2017 Ss 0130

Supporting Statement
Export Certification: Accreditation of Nongovernment Facilities
OMB No. 0579-0130
August 2017

A. JUSTIFICATION
1. Explain the circumstances that make the collection of information necessary. Identify any
legal or administrative requirements that necessitate the collection.
The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service
(APHIS), is responsible for preventing plant diseases or insect pests from entering the United
States, preventing the spread of pests and noxious weeds not widely distributed in the United States,
and eradicating those imported pests when eradication is feasible. The Plant Protection Act
authorizes the Department to carry out this mission.
In addition to its mission, APHIS also provides export certification services to ensure other
countries that the plants and plant products they are receiving from the United States are free of
plant diseases and insect pests.
The export certification regulations contained in Title 7 of the Code of Federal Regulations (CFR)
Part 353, describe the procedures for obtaining certification for plants and plant products offered for
export or re-export.
APHIS’ regulations do not require that APHIS engage in export certification activities; however,
APHIS performs this work as a service to exporters who are shipping plants or plant products to
countries that require phytosanitary certification as a condition of entry.
Currently, only tests conducted by public laboratories and only phytosanitary inspections carried out
by Federal, State, or county inspectors or agents may be used as the basis for issuing Federal
phytosanitary certificates. This service allows additional qualified personnel and laboratory
facilities to conduct export certification activities, thus relieving some of the demands placed upon
APHIS’ limited resources, by increasingly stringent foreign import requirements, and dwindling
Federal and State budgets.
This accreditation program necessitates the use of a number of information collection activities
APHIS must engage in to ensure that the individuals and laboratory facilities participating in its
export certification program have the necessary qualifications to do so.
APHIS is asking OMB to approve, for 3 additional years, its use of these information collection
activities, associated with this program.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a
new collection, indicate the actual use the agency has made of the information received from
the current collection.
APHIS uses the following information activities to ensure that individuals and laboratory facilities
participating in the export certification program have the necessary qualifications to do so.
Application for Accreditation (State and Business) - 7 CFR 353.8 (b)(2)
The operator/owner of a non-government facility seeking accreditation to conduct laboratory testing
or phytosanitary inspection must submit an application to APHIS. The application must contain the
legal name and full address of the facility; the name, address, telephone and fax number of the
facility’s operator; a description of the facility; and a description of the specific laboratory testing or
phytosanitary inspection services for which the facility is seeking accreditation.
Agreement for Fulfilling Accreditation Procedures (Business and State) - 7 CFR 353.8 (b)(3)
Before APHIS assesses a non-government facility to determine if it meets its accreditation
requirements, the operator/owner of the facility must sign an agreement with APHIS promising to
supply any information needed for the evaluation of the facility, to pay the fees APHIS charges to
conduct its assessment, and to accept the charges that will result from subsequent accreditation
maintenance.
Documentation of Equipment (Business and State) - 7 CFR 353.8 (b)(3)(iii)
The equipment used in the non-government facility (microscopes, computers, etc.) must be
calibrated and monitored so that it conforms to APHIS’ standards. This calibration and monitoring
must be documented by facility personnel.
Quality Manual or Equivalent Documentation (Business and State) - 7 CFR 353.8 (b)(3)(iii)
The facility must have a quality manual or equivalent documentation that describes the system in
place at the facility for the conduct of the laboratory testing or phytosanitary inspection services for
which the facility seeks accreditation. The manual must be available to, and in use by, the facility
personnel who perform the services. The methods and procedures followed by the facility to
conduct the laboratory testing or phytosanitary inspection services for which it seeks accreditation
must be commensurate with those identified in the accreditation standards and must be consistent
with or equivalent to recognized international standards for such testing or inspection.
Identity of Personnel and Subcontractor’s Qualifications (Business and State)
7 CFR 353.8(b)(3)(iv)
The personnel employed at the non-government facility must be identified and must possess the
training, education, or experience necessary to perform laboratory testing and phytosanitary
inspection services. The operator/owner of the facility is responsible for acquiring and maintaining
documentation concerning the training, education, and experience of facility personnel.
If the non-government facility uses a subcontractor to perform some of its testing and inspection
services, the qualifications of this subcontractor must be documented and made available to APHIS
upon request. The facility operator/owner is responsible for acquiring and maintaining this
documentation.

