDA estimates that eight respondents will submit one Form FDA 1815 report annually, for a total of eight responses. FDA estimates the reporting burden to be 0.5 hours per response, for a total burden of 4 hours.
With regard to records maintenance, FDA estimates that approximately eight recordkeepers will spend 0.05 hours annually maintaining the additional pasteurization records required by § 1210.15, for a total of 0.40 hours 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.
Estimated Annualized Cost for the Burden Hours
FDA estimates the annualized burden hour cost to a respondent for completion and submission of the required forms to be approximately $162,136. FDA estimates a respondent’s average wage to be that of a Federal government employee at the GS-12/Step-1 rate for the Washington-Baltimore locality pay area for the year 2008, which makes the annual wage cost for completion and submission approximately $81,067.75 (2,425 hours x $33.43 per hour). To account for overhead, this cost is increased by 100 percent, making the total estimated burden hour cost to the respondent $162,135.50, rounded to $162,136.
13. Estimates
of Other Total Annual Cost Burden to Respondents and Record
Keepers
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 Federal
Government
FDA
estimates 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 $33.43/hour, the
GS-12/Step-1 rate for
the Washington-Baltimore locality pay area for the year 2008 (160
hours x $33.43 /hour
= $5,349). 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 $39.75/hour,
the GS-13/Step-1
rate for the Washington-Baltimore locality pay area for the year
2008 (16 hours x $39.75/hour = $636). Thus, the total cost is
$5,985 ($5,349 + $636). To account for overhead, this cost is
increased by 100 percent, making the total estimated annual cost to
the Federal Government $11,970.
15. Explanation
for Program Changes or Adjustments
The
one burden hour increase is due to rounding in ICRAS. The increase
of eight respondents is also due to ICRAS. The system calculated
these eight recordkeepers in the total number of respondents. These
increases are system-related and do not reflect a revision in the
agency estimate nor any program changes.
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
N/A
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Drew Perraut |
| File Modified | 2009-06-18 |
| File Created | 2009-06-18 |