0155 Ss 20200123

SUPPORTING STATEMENT
IRRADIATION PHYTOSANITARY TREATMENT OF
IMPORTED FRUITS AND VEGETABLES
OMB NO. 0579-0155
January 2020
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) is responsible for preventing plant disease
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.
Under the Plant Protection Act (7 U.S.C. 7701 – et seq), the Animal and Plant Health Inspection
Service (APHIS) is authorized, among other things, to regulate the importation of plants, plant
products, and other articles to prevent the introduction of plant pests into the United States.
The regulations in 7 CFR § 319 include specific requirements for the importation of fruits and
vegetables. For example, fruits and vegetables from certain regions of the world must be treated
for inspect pests in order to be eligible for entry into the United States.
The regulations in 7 CFR § 305 provide for the use of irradiation as a phytosanitary treatment for
fruits and vegetables imported into the United States. The irradiation treatment provides
protection against all insect pests including fruit flies, the mango seed weevil, and others. It may
be used as an alternative to other approved treatments for these pests in fruits and vegetables,
such as fumigation, cold treatment, heat treatment, and other techniques.
APHIS is asking the Office of Management and Budget (OMB) to approve, for an additional 3
years, its use of these information collection activities, associated with this program, to employ
irradiation as an effective phytosanitary treatment for importing fresh fruit and vegetables into
the United States.
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 collection activities associated with this program, to
employ irradiation as an effective phytosanitary treatment for importing fresh fruit and
vegetables into the United States.

Compliance Agreement PPQ Form 519 (Business-Importer/Facility Operator)
7 CFR 305.9(c)(1)(i)
If irradiation treatment occurs in the United States (as opposed to being performed in a foreign
country prior to being exported to the United States), both the importer and the operator of the
irradiation facility must sign compliance agreements with APHIS. In the facility compliance
agreement, the facility operator must agree to comply with any additional requirements found
necessary by APHIS to prevent the escape, prior to irradiation, of any pests of concern that may
be associated with the articles to be irradiated. The importer must sign a compliance agreement
with APHIS and by signing this document, the importer agrees to comply with additional
requirements to prevent the escape of plant pests from the commodities to be irradiated during
their transit from the port of first arrival to the irradiation facility, and also during the time the
commodities are in the irradiation facility.
Compliance Agreement with Irradiation Facilities Outside the United States PPQ Form
519 (Foreign Government) - 7 CFR 305.9(c)(1)(ii)
If irradiation of imported articles is conducted outside the United States, the operator of the
irradiation facility must sign a compliance agreement with APHIS and the national plant
protection organization (NPPO) of the country in which the facility is located. In this agreement,
the facility operator must agree to comply with the requirements of this section, and the NPPO of
the country in which the facility is located must agree to monitor that compliance and to inform
the Administrator of any noncompliance.
Dosimetry Systems at the Irradiation Facility (Business-Importer/Facility Operator)
7 CFR 305.9(j)
APHIS will require the owner/operator of an approved irradiation facility to have in place a
dosimetry system (the system that is used for determining the dose being absorbed by fruits and
vegetables during the irradiation process).
There are requirements for certification of the facilities, treatment monitoring, pallet security,
and recordkeeping for irradiation at all facilities, and packaging and labeling requirements for
articles irradiated before arrival in the United States. Irradiation facilities must use an approved
dosimetry system during treatment and keep records to verify effective irradiation. For
irradiation after arrival, compliance agreements will impose requirements on the transit from
ports to irradiation facilities, to ensure all shipments requiring irradiation are delivered to the
facility and are not rerouted for sale prior to treatment.
This system will consist of dosimeters, measurement instruments, reference standards, and
procedures. The information obtained via the dosimetry system must be recorded by facility
personnel and maintained on file so that APHIS inspectors can review it.
Request for Approval of Dosimetry Device (Business-Importer/Facility Operator)
7 CFR 305.9(j)
The owner/operator of an approved irradiation facility must have the facility’s dosimetry devices
approved by APHIS. The dosimetry systems is employed during calibration or on a routine
bases as part of quality assurance to meet USDA is required entry inspections. The information