Notification of Changes in Personnel (Business) - 7 CFR 353.8(b)(4)(v)
The facility operator/owner must notify APHIS whenever the facility undergoes any changes in
personnel. This notification may be written, communicated via telephone, or via any other means
of communication convenient to the facility’s operator/owner.
Report Changes in Location, Ownership, Physical Plant Equipment or Other Conditions
(Business) - 7 CFR 353.8(b)(4)(vi)
The facility operator/owner must notify APHIS if the facility moves its operations to a new
location, undergoes an ownership change, replaces equipment, or experiences any other change in
conditions that existed at the time the facility received accreditation. This notification may be
written, communicated via telephone, or via any other means of communication convenient to the
facility’s operator/owner.
Denial-Written Appeal and Request for Hearing (Business) - 7 CFR 353.8 (a)(2)(i)
The Administrator may deny accreditation to, or withdraw the accreditation of, any non-government
facility to conduct laboratory testing or phytosanitary inspection services upon a determination that
the facility does not meet the criteria for accreditation or maintenance of accreditation. In the case
of a denial, the operator of the facility will be informed of the reasons for the denial and may appeal
the decision in writing to the Administrator within 10 days after receiving notification of the denial.
The Administrator will grant or deny the appeal in writing as promptly as circumstances permit,
stating the reason for his/her decision. If there is a conflict as to any material fact, a hearing will be
held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the
Administrator.
Withdrawal-Appeal and Request for Hearing (Business) - 7 CFR 353.8 (a)(2)(ii)
In the case of withdrawal, before such action is taken, the operator of the facility will be informed
of the reasons for the proposed withdrawal. The operator of the facility may appeal the proposed
withdrawal in writing to the Administrator within 10 days after being informed of the reasons for
the proposed withdrawal. The appeal must include all of the facts and reasons upon which the
person relies to show that the reasons for the proposed withdrawal are incorrect or do not support
the withdrawal of the accreditation of the facility. The Administrator will grant or deny the appeal
in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is
a conflict as to any material fact, a hearing will be held to resolve the conflict.
Written Request to Eliminate Accredited Status (Business) - 7 CFR 353.8 (a)(3)
The Administrator will withdraw the accreditation of a non-government facility if the operator of
the facility informs APHIS in writing that the facility wishes to terminate its accredited status.
Documentation of Corrective Action (Business) - 7 CFR 353.8 (a)(4)
A non-government facility whose accreditation has been denied or withdrawn may reapply for
accreditation using the application procedures. If the facility's accreditation was denied or
withdrawn, the facility operator must include with the application written documentation specifying
what actions have been taken to correct the conditions that led to the denial or withdrawal of
accreditation.

3. Describe whether, and to what extent, the collection of information involves the use of
automated, electronic, mechanical, or other forms of information technology, e.g., permitting
electronic submission of responses, and the basis for the decision for adopting this means of
collection. Also describe any consideration of using information technology to reduce burden.
The Application for Accreditation and Agreement for Fulfilling Accreditation Procedures are
electronic and posted at: www.seedhealth.org.
Documentation of equipment, quality manual or equivalent documentation, identity of personnel
and subcontractor’s qualifications, notification of changes in personnel, and report changes in
location and ownership documents are prepared by the applicant and APHIS has no control over the
automation of this documentation.

4. Describe efforts to identify duplication. Show specifically why any similar information
already available cannot be used or modified for use for the purpose described in item 2
above.
APHIS is the only Federal Agency responsible for the establishment of a program which nongovernment facilities can become accredited to perform specific lab testing or phytosanitary
inspections.

5. If the collection of information impacts small businesses or other small entities, describe
any methods used to minimize burden.
APHIS has determined there are no small entities involved with this information collection.

6. Describe the consequences to Federal program or policy activities if the collection is not
conducted or is conducted less frequently, as well as any technical or legal obstacles to
reducing burden.
This information collection activity is the minimum needed to ensure that non-government facilities
have the necessary resources to conduct export certification activities on APHIS’ behalf. If these
activities are not conducted properly, APHIS’ export certification program will be compromised,
causing a disruption in plant and plant product exports that could prove financially damaging to
United States exporters.

7. Explain any special circumstances that require the collection to be conducted in a manner
inconsistent with the general information collection guidelines in 5 CFR 1320.5.
•

requiring respondents to report information to the agency more often than quarterly;

•

requiring respondents to prepare a written response to a collection of information in
fewer than 30 days after receipt of it;

Denial-Written Appeal and Request for Hearing - If an Administrator denys accreditation to any
non-government facility, the operator of the facility will be informed of the reasons for the denial
and may appeal the decision in writing to the Administrator within 10 days after receiving
notification of the denial.
•

requiring respondents to submit more than an original and two copies of any
document;

•

requiring respondents to retain records, other than health, medical, government
contract, grant-in-aid, or tax records for more than three years;

•

in connection with a statistical survey, that is not designed to produce valid and
reliable results that can be generalized to the universe of study;
requiring the use of a statistical data classi­fication that has not been reviewed and
approved by OMB;

•
•

that includes a pledge of confidentiality that is not supported by authority established
in statute or regulation, that is not supported by disclosure and data security policies
that are consistent with the pledge, or which unnecessarily impedes sharing of data
with other agencies for compatible confidential use; or

•

requiring respondents to submit proprietary trade secret, or other confidential
information unless the agency can demonstrate that it has instituted procedures to
protect the information's confidentiality to the extent permitted by law.

No other special circumstances exist that would require this collection to be conducted in a manner
inconsistent with the general information collection guidelines in 5 CFR 1320.5.

8. Describe efforts to consult with persons outside the agency to obtain their views on the
availability of data, frequency of collection, the clarity of instructions and recordkeeping,
disclosure, or reporting form, and on the data elements to be recorded, disclosed, or reported.
If applicable, provide a copy and identify the date and page number of publication in the
Federal Register of the agency’s notice, soliciting comments on the information collection
prior to submission to OMB.
APHIS recently consulted with the following individuals regarding this program:
Alan J Galbreth, Chief Executive Officer
Indiana Crop Improvement Association.
7700 Stockwell Road
Lafayette, IN 47909
Phone: 765-523-2535

Charles Block, Seed Health Coordinator
Iowa State University Seed Science Center
2115 Osborn Dr
Ames, IA 50011
Phone: 515-294-0551
Gary Munkvold
Professor, Department of Plant Pathology & Microbiology Chair
Iowa State University Seed Science Center
2115 Osborn Dr
Ames, IA 50011
Phone: 515-294-7560
Dr. Scott Heucelin
DuPont Pioneer
7300 NW 62nd Avenue P.O. Box 1004
Johnston, IA 50131-1004
Phone: 515-535-2288
On Friday, June 16, 2017, pages 27678-27679, APHIS published in the Federal Register, a 60-day
notice seeking public comments on its plans to request a 3-year renewal of this collection of
information. No comments were received from the public.

9. Explain any decision to provide any payment or gift to respondents, other than
reenumeration of contractors or grantees.
This information collection activity involves no payments or gifts to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the
assurance in stature, regulation, or agency policy.
No additional assurance of confidentiality is provided with this information collection. Any and all
information obtained in this collection shall not be disclosed except in accordance with
5 U.S.C. 552a.

11. Provide additional justification for any questions of a sensitive nature, such as sexual
behavior and attitudes, religious beliefs, and others that are considered private. This
justification should include the reasons why the agency considers the questions necessary, the
specific uses to be made of the information, the explanation to be given to persons from whom
the information is requested, and any steps to be taken to obtain their consent.
This information collection activity asks no questions of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information. Indicate the
number of respondents, frequency of response, annual hour burden, and an explanation of
how the burden was estimated.
. Indicate the number of respondents, frequency of response, annual hour burden, and an
explanation of how the burden was estimated. If this request for approval covers more than
one form, provide separate hour burden estimates for each form and aggregate the hour
burdens in Item 13 of OMB Form 83-I.
See APHIS Form 71 for hour burden estimates.
. Provide estimates of the annualized cost to respondents for the hour burdens for collections
of information, identifying and using appropriate wage rate categories.
The estimated annualized cost to respondents was determined by multiplying the total number of
burden hours times the estimated hourly wage. APHIS estimates that the average hourly wage is
$42.12. (209 burden hours X $42.12 estimated hourly wage = $9,012.08)
The estimated hourly rate of $43.12 was derived from the U.S. Department of Labor, Bureau of
Labor Statistics May 2016 Report - Occupational Employment and Wages in the United States. See
http://www.bls.gov/news.release/pdf/ocwage.pdf.