collected assists APHIS in certifying that the facility has met the desired minimum dose of
irradiation treatment.
APHIS will approve these devices after determining that they reliably indicate an absorbed dose
in the ranges required, and that they can be read by an inspector under normal working
conditions. Requests for approval of these devices must be made to APHIS in writing.
30-Day Notification (Business-Importer/Facility Operator and Foreign Government)
7 CFR 305.9(e)(2)
Facilities that carry out irradiation operations must notify the Director of Preclearance of
scheduled operations at least 30 days before operations commence, except where otherwise
provided in the facility preclearance work plan.
Labeling/Packaging (Business-Importer/Facility Operator) - 7 CFR 305.9(f)
Pallet loads of treated fruit and vegetables must be marked (either by irradiation facility
personnel or by the shipper) with treatment lot numbers, packing and treatment facility
identification and locations, and the dates of packing and treatment.
This information will allow APHIS inspectors to identify the treatment lots and, if necessary,
trace them back to the packing and treatment facilities from which they originated. Without this
information, APHIS would be severely hampered in their efforts to conduct a traceback
investigation. It should be noted that packing and treatment facilities already include much of
this labeling information on their treatment lots.
Recordkeeping (Business-Importer/Facility Operator) - 7 CFR 305.9(k)(1)
Approved irradiation facilities must maintain the treatment records for a period of time that
exceeds the shelf life of the irradiated product by 1 year. These records must include (among
other things) the lot identification, ionizing energy source, source calibration, dosimetry data,
dose distribution in the product, and the date of irradiation. These detailed records area
necessary to ensure system integrity for irradiation treatments and for successful enforcement of
APHIS regulations.
Request for Certification and Inspection of Facility (Business) - 7 CFR 305.9(k)(1)
Anyone requesting approval of an irradiation treatment facility (and treatment protocol) must
submit their request to APHIS in writing.
Irradiation Treatment Framework Equivalency Work Plan - (Foreign Government)
7 CFR 305.9(e)(1)
The plant protection service of a country from which articles are to be imported into the United
States in accordance with this section must sign a framework equivalency work plan with
APHIS. In this plan, both the foreign plant protection service and APHIS will specify the
following items for their respective countries: (i) Citations for any requirements that apply to the
importation of irradiated articles; (ii) The type and amount of inspection, monitoring, or other
activities that will be required in connection with allowing the importation of irradiated articles
into that country; and (iii) Any other conditions that must be met to allow the importation of
irradiated articles into that country.

Facility Preclearance Work Plan (Foreign Government) - 7 CFR 305.9(e)(2)(i)
Prior to commencing importation into the United States of articles treated at a foreign irradiation
facility, APHIS and the plant protection service of the country from which articles are to be
imported must jointly develop a preclearance work plan that details the activities that APHIS and
the foreign plant protection service will carry out in connection with each irradiation facility to
verify the facility's compliance with the requirements of this section. Typical activities to be
described in this work plan may include frequency of visits to the facility by APHIS and foreign
plant protection inspectors, methods for reviewing facility records, and methods for verifying
that facilities are in compliance with the requirements for separation of articles, packaging,
labeling, and other requirements of this section. This facility preclearance work plan will be
reviewed and renewed by APHIS and the foreign plant protection service on an annual basis.
Trust Fund Agreement (Foreign Government) - 7 CFR 305.9(e)(2)(ii)
Irradiated articles may be imported into the United States in accordance with this section only if
the plant protection service of the country in which the irradiation facility is located has entered
into a trust fund agreement with APHIS. That agreement requires the plant protection service to
pay, in advance of each shipping season, all costs that APHIS estimates it will incur in providing
inspection and treatment monitoring services at the irradiation facility during that shipping
season. Those costs include administrative expenses and all salaries (including overtime and the
Federal share of employee benefits), travel expenses (including per diem expenses), and other
incidental expenses incurred by APHIS in performing these services. The agreement will
describe the general nature and scope of APHIS services provided at irradiation facilities covered
by the agreement, such as whether APHIS inspectors will monitor operations continuously or
intermittently, and will generally describe the extent of inspections APHIS will perform on
articles prior to and after irradiation. The agreement requires the plant protection service to
deposit a certified or cashier's check with APHIS for the amount of those costs, as estimated by
APHIS. If the deposit is not sufficient to meet all costs incurred by APHIS, the agreement further
requires the plant protection service to deposit with APHIS a certified or cashier's check for the
amount of the remaining costs, as determined by APHIS, before any more articles irradiated in
that country may be imported into the United States. After a final audit at the conclusion of each
shipping season, any overpayment of funds would be returned to the plant protection service or
held on account until needed, at the option of the plant protection service.
Phytosanitary Certificate (Business-Importer/Facility Operator and Foreign Government)
7 CFR 305.9(h)
For each shipment treated in an irradiation facility outside the United States, a phytosanitary
certificate, with the treatment section completed and issued by the national plant protection
organization, must accompany the shipment.
Denial and Withdrawal of Certification (Business) - 7 CFR 305.9(m)
The Administrator will withdraw the certification of any irradiation treatment facility upon
written request from the irradiation processor. The Administrator will deny or withdraw
certification of an irradiation treatment facility when any provision of this section is not met.
Before withdrawing or denying certification, the Administrator will inform the irradiation
processor in writing of the reasons for the proposed action and provide the irradiation processor

with an opportunity to respond. The Administrator will give the irradiation processor an
opportunity for a hearing regarding any dispute of a material fact, in accordance with rules of
practice that will be adopted for the proceeding. However, the Administrator will suspend
certification pending final determination in the proceeding if he or she determines that
suspension is necessary to prevent the spread of any dangerous insect. The suspension will be
effective upon oral or written notification, whichever is earlier, to the irradiation processor. In
the event of oral notification, written confirmation will be given to the irradiation processor
within 10 days of the oral notification. The suspension will continue in effect pending
completion of the proceeding and any judicial review of the proceeding.
Limited Permit PPQ 530 (Business) 7 CFR 305.9(a)(2)
For articles that are moved interstate from areas quarantined for fruit flies, irradiation facilities
may be located either within or outside of the quarantined area. If the articles are treated outside
the quarantined area, they must be accompanied to the facility by a limited permit issued in
accordance with §301.32-5(b) of this chapter and must be moved in accordance with any
safeguards determined to be appropriate by APHIS.
A paper document (four parts) used to authorize the movement of regulated articles to a specified
destination and allows further inspection at destination. The decision to perform further
inspections will be made by the State plant protection official in the host State. The decision to
inspect is prompted by date of issuance and results of inspection prior to transport.
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 considerations of using information technology
to reduce burden.
A database or spreadsheet can be utilized by respondents to maintain records and for APHIS
review. Letters for facility approval and 30-day notification may be submitted electronically.
APHIS has no control or influence over when foreign countries will automate their phytosanitary
certificate. However, APHIS is involved with the Government-wide utilization of the
International Trade Data System (ITDS) via the Automated Commercial Environment (ACE) to
improve business operations and further Agency missions. This will allow respondents to submit
the data required by U.S. Customs and Border Protection and its Partner Government Agencies
(PGAs), through a Single Window concept. APHIS is also establishing a system known as eFile for CARPOL (Certification, Accreditation, Registration, Permitting, and Other Licensing)
activities. This new system will strive to automate some of these information collection
activities. The system is still being developed and business processes continue to be identified
and mapped.
The Compliance Agreement PPQ Form 519 is available electronically on the APHIS website
https://www.aphis.usda.gov/library/forms/pdf/ppq519.pdf.

The Limited Permit PPQ Form 530 are accountable forms that must be issued by a PPQ
employee, or a person under Compliance Agreement with PPQ. Strict control is needed for the
issuance of these forms, as they allow the movement of regulated products that are subject to
restrictions, and they can only be issued after an inspection proves that the shipment meets the
requirements for movement. Movement may also require a treatment, which has to be
determined by an inspector. The form must accompany the shipment throughout transport from
the inspection until destination.
4. Describe efforts to identify duplication. Show specifically why any similar information
already available cannot be used or modified for use of the purpose described in item 2
above.
The information APHIS collects is exclusive to its mission to prevent the introduction of plant
pests and plant diseases into the United States. The information is not available from any other
source.
5. If the collection of information impacts small businesses or other small entities, describe
any methods used to minimize burden.
The information collected is the absolute minimum needed to ensure that fruits and vegetables
have been properly irradiated and thus pose no threat of introducing or spread of destructive
insect pests into the United States. APHIS has determined that 80 percent of the business
respondents are small entities.
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.
If the information was collected less frequently or not collected at all, APHIS would have no
practical way of determining that any given commodity had actually been irradiated. Irradiation
leaves no residue and usually causes no discernible change to the commodity’s color or texture.
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;

30-Day Notification - Facilities that carry out irradiation operations must notify the Director of
Preclearance of scheduled operations at least 30 days before operations commence, except where
otherwise provided in the facility preclearance work plan.
•

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.