13. Provide estimates of the total annual cost burden to respondents or recordkeepers
resulting from the collection of information, (do not include the cost of any hour burden
shown in items 12 and 14). The cost estimates should be split into two components: (a) a total
capital and start-up cost component annualized over its expected useful life; and (b) a total
operation and maintenance and purchase of services component.
There is zero annual cost burden associated with capital and start-up, operation and maintenance,
and purchase of services in connection with this program. However, there are fee assosicated with
obtaining an accreditation. There is a $1,000 non-refundable deposit required by USDA-APHIS
with the initial application. Accreditation fees for Options 1 and 2 are based on a sliding scale that
accounts for the number of seed health tests, the number of crops for Phytosanitary Inspection, and
the number of sites to be accredited within the organization. A minimum fee of $3,000 is applied
for each option, but the fee is reduced to $2000 for entities that apply for both options, 1 and 2. Flat
fees of $1,000 are applied for Options 3 and 4. Additional costs are covered by the entity for auditor
fees and travel expenses.
There are also maintence fees assosiated with the accrediation. An annual fee of 16.5 percent of the
initial accreditation fee will be applied to cover annual reports and proficiency tests for accredited
entities that are required every 2 years. USDA-APHIS requires that accreditation certificates be
renewed every 3 years. Accredited entities must complete a new application form and submit it with
a non-refundable processing fee of $1,000.

14. Provide estimates of annualized cost to the Federal government. Provide a description of
the method used to estimate cost and any other expense that would not have been incurred
without this collection of information.
The estimated cost to the Federal Government is $10,536.74. (See APHIS Form 79.)

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14
of the OMB Form 83-I.
Program
Program
Change Due Change Due to
Change Due Change Due to to Adjustment
Potential
Requested
to New
Agency
in Agency
Violation of the
Statute
Discretion
Estimate
PRA
Annual Number of
Responses

Previously
Approved

54

0

-4

+1

0

57

Annual Time Burden
(Hr)

209

0

-1

+11

0

199

Annual Cost Burden
($)

0

0

0

0

0

0

Program Change: There is a program change of - 4 responses and -1 burden hour due to the
elimination of buden for Notification of Change in Personnel (State) which was removed from this
information collection.
Adjustment: There is an adjustment of +1 response and +11 burden hours. This increase is due to
the increase in time to complete the Application of Accredidation (which went from .17 to 2 hours),
and also the addition of an entry for burden for the Application for Accredidation (business) which
was inadvertently omitted in the last renewal package.but
Entry Errors in the Previous Renewal: (1) The burden entry for Report Changes in Location,
Ownership, Physical Plant Equipment or Other Countries was show as burden for States in the last
renewal, when it actually should have been burden on Businesses, which has been adjusted in this
renewal. (2) The burden entry for Documentation of Corrective Action was shown as burden for
States in the last renewal, when it actually should have been burden on Businesses, and that change
has been made also. (3) The burden entries for Quality Manual or Equivalent Documentation
(Businesses and States) were inadvertently switched in the last renewal, and now the burden figures
shown for each entry are correct. There are 30 hours of burden for Businesses, and 1 hour of
burden for States.

16. For collections of information whose results are planned to be published, outline plans for
tabulation and publication.
APHIS has no plans to tabulate or publish the information being collected.

17. If seeking approval to not display the expiration date for OMB approval of the
information collection, explain the reasons that display would be inappropriate.
APHIS will display all expiration dates.

18. Explain each exception to the certification statement identified in the “Certification for
Paperwork Reduction Act.”
APHIS is able to certify compliance with all the provisions of the Act.

B. Collections of Information Employing Statistical Methods.
Statistical methods are not used in this information collection.