There are no other special circumstances associated with this information collection. This
information collection is conducted in a manner consistent with the guidelines established 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 consulted the following individuals by email and phone to discuss their opinions on the
data collection efforts and the availability of data for the information collection. Overall they did
not hold a positive nor a negative viewpoint on data reporting, but felt it was the accordant
process. From a general standpoint, the respondents are familiar with the numerous and lengthy
forms and requirements for irradiation facilities and treatment of articles, but understand the
necessity of the documents and inspections.
Walter M. Rosebrough, Jr., President
Steris Corporation
5960 Heisley Road
Mentor, OH 44060
440-354-2600

Joshua Kress
Nursery Program Supervisor
California Dept of Food & Agriculture
Plant Health and Pest Prevention Services
Pest Exclusion Branch
1220 N Street, Room A372
Sacramento, California 95814
916-653-1440
Marisol Balisidias
Division of Plant Industry
Hawaii Department of Agriculture
1428 South King Street
Honolulu, HI 96814-2512
808-973-9560
On Wednesday, August 14, 2019, pages 40383 - 40384, Volume 84, No. 157, 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 from the public were received.
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 statute, 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 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. Burden estimates were developed by using historical data through
discussions with Program Specialist.
•

Provide estimates of annualized cost to respondents for the hour of burden for
collections of information, identifying and using appropriate wage rate categories.

APHIS estimates the total annualized cost to these respondents to be $32,714.22. APHIS arrived
at this figure by multiplying the total burden hours (803 hours) by the estimated average hourly
wage plus fringe benefits of the above respondents ($27.83 + 12.91 = 40.74).
803 X $40.74 = $32,714.22
APHIS determined the hourly rate derived from the U.S. Department of Labor, Bureau of Labor
Statistics May 2018 – Occupational Employment and Wages in the United States. See:
http://www.bls.gov/news/release/ocwage.t03.htm.
Benefits = wages X 46.4% (27.83 X 0.464 = $12.91)
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 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.
APHIS does not believe that complying with the dosimetry requirements will cause irradiation
facilities to incur any significant additional capital investment costs. Dosimetry systems are a
basic and unavoidable business cost for irradiation facilities, for two reasons. First, they are the
essential process-monitoring and quality control tool for irradiation; they are the means by which
facilities ensure that they are delivering their product (a specified radiation dose). Second,
dosimetry at irradiation facilities are required by a wide range of national and international
regulations quite apart from the APHIS rule, so facilities would have to invest in these systems
even `if the APHIS rule did not exist. The APHIS dosimetry requirements merely require that
the dosimetry systems the facility must have in any event be used to document that the doses
required by the APHIS rule are delivered.

APHIS decided not to require use of radiation sensitive indicators (RSI’s) (which included
replacing dosimeters in each box irradiated, which will minimize any impact or burden that the
industry would have.
14. Provide estimates of annualized cost 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 for the Federal Government is $57,619.44. (See APHIS Form 79).
15. Explain the reasons for any program changes or adjustments reported in Items 13 or
14 of the OMB 83-1.
Program
Program
Change Due to
Requested Change Due
Agency
to New Statute
Discretion
Annual
Number of
Responses

Change Due to
Adjustment in
Agency
Estimate

Change Due to
Potential
Violation of the
PRA

Previously
Approved

20,771

0

+23

-19,686

0

40,434

Annual Time
Burden (Hr)

803

0

+14

+442

0

347

Annual Cost
Burden ($)

0

0

0

0

0

0

There is a program change increase of +23 responses resulting in an increase of +14 burden
hours. This increase is due to APHIS is now accounting for the compliance agreement that is
signed with the NPPO foreign government respondents and limited permits issued from which
were not included in the previous information collection.
There is an adjustment decrease of -20 respondent and -19,686 responses, however, there is an
increase of +442 burden hours. The increase is a result of a more accurate count of the number of
irradiation facilities in compliance with APHIS and a more accurate count of burden activities.
16. For collections of information whose results are planned to be published, outline plans
for tabulation and publication.
APHIS has no plans to publish the information collected in connection with this program.

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.
The PPQ 519 and the PPQ 530 are used in multiple collections; therefore, it is not practical to
include an OMB expiration date because of the various expiration dates for each collection.
APHIS is seeking approval to not display the OMB expiration date on these forms; however,
APHIS is considering these forms into common forms.
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 identified in the Act.
B. Collections of Information Employing Statistical Methods.
Statistical methods are not used in this information collection.